calcipotriene and Psoriasis

To review the pharmacokinetics, efficacy, and safety of recently approved calcipotriene and betamethasone dipropionate (C-BD) cream.. A literature review was conducted using MEDLINE (PubMed) and ClinicalTrials.gov from 2002 to mid-May 2022.. Articles in English discussing the use of C-BD cream in the treatment of psoriasis were included.. In 2 phase I trials, there was no phototoxic or photoallergic skin reaction at irradiated C-BD cream sites at baseline, 24 hours, 48 hours, and 72 hours postirradiation. In 2 phase III trials, after 8 weeks of treatment, more subjects treated with C-BD cream achieved Physician's Global Assessment treatment success (37.4%), compared to C-BD topical suspension (TS) (22.8%,. Psoriasis has a multifactorial pathogenesis and topical treatments are considered first line. Poor adherence is a major hurdle in management; the combination of 2 separate first-line drugs may address this by decreasing the complexity of treatment regimens. A cream formulation can be preferred, and C-BD is now Food and Drug Administration (FDA) approved as one.. Newly FDA-approved C-BD cream with novel polyaphron dispersion (PAD) technology provides a safe efficacious combination therapy for mild-to-moderate psoriasis which may be preferred by some patients.

Topics: Betamethasone; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Treatment Outcome

Topics: Adult; Betamethasone; Clinical Trials, Phase III as Topic; Dermatologic Agents; Drug Combinations; Emollients; Humans; Psoriasis; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome; Venereology

Calcipotriol (calcipotriene) is a synthetic vitamin D3 derivative that is a standard treatment option for psoriasis. It is generally well tolerated with minimal side effects. Due to its ability to reduce keratinocyte proliferation and induce keratinocyte differentiation as well as its immunomodulatory effects, calcipotriol has been used to treat a variety of skin disorders such as atopic dermatitis, actinic keratoses, lichen planus, seborrheic keratoses, and vitiligo [1]. We surveyed the literature examining the use of calcipotriol for non-psoriatic dermatologic disease.

Topics: Calcitriol; Dermatitis, Atopic; Drug-Related Side Effects and Adverse Reactions; Humans; Psoriasis

Topical medications are commonly used to manage mild-to-moderate psoriasis and serve as adjunct therapies used in combination with phototherapy and systemic treatments. Fixed-dose calcipotriene (Cal) 0.005%/betamethasone dipropionate (BD) 0.064% aerosol foam is a safe, efficacious topical therapy approved for the treatment of psoriasis vulgaris in the United States and European Union. Several investigator-initiated studies (IISs) have been conducted to provide real-world evidence related to the safety, effectiveness, and therapeutic indications of Cal/BD foam and are relevant to clinicians' every-day practice. This paper summarizes the findings of the IISs around the globe published to date and presents the real-world data related to the effectiveness and clinical considerations of Cal/BD foam as a treatment for psoriasis. J Drugs Dermatol. 2023;22:9(Suppl 2):s5-14.

Topics: Aerosols; Calcitriol; Humans; Psoriasis

Tapinarof is an aromatic hydrocarbon receptor inhibitor for the treatment of adult psoriasis, and with the completion of Phase III clinical trials for this drug, it is important to understand its place among the medications used in the treatment of psoriasis for clinical application. Networks were constructed for 1% tapinarof cream with positive control (calcipotriol) and negative control (placebo). Network meta-analysis was performed using Preferred Reporting Items for Systematic Reviews and Meta-analyses (PISMA) 2015. Relevant randomized clinical trials were searched from PubMed, Cochrane Library, and National Knowledge Infrastructure (CNKI) as of February 2023. Data were analyzed using the gemtc package in R software (RStudio) to evaluate the efficacy and safety of 1% tapinarof cream in the treatment of psoriasis in adults. A total of 2408 patients were enrolled in 8 clinical studies of 1% tapinarof cream, and 6874 patients were enrolled in 14 clinial studies of calciptriol. 1% tapinarof cream was superior to placebo [OR: 8.3 (5.5, 13.0), 8.3 (5.9, 13.0), 7.3 (5.1, 11.0)] and calcipotriol in the treatment of psoriasis at 4, 8, and 12 weeks, and the incidence of adverse events was higher than that with placebo [OR: 3.3 (2.6, 4.3)] and calcipotriol, with no serious systemic adverse events. 1% tapinarof cream is a safe and effective treatment for psoriasis.

Topics: Adult; Dermatologic Agents; Emollients; Humans; Network Meta-Analysis; Psoriasis; Randomized Controlled Trials as Topic; Treatment Outcome

Plaque psoriasis is a common, chronic and relapsing inflammatory skin disease clinically characterized by erythema and scaling desquamation. As over 90% of psoriasis patients benefit from topical therapies, local treatments continue to play an eminent role in management strategies. One such topical treatment is the fixed dose combination of calcipotriol (CAL) and betamethasone dipropionate (BDP).. Pooled analysis of two different phase 3 clinical trails to compare superiority regarding efficacy, safety and quality of life (QoL) between CAL/BDP PAD-cream and CAL/BDP TS.. The data from two phase 3, multicentre, randomized, investigator-blind, active and vehicle-controlled trials enrolling patients with psoriasis were pooled and analysed. Investigational products included a CAL/BDP cream based on PAD™ Technology (PAD-cream) designed for high skin penetration and increased patient preference, an active control (marketed CAL/BDP topical suspension/gel, in the following abbreviated as CAL/BDP TS) and cream vehicle, which were applied once daily for 8 weeks.. Efficacy and safety of the novel CAL/BDP PAD-cream formulation for the topical treatment of psoriasis demonstrated superiority for all efficacy end points after 8 weeks of treatment. PGA treatment success for CAL/BDP PAD-cream (43.2%) was greater than CAL/BDP TS (31.9%; P < 0.0001), the mean per cent reduction in mPASI for CAL/BDP PAD-cream was 64.6% compared to 56.4% for CAL/BDP TS (P < 0.0001) and DLQI 0/1 was obtained by 43.8% in the CAL/BDP PAD-cream group versus 34.2% in the CAL/BDP TS group (P = 0.0005). There was no adverse drug reaction reported with a frequency of >1%, associated with the CAL/BDP PAD-cream.. The novel fixed dose combination CAL/BDP PAD-cream offers greater efficacy, superior patient QoL and equivalent favourable safety for the topical treatment of psoriasis, in comparison to the currently available topical suspension/gel.

Topics: Betamethasone; Calcitriol; Clinical Trials, Phase III as Topic; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome

Most patients with psoriasis present with localized mild-to-moderate disease. In this case, the application of topical treatments in the first-line setting is recommended in most cases.Among different topical options, the fixed-dose combination of betamethasone dipropionate (BD) and vitamin D analogue (Cal) aerosol foam (Enstilar®, Leo Pharma) is approved as first-line topical therapy for the treatment of psoriasis in USA and the EU, due to its high efficacy and its favorable administration scheme.The PSO-LONG was the first trial to report on the long-term efficacy and safety of the Cal/DB foam treatment for the proactive management of psoriasis and now, the indications of Cal/BD foam included its use in the psoriasis maintenance treatment. However, the precise role of this treatment and the potential therapeutic schemes in the long-term management of psoriasis need further clarification.This Position Paper, authored by a group of Italian Expert Dermatologists, critically discusses the long-term management of psoriasis with Cal/BD foam in clinical practice. In particular, the biological rationale in the proactive treatment with Cal/BD foam and current evidence regarding this therapeutic approach are presented, along with its application also in patients with moderate-to-severe disease, difficult-to-treat lesions, or within combination regimens. In addition, strategies to improve adherence to long-term treatment of psoriasis are discussed.

Topics: Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Treatment Outcome

Targeted UVB and topical calcipotriene have frequently been used in the treatment of psoriasis, but the joint effect of calcipotriene and targeted UVB has been controversial.. The purpose of this study was to systematically evaluate whether the efficacy of the combined use of targeted UVB and calcipotriene is superior to the targeted UVB alone.. We performed systematic review and meta-analysis of randomized controlled trials (RCTs) in patients with plaque-type psoriasis through searching the defined key words in the PubMed, EMBase, and Cochrane Central Register databases. Pooled mean difference of the Psoriasis Area and Severity Index (PASI) relative change (%) was estimated using a random effect model. The quality of included studies and publication bias were assessed using the Jadad scale and the Egger's test, respectively.. Addition of calcipotriene ointment may improve the efficacy of the targeted UVB phototherapy in the treatment of plaque-type psoriasis.

Topics: Calcitriol; Dermatologic Agents; Humans; Psoriasis; Randomized Controlled Trials as Topic; Treatment Outcome; Ultraviolet Therapy

The main objective is to evaluate clinical efficacy and safety of using calcipotriol-betamethasone compounding agent for psoriasis treatment through a systematic review and meta-analysis. We searched MEDLINE, Embase, The Cochrane Library, China National Knowledge Infrastructure (CNKI), China Biomedical Literature Database (CBM), and WanFang Data from inception till July 31, 2020. Efficacy was evaluated based on primary outcome indicators including skin lesion improvement and overall adverse reaction rate. Secondary outcome indicators included degree of life quality improvement, clinical effectiveness rate, and specific adverse reaction rates. RevMan5.3 was used to perform the meta-analysis. 22 studies finally met our inclusion criteria for the meta-analysis. The results indicated that for short-term treatment, a sequential therapy that uses calcipotriol betamethasone compounding agent and calcipotriol improves PASI score (MD = -0.94, 95% CI - 1.38 ~ - 0.49, P < 0.0001, I

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Treatment Outcome

Randomized controlled trials (RCTs) demonstrated the advantages of an aerosol foam formulation of calcipotriol/betamethasone dipropionate (Cal/BD) in patients with psoriasis. In this review, we investigated whether such benefits could also be obtained in real-world clinical practice.. PubMed was searched for studies reporting real-world data in patients with psoriasis treated with Cal/BD aerosol foam.. Three large real-world studies with Cal/BD aerosol foam were identified: a prospective non-interventional study from Germany, a medical chart review from the US, and a retrospective non-interventional study from Spain. Some key findings included the following: high levels of adherence to treatment (82-93%); after 4 weeks, about 50% of patients achieved complete/almost complete responses; at final assessment, 85-95% of patients were extremely satisfied/very satisfied/satisfied with Cal/BD aerosol foam; all healthcare providers were satisfied or somewhat satisfied with the efficacy of Cal/BD foam and they reported similar findings for symptom improvements (itch, pain, erythema/redness, flaking, and plaque thickness). Global ratings by investigators/healthcare providers for symptom control, overall efficacy and the emotional status of patients were also very high (75-100%).. The results from real-world studies undertaken in diverse healthcare systems reinforce the positive findings reported in RCTs with Cal/BD aerosol foam in patients with psoriasis.

Topics: Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Treatment Outcome

While many patients with psoriasis are candidates for topical agents, long-term treatment effects are unclear. This systematic review evaluated global findings from clinical trials and real-world studies of topical calcipotriol and the two-compound formulation of calcipotriol and betamethasone dipropionate for mild-to-moderate plaque psoriasis (including scalp psoriasis). PubMed, Embase and MEDLINE were searched for relevant English-language publications along with Chinese, Japanese, Korean and Latin American publication databases. Identified articles were screened by title and abstract against predefined inclusion/exclusion criteria. A narrative synthesis of key efficacy and safety findings from the full papers of selected publications was developed. Thirty-seven relevant papers were identified (25 English, 11 Chinese and one Japanese-language study) including 28 randomized controlled trials. While there was significant heterogeneity in study length, treatment intensity and clinical measures, following a critical review of the published data combined with expert opinion, the following clinical practice recommendations were agreed in order to assist healthcare providers: in adults, long-term treatment with calcipotriol/betamethasone dipropionate is well tolerated and efficacious for up to 1 year on an 'as needed' basis, and for up to 16 weeks on a fixed-treatment regimen. Calcipotriol is also well tolerated and efficacious when used long term (up to 52 weeks) 'as needed' and for up to 20 weeks on a fixed-treatment regimen. Used on an 'as needed' basis for up to 1 year, the safety and efficacy profile of fixed-dose combination calcipotriol/betamethasone dipropionate is more favorable than calcipotriol alone; regular consultation between patients and their dermatologist/primary care physician is required to review psoriasis symptoms and adjust treatment accordingly; a specific treatment goal should be agreed on initiation of topical agent(s) to determine when long-term treatment can begin or if a regimen change is warranted; and application frequency during the continued treatment phase should consider the patients' treatment expectations and goals.

Topics: Adult; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Treatment Outcome

Psoriasis is a very common chronic inflammatory skin disease affecting up to 3% of the general population with 75% of the psoriasis subjects being affected by a mild form of disease. Hence, topical therapy is the most frequent employed treatment in psoriasis also because it can be easily combined with systemic therapy. In this context, calcipotriol/betamethasone dipropionate (Cal/BD) fixed-dose association represents the first-line treatment due to its efficacy and once-daily application. Different Cal/BD formulations, such as ointment, gel (topical suspension), and aerosol foam, are approved by US Food and Drug Administration.. For this review, relevant English literature (trials, real-life studies, case series, and reviews) regarding Cal/BD different formulations efficacy in psoriasis was searched for through to 28 January 2020. The following database were consulted: PubMed, Embase, the Cochrane Library, Google Scholar, EBSCO, and clinicaltrials.gov.. Cal/BD formulations are efficacious treatment for psoriasis. Cal/BD aerosol foam shows a higher efficacy compared to Cal/BD ointment or gel formulations, appearing as a game-changer in psoriasis therapy not only for mild disease but also for moderate psoriasis as well as in selected severe cases in combination with systemic treatments.

Topics: Administration, Cutaneous; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Psoriasis

Calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam is a topical agent indicated for the treatment of plaque psoriasis. While topical treatments are typically reserved for milder disease, in clinical trials with Cal/BD foam, the vast majority of patients had beyond-mild psoriasis at baseline, and multiple studies (including subgroup analyses from randomized controlled trials and other small-scale studies) have demonstrated favorable outcomes with the use of Cal/BD foam in this population. The objective of this article is to review existing data on the efficacy, safety, and cost-effectiveness of Cal/BD foam used in patients with beyond-mild psoriasis, either alone as topical monotherapy or as adjunctive therapy. Practical recommendations for managing beyond-mild psoriasis with Cal/BD foam are also provided. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5300.

Topics: Administration, Cutaneous; Aerosols; Betamethasone; Biological Products; Calcitriol; Cost-Benefit Analysis; Dermatologic Agents; Drug Combinations; Drug Therapy, Combination; Humans; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Thalidomide; Treatment Outcome

Pruritus, a very broad, subjective, and complex symptom, troubles the majority of patients with psoriasis. However, the subjective and multidimensional nature of the symptom renders it challenging for patients to appropriately communicate their experiences with itch to providers. This review explores current perspectives regarding the underlying mechanisms, assessment tools, burden, and treatment modalities for psoriatic pruritus. It emphasizes the significance of incorporating a standardized, thorough, and verified metric that incorporates severity, distribution, and character of pruritus as well as its effects on various aspects of quality of life. It also underscores the importance of continued research to fully understand the pathogenesis of psoriatic itch for establishment of novel, targeted therapeutics.

Topics: Betamethasone; Calcitriol; Cost of Illness; Dermatologic Agents; Humans; Pruritus; Psoriasis; Quality of Life; Severity of Illness Index

Topical agents are the first-line treatment for mild and moderate psoriasis, but factors such as frequency of administration, organoleptic properties, and the limited short term results can reduce treatment adherence and effectiveness. Innovations in topical treatments are linked not only to the discovery of new molecules, but also to the reformulation of existing active ingredients based on improvements to administration, organoleptic properties, bioavailability, and ease of use. Calcipotriol and betamethasone dipropionate aerosol foam is a new formulation in which the active ingredients are dissolved in a mixture of volatile propellants that evaporate quickly, leaving a supersaturated solution of calcipotriol and betamethasone dipropionate that enhances penetration into the epidermis. In this article, we take a look at the new calcipotriol and betamethasone dipropionate aerosol formulation and briefly review the main evidence supporting the use of topical treatments for psoriasis.

Topics: Administration, Topical; Aerosols; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Humans; Psoriasis

Topical treatments are frequently used for the therapy of psoriasis. However, they may be associated with poor adherence in clinical practice. Therapeutic adherence is affected by patient's characteristics, as well as disease- and treatment-related factors; moreover, satisfaction with therapy, cosmetic acceptability, and complexity of the treatment regimen do also play a role. Since low adherence could lead to treatment failure, it is crucial to elaborate effective strategies aimed at improving patient adherence and thus clinical outcomes in psoriasis. To this purpose, here we have addressed several aspects of dermatological treatment that impact on adherence such as selection of therapy, selection of vehicle, and physician-patient communication. In addition, possible practical measures to improve adherence have also been discussed. In this light, we report that the use of calcipotriol and betamethasone dipropionate (Cal/BD) fixed-combination gel may be associated with improved patients' preference and better outcomes compared to similar formulations.

Topics: Administration, Cutaneous; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Medication Adherence; Patient Satisfaction; Physician-Patient Relations; Psoriasis; Severity of Illness Index

Most people with mild-to-moderate psoriasis manage their disease with topical therapies. However, adherence to topical treatment remains a challenge, as the daily application creates a significant treatment burden. New topical therapeutic options need to offer higher efficacy and better patient acceptability, including easier application, to reduce treatment burden and enhance patient adherence. Topical foam vehicles are innovative alternatives to creams and ointments, addressing many patient challenges with traditional vehicles. Well-designed foam vehicles are easily spread over large areas of the skin, while importantly not leaving a greasy or oily film on the skin after application. Calcipotriol/betamethasone diproprionate aerosol foam is a new psoriasis treatment option that is rapidly effective, offers greater efficacy versus ointment and gel formulations, and has been shown to increase patient treatment satisfaction. Hence, by addressing the several crucial unmet clinical needs in patients with mild-to-moderate psoriasis, this optimized foam formulation is poised to improve treatment follow-through.

Topics: Administration, Cutaneous; Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Randomized Controlled Trials as Topic

The largest proportion of psoriasis patients are candidates for topical treatment rather than treatment paradigms encompassing systemic, biologic and apremilast, and phototherapy, making skillfulness with topical therapy of paramount importance. As such, numerous studies have been conducted to demonstrate the benefits of using topical therapy in combination with other therapies. In addition, innovative uses of otherwise conventional methods, such as proactive use to minimize flare, have been developed. This article reviews five types of strategies for improved efficacy from topical agents beyond monotherapy. These strategies include proactive use, rotational therapy, sequential therapy, using topical agents to shorten the onset of therapeutic action for slower internal agents or phototherapy, and combination use for added efficacy. Each of these is reviewed in detail.

Topics: Administration, Topical; Calcitriol; Clobetasol; Databases, Factual; Dermatologic Agents; Humans; Nicotinic Acids; Phototherapy; Psoriasis; Tacrolimus

Psoriasis is a common chronic immune-mediated skin disease which has a significant impact on patients' quality of life, and is associated with numerous comorbidities (i.e., psoriatic arthritis, Crohn's disease and cardiovascular disease). A greater understanding of its immunopathogenesis has guided the development of novel, more targeted therapies. Nonetheless, traditional treatment with topical agents, phototherapy and systemic medications is used in the management of the majority of psoriasis patients. Mainstay topical treatments include corticosteroids and vitamin D derivatives. Calcipotriene/betamethasone dipropionate aerosol foam is a novel single product combination, which seeks to provide superior therapeutic efficacy in addition to enhanced cosmetic properties. This article reviews the literature on the pharmacology and clinical data in terms of safety, efficacy and patient satisfaction of this topical medication.

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Quality of Life

To review published literature describing the global use of topical antipsoriatics.. Search for English-language articles in Embase, Pubmed, PsycINFO and Cochrane Library.. Fifty-four selected publications were found, describing psoriasis patients' use of topical antipsoriatics, using six different methods to collect data. The eight most frequently used topical treatments from the regions North/South America, North/Central/South Europe, Asia, Middle East and Australia were: corticosteroids used by 16-79%, complementary and alternative medicines used by 10-62%, phototherapies used by 0.4-75%, calcipotriol used by 4.2-73%, corticosteroid/calcipotriol combinations used by 3.3-71%, tar used by 0.8-66%, anthralin used by 15% and emollients used as monotherapy by 1-23%. Rates of patient-reported adherence to topical remedies ranged from 51% to 90% and rates of patient-reported satisfaction with topical as it pertains to symptom control ranged from 12% to 52%.. The identified use patterns are varying and reflect a lack of data from large parts of the world and noncomparable studies using heterogeneous study designs. However, this study emphasizes the importance of medical professionals involvement of the patient with respect to choosing prescribed topical treatment and the possibility of patients' use of alternative treatments. More drug utilization studies, both survey and register based, from different parts of the world are needed to provide more conclusive evidence about patients' use of topical antipsoriatics.

Topics: Administration, Topical; Adrenal Cortex Hormones; Anthralin; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Humans; Patient Compliance; Psoriasis

Psoriasis is a chronic disease that has a substantial effect on quality of life of patients and often needs long-term treatment. Topical treatments for psoriasis include corticosteroids, vitamin D derivatives, tazarotene, anthralin, tacrolimus, pimecrolimus, and newer formulations of tar. Although many of these treatments are effective, they must be prescribed appropriately and used consistently for a period of weeks to months before clinical evidence of improvement can be seen and patients perceive that the treatment is working. As such, medication dosage/schedule, choice of vehicle, and especially patient adherence to medication are key factors for a treatment to be effective. Addressing patient preferences about treatments and concerns about treatment-related toxicities and managing their expectations represent additional aspects of patient care. Therapies such as calcipotriene and betamethasone dipropionate (Cal/BD) fixed combination foam and new drugs and vehicles continuously enhance the treatment landscape for psoriasis. Because adherence to topical treatment can be a major difficulty, keeping the treatment regimen simple and using new and sophisticated treatment vehicles that are acceptable to patients can likely improve treatment outcomes.

Topics: Administration, Cutaneous; Anthralin; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Drug Therapy, Combination; Evidence-Based Medicine; Glucocorticoids; Humans; Nicotinic Acids; Patient Compliance; Pharmaceutical Vehicles; Practice Guidelines as Topic; Psoriasis; Quality of Life; Severity of Illness Index; Tacrolimus; Treatment Outcome; Vitamin D

Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Hypothalamo-Hypophyseal System; Pituitary-Adrenal System; Psoriasis; Quality of Life

Psoriasis is a chronic inflammatory disease with a well-documented negative effect on the quality of life of affected patients. Psoriasis often occurs in the reproductive years, during which the issue of pregnancy needs to be addressed. The course of psoriasis during pregnancy is unpredictable, and many patients face the challenge of needing treatment during pregnancy. In this review we provide an overview of the key considerations for managing psoriasis in pregnant women, covering the potential effects of active psoriasis and co-morbid conditions on the health of the mother and fetus, as well as the effects of psoriasis treatment options on the developing fetus. Although there are no robust data on the safety of systemic treatment of pregnant women, increasing evidence regarding the safety of cyclosporine (ciclosporin) treatment as well as anti-tumor necrosis factor-α is available and should be considered in pregnant women with moderate to severe psoriasis unresponsive to local corticosteroids and UVB light treatment.

Topics: Acitretin; Administration, Cutaneous; Adrenal Cortex Hormones; Calcineurin Inhibitors; Calcitriol; Coal Tar; Contraindications; Cyclosporine; Dermatologic Agents; Female; Humans; Immunosuppressive Agents; Methotrexate; Nicotinic Acids; Pregnancy; Pregnancy Complications; Psoriasis; PUVA Therapy; Tumor Necrosis Factor-alpha; Ultraviolet Therapy; Ustekinumab

Topics: Adult; Antibodies, Monoclonal; Calcitriol; Dermatologic Agents; Dihydroxycholecalciferols; Fumarates; Humans; Psoriasis; Ultraviolet Therapy; Vitamins

The efficacy of the two-compound formulation (TCF) product containing calcipotriol and betamethasone dipropionate applied once daily in psoriasis has been demonstrated in phase III trials but no randomised clinical trial comparing all commonly used topical treatments exists. The aim of the study was to compare the efficacy of once-daily use of the TCF product relative to other commonly used topical agents in plaque psoriasis.. Data on change in Psoriasis Area and Severity Index (PASI) score from baseline and PASI 75 (percentage of patients achieving a 75% reduction in PASI score), after 4 weeks of treatment were obtained by means of a systematic literature review of randomised controlled trials and synthesised with a Bayesian mixed treatment comparison meta-analysis.. Relative to all active interventions, except for the unlicensed twice-daily application of the TCF product, the TCF once daily showed a greater efficacy based on PASI 75 response (relative risk ranging from 1.22 to 3.18) and improvement in PASI score from baseline (difference in % CFB PASI between TCF once daily and other active interventions ranged from 4.01 to 49.68).. Among topical therapies evaluated, TCF once daily can be considered the most efficacious treatment for plaque psoriasis.

Topics: Administration, Topical; Adult; Algorithms; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Chemistry, Pharmaceutical; Drug Combinations; Female; Humans; Male; Middle Aged; Psoriasis; Treatment Outcome

To compare the cost effectiveness of the two-compound formulation (TCF) calcipotriol plus betamethasone dipropionate gel used first-, second- or third-line to standard topical treatments for moderately severe scalp psoriasis from a Scottish NHS perspective.. Treatment pathways for scalp psoriasis patients in primary care were defined by Scottish prescribing statistics, an interview programme and published sources. The extensive 1-year Markov model included 12 different topical treatment pathways, each simulating three lines of therapy. Seven pathways contained the TCF gel in first-, second- or third-line. The remaining five pathways were included as comparators, reflecting the heterogeneity across clinical practice. The cost effectiveness of TCF gel was compared to the average of five non-TCF gel pathways. The clinical effectiveness measure was the ability of topical treatments to control disease at 4 weeks. Response rates were derived from indirect comparisons of ten randomised controlled trials. Utilities were elicited from SF-36 (v2) scores in one TCF gel trial. The main outcome was the incremental cost per quality-adjusted life-year (QALY). Extensive sensitivity analyses were performed to assess the robustness of the results.. TCF gel used first-, second- or third-line was projected to increase QALYs (around 0.0025) with cost savings per patient (£20-30) over 1 year. The study analysis acknowledged a number of limitations including lack of quality comparator data, the need to make assumptions in the absence of evidence and lack of model validation. However the results showed that TCF gel was the dominant treatment strategy across a broad range of credible scenarios.. Scalp psoriasis is difficult to treat. Many different topical preparations can be used but several factors such as greasiness, irritation, time needed to apply, and lack of efficacy often result in reduced adherence to treatment regimens. Where cosmetic properties are important for patient acceptability and compliance is a major issue contributing to treatment failure, the once-daily TCF gel offers patients with scalp psoriasis an attractive, cost-saving treatment option.

Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Chemistry, Pharmaceutical; Cost-Benefit Analysis; Drug Combinations; Gels; Humans; Models, Econometric; Psoriasis; Scalp Dermatoses; Scotland; Severity of Illness Index; Treatment Outcome

To evaluate the two-compound formulation (TCF) calcipotriol and betamethasone dipropionate (BDP) gel versus other topical therapies for scalp psoriasis in adults using direct and indirect comparisons.. A systematic review identified 10 randomised controlled trials (RCTs) of topical treatments used in clinical practice for moderately severe scalp psoriasis. A meta-analysis was undertaken to obtain estimates of clinical effectiveness using recommended efficacy and safety outcome measures. We determined the proportion of responding patients using two definitions: i) 'controlled disease' using the Investigator Global Assessment (IGA) rating scale and ii) a score of 0 or 1 on the Total Sign Score (TSS). Tolerability was extracted in terms of percentages of patients experiencing all adverse events (AEs), skin AEs and withdrawals due to AEs. Direct comparisons were performed where head-to-head data were available. For other comparators where TCF gel was compared indirectly, 'pairs' of trials were compared on the basis of a common comparator using meta-regression in order to derive an indirect comparison estimate, while preserving randomisation within trials. Assumptions of comparability were considered regarding study homogeneity (data can be pooled in a meta-analysis), similarity of trials (clinical and methodological) and consistency of findings from direct and indirect evidence.. The meta-analysis showed that TCF gel was statistically significantly more effective than other topical treatments in terms of achieving a response defined according to both IGA and TSS criteria. TCF gel was generally associated with a statistically significant lower risk of AEs, skin AEs or patients withdrawing from RCTs due to AEs.. Although direct and indirect evidence in this analysis is sparse, this indirect comparison suggests that the TCF gel has significant benefits over other topical therapies considered in the routine management of patients with moderately severe scalp psoriasis. Despite other analysis limitations in terms of study heterogeneity inevitable across an evidence base spanning decades, these results were consistent, using a number of efficacy and tolerability outcome measures.

Topics: Administration, Topical; Algorithms; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Chemistry, Pharmaceutical; Drug Combinations; Evidence-Based Practice; Gels; Humans; Psoriasis; Scalp Dermatoses; Severity of Illness Index; Treatment Outcome

Calcipotriol/betamethasone dipropionate (calcipotriol 50 μg/g and betamethasone 0.5 mg/g) is a fixed-dose combination of a vitamin D(3) analogue and a corticosteroid indicated for the once-daily, topical treatment of psoriasis vulgaris of the trunk, limbs and scalp in adults. Both the ointment (Daivobet®; Dovobet®) and gel (Xamiol®; Daivobet® Gel; Dovobet® Gel) formulations of calcipotriol/betamethasone dipropionate can be used to treat psoriasis vulgaris of the trunk and/or limbs, although the gel formulation was specifically developed for the treatment of scalp psoriasis. This article reviews the efficacy and tolerability of calcipotriol/betamethasone dipropionate in patients with psoriasis vulgaris, as well as summarizing its pharmacological properties. Calcipotriol/betamethasone dipropionate has low systemic absorption and displays local anti-inflammatory and immunoregulatory properties. It reduces the hyperproliferation of keratinocytes and helps normalize keratinocyte differentiation. In large, well designed clinical trials, calcipotriol/betamethasone dipropionate, either as the ointment or the gel formulation, applied once daily for 4-8 weeks, was more effective than placebo, calcipotriol and tacalcitol, as well as betamethasone dipropionate in most instances, for the topical, symptomatic treatment of psoriasis vulgaris of the trunk/limbs. Likewise, calcipotriol/betamethasone dipropionate gel applied once daily for 8 weeks was more effective than placebo or either component alone in the topical, symptomatic treatment of psoriasis vulgaris of the scalp. Long-term, once-daily, when required therapy with calcipotriol/betamethasone dipropionate for 52 weeks was more effective than calcipotriol alone for the treatment of scalp psoriasis, and was at least as effective as switching to calcipotriol for 48 weeks after 4 weeks of calcipotriol/betamethasone dipropionate or alternating between calcipotriol/betamethasone dipropionate and calcipotriol every 4 weeks for 52 weeks in the treatment of psoriasis vulgaris of the trunk/limbs. Calcipotriol/betamethasone dipropionate also improved health-related quality of life. Calcipotriol/betamethasone dipropionate was generally well tolerated, with most adverse drug reactions being lesional or perilesional effects of mild or moderate severity. Calcipotriol/betamethasone dipropionate was often associated with fewer lesional/perilesional adverse reactions than calcipotriol or tacalcitol and did not appear to be associa

Topics: Back; Betamethasone; Calcitriol; Clinical Trials as Topic; Dermatologic Agents; Drug Combinations; Extremities; Gels; Humans; Ointments; Psoriasis; Scalp; Thorax; Treatment Outcome

This article describes topical therapies and treatment guidelines for psoriasis and is based on a presentation given by the authors at a satellite symposium held during the 19th Congress of the European Academy of Dermatology and Venereology, 6-10 October, 2010, in Gothenburg, Sweden. The highly variable nature of psoriasis and its individual presentation in patients can make it difficult to choose the most appropriate treatment. There are many treatment options, from topical treatment with emollients for very mild psoriasis, to systemic therapy with fumaric acid esters, methotrexate or biologics for severe disease. For the treatment of mild-to-moderate psoriasis, topical therapy is generally the most appropriate and a variety of options, both historical and recent, are available. Newer therapies offer greater convenience and fewer side-effects. Of the more recently available therapies, vitamin D analogues and topical corticosteroids are the two with the greatest proven efficacy in randomized clinical trials. A recent Cochrane review showed the highest efficacy overall with the fixed combination vitamin D analogue (calcipotriol) and corticosteroid (betamethasone dipropionate). Indeed, clinical trials have shown that two-compound calcipotriol/betamethasone dipropionate ointment has higher efficacy than calcipotriol or betamethasone dipropionate alone. With regard to safety, two-compound calcipotriol/betamethasone dipropionate was shown to be suitable for intermittent long-term treatment of mild-to-moderate psoriasis. The findings of the Cochrane review are reflected in the current treatment guidelines from the USA and Germany regarding the treatment of mild-to-moderate psoriasis. In both these guidelines, which will be discussed in this article, the recommended treatments for this patient group are vitamin D analogues and corticosteroids, particularly when used in combination.

Topics: Administration, Topical; Betamethasone; Calcitriol; Dermatologic Agents; Humans; Practice Guidelines as Topic; Psoriasis

Calcipotriene (calcipotriol)/betamethasone dipropionate (calcipotriene 50 μg/g and betamethasone 0.5 mg/g) is a fixed-dose combination of a vitamin D3 analog and a corticosteroid indicated for the once-daily, topical treatment of psoriasis vulgaris of the trunk, limbs, and scalp in adults. Both the ointment (Daivobet®; Dovobet®) and gel (Xamiol®; Daivobet® Gel; Dovobet® Gel) formulations of calcipotriene/betamethasone dipropionate can be used to treat psoriasis vulgaris of the trunk and/or limbs, although the gel formulation was specifically developed for the treatment of scalp psoriasis. This article reviews the efficacy and tolerability of calcipotriene/betamethasone dipropionate in patients with psoriasis vulgaris, as well as summarizing its pharmacologic properties. Calcipotriene/betamethasone dipropionate has low systemic absorption and displays local anti-inflammatory and immunoregulatory properties. It reduces the hyperproliferation of keratinocytes and helps normalize keratinocyte differentiation. In large, well designed clinical trials, calcipotriene/betamethasone dipropionate, either as the ointment or the gel formulation, applied once daily for 4-8 weeks, was more effective than placebo, calcipotriene, or tacalcitol, as well as betamethasone dipropionate in most instances, for the topical, symptomatic treatment of psoriasis vulgaris of the trunk/limbs. Likewise, calcipotriene/betamethasone dipropionate gel applied once daily for 8 weeks was more effective than placebo or either component alone in the topical, symptomatic treatment of psoriasis vulgaris of the scalp. Long-term, once-daily, when required therapy with calcipotriene/betamethasone dipropionate for 52 weeks was more effective than calcipotriene alone for the treatment of scalp psoriasis, and was at least as effective as switching to calcipotriene for 48 weeks after 4 weeks of calcipotriene/betamethasone dipropionate or alternating between calcipotriene/betamethasone dipropionate and calcipotriene every 4 weeks for 52 weeks in the treatment of psoriasis vulgaris of the trunk/limbs. Calcipotriene/betamethasone dipropionate also improved health-related quality of life. Calcipotriene/betamethasone dipropionate was generally well tolerated, with most adverse drug reactions being lesional or perilesional effects of mild or moderate severity. Calcipotriene/betamethasone dipropionate was often associated with fewer lesional/perilesional adverse reactions than calcipotriene or tacalcitol and

Topics: Administration, Cutaneous; Adult; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Extremities; Gels; Humans; Ointments; Psoriasis; Scalp; Torso

Evidence-based recommendations for therapeutic decision making in childhood psoriasis are lacking.. We sought to systematically review all available literature concerning treatment efficacy and safety in childhood psoriasis and to propose a recommendation for topical and systemic treatment of childhood psoriasis.. Databases searched were PubMed, EMBASE, and the Cochrane Controlled Clinical Trial Register. All studies reporting on efficacy and safety of all treatment options in childhood psoriasis were obtained and a level of evidence was determined.. Literature search revealed 2649 studies, of which 64 studies met the inclusion criteria. The majority of topical and systemic therapies given in childhood psoriasis are efficacious. Short-term side effects were usually mild; long-term side effects were not described.. Most conclusions formulated are not based on randomized controlled trials.. A rough summary of the proposed algorithm is as follows: first, calcipotriene with/without topical corticosteroids, followed by dithranol. Methotrexate is considered to be the systemic treatment of choice.

Topics: Anthralin; Anti-Bacterial Agents; Calcineurin Inhibitors; Calcitriol; Child; Dermatologic Agents; Glucocorticoids; Humans; Methotrexate; Psoriasis

Scalp psoriasis has a significant psychosocial impact on individuals affecting their quality of life. It occurs in 50-80% of patients with psoriasis and may be the only affected area of the body. Current topical therapies for scalp psoriasis are difficult or unpleasant to apply, resulting in decreased adherence and efficacy. A combination of calcipotriol and betamethasone dipropionate in a gel formulation has been developed and approved in Germany for the treatment of scalp psoriasis. Multiple randomized controlled clinical trials have confirmed the efficacy and safety of the new formulation. After two weeks, 60% of patients showed significant improvement; this climbed to 70%, after eight weeks. It may be safely used for up to 52 weeks. No cases of atrophy, striae, or steroid purpura were noted in two 52-week studies. Although scalp psoriasis can often be adequately treated with topical therapy, there is a need for treatment recommendations and algorithms for severe forms and for patients with extended body involvement, taking the combination of systemic and topical treatment and the presence of comorbidities into account.

Topics: Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Gels; Humans; Incidence; Psoriasis; Scalp Dermatoses; Treatment Outcome

Psoriasis is a chronic inflammatory disease causing important physical and psychological morbidity. Topical treatments are the first choice therapeutic alternatives for mild and moderate psoriasis. We review the different topical treatment options for this common skin disease.

Topics: Administration, Cutaneous; Anthralin; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Therapy, Combination; Emollients; Humans; Keratolytic Agents; Nicotinic Acids; Ointments; Psoriasis; PUVA Therapy; Quality of Life; Tacrolimus; Treatment Outcome; Vitamins

Plaque-type psoriasis is a chronic and immune-mediated skin disease affecting approximately 1-3% of the Caucasian population. Most cases are of mild or moderate severity and benefit from local treatment that represents the mainstay therapy. Topical corticosteroids and vitamin D(3) analogues remain the option of choice. Optimization of these treatments is made by the combination of calcipotriene and betamethasone dipropionate. This formulation combines the keratinocyte differentiation and antiproliferative action of the vitamin D(3) analogues with the anti-inflammatory effect of steroids enhancing effectiveness while reducing the side-effect profile of the single topical agent. In this article, we highlight the advantages of the association of calcipotriene and betamethasone in the treatment of localized plaque-type, scalp and nail psoriasis.

Topics: Betamethasone; Calcitriol; Cell Differentiation; Dermatologic Agents; Drug Therapy, Combination; Glucocorticoids; Humans; Keratinocytes; Psoriasis; Treatment Outcome

High-potency topical corticosteroids are very effective for the treatment of psoriasis, but are associated with a number of cutaneous adverse effects. Vitamin D modulators have emerged as an important alternative to corticosteroids for the long-term topical treatment of psoriasis. Calcitriol 3 microg/g ointment has long been used to treat psoriasis in Europe and is now the only vitamin D3 ointment available for use in the United States (U.S.). Several randomized clinical trials have compared the safety, efficacy, and cosmetic acceptability of calcitriol ointment with other topical psoriasis therapies. In a three-week investigator-blinded study of 25 healthy subjects, calcitriol 3microg/g ointment was associated with markedly less cumulative skin irritation than was calcipotriene ointment. A multicenter, investigator-blinded study of patients with psoriasis found that investigator-rated global improvement of psoriasis symptoms with calcitriol ointment was statistically noninferior to calcipotriene ointment and that calcitriol use produced significantly fewer patients with cutaneous reactions or discomfort. A multicenter clinical trial of patients with psoriasis who had lesions affecting sensitive skin areas found that calcitriol use produced less skin irritation than did calcipotriene and was generally preferred to calcipotriene ointment by patients. Calcitriol was also significantly more effective for the treatment of psoriasis lesions affecting flexural areas. In another study, patients who received calcitriol ointment exhibited improvement in psoriasis symptoms that was similar to the corticosteroid betamethasone propionate, but were much less likely to have relapsed eight weeks after treatment discontinuation. Two clinical studies also suggested that calcitriol is similar in efficacy to short-contact dithranol, but with a lower incidence of skin irritation and staining. Together, the results of these studies demonstrate that calcitriol 3 microg/g ointment is a significant new option for topical therapy of psoriasis. Calcitriol ointment produces improvement in psoriasis symptoms that is generally similar to the improvement attained with other (except for high potency steroid) topical psoriasis therapies, with a low incidence of adverse events.

Topics: Administration, Topical; Calcitriol; Drug Therapy, Combination; Humans; Psoriasis; Vitamins

Chronic plaque psoriasis, the most common form of psoriasis, is a papulosquamous disease defined by erythematous plaques with a silvery scale. The diagnosis usually is clinical, but occasionally a biopsy is necessary. Psoriasis affects 0.6 to 4.8 percent of the U.S. population, and about 30 percent of affected patients have a first-degree relative with the disease. Psoriasis is a T-cell-mediated autoimmune disease, but certain medications and infections are well-known risk factors. Management of psoriasis includes education about chronicity, realistic expectations, and use of medication. Steroids and vitamin D derivatives (e.g., calcipotriene) are the mainstays of topical therapy. Topical steroids and calcipotriene together may work better than either agent alone. Patients with psoriasis involving more than 20 percent of their skin or those not responding to topical therapy are candidates for light therapy; traditional systemic therapy; or systemic treatment with immunomodulatory drugs such as alefacept, efalizumab, and etanercept.

Topics: Algorithms; Calcitriol; Chronic Disease; Comorbidity; Dermatologic Agents; Humans; Psoriasis; Risk Factors; Ultraviolet Therapy

Psoriasis is a chronic inflammatory dermatosis that affects 0.6% to 4.8% of the population and is seen in all ages. The disease is characterized by a well-demarcated, salmon-colored plaque surmounted by silver-white scales. Given the chronic nature of the disease, goal of treatment is to induce and maintain remission, with minimal short and long-term side effects from therapy. Most agents can be used alone or in combination with other treatment modalities.

Topics: Anti-Inflammatory Agents; Calcitriol; Dermatologic Agents; Diagnosis, Differential; Forecasting; Humans; Immunologic Factors; Immunosuppressive Agents; Psoriasis; PUVA Therapy; Remission Induction; Ultraviolet Therapy

The two-compound product calcipotriol/betamethasone dipropionate is arising as a first-line treatment for mild-to-moderate plaque psoriasis. Its beneficial action is attributed to the synergistic effect of its components on keratinocyte proliferation and differentiation, and on inflammation. The good tolerability of the two-compound product is thought to be due to the anti-inflammatory effect of betamethasone. Evidence from short-term (4-12 weeks) and long-term use (> 1 year) has shown a good safety profile. Areas such as the face or skin folds, which are sensitive to the components of the combination, should be avoided. Finally, it is unsuitable for use in unstable psoriasis, in which potent steroids may lead to an increased inflammatory response.

Topics: Anti-Inflammatory Agents; Betamethasone; Calcitriol; Cell Differentiation; Cell Proliferation; Cost-Benefit Analysis; Dermatologic Agents; Drug Combinations; Drug Synergism; Humans; Keratinocytes; Psoriasis; Randomized Controlled Trials as Topic; Treatment Outcome

Dermatological research continues to move toward the goal of developing an effective psoriasis treatment that would rapidly clear lesions and provide long-term freedom from visible signs and symptoms. Currently, topical corticosteroids remain a pivotal treatment due to their effective anti-inflammatory properties; however, potential adverse effects associated with chronic application limit long-term continuous therapy. Vitamin D analogues provide another mechanism of action, reducing lesions through effects on both keratinocytes and on the cytokine environment. A topical combination of corticosteroid and vitamin D derivative appears to provide a balanced approach to psoriasis treatment. The development of clobetasol propionate foam 0.05% (clobetasol propionate foam/Olux) offers a convenient topical corticosteroid that can be used concomitantly, that is, immediately followed by application of calcipotriene ointment 0.005% (Dovonex). This regimen has been shown to offer an increased short-term efficacy compared with either agent alone. Continued application of calcipotriene ointment on weekdays supplemented by long-term clobetasol propionate foam pulse therapy on weekends appears to provide an enhanced maintenance of remission compared with calcipotriene monotherapy.

Topics: Administration, Cutaneous; Calcitriol; Clobetasol; Dermatologic Agents; Drug Administration Schedule; Drug Therapy, Combination; Humans; Psoriasis

The combination of calcipotriol and betamethasone dipropionate in a single topical formulation is a recent advance in treatment of plaque type psoriasis. Studies rooted on evidence-based medicine have been recently published. We report a synthesis and a critical analysis, critical analysis of these investigations, and translate their data with a view to apply them in daily practice.

Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Therapy, Combination; Humans; Psoriasis

Most patients with mild to moderate psoriasis require--often longterm--topical treatments: this frequently results in non-compliance especially when large body areas or the face are treated. Monotherapy with anthralin has been abandoned to a great extent while new formulations of topical corticosteroids, vitamin D and vitamin D derivatives have greatly extended the spectrum of topical antipsoriatic treatment modalities. In most instances, combinations of preparations with different pharmacologic modes of action are superior when compared with the respective monotherapy. This also holds true for combinations with a UVB or UVA light therapy. Preparations containing both a corticosteroid and vitamin D derivative are well suited for combining topical treatment with modern systemic antipsoriatic drugs.

Topics: Administration, Topical; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Therapy, Combination; Humans; Patient Compliance; Psoriasis; Treatment Outcome; Vitamin D

Topics: Adalimumab; Alefacept; Anti-Inflammatory Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Attitude to Health; Betamethasone; Body Image; Calcitriol; Clobetasol; Dermatologic Agents; Diagnosis, Differential; Drug Monitoring; Etanercept; Humans; Immunoglobulin G; Immunosuppressive Agents; Infliximab; Psoriasis; Receptors, Tumor Necrosis Factor; Recombinant Fusion Proteins; Severity of Illness Index

Psoriasis is a common disease in children and adolescents. Because of the chronic course of the disease, appropriate choice of therapy in particular stage of the disease, so-called rotation therapy, is of paramount importance. This article provides a review of therapeutic options for childhood psoriasis. Local therapy for psoriasis in children consists of corticosteroid preparations, calcipotriol, tars and dithranol, local retinoids, and local immunomodulators. Phototherapy (narrow band UVB, photochemotherapy PUVA baths) is now a part of psoriasis therapy in children. Systemic therapy retinoids (acitretin) methotrexate, cyclosporine is only used in severe forms of the disease such as erythrodermic, pustular and arthritic psoriasis. All these therapeutic options can be used as monotherapy or in various combinations.

Topics: Adrenal Cortex Hormones; Anthralin; Calcitriol; Child; Cyclosporine; Humans; Methotrexate; Nicotinic Acids; Phototherapy; Psoriasis; Retinoids

Published data are reviewed on the pharmacology, efficacy, tolerability, and pleasantness of the vitamin D(3) analogue calcipotriol in a cream formulation (Daivonex/Dovonex cream; LEO Pharma AS, Denmark) in the treatment of psoriasis. Calcipotriol cream monotherapy is more effective than placebo, and as effective as betamethasone valerate cream and coal tar in psoriasis. A regimen of morning-cream and evening-ointment is equally effective as twice-daily calcipotriol ointment and is preferred by patients. Calcipotriol cream is also a highly efficacious maintenance treatment used alone or in an alternating regimen with calcipotriol/betamethasone dipropionate ointment. Short- and long-term trials have demonstrated that calcipotriol cream is well tolerated by patients with psoriasis. Irritation is observed less frequently than with calcipotriol ointment, making the cream very suitable for children and thin or sensitive areas, such as flexures or (off-label use) the face. Calcipotriol cream is generally preferred to the ointment formulation, as shown by preference testing, and leads to improved patient compliance. In conclusion, calcipotriol cream is not only an effective treatment for psoriasis but is pleasant to use and well tolerated even in sensitive areas. Therefore, calcipotriol cream is particularly useful for the maintenance treatment of psoriasis, after induction therapy with a fast-acting vitamin D/steroid two-compound product.

Topics: Calcitriol; Dermatologic Agents; Dosage Forms; Humans; Psoriasis

A two-compound product containing calcipotriol and betamethasone dipropionate (Daivobet/Dovobet) has been evaluated in a large clinical trial programme, providing a wealth of data on the treatment of psoriasis vulgaris.. To determine the effectiveness of the two-compound product in patients with mild, moderate and severe psoriasis vulgaris.. Data from over 1,534 patients with psoriasis vulgaris who received the two-compound product once daily for at least 4 weeks in four randomised, double-blind studies were pooled. A meta-analysis of the pooled data is presented. Severity of psoriasis at baseline was determined by investigator assessment and Psoriasis Area and Severity Index (PASI) score.. For patients with severe disease defined by PASI score (PASI baseline > or = 17), the mean reduction in PASI after up to 4 weeks of treatment was 71.6% compared with 68.9 and 67.2% for those with moderate (PASI baseline 5.1-16.0) and mild disease (PASI baseline < or = 5). Corresponding reductions for investigator-assessed severity were 72.6, 69.1 and 68.7%, respectively.. Although the meta-analysis of the data from these four studies was performed post hoc, we may conclude that the two-compound product provided highly effective treatment of psoriasis, regardless of the category of baseline disease severity.

Topics: Administration, Topical; Adult; Aged; Betamethasone; Calcitriol; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Psoriasis; Randomized Controlled Trials as Topic; Reference Values; Risk Assessment; Severity of Illness Index; Treatment Outcome

A variety of therapeutic options are available to treat psoriasis and atopic dermatitis (AD). Local agents typically are used to treat localized and milder forms of disease, whereas phototherapy and systemic agents are used for more generalized and severe disease. Various combinations and sequences of topical or systemic therapies, or both, have been utilized in the treatment of psoriasis and, less frequently, of AD. Conventional systemic therapies for psoriasis, such as corticosteroids, oral calcineurin inhibitors, antimetabolites, and retinoids, are limited by their propensity to cause serious side effects. More recently, a number of immunobiologic agents, such as monoclonal antibodies, recombinant cytokines, and fusion proteins, have been approved by the Food and Drug Administration or are undergoing development as systemic antipsoriatic treatments. In many of these categories, a number of exciting new therapies are in development that may augment the existing armamentarium available to clinicians for the treatment of inflammatory skin diseases.

Topics: Administration, Oral; Administration, Topical; Anti-Inflammatory Agents; Antibodies, Monoclonal; Calcineurin Inhibitors; Calcitriol; Dermatitis, Atopic; Humans; Immunologic Factors; Immunosuppressive Agents; Psoriasis; PUVA Therapy; Ultraviolet Therapy

Topical corticosteroids remain the most commonly used topical treatments for inflammatory dermatoses, including psoriasis and atopic dermatitis. Topical corticosteroids are available in a variety of vehicles-creams, ointments, lotions, gels, and, more recently, foam. The vehicle used can substantially affect the individual agent's clinical action, potency, and acceptability to the patient. Moreover, some vehicles are better suited for specific body areas. Selection of the appropriate product should be determined by area of usage, physician experience, cost, and patient preference, particularly regarding vehicle. Although topical corticosteroids are associated with several side effects, including skin atrophy, telangiectases, purpura, and striae formation, appropriate usage can minimize these occurrences. Judicious use includes short-term, appropriate application as initial monotherapy or in combination strategies with other therapeutic agents that ideally possess complementing mechanisms of action. Examples include pulsing with high-potency topical corticosteroids and combination regimens with other topical agents such as topical calcineurin inhibitors, calcipotriene, or tazarotene. Appropriate education of patients and caregivers alike will facilitate the optimal use of these medications.

Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Anti-Inflammatory Agents; Calcineurin Inhibitors; Calcitriol; Child; Combined Modality Therapy; Dermatitis, Atopic; Dosage Forms; Drug Therapy, Combination; Humans; Immunosuppressive Agents; Infant; Nicotinic Acids; Psoriasis; Ultraviolet Therapy

Topics: Administration, Topical; Calcitriol; Coal Tar; Dermatologic Agents; Female; Humans; Male; Psoriasis; Quality of Life; Scalp Dermatoses; Treatment Outcome

Topical agents for the treatment of psoriasis are indicated for patients whose affected area is less then 10% of their skin. However, for long-term use, their effectiveness can be limited. Topical sequential therapy involves the application of a class I corticosteroid and calcipotriene in three different phases: the clearance phase, the transition phase and the maintenance phase. It is an accepted and widely practiced technique that provides a balance between maximizing efficacy and minimizing side-effects thus offering patients rapid clearance of their psoriatic lesions and long-term maintenance of remission.

Topics: Administration, Topical; Adrenal Cortex Hormones; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Humans; Psoriasis

The topical treatment of psoriasis benefits from the alternate use of dermocorticosteroids and vitamin D3 analogues. A new galenic formulation allows to combine them in a single application. Dovobet (LEO Pharma) ointment is the association of calcipotriol 50 microg/g with betamethasone dipoprionate 0.5 mg/g. This formulation boosts the therapeutic activity of calcipotriol. It also decreases the irritative inflammatory reaction due to calcipotriol without increasing the atrophogenic risk of the dermocorticoid.

Topics: Administration, Topical; Betamethasone; Calcitriol; Drug Therapy, Combination; Humans; Inflammation; Psoriasis

In patients with moderate-to-severe psoriasis, remission can be difficult to achieve and sustain. Both acutely acting and long-term maintenance agents are needed. Speed and efficiency of available monotherapies tend to be inversely proportional to safety. Combination, rotational, and sequential approaches are often more effective and safer than single-agent therapy. Combining agents with complementary adverse effect profiles is preferable. Apparent synergistic enhancement is seen with most paired combinations of the four major therapies: acitretin, phototherapy (ultraviolet B/psoralen plus ultraviolet A), cyclosporine, and methotrexate. Of those, only cyclosporine in combination with psoralen plus ultraviolet A is contraindicated because of increased cancer risk. Combinations of each of those major therapies with topical agents (retinoids, steroids, vitamin D derivatives, and others) have been used with varying efficacy and safety. The immunomodulators, hydroxyurea and thioguanine, have also shown some success in combination therapy. The new biologic agents with their novel modes of action and adverse effect profiles may prove to be important adjuncts in combination/rotational/sequential approaches. In some cases, monotherapy (with either systemic agents or phototherapy) adequately controls moderate to severe disease. A regimen using a single agent has the advantages of lower cost and greater adherence by the patient. For any number of reasons, however, including loss of efficacy, adverse effects, or cumulative or acute toxicity-and especially the inability to clear resistant lesions-a single modality will not be adequate. Using two or more therapies is thus the rule rather than the exception for most patients with moderate-to-severe psoriasis, but picking a combination that serves to balance safety and efficacy needs careful consideration, especially since no evidence-based treatment guidelines exist.

Topics: Acitretin; Calcitriol; Drug Therapy, Combination; Humans; Methotrexate; Psoriasis; PUVA Therapy

Calcipotriene offers a safe and effective option in the treatment of plaque psoriasis. It helps regulate the abnormal growth and production of keratinocytes, as well as has a number of effects on inflammation seen with psoriasis. When used as monotherapy or in combination with corticosteroids, it may help reduce the adverse effects seen with chronic steroid use. Calcipotriene is currently only indicated for plaque psoriasis; however, it has shown promise for use in a wide range of dermatologic conditions.

Topics: Administration, Cutaneous; Calcitriol; Dermatologic Agents; Humans; Keratinocytes; Lichen Planus; Ointments; Patient Education as Topic; Patient Selection; Psoriasis; Scleroderma, Localized; United States; United States Food and Drug Administration; Vitamin D; Vitiligo

Fixed-dose combination therapy offers stable products containing two or more medications with different mechanisms of action and safety profiles. It is also convenient for patients since only one product rather than two or more needs to be applied. Topical corticosteroids are often the mainstay of therapy in psoriasis. Diprosalic and Nerisalic contain a topical corticosteroid (betamethasone dipropionate and diflucortolone, respectively) and salicylic acid. A left/right study showed that both products have comparable efficacy. It has also been shown that betamethasone dipropionate + salicylic acid ointment has similar efficacy to clobetasol and calcipotriene (calcipotriol) ointments. Betamethasone dipropionate + salicylic acid lotion has similar efficacy to clobetasol lotion. Faster improvement of scaling, itching, and redness was noted with betamethasone dipropionate + salicylic acid lotion compared with betamethasone dipropionate alone. Dovobet (Daivobet) ointment is a fixed-dose combination product containing betamethasone dipropionate and calcipotriene. Clinical studies have shown that it has greater efficacy and a faster speed of onset than the individual components or tacalcitol. Once daily and twice daily treatments have similar efficacy. Psoriasis Area and Severity Index reductions of approximately 40% after 1 week and 70% after 4 weeks of therapy were consistently noted in six large international studies involving >6000 patients. Betamethasone dipropionate + calcipotriene treatment is associated with approximately 75% less adverse cutaneous events as compared with tacalcitol, 50% less compared with calcipotriene, and a similar number as treatment with betamethasone dipropionate.

Topics: Administration, Cutaneous; Betamethasone; Calcitriol; Chemistry, Pharmaceutical; Dermatologic Agents; Drug Therapy, Combination; Humans; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index

Topics: Betamethasone; Calcitriol; Clinical Trials, Phase III as Topic; Drug Therapy, Combination; Humans; Psoriasis; Severity of Illness Index; Treatment Outcome

The two-compound product containing calcipotriol 50 microg/g plus betamethasone dipropionate 0.5 mg/g (Dovobet, Daivobet) [referred to here as calcipotriol/betamethasone dipropionate], is a topical treatment for psoriasis vulgaris, combining a vitamin D analog and a corticosteroid. For most adult patients with psoriasis vulgaris on the trunk and limbs, up to 4 weeks of therapy with calcipotriol/betamethasone dipropionate provides an effective and well tolerated treatment. In clinical trials, patients with a mean baseline psoriasis area and severity index (PASI) of 9.5-10.9 experienced a mean 65.0-74.4% PASI improvement within 4 weeks, significantly better than improvements with calcipotriol 50 microg/g monotherapy, betamethasone dipropionate 0.5 mg/g monotherapy, or placebo. In addition, in 6.4%-20.1% of patients, lesions cleared. In patients who were subsequently treated with calcipotriol maintenance therapy, benefits were retained for at least 4 weeks. The safety of calcipotriol/betamethasone dipropionate in patients treated for up to 1 year was generally good; fewer than 5% of patients experienced adverse events possibly associated with long-term corticosteroid use.

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Humans; Psoriasis; Randomized Controlled Trials as Topic; Treatment Outcome

Tazarotene is a receptor-selective retinoid, which is efficacious in the treatment of patients with psoriasis, acne vulgaris, and photoaging. It normalizes keratinocyte differentiation, reverses keratinocyte hyperproliferation, and has anti-inflammatory effects. Clinical studies have shown that tazarotene 0.1% gel has greater comedolytic activity than tretinoin (Retin-A 0.025% gel, Retin-A Micro 0.1%) and adapalene (Differin) 0.1% gel. Although it is efficacious as monotherapy, tazarotene is more commonly used as part of combination therapy with a topical antibacterial in patients with acne vulgaris, and with a mid- or high-potency topical corticosteroid or with phototherapy in patients with psoriasis. Combination therapy enhances efficacy and tolerability. Tazarotene 0.1% gel, used in combination with mometasone furoate 0.1% cream, was shown in psoriasis clinical trials to be more efficacious than calcipotriene (calcipotriol) ointment used twice daily, or mometasone furoate 0.1% cream used twice daily. Use of tazarotene in conjunction with broad band UVB, narrow band UVB or bath psoralens + UVA (PUVA) results in greater efficacy than with phototherapy alone. Tazarotene should not be administered during pregnancy or in women who are not practicing adequate contraception. Adverse events consist primarily of irritation, peeling, erythema, dryness, burning, and itching. They are most common during the first 1-2 weeks of therapy and can be minimized with use of the cream formulation, alternate day application, short contact therapy, mild cleansers, and combination therapy.

Topics: Acne Vulgaris; Administration, Topical; Adrenal Cortex Hormones; Calcitriol; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Keratolytic Agents; Male; Maximum Tolerated Dose; Nicotinic Acids; Phototherapy; Psoriasis; Randomized Controlled Trials as Topic; Risk Assessment; Treatment Outcome

Classical topical treatment regimens in psoriasis including dithranol and corticosteroids are widely used and have been supplemented in recent years by topical vitamin D preparations, by vitamin D analogues and topical retinoids. The combination of these preparations with each other, with UV light or with systemic drugs often lead to improved effectiveness and tolerability when compared with the respective monotherapy. In private offices, the combination of calcipotriol with various corticosteroids is very commonly prescribed for patients with mild to moderate psoriasis. This combination can be sequentially applied twice daily or--in a newly introduced fixed preparation--once daily. In severe psoriasis requiring systemic treatment a concomitant effective topical treatment regimen can greatly improve the overall longtime management in affected patients.

Topics: Administration, Topical; Anti-Inflammatory Agents; Calcineurin Inhibitors; Calcitriol; Drug Therapy, Combination; Glucocorticoids; Humans; Psoriasis

Psoriasis can have a profound impact on a patient, interfering in all aspects of life. Therefore, measuring the impact of disease and the effects of treatment must include both physiologic measurements as well as health-related quality of life tools. Psychosocial evaluation of patients at risk allows for early interventions that will promote positive patient outcomes and compliance with the treatment pathways.

Topics: Activities of Daily Living; Anti-Inflammatory Agents; Attitude to Health; Body Image; Calcitriol; Health Status; Health Status Indicators; Humans; Nurse's Role; Nursing Diagnosis; Patient Care Planning; Psoriasis; PUVA Therapy; Quality of Life; Self Concept; Social Isolation; Treatment Refusal

A new compound product containing calcipotriol 50 nanograms per gm and betamethasone dipropionate 0.5mg per gm (Dovobet, LEO Pharma) in an ointment base was recently introduced in Canada for the treatment of psoriasis. Known as Daivobet in Europe, it was introduced to the Danish Market in 2001, and approved for marketing by the European Union. This compound has been shown to be more active than either agent used along. The efficacy of once daily application was not shown to be different from that of twice daily use.

Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Glucocorticoids; Humans; Ointments; Psoriasis

Psoriasis in the elderly will constitute a significant challenge for the practising physician in this new millennium. Special considerations for the elderly include drug-induced or drug-aggravated psoriasis, especially for patients receiving polypharmacy or with recent worsening or poor response to conventional therapy. Other frequently encountered forms of psoriasis in the elderly include psoriatic arthritis and its complications, inverse psoriasis and potentially life-threatening complications such as erythrodermic or acute pustular psoriasis, where early recognition and systemic therapy is critical. Faced with an array of topical and systemic drug therapy options, it is of paramount importance that the physician remains focused on the holistic management of the patient, in order to achieve optimal compliance and benefit. This can be achieved through careful attention to quality-of-life issues, especially since many elderly patients may have other medical, social and economic comorbidities that can further negatively affect their overall quality of life. It is also essential that the severity of psoriasis be assessed on a more balanced, holistic scale that incorporates both physical and psychological parameters, such as the Salford Psoriasis Index. The patient and caregiver education should be multi-faceted, regularly conducted and practically orientated. Treatment goals should be kept simple and individualised for each patient, based on concomitant comorbidities, potential adverse effects, existing quality of life, self-care capability, drug history, caregiver situation, financial needs, feasibility for follow-up and patient's preferences. Topically applied medications, such as topical corticosteroids, salicylic acid, tar and dithranol preparations, calcipotriol and tazarotene, are the favoured first-line therapeutic options in the elderly. Narrowband ultraviolet B phototherapy is also well established as a standard therapy for psoriasis. Systemic therapy with agents such as methotrexate, acitretin and cyclosporin should be judiciously reserved for severe, extensive cases in view of their lower therapeutic index in the elderly. The ambulatory psoriasis treatment centre is an integral part of the overall cost-effective management of patients with psoriasis that can function as a 'one-stop' treatment and resource centre for the elderly patient.

Topics: Administration, Topical; Adrenal Cortex Hormones; Aged; Arthritis, Psoriatic; Calcitriol; Dermatologic Agents; Humans; Immunotherapy; Phototherapy; Psoriasis; Quality of Life; Tars

A sequential therapy regimen involving an initial clearing phase of daily applications of calcipotriene 0.005% ointment and halobetasol 0.05% ointment for 2 weeks, followed by halobetasol applied twice daily on weekends and calcipotriene applied twice daily on weekdays, has been shown to be effective in the management of chronic plaque psoriasis. As a clearing regimen, the combined use of halobetasol and calcipotriene for 2 weeks was superior to monotherapy with either agent. Subsequently, the use of halobetasol on weekends and calcipotriene on weekdays allowed 76% of patients to stay in remission for up to 6 months, compared with 40% of patients who applied halobetasol on weekends only and placebo on weekdays. Calcipotriene can be inactivated when mixed with some topical preparations; however, halobetasol propionate 0.05% ointment and cream have been shown to be compatible with calcipotriene for up to 2 weeks. The compatibility of calcipotriene and halobetasol permits the use of these agents together.

Topics: Administration, Topical; Calcitriol; Clinical Trials as Topic; Clobetasol; Dermatologic Agents; Drug Administration Schedule; Drug Therapy, Combination; Humans; Ointments; Psoriasis; Treatment Outcome; Vasoconstrictor Agents

Several studies have examined the combination of calcipotriene and UVB radiation in the treatment of psoriasis. Most show greater clearing with the combination than with monotherapy with either treatment. Data from one study found that calcipotriene had a UVB-sparing effect when combined with broadband UVB phototherapy, resulting in fewer UVB exposures and a lower cumulative dose. This finding suggests that patients treated with calcipotriene may be able to achieve lesion clearing with less frequent UVB radiation treatments than those not treated with calcipotriene. The combination of calcipotriene and UVB radiation does not alter the tolerability or safety of therapy. Calcipotriene may be applied at any time up to 2 hours before or immediately after UVB radiation.

Topics: Calcitriol; Clinical Trials as Topic; Combined Modality Therapy; Dermatologic Agents; Humans; Psoriasis; Ultraviolet Therapy

The most frequently used systemic treatments for severe psoriasis are methotrexate (MTX), oral retinoids, and cyclosporine; however, all of these agents are associated with dose-related toxicities that limit their use. The safety and efficacy of topical calcipotriene for the treatment of psoriasis have been demonstrated in numerous clinical studies. The rationale for using calcipotriene in combination with systemic therapies is based on their different modes of action and nonoverlapping side effects. Three controlled clinical trials have demonstrated that the addition of calcipotriene ointment to systemic antipsoriatic treatment with MTX, acitretin, and cyclosporine increases the therapeutic efficacy compared with systemic therapy alone and minimizes side effects by either reducing the dosage or duration of treatment.

Topics: Acitretin; Administration, Oral; Administration, Topical; Calcitriol; Clinical Trials as Topic; Cyclosporine; Dermatologic Agents; Drug Therapy, Combination; Humans; Keratolytic Agents; Methotrexate; Ointments; Psoriasis

Calcipotriene has been shown to be safe and effective for the treatment of psoriasis. For scalp psoriasis, the safety advantage of this nonsteroid agent is as important as its efficacy. Even though monotherapy with calcipotriene solution may not always be efficacious for severe scalp psoriasis, many patients are managed effectively with a sequential therapy regimen consisting of 3 phases. In phase 1 (clearing), patients apply clobetasol solution or gel in the morning and calcipotriene solution in the evening daily for 2 weeks. After the scalp psoriasis improves, clobetasol is reduced to weekends and calcipotriene solution is applied on weekdays (phase 2, transitional). Phase 3 is maintenance on calcipotriene solution alone to prevent recurrence. For patients with recalcitrant scalp psoriasis-where only a clobetasol-strength, superpotent topical corticosteroid is effective-a flip-flop therapy regimen has been proposed that allows for the safe, prolonged use of clobetasol solution by limiting its treatment to twice a day for 2-week periods with the use of calcipotriene solution twice a day for a minimum of 2 weeks during the corticosteroid-free in-between periods.

Topics: Administration, Topical; Anti-Inflammatory Agents; Calcitriol; Clobetasol; Drug Administration Schedule; Drug Therapy, Combination; Gels; Glucocorticoids; Humans; Ointments; Psoriasis; Scalp; Treatment Outcome

Calcipotriol is a vitamin D analog, which has antiproliferative and anti- inflammatory effects, and stimulates terminal differentiation. It has been an established treatment for psoriasis since 1991 in Europe and 1994 in the USA.. To assess the clinical efficacy of topical calcipotriol in diseases other than psoriasis.. A total of 36 original papers were found describing 21 different diseases in which the clinical use of calcipotriol ointment was described as having an effect. These papers were predominantly case reports (n = 22) and observational studies (n = 5), but nine papers described small randomized controlled trials.. Calcipotriol may generally be effective in diseases characterized by pathogenic elements, such as impaired differentiation or increased keratinocyte proliferation, and activated T lymphocytes. This study of the existing literature suggests that randomized, double-blind, placebo-controlled studies of calcipotriol therapy may be worthwhile in a number of diseases.

Topics: Calcitriol; Dermatologic Agents; Humans; Psoriasis; Skin Diseases

There is clinical uncertainty about the appropriate use of first-line topical treatments for psoriasis.. To assess the relative effectiveness and tolerability of topical treatments for psoriasis suitable for use both in primary and secondary care.. All major medical databases of published literature were searched electronically; references of trial reports and recent reviews were searched; authors and companies were contacted for missing data from published reports. The study selection comprised: (1) randomized placebo-controlled trials of topical treatments for psoriasis; and (2) randomized head-to-head studies of the new vitamin D3 derivative treatments for psoriasis that reported clinical outcome using a Total Severity Score (TSS), Psoriasis Area Severity Index or Investigator Assessment of Global Improvement. Eligibility and validity were assessed and data extracted independently by two authors. Clinical outcomes were pooled using a random effect standardized weighted mean difference (SWMD) metric, including 3380 patients randomized in 41 placebo (vehicle)-controlled trials and 4898 patients randomized in 28 head-to-head studies.. There was a significant benefit in favour of active treatments against vehicle, SWMD: -1.06 (95% confidence interval [CI]: -1.26 to -0.86), approximately a 2-point improvement on a 12-point TSS after 6-8 weeks of treatment. The only significantly different benefit was for very potent corticosteroids: SWMD: -1.51 (95% CI: -1.76 to -1.25), approximately a 3-point improvement on a 12-point TSS. Head-to-head studies support these findings, except that calcipotriol was estimated to be more effective than dithranol, coal tar and other vitamin D3 derivatives. Polytherapy, using a potent steroid and calcipotriol, was more effective than calcipotriol alone: SWMD 0.42 (95% CI: 0.12-0.72 ) approximately a 0.8-point improvement on a 12-point TSS. No important differences in withdrawal or reporting of adverse events were identified.. Trials of short duration neither adequately inform the management of chronic disease nor describe the sequelae of treatment. The evidence base for long-term care, reflecting the disease pathway, should be improved. Combination therapy with topical vitamin D analogues and steroids, and maintenance therapy following treatment response merit further investigation.

Topics: Administration, Cutaneous; Administration, Topical; Anti-Inflammatory Agents; Calcitriol; Drug Therapy, Combination; Glucocorticoids; Humans; Primary Health Care; Psoriasis; Randomized Controlled Trials as Topic; Treatment Outcome

Topics: Administration, Topical; Anti-Inflammatory Agents; Cholecalciferol; Clinical Trials as Topic; Glucocorticoids; Humans; Immunosuppressive Agents; Ligands; Methotrexate; Psoriasis; Receptors, Cytoplasmic and Nuclear; Receptors, Steroid; Vitamin A

Topics: Calcitriol; Clobetasol; Dermatologic Agents; Goals; Humans; Information Services; Internet; Nurse Practitioners; Patient Care Planning; Primary Health Care; Psoriasis; Quality of Life; Vasoconstrictor Agents

Day care treatment centres provide the best solution for the treatment of most patients with psoriasis. The centre is not only ideal for treatment but has other roles, such as education of patients and nurses. The specialist dermatology nurse is the key to success. Out patient treatment of psoriasis is less expensive than in patient treatment. The development of a treatment centre should be seen as an additional facility and not as a substitute for in patient beds.

Topics: Administration, Topical; Anti-Inflammatory Agents; Calcitriol; Coal Tar; Dermatologic Agents; Dermatology; Glucocorticoids; Humans; Nurse Clinicians; Outpatient Clinics, Hospital; Patient Education as Topic; Psoriasis; PUVA Therapy; Retinoids; Ultraviolet Therapy

Long-term management of psoriasis requires an individualized approach. Some treatments such as calcipotriol, methotrexate and acitretin may be used as maintenance treatment for many months. However, most anti-psoriasis treatments should be prescribed for restricted periods of time. Rotational treatment is a practical approach to reduce the cumulative toxicity of anti-psoriasis treatments. The selection of a treatment is based on the clinical presentation of psoriasis and whether contraindications might exist. Combination treatment is another approach, which is used by the majority of patients. Useful combinations are calcipotriol-acitretin, calcipotriol-cyclosporin, calcipotriol-PUVA, calcipotriol-topical corticosteroids, dithranol-UVB, dithranol-tar, coaltar-UVB, acitretin-UVB and acitretin-PUVA. Combinations which are contraindicated are coaltar-PUVA, UVB-cyclosporin, PUVA-cyclosporin and methotrexate-acitretin. Combined use of UVB-methotrexate, UVB-PUVA; PUVA-methotrexate; methotrexate-cyclosporin and cyclosporin-acitretin require careful monitoring and might be helpful in patients with severe and recalcitrant psoriasis. Depending on the individual presentation of psoriasis, previous anti-psoriatic treatments and side-effects, treatment adjustments are made.

Topics: Acitretin; Administration, Topical; Anti-Inflammatory Agents; Autoimmune Diseases; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Therapy, Combination; Fumarates; Glucocorticoids; Humans; Immunosuppressive Agents; Keratolytic Agents; Methotrexate; Phototherapy; Psoriasis; PUVA Therapy

Monotherapy with vitamin D analogues has been shown to be effective in the treatment of psoriasis. Vitamin D analogues have also been used in combination with other topical therapies, systemic therapies and phototherapy. In many instances, the efficacy of these other treatments can be maximized and adverse effects minimized when combined with vitamin D analogues. The combination of a topical corticosteroid with a vitamin D analogue can work synergistically to improve efficacy and reduce the side-effects from both treatments. However, caution must be used when mixing the two agents, as some topical corticosteroids will result in the degradation of the vitamin D analogue. Benefit from phototherapy is also increased when using vitamin D analogues, so that greater improvement occurs with fewer treatments. Effects on minimal erythema dose must be considered and the potential for ultraviolet blocking by vitamin D analogues may affect treatment. Some vitamin D analogues may also be susceptible to degradation by certain wavelengths of ultraviolet light. Combining vitamin D analogues with systemic agents exerts a dose-sparing effect, thus reducing the possibility of side-effects, but such combinations require further study. As long as treatments are used correctly, the benefits of combination therapy with vitamin D analogues usually outweigh the few drawbacks.

Topics: Calcitriol; Combined Modality Therapy; Dermatologic Agents; Drug Therapy, Combination; Humans; Phototherapy; Psoriasis; Ultraviolet Therapy; Vitamin D

Psoriasis of the scalp is a frequently occurring condition affecting approximately 2% of the Western population. The sharply demarcated erythematosquamous lesions with silver-white scaling characterize scalp psoriasis. Quality of life can be seriously reduced by this condition and therefore long term treatment is needed in most patients. Coal tar shampoos, containing 2 to 10% coal tar solution, are effective in scalp psoriasis. However, no double-blind studies are available to support such an assumption. Salicylic acid 5 to 10% has a pronounced keratolytic effect. Salicylic acid should be formulated in an ointment, which can be washed off easily. Crude coal tar is the most effective tar available for the treatment of psoriasis. An important feature of coal tar is its potent efficacy against pruritus. At the scalp, the application of crude coal tar is difficult. Therefore coal tar solution is the most frequently applied tar preparation in scalp psoriasis. Dithranol 0.1 to 3% is manufactured in various formulations. Treatment is initiated at a low concentration and the concentration is increased stepwise until a slight irritation, the feeling of warmth, is reached. In the treatment of scalp psoriasis, cream formulations are used. Imidazole antifungals have been used with success in scalp psoriasis. Overgrowth of the scalp with pityrosporon is a well-known feature of scalp psoriasis and seborrheic dermatitis. In case of resistance to other topical treatments use of a topical or systemic imidazole derivative might be helpful. So far, topical corticosteroids are the most frequently used treatments for psoriasis of the scalp. Corticosteroids inhibit epidermal proliferation, inhibit inflammation and modulate immune functions. Topical corticosteroids are fast acting: within 3 to 4 weeks maximal efficacy is reached. No data are available to support the efficacy and safety of topical corticosteroids during long term use. However, from epidemiologic surveys we know that these treatments are used by the majority of patients for more than 8 weeks. Since 1992 vitamin D3 formulations have been developed for the treatment of psoriasis. Calcipotriol is available in most countries. Tacalcitol is available in Japan and several other countries. Vitamin D3 analogues inhibit epidermal proliferation, enhance cornification and inhibit inflammation. Therefore, vitamin D3 analogues have a substantial antipsoriatic effect. Systemic treatments such as methotrexate, cyclosporine and

Topics: Administration, Cutaneous; Administration, Topical; Anthralin; Anti-Inflammatory Agents; Antifungal Agents; Calcitriol; Coal Tar; Diagnosis, Differential; Hair Preparations; Humans; Imidazoles; Keratolytic Agents; Patient Selection; Psoriasis; Salicylic Acid; Scalp Dermatoses; Severity of Illness Index

Calcipotriol, a vitamin D3 analog, acts not only to inhibit cell proliferation and enhance cell differentiation in the skin of patients with psoriasis, but also appears to have effects on immunologic markers that are thought to play a role in the etiology of the disease. In several well designed, short term studies in adults, calcipotriol ointment 50 micrograms/g twice daily provided similar or superior efficacy to several other antipsoriatic agents in adult patients with mild to moderate psoriasis. In patients with nonscalp psoriasis, the drug provided superior efficacy to twice daily placebo (vehicle ointment), twice daily fluocinonide 500 micrograms/g, once daily tacalcitol 4 micrograms/g and twice daily coal tar 5% plus allantoin 2% and hydrocortisone 0.5%. Furthermore, calcipotriol therapy generally provided superior efficacy to twice daily betamethasone valerate 1 to 1.2 mg/g or once daily dithranol 1 to 20 mg/g, and similar efficacy to twice daily betamethasone dipropionate plus salicylic acid or once daily maxacalcitol 6 to 50 micrograms/g. Limited data indicated that calcipotriol ointment 50 micrograms/g also improved overall disease severity in children. In combination with other antipsoriatic agents [acitretin, cyclosporine, betamethasone valerate, halobetasol (ulobetasol)], ultraviolet B or psoralen ultraviolet A (PUVA) phototherapy, calcipotriol ointment 50 micrograms/g twice daily improved the beneficial effects of these drugs on overall disease severity in adult patients with moderate to severe psoriasis. Furthermore, in separate trials, calcipotriol combination therapy reduced the dosage of acitretin required to achieve clearance of psoriasis and the duration of PUVA and dosage of UVA phototherapy, potentially improving the benefit/risk ratio for these other antipsoriatic treatments. Calcipotriol was generally well tolerated in short and long term studies in adult patients, with the majority of adverse events being mild to moderate in intensity and transient. The most common adverse events associated with calcipotriol therapy were dermatologic in nature and included lesional or perilesional irritations, face and scalp irritations, worsening of psoriasis and miscellaneous dermatologic events. Notably, there have been very few reports of patients developing hypercalcemia or hypercalciuria during calcipotriol therapy, with most occurring in patients who exceeded the recommended dosage of 100 g/week. Although data in children are limited, the. Extensive clinical experience, along with several short and long term clinical trials, has shown calcipotriol ointment to be an effective and well tolerated topical agent in adult patients with psoriasis. In addition, calcipotriol ointment proved beneficial in combination with other topical, phototherapy or systemic antipsoriatic treatments, reducing the dosage and/or duration of some of these treatments and potentially improving their benefit/risk ratio. Calcipotriol ointment is valuable as a first- or second-line therapy option for the management of mild to moderate psoriasis and in combination with other antipsoriatic agents for more severe psoriasis.

Topics: Administration, Topical; Adolescent; Adult; Calcitriol; Child; Child, Preschool; Dermatologic Agents; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Ointments; Psoriasis

Psoriasis affects more than 6% of Australian adults. While rarely life threatening it can have an enormous psychosocial impact on sufferers.. To outline the treatment options for psoriasis.. Localised psoriasis can usually be managed by topical therapy but more widespread psoriasis will require stronger treatments such as ultraviolet light, or various oral therapies. There is a great deal of psoriasis research underway and a number of new treatments have evolved over the past few years, some of which have yet to be released in Australia. As with any medical therapy the risks of the treatment must be weighed against the likely benefits. The patient needs to have an informed, sympathetic doctor to discuss the various available options.

Topics: Administration, Oral; Administration, Topical; Adrenal Cortex Hormones; Anthralin; Calcitriol; Coal Tar; Dermatologic Agents; Emollients; Humans; Psoriasis; Quality of Life; Ultraviolet Therapy

Because physicians from different nations frequently acquire the use of a new medication at different times, the international exchange of experiences with the new medication is valuable in maximizing its efficacy worldwide. In recent years, many new therapeutic agents have been approved for treating psoriasis in the United States. These include the topical agent calcipotriol and the systemic agents acitretin and cyclosporine. In addition to new agents, a new therapeutic paradigm, sequential therapy, has been introduced recently. It is the hope of the authors that by sharing this paradigm and experiences with these agents in the United States, dermatologists in Japan may gain further insight into optimizing the use of these agents in the treatment of psoriasis.

Topics: Acitretin; Calcitriol; Clobetasol; Cyclosporine; Dermatologic Agents; Humans; Photochemotherapy; Psoriasis; United States

Topical corticosteroids are important in psoriasis therapy. However, there are other worthwhile options available including tar, anthralin, tazarotene, calcipotriol, topical PUVA, and topical porphyrin derivatives. With growing public reluctance to use systemic medications, topical treatments for psoriasis could become increasingly important in the future.

Topics: Administration, Topical; Adrenal Cortex Hormones; Anthralin; Anti-Inflammatory Agents; Calcitriol; Dermatologic Agents; Female; Humans; Male; Nicotinic Acids; Psoriasis; Sensitivity and Specificity

To evaluate the comparative efficacy and tolerability of topical calcipotriol in the treatment of mild to moderate chronic plaque psoriasis.. Quantitative systematic review of randomised controlled trials.. 6038 patients with plaque psoriasis reported in 37 trials.. Mean difference in percentage change in scores on psoriasis area and severity index, and response rate ratios for both patients' and investigators' overall assessments of marked improvement or better. Adverse effects were estimated with the rate ratio, rate difference, and number needed to treat.. Calcipotriol was at least as effective as potent topical corticosteroids, calcitriol, short contact dithranol, tacalcitol, coal tar, and combined coal tar 5%, allantoin 2%, and hydrocortisone 0.5%. Calcipotriol caused significantly more skin irritation than potent topical corticosteroids (number needed to treat to harm for irritation 10, 95% confidence interval 6 to 34). Calcipotriol monotherapy also caused more irritation than calcipotriol combined with a potent topical corticosteroid (6, 4 to 8). However, the number needed to treat for dithranol to produce lesional or perilesional irritation was 4 (3 to 5). On average, treating 23 patients with short contact dithranol led to one more patient dropping out of treatment owing to adverse effects than if they were treated with calcipotriol.. Calcipotriol is an effective treatment for mild to moderate chronic plaque psoriasis, more so than calcitriol, tacalcitol, coal tar, and short contact dithranol. Only potent topical corticosteroids seem to have comparable efficacy at eight weeks. Although calcipotriol caused more skin irritation than topical corticosteroids this has to be balanced against the potential long term effects of corticosteroids. Skin irritation rarely led to withdrawal of calcipotriol treatment. Longer term comparative trials of calcipotriol versus dithranol and topical corticosteroids are needed to see whether these short term benefits are mirrored by long term outcomes such as duration of remission and improvement in quality of life.

Topics: Administration, Topical; Allantoin; Anti-Inflammatory Agents; Calcitriol; Coal Tar; Dermatologic Agents; Drug Administration Schedule; Glucocorticoids; Humans; Hydrocortisone; Psoriasis

Within the past decade it has been shown that psoriasis can be treated topically with analogs of vitamin-D3. Impaired differentiation and increased proliferation of keratinocytes are key features in psoriatic lesions together with a local activation of T lymphocytes. Evidence has accumulated showing that analogs of vitamin D3 increase differentiation and inhibit proliferation of keratinocytes. Therefore, analogs of vitamin D3 have been investigated in a number of trials showing improvement of psoriasis. It has been shown that vitamin D analogs are better than their vehicle and show the same potency as potent topical steroids. However, vitamin D analogs have been proven efficacious and without side effects also when used on long term basis. Vitamin D analogs can be used both as monotherapy and in combination topical steroids, UVB, PUVA, retinoids and cysclosporine. The vitamin D3 analog calcipotriol has been investigated in most detail and is available as an ointment, a creme and as a scalp solutation. From clinical studies involving thousands of patients, it can be concluded that calcipotriol is efficacious, safe, well tolerated and can be used on a long term basis. Other analogs are available, however, these analogs have not been studied in greater details yet.

Topics: Calcitriol; Cholecalciferol; Dermatologic Agents; Dihydroxycholecalciferols; Drug Therapy, Combination; Humans; Psoriasis

In the hope of increasing efficacy and improving safety, several combination regimens involving tazarotene gel have been explored for the treatment of plaque psoriasis. A number of large-scale studies have shown that the adjunctive use of a mid-potency or high-potency steroid can enhance both the efficacy and tolerability of tazarotene treatment. A small pilot study also suggested improved efficacy when used in combination with calcipotriene. Likewise, the adjunctive use of tazarotene can enhance the efficacy and potentially the safety of treatment with steroids, broad-band and narrow-band UVB phototherapy, and psoralens plus UVA bath therapy.

Topics: Adrenal Cortex Hormones; Calcitriol; Drug Therapy, Combination; Humans; Keratolytic Agents; Nicotinic Acids; Psoriasis; PUVA Therapy; Treatment Outcome

To examine the efficacy and tolerability of calcipotriene combined with phototherapy or systemic therapies compared with monotherapy for the treatment of chronic plaque psoriasis.. Quantitative systematic review of 11 randomized controlled trials involving a total of 756 patients with plaque psoriasis.. Rate ratios (RRs) for marked improvement or clearance in patient and investigator overall assessments of response; mean difference in percentage change in Psoriasis Area and Severity Index; and RRs for clearance in patient and investigator overall assessments of response. Adverse effects were estimated with the RR and the rate difference in terms of withdrawal rate, proportion of patients experiencing adverse events, and proportion of patients with cutaneous and noncutaneous adverse effects.. Antipsoriatic effects of acitretin, cyclosporine, and psoralen-UV-A phototherapy were enhanced with the addition of topical calcipotriene using the Psoriasis Area and Severity Index as the outcome, but this is not translated into an increase in the number of patients who achieve at least marked improvement. At the end of treatment, the RRs for marked improvement or clearance in patient assessments were as follows: calcipotriene plus acitretin vs acitretin alone (12 weeks), 1.4 (95% confidence interval [CI], 1.0-1. 9); calcipotriene plus cyclosporine vs cyclosporine alone (6 weeks), 1.2 (95% CI, 0.9-1.6); and calcipotriene plus psoralen-UV-A vs psoralen-UV-A alone (12 weeks), 1.2 (95% CI, 0.9-1.6). Patients were also no more likely to obtain marked improvement or better with calcipotriene plus UV-B therapy than with UV-B therapy alone (RR, 1. 0; 95% CI, 0.8-1.1 at 8 weeks in the patient assessment). There is limited evidence that use of calcipotriene might reduce the cumulative exposure to phototherapy and systemic treatment. During the short duration of these trials, there were no significant differences in withdrawal rates or adverse effects between the combined regimens and their corresponding monotherapy control interventions.. Overall, there is insufficient evidence to support any large effects in favor of combination treatment. In the patient assessments, the results do not show an adjuvant effect, but there is some evidence that use of calcipotriene might reduce cumulative exposure to systemic therapy to obtain clearance. There were no long-term morbidity data on the effectiveness of any of the combinations studied. Given that psoriasis is a chronic recurrent disease for most patients, longer trials are needed to determine whether the addition of topical calcipotriene to systemic therapy improves the risk-benefit ratio by reducing the long-term risk of toxic effects. Equally important is the need to examine the impact of such combinations on the duration of remission after treatment.

Topics: Administration, Cutaneous; Calcitriol; Chronic Disease; Dermatologic Agents; Drug Administration Schedule; Drug Therapy, Combination; Humans; Phototherapy; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome

A 64-year-old woman developed an itchy papulovesicular dermatitis at the periphery of psoriatic plaques on the lower legs after the daily application of calcipotriol ointment (Psorcutan Salbe) for 2 weeks. She had used the same ointment for 4 weeks 6 months before. Patch testing revealed strongly positive reactions to the marketed product and to the active ingredient calcipotriol in a concentration series (2.0, 10.0 and 50.0 microg/ml in isopropyl alcohol). A repeated open application test (ROAT) on the forearms showed a vesicular dermatitis after 4 days on the side that received the calcipotriol ointment, whereas the control with the placebo ointment remained completely negative. Histologic examination of the + + patch test reaction was in line with the picture of contact allergy. Retesting after 6 months confirmed the hypersensitivity, with a positive reaction even at 0.4 microg/ml. For comparison, the ROAT with calcipotriol ointment was performed for 2 weeks on both forearms of 15 volunteers never exposed to calcipotriol before. Only 2 subjects developed a slight reaction on days 5 and 11, respectively. Based on this case and on previous reports in the literature, calcipotriol must now be regarded as both a contact allergen and an irritant. For patch testing, a concentration of 2 microg/ml in isopropyl alcohol is the most suitable. If the reaction is only weakly positive and not reproducible after some time, it might be of the irritant type. In unclear cases, a ROAT should be performed. A severe papulovesicular dermatitis within 1 week will confirm the presence of contact allergy.

Topics: Administration, Cutaneous; Calcitriol; Dermatitis, Allergic Contact; Dermatologic Agents; Dose-Response Relationship, Drug; Female; Humans; Middle Aged; Ointments; Patch Tests; Psoriasis

Psoriasis is a common dermatosis, affecting from 1 to 3 percent of the population. Until recently, the mainstays of topical therapy have been corticosteroids, tars, anthralins and keratolytics. Recently, however, vitamin D analogs, a new anthralin preparation and topical retinoids have expanded physicians' therapeutic armamentarium. These new topical therapies offer increased hope and convenience to the large patient population with psoriasis.

Topics: Administration, Cutaneous; Administration, Topical; Anthralin; Anti-Inflammatory Agents; Calcitriol; Coal Tar; Dermatologic Agents; Humans; Keratolytic Agents; Nicotinic Acids; Patient Education as Topic; Psoriasis; Retinoids; Teaching Materials; Vitamin D

Calcipotrial has a well-documented effect in the treatment of psoriasis.. To confirm the beneficial effect of the combination of calcipotriol and UVB and to demonstrate that the combination is safe and well tolerated.. Data from two randomized right/left studies were analysed. Patients included in the studies had chronic stable plaque-type psoriasis with symmetrical lesions on the arms, the legs and/or the trunk. In one study, 101 patients were treated with calcipotriol on one side and calcipotriol + UVB on the other side of the body (open study). In the other study, 77 patients were treated with calcipotriol + UVB on one side and vehicle + UVB on the other side of the body (double-blind study). Calcipotriol ointment, 50 microg/g, was applied twice daily and UVB 3 times weekly for 8 weeks. UVB was increased from 0.7 MED before treatment in rapid steps up to the erythema threshold.. In both treatment series the therapeutic effect of the combination of calcipotriol and UVB was enhanced as compared to calcipotriol alone and UVB alone. In the first series there was a significant reduction of the psoriasis area and severity index (PASI) with the combination after 2 weeks as compared to calcipotriol alone. At the end of treatment significantly more sides were cleared after calcipotriol + UVB than after calcipotriol alone. In the other series there was a significantly faster onset of improvement on the sides treated with calcipotriol + UVB than on those treated with vehicle + UVB. After 2 weeks there was a significant difference in PASI in favour of calcipotriol + UVB. At the end of treatment, however, there was no difference between the treatments. There was a similar adverse event profile with either treatment. The addition of UVB to calcipotriol did not alter the tolerability or safety of topically applied calcipotriol.. The result indicates a beneficial effect of combining calcipotriol and phototherapy. The findings are compared to other published studies.

Topics: Administration, Cutaneous; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Female; Folliculitis; Follow-Up Studies; Humans; Male; Phototherapy; Psoriasis; Severity of Illness Index; Skin; Sunburn; Treatment Outcome; Ultraviolet Rays

This is an update of a previous report on the use of topical steroids in the management of psoriasis vulgaris. The current focus is on new combination therapies that enhance the efficacy of corticosteroids while diminishing their potential side effects.

Topics: Administration, Topical; Anti-Inflammatory Agents; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Glucocorticoids; Humans; Nicotinic Acids; Prednisolone; Psoriasis

An individualized treatment regimen is necessary for each patient with psoriasis because of the diverse nature of the disease. The manifestation of psoriasis, the severity and extent of the lesions, and the medical history and lifestyle of the patient are important factors that determine the selection of treatment, but in general therapies with the fewest side effects are preferred. First-line topical treatments are corticosteroids, calcipotriene, and tazarotene. If topical treatments are unsuccessful, phototherapy with ultraviolet B or photochemotherapy with psoralens plus ultraviolet A (PUVA) are the next choices. If psoriasis fails to respond to an adequate trial of topical therapy or phototherapy, systemic therapies including methotrexate, acitretin, or cyclosporin should be initiated. Because the regimens involved in systemic and phototherapy are complex and require frequent dose adjustments and specialized equipment, the patient should be referred to a dermatologist when topical therapy is not effective.

Topics: Administration, Cutaneous; Adrenal Cortex Hormones; Calcitriol; Cyclosporine; Dermatologic Agents; Diagnosis, Differential; Drug Therapy, Combination; Humans; Keratolytic Agents; Methotrexate; Nicotinic Acids; Phototherapy; Psoriasis; PUVA Therapy; Retinoids; Severity of Illness Index; United States

Topics: Administration, Topical; Calcitriol; Dermatologic Agents; Humans; Nicotinic Acids; Psoriasis

Topics: Calcitriol; Dermatologic Agents; Diagnosis, Differential; Foot Dermatoses; Hand Dermatoses; Humans; Keratolytic Agents; Psoriasis; PUVA Therapy

Topics: Absorption; Acitretin; Administration, Cutaneous; Calcitriol; Chemistry, Pharmaceutical; Clinical Trials as Topic; Cyclosporine; Dermatologic Agents; Humans; Immunosuppressive Agents; Keratolytic Agents; Ointments; Psoriasis

Topics: Acitretin; Aged; Aged, 80 and over; Calcitriol; Cyclosporine; Dermatitis, Exfoliative; Dermatologic Agents; Drug Combinations; Humans; Immunosuppressive Agents; Keratolytic Agents; Male; Methotrexate; Middle Aged; Prognosis; Psoriasis

Topics: Calcitriol; Dermatologic Agents; Humans; Psoriasis

Calcipotriol/calcipotriene (Dovonex/Daivonex) ointment plus phototherapy has been used in the treatment of psoriasis.. We will attempt to clarify two issues: First, is there any benefit to combining the above treatment modalities? Second, is there any increased risk associated with the use of the combination?. A complete review of the literature revealed four studies dealing with the combination of calcipotriol with UVB phototherapy and three studies dealing with the combination of calcipotriol with PUVA phototherapy.. These studies showed an advantage to the use of the combination compared with the use of either treatment alone.. Topical calcipotriol enhances the effect of UVB and PUVA phototherapy.

Topics: Calcitriol; Combined Modality Therapy; Controlled Clinical Trials as Topic; Dermatologic Agents; Humans; Multicenter Studies as Topic; Phototherapy; Psoriasis; PUVA Therapy; Risk; Ultraviolet Therapy

The vitamin D analog calcipotriene/calcipotriol (Dovonex/Daivonex) offers advantages over other forms of topical therapy in some patients with psoriasis.. We review the studies of the use of calcipotriol alone in the management of psoriasis.. The literature concerning topical calcipotriol therapy was reviewed.. Calcipotriol compares well with other standard forms of topical therapy for psoriasis. Irritation of the skin may occur but is generally mild. Treatment can often be restarted after the irritation has cleared.. Treatment with calcipotriol ointment, cream, or solution is effective and safe in many patients with psoriasis.

Topics: Administration, Cutaneous; Calcitriol; Dermatologic Agents; Follow-Up Studies; Humans; Irritants; Ointments; Psoriasis; Randomized Controlled Trials as Topic; Safety; Solutions

Plaque-type psoriasis may at times require systemic therapy. There are limited data as to whether topical calcipotriene ointment 0.005% can be used to increase the efficacy and improve the risk/benefit ratio of concurrent systemic antipsoriatic therapy.. We attempt to answer this question by means of a literature review and results of a written survey that was sent to 100 international psoriasis treatment experts.. The survey was sent to academic and psoriasis treatment center-based dermatologists who treat approximately 3000 to 4000 patients with psoriasis per month. The survey requested that dermatologists relate their experience regarding the safety and efficacy of topical, systemic, and combined topical/systemic agents in psoriasis after 8 weeks of therapy.. The results of the survey support the experience in the literature regarding the favorable use of calcipotriene ointment combined with systemic therapy for the treatment of psoriasis.. Combination therapy with calcipotriene ointment and acitretin/etretinate, cyclosporine, methotrexate, or phototherapy usually enhances efficacy while improving the risk/benefit ratio by decreasing exposure to the potentially hazardous systemic agent.

Topics: Acitretin; Administration, Topical; Calcitriol; Combined Modality Therapy; Cyclosporine; Dermatologic Agents; Drug Synergism; Drug Therapy, Combination; Etretinate; Humans; Immunosuppressive Agents; Keratolytic Agents; Methotrexate; Ointments; Phototherapy; Psoriasis; Risk; Safety; Treatment Outcome

Side effects of topical corticosteroids limit their long-term use. Calcipotriene/calcipotriol (Dovonex/Daivonex) ointment is not associated with any of the side effects of corticosteroids and has been shown to thicken the skin in contrast to the cutaneous atrophy caused by topical steroids.. We attempted to determine whether the addition of calcipotriene to a regimen of topical steroids results in an improved benefit/risk ratio.. Published and unpublished data on combination regimens were reviewed.. In long-term regimens for psoriasis, substituting calcipotriene for topical corticosteroids may result in a steroid-sparing effect. Conversely, topical corticosteroids may suppress the development of local cutaneous irritation that occurs in patients treated with calcipotriene ointment.. Psoriasis regimens combining calcipotriene ointment with superpotent steroids such as halobetasol ointment can result in greater improvement and fewer side effects.

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Atrophy; Calcitriol; Clobetasol; Dermatitis, Irritant; Dermatologic Agents; Drug Combinations; Drug Interactions; Glucocorticoids; Humans; Irritants; Longitudinal Studies; Ointments; Psoriasis; Risk; Skin

Topical calcipotriene ointment has been approved for the treatment of plaque-type psoriasis.. This article explores the possible use of topical calcipotriene ointment in the treatment of nail and intertriginous psoriasis, palmoplantar and pustular psoriasis, Reiter's syndrome, pityriasis rubra pilaris, and disorders of keratinization.. The recent literature is reviewed.. Recent reports suggest that certain ichthyoses (particularly the hyperproliferative variants) and keratodermas may respond to topical calcipotriene ointment. The activity of calcipotriene relates to a dose-dependent decrease in proliferation and an increase in terminal differentiation of keratinocytes.. Patients with other disorders characterized by epidermal hyperproliferation may also be candidates for treatment. The use of calcipotriene in treating congenital hyperproliferative disorders is limited by the theoretical risk of hypercalcemia from absorption of the drug after application to extensive areas of skin.

Topics: Administration, Topical; Arthritis, Reactive; Calcitriol; Cell Differentiation; Cell Division; Dermatologic Agents; Dose-Response Relationship, Drug; Foot Dermatoses; Hand Dermatoses; Humans; Hypercalcemia; Ichthyosis; Keratinocytes; Keratosis; Nail Diseases; Ointments; Pityriasis Rubra Pilaris; Psoriasis; Skin Absorption; Skin Diseases

Topics: Administration, Topical; Anti-Inflammatory Agents; Calcitriol; Dermatologic Agents; Glucocorticoids; Humans; Photochemotherapy; Psoriasis; Retinoids

Two patients with psoriasis were treated with calcipotriol cream, and both developed contact dermatitis. Patch test results were positive to calcipotriol and negative to the ingredients of the vehicle in both cases. The first case may be explained by a compound allergy or by a false-negative reaction to calcipotriol due to the very low concentration used for patch tests. The second patient was clearly positive to calcipotriol despite low concentration. This is the first case reported thus far with sensitivity to calcipotriol at a concentration < 2 mc/mL, as recommended in other studies.

Topics: Administration, Topical; Calcitriol; Dermatitis, Allergic Contact; Dermatologic Agents; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Patch Tests; Psoriasis

This article takes a historical perspective and makes an assessment of current and future changes in the treatment of psoriasis and cutaneous fungal infections. Both medical and physical therapies in the management of psoriasis are reviewed and an assessment of the new approaches, compared with the old, is made. The vexing problem of cutaneous fungal infections is considered and the newer topical preparations are reviewed. With the arrival of these newer products improved outcomes for psoriasis and cutaneous fungal infections are being found.

Topics: Antifungal Agents; Calcitriol; Dermatologic Agents; Dermatomycoses; Female; Humans; Male; Psoriasis; PUVA Therapy; Treatment Outcome

Topics: Calcitriol; Dermatologic Agents; Humans; Long-Term Care; Prospective Studies; Psoriasis; Randomized Controlled Trials as Topic

Vitamin D and its analogues are effective in the treatment of psoriasis. The principal concern about the use of these agents is the possibility of adverse effects on systemic calcium homeostasis. We review the effects of vitamin D and its analogues on systemic calcium homeostasis and discuss the implications for patients with psoriasis.

Topics: Calcitriol; Calcium; Dermatologic Agents; Homeostasis; Humans; Psoriasis

Vitamin D3 analogs interfere with various aspects of epidermal growth, inflammation, and cellular differentiation. Most data are derived from in vitro studies. In the present review, the in vivo effects of vitamin D3 analogues on the psoriatic plaque are discussed. Calcipotriol, tacalcitol, and calcitriol in ointment modulate aspects of epidermal growth, differentiation, and inflammation. Immunohistochemical studies suggest that the inflammatory changes might be more expressed after treatment with calcitriol and tacalcitol. Flow cytometric quantification of the percentage of cells in SG2M phase and of keratin 10-positive cells revealed that calcipotriol reduced both indices significantly during treatment of psoriatic plaques. Flow cytometric analysis of epidermal cell suspensions using triple labeling for epidermal proliferation, expression of keratin 10, and vimentin permits a quantitative assessment of DNA synthesis selectively in the basal cells of the epidermis, an estimation of the distribution of the basal and suprabasal compartments, and a quantification of the distribution of mesenchymal and nonmesenchymal cells. Using this approach, the interference of tacalcitol with growth control of basal cells was demonstrated. Remarkably, recompartmentalization of basal and suprabasal cells and mesenchymal and nonmesenchymal cells proved to be inconspicuous during this treatment.

Topics: Calcitriol; Dihydroxycholecalciferols; Epidermis; Flow Cytometry; Humans; Immunohistochemistry; Inflammation; Psoriasis

Psoriasis, a common skin disorder, affects over 1 percent of the population of the United States. The majority of these patients have limited disease that can be managed with topical therapy. Topical treatment includes corticosteroids, tar, anthralin and keratolytic agents. Calcipotriene, a new topical treatment for psoriasis of mild to moderate severity, is a vitamin D derivative that inhibits epidermal cell proliferation in vitro. Treatment with calcipotriene results in decreased redness, scaling and thickness of the plaque. Calcipotriene is comparable to mid-potency topical corticosteroids in efficacy, but it does not cause skin atrophy and apparently does not lead to tachyphylaxis. Irritant dermatitis is a common side effect of calcipotriene, especially when it is applied to the face. Careful patient monitoring is recommended because alterations in calcium metabolism have been reported to occur with use of calcipotriene.

Topics: Calcitriol; Dermatologic Agents; Humans; Patient Education as Topic; Psoriasis

Vitamin D is best known for its role in the regulation of calcium and bone metabolism. The effects of the biologically active form of vitamin D, 1,25-dihydroxyvitamin D3 (1,25 (OH)2D3), are mediated by binding to a specific intracellular vitamin D receptor, which is present in most tissues including the skin where it regulates the growth of epidermal cells. Calcipotriol is a synthetic analogue of 1,25(OH)2D3. In vitro the activity of calcipotriol is comparable to that of 1,25(OH)2D3. In vivo, however, the risk of calcipotriol changing calcium metabolism is greatly reduced. Animal studies have established that calcipotriol is 100-200 times less calcaemic than 1,25(OH)2-D3. This low calcaemic activity is mainly due to the rapid metabolism of calcipotriol. This pharmacological profile makes calcipotriol an ideal candidate for topical treatment of hyperproliferative skin disorders, such as psoriasis. This paper reviews the clinical experience with calcipotriol in psoriasis patients.

Topics: Administration, Topical; Calcitriol; Calcium; Cell Differentiation; Cell Division; Dermatologic Agents; Humans; Psoriasis; Receptors, Calcitriol

The natural form of vitamin D3, 1,25-dihydroxyvitamin D3, modulates epidermal proliferation and differentiation and inhibits immune induction. Calcipotriol (calcipotriene) is a synthetic vitamin D analogue that partially separates the newly identified effects from the classic hypercalcemic effect. Topical treatment with calcipotriene has been shown to be effective, well tolerated, and safe for psoriasis.

Topics: Administration, Cutaneous; Calcitriol; Cell Differentiation; Cell Division; Cholecalciferol; Dermatologic Agents; Epidermis; Humans; Psoriasis

Treatment of psoriasis is rapidly changing with improved understanding of the pathogenesis of the disease. Newer topical preparations such as calcipotriol and immunosuppressive agents such as cyclosporin A and FK506 are having a major impact on the therapy of psoriasis. This article reviews the conventional therapies and newer agents used in the treatment of this common dermatosis.

Topics: Administration, Topical; Adrenal Cortex Hormones; Anthralin; Calcitriol; Coal Tar; Combined Modality Therapy; Cyclosporine; Dermatologic Agents; Emollients; Humans; Immunosuppressive Agents; Methotrexate; Phototherapy; Psoriasis; Retinoids; Tacrolimus; United Kingdom

The introduction of this article is devoted to the physiological role of vitamin D3 and its synthesis. The authors refer to the accidental introduction of vitamin D3 into the psoriasis treatment, which later led to the development of a less toxic vitamin D3 analog named calcipotriol, and its administration as a topical antipsoriatic agent. Reviewing the literature the authors discuss the pharmacological and immunological effects of calcipotriol as well as the potential applications of vitamin D3.

Topics: Administration, Topical; Calcitriol; Cholecalciferol; Dermatologic Agents; Humans; Psoriasis

Topics: Administration, Topical; Adrenal Cortex Hormones; Anthralin; Calcitriol; Humans; Psoriasis; Retinoids; Tars

Topics: Adrenal Cortex Hormones; Calcitriol; Cyclosporine; Dermatologic Agents; Humans; Methotrexate; Psoriasis; Ultraviolet Therapy

Topics: 25-Hydroxyvitamin D3 1-alpha-Hydroxylase; Calcitriol; Cholecalciferol; Dermatologic Agents; Humans; Hydroxycholecalciferols; Psoriasis

Calcipotriol is a synthetic vitamin D analogue. In vitro it can regulate cell differentiation and proliferation and suppress lymphocyte activities. These actions of calcipotriol at the cellular level are very similar to those of the natural hormone 1,25-(OH)2-D3. In contrast, the systemic effects on calcium and bone metabolism are at least 100 to 200 times less than those of 1,25-(OH)2-D3. Because of this unique pharmacologic profile, calcipotriol has been evaluated for the topical treatment of psoriasis. In well-designed and properly conducted studies involving more than 3000 patients, calcipotriol ointment, 50 micrograms/g, has been shown to be effective and safe for the short- and long-term treatment of psoriasis vulgaris. Calcipotriol ointment should be applied twice daily in amounts up to 100 g/week (Table 1). Used according to these guidelines, calcipotriol treatment does not affect calcium or bone metabolism. Calcipotriol is indicated for the treatment of plaque-type psoriasis vulgaris and has already been approved in several countries. It should be considered a first-line drug for the topical treatment of psoriasis.

Topics: Administration, Cutaneous; Animals; Calcitriol; Dermatologic Agents; Humans; Ointments; Psoriasis

The naturally occurring 1,25(OH)2 vitamin D3 and the two synthetic derivatives 1,24(OH)2 vitamin D3 and calcipotriol (Calcipotriol, INN, Calcipotriene, USAN) have a profound effect on keratinocyte proliferation and differentiation. Clinical trials have shown an effect of all three derivatives in psoriasis. The limiting factor for the use of 1,25(OH)2 vitamin D3 is the risk of hypercalcemia, which is 100 to 200 times less for calcipotriol and that may be less also for 1,24(OH)2 vitamin D3. Presently, calcipotriol in an ointment base has been marketed in a number of countries and represents an alternative to treatment with topical glucocorticoids and dithranol.

Topics: Calcitriol; Cholecalciferol; Dermatologic Agents; Humans; Psoriasis

The physiologically active metabolite of vitamin D3, 1 alpha,25-dihydroxycolicalciferol [1,25(OH)2D3, calcitriol] has achieved the status of a hormone. It is believed to mediate its effects by binding to a specific receptor which belongs to the family of nuclear receptors for glucocorticoids, estrogens, thyroxine, and retinoid acid. It has been discovered that 1,25(OH)2D3 has the ability to regulate growth and differentiation in many cell types, including cancer cells, epidermal keratinocytes, and activated lymphocytes. This has set the stage for the development of a new class of compounds with potential usefulness in hyperproliferative and immune-mediated diseases. Ideally, such agents should possess potent effects as regulators of cell proliferation and differentiation at concentrations well below those that may induce side effects related to the classical vitamin D activity on calcium absorption and bone mineralization. In addition to 1,25(OH)2D3, the synthetic vitamin D3 analogues 1 alpha-OH-D3, 1,24(OH)2D3, and calcipotriol have undergone clinical evaluation. Calcipotriol has been studied most extensively. Compared with 1,25(OH)2D3, calcipotriol is about 200 times less potent in its effect on calcium metabolism although similar in receptor affinity. In double-blind, placebo-controlled multicenter studies, topical calcipotriol has been shown to be both efficacious and safe for the short- and long-term treatment of plaque-type psoriasis. Because some of the novel vitamin D analogues are potent regulators of cell growth and immune responses, they may be of potential interest in the treatment of ichthyoses, cancer, and autoimmune diseases.

Topics: Calcitriol; Cholecalciferol; Humans; Psoriasis; Skin; Vitamin D

Calcipotriol (calcipotriene) is a vitamin D3 analogue which inhibits epidermal cell proliferation and enhances cell differentiation. In patients with chronic plaque psoriasis involved in short term studies of 6 to 8 weeks' duration, calcipotriol ointment applied twice daily was significantly more effective than betamethasone valerate and dithranol (anthralin). Pooled data from clinical trials show that calcipotriol is well tolerated, with the majority of adverse events being mild and transient local reactions. Topically applied calcipotriol has low hypercalcaemic potential and, in contrast to topical corticosteroids, oral retinoids and orally administered calcitriol, methotrexate and cyclosporin, calcipotriol does not appear to be associated with a risk of serious adverse events. Thus, at this early stage in its clinical development, calcipotriol appears to be an effective and well tolerated topical therapy for the management of psoriasis; if promising preliminary clinical findings are confirmed, calcipotriol will represent a major advance in this difficult area of therapeutics.

Topics: Anthralin; Betamethasone; Calcitriol; Calcium; Cell Differentiation; Cell Division; Combined Modality Therapy; Humans; Psoriasis; Randomized Controlled Trials as Topic

Topical vitamin D analogues offer a new, effective, more convenient and generally well-tolerated option for the treatment of psoriasis. Only psoriasis vulgaris has been intensively studied, but other forms of the disease may also respond. Both calcitriol and calcipotriol have been shown to be effective in numerous clinical trials, and the latter has compared well with betamethasone valerate and short-contact dithranol in controlled studies. Their mechanism of action is not yet fully understood and may prove complex. The most important effect may be a direct regulation of keratinocyte proliferation and differentiation. However, these compounds also have potent immunological properties, and may act by inhibition of cytokine production by keratinocytes or lymphocytes. Topical application of vitamin D analogues appears generally to be remarkably safe, but hypercalcaemia and hypercalciuria may develop if large quantities are used.

Topics: Calcitriol; Dermatologic Agents; Humans; Psoriasis; Vitamin D

Topics: Administration, Topical; Calcitriol; Dermatologic Agents; Humans; Psoriasis; Randomized Controlled Trials as Topic

The discovery of a high-affinity receptor for the bioactive form of vitamin D3, 1,25-dihydroxyvitamin D3 (1,25[OH]D3), in most skin cells has led to the finding of previously unknown effects of vitamin D on epidermal growth and on the skin immune system. 1,25(OH)2D3 inhibits epidermal proliferation and promotes epidermal differentiation. These properties provided the rationale for introducing 1,25(OH)2D3 in the treatment of psoriasis vulgaris. In addition to 1,25(OH)2D3, the synthetic vitamin D3 analogues 1 alpha(OH)D3, 1,24(OH)2D3, and calcipotriol have undergone clinical evaluation. Calcipotriol has been studied most extensively. Compared with 1,25(OH)2D3, calcipotriol is about 200 times less potent in its effects on calcium metabolism, although similar in receptor affinity. In double-blind, placebo-controlled, randomized studies, topical calcipotriol (50 micrograms/gm, up to 100 gm weekly) has been shown to be efficacious and safe for the treatment of psoriasis. A similar therapeutic profile has been seen in long-term studies. In comparative studies topical calcipotriol is slightly more efficacious than betamethasone 17-valerate and dithranol. The mode of action of calcipotriol and other vitamin D3 analogues in psoriasis is not known. Although vitamin D3 analogues affect epidermal growth, their immunosuppressive properties may be equally important for their antipsoriatic effect.

Topics: Administration, Topical; Calcitriol; Dermatologic Agents; Humans; Psoriasis; Vitamin D

Topics: Calcitriol; Cyclosporine; Cytokines; Dermatologic Agents; Dihydroxycholecalciferols; Humans; Phototherapy; Psoriasis; PUVA Therapy

In conclusion, a number vitamin D analogues have been developed that have very low calcemic activity but retain several other properties of 1,25-(OH)2D3, including the ability to differentiate leukemia and skin cells, to enhance the immune response, and to suppress parathyroid hormone levels. Although the mechanism of this selective activity is not yet clear, these analogues may provide new insights into the differences in action of 1,25-(OH)2D3 in various target tissues. Most importantly, the selective action of these analogues may be exploited for the treatment of diseases such as leukemia, psoriasis and hyperparathyroidism.

Topics: Animals; Antineoplastic Agents; Calcitriol; Humans; Hyperparathyroidism; Leukemia; Psoriasis; Structure-Activity Relationship

Topics: Calcitriol; Humans; Psoriasis

Calcipotriol, a vitamin D analogue is widely used in the treatment of psoriasis. However, poor adherence to topical therapy has led to an ineffective use of the medication and built a barrier to the treatment's success. A water-free lipid-based formulation system has been developed to improve dosage and cosmetic properties along with patient compliance. This study was conducted to evaluate the efficacy and cutaneous safety of water-free lipid-based formulations containing calcipotriol (50 μg/g) as compared to their corresponding vehicles and marketed calcipotriol formulations in a psoriasis plaque test. In total, 24 subjects with chronic psoriasis vulgaris were enrolled in this single-center, randomized, vehicle, and comparator-controlled clinical trial and treated once daily over a 12-day period (10 applications). The anti-psoriatic effect was evaluated by sonographic measurement of psoriatic infiltrate and investigators' clinical efficacy assessments. The mean reduction in psoriatic infiltrate from baseline to day 12 (end of trial) with lipid-based calcipotriol formulations (-34% and -37%) was statistically significant (P<0.0001) when compared to their corresponding vehicles (6% and -4%) but not when compared with marketed calcipotriol solution and cream (-34% and -49% respectively). Mean total clinical assessment scores of these lipid-based calcipotriol formulations (1.7 each) were between those of the two comparators - greater than marketed calcipotriol solution (1.3) but lower than cream (2.0). Overall, nine mild non-serious treatment-emergent adverse effects related to all calcipotriol formulations were reported in four subjects, but all recovered at the follow-up visit. Therefore, novel lipid-based formulations of calcipotriol were clearly more efficacious than their corresponding vehicles and considered as safe therapy against psoriasis vulgaris. J Drugs Dermatol. 2023;22(2):197-202. doi:10.36849/JDD.7151Citation: Holmbäck J, Carlsson A, Rinwa P. Efficacy and safety of water-free lipid formulation system containing calcipotriol against psoriasis vulgaris. J Drugs Dermatol. 2023;22(2):197-202. doi:10.36849/JDD.7151  .

Topics: Calcitriol; Dermatologic Agents; Drug-Related Side Effects and Adverse Reactions; Emollients; Humans; Ointments; Psoriasis; Treatment Outcome

There is a paucity of data on usage of topical medications in patients with darker phototypes. This single-center, randomized, double-blinded, vehicle-controlled clinical study investigated the efficacy of a combination calcipotriene/betamethasone dipropionate (Cal/BD) aerosol foam 0.005%/0.064% in the treatment of psoriasis vulgaris in Fitzpatrick skin types IV to VI.. 25 adult subjects were randomized 4:1 to Cal/BD foam or foam vehicle once daily for 4 weeks followed by 4 weeks of open label treatment. From week 4 to week 8, subjects randomized to Cal/BD foam once daily switched to Cal/BD foam twice weekly for 4 weeks, while those randomized to vehicle applied Cal/BD foam once daily.. At week 4, 4/19 (21%) of Cal/BD foam patients achieved clear/almost clear Investigator Global Assessment (IGA) status with ≥2 grade improvement compared with 0/5 (0%) of vehicle patients (P=0.54). 12/19 (63%) of Cal/BD foam patients achieved a 50% reduction in Psoriasis Area and Severity Index (PASI 50) at week 4, compared with 0/5 (0%) of vehicle patients (P=0.04). Mean changes in melanin index at week 4 indicate a trend toward increased pigmentation in Cal/BD foam patients and decreased pigmentation in foam vehicle patients (P=0.30). All adverse events were mild and deemed unrelated to treatment by the investigators.. The sample size was small and underpowered to detect statistically significant changes in most endpoints.. Cal/BD foam was safe and well tolerated in plaque psoriasis patients with skin of color. Larger studies involving skin of color populations with psoriasis are warranted. Pigmentary changes (hyper- and hypopigmentation) in lesional skin were observed. J Drugs Dermatol. 2023;22(2): 165-173.doi:10.36849/JDD.6910.

Topics: Adult; Aerosols; Betamethasone; Dermatologic Agents; Drug Combinations; Excipients; Humans; Psoriasis; Skin; Skin Pigmentation; Treatment Outcome

The well-established sequential use of topical calcipotriene and topical betamethasone dipropionate in combination has been shown to provide greater benefit than either monotherapy. A newer topical fixed combination formulation of calcipotriene 0.005% and betamethasone dipropionate 0.064% in a cream base (Cal/BD cream) is effective with high patient ratings for convenience and tolerability. The current study compares patient satisfaction between Cal/BD foam and Cal/BD cream formulations. Study Design and Patient Demographics: This is a single-use, split body, open label study involving 20 subjects. Ten subjects additionally had scalp psoriasis. Study treatments were applied by the investigator in a randomized manner and patients completed questionnaires to assess treatment preferences.. Both Cal/BD formulations provided rapid and significant improvement in symptoms of pruritus, stinging, burning, and pain; with no statistically significant difference in response between the 2 treatments. Overall, Cal/BD cream outperformed Cal/BD foam on several key measures for vehicle features and patient satisfaction. For non-scalp application, 55% of subjects preferred Cal/BD cream over Cal/BD foam. For the scalp, 60% of subjects preferred Cal/BD cream over Cal/BD foam. No adverse events were reported during the study.. Results of this current study indicate high levels of patient satisfaction with Cal/BD cream and a preference for the cream base over foam for the treatment of body and scalp psoriasis.   J Drugs Dermatol. 2023;22(3): doi:10.36849/JDD.7165.

Topics: Emollients; Humans; Pain; Patient Preference; Pilot Projects; Psoriasis

Vitamin D analogues and NBUVB are both well-recognised modes of therapy in the treatment of chronic stable plaque psoriasis. The objective of this open label intraindividual, left right study was to compare two different vitamin D analogues, calcipotriol and calcitriol, in combination with NBUVB phototherapy in psoriasis.. Thirty patients with stable plaque psoriasis were enrolled for a 12-week clinical trial. The target lesion on the left side was treated topically with calcitriol ointment, while that on the right side was treated with calcipotriol ointment once daily. The whole body was irradiated with narrow-band ultraviolet B phototherapy (NBUVB) three times per week. Efficacy was assessed by target plaque scoring.. Both therapies resulted in a statistically significant reduction in erythema, scaling, thickness, and target plaque score, seen as early as 2 weeks into therapy. However, the calcipotriol combination led to an earlier clearance of plaques and a lesser relapse rate than the calcitriol combination. The number of treatment sessions and cumulative NBUVB doses were significantly lower in the calcipotriol-treated group.. Both vitamin D analogues appear to be safe, effective, and cosmetically acceptable, with calcipotriol being more efficacious, well tolerated, with a rapid onset of action and a better maintenance of response.

Topics: Calcitriol; Dermatologic Agents; Humans; Ointments; Phototherapy; Psoriasis; Treatment Outcome

Psoriasis affects diverse racial and ethnic groups. In July 2021, the US Food and Drug Administration approved calcipotriene/betamethasone dipropionate (CAL/BDP) 0.005%/0.065% cream to treat plaque psoriasis in adults. The efficacy and safety of CAL/BDP in patients with skin of color (SOC) who have psoriasis is not well characterized.. A post hoc analysis of phase 3 clinical trial data (NCT03308799) was conducted to assess the efficacy, convenience, and safety of CAL/BDP cream versus CAL/BDP topical solution and vehicle cream in people with Fitzpatrick skin types IV to VI.   Results: This study included 784 participants, 280 (35.7%) of whom had Fitzpatrick skin types IV to VI. Patients treated with CAL/BDP cream had greater disease improvement, treatment convenience scores, and overall satisfaction than those treated with CAL/BDP topical solution in the subgroup with skin types IV to VI and the total study population.  Adverse event rates were similar between the subgroup with skin types IV to VI and the total study population for all treatment arms.  Conclusion: Psoriasis is associated with a greater physical and psychosocial impact in patients with SOC. While many effective topical therapies exist, it may be helpful to conduct separate analyses of patients with SOC to assess the efficacy and safety of treatment in this population. This sub-analysis of phase 3 clinical trial data supports the efficacy and safety of CAL/BDP cream in the treatment of plaque psoriasis in patients with SOC. CAL/BDP cream also had greater convenience, formula acceptability, and overall satisfaction in both the subgroup with SOC and the total trial population, which may improve adherence to topical therapy and treatment outcomes for people with SOC who have psoriasis. Kontzias CL, Curcio A, Gorodokin B, et al. Efficacy, convenience, and safety of calcipotriene-betamethasone dipropionate cream in skin of color patients with plaque psoriasis. J Drugs Dermatol. 2023;22(7):668-672. doi:10.36849/JDD.7497.

Topics: Adult; Betamethasone; Dermatologic Agents; Drug Combinations; Emollients; Excipients; Humans; Psoriasis; Skin Pigmentation; Treatment Outcome

The fixed dose combination of calcipotriene (CAL) and betamethasone dipropionate (BDP) is a well-established topical treatment option for psoriasis based on strong scientific rationale for the single agents having complementary efficacy and safety. CAL/BDP PAD-cream is an easily spreadable cream based on PAD Technology™, an innovative formulation and drug delivery system.. A Phase 3, multicentre, randomized, investigator-blind, active and vehicle-controlled trial enrolling 490 patients with mild to moderate psoriasis according to the Physician Global Assessment (PGA) scale was conducted in three European countries. Products were applied once daily for 8 weeks. The aim of the trial was to evaluate the efficacy and safety of CAL/BDP PAD-cream as well as treatment acceptability compared to CAL/BDP gel and PAD-cream vehicle. Primary endpoint was percentage change in modified Psoriasis Area and Severity Index (mPASI) from baseline to Week 8.. The percentage mean change from baseline to Week 8 in mPASI for CAL/BDP PAD-cream (67.5%) was superior compared to PAD-cream vehicle (11.7%; p < 0.0001) and non-inferior to CAL/BDP gel (63.5%). The proportion of patients achieving PGA treatment success (at least two-step improvement to clear or almost clear) after 8 weeks was superior for CAL/BDP PAD-cream (50.7%) compared to PAD-cream vehicle (6.1%, p < 0.0001) and statistically significantly greater than CAL/BDP gel (42.7%, p = 0.0442). Patient-reported psoriasis treatment convenience score (PTCS) for CAL/BDP PAD-cream was rated superior to CAL/BDP gel at Week 8 (p < 0.0001) and the mean change in DLQI from baseline to Week 8 improved statistically significantly more in the CAL/BDP PAD-cream group compared to both PAD-cream vehicle (p < 0.0001) and CAL/BDP gel (p = 0.0110). Safety assessments during the trial demonstrated that CAL/BDP PAD-cream was well-tolerated.. CAL/BDP PAD-cream is a novel topical treatment of psoriasis that has a high efficacy and a favourable safety profile combined with a superior patient-reported treatment convenience.

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Emollients; Humans; Psoriasis; Treatment Outcome

Calcipotriene and betamethasone dipropionate (CAL/BDP) cream is a novel treatment of plaque psoriasis based on PAD™ Technology (PAD-cream) designed to improve patient reported treatment satisfaction and quality of life (QoL).. A pooled analysis of patient reported outcomes from two phase 3, multicenter, randomized, investigator-blind, active, and vehicle-controlled trials evaluating a total of 1271 patients with mild to moderate plaque psoriasis according to the Physician Global Assessment (PGA) scale. Products were applied once daily for 8 weeks.. The proportion of patients evaluating their treatment to have improved by 2 grades to clear or very mild disease on the 5-grade Subject Global Assessment (SGA) scale, defined as SGA Success, was significantly higher in the CAL/BDP PAD-cream group compared to active comparator (CAL/BDP suspension/gel) (week 8, 44.2% vs 27.9%, P<0.0001). A Dermatology Life Quality Index (DLQI) score of 0 or 1, indicating no impact of disease on the patient's life, was obtained by 43.8% of patients at week 8 in the CAL/BDP cream group versus 34.2% in the CAL/BDP suspension/gel group (P=0.0005). CAL/BDP PAD-cream demonstrated significantly greater psoriasis treatment convenience compared to CAL/BDP suspension/gel at all studied time points, including questions addressing greasiness of the formulation and overall satisfaction of treatment.. CAL/BDP PAD-cream is a novel topical treatment for psoriasis, which through PAD™ Technology offers substantial improvement in QoL and treatment satisfaction for patients. Given these data, CAL/BDP PAD-cream may lead to better adherence to treatment, which ultimately could result in better treatment outcomes in clinical practice.. gov: NCT03308799 and NCT03802344. J Drugs Dermatol. 2022;21(3):242-248. doi:10.36849/JDD.6611.

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Patient Reported Outcome Measures; Psoriasis; Quality of Life; Treatment Outcome

There is no consistently effective treatment for psoriatic nails. Topical and intralesional modalities have been recently investigated and showed promising efficacy and safety. To compare the efficacy and safety of intralesional injection of 5-fluorouracil (5-FU), methotrexate (MTX), triamcinolone acetonide (TA) versus topical calcipotriol plus urea 20% in the treatment of nail psoriasis. This study included 60 patients with nail psoriasis who were randomly assigned to 4 groups, each containing 15 patients. The first 3 groups received intralesional injection of 0.1 ml of 5-FU (group A), MTX (group B), and TA (group C) into the nail matrix and bed monthly for 3 months. Group D received a topical combination of calcipotriol/urea 20% twice daily for 3 months. Therapeutic response was assessed every month for 3 months using the target nail psoriasis severity index (NAPSI). The mean percentage of improvement was significantly higher in topical calcipotriol/urea combination (57.1 ± 26.4) than intralesional TA (44.2 ± 32.7), intralesional MTX (37.7 ± 14.2), and intralesional 5-FU (29.6 ± 14). Adverse effects were mild and insignificant in the studied groups. Topical calcipotriol/urea combination seems to be more effective and safe than intralesional injections of 5-FU, MTX, and TA.

Topics: Calcitriol; Dermatologic Agents; Fluorouracil; Humans; Injections, Intralesional; Methotrexate; Nail Diseases; Psoriasis; Treatment Outcome; Triamcinolone Acetonide; Urea

Psoriasis is a chronic inflammatory disease whereby long-term disease control remains a challenge for the patients. Latest evidence suggests that combined topical treatment with steroids and vitamin D analogue foam (Calcipotriol/Betamethasone) is efficient in long-term management of the disease and reducing the number of relapses. Its effects on cellular inflammation and cytokine production remain to be explored. We set out to examine the effect of topical therapies on cellular infiltrate and cytokine profile in the lesional skin of psoriasis patients. This was a monocentric, double-blind, randomized trial with 30 patients. Patients were treated with the combined Calcipotriol/Betamethasone foam, Betamethasone foam alone, Clobetasol Propionate ointment or placebo. 4 mm skin biopsies from lesional and non-lesional sites were taken before and 4 weeks after treatment. Cellular infiltrate, IFNγ and IL-17 were studied by immunofluorescence. Each patient was their own control. Evolution in skin inflammation was studied in parallel with changes in patient's epidermal thickness and their tPASI clinical score. Lesional skin was characterized by increased epidermal thickness, increased number of IL-17 and IFNγ producing CD8+ T cells, NK cells and neutrophils. All treatment reduced epidermal thickness and improved patients tPASI scores. Only the combined Calcipotriol/Betamethasone foam completely abolished epidermal and dermal influx of CD8+ T cells, reduced number of CD8 + IFNγ+ cells (but not CD8 + IL-17+ cells) and significantly reduced the number of MPO+ neutrophils which were predominantly IL-17+. None of the treatments had effect on NK cells. We have shown the combined topical treatment with Calcipotriol/Betamethasone foam to be effective in reducing cellular influx into lesional skin of psoriasis patients and this effect to be superior to emollient or Betamethasone alone. Its previously described efficacy in the clinic may be attributed to its unique and rapid ability to inhibit both adaptive CD8+ T cell and innate immune neutrophilia influx into the skin, which was not observed for the other treatments.

Topics: Betamethasone; Calcitriol; Emollients; Humans; Inflammation; Interleukin-17; Ointments; Psoriasis

There is a lack of efficacious topical treatments for patients suffering from psoriatic nail disease (PND). We investigated the efficacy of Calcipotriol-Betamethasone Dipropionate (Cal/BD) foam with and without ablative fractional laser (AFL) in patients with PND. A total of 144 nails from 11 patients were treated in a 24-week long, open-label, randomized, intra-patient controlled proof-of-concept hybrid trial. In addition to daily Cal/BD foam application, half of each patient's psoriatic nails were randomized to receive optical coherence tomography (OCT)-guided AFL treatment at baseline, 6-, and 12-week follow-ups. In-clinic assessment (N-NAIL), patient-reported outcomes (PROMs), and drug consumption were supplemented by remote evaluation of 15 subclinical OCT features, smartphone app-based safety monitoring, and photo-based assessment (NAPSI). After 24 weeks of Cal/BD foam treatment, patients achieved a significant improvement (p < 0.001) in both clinical (N-NAIL -76%, NAPSI -68%) and subclinical (OCT -43%) PND severity as well as a 71% reduction in PROMs. AFL-assisted Cal/BD treatment led to higher clinical (N-NAIL -85%, NAPSI -78%) and OCT-assessed (-46%) reduction of PND signs than Cal/BD alone (N-NAIL -66%, NAPSI -58%, OCT -37%), but did not reach statistical significance. Smartphone app images documented adverse events and mild local skin reactions, particularly erythema (75%), laser-induced swelling (28%), and crusting (27%). This hybrid trial demonstrated a reduction in clinical NAPSI and N-NAIL scores, subclinical OCT features, and PROMs, suggesting that Cal/BD foam is a safe and efficacious treatment for PND. Larger trials are warranted to prove the clinical benefit of AFL pretreatment as a Cal/BD delivery enhancer.

Topics: Aerosols; Betamethasone; Dermatologic Agents; Drug Combinations; Humans; Lasers; Mobile Applications; Nail Diseases; Patient Reported Outcome Measures; Psoriasis; Smartphone; Tomography, Optical Coherence; Treatment Outcome

Proactive management of plaque psoriasis with twice-weekly topical calcipotriol/betamethasone dipropionate (Cal/BD) foam has a demonstrated clinical benefit in preventing disease relapse compared to reactive management, where Cal/BD foam is only given as rescue therapy once-daily for four weeks after relapse. The impact of proactive management with Cal/BD foam on a wider range of clinical responses is not yet known, nor is its potential cost-effectiveness in the healthcare system of Finland.. This study involved a post-hoc analysis exploring the clinical and patient-reported benefits of proactive versus reactive management with Cal/BD foam observed in the PSO-LONG trial (NCT02899962). A range of response criteria based on modified psoriasis area and severity index (mPASI) and dermatology life quality index (DLQI) were analyzed, and the cost-effectiveness of proactive versus reactive management was estimated in a Finnish healthcare setting.. The analysis found a consistent clinical benefit of proactive management compared to reactive management on all response criteria, and a markedly lower cost-per-responder for the response criteria of mPASI 75, mPASI ≤ 2 and DLQ1 ≤ 1. The analysis was robust to sensitivity analyses on key inputs and demonstrates the cost and clinical benefits of proactive over reactive management of plaque psoriasis with Cal/BD foam in the Finnish healthcare setting.

Topics: Aerosols; Betamethasone; Calcitriol; Cost-Benefit Analysis; Dermatologic Agents; Drug Combinations; Finland; Humans; Psoriasis; Recurrence; Treatment Outcome

In PSO-LONG, long-term proactive management (PAM) of psoriasis with fixed-dose combination calcipotriol 50 µg/g and betamethasone dipropionate 0.5 mg/g (Cal/BD) aerosol foam was superior to conventional reactive management. This post-hoc analysis investigated long-term PAM with Cal/BD foam in PSO-LONG patients who could be more susceptible to corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression.. Efficacy and safety of PAM with Cal/BD foam (twice-weekly) versus reactive management (twice-weekly vehicle foam), with once-daily rescue Cal/BD foam for four weeks following relapse, was assessed in the HPA subgroup (. PAM with Cal/BD foam was associated with longer median time to first relapse (111 versus 31 days), reduced risk of first relapse (hazard ratio: 0.49;. Efficacy of PAM with Cal/BD foam is maintained in patients with moderate-to-severe psoriasis, with no new safety signals.

Topics: Administration, Cutaneous; Adrenal Cortex Hormones; Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Recurrence; Treatment Outcome

Treatment response for psoriasis is typically evaluated using clinical scores. However, patients can relapse after clinical clearance, suggesting persistent inflammation. Dermoscopy, reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) can non-invasively improve treatment response assessment.. To compare the clinical and non-invasive microscopic features in a psoriatic target lesion treated with clobetasol cream or calcipotriol/betamethasone dipropionate foam (Cal/BD foam).. Prospective, unicentric, open, randomized clinical trial comparing clinical data [total clinical score (TCS)] and microscopic data (dermoscopy, RCM and OCT) in psoriasis patients treated with clobetasol or Cal/BD foam.. We included 36 adult patients (22 men). At week 4, more patients treated with Cal/BD foam achieved TCS ≤1 than with clobetasol (63.2% vs. 18.8%, P = 0.016). Treatment satisfaction was higher with Cal/BD foam (P < 0.03). Microscopically, Cal/BD foam induced more reduction in epidermal thickness at week 4 (P < 0.049). Dilated horizontal blood vessels were more common with clobetasol than with Cal/BD foam at week 8 (69.2% vs. 31.2%, P = 0.159). If epidermal hyperplasia was noted at baseline, the response was poorer with clobetasol (P = 0.029).. Small sample size, open study, imaging sampling bias.. Cal/BD foam is more effective than clobetasol, has better patient satisfaction and induces greater reduction in the hyperkeratosis/acanthosis, regardless of baseline epidermal hyperplasia.

Topics: Adult; Betamethasone; Calcitriol; Clobetasol; Dermatologic Agents; Humans; Male; Prospective Studies; Psoriasis; Treatment Outcome

Topical psoriasis treatment relies on a reactive rather than a long-term proactive approach to disease relapse.. Assess long-term efficacy and safety of proactive psoriasis management with twice-weekly calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam.. Phase III trial (NCT02899962) included a 4-week open-label lead-in phase (Cal/BD foam once daily) and a 52-week, randomized, double-blind, maintenance phase. A total of 545 patients achieved treatment success (physician's global assessment "clear"/"almost clear," ≥2-grade improvement from baseline) and were randomized to proactive management (Cal/BD foam; n = 272) or reactive management (vehicle foam; n = 273) twice-weekly, with rescue treatment of Cal/BD foam once daily for 4 weeks upon relapse. Primary endpoint was time to first relapse (physician's global assessment "mild" or higher).. A total of 251 randomized patients (46.1%) completed the trial. Median time to first relapse was 56 days (proactive) and 30 days (reactive). Patients in the proactive group had an additional 41 days in remission compared with the reactive group over 1 year (P < .001). Number of relapses per year of exposure was 3.1 (proactive) and 4.8 (reactive). Cal/BD foam was well tolerated.. Maintenance phase dropout rate (53.9%) was within the expected range but provides challenges in statistical analysis.. Long-term proactive management with Cal/BD foam demonstrated superior efficacy vs reactive management.

Topics: Administration, Cutaneous; Adult; Aerosols; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Female; Humans; Male; Middle Aged; Psoriasis; Secondary Prevention; Time Factors; Treatment Outcome; Young Adult

Mild-moderate psoriasis vulgaris is a common dermatological autoimmune condition with limited conventional therapeutic options. Safe and effective adjunct therapies to topical non-steroidal antipsoriatic therapy are needed. The oral Chinese herbal medicine (CHM) formula PSORI-CM01 has been evidenced potential antipsoriatic pharmacological activity. This article reports a pilot study which was designed as a double-blinded, placebo-controlled randomized controlled trial (RCT) evaluating the effects of PSORI-CM01 when added to topical calcipotriol cream.. People with moderate psoriasis vulgaris were randomized to receive oral PSORI-CM01 or placebo administered for 12 weeks in combination with calcipotriol. The primary clinical outcome was the change of psoriasis area severity index (PASI) score at week 12 and week 24. Secondary clinical outcomes were PASI75, PASI50, relapse rate, change in body surface area, dermatology life quality index and Skindex29, and adverse events (AEs). Participants' satisfaction and willingness to repeat were also assessed.. The pilot study was conducted in Australia and China, 29 participants were randomized with 26 completed the treatment and follow-up. Participants' baseline basic characteristics were comparable. No between-group statistical significance was found on pre-defined clinical outcome measures, although there seemed a trend of treatment effects favoring the combination of PSORI-CM01 with calcipotriol. Frequency and severity of AEs were similar between two groups, with no severe AEs reported.. The design and duration of the study appears feasible. A proper powered RCT with slight adjustments in the methods is needed to reveal the add-on effects of oral CHM PSORI-CM01. The experience and results from this pilot study will contribute to the refine of objectives and design of a future study, and assist the sample size calculation for the full-scale RCT.

Topics: Administration, Topical; Adult; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Therapy, Combination; Drugs, Chinese Herbal; Female; Humans; Male; Pilot Projects; Psoriasis; Treatment Outcome

Nail psoriasis is a common and potentially debilitating condition for which no effective and safe nonsystemic therapy is currently available. Recently, laser-assisted drug delivery (LADD) is being increasingly used to facilitate transcutaneous penetration of topical treatments.. We set to assess the efficacy and safety of combined pulse-dye laser and fractional CO2 laser-assisted betamethasonecalcipotriol gel delivery for the treatment of nail psoriasis.. We conducted a prospective, intrapatient comparative study in a series of 22 patients with bilateral fingernail psoriasis. Nails on the randomized hand were treated with 3 monthly sessions of pulse-dye laser to the proximal and lateral nail folds followed by fractional ablative CO2 laser to the nail plate. Between treatments and one month following the last treatment, the participants applied betamethasone propionate-calcipotriol gel once daily to the nail plate. Clinical outcome was ascertained using nails photography, the Nail Psoriasis Severity Index (NAPSI) and patient satisfaction.. Seventeen completed the study. Three participants withdrew from the study because of treatment-associated pain. Treatment was associated with a statistically significant improvement of the NAPSI scale (p < .002). Patient satisfaction was high.. Combined PDL and fractional ablative CO2-LADD of betamethasone-calcipotriol gel should be considered for the treatment of nail psoriasis.

Topics: Administration, Topical; Adult; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Follow-Up Studies; Glucocorticoids; Humans; Lasers, Dye; Male; Middle Aged; Nail Diseases; Prospective Studies; Psoriasis; Young Adult

The fixed dose combination of calcipotriene and betamethasone dipropionate (CAL/BDP) is a well-established, efficacious, and safe topical treatment of psoriasis.. A Phase 3, multicenter, randomized, investigator-blind, active, and vehicle-controlled trial enrolling 796 patients with moderate to severe psoriasis according to the Physician Global Assessment (PGA) scale. Products were applied once daily for 8 weeks.. The proportion of patients achieving PGA treatment success after 8 weeks was statistically significantly greater for CAL/BDP cream (37.4%) compared to CAL/BDP TS (22.8%, P<0.0001), and vehicle (3.7%, P<0.0001). A similar statistically significant difference in favor of CAL/BDP cream at week 8 was demonstrated for the percentage change in mPASI from baseline and the proportion of patients obtaining mPASI75. Patient reported treatment convenience for CAL/BDP cream was rated superior to CAL/BDP TS. Safety assessments during the trial demonstrated that CAL/BDP cream was well-tolerated with no adverse reactions with a frequency greater than 1%.. CAL/BDP cream is a novel topical treatment of psoriasis, which in a single product, offers a unique combination of high efficacy combined with favorable safety and excellent treatment convenience. For these reasons, CAL/BDP cream offers a distinctive advantage for the topical treatment of plaque psoriasis. ClinicalTrials.gov: NCT03308799J Drugs Dermatol. 20(4):420-425. doi:10.36849/JDD.5653.

Topics: Adult; Aged; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Psoriasis; Skin Cream; Treatment Outcome

Psoriasis is a chronic disease requiring long-term treatment strategies. Optimal strategies should include initial rapid relief of symptoms followed by long-term management to maintain remission. This 4-week open-label phase of a long-term proactive management phase 3 trial aimed to select responders to once daily, fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% (Cal/BD) foam in adults with psoriasis and assess patient-reported outcomes.. This phase 3 trial in adults with psoriasis included a 4-week open-label lead-in phase to determine treatment success prior to entering the randomized maintenance phase. Success was defined as Physician Global Assessment (PGA) score ‘clear’/‘almost clear’ (PGA <2) with ≥2-grade improvement from baseline. Those achieving treatment success at week 4 entered the maintenance phase; non-responders were withdrawn from the trial.. 650 patients enrolled in the open-label phase, and 623 were treated with Cal/BD foam for 4 weeks; 521 (80%) patients achieved treatment success and were included in the maintenance phase. In those patients achieving success (responders), 21.1% and 78.9% achieved a PGA score of ‘clear’ and ‘almost clear’, respectively. Mean change from baseline in modified Psoriasis Area and Severity Index (± standard deviation [SD]) and body surface area (± SD) in responders at week 4 was −82.1% (16.4%) and −56.6% (38.3%), respectively. Mean Dermatology Life Quality Index score reduced by 6.0 from baseline to week 4 (n=521). 17.7% of patients experienced AEs; with only one severe AE reported.. Cal/BD foam was highly efficacious and well tolerated during the 4-week lead-in phase of PSO-LONG. J Drugs Dermatol. 2021;20(4):436-441, doi:10.36849/JDD.5728.

Topics: Administration, Cutaneous; Adult; Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Psoriasis; Quality of Life; Severity of Illness Index; Treatment Outcome

Reduction of psoriasis body surface area (BSA) is associated with improved patient quality of life. Post-hoc analyses of the PSO-LONG study compared impact on BSA of proactive management versus reactive management strategies using calcipotriol/betamethasone dipropionate (Cal/BD) foam. Mean BSA values, as well as normalized area under the curves (AUCs) for patient BSA were assessed. Analyses found that after the PSO-LONG study’s four-week open-label lead-in phase, when all patients received once-daily Cal/BD foam, mean BSA was significantly reduced. Thereafter, mean BSA remained at lower levels in patients on proactive management compared to reactive management. This was reflected in AUC BSA, which was consistently lower in the proactive management arm. Treatment-related differences were statistically significant when analyzing the full analysis set (FAS) population, as well as when restricting the analysis to study completers. Additional analyses restricted the dataset to include only observations from psoriasis remission periods, or periods of disease relapse. Treatment-related differences in AUC were statistically significant in observations during remission, but not during relapse. This could be expected given the trial’s design, wherein all patients who relapsed were offered the same rescue therapy with once daily Cal/BD foam. Similarly, for patients who dropped out, there was no treatment-related difference in mean BSA during the two weeks preceding dropout, likely due to the common occurrence of relapse in these patients. This paper found that proactive management, in addition to preventing more relapses as previously shown, also maintained BSA at a lower level during remission than reactive management. J Drugs Dermatol. 20(5):567-570. doi:10.36849/JDD.5870.

Topics: Aerosols; Betamethasone; Body Surface Area; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Humans; Maintenance Chemotherapy; Psoriasis; Quality of Life; Recurrence; Remission Induction; Secondary Prevention; Severity of Illness Index; Treatment Outcome

The chronicity of psoriasis often requires continuous topical treatment.. Here, the radical protection of a cream containing various herbal oils was evaluated in vivo by electron paramagnetic resonance (EPR) spectroscopy and its skin penetration by Raman microscopy in intact and barrier-disturbed skin. Changes in skin barrier properties were evaluated after 4 weeks of daily topical application using in vivo laser scanning microscopy (LSM) and transepidermal water loss in 26 healthy volunteers. A randomized, controlled, double-blind, three-arm parallel clinical study evaluated the efficacy of the herbal oil cream compared to a 0.05% calcipotriol-containing cream and to a vehicle cream, in 135 patients with mild to moderate plaque psoriasis with the change in Psoriasis Area and Severity Index (PASI) from baseline to week 12 as the primary endpoint.. EPR spectroscopy disclosed a significantly higher radical formation in untreated than skin treated with the herbal oil cream (p ≤ 0.05). LSM measurements indicated a protective skin barrier effect in treated compared to untreated skin. In the clinical trial, the topical application of herbal oils showed a significant reduction of the PASI score compared to topical calcipotriol at week 12 (p = 0.016). The mean reduction in PASI was 49% for the herbal oil cream, 38% for calcipotriol, and 55% for the vehicle cream. The percentage of patients, who reached PASI 50 and 75 at any time point, was 55.9% and 29.4% for the herbal oil cream, 47.4% and 15.8% for calcipotriol, and 23 (60.5%) and 13 (34.2%) for the vehicle, respectively (p > 0.05). The vehicle, originally designed as a placebo, contained a main ingredient of the herbal oil cream and therefore showed corresponding results.. The herbal oil cream demonstrated effectiveness in the treatment of mild to moderate plaque psoriasis.

Topics: Calcitriol; Dermatologic Agents; Double-Blind Method; Humans; Oils; Psoriasis; Severity of Illness Index; Treatment Outcome

Psoriasis is commonly treated with topical corticosteroids, oral cytotoxic drugs and biologic agents, which can be associated with significant adverse effects (AEs), high cost and response attenuation. Additionally, patients often use alternative therapies ad hoc, which can be challenging to integrate into a treatment regimen, owing to a lack of adequately powered controlled trials assessing efficacy and safety. We developed a novel topical botanical complex, herbal anti-inflammatory treatment (HAT1), through extensive preclinical in vitro and in vivo modelling to define key mechanisms of action and clinical potential. To assess the efficacy and safety of HAT1 in psoriasis, we performed a 10-week, open-label, pilot clinical trial comparing topical treatment of HAT1 with calcipotriol 0.005% in adult patients with mild to moderate psoriasis. Primary and secondary endpoints included the percentage of patients obtaining improvement of ≥ 75% in Psoriasis Area and Severity Index (PASI 75), Physician's Global Assessment (PGA) response, and evaluation of tolerability and safety of HAT1. In the HAT1 arm, 85.7% of study patients reached PASI 75 compared with 21.4% in the calcipotriol comparator group. Additionally, 78.6% of patients in the HAT1 arm achieved a 'clear' or 'minimal' PGA response. HAT1 was well tolerated, with no AEs observed throughout the trial. These results suggest that HAT1 reduces psoriasis disease activity in a clinically relevant manner. Ongoing studies, including well-powered, double-blind, randomized controlled trials will be required to assess the potential of HAT1 in psoriasis.

Topics: Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents; Calcitriol; Child; Chronic Disease; Dermatologic Agents; Female; Humans; Intention to Treat Analysis; Male; Middle Aged; Pilot Projects; Plant Extracts; Psoriasis; Young Adult

Psoriasis is a disease that commonly manifests in adolescence. Up to half of adults with psoriasis develop it before the age of 20. Topical formulations containing corticosteroids and/or vitamin D3 analogs are recommended for treatment.. This phase II study aimed to evaluate the safety, including any potential effect on the hypothalamic-pituitary-adrenal axis and calcium metabolism, and efficacy of fixed-dose combination calcipotriene (0.005%) and betamethasone (0.064% as dipropionate) (Cal/BD) gel in adolescents with psoriasis.. Patients aged 12 to <17 years, with at least mild psoriasis on the body and scalp, received topical Cal/BD gel once daily for ≤8 weeks. Safety response criteria included adverse drug reactions [ADRs; any adverse event (AE) possibly or probably related to treatment as determined by the investigator; a primary response criterion] and AEs (a secondary response criterion). Only treatment-emergent AEs (events that occurred after the first application of Cal/BD gel or events which started before this and increased in intensity after the first application of Cal/BD gel) are presented here. Efficacy response criteria included controlled disease, by physician's global assessment of disease severity (PGA), following Cal/BD gel treatment.. A total of 107 patients (median age 14 years; range 12-16) were enrolled and treated. Eight ADRs were observed in 7 (7%) patients and 38 (36%) patients experienced ≥1 AE. The most common AEs were headache [6 (6%) patients], nasopharyngitis [6 (6%) patients] and blood parathyroid hormone increased [4 (4%) patients]. One severe AE was reported (attempted suicide) but was considered unrelated to treatment. At the end of treatment, 58% of patients had controlled disease on the body and 69% on the scalp according to PGA.. In this uncontrolled phase II study, Cal/BD gel was well tolerated and effective for treating scalp and body psoriasis in adolescents.

Topics: Adolescent; Betamethasone; Calcitriol; Child; Dermatologic Agents; Drug Combinations; Humans; Hypothalamo-Hypophyseal System; Pituitary-Adrenal System; Psoriasis; Scalp; Treatment Outcome

Fixed-dose combination of calcipotriol (50 μg/g; Cal) and betamethasone dipropionate (0.5 mg/g; BD) foam is approved for plaque psoriasis treatment in adults, with a paucity of data supporting use in adolescents.. To evaluate safety of 4 weeks' treatment with Cal/BD foam in adolescent patients with psoriasis, and additional safety outcomes in patients with more severe disease (HPA-axis cohort). Primary objectives included treatment-emergent adverse events (TEAEs) and systemic calcium levels in the overall population, and HPA-axis function, change in calcium excretion and the calcium:creatinine ratio in the HPA-axis cohort. Secondary objectives included exploratory efficacy endpoints [treatment success: change in Psoriasis Area and Severity Index (PASI)]. Systemic exposure to Cal/BD was also assessed.. A phase II, open-label, study (NCT02387853) in patients (12 to <17 years) with at least mild psoriasis, to evaluate Cal/BD foam applied once daily for ≤4 weeks.. In patients assigned to treatment (n = 106), 32 TEAEs occurred in 22 patients (20.8%). All but two TEAEs were mild; none led to study withdrawal or death. Changes (0-4 weeks) in albumin-corrected serum calcium (overall population) and urinary calcium excretion (HPA-axis cohort) were small, transient and not considered clinically relevant. In the HPA-axis cohort, no change in urinary calcium:creatinine ratio was observed and responses to adrenocorticotropic-hormone (ACTH) challenge did not suggest disruption of the HPA-axis. Prespecified treatment success on the body and scalp was achieved by 71.8% and 75.7% of the overall population, respectively. Mean PASI decreased by 82.0% vs. baseline at Week 4. Systemic exposure to Cal/BD was minimal.. Cal/BD foam was well tolerated in adolescent patients with body/scalp psoriasis. There was no evidence for dysregulation of the HPA-axis nor calcium homoeostasis in patients with more severe disease. Exploratory efficacy data in the overall population were encouraging.

Topics: Adolescent; Betamethasone; Calcitriol; Child; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Treatment Outcome

Objective: Investigate the effect of fixed-combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam on target lesion severity in plaque psoriasis.\ \ Design: Post-hoc analysis was conducted on data from a Phase 3, randomized, double-blind, multicenter clinical study of Cal/BD foam in the treatment of psoriasis vulgaris for 4 weeks (PSO-FAST; NCT01866163).\ Participants: In PSO-FAST, 426 patients (≥18 years) with psoriasis vulgaris (≥mild severity) were randomized 3:1 to Cal/BD foam (n=323) or vehicle foam (n=103), applied once daily.\ \ Measurements: Assessments included (1) target lesion severity (redness, scaliness, and thickness) at baseline and weeks 1, 2, and 4; and (2) the proportion of patients with ≥50% reduction in total sign score (TSS-50) from baseline at weeks 1, 2, and 4.\ \ Results: A greater proportion of patients achieved considerable improvement (a score of 0 or 1) in the severity of target lesions after 4 weeks of treatment with Cal/BD foam vs vehicle foam at week 4 (redness: 76.2% vs 21.4%; P<.001; scaliness: 91.3% vs 61.2%; P<.001; and thickness: 83.3% vs 35.0%; P<.001, respectively). Rapid onset of efficacy was observed as early as week 1. Significantly more patients also achieved TSS-50 at week 4 with Cal/BD foam vs vehicle foam for their target lesions regardless of treatment area, including the elbows and knees (P<.05 for all).\ \ Conclusions: Significant improvements in target lesion severity were achieved with up to 4 weeks of treatment with once-daily Cal/BD foam for adults with plaque psoriasis versus vehicle foam, with rapid onset of efficacy observed at week 1.\ \ J Drugs Dermatol. 2020;19(2)121-126. doi:10.36849/JDD.2020.4750

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis; Young Adult

The product of the Physician Global Assessment and body surface area (PGA×BSA) is simpler to use than the Psoriasis Area and Severity Index (PASI), which lacks sensitivity in patients with mild psoriasis.. To compare the PGA×BSA versus the modified PASI (mPASI) for assessing disease severity and therapeutic response to calcipotriol/betamethasone dipropionate (Cal/BD) foam.. This post hoc analysis evaluated the efficacy of Cal/BD foam in mild, moderate, and severe psoriasis, as assessed by the PGA×BSA and mPASI, using data from 3 randomized controlled trials (NCT01536886, NCT01866163, NCT02132936). Spearman correlation and Bland-Altman plots were used to compare the PGA×BSA with the mPASI.. Proportions of patients receiving Cal/BD foam achieving 75% response for PGA×BSA and mPASI at weeks 1, 2, and 4 were similar and significantly greater than with vehicle (P ≤ .002 at all timepoints); at week 4, mean improvements were 51.0% and 50.7%, respectively. Spearman correlations for mild, moderate, and severe psoriasis were moderate to high between PGA×BSA and mPASI at baseline (r = .51, .72, and .86, respectively; n = 126, 465, and 58, respectively) and high at week 4 (r = .80, .81, and .89, respectively; n = 121, 452, and 58, respectively) (P < .001).. Pooled data from different trials were not prespecified for post hoc analysis. Interrater reliability was not assessed.. Pooled data analysis showed that the PGA×BSA and mPASI correlation was higher with increasing psoriasis severity.

Topics: Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Body Surface Area; Calcitriol; Data Interpretation, Statistical; Dermatologic Agents; Female; Humans; Intention to Treat Analysis; Male; Middle Aged; Psoriasis; Severity of Illness Index; Treatment Outcome

Two Phase 2 studies investigated the effect of a fixed-dose combination foam containing calcipotriene monohydrate (Cal) and betamethasone dipropionate (BD) on scalp psoriasis in adult and adolescent patients. Patients had psoriasis classified as at least 'mild' per PGA. NCT01536938 enrolled adult patients (≥18 years) randomized 1:1:1 to once-daily (QD) Cal/BD foam (Cal 0.005%, BD 0.064%), Cal foam (0.005%) or BD foam (0.064%). NCT02387853 enrolled adolescent patients (12- <17 years) to Cal/BD foam QD (dose as previously). Treatment success was based on improvement in PGA classification at week 4. Additional efficacy endpoints included mPASI in adults and effect on extent of scalp surface area (SSA) in adolescents. Safety was also assessed. Overall, 302 adults (n=100 Cal/BD foam; n=101 Cal foam; n=101 BD foam) and 106 adolescents received treatment. Treatment success in adults was significantly higher with Cal/BD vs Cal foam (53.0% vs 35.6%, P=0.021) and numerically higher than with BD foam (47.5%, P=0.45). Mean percentage changes in mPASI were -80.0%, -57.8% and -71.2%, for Cal/BD, Cal and BD foam, respectively. In adolescents, 73.6% of patients treated with Cal/BD foam achieved treatment success and mean SSA fell from 50.6% at baseline to 12.5% at week 4. All treatment-related AEs were considered mild-to-moderate across both studies, except one severe AE (hypersensitivity reaction with urticaria) in the adult Cal/BD foam group, which led to withdrawal from the study. In these studies, treatment of scalp psoriasis with Cal/BD foam provided good efficacy for adults and adolescents and was generally well tolerated. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5168.

Topics: Administration, Topical; Adolescent; Adult; Aerosols; Aged; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Psoriasis; Scalp Dermatoses; Severity of Illness Index; Treatment Outcome

To demonstrate the efficacy and safety of adding fixed-dose combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam to oral apremilast in treating moderate plaque psoriasis.. A 16-week, investigator-blinded study in patients with moderate psoriasis (Physician’s Global Assessment [PGA] score of 3). Patients were randomized 1:1 to Cal/BD foam plus apremilast or vehicle foam plus apremilast for 4 weeks, followed by 8 weeks of apremilast monotherapy, and then 4 weeks of combination therapy as in the original randomization schedule. Efficacy assessments – Psoriasis Area and Severity Index (PASI), PGA, body surface area (BSA), visual analog scale (VAS) for pruritus, and quality of life (QoL) – and safety were evaluated at weeks 1, 2, 3, 4, 12, and 16.. 28 subjects were enrolled (mean age, 64 years; 67.9% males). Cal/BD foam plus apremilast group achieved statistically significantly greater improvement than vehicle foam plus apremilast in PASI75 (50% vs 7%; P=.003), PGA score of “clear” or “almost clear” (43% vs 7%; P=.001), and VAS score (2 vs 5; P=.0079) at week 4. BSA and QoL improvements were also observed. Most efficacy assessments worsened after withdrawing Cal/BD foam for 8 weeks but recovered after reinitiating Cal/BD foam from week 12 to week 16. Cal/BD foam plus apremilast appeared to be safe and well tolerated.. In the treatment of moderate plaque psoriasis, Cal/BD foam plus apremilast provided more benefits than with apremilast alone. These improvements appeared to be lost when Cal/BD foam was withdrawn but recovered when Cal/BD foam was reinitiated. J Drugs Dermatol. 2020;19(9):874-880. doi:10.36849/JDD.2020.5020.

Topics: Administration, Cutaneous; Administration, Oral; Adult; Aerosols; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Pruritus; Psoriasis; Quality of Life; Severity of Illness Index; Thalidomide; Treatment Outcome; Visual Analog Scale

The efficacy and safety of calcipotriol plus betamethasone dipropionate gel for the treatment of scalp psoriasis has previously been demonstrated in a four-week trial in a Chinese population.. To evaluate the long-term safety and efficacy of two-compound gel in Chinese adult patients with scalp psoriasis.. A multicentre, prospective, randomized, active-controlled trial was established in which subjects were randomized (at a ratio of 4:1) to receive either two-compound gel once daily or calcipotriol scalp solution twice daily for 28 weeks. Incidence of adverse drug reactions (ADRs) of any type and adverse events (AEs) of concern associated with long-term corticosteroid use on the scalp were evaluated.. A total of 951 subjects were randomly assigned to receive either two-compound gel (n=760) or calcipotriol scalp solution (n=191). The incidence of ADRs was significantly lower in the two-compound gel group compared with the calcipotriol scalp solution group (11.7 vs. 22.2%, p<0.001). There was no significant difference in treatment-emergent adverse events (TEAEs) associated with long-term topical corticosteroid use on the scalp (1.1% vs. 0%, p=0.369) between the two groups. A statistically significant difference in the percentage of visits with treatment success according to the Subject's Global Assessment was observed (p=0.009); more subjects had visits with 100% treatment success (15.2 vs. 6.3%) and fewer subjects had visits with 0% treatment success (23.7 vs. 30.8%) using two-compound gel compared to calcipotriol scalp solution.. The two-compound gel was well tolerated and effective in the long-term management of scalp psoriasis in Chinese patients.

Topics: Adult; Aged; Anti-Inflammatory Agents; Asian People; Betamethasone; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Therapy, Combination; Female; Gels; Humans; Male; Middle Aged; Prospective Studies; Psoriasis; Scalp Dermatoses; Solutions; Treatment Outcome

About 20% of patients taking apremilast alone obtain PASI 75 by week 8. This single-center, pilot study aimed to determine whether add-on topical therapy with calcipotriene/betamethasone dipropionate (C/BD) could improve responses of partial apremilast responders by week 12.. Adults (≥18 years of age) with moderate to severe plaque psoriasis (baseline PGA ≥3, BSA affected ≥10%, PASI ≥12) took oral apremilast (30 mg twice daily) for 8 weeks. Patients who achieved between PASI 25–74 at week 8 used add-on, daily topical C/BD (.005%/.064%) foam up to week 12; those with <PASI 25 at week 8 were discontinued.. Of 50 patients enrolled, 26 achieved PASI 25−74 and 8 PASI 75 at week 8. At week 12, 29 achieved PASI 75, and 24 at week 16. Of the week-8 partial responders, 21/26 achieved PASI 75 at week 12 on combination therapy and 15 maintained PASI 75 through week 16 on apremilast alone (4 did not maintain; 2 lost to follow up). In partial responders, mean PGA and BSA affected improved by 30% and 33% on apremilast, respectively, and by 67% and 86% at week 12 on the combination therapy, respectively. The most commonly reported adverse events (AEs; >5% occurrence) were headache (14%), diarrhea (10%), and nausea (8%); majority were mild. No related serious AEs occurred.. We show that most week-8 partial apremilast responders can achieve PASI 75 at week 12 with combination C/BD topical therapy, and maintain PASI 75 through week 16 with apremilast monotherapy. J Drugs Dermatol. 2020;19(12): doi:10.36849/JDD.2020.5435.

Topics: Administration, Cutaneous; Adult; Aerosols; Aged; Betamethasone; Calcitriol; Diarrhea; Drug Combinations; Drug Therapy, Combination; Female; Headache; Humans; Male; Middle Aged; Nausea; Pilot Projects; Psoriasis; Severity of Illness Index; Thalidomide; Treatment Outcome; Young Adult

Several factors have been shown to affect psoriasis pathogenesis, clinical presentation and treatment response.. The aim of this study was to investigate the potential relationship between patients' baseline characteristics and the efficacy of calcipotriol-betamethasone ointment in patients with mild to moderate plaque psoriasis and to evaluate whether the efficacy is consistent across subgroups.. Using data from the therapeutic equivalence study on patients with plaque psoriasis, post hoc analyses were performed to evaluate the impact of baseline demographic and disease characteristics, habits and comorbidities on the response to treatment with calcipotriol-betamethasone ointment.. Body mass index (BMI) and obesity were each independently associated (univariate analysis, p < 0.05) with reduction in modified Psoriasis Area and Severity Index (mPASI) and PASI75 (≥75% improvement in mPASI from baseline). Increased body weight is more common in patients with late-onset psoriasis. There was a significant trend for lower response rates with increasing BMI (p = 0.007) and obesity (p = 0.003). The odds of achieving PASI75 is 2.3 times lower for obese compared to normal-weight subjects.If patients with obesity or hypertension were treated with calcipotriol-betamethasone, they were still more likely to achieve PASI75 after 4-week treatment compared to vehicle (p < 0.001).. Increased BMI and obesity present risk factors for reduced treatment effectiveness. Importantly, the efficacy of calcipotriol-betamethasone ointment was consistent in all subgroups.

Topics: Adult; Anti-Inflammatory Agents; Betamethasone; Body Mass Index; Body Weight; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Humans; Male; Obesity; Ointments; Psoriasis; Severity of Illness Index

Psoriasis is a chronic, immune-mediated disorder with chronic plaque psoriasis being the primary manifestation during the remission stage. Patients often have a slow course and long history of the disease. The refractory type of psoriasis is a stubborn rash that does not subside easily. We designed this randomized controlled trial to compare the effectiveness and relapse rates of plaque psoriasis in patients treated with either acupuncture, moxibustion or calcipotriol ointment. The ultimate aim of the study is to select an effective traditional Chinese medicine therapy for patients with plaque psoriasis.. The study will be a multicenter, prospective, randomized controlled trial that compares the effectiveness of fire needle therapy, moxibustion and calcipotriol ointment. In total, 160 patients with plaque psoriasis who meet the inclusion criteria will be recruited from three hospitals in Beijing and then randomly assigned to receive either fire needle therapy (group A1), moxibustion (group A2) or calcipotriol ointment (group B). All participants will receive an 8-week treatment and will then be followed up for another 24 weeks, with time points at weeks 12 and 24 after treatment completion. The primary outcomes to be measured are relapse rates and psoriasis area and severity index score of the target lesions. In addition, the target lesion onset time, dermatology life quality index, traditional Chinese medicine syndrome score, and the relapse interval of the target lesion will be measured. Adverse events will be recorded for safety assessment.. The aim of this study is to determine whether fire needle therapy or moxibustion could improve the clinical effectiveness for psoriasis lesions and reduce the relapse rate. Once completed, it will provide information regarding therapeutic evaluation on fire needle therapy or moxibustion for plaque psoriasis, which will assist clinicians in selecting the most effective treatment options for patients.. International Clinical Trials Registry Platform (ICTRP), ChiCTR1800019588. Registered on 19 November 2018.

Topics: Acupuncture Therapy; Adolescent; Adult; Aged; Calcitriol; Chronic Disease; Humans; Middle Aged; Moxibustion; Outcome Assessment, Health Care; Prospective Studies; Psoriasis; Randomized Controlled Trials as Topic; Research Design; Young Adult

A wide range of treatments are available for psoriasis, including pharmaceuticals and phototherapy. Calcipotriol/betamethasone dipropionate and narrow-band ultraviolet phototherapy (NB-UVB) are both effective monotherapies for psoriasis; however, these two therapies have never been directly compared in a prospective clinical study. In this study, we compared the efficacy of combined calcipotriol/betamethasone dipropionate to NB-UVB in psoriatic patients with Psoriasis Area Severity Index (PASI) 9-10 treated in a routine clinical practice.. This prospective, observational study included 58 consecutive patients (age range, 19-65 years) diagnosed with recurrent chronic small plaque psoriasis. Patients were offered either topical therapy with a two-compound ointment containing calcipotriol (50 μm/g) and betamethasone dipropionate (0.5 mg/g) or NB-UVB (311 nm). Disease severity was assessed at baseline and posttreatment according to PASI and target lesion score (TLS) and by high-frequency (20 MHz) ultrasonography (HF-USG).. No statistically significant difference between the groups was observed in baseline or posttreatment PASI scores. Both treatments resulted in substantial reductions in PASI: 85% and 82%, respectively, for the calcipotriol/betamethasone group and the NB-UVB group. Both treatments significantly decreased the subepidermal low echogenic band (SLEB) thickness, with no significant differences between the two groups in terms of the percentage reduction in SLEB.. This study demonstrates, for the first time, that NB-UVB phototherapy and fixed combination calcipotriol/betamethasone ointment are equally effective in treating plaque psoriasis in patients with PASI 9-10 in routine clinical practice. In addition, measurement of SLEB thickness with HF-USG may be a useful objective parameter to assess skin lesions.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Ointments; Prospective Studies; Psoriasis; Recurrence; Treatment Outcome; Ultrasonography; Ultraviolet Therapy; Young Adult

Calcipotriene 0.005%, a vitamin D analog, plus betamethasone dipropionate 0.064%, a high potency topical corticosteroid, are combined in an aerosol foam formulation proven to be effective and safe using once daily topical application for plaque psoriasis. In this investigator initiated open phase study, therapeutic response mirrored the clinical outcomes that were reported in pivotal studies. What is added to the body of medical literature on this topical combination formulation for plaque psoriasis is documentation of effective results with use on both elbows and knees as target sites. Skin tolerability was also highly favorable with this specific formulation.\ \ J Drugs Dermatol. 2019;18(4):358-361.

Topics: Adult; Aerosols; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Elbow Joint; Female; Humans; Knee Joint; Male; Middle Aged; Pilot Projects; Psoriasis; Severity of Illness Index; Treatment Outcome

Psoriasis vulgaris is a common skin disease characterized by persistent localized erythematous scaly plaques, typically on the elbows, knees, and scalp. It is an immune-abnormal disease that progresses slowly over a long period with frequent symptom recurrence. Current studies have shown that acupuncture is an effective therapy for psoriasis. However, the scientific evidence of the efficacy of auricular acupressure treatment for patients with psoriasis is still insufficient. Therefore, we designed a randomized controlled clinical trial to investigate the effect, safety, and cost-effectiveness of auricular acupressure in addition to medication in patients with psoriasis.. This on-going study is a two-arm parallel, assessor-blinded, randomized controlled trial in which 180 participants with psoriasis will be recruited and then randomly allocated into two groups in a 1:1 ratio. Equal randomization will be conducted using a computer-generated random allocation sequence. Participants in the intervention group will receive auricular acupressure treatment once per week for 4 weeks, and calcipotriol betamethasone ointment for topical use once daily for 4 weeks. Participants in the control group will receive only calcipotriol betamethasone ointment treatment once daily for 4 weeks. All patients will be followed up for 12 weeks. The primary outcome is relapse rate. The secondary outcomes include time to relapse, rebound rate, time to new onset, Psoriasis Area and Severity Index score improvement rate, body surface area affected, a visual analogue scale, and Dermatology Life Quality Index. Cost-effectiveness analysis will be carried out from a health and community care provider perspective.. This multicenter randomized controlled trial will provide important clinical evidence for the effect and safety of auricular acupressure as a complementary therapy in patients with psoriasis.. Chinese Clinical Trial Registry, ChiCTR-TRC-14004916 . Registered on 20 May 2014. This protocol is version 3.0 which was updated on 24 September 2016.

Topics: Acupressure; Adolescent; Adult; Aged; Betamethasone; Calcitriol; Ear; Humans; Middle Aged; Ointments; Outcome Assessment, Health Care; Psoriasis; Randomized Controlled Trials as Topic; Young Adult

Topical corticosteroid or corticosteroid/calcipotriol preparations are recommended first-line topical treatments of psoriasis, but a main cause for the lack of efficacy of topical treatments is considered low rates of adherence to topical drugs. Patient support by the use of applications (apps) for smartphones is suggested to improve medical adherence.. Design: An investigator-initiated, single-center, single-blind, parallel-group, phase-4 clinical superiority randomized controlled trial (RCT).. 134 patients 18 to 75 years of age with mild-to-moderate psoriasis, who are capable of reading English language, own a smartphone, and are candidates for the study drug calcipotriol and betamethasone dipropionate (Cal/BD) cutaneous foam once daily prn (pro re nata).. A 28-day adherence-supporting app providing compulsory daily treatment reminders that pop-up on the smartphone screen with a short alert sound. The app synchronizes through Bluetooth® to an electronic monitor (EM) attached to the medication canister. The EM contains a chip registering the amount of foam, day and time the patient use the foam dispenser. The information is displayed in a diary that shows the amount of Cal/BD cutaneous foam used and the number of applied treatment sessions. The app has an optional diary with the patient's rating of symptoms. Non-intervention: Use of Cal/BD cutaneous foam and EM without the app. All participants are prescribed Cal/BD cutaneous foam prn for the entire study period. Primary outcome obtained in week 4: rates of adherence measured by patient report, weight of medication canisters, and number of treatment sessions measured by the EM. Secondary outcomes obtained at baseline, weeks 4, 8, and 26: Lattice System Physician's Global Assessment (LS-PGA) and Dermatology Quality of Life Index (DLQI).. This trial tests of whether an app can improve rates of adherence to a topical antipsoriatic drug. If the app improves rates of adherence and reduces the burden of psoriasis in a clinically significant way, the app could easily be implemented as a standard routine of care in the clinic.. NCT02858713 , registered on August 3, 2016. EudraCT number 2016-002143-42.

Topics: Administration, Topical; Betamethasone; Calcitriol; Dermatologic Agents; Humans; Medication Adherence; Mobile Applications; Psoriasis; Single-Blind Method

Very few studies have assessed the efficacy of excimer in the treatment of palmoplantar psoriasis (PPP), and none has compared the excimer with calcipotriol-clobetasol propionate combination.. To compare the effectiveness and safety of excimer lamp vs topical ointment containing calcipotriol (0.005% w/w) and clobetasol propionate (0.05% w/w) combination in PPP.. This right-left randomization trial included 36 patients with PPP, who received treatment with excimer lamp (twice weekly) on one side and calcipotriol-clobetasol combination (once daily) on another side for 12 weeks, followed by 8 weeks of follow-up. Recruitment and response assessment was done by 2 experienced dermatologists (SD and TN) using modified palmoplantar pustular psoriasis area and severity index score (mPPPASI, originally devised for palmoplantar pustulosis, suitably modified to assess response in PPP). Primary outcome measure was percentage improvement in mPPPASI at 12 weeks, which was classified as minimal (≤25%), mild (>25%-50%), moderate (>50%-75%), and marked (>75%). Secondary outcome measures were the proportion of patients achieving >75% reduction in mPPPASI and the time taken to achieve it.. Of 36 recruited patients, 33 completed treatment and 21 adhered to 8-weeks follow-up. The mean mPPPASI on the excimer-treated sides reduced significantly from 7.75 ± 4.62 to 4.01 ± 4.07 (P < .001) at 12th week (end of the treatment) and 2.66 ± 3.97 at 20th week (at 8 weeks follow-up). The mean mPPPASI on the calcipotriol-clobetasol combination treated sides reduced significantly from 7.36 ± 4.46 to 3.55 ± 3.77 (P < .001) and 2.70 ± 3.97 at 12th week and 20th week, respectively. The reduction was significant for both treatment and the difference between the two was not statistically significant. Minimal, mild, moderate, and marked improvement was seen in 5/33 (15.2%) and 1/33 (3.0%), 6/33 (18.2%) and 8/33 (24.2%), 12/33 (36.4%) and 13/33 (39.4%), and 8/33 (24.2%) and 8/33 (24.2%) sides in the excimer and calcipotriol-clobetasol combination, respectively. A total of 8 patients in each group achieved mPPPASI 75 at 12 weeks. The mPPPASI 75 was achieved at 2, 4, and 8 weeks in 1, 2, and 8 patients, respectively, using either modalities. The adverse effects (most commonly hyperpigmentation) were noted more frequently on the excimer-treated sides; however, they were well tolerated.. Both excimer lamp and calcipotriol-clobetasol propionate combination are equally effective in the treatment of PPP.

Topics: Adult; Aged; Calcitriol; Clobetasol; Female; Follow-Up Studies; Humans; Male; Middle Aged; Photochemotherapy; Psoriasis; Severity of Illness Index

Health-related quality of life (HRQoL) measures provide patient-centred evaluations of response to treatment. In the 12-week, Phase III PSO-ABLE study, fixed-combination calcipotriol 50 μg/g as hydrate (Cal) plus betamethasone 0.5 mg/g as dipropionate (BD) aerosol foam was significantly more effective for the treatment of psoriasis than Cal/BD gel.. To compare HRQoL in mild-severe psoriasis vulgaris patients (involving 2-30% body surface area) over 12 weeks of treatment with Cal/BD foam or gel.. HRQoL was assessed using: Dermatology Life Quality Index (DLQI), EuroQoL-5D-5L-PSO (EQ-5D), and Psoriasis QoL (PQoL-12) questionnaires (baseline, Weeks 4, 8 and 12); DLQI score of 0/1 (range: 0-30) and weighted EQ-5D utility index score of 1 (range: 0-1) indicates there is no impact on a patient's QoL and perfect health, respectively. Itch, itch-related sleep loss, and work impairment were also assessed.. In total, 463 patients were randomized to the study (Cal/BD foam, n = 185; Cal/BD gel, n = 188; foam vehicle, n = 47; gel vehicle, n = 43). Significantly more Cal/BD foam patients achieved DLQI scores of 0/1 at Weeks 4 (45.7% vs 32.4%; p = 0.013) and 12 (60.5% vs 44.1%; p = 0.003) than Cal/BD gel patients. Cal/BD foam significantly improved EQ-5D utility index (0.09 vs 0.03; p<0.001) and PQoL-12 scores (-2.23 vs -2.07; p = 0.029) from baseline to Week 4 versus Cal/BD gel. Itch, itch-related sleep loss, and work impairment improved more with Cal/BD foam than gel.. Cal/BD foam demonstrated greater HRQoL improvement in patients with psoriasis than Cal/BD gel over 12 weeks of treatment.

Topics: Absenteeism; Aerosols; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Gels; Humans; Medication Adherence; Middle Aged; Pruritus; Psoriasis; Quality of Life; Single-Blind Method; Surveys and Questionnaires; Treatment Outcome

To assess the effectiveness and safety of combining calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam with biologic therapies for patients with plaque psoriasis who have not obtained an adequate response with biologic therapy.. This was a prospective, open-label, single-arm study of patients with chronic plaque-type psoriasis (body surface area [BSA] ≤5%) who were being treated with biologic agents for ≥24 weeks. All patients received once-daily Cal/BD foam for 4 weeks, followed by twice-weekly use on consecutive days for 12 weeks (maintenance regimen). The end points were assessed at weeks 4 and 16, and included the Physician's Global Assessment (PGA), BSA, PGA×BSA, Dermatology Life Quality Index (DLQI), and Treatment Satisfaction Questionnaire for Medication (TSQM)-9. Safety evaluations included assessments of local skin reactions and adverse events (AEs).. Enrolled were 25 patients (18 men and 7 women; mean age, 53 ± 11 years). Patients had significant disease activity despite being on stable biologic therapy (median values: BSA, 3%; PGA, 3; PGA×BSA, 8). At weeks 4 and 16 versus baseline, adjunctive therapy with Cal/BD foam significantly improved PGA score (1 vs 1 vs 3; P less than .01), BSA involvement (1% vs 1% vs 3%; P less than .01), and PGA×BSA measure (1 vs 1 vs 8; P less than .01). Most patients achieved treat-to-target criteria for BSA ≤1% and PGA ≤1 at week 4 (both 76%) and week 16 (both 68%) versus 12% and 4%, respectively, at baseline. Quality of life was improved at both weeks 4 and 16, with high treatment satisfaction. Overall, adjunctive Cal/BD foam was safe and well-tolerated, with no serious AEs.. Adjunctive therapy with Cal/BD foam was associated with an improvement of every measure of disease activity in patients with inadequate response to biologics, an effect that was maintained throughout the study. The majority of patients achieved treat-to-target goals. J Drugs Dermatol. 2018;17(8):845-850.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Betamethasone; Biological Therapy; Calcitriol; Dermatologic Agents; Drug Compounding; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prospective Studies; Psoriasis; Treatment Outcome

We observed the promoting effects of the 2940-nm erbium:YAG (Er:YAG) fractional laser in topical drug delivery for psoriasis. A total of five (four males and one female) recalcitrant psoriasis patients were given laser treatment eight times at 1-week intervals with the following parameters: 5-11% spot density and 100-μm energy depth. The psoriatic skin lesions on the left knee and the corresponding lesions at the right ones of each psoriasis patient were randomly divided into two groups: laser + topical drug group (L) and drug alone group (D). The psoriatic lesions in both groups were treated with the same topical treatment (calcipotriol ointment). The corresponding psoriatic lesions in the L group received extra 2940-nm Er:YAG laser irradiation before topical treatment. The photos of psoriatic lesions were taken before each treatment. The final photos were obtained from the patients at the seventh day after the final treatment. Drug alone or in combination with laser Er:YAG both reduced psoriatic lesions. However, with the increase in the number of treatments, increasing differences were observed between the treatment and the control sides. The therapeutic outcomes in the L groups were better than those in the D groups. Psoriasis area and severity index (PASI) scores for five cases of both groups were decreased. However, the scores in the L groups were lower than those in the D groups. The use of 2940 nm Er:YAG promoted the absorption of topical drugs for psoriasis, improving the therapeutic effect.

Topics: Administration, Topical; Adult; Calcitriol; Combined Modality Therapy; Female; Humans; Lasers, Solid-State; Male; Psoriasis; Severity of Illness Index; Young Adult

Poor adherence to topical therapy in psoriasis remains an issue; it is associated with poor clinical outcomes, reduced quality of life and increased costs. Treatment-related factors leading to poor adherence include lack of efficacy, excessive time applying medication and poor cosmetic characteristics (e.g. slow absorption, greasiness).. To assess the topical treatment attributes that influence patient preference for fixed combination calcipotriol 50 μg/g (Cal) and betamethasone 0.5 mg/g as dipropionate (BD) foam vs. gel, as well as in comparison with the latest topical treatment (LTT) a patient received.. PSO-INSIGHTFUL was a Phase IIIb, prospective, multicentre (Canada/Germany), open-label, randomized, two-arm crossover study in patients aged ≥18 years with mild-to-severe psoriasis (NCT02310646). Following a washout period of up to 4 weeks, patients were randomized 1 : 1 to once-daily Cal/BD foam for 1 week, followed by Cal/BD gel for 1 week, or vice versa. Patients completed six questionnaires evaluating patient preferences.. A total of 213 patients were randomized; 118 had received a topical treatment in the previous 3 months. Based on the Subject's Preference Assessment, 50% of patients preferred Cal/BD foam and 50% preferred Cal/BD gel. Based on the Topical Product Usability Questionnaire (TPUQ), overall mean scores were high for both Cal/BD foam and gel, and were often significantly in favour of both products compared with LTT. Greater differences between Cal/BD foam and gel vs. LTT occurred when the previous treatment was an ointment or cream. Cal/BD foam was generally preferred by younger patients (aged 18-39 years), whereas Cal/BD gel tended to be preferred by older patients (aged ≥40 years). Results from other questionnaires were aligned with the TPUQ.. Patients with psoriasis have diverse needs and different preferences for topical treatment. This knowledge may help prescribers to choose the right formulation for the right patient, potentially leading to improved adherence and better treatment outcomes.

Topics: Administration, Topical; Adolescent; Adult; Betamethasone; Calcitriol; Cross-Over Studies; Female; Humans; Male; Middle Aged; Patient Compliance; Patient Preference; Prospective Studies; Psoriasis; Severity of Illness Index; Surveys and Questionnaires; Young Adult

The single-item Psoriasis Itch VAS was developed to measure itch intensity within the last 24 hours in psoriasis vulgaris to assess treatment benefit. Its psychometric properties were explored in two trials.. Data from two randomized, parallel-group phase 3 trials with subjects suffering from psoriasis vulgaris on the body (n = 426, 463) were analyzed. Cross-sectional distributional properties and construct validity of the Psoriasis Itch VAS as well as longitudinal test-retest reliability and sensitivity to change of the Psoriasis Itch VAS were investigated. All statistical tests were two-tailed.. Across both trials, acceptable distributional properties were observed. Convergent-validity correlations between the Psoriasis Itch VAS and other patient-reported and clinician-reported outcomes provided strong endorsement for construct validity as did tests of known-groups validity. Longitudinal measurement properties, involving test-retest reliability and sensitivity to change, also offered evidence for the measurement integrity of the Psoriasis Itch VAS.. Results from the assessment of validity, reliability, and sensitivity to change support the use of the Psoriasis Itch VAS to measure itch intensity in psoriasis vulgaris. Data from two trials provided evidence that the Psoriasis Itch VAS is well-defined and reliable for measuring itch in psoriasis vulgaris to assess treatment benefit (i.e. therapeutic response).

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Cross-Sectional Studies; Double-Blind Method; Female; Humans; Male; Middle Aged; Prospective Studies; Pruritus; Psoriasis; Treatment Outcome; Visual Analog Scale; Young Adult

Fixed combination calcipotriol 50 μg/g (Cal) plus betamethasone 0.5 mg/g (BD) foam has been developed as a new treatment option for patients with psoriasis.. The randomized, parallel-group, investigator-blinded Phase III, 12-week PSO-ABLE study compared the efficacy and safety of Cal/BD foam with Cal/BD gel. Patients aged ≥18 years with mild-to-severe psoriasis were randomized 4:4:1:1 to once-daily Cal/BD foam, Cal/BD gel, foam vehicle or gel vehicle (NCT02132936). The primary efficacy endpoint was the proportion of patients who were clear/almost clear with a ≥ 2 grade improvement according to the physician's global assessment of disease severity (i.e. treatment success) at week 4 for Cal/BD foam vs. week 8 for Cal/BD gel. Secondary efficacy endpoints included: proportion of patients achieving at least a 75% reduction in modified psoriasis area and severity index (mPASI75), and time to treatment success (TTTS). Safety was monitored throughout.. A total of 463 patients were randomized: Cal/BD foam (n = 185), Cal/BD gel (n = 188), foam vehicle (n = 47), gel vehicle (n = 43); overall completion rate was 90%. Cal/BD foam achieved higher treatment success rates (38% vs. 22%; P < 0.001) and mPASI75 (52% vs. 35%; P < 0.001) by week 4 than Cal/BD gel by week 8. Median TTTS with Cal/BD foam was 6 weeks; this could not be determined for Cal/BD gel as 50% treatment success was not achieved (P < 0.001). Adverse drug reactions were reported in 14 (7.6%) Cal/BD aerosol foam patients and 7 (3.7%) Cal/BD gel patients; all were single events except for itch with Cal/BD aerosol foam (n = 5; 2.7%) and worsening psoriasis with Cal/BD gel (n = 3; 1.6%).. Cal/BD aerosol foam showed significantly greater efficacy after 4 weeks, than 8 weeks of treatment with Cal/BD gel, with similar tolerability.

Topics: Adult; Aerosols; Betamethasone; Calcitriol; Female; Gels; Humans; Male; Middle Aged; Psoriasis

Fixed combination calcipotriol as hydrate (Cal) 50 µg/g plus betamethasone as dipropionate (BD) 0.5 mg/g aerosol foam is an alcohol-free treatment for psoriasis. Betamethasone 17-valerate 2.25 mg (BV)-medicated plasters are recommended for treating psoriasis plaques localized in difficult-to-treat (DTT; elbow, knee, anterior face of the tibia) areas.. The aim of this study was to compare the efficacy of Cal/BD foam with BV-medicated plaster in patients with plaque psoriasis.. In this phase IIa, randomized, single-center, investigator-blinded, 4-week study, both Cal/BD foam and BV-medicated plaster were applied once daily to six test sites (three for each treatment). The primary efficacy endpoint was absolute change in total clinical score (TCS; sum of erythema, scaling, and infiltration); secondary endpoints were changes from baseline in each individual clinical score, ultrasonographic changes (total skin and echo-poor band thickness), and safety; and post hoc analysis was change from baseline in TCS on DTT areas.. Thirty-five patients were included. Least-squares mean change in TCS from baseline was significantly greater for Cal/BD foam (-5.8) than BV-medicated plaster (-3.7; difference -2.2; 95% confidence interval -2.6 to -1.8; p < 0.001); greater changes for Cal/BD foam were observed from day 8 for each clinical sign. Absolute total skin and echo-poor band thickness change was significantly greater for Cal/BD foam than for BV-medicated plaster (both p < 0.001). Post hoc analyses showed that Cal/BD foam was significantly more effective than BV-medicated plaster on DTT areas after 4 weeks (p < 0.001), and both treatments were well tolerated.. Cal/BD foam demonstrated superior efficacy versus BV-medicated plasters, including on DTT areas, in patients with plaque psoriasis.. NCT02518048.

Topics: Adult; Aerosols; Betamethasone; Betamethasone Valerate; Calcitriol; Dermatologic Agents; Female; Glucocorticoids; Humans; Male; Middle Aged; Psoriasis; Single-Blind Method; Treatment Outcome

Treatment of nail psoriasis remains a challenging and often disappointing situation.. To compare the efficacy, adverse reactions and tolerability of treatment of nail psoriasis with PDL vs. Nd:YAG, in association with betametasona calcipotriol gel.. An open, prospective intrapatient left-to-right study was designed. The right hand of each patient received treatment with PDL and the left hand with Nd:YAG. Betamethasone calcipotriol gel was applied once a day during the first week after each laser session. A total of four sessions were administered.. The clinical efficacy was evaluated according to the NAPSI score. All patients showed improvement in nail bed and nail matrix psoriasis. The global NAPSI mean declined in 15.46 (p<0.000). There was neither statistical difference between the reduction in nail bed and matrix NAPSI nor in the treatment with PDL vs. Nd:YAG. The administration of Nd:YAG was more painful. No serious adverse effects were documented.. No random assignment and the small number of patients.. PDL and Nd:YAG have proven to be an effective treatment for nail psoriasis with no serious adverse effect. No statistically significant difference was found between the two treatments.

Topics: Adult; Aged; Betamethasone; Calcitriol; Combined Modality Therapy; Drug Combinations; Female; Gels; Humans; Lasers, Dye; Lasers, Solid-State; Low-Level Light Therapy; Male; Middle Aged; Nail Diseases; Prospective Studies; Psoriasis; Treatment Outcome

Fixed-combination calcipotriol 50 μg/g plus betamethasone 0.5 mg/g (Cal/BD) aerosol foam is a new topical treatment for psoriasis. Although moderate-to-severe psoriasis is typically treated with systemic/biologic therapies, a topical treatment that is efficacious in these patients may be a significant cost-saving alternative to systemic therapy.. The objective of this study was to assess the response to Cal/BD foam and gel in patients with moderate-to-severe psoriasis enrolled in the phase III, 12-week PSO-ABLE study.. Patients eligible for this analysis had moderate-to-severe psoriasis, defined by the 'Rule of Tens': body surface area ≥10% or Psoriasis Area and Severity Index (PASI) [excluding head; modified PASI (mPASI)] >10 or Dermatology Life-Quality Index >10. Endpoints included: proportion of patients achieving mPASI75 or mPASI90; change in body surface area; proportion of patients clear/almost clear with a ≥2 grade improvement (i.e., treatment success); change in Dermatology Life-Quality Index.. Seventy-seven Cal/BD foam patients and 82 gel patients had moderate-to-severe psoriasis. A greater proportion achieved mPASI75 and mPASI90 with Cal/BD foam than gel at weeks 4, 8, and 12 (57.1 vs. 35.4%; p = 0.006 and 15.6 vs. 12.2% at week 12, respectively); overall reduction in mPASI from baseline to week 12 was 64% with the foam vs. 51% with the gel. Overall reduction in body surface area at week 12 was 50% with the foam and 39% with the gel. Treatment success rates were higher with the Cal/BD foam than the gel at weeks 1, 2, 4, 8 (p = 0.0089), and 12, and a greater proportion of foam patients achieved a Dermatology Life-Quality Index score of 0/1 at weeks 4 (p = 0.004), 8, and 12 (p = 0.001).. Cal/BD foam can be considered as a treatment option in some patients with moderate-to-severe psoriasis who are potential candidates for systemic therapy. CLINICALTRIALS.. NCT02132936.

Topics: Administration, Cutaneous; Adult; Aerosols; Aged; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Gels; Humans; Male; Middle Aged; Prospective Studies; Psoriasis; Quality of Life; Severity of Illness Index; Treatment Outcome

Around two-thirds of patients with psoriasis do not adhere to topical treatment. The Topical Treatment Optimization Programme (TTOP), a five-element tool, includes guidance for the conversation between dermatologists/nurses and patients, patient information material, telephone/e-mail helpdesks and treatment reminders. It has been developed by patients and dermatologists to help increase adherence to treatment in psoriasis.. To compare TTOP with standard of care ('non-TTOP') within a large European investigator-initiated study, PSO-TOP (clinicaltrials.gov NCT01587755).. Patients with mild-to-moderate psoriasis received calcipotriol/betamethasone dipropionate gel as standardized study medication and were randomized 1 : 1 to either TTOP or non-TTOP management. Study medication was applied once daily for 8 weeks followed by 'as needed' application for an additional 56 weeks. Response was defined as a Physician's Global Assessment (PGA) of 'clear' or 'almost clear'.. In 1790 patients (full analysis set), response rates after 8 weeks (primary objective) were significantly higher for TTOP (36·3%) than for non-TTOP (31·3%, P = 0·0267). Better clinical outcome was accompanied by higher rates of patients feeling well informed about their skin condition, treatment and other factors related to adherence, but the Dermatology Life Quality Index was not statistically different. TTOP patients regarded the structured one-to-one conversations with their dermatologist/nurse as the most important element of TTOP.. Patients randomized to the TTOP intervention had a better clinical response than patients receiving standard of care. Improved communication between the healthcare provider and patient might be an important element in increasing adherence to topical therapy in psoriasis.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Betamethasone; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Female; Humans; Male; Medication Adherence; Middle Aged; Patient Satisfaction; Physician-Patient Relations; Psoriasis; Quality of Life; Treatment Outcome; Young Adult

Calcipotriol/betamethasone dipropionate combination in a non-alcoholic, lipophilic gel formulation (two-compound gel) has previously been demonstrated as a safe and effective treatment for scalp psoriasis in Caucasian, Hispanic/Latino, and Black/African American populations. The purpose of this randomized, investigator-blinded, active-controlled, 4-week study was to evaluate the efficacy and safety of the two-compound gel in Chinese subjects with scalp psoriasis.. Subjects were randomized in a 1 : 1 ratio to four weeks of treatment with either the two-compound gel once daily or calcipotriol scalp solution twice daily. Subjects were evaluated after one, two, and four weeks of treatment. The primary efficacy endpoint was the proportion of subjects who achieved "controlled disease" defined as "clear" or "minimal" disease according to investigator's global assessment of disease severity at week 4.. The proportion of subjects who achieved "controlled disease" at week 4 was statistically significantly higher in the two-compound gel group (87.5%) than in the calcipotriol solution group (50.8%), (P < 0.0001). Greater and more rapid improvements with the two-compound gel were also observed in clinical signs (redness, thickness, and scaliness) and itching. The two-compound gel was associated with fewer adverse drug reactions than calcipotriol scalp solution (18.6% vs. 33.1%) (P = 0.011).. The calcipotriol/betamethasone dipropionate gel applied once daily was significantly more effective and better tolerated than calcipotriol scalp solution applied twice daily in the treatment of scalp psoriasis over four weeks in Chinese subjects.

Topics: Administration, Topical; Adult; Asian People; Betamethasone; Calcitriol; China; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Middle Aged; Patient Safety; Psoriasis; Scalp Dermatoses; Severity of Illness Index; Solutions; Treatment Outcome

An aerosol foam formulation of fixed combination calcipotriene 0.005% (as hydrate; Cal) plus betamethasone dipropionate 0.064% (BD) was developed to improve psoriasis treatment.. To compare the efficacy and safety of Cal/BD aerosol foam with Cal/BD ointment after 4 weeks.. In this Phase II, multicenter, investigator-blind, 4-week trial, adult patients with psoriasis vulgaris were randomized to Cal/BD aerosol foam, Cal/BD ointment, aerosol foam vehicle or ointment vehicle (3:3:1:1). The primary efficacy endpoint was the proportion of patients at week 4 who achieved treatment success (clear or almost clear with at least a two-step improvement) according to the physician's global assessment of disease severity.. In total, 376 patients were randomized. At week 4, significantly more patients using Cal/BD aerosol foam achieved treatment success (54.6% versus 43.0% [ointment]; p = 0.025); mean modified (excluding the head, which was not treated) psoriasis area and severity index score was significantly different between Cal/BD aerosol foam and Cal/BD ointment (mean difference -0.6; p = 0.005). Rapid, continuous itch relief occurred with both active treatments. One adverse drug reaction was reported with Cal/BD aerosol foam (application site itch).. Cal/BD aerosol foam demonstrates significantly greater efficacy and similar tolerability compared with Cal/BD ointment for psoriasis treatment.

Topics: Adult; Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Ointments; Psoriasis; Single-Blind Method; Treatment Outcome

Calcipotriene 0.005% (Cal)/betamethasone dipropionate 0.064% (BD) aerosol foam was developed as a new treatment option for patients with psoriasis. This pooled analysis evaluated the efficacy of this formulation for 4 weeks of treatment.
. Patients aged ≥18 years with mild-severe psoriasis were enrolled into three Phase II/III studies (nCT01536886, nCT01536938, nCT01866163); each study evaluated Cal/BD aerosol foam versus different comparators. Endpoints included: proportion of patients clear/almost clear with ≥2-step improvement in physician's global assessment of disease severity ('treatment success'); modified (excluding head) psoriasis area and severity index (mPASI); proportion of patients with ≥75% reduction in mPASI (PASI75); change in itch (according to visual analog scale [VAS]).
. 1104 patients were included in the pooled analysis: Cal/BD aerosol foam (n=564), Cal/BD ointment (n=135), BD aerosol foam (n=101), Cal aerosol foam (n=101), aerosol foam vehicle (n=152), ointment vehicle (n=51). At week 4, 51% of Cal/BD aerosol foam patients achieved treatment success, a higher proportion than in all other groups (Cal/BD ointment, 43%; BD aerosol foam, 31%; Cal aerosol foam, 15%; aerosol foam vehicle, 5%; ointment vehicle, 8%). Greater percentage mean decrease in mPASI with Cal/BD aerosol foam was noted versus other treatments at week 4 (72% vs 63%, 53%, 43%, 32%, and 33%, respectively); week 4 PASI75 rate was also greater (51% vs 41%, 34%, 18%, 7%, and 10%, respectively). Cal/BD aerosol foam was efficacious irrespective of baseline disease severity and on all body areas assessed (arms, legs, trunk). Cal/BD aerosol foam alleviated itch as early as week 1 (change in itch VAS: -30 mm), maintained to week 4 (change in itch VAS: -41 mm).
. Cal/BD aerosol foam was significantly more effective than Cal/BD ointment and the individual active ingredients for treating psoriasis vulgaris, resulting in greater and faster reduction in disease severity and rapid, effective relief of itch.

J Drugs Dermatol. 2016;15(8):951-957.

Topics: Adolescent; Adult; Aerosols; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Drug Combinations; Drug Compounding; Female; Humans; Male; Middle Aged; Ointments; Psoriasis; Statistics as Topic; Treatment Outcome; Young Adult

To compare the impact on HRQoL of Cal/BD foam vs vehicle in patients with mild-to-severe psoriasis.
. HRQoL was assessed by dermatology life-quality index (DLQI; baseline, weeks 1, 2, 4) and EQ-5D-5L (EQ-5D; baseline, week 4) questionnaires. A DLQI score of 0 (range, 0-30) indicates no effect on the patient's life; an EQ-5D utility score of 1 (range, 0-1) and an EQ-5D visual analog scale (VAS) score of 100 (range, 1-100) indicate perfect health.
. 426 patients were randomized (Cal/BD foam, n=323; vehicle, n=103). Baseline mean DLQI scores were 9.9 (Cal/BD foam) and 10.3 (vehicle). The impact of psoriasis on HRQoL (EQ-5D utility score) at baseline was primarily driven by pain/discomfort (Cal/BD foam: 69.9%; vehicle: 65.0%) and anxiety/depression (Cal/BD foam: 45.3%; vehicle 44.7%). There was a greater improvement from baseline in DLQI score for Cal/BD foam vs vehicle at week 4 (-7.0 vs -4.4; P<.001); increased improvement was also seen in EQ-5D scores. At week 4, 48.1% of patients using Cal/BD foam reported no effect of psoriasis on their lives (DLQI = 0/1), and of patients using Cal/BD foam with baseline DLQI scores ≥5, 81.2% achieved a ≥5-point improvement.
. Cal/BD aerosol foam improved HRQoL after 4 weeks, with most patients experiencing a clinically meaningful improvement and almost 50% reporting no impairment.

J Drugs Dermatol. 2016;15(8):981-987.

Topics: Adult; Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Drug Compounding; Female; Health Status; Humans; Male; Psoriasis; Quality of Life

Psoriasis vulgaris (PV) has been causing increasing concern due to its highly prevalent, harmful and therapy-resistant characteristics. The YXBCM01 (Chinese herbal medicine) for PV trial evaluates the effects of YXBCM01 on relapse rate in patients suffering from PV. As an update to the published design and method for the trial, this paper presents the statistical plan for the main publication to avoid the risk of outcome reporting bias, selective reporting, and data-driven results.. This trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 600 PV patients (300 in each group) will be randomized to one of two arms: participants in the experimental group will receive the YXBCM01 granule 5.5 g twice daily for 12 weeks. Placebo granules are given to patients in the control group at a dose of 5.5 g twice daily for 12 weeks. The sequential topical therapy is administrated simultaneously to all eligible patients by using calcipotriol betamethasone ointment once daily (a treatment area of up to 30 % body surface area (BSA), fingertip unit is recommended) in the first 4 weeks (maximum of 100 g weekly), followed by calcipotriol betamethasone ointment once daily for the remaining 8 weeks (maximum of 100 g weekly). The primary outcome measure is relapse rate in the treatment period and follow-up period. The secondary outcome measures include time to relapse, time to onset, rebound rate, cumulative consumption of topical medicine, visual analog scale (VAS), BSA, the Dermatology Life Quality Index (DLQI) and the Medical Outcomes Study (MOS) 36-item short form health survey (SF-36).. Application of this statistical analysis plan to the YXBCM01 for PV trial will facilitate unbiased evaluation of these important clinical data. This study will provide evidence regarding the value of YXBCM01 as an intervention for PV patients.. Chinese Clinical Trial Registry: ChiCTR-TRC-13003233 , registered on 26 May 2013.

Topics: Administration, Cutaneous; Administration, Oral; Adolescent; Adult; Aged; Betamethasone; Calcitriol; China; Clinical Protocols; Data Interpretation, Statistical; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Drugs, Chinese Herbal; Female; Humans; Male; Middle Aged; Models, Statistical; Psoriasis; Quality of Life; Recurrence; Remission Induction; Research Design; Skin; Surveys and Questionnaires; Time Factors; Treatment Outcome; Young Adult

Psoriasis is a common, chronic, inflammatory skin disease with the majority of individuals having limited disease, treated with topical medication. However, special attributes of topical treatments like galenic/cosmetic properties or an inconvenient treatment schedule may result in low preference for topical treatments. Hence, there is strong medical need for a topical medication, which is highly efficacious, easy-to-use and preferred by both physicians and patients.. Blinded interim analysis with the purpose to assess efficacy of (both from the physician's and patient's perspective) and the patients' preference with a highly efficacious and easy-to-use fixed combination of calcipotriol/betamethasone dipropionate topical gel after 8 weeks of once daily treatment in a large patient population.. In this phase IV, international, multicentre, randomized, controlled, prospective, parallel group study, adult patients with active, mild to moderate psoriasis despite previous topical psoriasis treatment, i.e. unsuccessful in the 8 weeks preceding study participation, are followed over 64 weeks. During the first 8 weeks the patients apply their medication once a day followed by a 56-weeks maintenance period according to SmPC. Blinded interim analysis of all patients included demographics, Physician's Global Assessment, the novel Patient's self Global Assessment (PsGA) and Patient Preference Questionnaire (PPQ).. 1795 patients were analysed. At week 8, 36.5% of the physicians rated the patients' psoriasis as clear/almost clear. Similarly, based on the patients' self-assessment, 34.2% had a clear/almost clear score of PsGA in week 8. Analysis of the PPQ showed that the vast majority of the patients judged their 8-week treatment to be preferable compared with their previous treatments.. Results of this blinded interim analysis indicate that the fixed combination of calcipotriol/betamethasone dipropionate gel is highly efficacious and preferred by the majority of analysed patients.

Topics: Administration, Cutaneous; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Gels; Humans; Male; Middle Aged; Patient Preference; Prospective Studies; Psoriasis; Severity of Illness Index; Surveys and Questionnaires; Treatment Outcome

Vascular modifications represent a key feature in psoriatic plaques. Previous research with Laser Doppler Perfusion Imaging (LDPI) revealed a remarkable heterogeneity in the cutaneous perfusion within homogenous-appearing psoriatic lesions. Insights in the relation between perfusion during treatment and related biological changes are lacking.. To study the effect of calcipotriol-betamethasone dipropionate ointment on the microcirculation and the expression levels of immunohistochemical markers in psoriatic lesions compared to the distant uninvolved skin.. Psoriatic lesions of fourteen patients were treated once a day during 8 weeks. Clinical SUM scores and the perfusion intensity by means of LDPI were assessed every 2 weeks. After 8 weeks, a biopsy from the target lesion and one from the distant uninvolved skin were taken and stained for psoriasis-related markers, like IL-17 and CD31.. After 8 weeks, seven patients reached a SUM score of 0 or 1, and were classified as good-responders. The other patients were classified moderate-responders. The perfusion intensity decreased in all lesions during therapy. In the good-responders, all investigated psoriasis-related proteins within the treated lesions reached the expression level found within the distant uninvolved skin. The expression of CD31, however, was significantly higher in the treated lesions as compared to the distant uninvolved skin (p = 0.0156). In the moderate responders, almost all expression levels remained significantly elevated compared to the uninvolved skin.. In the skin of good-responders the expression of dermal CD31(+) endothelium remains significantly elevated within the treated lesions compared with the distant uninvolved skin, whereas a marked reduction in the perfusion intensity and SUM score was found. This indicates that clinical improvement might outrun endothelial changes.

Topics: Administration, Topical; Adult; Aged; Betamethasone; Biomarkers; Blood Flow Velocity; Calcitriol; Cytokines; Dermatologic Agents; Drug Combinations; Female; Humans; Laser-Doppler Flowmetry; Male; Middle Aged; NK Cell Lectin-Like Receptor Subfamily K; Ointments; Perfusion Imaging; Psoriasis; Reproducibility of Results; Sensitivity and Specificity; Skin; Up-Regulation

The antipsoriatic effect of an innovative aerosol foam formulation of fixed combination calcipotriol 50 μg/g (as hydrate; Cal) and betamethasone 0.5 mg/g (as dipropionate; BD) was explored in order to compare the effect with that of the first-line treatment Cal/BD ointment.. This was a Phase IIa, single-centre, investigator-blinded, exploratory study, with intra-individual comparison using a modified psoriasis plaque test. Patients were treated once daily (6 days/week) for 4 weeks with Cal/BD foam, Cal/BD ointment, BD foam and Cal/BD foam vehicle, randomized to four plaque test sites (5 cm(2) each). The primary efficacy endpoint was change in total clinical score (TCS; sum of erythema, scaling and lesional thickness). Secondary endpoints included ultrasonographic changes in total skin thickness and echo-poor band thickness, and adverse events.. Twenty-four patients, median age 52.5 years (range 21-75), completed this study. At week 4, test sites treated with Cal/BD foam had a significantly greater decrease in mean (±SD) TCS (-6.00 ± 1.27) versus those treated with Cal/BD ointment (-5.25 ± 1.78; difference -0.75; 95 % CI -1.46 to -0.04; p = 0.038), BD foam (-4.96 ± 1.85; difference -1.04; 95 % CI -1.75 to -0.33; p = 0.005) or foam vehicle (-1.88 ± 1.12; difference -4.13; 95 % CI -4.83 to -3.42; p < 0.001). Total skin thickness and echo-poor band thickness of Cal/BD foam-treated sites were reduced to a greater extent than those treated with comparators. Eleven patients reported 17 adverse events, the most frequent being headache (five patients). There were no lesional/perilesional adverse events or adverse drug-related events.. Cal/BD foam demonstrated a significant improvement in antipsoriatic effect over Cal/BD ointment, BD foam and foam vehicle alone.

Topics: Adult; Aerosols; Aged; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Ointments; Psoriasis; Single-Blind Method; Ultrasonography; Young Adult

Topics: Administration, Topical; Adult; Aged; Calcitriol; Drugs, Chinese Herbal; Female; Humans; Male; Middle Aged; Nail Diseases; Psoriasis; Treatment Outcome; Young Adult

The vitamin D analogue calcipotriol is an immunomodulatory drug widely used to treat psoriasis; however, how calcipotriol affects the immune cells in psoriasis lesions is not fully understood. The aim of this study was to investigate the effect of calcipotriol on the frequency of CD4(+) and CD8(+) T cells and innate lymphoid cells (ILC) and their production of IL-17A, IFN-γ and IL-22 in psoriasis lesions in patients with chronic plaque psoriasis. Eighteen patients with psoriasis were included, and two similar psoriasis lesions were chosen for each patient. One lesion was treated with calcipotriol (50 μg/g) and the other with vehicle twice a day for 14 days. The clinical effect was measured by degree of erythema, scaling and induration in each lesion (SUM score). Skin biopsies were collected for histological and immunohistochemical analyses. Skin-derived cells were isolated and analysed by flow cytometry. After 14 days of treatment with calcipotriol, a significant clinical and histological effect was seen; however, we found no differences in the frequency of CD4(+) and CD8(+) T cells or ILC between calcipotriol- and vehicle-treated skin. The main finding was a significant decrease in CD8(+) IL-17(+) T cells in skin-derived cells from calcipotriol-treated skin, which was further supported by the absence of CD8(+) IL-17(+) T cells in immunohistochemical staining of calcipotriol-treated skin. No changes in the frequency of IL-22(+) or IFN-γ(+) cells were observed. Our findings show that the vitamin D analogue calcipotriol reduces the frequency of CD8(+) IL-17(+) T cells in psoriasis lesions concomitant with clinical improvement.

Topics: Adult; Aged; Calcitriol; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; Dermatologic Agents; Erythema; Female; Humans; Interferon-gamma; Interleukin-17; Interleukin-22; Interleukins; Lymphocyte Count; Male; Middle Aged; Psoriasis; Young Adult

An innovative aerosol foam formulation of calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) designed to improve treatment outcomes.. To compare the efficacy and safety of Cal/BD aerosol foam with aerosol foam vehicle in patients with psoriasis.. Phase III, double-blind, randomized PSO-FAST (Cal/BD foam in PSOriasis vulgaris, a Four-week, vehicle-controlled, efficacy And Safety Trial) study recruited patients with ≥ mild severity psoriasis of the trunk and/or limbs from 27 US outpatient sites (NCT01866163). Patients were randomized (3:1) to Cal/BD foam or vehicle once-daily for 4 weeks.. proportion of patients at week 4 who achieved treatment success according to physician's global assessment.. modified (excluding head) psoriasis area and severity index (mPASI) and patient's assessment of itch (visual analog scale). Safety was monitored by adverse events/calcium homeostasis.. 426 patients enrolled between June and October 2013 (Cal/BD foam, n=323; vehicle, n=103). At week 4, significantly more patients using Cal/BD foam achieved treatment success versus vehicle (53.3 versus 4.8%; OR 30.3, 95% CI 9.7,94.3; P < .001) and mean mPASI score was significantly lower for patients using Cal/BD foam than vehicle (2.0 versus 5.5; adjusted difference -3.3, P <.001). Significantly greater itch relief was observed for patients using Cal/BD foam than vehicle (P = .010 at day 3, P < .001 from day 5). Adverse drug reactions were reported in 10 Cal/BD foam patients (3.1%) and two vehicle patients (1.9%); events occurred in one patient each except application site pain (Cal/BD foam, two patients; vehicle, one patient). There were no clinically significant changes in calcium homeostasis.. Cal/BD foam was efficacious, achieved rapid itch relief and was well tolerated in patients with body psoriasis. This innovative aerosol foam formulation is expected to become a valuable treatment option.

Topics: Adolescent; Adult; Aerosols; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Psoriasis; Skin; Treatment Outcome; Young Adult

Treatment of psoriasis is very complex and there are no still universal, nor unique treatment modalities. Apart from conventional treatment, which includes topical calcipotriol (vitamin D3 analogue), balneotherapy is drawing increased attention worldwide. Being part of climatotherapy, balneotherapy is defined as the use of natural environmental factors in the treatment of health conditions, whereas in the treatment of psoriasis it means the use of mineral baths and peloids. The aim of this study was to examine the therapeutic efficacy of mineral waters and peloids of the Rusanda Spa on plaque psoriasis in patients also treated with calcipotriol.. The study included 60 patients divided into two groups. The first group included patients treated with mineral waters, peloids and calcipotriol in the Rusanda Spa, while the second one included those treated only with calcipotriol. The study took 21 days, and each patient was followed up for at least one month after ending the treatment. The treatment efficacy was measured by psoriasis area severity index (PASI) scores on the days 0, 7, 14 and 21 during the treatment and 30 after the end of the therapy.. After a 3-week treatment in the Rusanda Spa, the first group showed a decrease in PASI score by 59.45%, whereas in the group of outpatients treated by calcipotriol it was 39.34%. On the day 30 following the treatment, the first group presented with the PASI score reduction of 58.44%, and the second group of 34.78%. The therapeutic efficacy of mineral waters and peloids combined with calcipotriol showed to be significantly higher in regard to monotherapy with calcipotriol (p < 0.05). In regard to clinical symptoms, the best results were obtained in the reduction of desquamation (p < 0.001).. The results of our study show that in the treatment of plaque-type psoriasis, topical calcipotriol combined with Spa Rusanda balineotherapy is more effective than topical calcipotriol alone. Randomized controlled trials are needed to confirm the effects of balneotherapy as monotherapy in treatment of this type of psoriasis.

Topics: Adult; Aged; Balneology; Calcitriol; Dermatologic Agents; Female; Humans; Male; Middle Aged; Psoriasis; Treatment Outcome

Previous studies showed the efficacy of a formulation containing calcipotriol and betamethasone dipropionate for the treatment of psoriasis.. To investigate maintenance strategies of a formulation containing calcipotriol (50 µg/g) and betamethasone dipropionate (0.5 mg/g) for the treatment of scalp psoriasis.. Nine-hundred and four patients were screened and randomised on a 1:1 basis in two groups: maintenance of two applications per week (group A) versus on-demand therapy (group B). Clinical evaluation was performed at weeks 0, 2, 4, 8 and 12.. Eight-hundred and eighty-five patients were randomised: 441 in group A and 444 in group B. From week 2, both groups showed a significant clinical improvement compared with baseline; at weeks 8 and 12, group A demonstrated a higher clinical response compared with group B (p < 0.05). This difference was statistically significant (OR 0.47, 95% CI 0.37, 0.60).. The maintenance of twice-weekly application versus on-demand treatment of calcipotriol/betamethasone dipropionate gel is more effective and is associated with a lower rate of relapse.

Topics: Adult; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Chemistry, Pharmaceutical; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Female; Gels; Humans; Male; Middle Aged; Psoriasis; Recurrence; Scalp Dermatoses; Young Adult

A ready-to-use betamethasone valerate 0.1% (BMV) dressing was found to be superior to placebo dressing and a reference 0.1% BMV cream in the treatment of patients with chronic plaque psoriasis (CPP).. This multicentre, prospective, randomized, investigator-blinded, controlled, non-inferiority trial compared the efficacy and safety of the BMV dressing to the calcipotriol-betamethasone dipropionate (CBD) ointment during a 4-week treatment of patients with mild to moderate CPP. The primary efficacy endpoint was the 4-item psoriasis total severity score (TSS-4) at week 4, and the associated non-inferiority margin was 1 point. Secondary outcome measures included the psoriasis global assessment (PGA) score and patients' quality of life (QoL). Safety was assessed through adverse events (AE) reporting in each treatment group.. Of 325 screened patients, 324 were randomized to BMV (N = 165) or CBD (N = 159), and were considered evaluable for the safety and intention-to-treat (ITT) efficacy analyses. Per protocol (PP) populations included 133 and 131 patients in the BMV and CBD groups respectively. The mean adjusted TSS-4 significantly decreased through the study from baseline in both groups. The PP (primary) analysis of week 4 data revealed a -0.288 (95% CI: -0.610 to 0.034) not significant between-group difference in adjusted means, demonstrating non-inferiority of BMV to CBD. Non-inferiority was also demonstrated in the ITT analysis. The PGA and other secondary outcomes were significantly improved from baseline in both groups at week 4. The QoL score was slightly better in the CBD group at week 4, but no difference was observed at follow-up. No safety or tolerability concerns were observed in either group.. BMV dressing is non-inferior to CBD ointment in patients with mild to moderate CPP. Both treatments significantly improve patients' psoriasis and QoL.

Topics: Anti-Inflammatory Agents; Bandages; Betamethasone; Betamethasone Valerate; Calcitriol; Chronic Disease; Dermatologic Agents; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Ointments; Prospective Studies; Psoriasis; Single-Blind Method

Plaque psoriasis has a relatively high prevalence in adolescence, resulting in a significant impact on quality of life, including social interactions.. The primary objective was to assess the safety of once-daily application of fixed-combination calcipotriol plus betamethasone dipropionate gel in adolescent scalp psoriasis. Assessment of efficacy was a secondary objective.. This phase II, multicentre, single-arm, open-label, 8-week trial included patients aged 12-17 years with moderate-to-very severe scalp psoriasis according to Investigator's Global Assessment (IGA) (≥ 10% of the scalp area affected).. Seventy-eight patients received treatment. Twenty-seven patients (35%) reported a total of 64 adverse events (AEs); most were mild (33/64) or moderate (22/64) in severity and there were no serious AEs. No cases of hypercalcaemia were reported, and the mean changes from baseline to end of treatment in albumin-corrected serum calcium (0·00 mmol L(-1)), 24-h urinary calcium excretion (-0·03 mmol per 24 h) and urinary calcium-to-creatinine ratio (-0·12 mmol g(-1)) were not considered clinically relevant. At the end of treatment 66 patients (85%) were clear or almost clear according to IGA. There was an 80% improvement in mean Total Sign Score from baseline to end of treatment. In total, at the end of treatment, 87% of patients rated their scalp psoriasis as clear or very mild, and 75 (96%) had no or mild pruritus compared with 14 (18%) at baseline.. Once-daily calcipotriol plus betamethasone dipropionate gel is well tolerated and efficacious for scalp psoriasis in adolescents.

Topics: Administration, Cutaneous; Adolescent; Betamethasone; Calcitriol; Child; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Female; Gels; Humans; Male; Psoriasis; Scalp Dermatoses; Treatment Outcome

Psoriasis causes worldwide concern because of its high-prevalence, as well as its harmful, and incurable characteristics. Topical therapy is a conventional treatment for psoriasis vulgaris. Chinese medicine (CM) has been commonly used in an integrative way for psoriasis patients for many years. Some CM therapies have shown therapeutic effects for psoriasis vulgaris (PV), including relieving symptoms and improving quality of life, and may reduce the relapse rate. However, explicit evidence has not yet been obtained. The purpose of the present trial is to examine the efficacy and safety of the YXBCM01 granule, a compound Chinese herbal medicine, with a combination of topical therapy for PV patients.. Using an add-on design, the trial is to evaluate whether the YXBCM01 granule combined topical therapy is more effective than topical therapy alone for the treatment of PV. The study design is a double-blind, parallel, randomized controlled trial comparing the YXBCM01 granule (5.5 g twice daily) to a placebo. The duration of treatment is 12 weeks. A total of 600 participants will be randomly allocated into two groups, YXBCM01 granule group and placebo group, from 11 general or dermatological hospitals in China. Topical use of calcipotriol betamethasone for the first 4 weeks and calcipotriol ointment for the remaining 8 weeks will be the same standard therapy for the two groups. Patients will be enrolled if they have a clinical diagnosis of PV, a psoriasis area severe index (PASI) of more than 10 or body surface area (BSA) of more than 10%, but PASI of less than 30 and BSA of less than 30%, are aged between 18 and 65-years-old, and provide signed informed consent. The primary outcome, relapse rate, is based on PASI assessed blindly during the treatment. Secondary outcomes include: (i) relapse time interval, (ii) time to onset, (iii) rebound rate, (iv) PASI score, (v) cumulative consumption of medicine, (vi) the dermatology quality life index (DLQI), and (vii) the medical outcomes study (MOS) item short form health survey (SF-36). Analysis will be on intention-to-treat and per-protocol subject analysis principles.. To address the effectual remission of the YXBCM01 granule for PV, this trial may provide a novel regimen for PV patients if the granule can decrease relapse rate without more adverse effects.. Chinese Clinical Trial Registry (http://cwww.chictr.org): ChiCTR-TRC-13003233, registered 26 May 2013.

Topics: Betamethasone; Calcitriol; Clinical Protocols; Dermatologic Agents; Double-Blind Method; Drug Therapy, Combination; Drugs, Chinese Herbal; Humans; Ointments; Outcome Assessment, Health Care; Psoriasis

Topics: Adult; Aged; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Female; Gels; Humans; Male; Middle Aged; Psoriasis; Treatment Outcome; Young Adult

Probably related to immune dysfunction, psoriasis vulgaris is a chronic, painful, disfiguring and disabling dermatological disease, carrying an increased risk of serious comorbidities. Current conventional therapies can be costly, show risks of side effects and have limited efficacy, with relapse common on treatment cessation. Chinese herbal medicine is effective in treating psoriasis vulgaris. However, any benefit of adding Chinese herbal medicine to conventional treatments when treating psoriasis vulgaris is yet to be determined.. This is a pilot randomized, placebo controlled, double-blinded trial. The pilot is primarily to determine the feasibility of undertaking a full size randomized trial. Thirty participants with psoriasis vulgaris and Psoriasis Area Severity Index (PASI) scores ≥ 7 and ≤ 12 will be included. Participants will be randomized (in a 1:1 ratio) to receive oral granulated Chinese herbal medicine YXBCM01 plus topical calcipotriol 0.005% or oral YXBCM01 placebo plus topical calcipotriol 0.005% treatment for 12 weeks, with a 12-week follow-up phase. The Chinese herbal medicine or placebo will be administered orally as dissolvable granules. The primary outcome measure will be PASI change (%) from baseline to the end of treatment phase. Secondary outcomes will include safety, key psoriasis-related cytokine changes (for example, IL12, IL17 and IL 23) during the entire trial and symptom relapse rates at the end of the follow-up phase.. The study will evaluate the feasibility of a randomized controlled trial investigating combined conventional and Chinese herbal medicine therapy for psoriasis vulgaris. The ingredients of YXBCM01 were selected based on literature, the expert opinion on herbal medicine and pre-clinical evidence, for instance Chinese herbal medicine possesses anti-inflammatory or antiproliferative properties.. Australian New Zealand Clinical Trials Registry ACTRN12614000493640.

Topics: Administration, Cutaneous; Administration, Oral; Biomarkers; Calcitriol; Clinical Protocols; Cytokines; Dermatologic Agents; Double-Blind Method; Drug Therapy, Combination; Drugs, Chinese Herbal; Feasibility Studies; Humans; Inflammation Mediators; Pilot Projects; Psoriasis; Recurrence; Remission Induction; Research Design; Time Factors; Treatment Outcome; Victoria

Vehicle formulation plays a major role in patient adherence to topical psoriasis treatments. The objective of this study was to conduct a preliminary assessment of patient preference for ointment versus topical suspension formulations of calcipotriene 0.005%-betamethasone dipropionate 0.064% for treatment of plaque psoriasis. In our small cohort of 20 participants with mild to moderate plaque psoriasis, the topical suspension formulation was preferred over the ointment, though the difference was not statistically significant (P=.32). Overall, the topical suspension was rated as moderately appealing, while the ointment was rated as slightly appealing (P=.06). Subgroup analyses were limited due to the small sample size. The results of this study may provide clinicians with an alternative topical treatment of plaque psoriasis that provides the benefits of a combination product. In clinical practice, it may be best to offer patients both formulations and they can choose the product that is right for them.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Antineoplastic Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Ointments; Patient Preference; Pilot Projects; Psoriasis; Severity of Illness Index; Suspensions; Treatment Outcome

We compared the clinical efficacy of various psoriasis treatments among: (i) topical application of calcipotriol ointment twice daily (group I); (ii) topical application of calcipotriol ointment twice daily and narrowband ultraviolet B NB-UVB phototherapy once a week (group II); (iii) topical application of heparinoid ointment twice daily and NB-UVB phototherapy more than twice a week (group III); and (iv) topical application of calcipotriol ointment twice daily and NB-UVB phototherapy more than twice a week (group IV). Ten patients were randomly selected for each group and treated by the indicated regimens for 12 weeks. All treatments were effective and significantly improved Psoriasis Area and Severity Index (PASI) scores, self-administered PASI scores and visual analog scale scores of pruritus. Group IV showed most marked and rapid reduction in PASI and self-PASI scores among the four regimens. Although the serum levels of interleukin (IL)-17, IL-20 and IL-22 and psoriasis disability index were significantly decreased after the treatments, no significant difference was detected among the four groups. Our study indicates that combination of calcipotriol ointment plus NB-UVB more than twice a week is superior to other treatment regimens, rapidly improving psoriasis lesions.

Topics: Adult; Aged; Aged, 80 and over; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Female; Humans; Male; Middle Aged; Psoriasis; Ultraviolet Therapy

Calcipotriene ointment and cream are effective treatments for psoriasis, but many patients with scalp psoriasis prefer lighter, less messy vehicles.. To evaluate the efficacy and safety of calcipotriene foam, 0.005%, for plaque-type psoriasis of the scalp.. Subjects (n=363) were randomized into an 8-week, multicenter, double-blind, vehicle-controlled, parallel-group, phase 3b study of calcipotriene foam, 0.005% (NCT01139580). Primary end point was the proportion of subjects with an Investigator's Static Global Assessment (ISGA) score of 0 (clear) or 1 (almost clear) at week 8 for scalp involvement. Body involvement, target lesion score, and improvement for erythema, scaling, and plaque thickness were also assessed.
. At week 8, more subjects in the calcipotriene foam, 0.005% group (40.9%) met the primary end point vs the vehicle foam group (24.2%; intent-to-treat [ITT] population; P <.001); a significant difference between groups was also observed at weeks 2 (P = .041) and 4 (P <.001). No significant difference was observed between treatment groups for ISGA of body psoriasis (ITT population; P = .544). In the per-protocol population, but not the ITT population, more subjects in the calcipotriene foam, 0.005%, group than the vehicle foam group met the secondary end points for scaling (P = .019) and plaque thickness (P =.027). Incidence of adverse events in both treatment groups was low; calcipotriene foam, 0.005%, was associated with erythema.. An 8-week study provides limited safety and efficacy data.
. Calcipotriene foam, 0.005%, was more effective than vehicle foam for improving scalp psoriasis over an 8-week period, with improvements evident from week 2, and had a similar safety profile to vehicle foam.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Calcitriol; Child; Dermatologic Agents; Double-Blind Method; Erythema; Female; Humans; Male; Middle Aged; Psoriasis; Scalp Dermatoses; Treatment Outcome; Young Adult

Calcipotriol is a newer topical treatment option available for plaque psoriasis and coal tar being one of the oldest treatment and still in use.. To evaluate and compare the differences in terms of efficacy, safety and relapse with Calcipotriol 0.005% (50 mcg/gm) and 6% coal tar and 3% salicylic ointment in patients with Plaque psoriasis. SETTING and. Study conducted on 60 patients of plaque psoriasis, who attended the skin OPD in our hospital.. The patients with mild to moderate plaque psoriasis were selected. 60 patients were enrolled for the study after obtaining informed consent. Subjects were asked to apply Calcipotriol 0.005% (50 mcg/gm) (Heximar Win care) twice a day on the right side plaques and on left side plaques, Petroleum jelly (Vaseline) in the morning and 6% coal tar and 3% salicylic ointment (Protar® Percos) at nighttime. PASI score was used to assess the reponse to therapy at 2nd, 4th, 6th and 8th week. After treatment subjects were observed for 6 weeks for any relapse.. It was done by paired t-test and independent sample t-test.. The results showed that statistically significant difference was seen in the mean percentage reduction of PASI score between both the groups, at all the assessment visits, 2, 4, 6, and 8 weeks, the mean percentage reduction at 2 weeks for calcipotriol being 21±12.06 and for coal tar being 13.44±11.19 (P=0.000), at 4 weeks for calcipotriol was 40±16.71 and for coal tar 25±99 (P=0.000), at 6 weeks for calcipotriol was 53.99+-22.43 and for coal tar 41±21.23 (P=0.002), at 8 weeks for calcipotriol was 62.73±24.04 and for coal tar was 51.53±23.27 (P=0.11). Relapse was seen in 5/60 (8.3%) of patients on calcipotriol treated side and 9/60 (15%) of patients with coal tar treated side. Thus it can be concluded that calcipotriol cream is more efficacious when compared with coal tar and does have a quick response. It is well tolerated and acceptable cosmetically.

Topics: Adolescent; Adult; Calcitriol; Chronic Disease; Coal Tar; Dermatologic Agents; Drug Combinations; Female; Follow-Up Studies; Humans; Male; Middle Aged; Ointments; Prospective Studies; Psoriasis; Salicylic Acid; Secondary Prevention; Severity of Illness Index; Treatment Outcome; Young Adult

The two-compound topical suspension/gel containing calcipotriene plus betamethasone dipropionate is effective and safe in the treatment of psoriasis on the body and scalp within the general psoriasis patient population.. To evaluate the systemic effects of once-daily use of two-compound topical suspension/gel on the hypothalamic-pituitary-adrenal (HPA) axis and calcium homeostasis in subjects with extensive psoriasis vulgaris.. An open-label, single-group, 8-week trial in 43 subjects with extensive psoriasis covering 15-30% of the body surface area. Blood and 24-hour urine samples were collected and a standard-dose adrenocorticotropic hormone (ACTH) stimulation test was performed at baseline, weeks 4 and 8. Primary endpoints were serum cortisol 30 minutes after ACTH injection (HPA axis response abnormal at serum cortisol ≤18 μg/dL) and changes from baseline in albumin-corrected serum calcium (sCa), 24-hour urinary calcium excretion (24hCa) and urine calcium:creatinine ratio (Ca:Crea).. Two (4.7%) subjects showed signs of adrenal suppression based on the ACTH stimulation test results at week 4; both were withdrawn from treatment and had normal serum cortisol 30-minute values at follow-up 4 weeks later. None of the subjects who continued treatment to week 8 showed signs of adrenal suppression. There were no clinically relevant mean changes from baseline to weeks 4 and 8 in sCa, 24hCa or Ca:Crea and no subject had sCa above the reference range.. The two-compound topical suspension/gel containing calcipotriene plus betamethasone dipropionate may be applied once daily to extensive psoriasis vulgaris without generally causing adrenal suppression or disturbance of calcium homeostasis, consistent with previous findings. In a small number of patients with extensive psoriasis treated with large volumes of topical suspension, adrenal suppression may be observed. In the real-world setting, it is anticipated that systemic side-effects would occur in only a few cases within the general psoriasis patient population. ClinicalTrials.gov Identifier:

Topics: Administration, Cutaneous; Adult; Betamethasone; Calcitriol; Calcium; Creatinine; Dermatologic Agents; Drug Combinations; Female; Follow-Up Studies; Gels; Humans; Hypothalamo-Hypophyseal System; Male; Middle Aged; Pituitary-Adrenal System; Psoriasis; Severity of Illness Index; Suspensions; Time Factors

A combination topical suspension/gel containing calcipotriene plus betamethasone dipropionate has been developed as a safe and effective treatment for patients with psoriasis vulgaris of the scalp. This same preparation has the potential to be a convenient, effective, and cosmetically appealing formulation for psoriasis on the body. This trial evaluated the efficacy and safety of a topical suspension containing calcipotriene plus betamethasone dipropionate compared with its constituent components and topical suspension vehicle in the treatment of mild to moderate psoriasis on the trunk and limbs.. This was a randomized, double-blind, vehicle-controlled, 4-arm trial in 1,152 subjects. The co-primary efficacy end points were the proportion of subjects achieving controlled disease based on the Investigators' Global Assessment of disease severity at weeks 4 and 8. Adverse events, vital signs, and clinical laboratory measurements were also assessed.. At week 4, a greater proportion of subjects in the calcipotriene plus betamethasone group achieved controlled disease compared with subjects in the calcipotriene-only and vehicle-only treatment groups. At week 8, a statistically significantly (P<.01) greater proportion of subjects in the calcipotriene plus betamethasone group achieved controlled disease compared with subjects in the 3 other treatment groups. Adverse events and other safety assessments were similar between the groups.. The topical suspension containing calcipotriene plus betamethasone dipropionate traditionally used for scalp psoriasis is also a safe and effective once-daily treatment for psoriasis vulgaris on the body.

Topics: Administration, Topical; Adult; Aged; Betamethasone; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Endpoint Determination; Female; Humans; Immunoglobulin A; Male; Middle Aged; Pharmaceutical Vehicles; Psoriasis; Quality of Life; Skin; Suspensions

Combination therapy is a common approach to psoriasis, aimed at improving clinical response and minimizing the risk of side effects. The aim of this pilot randomized open-label study was to evaluate the efficacy and safety of the combination of low-dose cyclosporine (CsA) with calcipotriol-betamethasone dipropionate (CBD) ointment in the treatment of psoriasis. Sixty patients with moderate-to-severe plaque psoriasis were randomized to receive CsA, 2 mg/kg/day, combined with CBD ointment (n = 30) or CsA, at the same daily dosage, in combination with an emollient (n = 30), for 8 weeks. The primary efficacy parameter was the Psoriasis Area and Severity Index (PASI) 75 response rate at 8 weeks. Combination therapy with CsA and CBD ointment was more effective than CsA and emollient treatment, with statistically significant results, particularly less itching after 4 and 8 weeks and PASI reduction at all post-baseline visits. Significantly more patients treated with CsA + CBD achieved the PASI 75 at 8th week (87% vs 37% in the CsA-emollient group; p = 0.0001). The efficacy results were paralleled by the investigator and patient's global assessment of disease severity at the end of study. Our results suggest that the addition of CBD ointment to low-dose CsA enhances clinical response and improves the risk/benefit ratio.

Topics: Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Cyclosporine; Dermatologic Agents; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Ointments; Pilot Projects; Psoriasis; Severity of Illness Index; Young Adult

Topics: Adult; Aged; Aged, 80 and over; Calcitriol; Cholecalciferol; Dermatologic Agents; Dihydroxycholecalciferols; Female; Humans; Male; Middle Aged; Psoriasis; Treatment Outcome

Janus-associated kinases (JAKs) are involved in signal transduction from a variety of cytokines implicated in the pathogenesis of psoriasis, including interleukin (IL)-12, IL-23, and interferon-γ. INCB018424, a small molecule inhibitor of JAK1 and JAK2, inhibits cytokine-induced JAK/signal transducers and activators of transcription signaling and the resultant production of inflammatory proteins (eg, IL-17).. We sought to demonstrate proof of concept in patients with stable plaque psoriasis.. Patients were dosed with vehicle, 0.5% or 1.0% INCB018424 phosphate cream once a day or 1.5% twice a day for 28 days. Additional groups included two active comparators (calcipotriene 0.005% cream or betamethasone dipropionate 0.05% cream).. Both the 1% and the 1.5% cream improved lesion thickness, erythema, and scaling and reduced lesion area compared with placebo. A composite lesion score decreased by greater than 50% with the efficacious doses of INCB018424 compared with 32% for vehicle controls. Topical application of INCB018424 was well tolerated with few mild adverse events noted. Mean plasma concentrations of INCB018424 after topical application of 0.5% to 1.5% cream were in the low nanomolar range, representing a fraction (<1%) of the half maximal inhibitory concentration (IC(50)) in whole blood for inhibition of cytokine-stimulated signal transducers and activators of transcription-3 phosphorylation.. This study was limited by the relatively short study duration and small sample size.. Topical INCB018424 is safe, is well tolerated, and exhibits clinical activity in the topical treatment of psoriasis.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Enzyme Inhibitors; Female; Follow-Up Studies; Humans; Janus Kinase 1; Janus Kinase 2; Male; Middle Aged; Nitriles; Pilot Projects; Psoriasis; Pyrazoles; Pyrimidines; Signal Transduction; Treatment Outcome; Young Adult

The combination of excimer laser and topical treatment has not been studied in clinical trials. This within-patient comparison study evaluates the response rates of plaque-type psoriasis after treatment with topical only (dithranol or calcipotriol), laser only, and combination therapy with topical medication and laser.. A total of 61 patients with psoriatic plaques located at symmetric body areas (PASI ≥ 6) were screened, 59 were enrolled, 54 completed treatment and 45 completed the 6 months follow-up. Treatments with the excimer laser were performed twice weekly until resolution or a maximum of 15 treatments. Each ointment was applied on one of the test lesions, which had to be at least 10 cm apart from each other. Efficacy was rated with a modified PASI score.. At the end of the treatment phase only one patient in both topical therapy regimens met the criteria of partial clearance (modified PASI ≤ 2). The combined therapies resulted in 23 cases of partial clearance in both treatment arms. Four areas treated with calcipotriol, respectively six areas treated with dithranol resulted in total clearance at the end of the treatment phase. The average reduction of modified PASI scores was higher in combination than in topical treatment alone (49.8% calcipotriol + excimer versus 22.9% calcipotriol, 49.7% dithranol + excimer versus 26.8% dithranol). After six months there was a total clearance of 30.5% dithranol + excimer.. Treatment of plaque-type psoriasis with laser in combination with topical treatment is a safe and effective therapy. The best long-term results can be obtained by the application of dithranol and excimer laser.

Topics: Administration, Topical; Adult; Aged; Anthralin; Calcitriol; Combined Modality Therapy; Female; Humans; Lasers, Excimer; Male; Middle Aged; Psoriasis; Treatment Outcome

Topical drugs enhance the therapeutic effects of ultraviolet (UV)-based therapy for psoriasis. However, their efficacy has yet to be established in a clinical trial.. This study aimed to compare the efficacy of targeted microphototherapy alone and in combination with psoralen or calcipotriol in the treatment of plaque-type psoriasis.. Thirty individuals, affected by plaque-type psoriasis, were treated with targeted narrowband UVB phototherapy alone (Group 1), in combination with psoralen gel (Group 2), or in combination with calcipotriol ointment (Group 3) three times per week based on predetermined minimal erythema doses for 10 weeks.. All patients in each group completed the study. The percentages of improvement in Psoriasis Area and Severity Index (PASI) and Psoriasis Severity Index (PSI) scores were 33.9% and 38.3% in Group 1, 29.9% and 29.8% in Group 2, and 67.2% and 59% in Group 3, respectively. There was no statistically significant difference in improvement between Groups 1 and 2 (P > 0.05). Outcomes in Group 3 were found to be superior compared with those in the other groups.. The addition of calcipotriol ointment in targeted phototherapy enhances the therapeutic effects of phototherapy in the treatment of plaque-type psoriasis.

Topics: Adolescent; Adult; Calcitriol; Dermatologic Agents; Erythema; Female; Ficusin; Gels; Humans; Male; Middle Aged; Ointments; Photochemotherapy; Photosensitizing Agents; Pruritus; Psoriasis; Severity of Illness Index; Ultraviolet Therapy; Young Adult

Topical calcipotriene is frequently prescribed for the treatment of plaque-type psoriasis. Calcipotriene is currently available in the US as an ointment, a solution, a cream, and in a fixed-dose combination ointment with betamethasone dipropionate. Calcipotriene 0.005% has recently been formulated as a foam using a novel aqueous-based formulation to provide a new topical treatment option for patients with psoriasis.. The objective of this study was to evaluate the efficacy and safety of topical calcipotriene 0.005% foam for the treatment of mild to moderate plaque-type psoriasis.. Two identical, randomized, double-blind, vehicle-controlled, 8-week phase III clinical trials.. Subjects with plaque-type psoriasis affecting 2-20% of the body surface area, with an identifiable target lesion affecting the trunk or extremities, were randomized in a 2:1 ratio to calcipotriene foam (n = 437) or vehicle foam (n = 222). Study medication was applied twice daily for 8 weeks.. Treatment success was defined as a score of 0 or 1 (clear or almost clear) on the Investigator's Static Global Assessment (ISGA) psoriasis rating scale and a minimum improvement of ISGA score of at least 2 grades from baseline. Predefined target lesions were assessed for erythema, scaling, and plaque thickness. Primary endpoint was the proportion of subjects in each treatment group who achieved treatment success after 8 weeks, analyzed on an intent-to-treat (ITT) basis. In the primary endpoint analysis, subjects missing 8-week outcomes data were classified as treatment failures regardless of their outcomes at earlier evaluations. As part of the sensitivity analysis, a last-observation-carried-forward (LOCF) approach to impute missing 8-week efficacy outcomes also examined treatment. Secondary endpoints included treatment success as a function of baseline ISGA score (mild or moderate), ISGA score of 0 or 1 (clear or almost clear), and effects of treatment on target lesion. Adverse events (AEs) were recorded throughout the study.. In the ITT population of Study 1, treatment success after 8 weeks was achieved by 14% of subjects in the calcipotriene foam group versus 7% of subjects in the vehicle foam group (p = 0.058). In the LOCF analysis, treatment success was achieved by more subjects with calcipotriene foam than with vehicle foam (15% vs 7%; p = 0.034). In Study 2, treatment success was achieved by more subjects in the calcipotriene foam group for the primary endpoint (27% vs 16%; p = 0.016) and the LOCF analysis (28% vs 16%; p = 0.010). Subjects in the calcipotriene foam group exhibited better response rates than did the vehicle foam group for most of the secondary outcomes. Calcipotriene foam was safe with an overall incidence of AEs similar to those experienced in the vehicle foam group. Application-site reactions were noted in approximately 1-2% of subjects in each group. No AE was reported in more than 2% of subjects in the calcipotriene foam group. Treatment was discontinued because of AEs in approximately 2% of subjects in both groups.. In two identically designed, phase III clinical trials, calcipotriene 0.005% foam was safe and effective for the treatment of mild to moderate plaque-type psoriasis for up to 8 weeks.. Registered at clinicaltrials.gov: NCT00688519 and NCT00689481.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Calcitriol; Child; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis; Treatment Outcome; Young Adult

In 1972, Dumas and Scholtz developed the psoriasis plaque test to evaluate the potency of local corticosteroids. Through further modification of this method, the efficacy between antipsoriatic products can be differentiated. This method allowed for the simultaneous application of several products to different test sites in the same psoriasis patient. The objective of this current study was to compare the antipsoriatic effect of six topical products using a modified version of the original psoriasis plaque test with emphasis on the predictive capacity of this model. Validation of the use of immunohistochemical and histological scoring of biopsy material, in conjunction with clinical scoring, in the prediction of antipsoriatic effects was an additional objective.. This study was a single-centre, investigator-blinded, within-subject randomized, active- and vehicle-controlled, intraindividual comparison of six topical products in patients with psoriasis vulgaris. The products evaluated were calcipotriol ointment (50 μg/g); calcipotriol cream (50 μg/g); two-compound ointment (calcipotriol 50 μg/g; betamethasone dipropionate 0.5 mg/g); two-compound gel (calcipotriol 50 μg/g; betamethasone dipropionate 0.5 mg/g) [all in their marketed formulations]; an investigational ointment (calcipotriol 25 μg/g; hydrocortisone 10 mg/g); and a vehicle control. Psoriasis patients (≥18 years of age; n = 24) received simultaneous topical application of each of the products 6 days a week for a period of 21 days, at different test sites located on psoriasis plaques. Clinical assessment of the test sites was completed twice a week. Test site biopsies were taken at the final visit for histological analysis. The primary endpoint was the absolute change in total clinical score (TCS; erythema, scaling and infiltration) from baseline.. For all products, the change in TCS correlated well with changes in histological and immunohistochemical values. The two-compound ointment and the two-compound gel both resulted in a large and significant reduction in TCS. Calcipotriol ointment and the calcipotriol/hydrocortisone ointment were less effective, although they were still more effective than the calcipotriol cream and the ointment vehicle.. This study has demonstrated that the modified psoriasis plaque test can provide a relatively quick and effective method to evaluate the antipsoriatic effect of several topical treatments in small cohorts and that, by combining clinical scoring and histological assessment, a more accurate prediction of the antipsoriatic effect can be made. The two-compound formulations (ointment and gel) had a comparable antipsoriatic effect, which was superior to the other products tested. Furthermore, these data indicate that the gel formulation could provide an alternative effective treatment option to the well established two-compound ointment for psoriasis patients.. Registered as EudraCT no: 2007-005463-10.

Topics: Adult; Aged; Calcitriol; Dosage Forms; Female; Humans; Immunohistochemistry; Male; Middle Aged; Psoriasis

Calcipotriene ointment is widely used in the topical treatment of psoriasis, with tacrolimus ointment as an effective alternative in controlling stable plaque psoriasis. The efficacy of the combination of both products on stable plaque psoriasis has not been assessed in the literature consulted. We evaluated the efficacy of calcipotriene ointment 0.005% applied twice daily, tacrolimus ointment 0.1% applied twice daily, or a morning application of calcipotriene and an evening application of tacrolimus in 27 participants with stable plaque psoriasis over an 8-week treatment period. The mean reduction in the sum of the scores between baseline and week 8 was significant (P = .001) for calcipotriene alone (39.5%), tacrolimus alone (38.2%), and the combination of calcipotriene and tacrolimus (60.7%). Combination therapy was statistically more effective than tacrolimus alone (P = .043) but not statistically superior to calcipotriene alone (P=.056). Most adverse events (AEs) were related to skin irritation and pruritus; however, no AEs were evident in participants given the combination therapy.

Topics: Adolescent; Adult; Aged; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Ointments; Pilot Projects; Psoriasis; Tacrolimus; Treatment Outcome; Young Adult

A two-compound scalp formulation containing calcipotriol (50 μg/g) and betamethasone (0.5mg/g; as dipropionate) (Xamiol, Taclonex Scalp) has been shown to be an effective and safe treatment for scalp psoriasis.. The aim of this study was to investigate the clinical efficacy of the two-compound scalp formulation after 1 week of treatment. methods: Pooled data from two large pivotal phase III trials with 2920 patients receiving once-daily treatment for up to 8 weeks with either the two-compound scalp formulation (n = 1108), betamethasone dipropionate (n = 1118), calcipotriol (n = 558), or the vehicle (n = 136) were analysed.. The percentage of patients who had 'absent' or 'very mild' disease according to Investigator's Global Assessment after 1 week of treatment was significantly higher with the two-compound scalp formulation (30.6%) compared to betamethasone (24.1%; P < 0.001), calcipotriol (10.0%; P < 0.001) or vehicle (6.9%; P < 0.001).. This data indicates that the two-compound scalp formulation demonstrated significant efficacy already after 1 week, with a faster onset of effect than either of the individual components in the same vehicle, in the treatment of scalp psoriasis.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Psoriasis; Scalp; Young Adult

Few large clinical studies have evaluated whether switching tumour necrosis factor antagonists (anti-TNFs) is likely to improve psoriasis in patients with prior anti-TNF treatment.. The aim of this subanalysis of the BELIEVE study was to assess the efficacy and safety of adalimumab for psoriasis in patients with and without previous anti-TNF treatment.. The BELIEVE study enrolled patients with moderate to severe psoriasis and prior failure, intolerance or contraindication to ≥2 systemic therapies. In this 16-week, double-blind, randomized, controlled trial, patients received adalimumab (80 mg, week 0; 40 mg every other week, weeks 1-15) with either topical vehicle or topical calcipotriol/betamethasone dipropionate (C/B) applied once daily for 4 weeks, then as needed. The primary endpoint was ≥75% improvement from baseline in Psoriasis Area and Severity Index score (PASI 75) at week 16. This post hoc subanalysis evaluated the safety and efficacy of adalimumab, with and without topical therapy, in BELIEVE patients who had prior exposure to anti-TNFs.. Of 730 patients enrolled, 282 (38.6%) had prior anti-TNFs and 448 (61.4%) were anti-TNF-naïve. Combining topical vehicle and topical C/B study populations, 61.7% of patients with prior anti-TNFs achieved PASI 75 at week 16, compared with 71.7% of anti-TNF-naïve patients (P=0.095). Adalimumab resulted in clinically meaningful improvement regardless of which prior anti-TNF agent had been used, the number of prior anti-TNFs tried, or reasons for discontinuation of prior anti-TNF therapy. Adverse event incidences were similar between patients with and without prior anti-TNF therapy.. Adalimumab was effective and well-tolerated in patients with psoriasis previously treated with anti-TNF therapy.

Topics: Adalimumab; Administration, Topical; Adult; Anti-Inflammatory Agents; Antibodies, Monoclonal, Humanized; Betamethasone; Calcitriol; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis; Tumor Necrosis Factor-alpha

This pilot randomized intra-patient side to side trial was designed to assess the antipsoriatic efficacy, safety and tolerability of once daily versus the separate application of a vitamin D3 analogue and a powerful corticosteroid.. Twenty patients with plaque type psoriasis were enrolled. Two similar symmetrical lesions were randomized to be treated with an application of an ointment containing calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g once daily or the application of budesonide 0.25 mg/g cream in the morning and tacalcitol 4 µg/g ointment in the evening.. Eighteen patients completed the study. Both treatments proved to be effective but budesonide cream and tacalcitol ointment gave a faster improvement of lesions and itching relief at t1 and were better tolerated.. The separate daily regimen may represent a suitable treatment option for patients who need a faster improvement and a better moisturizing activity. Further studies which compare the efficacy and safety of these regimens need to be developed.

Topics: Administration, Cutaneous; Adult; Aged; Betamethasone; Budesonide; Calcitriol; Dermatologic Agents; Dihydroxycholecalciferols; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Ointments; Pruritus; Psoriasis; Time Factors; Young Adult

Etanercept is approved for the treatment of plaque psoriasis at a subcutaneous (SC) dosage of 50 mg twice-weekly for three months, followed by 50 mg SC once-weekly thereafter. It is of note, however, that many patients experience loss of efficacy when they step down to etanercept 50 mg/week, often instigating a switch to another biological. The current pilot study investigated the adjunctive use of a topical calcipotriene 0.005% and betamethasone dipropionate 0.064% combination ointment, approved for the treatment of psoriasis, to sustain the original efficacy of etanercept by augmenting response to the 50 mg/week SC dose, thus stabilizing the disease.. In this single-center, open-label study, subjects (n=20) underwent 12 weeks treatment with etanercept 100 mg/week (50 mg, 2x week; weeks -12 to -1), followed by etanercept 50 mg/week maintenance therapy for 40 weeks (weeks 0 to 40). Subjects were followed at four-week intervals. Starting at week 4, subjects who demonstrated an increase from baseline (week 0) body surface area (BSA) of is greater than 2% initiated therapy with calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment for four weeks. The study is limited by its small sample size, open-label nature, and lack of blinding.. Mean BSA involvement decreased significantly from week -12 to 0 with etanercept 50 mg twice a week. At week 4, on the etanercept 50 mg/week dose, mean BSA increased to 9.42 ± 9.39 compared to week 0. With introduction of calcipotriene 0.005%/betamethasone dipropionate 0.064% ointment at week 4, mean BSA decreased to 4.62 ± 8.19 by week 24 and was relatively stable for the remainder of the study period. Similarly, mean PASI (Psoriasis Area and Severity Index) scores improved from week -12 to week 0, increased at week 4, then decreased significantly by week 24 with adjunctive topical treatment.. Topical calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment is a safe and effective adjunct to etanercept 50 mg/week maintenance therapy.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Betamethasone; Calcitriol; Contraceptives, Oral, Combined; Dermatologic Agents; Disease Progression; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Synergism; Drug Therapy, Combination; Etanercept; Female; Humans; Immunoglobulin G; Male; Middle Aged; Pilot Projects; Psoriasis; Receptors, Tumor Necrosis Factor; Sample Size; Treatment Outcome

Occlusive therapy with or without topical agents is effective in the treatment of psoriasis. This study assessed the efficacy and safety of an occlusive hydrogel dressing. Participants were treated with calcipotriene 0.005%-betamethasone dipropionate 0.064% ointment with and without a hydrogel patch. Thirty participants completed the 6-week, bilaterally controlled, investigator-blinded, single-center study. Substantial reductions in total modified psoriasis area and severity index (PASI) scores of occluded lesions versus nonoccluded lesions were seen as early as the first week of treatment and sustained through 4 weeks of the study. No adverse effects related to the study, including skin irritation, were observed or reported. Hydrogel dressings provide an effective and safe occlusive option to enhance topical therapy for psoriasis.

Topics: Adult; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Female; Humans; Hydrogel, Polyethylene Glycol Dimethacrylate; Male; Middle Aged; Occlusive Dressings; Ointments; Psoriasis; Single-Blind Method; Treatment Outcome

Data are lacking on the use of topical therapies in combination with tumour necrosis factor blockers for the treatment of psoriasis.. To assess the efficacy and safety of adalimumab (ADA) with topical calcipotriol/betamethasone (C/B) in patients with psoriasis resembling those treated in routine clinical practice.. A 16-week, randomized, vehicle-controlled trial was conducted in patients with moderate to severe psoriasis and previous failure, intolerance or contraindications to two or more systemic treatments. All patients received ADA (80 mg, week 0; 40 mg every other week, weeks 1-15) in addition to either topical C/B or drug-free vehicle applied once daily for 4 weeks, and as needed thereafter. The primary endpoint was 75% improvement from baseline in Psoriasis Area and Severity Index (PASI 75) at week 16.. A total of 730 patients received either ADA + C/B (n = 366) or ADA + vehicle (n = 364). PASI 75 response was initially higher with the combination therapy [14.8% for ADA + C/B vs. 5.8% for ADA + vehicle at week 2 (P < 0.001); and 40.7% vs. 32.4%, respectively, at week 4 (P = 0.021)]. After week 4, the trend was towards a higher response with ADA monotherapy, with no statistical difference in the PASI 75 response at week 16 (64.8% for ADA + C/B vs. 70.9% for ADA monotherapy, P = 0.086). Safety findings were consistent with previous ADA trials.. ADA + C/B resulted in more rapid and higher efficacy within the first 4 weeks; thereafter, the trend was towards a higher response with ADA monotherapy. There was no statistical difference in the PASI 75 response at week 16. Both treatment regimens were well tolerated.

Topics: Adalimumab; Administration, Topical; Adult; Anti-Inflammatory Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Betamethasone; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Therapy, Combination; Europe; Female; Humans; Male; Medication Adherence; Middle Aged; Psoriasis; Severity of Illness Index

Although generally recognized as an effective therapy for psoriasis, coal tar therapy lost appeal in modern clinical practice due to poor patient acceptability of its aesthetic properties. A new liquor carbonis distillate (LCD) solution 15% (equivalent to coal tar 2.3%) that uses an evaporative and transparent vehicle, fragrance, and a dab-on applicator was developed. Cosmetic acceptability of the LCD solution was compared to calcipotriene cream 0.005% during a randomized, active-controlled, investigator-blinded clinical trial. Participants with moderate plaque psoriasis applied LCD solution or calcipotriene cream twice daily to body lesions for 12 weeks and then were followed for 6 additional weeks without treatment. Participants completed a cosmetic acceptability survey about their medications after starting therapy. Mean ratings for aesthetic and product performance attributes were high in both groups; however, more participants treated with LCD solution versus calcipotriene cream rated their product as more convenient and beneficial compared to prior psoriasis therapies. Ratings of the scent, staining, drying time, and dab-on applicator for the LCD solution were favorable. Participant experience with LCD solution in this study suggests that it is a cosmetically acceptable psoriasis treatment that is comparable to calcipotriene cream.

Topics: Administration, Cutaneous; Adolescent; Adult; Calcitriol; Coal Tar; Dermatologic Agents; Follow-Up Studies; Humans; Odorants; Patient Satisfaction; Psoriasis; Single-Blind Method; Young Adult

Topical coal tar is a well known and effective treatment for psoriasis, but the messiness, staining, odor, and inconvenience associated with its use make patient satisfaction and compliance a challenge.. To determine the efficacy, patient tolerability, and cosmetic acceptability of a new topical liquor carbonis distillate (LCD) 15% solution compared with calcipotriene (calcipotriol) cream in patients with moderate, chronic plaque psoriasis.. A randomized, single-blind, active-controlled, parallel-group, clinical trial consisting of a 12-week treatment phase and a 6-week post-treatment follow-up phase.. Outpatient dermatology research unit in an academic hospital.. Sixty adults with moderate, chronic plaque psoriasis (3-15% body surface area affected) not receiving other psoriasis therapies.. Patients were randomized to apply either an LCD 15% solution (Psorent) or a commercially available calcipotriene 0.005% cream (Dovonex) to their psoriasis areas (excluding the head) twice daily at home for 12 weeks.. A blinded investigator evaluated the patients' psoriasis using a modified Psoriasis Area and Severity Index (PASI) that excluded the head, and a Physician's Global Assessment (PGA) scale at weeks 0 (baseline), 2, 4, 8, and 12 (end of treatment), and 18 (6 weeks after treatment was withdrawn). Patients assessed their psoriasis symptoms and quality of life and completed a cosmetic acceptability survey about their medication.. The changes in the baseline PASI scores after 12 weeks of treatment were compared between LCD and calcipotriene groups. Additional comparisons were performed for success rates during treatment (PASI 75 and PASI 50), changes in PGA scores, patient-reported psoriasis symptom scores, patients' quality-of-life scores, and recurrence rates during post-treatment follow-up.. Both treatment groups showed improvement in psoriasis severity and quality of life. However, the LCD group had greater mean reductions in PASI scores: 58% vs 37% in the calcipotriene group (p < 0.05) at week 12. Additionally, the LCD group had more patients (14/27) with absent or minimal psoriasis on the PGA scale than the calcipotriene group (6/28) by the end of treatment (p < 0.05). LCD-treated patients also maintained their improvement better than calcipotriene-treated patients through week 18 after treatment was withdrawn for 6 weeks. Both treatments were well tolerated and cosmetically acceptable to patients.. The newly formulated LCD solution, applied twice daily at home for 12 weeks, was more effective and as well tolerated and cosmetically acceptable as the calcipotriene cream over 12 weeks of treatment and 6 weeks of follow-up. The LCD solution is a patient-accepted and effective corticosteroid-sparing treatment alternative for psoriasis patients.

Topics: Administration, Cutaneous; Adult; Aged; Calcitriol; Coal Tar; Dermatologic Agents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Patient Acceptance of Health Care; Psoriasis; Quality of Life; Recurrence; Severity of Illness Index; Single-Blind Method; Treatment Outcome; Young Adult

Calcipotriene has limited efficacy in treating psoriasis. By inhibiting proinflammatory cytokines such as interleukin-12, interleukin-23, and tumor necrosis factor-alfa, nicotinamide may enhance the efficacy of calcipotriene therapy when used in combination.. We sought to determine if the combination of nicotinamide with calcipotriene is more effective than either component alone.. In this randomized, double-blinded, multicenter 7-arm bilateral comparison-controlled trial, patients were randomized to two of 7 treatments--placebo, calcipotriene 0.005% alone, nicotinamide 1.4% alone, calcipotriene plus nicotinamide 0.05%, calcipotriene plus nicotinamide 0.1%, calcipotriene plus nicotinamide 0.7%, or calcipotriene plus nicotinamide 1.4%--each administered to lesions on one side of the body or to one of two lesions at least 5 cm apart, for 12 weeks. Efficacy was measured using a clear to almost clear outcome.. In all, 50.0% of patients in the calcipotriene and nicotinamide 1.4% combination group achieved a clear to almost clear outcome at week 12, compared with only 18.8% of patients treated with placebo (P = .002), 25% of patients treated with nicotinamide 1.4% alone (P = .02), and 31.5% of patients treated with calcipotriene alone (P = .096). A dose-response trend existed for increasing concentrations of nicotinamide, but it was not significant.. The relatively small patient numbers, relatively high placebo effect, and maximum in-life portion of only 12 weeks of dosing are weaknesses of the study.. This study provides evidence that using the combination nicotinamide and calcipotriene may provide additional benefit in the topical treatment for patients with psoriasis and may be an adequate steroid-sparing substitute treatment.

Topics: Adult; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Synergism; Drug Therapy, Combination; Female; Humans; Male; Niacinamide; Pilot Projects; Placebos; Psoriasis; Treatment Outcome; Vitamin B Complex

The calcipotriene/betamethasone dipropionate two-compound scalp formulation has been shown to be safe and effective in the treatment of scalp psoriasis over 8 weeks, but the patients studied were mainly White and non-Hispanic. The aim of this study was to evaluate the efficacy and safety of the two-compound scalp formulation in the treatment of scalp psoriasis in Hispanic/Latino and Black/African American patients. A total of 99 Hispanic/Latino and 78 Black/African American patients were randomized double-blind in a 3:1 ratio to 8 weeks of once daily treatment of scalp psoriasis with either the two-compound scalp formulation (n=135) or its vehicle (n=42). In the two-compound group, 71.9% of patients had cleared or minimal disease at week 8 by the investigator's global assessment compared to 40.5% in the vehicle group (odds ratio 3.30; 95% CI 1.62-6.72; P<0.001). For the five secondary efficacy response criteria, three (total sign score, thickness of scalp psoriasis, patient's global assessment) showed that two-compound scalp formulation was statistically significantly more effective than its vehicle, and the other two (redness and scaliness of scalp psoriasis) approached statistical significance in favor of the two-compound scalp formulation. There was no statistically significant difference (P=1.00) between the percentage of patients with adverse reactions in the two-compound group (7.0%) and the vehicle group (7.9%). The two-compound scalp formulation is safe and effective in the treatment of scalp psoriasis over 8 weeks in Hispanic/Latino and Black/African American patients.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Black or African American; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Hispanic or Latino; Humans; Middle Aged; Psoriasis; Scalp Dermatoses; Treatment Outcome; Young Adult

There is a need for new treatments for scalp psoriasis, as many topical treatments are cosmetically unacceptable and difficult to apply, resulting in poor compliance.. To compare the efficacy and safety of a new, once-daily, two-compound scalp formulation (Xamiol; LEO Pharma A/S, Ballerup, Denmark) containing calcipotriol 50 microg g(-1) plus betamethasone 0.5 mg g(-1) (as dipropionate), with the active ingredients as single compounds in the same vehicle.. This 8-week, multicentre, double-blind, parallel-group study, randomized adult patients with scalp psoriasis involving > 10% of the scalp to the two-compound scalp formulation (n = 568), betamethasone dipropionate 0.5 mg g(-1) (n = 563), or calcipotriol 50 microg g(-1) (n = 286). The primary efficacy measure was the proportion of patients with 'absence of disease' or 'very mild disease' according to investigators' assessments at week 8.. The proportion of patients with 'absence of disease' or 'very mild disease' at week 8 was significantly higher in the two-compound group (68.4%) than the betamethasone dipropionate (61.0%, P = 0.0079) or calcipotriol (43.4%, P < 0.0001) groups. The proportion of patients rating their scalp psoriasis as 'clear' or 'almost clear' was significantly higher for the two-compound scalp formulation (69.6%) than for betamethasone dipropionate (59.9%, P = 0.0006) or calcipotriol (44.7%, P < 0.0001). The incidence of lesional/perilesional adverse events was lower in the two-compound and betamethasone dipropionate groups than the calcipotriol group.. The two-compound scalp formulation was well tolerated and more effective in the treatment of scalp psoriasis than either of its individual components in the same vehicle.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Drug Administration Schedule; Drug Combinations; Epidemiologic Methods; Female; Humans; Male; Middle Aged; Psoriasis; Scalp Dermatoses; Treatment Outcome; Young Adult

Topical corticosteroids are widely used in the treatment of psoriasis. This study was conducted to compare the efficacy and safety of clobetasol propionate (CP) 0.005% spray to calcipotriene 0.005%-betamethasome diproprionate 0.064% (C-BD) ointment in patients with moderate to severe plaque psoriasis. Assessments were made at baseline, week 2, week 4 (end of treatment) and week 8 (4 weeks posttreatment). An assessment for Overall Disease Severity (ODS) found that 75% of CP spray-treated patients achieved a rating of clear or almost clear after 4 weeks of treatment compared to 45% of C-BD ointment-treated patients (P=.003). Adverse events were reported by less than one-third of patients from each treatment group (31% for CP spray and 33% for C-BD ointment).

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Clobetasol; Dermatologic Agents; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Ointments; Patient Satisfaction; Psoriasis; Quality of Life

Treatment of nail psoriasis remains a challenge.. To evaluate the efficacy of a two-compound product of calcipotriol plus betamethasone dipropionate ointment on nail psoriasis in an open-label study.. Twenty-five psoriatic patients with nail involvement and mild cutaneous psoriasis were instructed to apply a calcipotriol-betamethasone valerate ointment formulation once daily for 12 weeks on affected nails. Outcome measures were assessed at baseline and at weeks 4, 8 and 12 using the nail psoriasis severity index (NAPSI).. Twenty-two patients having 114 nails involved at baseline with a mean NAPSI of 5.8 +/- 1.7 were followed up for 12 weeks. The mean NAPSI at the end of the treatment period was reduced to 1.6 +/- 0.6 presenting a 72% improvement. Significant improvement was observed for hyperkeratosis and onycholysis (reduction of mean hyperkeratosis NAPSI from 2.2 +/- 0.5 to 0.5 +/- 0.1 and mean onycholysis NAPSI from 2.0 +/- 0.6 to 0.4 +/- 0.2), moderate improvement for oil drops (reduction of mean oil drop NAPSI from 1.2 +/- 0.4 to 0.8 +/- 0.3) and slight improvement for pitting (reduction of mean pitting NAPSI from 0.8 +/- 0.2 to 0.6 +/- 0.2).. The calcipotriol plus betamethasone dipropionate two-compound ointment, applied once daily for 12 weeks, was shown to improve nail psoriasis.

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Nail Diseases; Ointments; Psoriasis

Current topical therapies for scalp psoriasis are difficult or unpleasant to apply, resulting in decreased adherence and efficacy.. To compare the efficacy and safety of once-daily treatment with a combination of calcipotriol 50 microg g(-1) plus betamethasone 0.5 mg g(-1) (as dipropionate) (Xamiol; LEO Pharma A/S, Ballerup, Denmark) and twice-daily calcipotriol 50 microg mL(-1) scalp solution in patients with scalp psoriasis.. This 8-week, multicentre, randomized, investigator-blind, parallel-group study compared two-compound calcipotriol/betamethasone scalp formulation with calcipotriol scalp solution in patients with moderately severe scalp psoriasis. Primary efficacy outcome was the proportion of patients who achieved 'clear' or 'minimal' disease severity according to investigator's global assessment of disease severity at week 8. Secondary efficacy outcomes and adverse events were also evaluated. Relapse and rebound were assessed in an 8-week, post-treatment observation phase.. In total, 207 patients received the two-compound scalp formulation and 105 patients received calcipotriol scalp solution. The proportion of patients with 'clear' or 'minimal' disease at week 8 was significantly greater in the two-compound scalp formulation group (68.6%) than in the calcipotriol scalp solution group (31.4%; P < 0.001). Improvement was more rapid with the two-compound scalp formulation than with calcipotriol scalp solution. Further evidence of the superiority of the two-compound scalp formulation over the scalp solution was demonstrated through greater improvements in clinical signs and fewer adverse events.. A once-daily combination of calcipotriol plus betamethasone dipropionate was significantly more effective and better tolerated than twice-daily calcipotriol scalp solution in the treatment of scalp psoriasis.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Glucocorticoids; Humans; Male; Middle Aged; Psoriasis; Scalp Dermatoses; Young Adult

Psoriasis vulgaris of the scalp has a significant psychosocial impact on individuals affecting their quality of life (QoL). A combination of calcipotriol and betamethasone dipropionate in a formulation suitable for treatment of scalp psoriasis has been developed.. To assess the impact of treatment with either calcipotriol plus betamethasone dipropionate scalp formulation or calcipotriol scalp solution on QoL in patients with scalp psoriasis (both within and between treatment groups).. This 8-week, randomized, investigator-blind study, compared the once-daily, two-compound scalp formulation (calcipotriol 50 microg/g plus betamethasone 0.5 mg/g as dipropionate; Xamiol, LEO Pharma A/S, Ballerup, Denmark) with twice-daily calcipotriol scalp solution (50 microg/mL; Daivonex, LEO Pharma A/S) in patients with scalp psoriasis of at least moderate severity covering > or = 10% of the scalp. QoL was assessed (weeks 0, 2, 4, 8) using the 36-item Short Form Health Survey (version 2; SF-36v2) and Skindex-16.. Treatment with the two-compound scalp formulation (n = 207) resulted in significant improvements from baseline on the SF-36v2 (Physical Component Summary, P = 0.005, week 8; Mental Component Summary, P < 0.05, weeks 2, 4, 8). A significant change from baseline in the calcipotriol scalp solution group (n = 105) was seen only on the Mental Component Summary (P = 0.04, week 8). Change from baseline in Skindex-16 was significantly in favour of the two-compound scalp formulation. Change was significant on both total score and individual scales.. The two-compound scalp formulation was superior to calcipotriol scalp solution in improving QoL in patients with scalp psoriasis.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Chemistry, Pharmaceutical; Dermatologic Agents; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Psoriasis; Psychology; Quality of Life; Scalp Dermatoses; Single-Blind Method; Treatment Outcome; Young Adult

Videocapillaroscopy (VCP) can be used to explore microcirculatory modifications in skin diseases. Psoriasis presents a specifically altered capillaroscopic pattern with 'bushy' capillaries and a disarranged microangioarchitecture. The aim of the present study is to compare the clinical and capillaroscopic modifications of a psoriatic target lesion during topical therapy.. Thirty patients with chronic plaque psoriasis were included in the study. Clinical and capillaroscopic modifications in comparable lesions of the elbows were analyzed during different topical therapies (calcipotriol, betamethasone dipropionate and calcipotriol plus betamethasone dipropionate) at baseline, and after 15 and 30 days of therapy. A clinical global score (modified Psoriasis Area Severity Index), the mecapillary density per square mm and the mean diameter of capillary loops were measured.. Topical therapy with combined betamethasone dipropionate and calcipotriol induced a higher decrease in erythema, infiltration and desquamation (P<0.001), and a significant reduction of the mean 'bush' diameter (P<0.001) and capillary number/mm(2) (P<0.05) compared with betamethasone and calcipotriol alone. Microvascular restoration to a normal pattern, as detected by VCP, was faster than clinical improvement (P<0.05).. Videocapillaroscopy is an easily executable and non-invasive technique that detects early microcirculatory changes in psoriasis during topical therapy.

Topics: Administration, Topical; Adult; Aged; Betamethasone; Calcitriol; Capillaries; Dermatologic Agents; Dermoscopy; Drug Therapy, Combination; Female; Humans; Male; Microcirculation; Microscopic Angioscopy; Middle Aged; Psoriasis; Skin; Treatment Outcome; Young Adult

The aim of the present study was to compare the effects of Daivobet and calcipotriol on clinical score and biomarker responses in a modified version of the Scholtz-Dumas psoriasis plaque assay. Furthermore, it was the aim to compare the effects of calcipotriol and betamethasone in the murine psoriasis xenograft model. Twenty four patients with psoriasis were treated topically once daily for three weeks, whereas the grafted mice were treated for four weeks. Clinical responses were scored twice weekly and biopsies were taken at the end of each study to analyse for skin biomarkers by histology and immunohistochemistry. The results clearly demonstrate effects on both clinical signs and biomarkers. In the patient study the total clinical score was reduced significantly with both Daivobet and calcipotriol. Both treatments reduced epidermal thickness, Ki-67 and cytokeratin 16 expression. T cell infiltration was significantly reduced by Daivobet but only marginally by calcipotriol. Both treatments showed strong effects on the epidermal psoriatic phenotype.Results from the xenograft model essentially showed the same results. However differences were observed when investigating subtypes of T cells.The study demonstrates the feasibility of obtaining robust biomarker data in the psoriasis plaque test that correlate well with those obtained in other clinical studies. Furthermore, the biomarker data from the plaque test correlate with biopsy data from the grafted mice.

Topics: Animals; Betamethasone; Biomarkers; Biopsy; Calcitriol; Dermatologic Agents; Disease Models, Animal; Drug Combinations; Endpoint Determination; Humans; Immunohistochemistry; Mice; Mice, SCID; Psoriasis; Skin; Skin Tests; Transplantation, Heterologous; Vitamin D

New topical treatments in scalp psoriasis are needed because many current topical treatments are disliked by patients and associated with poor compliance.. To compare the efficacy and safety of once-daily, two-compound scalp formulation containing calcipotriene plus betamethasone dipropionate with the individual components in the same vehicle and the vehicle alone.. In this 8-week, multicenter, randomized, double-blind study, patients with scalp psoriasis were randomized to treatment with the two-compound scalp formulation (calcipotriene 50 microg/g plus betamethasone 0.5 mg/g, as dipropionate) (n = 541), betamethasone 0.5 mg/g (as dipropionate) in the same vehicle (n = 556), calcipotriene 50 microg/g in the same vehicle (n = 272), or vehicle alone (n = 136).. More patients achieved "absent" or "very mild" disease at week 8 with the two-compound scalp formulation (71.2%) compared with betamethasone dipropionate in the same vehicle (64.0%, p = .011), calcipotriene in the same vehicle (36.8%, p < .0001), or the vehicle (22.8%, p < .0001).. Efficacy of the active comparators in the study has not been established in relation to calcipotriene and betamethasone formulations available for clinical use.. Calcipotriene plus betamethasone dipropionate scalp formulation was more effective than either of the individual components or the vehicle alone.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Pharmaceutical Vehicles; Psoriasis; Scalp Dermatoses; Severity of Illness Index; Skin; Treatment Outcome

Three high-concentration vitamin D3 ointments are currently available in Japan for the treatment of psoriasis. The aim of the present study is to investigate the efficacy of high-concentration tacalcitol in patients with psoriasis vulgaris who have already been treated with another high-concentration vitamin D3 ointment, calcipotriol or maxacalcitol. The psoriasis area and severity index score was improved in more than half the patients after changing to the tacalcitol ointment. Many patients treated with maxacalcitol once a day achieved greater clinical improvement by changing to high-concentration tacalcitol. In contrast, some patients who had responded to a high-concentration tacalcitol ointment showed exacerbation after changing to maxacalcitol once a day. Interviews with 50 patients (including the 34 patients enrolled in the present study) indicated that high-concentration tacalcitol ointment was an acceptable therapy in terms of the number of daily applications and drug cost. The results of this clinical study suggest that high-concentration tacalcitol ointment meets the preference of many patients who wish to use an ointment once a day.

Topics: Calcitriol; Dihydroxycholecalciferols; Drug Administration Schedule; Humans; Ointments; Patient Acceptance of Health Care; Prescription Fees; Psoriasis; Severity of Illness Index; Treatment Outcome

Effective and safe products are needed for long-term management of scalp psoriasis. This study investigated the long-term safety and efficacy of a two-compound formulation (calcipotriol 50 microg/g plus betamethasone dipropionate 0.5 mg/g) for scalp psoriasis.. In this 52-week, international, double-blind study, 869 patients with moderate-to-severe scalp psoriasis were randomized to either a two-compound scalp formulation (n = 429) or calcipotriol (n = 440).. Adverse drug reactions were less frequent in the two-compound group compared with the calcipotriol group (17.2 vs. 29.5%; p < 0.001). Incidences of adverse events possibly associated with long-term corticosteroid use were low in both the two-compound (2.6%) and the calcipotriol (3.0%) groups. Disease was satisfactorily controlled in 92.3% of visits in the two-compound group versus 80.0% in the calcipotriol group (p < 0.001).. The two-compound scalp formulation demonstrated a high level of safety and efficacy in long-term management of scalp psoriasis.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Canada; Denmark; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; France; Germany; Humans; Male; Middle Aged; Ointments; Pharmaceutical Vehicles; Prospective Studies; Psoriasis; Scalp; Severity of Illness Index; Treatment Outcome; United Kingdom

Calcipotriol ointment and short-contact dithranol cream therapy are well-established topical treatments for psoriasis. Quality of life, i.e. the physical, psychological, and social functioning and well-being of the patient, has become an essential outcome measure in chronic skin disease.. To compare the quality-of-life outcomes of calcipotriol ointment with that of short-contact dithranol cream in a supervised treatment regimen, and to determine the degree of improvement in quality of life these topical treatments can accomplish.. In a multicentre randomized controlled trial in six centres in the Netherlands, 106 patients with chronic plaque psoriasis were included, 54 receiving calcipotriol ointment twice daily and 52 dithranol cream once daily in a 12-week intensive treatment programme. Patients were treated at the day-care centre, using the care instruction principle of daily visits during the first week and twice-weekly visits subsequently for up to 12 weeks. Quality of life was assessed with the Skindex-29 and the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36).. At the end of treatment, no statistically significant differences were found between the calcipotriol and the dithranol group in any of the quality-of-life domains or scales of the Skindex-29 and the SF-36. Over time, a significant improvement of quality of life was found on all three scales of the dermatology-specific Skindex-29, predominantly of a moderate magnitude. In the calcipotriol group, a significant change of a small magnitude was found in the Physical Component Summary of the SF-36. No significant changes were found in the Mental Component Summary (or on any of the eight scales composing the questionnaire) of the SF-36.. The hypothesis was confirmed, that no statistically significant differences in improvement of quality of life could be found between calcipotriol ointment and dithranol short-contact cream in a day-care setting. Given this result, both calcipotriol and dithranol can be welcome alternatives for the patient. Calcipotriol, being more practical and patient friendly, can be considered as a first-line approach in clinical practice. However, in patients recalcitrant to calcipotriol and/or other topical treatments, preference should be given to the dithranol regimen. Topical treatment in combination with interventions explicitly focusing on improvement of coping behaviour and psychosocial functioning may further increase the degree of improvement in the psychosocial domains of quality of life. The results of this study are likely to give further evidence to the notion that the generic SF-36 is little or not responsive to small to moderate changes in quality of life in mild to moderate psoriasis.

Topics: Administration, Topical; Anthralin; Calcitriol; Day Care, Medical; Dermatologic Agents; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Netherlands; Ointments; Prospective Studies; Psoriasis; Quality of Life; Treatment Outcome

Combining phototherapy with topical vitamin D3 analogues is a useful therapy for the treatment of psoriasis by reducing the cumulative UV dose required for clearance of lesions. Experimental investigations demonstrated that calcipotriol is degraded by UV radiation, and suggested that calcipotriol should be applied after phototherapy but not immediately before.. Calcipotriol or maxacalcitol ointment was topically applied to psoriatic plaques of six patients immediately before or after phototherapy on the right or left side of the body, respectively.. Topical application of vitamin D3 analogues either before or after irradiation by psoralen and UVA radiation (PUVA) or narrow-band (NB)-UVB showed exactly similar effects in all patients.. Therapeutic effects of vitamin D3 analogues are not clinically inactivated by subsequent irradiation with PUVA or NB-UVB phototherapy.

Topics: Administration, Cutaneous; Adult; Calcitriol; Cholecalciferol; Combined Modality Therapy; Dermatologic Agents; Female; Humans; Male; Middle Aged; Prospective Studies; Psoriasis; Severity of Illness Index; Treatment Outcome; Ultraviolet Therapy

Tacrolimus gel 0.3% and tacrolimus cream 0.5% were studied and compared with calcipotriol ointment 0.005%, as topical treatment for mild to moderate plaque psoriasis. Tacrolimus is able to inhibit several cellular processes thought to be important in the pathogenesis of psoriasis, e.g. the transcription of proinflammatory cytokines, keratinocyte hyperproliferation and the expression of HLA-DR in lesional psoriatic skin.. In the present study we investigated the effects of preparations of tacrolimus and calcipotriol ointment on SUM score, hyperproliferation (Ki67-positive keratinocytes), keratinization (percentage keratin 10 (K10)-positive epidermal surface), T-cell subsets (CD4, CD8, CD45RO, CD45RA, CD2, CD25), cells expressing natural killer receptors and HLA-DR expression. The following three topical treatments were studied in chronic plaque psoriasis over a 12-week treatment period: calcipotriol ointment 0.005% twice daily, tacrolimus gel 0.3% twice daily and tacrolimus cream 0.5% twice daily.. The mean reductions in SUM score between day 0 and week 12 for calcipotriol ointment, tacrolimus gel and cream were significant. Calcipotriol ointment, and tacrolimus gel and cream had a comparable effect on epidermal proliferation (Ki67-positive cells), but calcipotriol is significantly more effective in normalizing differentiation (K10-positive epidermal surface). Calcipotriol and tacrolimus gel both reduced several lesional T-cell subsets significantly, whereas the effect induced by tacrolimus cream was modest.. Calcipotriol and tacrolimus gel are comparable in reducing the SUM score, the number of Ki67-positive cells and T-cell subsets and HLA-DR expression, although calcipotriol induces a more substantial improvement of keratinization.

Topics: Calcitriol; Dermatologic Agents; Drug Administration Routes; Gels; HLA-DR Antigens; Humans; Immunohistochemistry; Immunosuppressive Agents; Keratinocytes; Psoriasis; Severity of Illness Index; Skin Physiological Phenomena; T-Lymphocyte Subsets; Tacrolimus; Treatment Outcome

There is a need for more effective therapy for scalp psoriasis.. To assess the efficacy and safety of a 2-compound scalp formulation including calcipotriol and betamethasone dipropionate in the treatment of scalp psoriasis.. Patients (n = 218) with scalp psoriasis were randomized to treatment with the 2-compound scalp formulation (n = 108) or betamethasone dipropionate in the same vehicle (n = 110). The treatments were applied once daily on the scalp for up to 8 weeks.. The 2-compound scalp formulation showed a significantly higher efficacy than betamethasone dipropionate on the total sign score at the end of treatment (p = 0.042) and after 2 weeks (p = 0.005).. The calcipotriol plus betamethasone dipropionate scalp formulation was superior to betamethasone dipropionate in the same vehicle when used once daily for up to 8 weeks in the treatment of scalp psoriasis.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Female; Follow-Up Studies; Humans; Logistic Models; Male; Maximum Tolerated Dose; Middle Aged; Patient Satisfaction; Probability; Prospective Studies; Psoriasis; Reference Values; Risk Assessment; Scalp Dermatoses; Severity of Illness Index; Treatment Outcome

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Nail Diseases; Psoriasis; Severity of Illness Index; Single-Blind Method

Calcitriol and calcipotriol are widely used in the topical treatment of psoriasis. However, studies comparing both treatment modalities are scarce. Especially, there are almost no studies comparing the effects on epidermal cell populations in a quantitative manner.. The aim of this study was to quantitatively compare the effects of topical calcitriol and topical calcipotriol on clinical scores and epidermal subpopulations.. From five patients with stable plaque psoriasis, skin biopsies were taken from two symmetrical regions on the trunk or extremities before and after treatment with either calcitriol or calcipotriol. Frozen sections were labelled immunofluorescently using direct immunofluorescence for beta-1 integrin and the Zenon labelling technique for keratin (K) 6, K10 and K15. The digital photographs of the stained sections were quantitatively analysed and the results of both treatments were compared.. The clinical SUM-score improved significantly for both the calcitriol- and the calcipotriol-treated lesions. In the calcipotriol-treated group the expression of K10 and K15 increased and the expression of K6 decreased significantly. No changes were seen for the marker beta-1 integrin. In the calcitriol-treated group none of the markers changed significantly. A tendency towards significance was seen for the changes in the expression of K6 and K15 in favour of calcipotriol.. Both calcitriol and calcipotriol gave a significant improvement in clinical scores. However, treatment with calcipotriol resulted in a normalization of K6, K10 and K15, whereas treatment with calcitriol did not. Comparison of both treatments showed a tendency towards significance for the above-mentioned markers for calcipotriol only.

Topics: Administration, Topical; Calcitriol; Calcium Channel Agonists; Cell Differentiation; Cell Proliferation; Dermatologic Agents; Double-Blind Method; Epidermal Growth Factor; Humans; Immunohistochemistry; Keratins; Ointments; Psoriasis; Treatment Outcome

Calcitriol and calcipotriol, two vitamin D derivatives, are available for topical treatment of psoriasis and have been shown to be effective.. To compare the efficacy and safety of calcitriol 3 microg/g and calcipotriol 50 microg/g.. This was a multicentre, randomized, investigator-masked, and parallel comparison in subjects with mild to moderate chronic plaque-type psoriasis receiving either calcitriol or calcipotriol ointment twice daily for 12 weeks. Efficacy evaluations comprised global improvement (on a 4-point scale from 0: no change or worse, to 3: clear or almost clear) assessed by the investigator and by the subject. Efficacy further included the 'dermatological sum score' at each study visit. Safety evaluations included adverse event reporting, cutaneous safety assessed by the investigator and cutaneous discomfort assessment by the subject (both on a 5-point scale from 0: none, to 4: very severe).. A total of 250 subjects of both gender were recruited. At week 12, the LSmean score of global improvement rated by the investigator was 2.27 for calcitriol and 2.22 for calcipotriol. This difference was not statistically significant, with calcitriol demonstrating to be non-inferior to calcipotriol for global improvement. This same parameter was scored by the subject, with a mean of 2.12 for calcitriol and 2.09 for calcipotriol. The percentage of patients with at least marked improvement tended to be in favour of calcitriol (95.7% vs. 85% for calcipotriol). However, differences were not statistically significant. The mean worst score for the cutaneous safety assessment was higher in the calcipotriol group (0.3 vs. 0.1 and 0.4 vs. 0.2, by the investigator and the patient, respectively). These differences were statistically significant in favour of a better safety profile for calcitriol (P=0.0035). Fourteen dermatological and treatment-related adverse events were reported with calcipotriol vs. only five with calcitriol for a total of 22 adverse events reported throughout the study.. Calcitriol administered twice daily over a 12-week treatment period demonstrated similar efficacy to calcipotriol, while showing a significantly better safety profile.

Topics: Administration, Cutaneous; Adolescent; Adult; Body Surface Area; Calcitriol; Calcium Channel Agonists; Chronic Disease; Dermatitis, Irritant; Dermatologic Agents; Drug Eruptions; Female; Follow-Up Studies; Humans; Male; Middle Aged; Ointments; Psoriasis; Safety; Single-Blind Method; Treatment Outcome

Psoriasis vulgaris requires lifelong treatment associated with considerable health cost. Studies showed that a combination of a steroid and a vitamin D(3) analogue is more effective than both compounds in monotherapy.. To determine the cost-effectiveness of a fix calcipotriol/betamethasone combination (Daivobet/Dovobet/Taclonex) compared to a morning/evening non-fix calcipotriol/betamethasone combination in psoriasis treatment.. A Markov model (discrete-time stochastic process based on transitions between health states) with 2 treatment arms (Daivobet/Dovobet/Taclonex vs. non-fix calcipotriol/betamethasone) over a 48-week time period was developed. The effectiveness criterion was the number of days with clearance or marked improvement. Clinical and health resource utilisation data were derived from randomised studies.. Treatment with Daivobet/Dovobet/Taclonex showed a higher cost-effectiveness compared to the non-fix combination, even when assuming a maximum compliance for the twice daily non-fix combination and varying the effectiveness of Daivobet/Dovobet/Taclonex by 10%.. Psoriasis treatment with a fix calcipotriol/betamethasone combination is more cost-effective than a non-fix morning/evening combination.

Topics: Administration, Topical; Adult; Aged; Betamethasone; Calcitriol; Cost-Benefit Analysis; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Female; Germany; Humans; Male; Markov Chains; Middle Aged; Models, Economic; Models, Theoretical; Psoriasis

A clinical trial was performed to evaluate the efficacy, speed of response, side effects and quality of life of patients treated with calcipotriol/betamethasone dipropionate (Dovobet) for 4 weeks followed by maintenance with calcipotriol for 8 weeks (group A) versus calcipotriol (Daivonex) alone for 12 weeks (group B) for the treatment of psoriasis.. A total of 150 patients were enrolled and randomized to groups A and B. PASI and Skindex-29 were considered the outcome measures.. Ninety-six patients completed the trial. At weeks 2 and 4, both groups showed a significant clinical improvement compared to baseline; group A demonstrated a higher clinical response compared with group B (p< 0.001). Treatment with calcipotriol was associated with a gradual improvement in group B and maintenance of the results in group A. Similarly, the quality of life assessment showed a marked improvement in terms of Skindex-29 in both groups at weeks 2 and 4 compared to baseline. Both treatments were safe and well tolerated.. Our results demonstrate a higher efficacy and more rapid onset of action with the two-compound ointment compared with calcipotriol cream alone in short-term treatment. However, sequential application of calcipotriol allows maintenance of the results.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Analysis of Variance; Betamethasone; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Female; Humans; Male; Middle Aged; Psoriasis; Quality of Life; Severity of Illness Index; Treatment Outcome

The Clobex Spray Community-Based Research Assessment (COBRA) trial was a 4-week, open-label, observational, community-based trial that evaluated the use of twice-daily clobetasol propionate spray 0.05% either as monotherapy (n = 1254, effectiveness-evaluable [EE] population) or therapy added on to an existing regimen (n = 731, EE population) in subjects with moderate to severe plaque psoriasis. The key outcome measures were the change in target plaque severity (TPS) rating between weeks 0 (baseline) and 4 and the investigators' global assessment of improvement (GAI) rating at 4 weeks. This article focuses on clobetasol spray 0.05% when it is added to the 5 most commonly used treatment regimens in the COBRA trial add-on therapy group. Among the group of subjects receiving clobetasol propionate spray 0.05% as add-on therapy, the most common ongoing treatment was a biologic agent. The other more common ongoing treatments were topical calcipotriene, oral antipsoriatic agents, other topical corticosteroids (non-class 1), and topical calcipotriene plus other topical corticosteroids. Similar rates of treatment success (clear or almost clear) were seen in the subgroup analysis for each of the add-on regimens when assessed by both the TPS and GAI scales. On the TPS scale, success rates at week 4 were 76.0% to 84.0% for clobetasol propionate spray 0.05% added to biologic agents, topical calcipotriene, oral antipsoriatic agents, other topical corticosteroids, or topical calcipotriene plus other topical corticosteroids. It is notable that in subjects who were being treated with a variety of agents, the addition of clobetasol propionate spray 0.05% during the course of the study resulted in improvements in disease severity.

Topics: Administration, Oral; Administration, Topical; Adult; Aged; Biological Products; Calcitriol; Clobetasol; Dermatologic Agents; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Patient Satisfaction; Psoriasis; Quality of Life; Severity of Illness Index; Skin; Treatment Outcome

The efficacy and safety of 0.3% tacrolimus gel and 0.5% tacrolimus cream compared with calcipotriol ointment were evaluated in adults (n = 124) with mild to moderate plaque psoriasis. Treatment was twice daily for a maximum of 12 weeks. Clinical efficacy was assessed by the percentage change in the local psoriasis severity index of a target lesion between baseline and week 12. By week 12, the median percentage changes in local psoriasis severity index of the target lesions in the tacrolimus gel, tacrolimus cream and calcipotriol groups were 55.6%, 50.0% and 58.6%, respectively (no statistically significant differences). Clinical improvement was observed after one week and increased throughout the study. Tacrolimus-treated patients experienced more application site skin burning (tacrolimus gel and cream both 31.0% versus 7.5% for calcipotriol; p = 0.011). Skin burning was mostly mild in intensity and decreased substantially after 1 week of treatment. There were no differences in the nature and incidence of infections and no clinically relevant changes in laboratory values.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Calcitriol; Dermatologic Agents; Dose-Response Relationship, Drug; Female; Gels; Humans; Immunosuppressive Agents; Male; Middle Aged; Ointments; Psoriasis; Severity of Illness Index; Tacrolimus; Treatment Outcome

Topics: Administration, Topical; Adolescent; Adult; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Ointments; Psoriasis; Scalp Dermatoses; Treatment Outcome

The decrease of physiological apoptosis in the psoriatic lesions is thought to be involved in the pathogenesis of psoriasis, and induction of apoptosis was shown to contribute to the regression of psoriatic hyperplasia. In the present study, we compared the effects of calcipotriol and methylprednisolone aseponate (MPA) treatments on bcl-2, p53 and ki-67 expressions in psoriatic patients in order to define a relationship between regulation of apoptosis and healing process in psoriasis.. Thirty psoriatic patients with stable and moderate chronic plaque psoriasis applied either calcipotriol or MPA ointment for 6 weeks twice daily. Evaluation of bcl-2, p53 and ki-67 positivity was performed at baseline and was repeated at sixth week for each therapy.. The mean percentage of positive keratinocytes was 8.63 +/- 7.15% for p53, 20.66 +/- 14.45% for ki-67, and 3.74 +/- 2.83% for bcl-2 in psoriatic skin at baseline. Normal skin values were 3.27 +/- 3.21% for p53, 4.93 +/- 4.77% for ki-67, and 1.80 +/- 0.41% for bcl-2. The psoriatic skin showed higher ki-67 (P < 0.05) and bcl-2 (P < 0.05) expression rates when compared to normal skin. The p53 positivity observed in psoriatic skin and normal skin was not significantly different (P > 0.05). Following calcipotriol and MPA treatments, there was a significant reduction in p53 and ki-67 positivity accompanied by an increase in bcl-2 positivity (P < 0.05 each). No significant differences were found at sixth week between calcipotriol and MPA groups with respect to p53, ki-67 and bcl-2 positivity (P > 0.05). The post-treatment psoriatic skin showed lower expression of p53, higher expressions of ki-67 and bcl-2 when compared to normal skin (P < 0.05 each).. The results of this study provide evidence that both calcipotriol and MPA decrease the p53 and ki-67 expression and increase bcl-2 expression. However, it should further be elucidated if these changes were the common behaviour of psoriatic keratinocytes to any antipsoriatic medication.

Topics: Administration, Topical; Adult; Apoptosis; bcl-2-Associated X Protein; Calcitriol; Dermatologic Agents; Female; Humans; Ki-67 Antigen; Male; Methylprednisolone; Middle Aged; Psoriasis; Statistics, Nonparametric; Treatment Outcome; Tumor Suppressor Protein p53

The calcipotriol/betamethasone dipropionate two-compound product Dovobet/Daivobet/Taclonex(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks. As psoriasis is a chronic disease, long-term treatment may be required, so there is a need to investigate the safety of its use over a longer period of time.. To investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks in the treatment of patients with psoriasis.. Patients (n = 634) were randomized double-blind to treatment with: (i) 52 weeks of the two-compound product (two-compound group); (ii) 52 weeks of alternating 4-week periods of the two-compound product and calcipotriol (alternating group); or (iii) 4 weeks of the two-compound product followed by 48 weeks of calcipotriol (calcipotriol group). Treatments in all groups were used once daily when required.. Adverse drug reactions (ADRs) occurred in 45 (21.7%) patients in the two-compound group, 63 (29.6%) in the alternating group and 78 (37.9%) in the calcipotriol group. The odds ratio for an ADR in the two-compound group relative to the calcipotriol group was 0.46 (95% confidence interval 0.30-0.70; P < 0.001). ADRs of concern associated with long-term topical corticosteroid use occurred in 10 (4.8%) patients in the two-compound group, six (2.8%) in the alternating group and six (2.9%) in the calcipotriol group; those with the highest incidence were skin atrophy, occurring in four (1.9%), one (0.5%) and two (1.0%) patients, respectively, and folliculitis, in three (1.4%), one (0.5%) and no patients, respectively.. Treatment with the two-compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with calcipotriol treatment.

Topics: Adult; Betamethasone; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Eruptions; Female; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index

A calcipotriene/betamethasone dipropionate two-compound product (Taclonex ointment) has been shown to be safe and effective in the treatment of psoriasis over 4 weeks. Since treatment of psoriasis is generally long-term, the objective of this study was to investigate the efficacy and safety of transferring patients to maintenance treatment with calcipotriene cream (Dovonex cream) following a 4-week treatment period with the two-compound product.. Patients with psoriasis were randomized to one of the following three treatment groups: 4 weeks of the two-compound product followed by 8 weeks of calcipotriene cream (calcipotriene cream group); 4 weeks of the two-compound product followed by 8 weeks of calcipotriene cream on weekdays and the two-compound product on weekends (alternating group); 4 weeks of the two-compound product followed by 8 weeks of vehicle of calcipotriene cream (vehicle group). All medications were applied once daily.. A total of 1136 patients were randomized: 383 to the calcipotriene cream group, 377 to the alternating group, and 376 to the vehicle group. The mean percentage change in the Psoriasis Area and Severity Index from baseline to the end of the trial was -44.5% in the calcipotriene cream group, -58.4% in the alternating group, and -33.1% in the vehicle group. The mean difference between the calcipotriene cream and vehicle groups (primary treatment comparison) was -11.7% (95% CI -17.9, -5.5), which was statistically significant (p<0.001), and the mean difference between the alternating and vehicle groups was -24.7% (95% CI -30.9, -18.5), which was also statistically significant (p<0.001). For the investigators' global assessment of disease severity at the end of the trial, the differences between the calcipotriene cream and vehicle groups, and between the alternating and vehicle groups, were statistically significant (p<0.001), showing superior efficacy in the nonvehicle groups. The results were similar for the patients' global assessment of response to treatment. There were 43 patients (11.3%) with adverse drug reactions in the calcipotriene cream group, 28 (7.6%) in the alternating group, and 32 (8.6%) in the vehicle group. There were no statistically significant differences in the incidence of adverse drug reactions in the calcipotriene cream group relative to the vehicle group (odds ratio 1.36; 95% CI 0.84, 2.21; p=0.21), or in the alternating group relative to the vehicle group (odds ratio 0.87; 95% CI 0.51, 1.48; p=0.61).. Four weeks of treatment with the calcipotriene/betamethasone dipropionate two-compound product followed by 8 weeks of maintenance treatment with calcipotriene cream is effective and safe. As an alternative maintenance regimen, treatment with calcipotriene cream on weekdays and the two-compound product on weekends is also effective and safe.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Chi-Square Distribution; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Ointments; Psoriasis; Treatment Outcome

Localized chronic plaque psoriasis, resistant to local therapy, may be very hard to treat. The treatment of these lesions with a pulsed dye laser (PDL) has been described before, but a comparative study between the PDL and a potent topical treatment has never been performed.. To compare the efficacy of the PDL in the treatment of localized, recalcitrant plaque psoriasis with a potent topical therapy, using calcipotriol/betamethasone dipropionate (Dovobet) as an active comparator.. Eight patients with psoriasis were treated with both PDL (585 nm) and calcipotriol/betamethasone dipropionate in an open, intrapatient, left-right comparison. A plaque severity score (sum score) and photographs were used to document the course of therapy. Patients reported pain on a visual analogue scale.. Both treatments were well tolerated, although one patient left the study due to post-PDL treatment pain. A significant difference in the sum score 12 weeks after treatment was seen in favour of the PDL (62% vs. 19% reduction; P<0.05). Scores for erythema declined significantly at week 12 in both the PDL and the calcipotriol/betamethasone dipropionate group (P<0.001). Induration and desquamation scores were significantly reduced at week 12 in the PDL group, without a statistically significant reduction in calcipotriol/betamethasone-treated lesions. The pain scores declined with progressive PDL treatments, although not statistically significantly.. PDL treatment might be considered for the treatment of localized, recalcitrant plaque psoriasis, when other topical therapies have failed.

Topics: Adult; Analysis of Variance; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Follow-Up Studies; Humans; Laser Therapy; Male; Middle Aged; Psoriasis; Treatment Outcome

Topics: Calcitriol; Dermatologic Agents; Dose-Response Relationship, Drug; Double-Blind Method; Humans; Occlusive Dressings; Ointments; Psoriasis; Time Factors

The US National Psoriasis Foundation recently recommended that PASI 50 and PASI 75 response rates be used in clinical trials to enable comparisons across studies of different psoriasis therapies. To date, these response rates have not been reported for the two-compound ointment containing calcipotriol and betamethasone dipropionate (Daivobet/Dovobet; LEO Pharma, Ballerup, Denmark). Further, in order to compare Daivobet with other therapeutics recently presented to the European regulatory authorities and the FDA, comparison with the biologicals, efalizumab, etanercept and alefacept, were also made.. To present the PASI 50 and PASI 75 results for the two-compound ointment containing calcipotriol and betamethasone dipropionate.. Data from six phase III studies conducted with the two-compound ointment were pooled and the PASI 50 and PASI 75 response rates calculated for patients with severe (PASI>or=17) or less severe disease (PASI<17) at treatment commencement. Results for the biological therapies, efalizumab, etanercept and alefacept, were obtained from relevant published phase III studies.. PASI 50 and PASI 75 were achieved by more patients treated with the two-compound ointment than with the individual components. In patients with severe disease, the PASI 50 response rate after 4 weeks' treatment was 88.8% with the two-compound ointment, 69.2% with betamethasone dipropionate, 53.8% with calcipotriol, and 30.0% with ointment vehicle. In comparison, 12 weeks' treatment with the biologicals resulted in PASI 50 response rates of 59% with efalizumab, 74% with etanercept, and 56% with alefacept.. The two-compound ointment is effective, producing a PASI 50 and PASI 75 response in greater than 80% and 50% of patients, respectively, regardless of psoriasis severity.

Topics: Alefacept; Anti-Inflammatory Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Betamethasone; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Etanercept; Female; Humans; Immunoglobulin G; Male; Middle Aged; Ointments; Psoriasis; Receptors, Tumor Necrosis Factor; Recombinant Fusion Proteins; Retrospective Studies; Severity of Illness Index

Calcipotriol has become a first-line treatment for psoriasis. Its efficacy and safety have been shown in many comparative clinical trials carried out in outpatients. In a comparative study in patients visiting the outpatient department once every 14 days, it was shown that calcipotriol was more effective and better tolerated compared with dithranol.. To compare the clinical efficacy of calcipotriol ointment with that of dithranol cream in a supervised treatment regimen.. In a multicentre randomized controlled trial in six centres in the Netherlands, 106 patients with chronic plaque psoriasis were included, 54 receiving calcipotriol ointment twice daily and 52 dithranol cream once daily. Patients were treated at the day-care centre, using the care instruction principle of daily visits during the first week and twice-weekly visits subsequently for up to 12 weeks.. This study failed to prove that calcipotriol is as efficacious as dithranol when used in a day-care setting (noninferiority test). The mean percentage reduction in Psoriasis Area and Severity Index from baseline to end of treatment was 57.0% in the calcipotriol group vs. 63.6% in the dithranol group. However, the two-sided test for superiority indicated no statistically significant difference between the treatment groups (P = 0.39). At the end of treatment, 15% of the patients treated with calcipotriol ointment and 25% of those treated with dithranol cream did not require any further treatment. Although calcipotriol ointment appeared to be more effective during the first 8 weeks, a difference was no longer apparent at 12 weeks. In comparison with the high number of drop-outs due to cutaneous side-effects in the calcipotriol group, the frequency of a tolerable degree of irritation appeared to be higher in patients treated with dithranol. However, concomitant corticosteroid treatment of dithranol irritation in seven patients may have contributed to this difference between both treatments. Moreover, patients receiving therapy with calcipotriol ointment experienced fewer application-related skin and subcutaneous tissue disorders than patients treated with dithranol cream: 21 of 53 (40%) and 37 of 52 (71%), respectively. This difference is statistically significant (P = 0.001).. The hypothesis that calcipotriol ointment might be at least as effective as dithranol cream in the day-care setting could not be proven in the present study. Whereas calcipotriol has become a mainstay in the routine outpatient treatment of psoriasis not requiring a day-care setting, dithranol treatment, being difficult as a routine outpatient therapy, has increased efficacy and improved tolerability if the treatment is carried out in a day-care setting.

Topics: Adult; Aged; Aged, 80 and over; Anthralin; Calcitriol; Day Care, Medical; Dermatologic Agents; Drug Administration Schedule; Humans; Middle Aged; Ointments; Prospective Studies; Psoriasis; Severity of Illness Index; Treatment Outcome

During the last decades, management of intertriginous psoriasis (IP) has been unsatisfactory because of the adverse effects associated with long-term corticosteroid application and the lack of alternatives. Recently, both pimecrolimus and tacrolimus have been investigated for this indication and shown to be safe and effective. So far, to our knowledge, a comparison of one of these drugs with standard regimens for IP has not been performed.. A single-center, 4-week, double-blind, randomized, vehicle-controlled comparison study to assess the safety and efficacy of 1% pimecrolimus, 0.005% calcipotriol, and 0.1% betamethasone valerate in the treatment of IP.. Dermatologic hospital at Ruhr University of Bochum.. Eighty adults with IP.. Treatment of IP with 1% pimecrolimus, 0.005% calcipotriol, 0.1% betamethasone, or the vehicle once daily for 28 days.. Mean reduction of the Modified Psoriasis Area and Severity Index (M-PASI) score after 28 days of treatment was considered the primary outcome measure, which was analyzed on an intention-to-treat basis. The secondary outcome was a visual analog scale score for itching.. After 4 weeks of treatment, the 3 active compounds and the vehicle resulted in a significant decrease in mean M-PASI score (86.4% for 0.1% betamethasone, 62.4% for 0.005% calcipotriol, 39.7% for 1% pimecrolimus, and 21.1% for vehicle). The 0.1% betamethasone was significantly more effective than 1% pimecrolimus during the study period (P<.05). No significant difference was found between 0.005% calcipotriol and 0.1% betamethasone and between 0.005% calcipotriol and 1% pimecrolimus. The visual analog scale score for pruritus decreased by 78% for 0.1% betamethasone, 57% for 0.005% calcipotriol, 35% for 1% pimecrolimus, and 43% for the vehicle, again demonstrating a clear advantage for the corticosteroid (P<.05).. The 1% pimecrolimus was shown to be less potent than 0.1% betamethasone in the treatment of IP. Considering the adverse-effect profile of long-term application of corticosteroids, occasional or intermittent rescue therapy with short-term topical corticosteroids and maintenance with a less potent agent, such as 1% pimecrolimus or 0.005% calcipotriol, might be appropriate for patients with IP in general practice.

Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Betamethasone; Calcineurin Inhibitors; Calcitriol; Double-Blind Method; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Peptidylprolyl Isomerase; Psoriasis; Severity of Illness Index; Tacrolimus; Treatment Outcome

The merit of topical sequential therapy involving clobetasol foam and calcipotriene ointment has not been experimentally demonstrated.. We sought to assess the short-term efficacy of twice-daily clobetasol foam plus calcipotriene ointment compared with either agent alone as monotherapy and to compare long-term use of weekday calcipotriene ointment with or without clobetasol foam weekend pulse therapy.. Eighty-six subjects with plaque-type psoriasis received twice-daily treatment with clobetasol foam plus calcipotriene ointment or either agent as monotherapy for 2 weeks. Subjects in the combination group who achieved remission received weekday calcipotriene plus weekend pulse therapy with either clobetasol foam or vehicle for 6 months.. After 2 weeks, psoriasis scores were significantly lower (P < .001) in the combination therapy group (adjusted trunk lesion score = 0.67) compared with monotherapy with either agent (lesion scores = 1.40 calcipotriene, 1.13 clobetasol foam). During the follow-up "weekday-weekend" phase, after 6 months, weekend pulse clobetasol foam was associated with a trend toward greater maintenance of remission compared with vehicle (92% improvement of trunk lesion vs 62%).. Small sample size may have hampered the detection of statistical significance during long-term therapy.. The combination of clobetasol foam and calcipotriene ointment is significantly more effective than monotherapy for short-term treatment. Weekday calcipotriene plus weekend pulse clobetasol foam shows a consistent trend toward greater maintenance of remission.

Topics: Adult; Calcitriol; Clobetasol; Dosage Forms; Drug Administration Schedule; Female; Humans; Male; Ointments; Psoriasis; Time Factors; Treatment Outcome

The calcipotriol/betamethasone dipropionate two-compound product is safe and effective in the short-term treatment of psoriasis.. The primary objective was to investigate the safety of two treatment regimens involving use of the two-compound product over 52 weeks. The efficacy results are presented here.. Six hundred and thirty-four patients were randomised double-blind to treatment (once daily, when required) with either: 52 weeks of two-compound product (two-compound group), 52 weeks of alternating 4-week periods of two-compound product and calcipotriol (alternating group), or 4 weeks of two-compound product followed by 48 weeks of calcipotriol (calcipotriol group).. There was a trend towards a difference between treatments from the overall treatment effect for the percentage of satisfactory responses for each patient during the study (p = 0.071). This appeared to be due to the comparison of the two-compound and calcipotriol groups (p = 0.025).. There was a trend towards the efficacy of the two-compound product used for up to 52 weeks being better than that of 4 weeks of the two-compound product followed by 48 weeks of calcipotriol.

Topics: Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Follow-Up Studies; Humans; Male; Middle Aged; Patient Satisfaction; Psoriasis; Safety; Time Factors; Treatment Outcome

A calcipotriol (calcipotriene)/betamethasone dipropionate two-compound product has been shown to be efficacious for the treatment of psoriasis vulgaris. It is usually administered once daily for up to 4 weeks followed by treatment with corticosteroid-free conventional products (e.g. calcipotriol). The aim of this study was to evaluate the efficacy and tolerability of a 4-week treatment with the two-compound product in psoriasis vulgaris and the effects of sequential 8-week maintenance treatment with different calcipotriol formulations.. After an initial 4-week phase with the once-daily calcipotriol/betamethasone dipropionate two-compound product, adult patients with stable psoriasis vulgaris entered an 8-week maintenance phase and were allocated to one of the following treatments: calcipotriol ointment twice daily, calcipotriol cream twice daily, or calcipotriol cream once daily in the morning and calcipotriol ointment once daily in the evening. Clinical assessment was performed at baseline, after 4 weeks and after 12 weeks, and employed evaluation of the severity of pruritus using a scale from zero to four and the Psoriasis Area and Severity Index (PASI).. After 4 weeks' treatment with the calcipotriol/betamethasone dipropionate two-compound product, a significant improvement in the severity of psoriasis was observed in all groups, with a mean reduction in the PASI of 71.3% (p < 0.001 vs baseline). A significant improvement in pruritus was also obtained after 4 weeks. These results were maintained after 8 weeks of treatment with calcipotriol, regardless of the formulation used. Treatment was very well tolerated and accepted by patients. On a scale ranging from poor to excellent, more patients treated with calcipotriol cream (49%) rated the acceptability of the treatment as excellent when compared with patients treated with the calcipotriol ointment (33%) or both calcipotriol formulations (36%).. This study shows that the calcipotriol/betamethasone dipropionate two-compound product causes a rapid and marked improvement in both psoriasis lesions and pruritus. Our preliminary results suggest that the three calcipo- triol-based regimens are equally effective in maintaining the therapeutic results obtained with the calcipotriol/betamethasone dipropionate two-compound product and that the use of calcipotriol cream was the best accepted maintenance treatment.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Female; Humans; Male; Middle Aged; Patient Compliance; Patient Dropouts; Pilot Projects; Pruritus; Psoriasis; Severity of Illness Index; Time Factors; Treatment Outcome

Psoriasis is a genetically determined disease characterized by hyperproliferation and disordered maturation of the epidermis. Th1 lymphocytes are implicated in its pathogenesis. The vitamin D receptor (VDR) is a candidate modifying gene, having immunosuppressive effects and being involved in anti-proliferative and pro-differentiation pathways in keratinocytes. There is suggestive evidence that the A allele of the A-1012G polymorphism is associated with down-regulation of the Th1 response, via GATA-3. The F and T alleles of Fok1 and Taq1 have been associated with increased VDR activity. The present study aimed to test the hypothesis that the A allele of A-1012G is protective for occurrence and severity of psoriasis and enhances therapeutic response to vitamin D analogues and that these effects would be additive to those of Fok1 and Taq1. The study group comprised 206 psoriasis patients who had received topical calcipotriol treatment and 80 controls. There was no significant linkage disequilibrium between any pair of the three polymorphic sites (P=0.3-0.8). The A, F and T alleles were positively associated with calcipotriol response: AA genotype (compared to AG/GG), odds ratio (OR)=2.18 (P=0.04); TT, OR=1.97 (P=0.03); AAFF genotype combination, OR=4.11 (P=0.03); AATT, OR=5.64 (P=0.005); and FFTT, OR=3.22 (P=0.01). Comparing patients without, to patients with, a family history of psoriasis, the A allele was under represented (P=0.01) and the AAFF genotype combination even more so (compared to residual genotypes) (OR=0.24; P=0.005). AAFF was also under-represented in patients without a family history compared to controls (OR=0.31; P=0.04). There were no associations of family history with Fok1 and Taq1. There were no associations of severity of psoriasis with any polymorphism. In conclusion, the A-1012G, Fok1 and Taq1 VDR polymorphisms were associated with response to calcipotriol. A-1012G and Fok1 were associated with susceptibility to non-familial psoriasis.

Topics: Adolescent; Adult; Aged; Calcitriol; Dermatologic Agents; Female; Genetic Predisposition to Disease; Humans; Male; Middle Aged; Polymorphism, Genetic; Promoter Regions, Genetic; Psoriasis; Receptors, Calcitriol; Treatment Outcome

Scalp involvement in psoriatic patients represents a common issue. Treatment of the hairy skin requires adequate pharmaceutical formulations; hence, a new specific shampoo formulation of clobetasol propionate 0.05% was developed by Galderma R&D, Inc.. For this multicenter, randomized, investigator-masked, parallel group study, 151 subjects with moderate to severe scalp psoriasis were randomized to 4 weeks of treatment with clobetasol propionate shampoo or calcipotriol solution.. Clobetasol propionate demonstrated significantly superior efficacy to calcipotriol solution (total severity score: mean difference 0.51, 95% CI 0.05-0.97, p = 0.028; global severity score: mean difference 0.43, 95% CI 0.08-0.78, p = 0.016). Adverse events were more common in the calcipotriol group than in the clobetasol propionate shampoo group. Telangiectasia and skin atrophy did not differ significantly between treatments; however, a burning sensation was significantly more common in the calcipotriol solution group.. Short contact therapy of scalp psoriasis with this new shampoo formulation of clobetasol propionate was significantly more effective and better tolerated than calcipotriol solution for the treatment of scalp psoriasis.

Topics: Administration, Topical; Adult; Calcitriol; Clobetasol; Dermatologic Agents; Female; Hair Preparations; Humans; Male; Middle Aged; Psoriasis; Scalp Dermatoses; Severity of Illness Index; Solutions; Treatment Outcome

Tazarotene and calcipotriol are both effective in the treatment of psoriasis. An investigator-blind, bilateral comparison of 44 lesion pairs in 19 patients was conducted to evaluate the efficacy, side effects and duration of therapeutic effects of once-daily tazarotene 0.1% gel plus petrolatum with twice-daily calcipotriol 0.005% ointment in plaque psoriasis. It consisted of a 12-week treatment phase, followed by a 4-week post-treatment observation phase. At the end of the treatment phase, tazarotene-petrolatum was as effective as calcipotriol in both objective and subjective overall efficacy assessment. Calcipotriol had a significantly greater effect in reducing erythema than tazarotene-petrolatum at weeks 2-8. At week 16, tazarotene-petrolatum demonstrated a significantly better maintenance effect in all parameters. Local irritation was noted only in tazarotene-petrolatum-treated lesions. Once-daily tazarotene 0.1% gel plus petrolatum was as effective as twice-daily calcipotriol 0.005% ointment in the treatment of plaque psoriasis, but had a better maintenance effect after the cessation of therapy.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Calcitriol; Child; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Female; Gels; Humans; Male; Middle Aged; Nicotinic Acids; Ointments; Petrolatum; Prospective Studies; Psoriasis; Severity of Illness Index; Treatment Outcome

Daivobet is a once-daily treatment of psoriasis vulgaris containing betamethasone dipropionate and calcipotriol in a new ointment vehicle.. To assess the cost-effectiveness of once-daily treatment with Daivobet (4 weeks) followed by calcipotriol (4 weeks) compared to tacalcitol (8 weeks).. Resource utilization was assessed within a double-blind 8-week clinical trial (all treatments for psoriasis, adverse events and concomitant dermatological medication), estimated from the French societal perspective.. Total direct medical costs for psoriasis were comparable (Daivobet: EUR 107.53 and tacalcitol EUR 113.50) despite a higher acquisition cost for Daivobet. The probability of > or =75% reduction in the Psoriasis Area and Severity Index (effectiveness criterion) was 46.6% with Daivobet and 13.9% with tacalcitol at 4 weeks, and 44.6 and 23.8%, respectively, at 8 weeks (both: p < 0.001). Over 8 weeks, Daivobet was almost twice as cost-effective as tacalcitol (EUR 241.22 per successful treatment vs. EUR 476.70); this result was robust to sensitivity assumptions.. Daivobet is more effective and less costly than tacalcitol for treating psoriasis.

Topics: Administration, Topical; Adult; Aged; Betamethasone; Calcitriol; Confidence Intervals; Cost-Benefit Analysis; Dihydroxycholecalciferols; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Costs; Europe; Female; Follow-Up Studies; Humans; Male; Middle Aged; Ointments; Probability; Psoriasis; Reference Values; Risk Factors; Severity of Illness Index; Treatment Outcome

Topics: Administration, Topical; Calcitriol; Coal Tar; Dermatologic Agents; Female; Humans; Male; Psoriasis; Quality of Life; Scalp Dermatoses; Treatment Outcome

There are few reports regarding the treatment of nail psoriasis with topical calcipotriol. We undertook a case series study to evaluate the efficacy and safety of calcipotriol ointment (50 microg/g) in the treatment of nail psoriasis in 24 patients. This study involved 19 women and 5 men with nail psoriasis referred to Dermatology clinics of Razi hospital. The duration of trial was from October 2002 to September 2004. Informed consent was obtained from all patients before entering into the study. The patients applied calcipotriol ointment to the affected nails twice daily without occlusion for 3 months. Patients were seen by two academic dermatologists initially, after 2 weeks, and then at monthly intervals. The efficacy and safety were clinically assessed and any side effect was recorded. Patients who showed 50 percent or greater reduction in the baseline subungual thickness in at least one nail were considered to be responders and were offered continuation of therapy for an additional 2 months. After discontinuation of therapy, followup visits were performed at 1 and 2 months. After 3 months of therapy, fourteen patients showed significant clinical improvement, two of them were completely free from nail lesions after 5 months. Calcipotriol was particularly effective in subungual hyperkeratosis, onycholysis, and discoloration. In four patients fingertip tenderness and in one case the pain of involved distal phalanx were significantly reduced. No clinical response was observed in four patients. Only two cases showed adverse reactions. Topical Calcipotriol is an effective treatment for nail psoriasis and can be considered to be a safe topical treatment in chronic cases; its high tolerability allows prolonged usage without severe side effects.

Topics: Administration, Topical; Adolescent; Adult; Aged; Calcitriol; Dermatologic Agents; Female; Humans; Male; Middle Aged; Nail Diseases; Psoriasis

The purpose of this study was to evaluate the efficacy of calcipotriol ointment as monotherapy versus calcipotriol in combination with narrow-band ultraviolet (UV)-B or UVA1 phototherapy and to determine whether calcipotriol in combination with UVA1 is an alternative to calcipotriol with narrow-band UVB phototherapy. Forty-five patients with plaque psoriasis were divided into three treatment groups with no significant differences in Psoriasis Area and Severity Index (PASI) scores, mean age, sex or skin type. The total duration of the treatment was 3 months. Regarding PASI score, psoriasis regression was statistically significant between the groups. The response to UVA1 and narrow band UVB with calcipotriol was superior to calcipotriol monotherapy. UVA1 phototherapy with calcipotriol could be an alternative to narrow-band UVB phototherapy with calcipotriol.

Topics: Adult; Aged; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Female; Humans; Male; Middle Aged; Psoriasis; Ultraviolet Therapy

Of 17 patients (10 men and 7 women) with psoriasis vulgaris, aged between 12 and 59 years, included in this study, 4 patients were excluded (3 because of a treatment follow-up irregularity and 1 due to severe irritation). Thirteen patients completed the 6-week treatment course where each patient was instructed to apply calcipotriol-betamethasone ointment on the right side and calcipotriol ointment on the left side. The treatment effect was assessed according to the psoriasis area severity index (PASI) changes, and complete blood count and serum calcium was done prior to and at the end of the treatment. Results showed that both sides had improved by 92.3%, with a marked reduction in the mean PASI (from 11.5 to 2.2); a better reduction was observed in the right side during the second and third visits. A marked improvement to complete clearance was seen in 84.6% in calcipotriol-betamethasone side and 76.9% in calcipotriol alone. Mild irritation was reported in the left side in 15.4% which was tolerated with the continuation of treatment application. No telangiectasia or atrophy was observed on the right side. In conclusion, calcipotriol-betamethasone may be recommended in the early weeks of the treatment of psoriasis vulgaris, and it is helpful in psoriasis patients with irritation to calcipotriol alone.

Topics: Adolescent; Adult; Betamethasone; Calcitriol; Child; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Ointments; Psoriasis

The cause of psoriasis is still unknown. It occurs with equal frequency in both sexes. In many patients topical application alone will suffice to keep psoriasis under control. Vitamin D3 affects keratinocyte differentiation in psoiasis. Thirteen patients with mild to moderate psoriasis vulgaris were enrolled in this trial (eight men and five women), aged between 14 and 40 years. Each patient was instructed to apply calcipotriol cream once daily on the right side and twice daily on the left side for 6 weeks. The treatment assessment was based on psoriasis area severity index (PASI) at 0, 2, 4 and 6 weeks. Serum calcium was assessed prior to and at the end of treatment. Calcipotriol cream was clearly effective in psoriasis and in both sides an almost similar effect was seen. The reduction in PASI was remarkable in both sides and the change was from 7.9 (pretreatment) to 2.4 (once daily) and 2.1 (twice daily). Out of the treated patients, seven (53.8%) had complete to marked clearance of both sides. Two patients (once daily) versus three patients (twice) had moderate improvement. Mild improvement was observed in three with twice-daily and in two with once-daily application. Post-treatment serum calcium was normal in all cases. In conclusion, there was no significant difference between once- and twice-daily application of calcipotriol cream, and single night application of topical calcipotriol could be more practical and reliable, and less expensive.

Topics: Administration, Topical; Adolescent; Adult; Calcitriol; Drug Administration Schedule; Emollients; Female; Humans; Male; Psoriasis; Severity of Illness Index

Psoriasis is characterized by three main pathogenic features: abnormal differentiation, keratinocyte hyperproliferation and inflammation. The lesions may disappear spontaneously or as a result of therapy, but recurrences are almost certain. Twenty-seven patients with scalp psoriasis were treated with calcipotriol solution 50 g/ml as twice-daily application for 8 weeks. The assessment was based on the mean sign scores (erythema, thickness and scaliness) at 0, 2, 4, 6 and 8 weeks. The results indicated that five patients were excluded from the study (four because of irregularity and one because of irritation), and 22 patients had completed the treatment course. There was a marked reduction in the total mean scores of erythema, thickness and scaling from 2.8, 2.7 and 2.7 to 0.3, 0.34 and 0.4, respectively. Fifteen patients (68.2%) showed complete clearance of their psoriasis, and most of the lesions cleared by week 6 of treatment. Two patients (9.1%) had marked improvement and four (18.2%) patients showed moderate improvement. No response to calcipotriol solution was seen in only one patient. No adverse effects occurred except severe irritation in one patient, who was excluded from this study. In conclusion, calcipotriol could be a valid choice for the treatment of scalp psoriasis.

Topics: Adolescent; Adult; Calcitriol; Child; Dermatologic Agents; Humans; Middle Aged; Psoriasis; Recurrence; Scalp Dermatoses; Solutions

Several reports have indicated that the combination of calcipotriol ointment and potent or ultrapotent corticosteroids are more effective and better tolerated, as compared to the monotherapies. The aim of the present study was to find out the effect of combination of calcipotriol ointment once daily and betamethasone dipropionate ointment once daily vs. the effect of twice-daily applications of each of the two treatments as monotherapy during a four-week treatment period. Seven patients with chronic plaque psoriasis were included for treatment with the three treatment schedules. Biopsies were taken before treatment and after four weeks of treatment, and markers for epidermal proliferation (Ki-67) and epidermal differentiation (keratin-10) were studied using a quantitative image analysis, and T-cell subsets in epidermis and dermis (CD4, CD8, CD25, CD45RO, CD45RA, CD94, CD161, and CD2) were studied using immunohistochemical scoring. The most impressive clinical result was reached with the combination. Calcipotriol proved to have a major effect on the proliferation marker Ki-67 and differentiation marker keratin-10, whereas the effect on T-cell subsets was more selective with major reductions of CD45RO(+) and CD8(+) T cells. In contrast, the effect of betamethasone dipropionate on the epidermis was restricted to a normalization of differentiation with a highly significant increase of keratin-10 positive epidermal surface without a significant effect on Ki-67 positive nuclei, and the effect on T-cell subsets was restricted to a reduction of natural killer T-cell receptors designated by CD94 and CD161 in the epidermis. The combination of the two treatments did not affect the proliferation marker Ki-67 and keratinization marker keratin-10, beyond the effect of calcipotriol monotherapy. However, the combination had a profound effect on, virtually, all T-cell subsets, beyond the effect of the monotherapies. It is concluded that the action spectra of calcipotriol and betamethasone on the psoriatic plaque are different and that the combination has effects on T-cell subsets, beyond the addition of the effects of monotherapies.

Topics: Anti-Inflammatory Agents; Antigens, CD; Betamethasone; Calcitriol; Cell Division; Dermis; Drug Therapy, Combination; Epidermis; Humans; Keratins; Ointments; Psoriasis; Skin; T-Lymphocyte Subsets; T-Lymphocytes

Vitamin D3 analogues are a first-line treatment of chronic plaque psoriasis, but so far, comparative clinical studies on calcipotriol and calcitriol ointment are sparse, and in particular no comparative studies are available on cell biological effects of these compounds in vivo. Using flow cytometric assessment, we investigated whether these compounds had different effects on the composition and DNA synthesis of epidermal cell populations responsible for the psoriatic phenotype. For 8 weeks, 20 patients with psoriasis vulgaris were treated twice daily with calcipotriol and calcitriol ointment in a left/right comparative study. Before and after treatment, clinical assessment of target lesions was performed, together with flow cytometric analysis of epidermal subpopulations with respect to keratin (K) 10, K6, vimentin and DNA distribution. Treatment with each compound resulted in a substantial clinical improvement, a reduction of the K10-K6- population and an increase of the K10+K6- population. A correlation was found between the clinical response of calcipotriol and the K10+K6- population, and the clinical response of calcitriol and the K10+K6- population, as well as the percentage of cells in the S, G2 and M phase of the cell cycle within the K10-K6- population, suggesting that the analogues have a different preference for affecting the K10+K6- pool (committed differentiated cells) or affecting the K10-K6- pool (basal cells).

Topics: Adult; Aged; Calcitriol; Cell Cycle; Dermatologic Agents; Drug Administration Schedule; Female; Flow Cytometry; Humans; Keratins; Male; Middle Aged; Ointments; Psoriasis; Regression Analysis; Vimentin

The addition of calcipotriol ointment to PUVA therapy for psoriasis vulgaris results in a lower total UVA dose and a faster onset of response. The addition of calcipotriol cream to PUVA, however, has not been studied.. To investigate whether combining calcipotriol cream with PUVA therapy has a UVA sparing effect.. We performed a randomized, multicentre, vehicle-controlled, double-blind, 12-week comparative study including 120 patients with psoriasis covering 20-50% body surface area. The study consisted of a washout phase followed by a 10-week treatment phase. PUVA therapy three times weekly was added within 1 week after randomization. Efficacy was assessed by the Psoriasis Area and Severity Index (PASI).. At baseline the mean PASI scores were 17.5 and 19.2 in the calcipotriol and vehicle (placebo) groups, respectively. At the end of treatment, the mean PASI scores were 2.65 and 7.03 (p<0.01), respectively. A reduction in PASI score >90% was observed in 69% of the patients in the calcipotriol-treated group and in 36.4% of the patients in the vehicle group (p<0.01).. Calcipotriol cream plus PUVA clearly reduces the cumulative dose of UVA and improves the response of psoriasis vulgaris to PUVA.

Topics: Administration, Cutaneous; Adult; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis; PUVA Therapy; Severity of Illness Index; Spain; Treatment Outcome

A two-compound ointment containing calcipotriol 50 micro g g-1 and betamethasone dipropionate 0.5 mg g-1 has recently been shown to be an effective treatment for psoriasis.. This study was designed to investigate efficacy and safety of different treatment regimens with the two-compound product (Daivobet/Dovobet; LEO Pharma, Ballerup, Denmark) and calcipotriol 50 micro g g-1 ointment (Daivonex/Dovonex; LEO Pharma).. In total, 972 patients with psoriasis vulgaris were randomized to one of three treatment regimens: group 1, the two-compound product once daily for 8 weeks followed by calcipotriol ointment once daily for 4 weeks; group 2, the two-compound product once daily for 4 weeks followed by 8 weeks of treatment with calcipotriol ointment once daily on weekdays and the two-compound product once daily at weekends; and group 3, calcipotriol ointment twice daily for 12 weeks. The efficacy was evaluated by Psoriasis Area and Severity Index (PASI) and investigators' global assessments of disease severity. The primary response criteria were percentage reduction in PASI and proportion of patients with absent/very mild disease according to the investigators' global assessments after 8 weeks of treatment.. The mean reduction in PASI from baseline to the end of 8 weeks of treatment was 73.3% for group 1, 68.2% for group 2 and 64.1% for group 3. The proportion of patients with absent/very mild disease at the end of 8 weeks of treatment was 55.3% for group 1, 47.7% for group 2 and 40.7% for group 3. For both primary response criteria, group 1 was statistically superior to group 3 (P < 0.001), whereas group 2 did not differ significantly from group 3. The difference between group 1 and group 2 was statistically significant with regard to PASI but not regarding the proportion of patients with absent/very mild disease. Patients receiving initial therapy with the two-compound product achieved the fastest treatment response, and the maximum treatment effect for these patients was seen after 5 weeks. This effect was maintained with continued treatment with the two-compound product for up to 8 weeks. After 12 weeks of treatment, no significant differences were seen between the three groups with regard to reduction in PASI, whereas the proportion of patients with absent/very mild disease in group 2 was superior to that in group 3. Patients receiving therapy with the two-compound product experienced fewer lesional/perilesional adverse drug reactions than the calcipotriol-treated patients (P < 0.001): 10.9% in group 1, 11.5% in group 2 and 22.3% in group 3.. Two different short-term treatment regimens employing a recently developed two-compound product (calcipotriol/betamethasone dipropionate) provided rapid and marked clinical efficacy and were shown to be safe therapies for psoriasis vulgaris.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Canada; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Europe; Female; Humans; Male; Middle Aged; Ointments; Prospective Studies; Psoriasis; Severity of Illness Index

Psoriasis is a common disease and may have a significant impact on patients' quality of life (QoL).. To assess the impact on QoL of a new two-compound product (TCP) (Daivobet/Dovobet; LEO Pharma) which combines the topical vitamin D analogue calcipotriol (50 microg g(-1)) and the World Health Organization group III corticosteroid betamethasone dipropionate (0.5 mg g(-1)) in a single ointment vs. calcipotriol monotherapy using a placebo-controlled study design.. The Psoriasis Disability Index and the EuroQoL 5D questionnaire and visual analogue scale (VAS) were used in this study, which enrolled 828 patients with psoriasis vulgaris for treatment lasting up to 4 weeks. These QoL instruments were completed by patients before and after treatment with the TCP of calcipotriol and betamethasone dipropionate used once or twice daily, calcipotriol alone twice daily and vehicle twice daily.. The TCP used once or twice daily and calcipotriol used twice daily were found to have statistically significant beneficial effects on patients' QoL over the course of treatment, and each was demonstrated to have a statistically significant benefit on QoL over vehicle. The TCP, applied once daily, was superior to calcipotriol twice daily in terms of reductions on the EuroQoL 5D questionnaire and VAS.. The results suggest that calcipotriol twice daily and the new TCP applied twice daily have a substantial effect on QoL. Once-daily application of the TCP is superior to calcipotriol twice daily terms of QoL, which reflects the superior efficacy of this combination and the advantage of once-daily application when compared with twice-daily application.

Topics: Activities of Daily Living; Adult; Betamethasone; Calcitriol; Dermatologic Agents; Disability Evaluation; Double-Blind Method; Drug Combinations; Female; Health Status Indicators; Humans; Male; Middle Aged; Prospective Studies; Psoriasis; Quality of Life; Treatment Outcome

We investigated the value of the dermoscope for monitoring the long term safety of high potency topical steroids in patients with chronic psoriasis. We observed for the first time that the overuse of topical steroids resulted in the appearance of clinically unapparent but dermoscopically apparent "red lines" (linear telangiectasias) in the treated plaques and/or skin adjacent to the treated plaques (P < .03). We concluded that dermoscopy may help reveal the early signs of impending steroid-induced atrophy ("red lines") before they become clinically evident with the naked eye and before the atrophy becomes permanent.

Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Atrophy; Calcitriol; Chronic Disease; Clobetasol; Dermatologic Agents; Dermoscopy; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Patient Compliance; Pilot Projects; Psoriasis

A two-compound product containing calcipotriol 50 microg/g and betamethasone dipropionate 0.5 mg/g (Daivobet, Dovobet) has been demonstrated to be an effective, once daily, treatment for psoriasis vulgaris.. To compare the efficacy and safety of treatment with the two-compound product for 4 weeks followed by calcipotriol for 4 weeks, with that of tacalcitol for 8 weeks in patients with stable psoriasis vulgaris.. 501 patients were randomised to double-blind treatment with the two-compound product followed by calcipotriol 50 microg/g once daily, or to tacalcitol 4 microg/g once daily.. Treatment with the two-compound product/calcipotriol was significantly more effective than tacalcitol in terms of mean percentage PASI reduction (65.0 vs. 33.3% at week 4 and 59.0 vs. 38.4% at week 8; p < 0.001 for both).. A treatment regimen comprising calcipotriol/betamethasone ointment (Daivobet) for 4 weeks followed by calcipotriol for 4 weeks is superior to tacalcitol ointment for 8 weeks in patients with psoriasis vulgaris.

Topics: Administration, Topical; Adolescent; Adult; Betamethasone; Calcitriol; Confidence Intervals; Dihydroxycholecalciferols; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Middle Aged; Odds Ratio; Prospective Studies; Psoriasis; Reference Values; Risk Assessment; Severity of Illness Index; Statistics, Nonparametric; Treatment Outcome

Calcipotriene and betamethasone dipropionate are topical treatments for psoriasis vulgaris. Their mode of action is different. Improved risk/benefit may result with concomitant use of the two compounds together. A new vehicle has been created with the objective of obtaining optimal stability of both calcipotriene and betamethasone dipropionate in the combination product.. We compared the clinical efficacy of a fixed combination of calcipotriene and betamethasone dipropionate in a new vehicle to calcipotriene in the new vehicle, betamethasone in the new vehicle, and the new vehicle alone.. This was an international, multicenter, prospective, randomized, double-blind, parallel-group, 4-week study in patients with psoriasis vulgaris amenable to topical treatment.. The mean percentage reduction in PASI from baseline to end of treatment was 73.2% in the combination group (n = 301), 48.8% in the calcipotriene group (n = 308), 63.1% in the betamethasone dipropionate group (n = 312) and 28.8% in the new vehicle group (n = 107), (P < .001). The mean percentage reduction in PASI during the first week was 48.1%, 28.4%, 41.4%, and 21.5%, respectively (P < .001).. A combination product of calcipotriene 50 microg/g and betamethasone dipropionate 0.5 mg/g in the new vehicle shows superior efficacy with a more rapid onset of action than the new vehicle containing either constituent alone in the treatment of psoriasis vulgaris.

Topics: Adolescent; Betamethasone; Calcitriol; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Pharmaceutical Vehicles; Prospective Studies; Psoriasis; Treatment Outcome

The scalp is a common area for plaque psoriasis. Corticosteroid-based lotions are the most widely used therapy in this clinical setting. A new formulation of betamethasone valerate 0.12% in a thermophobic, low-residue foam vehicle (Bettamousse trade mark, Mipharm, Italy; BVM) is available for the treatment of scalp dermatoses.. In an open, investigator-blinded, multicentre (28 dermatology clinics), randomized, cross-over study, the efficacy, safety and patient acceptability of BVM in scalp psoriasis were evaluated in comparison with standard therapies (ST, i.e. corticosteroids or vitamin D analogues). ST were chosen by each centre according to its usual therapeutic protocols.. In total, 241 patients with moderate to severe scalp psoriasis participated in the trial. After a 2-week run-in period, each active treatment (BVM or ST) was applied for 4 weeks, with a wash-out period between the two active treatment phases of at least 4 weeks. Efficacy was evaluated by investigators unaware of treatment sequence analysing a 'target' lesion for erythema, scaling, itching and burning using a five-point grading score. Patient treatment acceptability and assessment of the influence on Psoriasis Disability Index were evaluated using an eight-item modified Finlay-Khan questionnaire at baseline and at the end of each treatment period. Safety was evaluated by recording any adverse event occurring during the study duration. BVM was applied twice daily, and ST were applied once or twice daily, according to the approved scheduled regimens.. Analyses were by intention-to-treat. Two hundred and ten patients concluded the study. Fifteen patients withdrew from the study during BVM treatment, and 16 during ST (not significantly different). Both treatments were well tolerated. At baseline, the mean +/- SD clinical global score (the 'Sum' score = erythema + scaling + itching + burning) was 7.6 +/- 2.6. The ST chosen were topical corticosteroids (55% of cases; mainly mometasone and betamethasone dipropionate) or calcipotriol lotion (45% of cases). At the end of active treatments, BVM was significantly superior to ST (P < 0.001) in reducing, as compared with baseline, the mean +/- SD Sum score (1.5 +/- 1.9 with BVM and 3.1 +/- 2.7 with ST). During BVM treatment, 88% (95% confidence interval, CI 82-94%) of patients had a complete or nearly complete resolution of scaling in comparison with 66% (95% CI 58-74%) during ST therapy (P < 0.001). BVM was also considered an easier and more convenient formulation to use in comparison with ST (P < 0.01).. BVM is more effective than lotion-based ST commonly used in the treatment of scalp psoriasis, and has higher patient acceptability.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Betamethasone Valerate; Calcitriol; Cross-Over Studies; Dermatologic Agents; Drug Carriers; Female; Glucocorticoids; Humans; Male; Middle Aged; Patient Satisfaction; Psoriasis; Scalp Dermatoses; Severity of Illness Index; Single-Blind Method; Treatment Outcome

A multicentre, randomized, double-blind, vehicle-controlled, parallel-group study was carried out to study the effect of the addition of calcipotriol ointment to methotrexate (MTX) therapy in patients with psoriasis vulgaris.. To investigate whether the addition of calcipotriol to treatment with MTX has an MTX-sparing effect, and whether the combination of treatments is safe. Additionally, to compare the effect of calcipotriol or vehicle on the duration of the relapse-free interval after cessation of MTX.. Patients on maintenance therapy with MTX with controlled psoriasis were selected. The study was divided into three phases: (i) an MTX-free phase with double-blind treatment with either calcipotriol ointment or vehicle; (ii) an MTX titration phase with open MTX treatment and additional double-blind treatment with either calcipotriol or vehicle until target response; and (iii) follow-up phase: in a group of 97 patients, psoriasis was assessed using the modified psoriasis severity score, patients' assessment and safety parameters were monitored as well.. The combined use of calcipotriol with MTX resulted in an MTX-sparing effect of 3.4 mg week-1 (phase (II) and 2.6 mg week-1 (phase I and II taken together), while still maintaining efficacy. Calcipotriol treatment increased the time to relapse of psoriasis following discontinuation of MTX: 113 days vs. 35 days. A decrease in aspartate aminotransferase and alanine aminotransferase was seen during the study of 8% (calcipotriol) and 12% (vehicle).. The combination of calcipotriol and MTX was safe and well tolerated. The combination resulted in lower cumulative dosages of MTX compared with MTX and vehicle. Therefore the risk of side-effects is substantially decreased.

Topics: Adult; Aged; Aged, 80 and over; Alanine Transaminase; Aspartate Aminotransferases; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Methotrexate; Middle Aged; Ointments; Pharmaceutical Vehicles; Psoriasis; Severity of Illness Index

Psoriasis involving sensitive skin areas remains difficult to treat because of the side-effects of topical corticosteroids and the irritancy potential of vitamin D3 derivatives. Several clinical trials have demonstrated that calcitriol, the naturally occurring and hormonally active form of vitamin D3, is effective and safe at the dose of 3 microg g(-1) for the treatment of psoriasis affecting the trunk and limbs.. We compared the safety and efficacy of calcitriol 3 microg g(-1) ointment and calcipotriol 50 microg g(-1) ointment in a multicentre, randomized, investigator-blinded, left-right comparison in mild to moderate chronic plaque psoriasis affecting sensitive areas, defined as being the face, hairline, retroauricular and flexural areas. One pair of symmetrical and bilateral target lesions was selected from each area and assessed for perilesional erythema, oedema, and stinging/burning. Global assessment of local tolerability and global improvement were rated by the investigator, and the subjects were asked to evaluate the tolerability and efficacy of each product and to express their global preference.. In the 75 subjects, calcitriol and calcipotriol both led to clearing of at least one target lesion in 21 (28%) of the subjects each. Perilesional erythema (P < 0.001), perilesional oedema (P < 0.02) and stinging/burning (P < 0.001) were all significantly less severe with calcitriol than with calcipotriol. The subjects' evaluation of local tolerability was significantly (P < 0.0001) in favour of calcitriol. Ten treatment-related dermatological events occurred in eight subjects, including one subject who experienced skin discomfort on both sides. All other events occurred only on the calcipotriol-treated side (irritant dermatitis, six subjects; contact dermatitis, one subject). Global assessment of improvement from baseline by the investigators was significantly greater for the calcitriol-treated lesions (P < 0.02). The subjects' global preference was significantly in favour of calcitriol (P < 0.02).. In the present study, calcitriol ointment was found to be better tolerated and would appear to be more effective than calcipotriol ointment in the treatment of psoriasis in sensitive areas.

Topics: Adolescent; Adult; Aged; Axilla; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Tolerance; Ear, External; Edema; Erythema; Facial Dermatoses; Female; Humans; Male; Middle Aged; Ointments; Patient Satisfaction; Psoriasis; Treatment Outcome

Psoriasis is an immunogenetic disorder. Factor XIIIa+ dermal dendrocytes (DD) are part of the pathobiological changes in the plaque type of the disease.. The present study aimed at comparing the effect of 3 vitamin D(3) derivatives on the epidermis, microvasculature and DD in psoriasis.. Twenty men suffering from chronic plaques of psoriasis on the trunk were enrolled in this study. They applied twice a day for 3 weeks calcipotriol, tacalcitol and calcitriol, each to one plaque. Another similar lesion received petrolatum as a placebo treatment. Skin biopsies were taken at entry and at completion of the 3-week treatment phase. Immunohistochemistry was performed using the lectin of Ulex europaeus and an antibody to factor XIIIa. Computerized image analysis served to measure the stratum Malpighii area, the microvasculature area and the DD numerical density in the papillary dermis.. At entry in the study, the 4 test sites were indistinguishable with regard to the stratum Malpighii area, the papillary microvasculature area and the papillary DD density. The 3 histometric parameters appeared correlated with each other. At completion of the 3-week treatment phase, the 3 vitamin D derivatives had decreased the size of the stratum Malpighii. In addition, calcitriol had also reduced the DD density in the papillary dermis. No other significant changes were yielded.. As assessed by histometry, the psoriatic epidermis responded to a short treatment using the 3 vitamin D derivatives. The better result compared to the control site was achieved by calcitriol. DD appeared to be most controlled by the same drug. The microvasculature did not appear to be decreased at the 3-week time point in treatment.

Topics: Adult; Calcitriol; Calcium Channel Agonists; Dermatologic Agents; Dihydroxycholecalciferols; Humans; Male; Psoriasis; Statistics, Nonparametric

Although the use of an oral retinoid as monotherapy is an effective treatment for psoriasis, it is usually used in combination with other topical or systemic therapies including topical corticosteroids, UVB phototherapy, psoralens + UVA (PUVA) chemotherapy and cyclosporine mainly in an effort to reduce or avoid adverse effects.. To compare the efficacy of the calcipotriol + acitretin combination treatment with acitretin alone over a long period in Korean patients with psoriasis.. A randomized, bilateral paired comparison was conducted involving 40 patients with psoriasis who received calcipotriol + acitretin combination therapy and 20 psoriasis patients who received acitretin alone. The initial dose of acitretin was 10 or 20 mg/day. The dose was adjusted at each visit (2, 4 and 6 weeks) in steps of 10mg according to patient responsiveness and adverse effects. The maximum dose was 40 mg/day. The treatment duration for all patients ranged from 4-52 weeks. After 12 weeks, the efficacy of therapy, according to Psoriasis Area and Severity Index scores, was assessed. At the end of the study (52 weeks), we selected patients who had achieved complete clearance and compared the duration of treatment and total dose of acitretin used in both groups.. After 12 weeks, 16 patients (40%) achieved complete clearance in the calcipotriol + acitretin group and 3 patients (15%) in the acitretin monotherapy group (p < 0.05). After 52 weeks, 24 patients (60%) in the calcipotriol + acitretin group and 8 patients (40%) in the acitretin monotherapy group achieved complete clearance. The duration of treatment and total dose of retinoid required to achieve clearance were slightly lower in the calcipotriol + acitretin combination group, however, this was not statistically significant. With the exception of liver enzyme elevation (which affected more patients in the acitretin monotherapy group than in the combination group), adverse effects were not significantly different.. Our results showed that calcipotriol might enhance the clinical outcome of systemic acitretin therapy. More large, well-controlled, long-term studies need to be conducted to determine whether there is indeed a beneficial effect of the addition of calcipotriol to acitretin treatment and whether this effect is maintained over long-term periods.

Topics: Acitretin; Adult; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Female; Humans; Keratolytic Agents; Male; Middle Aged; Psoriasis

Previous studies have demonstrated the ultraviolet (UV)-sparing effect of combining topical calcipotriol with broadband UVB in the treatment of psoriasis.. To determine if the combination of narrowband TL01 UVB phototherapy and topical calcipotriol produces the same UVB-sparing effect.. This was a randomized, placebo-controlled, blinded clinical trial. Fifty psoriasis patients were recruited, 25 of whom were randomized into the active group who received TL01 phototherapy together with twice-daily application of calcipotriol cream 50 microg g(-1). The control group received TL01 phototherapy and twice-daily application of a topical emollient as placebo. TL01 phototherapy was given three times per week starting at 70% minimal erythema dose with 20% increments as tolerated for up to approximately 20 sessions. Patients were assessed using the Psoriasis Area and Severity Index (PASI) and Psoriasis Disability Index (PDI). They were evaluated at treatment sessions 8, 14 and 20, and followed up at 5 and 10 weeks post-treatment. Statistical analysis was performed using a two-tailed t-test.. There were no significant differences in demographic characteristics and baseline PASI and PDI scores between the two groups. The mean PASI score declined significantly (P < 0.01) for both groups after treatment. The difference in mean PASI score reduction from baseline between the two groups was only significant during the first eight sessions, with a net reduction of 3.6 (95% confidence interval 1.0-6.2, P = 0.008) in the active group relative to the control group. The mean PDI score declined significantly (P < 0.05) for both groups, but there was no statistical difference in mean PDI score reduction between the two groups (P = 0.8) at the end of treatment. The mean cumulative UVB dose for the active group was significantly lower (P < 0.02) at 16 204 mJ cm-2 compared with 21 082 mJ cm-2 for the control group.. We conclude that combining TL01 phototherapy with topical calcipotriol cream has a UVB-sparing effect.

Topics: Adult; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Psoriasis; Radiation Dosage; Severity of Illness Index; Treatment Outcome; Ultraviolet Therapy

Recently, a combination product (Daivobet) ointment: calcipotriol 50 micro g/g, betamethasone dipropionate 0.5 mg/g) has been developed for the treatment of psoriasis.. This study aimed to demonstrate that the atrophogenic potential of Daivobet is less or equal to the skin thinning produced by Diprosone (betamethasone dipropionate 0.05 mg/g).. The forearms of 45 subjects were treated with Daivobet and Diprosone or Daivobet and its vehicle twice daily over a 4-week period. Sonographic measurements for full skin thickness, clinical assessments and biopsies were carried out.. A confidence interval approach was used to establish that skin thinning following treatment with Daivobet was equal to or less than thinning with Diprosone. Histological results did not suggest differences between Daivobet and Diprosone. Clinical signs of atrophy or irritation were not observed.. The atrophogenic potential of Daivobet and Diprosone was similar following twice daily application over a 4-week treatment period. Skin irritation was not observed.

Topics: Adult; Atrophy; Betamethasone; Biopsy, Needle; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Ointments; Psoriasis; Skin; Ultrasonography

In a recent pilot study a novel, patented fatty acid-based 1% coal tar preparation (Exorex) has been found to be similar in efficacy to calcipotriol in the treatment of psoriasis.. Our aim was to investigate the therapeutic efficacy, safety and cosmetic acceptability of the new 1% coal tar preparation in comparison with calcipotriol cream in a larger patient cohort.. Forty patients with chronic plaque type psoriasis were included in this randomized, observer-blind, intrapatient comparison trial. In each patient two comparable target plaques were treated twice daily with 1% coal tar preparation or calcipotriol cream. At the onset of therapy and at weeks 2, 4, 6 and 8, the response to treatment was determined by the psoriasis severity index (PSI) that assesses the degree of erythema, infiltration and scaling of the psoriatic lesions on a five-point scale. In addition, all treatment-related side-effects were recorded and cosmetic acceptability of both treatments was rated every second week by the patients. After complete or near complete clearing the patients were followed up until relapse or for a maximum period of 18 months.. Thirty-eight patients completed the study. At termination of the trial the mean +/- SD baseline PSI score of 9.2 +/- 1.5 was reduced to 3.0 +/- 2.9 by 1% coal tar preparation and to 2.8 +/- 2.7 by calcipotriol. The mean PSI reduction between baseline and final assessment did not differ significantly between 1% coal tar preparation and calcipotriol (P = 0.77). The mean intraindividual difference in reduction of PSI score between 1% coal tar preparation and calcipotriol was 0.1 score points (95% confidence interval - 0.84 to + 0.63). No difference between either preparation was observed with regard to time until relapse. Itching was caused by 1% coal tar preparation in four patients and by calcipotriol in one patient. Unpleasant odour or staining of the 1% coal tar preparation was reported by six patients, whereas one patient complained about the smell of the calcipotriol cream.. The novel 1% coal tar preparation was found to be comparably as effective as calcipotriol in treating psoriasis. Tolerability and cosmetic acceptability was better for calcipotriol. Taking into consideration that the coal tar preparation is considerably less expensive than calcipotriol this new product appears as a very useful topical medication for chronic plaque type psoriasis.

Topics: Adult; Calcitriol; Coal Tar; Dermatologic Agents; Fatty Acids, Essential; Female; Follow-Up Studies; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Single-Blind Method; Treatment Outcome

Topics: Calcitriol; Cytochrome P-450 Enzyme System; Dermatologic Agents; Humans; Psoriasis; RNA, Messenger; Skin; Steroid Hydroxylases; Treatment Outcome; Vitamin D3 24-Hydroxylase

Topical therapies are the first line of treatment for patients with stable plaque psoriasis (SPP) affecting a limited body surface area. Very few trials comparing newer agents, such as 0.005% topical calcipotriol, with conventional modes of therapy, such as coal tar ointment, have been reported.. A prospective, right-left randomized, investigator-blinded study with a 12-week treatment period and an 8-week follow-up period was performed. Thirty-six patients with nearly bilaterally symmetrical SPP lesions on the limbs were instructed to apply 5% coal tar ointment overnight on one side once daily and 0.005% calcipotriol ointment on the other side twice a day. All patients were advised to expose both sides to the sun for 2 h every day. Psoriatic lesions and progress during treatment were evaluated using the severity (0-3) scale of erythema, scaling and induration (ESI score). Evaluation was carried out every 2 weeks during the treatment period and monthly during follow-up. At the end of 12 weeks, patients with > 75% reduction in the ESI score were considered to be markedly improved, those with 51-75% reduction to be moderately improved, those with 26-50% reduction to be minimally improved and those with < 25% to be non-responders. Self-assessment by the patients regarding the efficacy and acceptability of the two modalities was on a five-point scale. Serum calcium, serum phosphate, total and differential serum proteins, 24-h urinary calcium and phosphate were monitored both at baseline and after completion of therapy.. Thirty of the 36 recruited patients completed the study. The difference in clinical response between the two sides was statistically significant at 4, 6 and 8 weeks, with the percentage reduction in ESI score with calcipotriol being 65.7 +/- 12.2% compared with 45.8 +/- 16.6% with coal tar at 8 weeks (P < 0.01, t = 6.4). However, the difference in clinical response at 10 and 12 weeks between the two sides was not significant, with a mean reduction of 71.9 +/- 13.3% in ESI score on the calcipotriol-treated side compared with 69.4 +/- 15.4% with coal tar ointment (P > 0.05). In the follow-up period of 8 weeks, recurrence of lesions was noted in 10% of patients treated with calcipotriol compared with 16.7% in those treated with coal tar after an average period of 6 +/- 1.2 and 5 +/- 1.3 weeks, respectively (P > 0.05).. It was found that 0.005% calcipotriol ointment produced a faster initial response and had better cosmetic acceptability in patients, although after a long period of treatment, i.e. 12 weeks, 5% coal tar ointment had comparable efficacy. There was no statistically significant difference in the relapse rates between the two modalities.

Topics: Administration, Topical; Adolescent; Adult; Calcitriol; Coal Tar; Dermatologic Agents; Drug Administration Schedule; Esthetics; Female; Humans; Keratolytic Agents; Male; Middle Aged; Ointment Bases; Patient Satisfaction; Prospective Studies; Psoriasis; Recurrence; Severity of Illness Index; Time Factors; Treatment Outcome

To investigate if there is a synergy between the presence of the Malassezia yeasts and the adverse reaction during treatment of scalp psoriasis with calcipotriol scalp solution, patients were treated with itraconazole to reduce the number of Malassezia yeasts. This study was a double-blind, placebo-controlled parallel group study between oral itraconazole or placebo for 8 weeks in patients with scalp psoriasis. After 2 weeks, calcipotriol scalp solution was applied twice daily for 6 weeks. Altogether 137 patients, 67 in the itraconazole group and 70 in the placebo group, comprised the intention-to-treat population. There were 13 (19.4%) patients with local skin irritation in the itraconazole group compared to 33 (47.1%) in the placebo group (p < 0.001). The skin irritation was significantly lower in patients with a low number of cultured Malassezia yeasts (p = 0.017). Thus, when Malasessia was eliminated or the numbers reduced, the irritation produced by calcipotriol was significantly diminished.

Topics: Administration, Oral; Administration, Topical; Adolescent; Adult; Aged; Calcitriol; Dermatomycoses; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug Synergism; Female; Follow-Up Studies; History, 18th Century; Humans; Itraconazole; Logistic Models; Malassezia; Male; Middle Aged; Probability; Psoriasis; Risk Assessment; Scalp Dermatoses; Severity of Illness Index; Treatment Outcome

Psoriasis is a multifactorial, chronically relapsing, inflammatory skin disease occurring in 1-3% of the world's population. Vitamin D3 analogs have effects on proliferation and differentiation, as well as on the infiltration and activation of neutrophils and immunocytes in psoriatic skin lesions. This study aims to assess the efficacy and safety of topical calcipotriol and to compare ointment and cream formulations in the treatment of psoriasis vulgaris. A total of 41 patients with mild to moderate psoriasis vulgaris (18 men and 23 women aged between 5 and 63 years) were enrolled in the study. Each patient was instructed to apply the treatment twice daily over the psoriatic lesions. Routine blood tests and serum calcium were performed prior to and at the end of treatment. Treatment assessment was carried out on weeks 2, 4 and 6 and was based on the Psoriasis Area and Severity Index (PASI) score. Of the 41 patients included in our study, only 29 completed the treatment course. Their PASI before treatment ranged from 1.2 to 43 (mean: 12.1). Both groups, calcipotriol 50 microg/g ointment (11 patients) and calcipotriol 50 microg/g cream (18 patients) showed time-dependent improvement and after 6 weeks there was excellent improvement with a marked reduction in the total mean PASI from 12.1 to 1.02. There was a significant reduction of PASI in the ointment group in comparison with the cream group (mean PASI from 12.7 to 0.8 and 11.1 to 1.15, respectively). No significant adverse effects were observed in either group, except for mild irritation in a few patients in the calcipotriol cream group. In conclusion, calcipotriol was effective, safe and well tolerated in the treatment of psoriasis vulgaris and better results were observed with the ointment formulation. Longer treatment courses could be advised.

Topics: Administration, Topical; Adolescent; Adult; Calcitriol; Chemistry, Pharmaceutical; Child; Child, Preschool; Dermatologic Agents; Female; Humans; Male; Middle Aged; Ointments; Psoriasis; Treatment Outcome

In patients with psoriasis, 2-6% suffer from flexural psoriasis. Areas where flexural psoriasis is found are the axillae, groin, submammary region, perianal region, and retroauricular fold. Eleven patients with flexural psoriasis were enrolled in this study: six men and five women, aged between 5 and 55 years. All patients had common psoriasis presented with psoriatic lesions involving the axillae, groin and submammary region. Each patient was instructed to apply calcipotriol 50 microg/gm twice daily for 6 weeks. The treatment assessment, based on changes in erythema, scaling and thickness scores, was carried out at 2, 4 and 6 weeks. The overall assessment of our cases in this study showed a marked and significant improvement in the treated intertriginous areas. The mean scores of erythema, scaling and thickness before treatment were 2.7, 2.3 and 2.5, respectively. There was a marked and dramatic improvement in seven patients (63.6%) within the first 2 weeks in which the response was more significant than other nonintertriginous psoriatic lesions. At the end of treatment, 10 patients (91%) showed complete clearance, and the mean scores were reduced to 0. One patient showed only moderate improvement. No significant adverse effect was reported. In conclusion, calcipotriol cream is effective, safe and well tolerated in the treatment of flexural psoriasis. Because tar preparations and anthralin are irritants and potent steroids are absorbed more in these areas, calcipotriol cream could be a better choice for the treatment of these cases.

Topics: Adolescent; Adult; Calcitriol; Child; Child, Preschool; Dermatologic Agents; Dosage Forms; Female; Humans; Male; Middle Aged; Psoriasis; Treatment Outcome

In this study, we compared a new combination ointment containing both calcipotriol and betamethasone dipropionate with betamethasone dipropionate ointment (Diprosone) and calcipotriol ointment (Daivonex) in patients with psoriasis vulgaris; 1106 patients were randomized to twice daily double-blind treatment with combination, betamethasone dipropionate or calcipotriol for 4 weeks. Patients then received twice daily calcipotriol, unblinded, for a further 4 weeks. Mean percentage change in PASI at end of the double-blind phase was -74.4 (combination group), -61.3 (betamethasone group) and -55.3 (calcipotriol group). Mean difference (95% Cl) combination-betamethasone was -13.1 (-16.9 to -9.3, p < 0.001) and for combination-calcipotriol -19.0 (-22.8 to -15.2, p <0.001). The differences in PASI were also statistically significant after 1 week. In the double-blind phase, 8.1% of patients (combination) reported lesional/ perilesional adverse reactions compared to 4.7% (betamethasone) and 12.0% (calcipotriol). In the combination group, mean PASI at the end of the double-blind phase was 2.5, and at end of the unblinded phase 3.6, compared with 3.9 and 4.1 (betamethasone) and 4.4 and 3.7 (calcipotriol). Calcipotriol/betamethasone combination is more effective and has a more rapid onset of action than either active constituent used alone, and is well tolerated. It is safe to transfer patients from combination to calcipotriol, with maintenance of clinical effect.

Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Glucocorticoids; Humans; Male; Middle Aged; Ointments; Psoriasis

Topics: Administration, Topical; Anti-Inflammatory Agents; Calcitriol; Clobetasol; Dermatologic Agents; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Nail Diseases; Ointments; Psoriasis

Calcipotriol is an established topical therapy for psoriasis vulgaris.. This study aimed to investigate whether the addition of calcipotriol to fumaric acid ester (FAE) monotherapy had an additive efficacy and an FAE-sparing effect in patients with severe plaque psoriasis.. This multicentre, randomised, double-blind, vehicle-controlled study included 143 patients for up to 13 weeks treatment. Group A received FAE tablets (Fumaderm) with an increasing daily dosage from 105 to 1,075 mg + ointment vehicle. Group B received FAE tablets + calcipotriol ointment (50 microg/g). Ointments were applied twice daily. Clinical response was assessed using percentage changes in the Psoriasis Area and Severity Index (PASI), from baseline to treatment end.. The mean percentage change in the PASI was -76.1% in group B and -51.9% in group A, the difference between treatments was -24.2% (95% CI from -34.2 to -14.2%; p < 0.001). Group B responded more rapidly to treatment. Investigators' and patients' overall efficacy assessments were significantly more favourable for group B (p < or = 0.001). Group B was prescribed less FAE than group A. This difference was greatest at the last visit (mean daily dose 529 and 685 mg, respectively; p = 0.006). Overall adverse events in the two groups were similar.. This study shows that the combination of calcipotriol and FAEs is significantly more effective and faster acting than FAE monotherapy in the treatment of severe plaque psoriasis. The combination has a slight FEA-sparing effect and therefore a superior benefit/risk ratio.

Topics: Administration, Oral; Administration, Topical; Adult; Calcitriol; Chronic Disease; Dermatologic Agents; Dimethyl Fumarate; Double-Blind Method; Drug Therapy, Combination; Female; Fumarates; Humans; Male; Prospective Studies; Psoriasis

Calcipotriol and betamethasone dipropionate are both widely used, effective treatments for psoriasis. Vitamin D analogues and topical corticosteroids have different mechanisms of action in the treatment of psoriasis. A new vehicle has been developed in order to contain both calcipotriol (50 micro g g-1) and betamethasone dipropionate (0.5 mg g-1) in an ointment form. By using calcipotriol and a corticosteroid together, greater efficacy may be achieved than by using either compound alone.. The present study was conducted in order to compare the clinical efficacy and safety of the combined ointment formulation used once daily with the vehicle ointment used twice daily, calcipotriol ointment used twice daily and the combined formulation used twice daily in psoriasis vulgaris.. This was an international, multicentre, prospective, randomized, double-blind, vehicle-controlled, parallel group, 4-week study in patients with psoriasis vulgaris amenable to topical treatment. Patients were randomized to one of four treatment groups: combined formulation once daily, combined formulation twice daily, calcipotriol twice daily or vehicle twice daily. Efficacy and safety were assessed.. There was no statistically significant difference in the mean percentage change in the Psoriasis Area and Severity Index (PASI) from baseline to end of treatment between the two combined formulation groups, but the difference in PASI reduction was significantly higher in the combined formulation groups (68.6% once daily, 73.8% twice daily) than in both the twice daily calcipotriol group (58.8%) and the vehicle group (26.6%). Safety data showed the frequency of adverse events to be less in the combined formulation groups than in both the calcipotriol group and the vehicle group. The proportion of patients with lesional/perilesional adverse reactions was less in the combined formulation groups and vehicle group than in the calcipotriol group (9.9% combined formulation once daily, 10.6% combined formulation twice daily, 19.8% calcipotriol, 12.5% vehicle).. No statistically significant nor clinically relevant difference in efficacy was seen between the combined formulation used once daily and twice daily. When compared to vehicle ointment or calcipotriol ointment alone, the combined formulation was shown to be clearly more efficacious.

Topics: Adolescent; Adult; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Ointments; Prospective Studies; Psoriasis

The successful use of narrow-band ultraviolet B (UVB) phototherapy for the management of psoriasis has prompted the examination of various combination treatments with narrow-band UVB. However, there have been contradictory reports on the effect of the calcipotriol-narrow-band UVB combination. This study was performed to compare the clinical efficacy of the calcipotriol-narrow-band UVB combination with narrow-band UVB alone.. Of the 28 psoriasis patients, 10 were treated with the calcipotriol-narrow-band UVB and 18 with narrow-band UVB alone. Phototherapy was done once daily three times a week and the dose was gradually increased in a stepwise fashion by 0.05 J/cm2. At the end of therapy, overall efficacy was classified according to the chosen grading system.. On assessing the therapeutic results using the criteria selected, 90.0% patients (n = 9) in the calcipotriol-narrow-band UVB group and 61.1% patients (n = 11) in the narrow-band UVB group showed grade IV at the end of therapy. The calcipotriol-narrow-band UVB group showed more rapid improvement at the early stage. The final and total UVB dose were slightly lower in the calcipotriol-narrow-band UVB group but no significant difference was observed with respect to the total number of irradiations, duration of treatment, final UVB dose or total cumulative UVB dose required to reach grade IV in both groups (P > 0.05). The pattern of adverse effects was similar in both groups with a slightly higher frequency in the calcipotriol-narrow-band UVB group.. Our results demonstrated that the total cumulative UVB dose required to reach grade IV was not significantly different in both groups, although it was slightly lower in the calcipotriol-narrow-band UVB group. However, a higher percentage of patients attained grade IV at the end of therapy in the combination group and this therapy was more effective in reducing the Psoriasis Area and Severity Index early in treatment. More studies are warranted to confirm these results.

Topics: Administration, Cutaneous; Adult; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Female; Humans; Male; Phototherapy; Psoriasis; Severity of Illness Index; Statistics, Nonparametric; Treatment Outcome; Ultraviolet Rays

Topical corticosteroids and calcipotriol have been used separately for many years to treat psoriasis. A new combination ointment has been formulated, which contains both calcipotriol and the corticosteroid betamethasone dipropionate.. To compare the combination ointment with betamethasone dipropionate ointment, calcipotriol ointment and ointment vehicle in patients with psoriasis vulgaris.. 1,603 patients were randomised to one of the 4 double-blind treatments used once daily for 4 weeks.. The mean percentage change in the PASI at the end of treatment was -71.3 (combination), -57.2 (betamethasone), -46.1 (calcipotriol) and -22.7 (vehicle). The mean difference of combination minus betamethasone was -14.2 (95% CI: -17.6 to -10.8, p < 0.001), of combination minus calcipotriol -25.3 (95% CI: -28.7 to -21.9, p < 0.001) and of combination minus vehicle -48.3 (95% CI: -53.2 to -43.4, p < 0.001). 6.0% of patients (combination) reported local adverse reactions compared to 4.9% (betamethasone), 11.4% (calcipotriol) and 13.6% (vehicle).. Calcipotriol/betamethasone dipropionate combination ointment used once daily is well tolerated and more effective than either active constituent used alone.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Female; Follow-Up Studies; Humans; Male; Middle Aged; Ointments; Patient Satisfaction; Psoriasis; Reference Values; Severity of Illness Index; Sweden; Treatment Outcome

Psoralen plus UVA (PUVA) light is a very effective and widely used monotherapy for psoriasis. However, it is associated with cumulative long-term risks, including premature cutaneous aging and skin cancers. Several studies have shown that the addition of calcipotriene ointment to PUVA radiation has a UVA-sparing effect, clearing psoriatic lesions sooner with lower cumulative doses of UVA radiation compared with doses of PUVA radiation alone. A recently completed multicenter study in Spain demonstrated that the use of calcipotriene cream plus PUVA radiation was also safe and effective for the treatment of plaque psoriasis, achieving results that were similar to those obtained with calcipotriene ointment plus PUVA radiation. Because creams are cosmetically more acceptable and less likely to stain, patients may prefer calcipotriene cream formulations. When used in conjunction with PUVA radiation, calcipotriene should be applied after the UVA radiation treatment because standard doses of UVA radiation have been shown to inactivate calcipotriene.

Topics: Calcitriol; Combined Modality Therapy; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Ointments; Psoriasis; PUVA Therapy; Spain; Treatment Outcome

In the vast majority of psoriatic patients, psoriatic lesions are localised on the body as well as on the scalp. Therefore, safety data on the combined use of calcipotriol in lotion and calcipotriol in ointment are needed.. This study investigated the effect of high-dose treatment with a combination of calcipotriol ointment and scalp solution on calcium metabolism, indices of bone turnover and PASI in patients with extensive psoriasis.. Following a 2-week wash-out period, 88 patients were randomised to 4 weeks of treatment with either calcipotriol ointment/scalp solution (80-100 g/week and 30-50 ml/week, respectively; n = 41) or with a dithranol/tar regimen (n = 47). Patients were seen at weeks 1, 2 and 4 during treatment and 1 week following cessation of treatment.. No significant differences at the end of treatment were found between the 2 groups with respect to 24-hour urinary excretion of calcium (expressed as calcium/creatinine ratio), phosphate or pyridinoline, serum concentrations of calcium (albumin corrected), creatinine, phosphate, parathyroid hormone, 25-hydroxyvitamin D(3), 1,25-dihydroxyvitamin D(3), osteocalcin, alkaline phosphatase (total and bone-specific iso-enzymes) or 1-collagen telopeptide. At the end of treatment, the psoriasis area and severity index had decreased by 57.4% in the calcipotriol group and by 36.1% in the dithranol/tar group (p = 0.004). Investigators' and patients' assessments of overall efficacy also favoured treatment with calcipotriol (p < 0.001).. The combined use of calcipotriol ointment/scalp solution did not affect the indices of calcium metabolism or bone turnover and was significantly more effective than dithranol/tar in reducing disease severity and extent in patients with extensive psoriasis.

Topics: Administration, Topical; Adult; Aged; Analysis of Variance; Anthralin; Calcitriol; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Middle Aged; Ointments; Probability; Psoriasis; Severity of Illness Index; Solutions; Treatment Outcome

Retinoids like tazarotene are approved for the treatment of chronic plaque psoriasis. In the beginning of topical retinoid therapy, 15-20% of the patients suffer from mild to moderate adverse reactions with burning and erythema. The aim of the study was to find predicative parameters of the individual irritative potential and to suggest options to reduce these initial irritations.. Twenty in-patients with different skin types (1 + 2: 11, 3 + 4: 9), with chronic plaque psoriasis were included in this open study. In each patient, 7 randomized plaques on the forearm were treated for 14 days on different ways: test area 1: morning (m) and evening (e) placebo, test area 2: placebo (m) and tazarotene 0.05% (e), test area 3: placebo (m) and tazarotene 0.1% (e), test area 4: calcipotriol (m) and calcípotriol (e), test area 5: mometasone furoate (m) and tazarotene 0.05% (e), test area 6: mometasone furoate (m) and tazarotene 0,1% (e), test area 7: placebo (m) and tazarotene in increasing concentrations (e), test area 8: healthy skin for control. Before and after therapy, skin barrier function, blood flow and plaque thickness in 20-MHz sonography were assessed in different test areas intraindividually by non- invasive biophysical measurements.. After 14 days of therapy, tazarotene 0.05% and 0.1% produced a stronger increase of laser Doppler flow in patients with skin type 1 and 2 than in patients with skin type 3 and 4. When using the combination therapy of tazarotene and mometasone, the laser Doppler flow was significantly lower than in tazarotene as monotherapy. 20-MHz-ultrasound showed a significant decrease in the thickness of the echo-poor band in all topical therapy regimens compared to placebo. Patients of skin type 1 and 2 reached a higher density of the dermis than patients of skin type 3 and 4, meaning a stronger decrease of inflammatory infiltration and acanthosis.. Adapting retinoid therapy to the patient's skin type can reduce the initial irritative side-effects. During the first days, patients with skin type 1 or 2 should add a medium potency corticosteroid. Stronger skin irritation caused by tazarotene therapy increases therapy effects.

Topics: Administration, Cutaneous; Adult; Calcitriol; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Forearm; Humans; Irritants; Male; Mometasone Furoate; Nicotinic Acids; Pregnadienediols; Psoriasis; Reproducibility of Results; Retinoids; Sensitivity and Specificity; Skin; Water Loss, Insensible

Both calcipotriene and tazarotene have been shown to be effective in the treatment of psoriasis. No study has evaluated the effect of using both agents simultaneously.. Our purpose was to evaluate the effectiveness of combination treatment of psoriasis with calcipotriene ointment and tazarotene gel by comparing them with clobetasol ointment, a class I topical corticosteroid. A secondary objective was to evaluate the clinical compatibility of applying both agents at the same time.. This pilot study was a prospective, single-center, open-label, right/left comparison of 28 lesion pairs in 15 patients. It consisted of a 2-week treatment phase, followed by a 4-week post-treatment observation phase.. All 15 patients completed the treatment phase of the study. At the end of the active treatment phase (end of week 2), calcipotriene- and tazarotene-treated lesions showed nearly identical reductions in scaling (P =.93), plaque elevation (P =.76), and overall lesional severity scores (P =.29) compared with their matched clobetasol-treated counterparts. Erythema improved significantly more in clobetasol-treated lesions (P <.05) during the treatment period, but differences became statistically insignificant during the post-treatment period (;P =.20). No patients had significant irritation from the treatments. During the post-treatment phase (weeks 3-6), all lesions worsened; plaque elevation returned somewhat more rapidly in calcipotriene- and tazarotene-treated lesions (P <.01), whereas changes in scaling, erythema, and overall lesional severity were not significantly different between the two treatment groups (P >.05).. The nonsteroid combination of twice-daily calcipotriene ointment and once-daily tazarotene gel was not statistically different from twice-daily application of the class I corticosteroid clobetasol ointment in reducing psoriatic scaling, plaque elevation, and overall lesional severity over a 2-week period. There does not seem to be any chemical incompatibility between calcipotriene ointment and tazarotene gel that is clinically significant.

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Arm; Calcitriol; Clobetasol; Dermatologic Agents; Drug Synergism; Drug Therapy, Combination; Elbow; Female; Gels; Glucocorticoids; Humans; Leg; Male; Nicotinic Acids; Ointments; Pilot Projects; Prospective Studies; Psoriasis; Severity of Illness Index; Thorax; Treatment Outcome

Conflicting results have been reported on the association between BsmI restriction fragment length polymorphism (RFLP) at the vitamin D receptor gene (VDR) locus and the clinical response of psoriasis patients to calcitriol or calcipotriol therapy. We evaluated RFLPs of the VDR gene by analyzing the restriction pattern of polymerase chain reaction products in 55 Korean psoriasis patients receiving topical calcipotriol therapy, and evaluated the clinical response. Of the 55 patients, 43 completed the 8-week treatment protocol, and the response was evaluated as excellent in 9 patients, good in 20, and poor in 14. Thus, in our 43 patients BsmI and ApaI polymorphism in the VDR gene did not correlate with response to calcipotriol. The marked predominance of the b allele in the Korean population precludes the possibility that BsmI polymorphism is associated with clinical response to calcipotriol. The pattern of prevalence of the VDR genotypes in the Korean population is very different from that in Western populations. There were no differences in VDR genotype between controls and psoriasis patients at the BsmI site, but there were significant difference in terms of ApaI RFLP as previously reported. In conclusion, polymorphism analysis of the VDR gene with BsmI and ApaI restriction enzymes in psoriasis patients was not helpful in predicting clinical response to calcipotriol.

Topics: Adolescent; Adult; Aged; Calcitriol; Dermatologic Agents; Female; Genotype; Humans; Korea; Male; Middle Aged; Polymorphism, Restriction Fragment Length; Psoriasis; Receptors, Calcitriol; Treatment Outcome

The high prevalence and chronic nature of psoriasis leads to high costs in relation to the treatment and control of the disease. A number of clinical trials have shown that a combination therapy of calcipotriol cream (Daivonex/Dovonex), Leo Pharmaceutical Products) and ultraviolet B phototherapy (UVB) decreases the total number of UVB exposures required compared to UVB treatment alone. From a societal point of view, the addition of calcipotriol to UVB therapy could achieve cost savings due to the fewer UVB treatments needed and the reduced travelling and time off work for patients. Fewer UVB exposures may also have other beneficial effects, i.e., shortened waiting lists and less risk to patients of developing cancer or photoaging of the skin.. To compare the cost-effectiveness of treating psoriatic patients in the Netherlands with calcipotriol cream used daily combined with twice weekly UVB treatments to emollient used daily combined with UVB given 3 times weekly.. Based on the clinical results from a Canadian trial, a decision-analytical model was constructed to simulate treatment outcomes and estimate the costs of managing psoriatic patients in the Netherlands over a period of 20 weeks from initiation of therapy. Unit costs and details of standard treatment protocols were collected from Dutch dermatology centres in hospitals and the community for use in the model. Other therapies, such as topical corticosteroids, tar or dithranol were not investigated in this analysis.. The total cost of managing psoriatic patients in the Netherlands over a 20-week period is estimated as EUR 1,175.90 for those treated with calcipotriol and UVB and EUR 1,212.14 for patients treated with emollient and UVB. Thus, the former treatment, adding calcipotriol to UVB phototherapy, provides a minor cost saving of EUR 36.24 (3%) compared to the cost of UVB treatment alone. Sensitivity analyses demonstrated that these results are sensitive to changes in the cost of UVB treatment.. Calcipotriol treatment combined with UVB phototherapy is a cost-neutral alternative to UVB phototherapy used with an emollient. The patients achieve treatment success in the same time on both treatments but the former, with calcipotriol, requires less exposure to UVB radiation. The additional drug costs from using calcipotriol are offset by savings from the fewer UVB sessions required. Essential beneficial effects for patients are less inconvenience, less risk of developing photoaging of the skin and less exposure to potentially carcinogenic radiations.

Topics: Calcitriol; Combined Modality Therapy; Cost-Benefit Analysis; Economics, Pharmaceutical; Humans; Markov Chains; Netherlands; Psoriasis; Skin; Time Factors; Treatment Outcome; Ultraviolet Therapy

Thirty-nine patients with a clinical diagnosis of palmoplantar psoriasis [23 (58%) males and 16 (42%) females] were included in this study with the aim of evaluating the efficacy of occlusive calcipotriol 50 micrograms/mg ointment vs. nonocclusive therapy. Patients were randomized to either twice-weekly overnight calcipotriol ointment under occlusion or twice-daily topical nonocclusive application of the same ointment for 6 weeks. The effect of treatment was assessed on the basis of a psoriasis signs score for erythema, thickness and scaliness, which was graded from 0 (absent) to 4 (most severe) at the first visit, after 2 weeks and at the end of treatment. Analysis of our results showed that twice-weekly occlusive calcipotriol ointment was as effective as the twice-daily application. The mean total score at baseline was 6 for the occlusive group and 6.1 for the nonocclusive group. The score decreased to 1.5 in both groups at the end of treatment. No significant adverse effects were reported by patients or investigators. We conclude that occlusive calcipotriol ointment is effective in the treatment of palmoplantar psoriasis and may produce even better results with more frequent use, such as application on alternate days.

Topics: Administration, Topical; Adult; Calcitriol; Dermatologic Agents; Female; Foot Dermatoses; Hand Dermatoses; Humans; Male; Matched-Pair Analysis; Occlusive Dressings; Ointments; Psoriasis; Time Factors

This study was a left-right comparison of the efficacy of 0.005% calcipotriol ointment and 5% coal tar ointment in conjunction with sun exposure in 10 patients with stable plaque psoriasis. After four weeks of therapy, the calcipotriol treated site showed a significantly faster fall in PASI compared to the coal tar treated site. At eight weeks, this difference was not significant with both sides showing comparable improvement in lesions, as shown by PASI values. There were no significant side effects from either therapy. We conclude that both calcipotriol and coal tar ointments have comparable efficacy in treating stable plaque psoriasis when used simultaneously with sun exposure, although the initial response to calcipotriol is faster.

Topics: Administration, Topical; Adult; Aged; Calcitriol; Chronic Disease; Coal Tar; Combined Modality Therapy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Pilot Projects; Psoriasis; Treatment Outcome; Ultraviolet Rays

There are already many effective topical therapies available for use in the treatment of chronic plaque psoriasis. Unfortunately, these treatments are often associated with a rather significant risk of undesirable effects.. In this randomized, prospective clinical trial, the effects of the vitamin D(3) analog calcipotriol were evaluated against those of a recently developed vitamin B(12) cream containing avocado oil in an intraindividual right/left-side comparison. The trial population consisted of 13 patients, 10 men and 3 women, with chronic plaque psoriasis. The observation period was 12 weeks; the effects of therapy were assessed on the basis of a PASI score adapted to the right/left-side comparison technique, the subjective evaluations of the investigator and patients and the results of 20-MHz sonography.. There was a more rapid development of beneficial effects with the use of calcipotriol in the initial 8 weeks, although differences in effects were significant only at the time point of therapy week 8 (p < 0.05). After 12 weeks, neither the PASI score nor 20-MHz sonography showed significant differences between the two treatments. While the efficacy of the calcipotriol preparation reached a maximum in the first 4 weeks and then began to subside, the effects of the vitamin B(12) cream containing avocado oil remained at a constant level over the whole observation period. This would indicate that the vitamin B(12) preparation containing avocado oil may be suitable for use in long-term therapy, a hypothesis further supported by the fact that the investigator and the patients assessed the tolerability of the vitamin B(12) cream containing avocado oil as significantly better in comparison with that of calcipotriol.. The results of this clinical trial provide evidence that the recently developed vitamin B(12) cream containing avocado oil has considerable potential as a well-tolerated, long-term topical therapy of psoriasis.

Topics: Adult; Aged; Calcitriol; Dermatologic Agents; Female; Humans; Male; Middle Aged; Ointments; Persea; Phytotherapy; Plant Oils; Prospective Studies; Pruritus; Psoriasis; Severity of Illness Index; Skin; Time Factors; Treatment Outcome; Ultrasonography; Vitamin B 12

Calcipotriol and corticosteroids are established topical antipsoriatics. Previous studies have shown that combined therapy with calcipotriol and betamethasone dipropionate was more effective than monotherapy. In the present study, a recently developed combination product of calcipotriol and betamethasone dipropionate was compared with both monotherapies and the vehicle.. Twenty-five psoriatic patients were treated twice daily with the combination product, monotherapy or vehicle during 4 weeks. Skin biopsies, taken before and after treatment, were analysed using a multi-parameter flow cytometric method. Parameters of inflammation (vimentin-positive cells), normal differentiation (keratin-10-positive cells) and proliferation (cells in SG(2)M-phase) were assessed.. Flow cytometric analysis showed that the combination product turned out to be more effective in reducing inflammation compared with the other treatments. Restoration of normal differentiation was more advanced in patients treated with the combination product or betamethasone dipropionate compared to the vehicle. The highest number of normally differentiated cells was seen after use of the combination product. All treatments, except for the vehicle, decreased hyperproliferation. CONCLUSIONS This study shows that the combination product is a valuable new approach to the treatment of psoriasis.

Topics: Adult; Aged; Betamethasone; Calcitriol; Cell Cycle; Cell Division; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Flow Cytometry; Humans; Keratin-10; Keratins; Male; Middle Aged; Psoriasis; Skin; Vimentin

Psoriasis of the scalp is a very common disease, cosmetically disturbing and therapeutically difficult to manage.. The aim of our study was to investigate the efficacy, safety and cosmetic acceptance of calcipotriol solution in a large number of patients with mild to moderate scalp psoriasis and to compare this treatment with previous therapies used.. In this multicentre prospective observational cohort study 3,396 patients were treated with calcipotriol solution (50 microg/ml) twice daily over an 8-week period either alone or in combination with other treatments. The psoriasis scalp severity index (PSSI) and investigator/patient global assessment were used for the evaluation of clinical response.. All psoriasis severity parameters measured were reduced with a significant decrease in PSSI scores from 18.4 to 5.6 after 8 weeks of therapy (p < 0.001). About 80% of the patients showed very good or good clinical improvement. Combination of calcipotriol solution with other treatment modalities e.g. corticosteroids or salicylic acid, showed an increased treatment response. In only 2.4% of the patients side effects occurred (e.g. irritation).. Calcipotriol solution is an effective, safe, well-tolerated and cosmetically acceptable treatment modality. By patients and physicians, this treatment was found to be a valuable supplement to previously available and established treatments for scalp psoriasis.

Topics: Adult; Calcitriol; Cohort Studies; Combined Modality Therapy; Dermatologic Agents; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prospective Studies; Pruritus; Psoriasis; Salicylic Acid; Scalp Dermatoses; Severity of Illness Index; Skin; Solutions; Treatment Outcome; Ultraviolet Therapy

Calcipotriol has been combined with a number of systemic antipsoriatric treatments, improving efficacy or reducing the systemic treatment required. Although studies on calcipotriol and UVB have also been performed, there are no data on the UVB-saving effect of calcipotriol combined with broad-band UVB to reduce overall UVB exposure, while maintaining efficacy.. To assess the efficacy and safety of calcipotriol cream (50 microg/g) combined with twice weekly broad-band UVB and to determine if this treatment would require fewer UVB treatments and lower cumulative UVB irradiance when compared to a standard 3 times weekly broad-band UVB regime in patients with extensive psoriasis.. This multicentre, prospective, randomised, parallel-group, vehicle-controlled, single-blind (investigator) study consisted of a 1-week wash-out phase, 12-week treatment phase and 12-week follow-up phase. Broad-band UVB equipment was standardised and calibrated prior to the study. The UVB starting dose was based on the patient's minimal erythema dose. Assessments included PASI, extent, severity and investigator and patient's overall assessments of the psoriasis.. Fewer exposures (12 vs. 19) and less cumulative UVB irradiance (1,570 vs. 5,430 mJ/cm(2)) were required by the calcipotriol + twice weekly UVB group to achieve 80% reduction in PASI (p < 0.001). Similarly, fewer exposures (22 vs. 25) and less cumulative UVB irradiance (4,147 vs. 9,670 mJ/cm(2)) were required by this group to achieve total clearance (p < 0.001). There was no difference in the PASI, patient's and investigator's overall assessments and number of adverse events recorded by either group for both the treatment and follow-up phases.. Calcipotriol cream + twice weekly broad-band UVB phototherapy is an effective and safe antipsoriatric treatment, resulting in fewer UVB exposures, lower cumulative irradiance and a saving of time.

Topics: Adult; Aged; Aged, 80 and over; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Dose-Response Relationship, Radiation; Erythema; Female; Follow-Up Studies; Humans; Male; Middle Aged; Ointments; Patient Compliance; Prospective Studies; Pruritus; Psoriasis; Radiotherapy Dosage; Severity of Illness Index; Single-Blind Method; Sunburn; Treatment Outcome; Ultraviolet Therapy

Hydrocolloid (HCD) dressings enhance the efficacy of topical corticosteroids.. We wanted to evaluate the effect of calcipotriol ointment under an HCD dressing in the treatment of psoriatic plaques.. In 9 psoriatic patients, we cleared one plaque using this approach and took biopsies at start, clearance and relapse. Clinical and immunohistochemical validation was assessed.. After an average treatment of 3.6 weeks, each lesion had cleared (apart from some residual erythema). The average remission period was 8 weeks. During this treatment, the number of cycling epidermal cells (Ki-67-positive nuclei) and the expression of keratin 14 and keratin 16 had decreased substantially. In biopsies taken from the skin immediately adjacent to the relapsing lesion, these markers remained reduced which indicated the prolonged effect of calcipotriol on epidermal differentiation.. It is speculated that combination therapy of calcipotriol with treatments with a different mode of action such as photo(chemo)therapy, corticosteroids and cyclosporine might be worthwhile.

Topics: Adult; Aged; Antigens, Nuclear; Apoptosis; Calcitriol; Colloids; Dermatitis, Irritant; Dermatologic Agents; ErbB Receptors; Female; Humans; Immunohistochemistry; In Situ Nick-End Labeling; Keratin-14; Keratins; Ki-67 Antigen; Male; Middle Aged; Nuclear Proteins; Occlusive Dressings; Ointments; Patient Dropouts; Psoriasis; Skin; Treatment Outcome

Topical corticosteroids, commonly used for psoriasis, show diminished response on continuous use.. We tested efficacy of topical corticosteroid and calcipotriene used on alternate weeks versus daily corticosteroid in patients with psoriasis.. In a randomized, observer-blind design, the experimental group of 25 patients with stable plaque psoriasis received augmented betamethasone dipropionate 0.05% cream once daily in the first and third weeks and calcipotriene 0.005% ointment twice daily in the second and fourth weeks. The control group of 27 patients received augmented betamethasone once daily for 4 weeks.. The experimental regimen was more effective than the control regimen as evidenced by (1) more patients with at least a 90% reduction in Psoriasis Area and Severity Index (PASI) score (difference 49.5%, 95% confidence interval [CI], 26.1%-72.9%, P <. 001), (2) lower PASI after 2 weeks (P < or =.04), and (3) greater percentage reduction in PASI after 2 and 4 weeks (difference 23.1% [CI, 11.1%-35.1%] and 46.4% [28.9%-63.8%], respectively; P <.001). The study had power of 93.7%. No patient had skin irritation.. Use of augmented betamethasone and calcipotriene on alternate weeks is more effective than daily corticosteroid and represents a novel strategy for treating psoriasis.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Female; Glucocorticoids; Humans; Male; Middle Aged; Psoriasis; Single-Blind Method; Treatment Outcome

Assessment of patient preference for antipsoriatic treatment with calcipotriol ointment or short-contact dithranol cream.. Two hundred and fifty-eight psoriatic patients treated with calcipotriol (n = 138) or dithranol (n = 120) for up to 3 months, assessed the acceptability of treatment, overall satisfaction with treatment, their treatment preference using the 'willingness to pay' principle and selected their treatment of choice.. Overall satisfaction with calcipotriol was significantly better (72.7%, dithranol 60.3%; odds ratio 1.75, 95% CI 1.03, 2.99: P = 0.04). Patients considered calcipotriol a more acceptable treatment than dithranol in its appearance, smell, non-irritancy, method and ease of application and lack of staining. Dithranol was considered less sticky than calcipotriol. Patients were 'willing to pay' a mean of pound sterling 12.16 monthly for calcipotriol and pound sterling 10.66 monthly for dithranol. 'Willingness to pay' did not correlate well with overall treatment satisfaction and was not correlated with household income. Calcipotriol was the preferred treatment of choice (calcipotriol 63%, dithranol 24%).. Patients with psoriasis prefer treatment with calcipotriol ointment over short-contact dithranol cream.

Topics: Administration, Topical; Anthralin; Anti-Inflammatory Agents; Attitude; Calcitriol; Dermatologic Agents; Female; Humans; Male; Middle Aged; Ointments; Patient Satisfaction; Patients; Psoriasis

Phosphorylase kinase (PhK), also known as adenosine triphosphate (ATP)-phosphorylase b phosphotransferase, integrates multiple calcium/calmodulin-dependent signalling pathways, including those involved in cell migration and cell proliferation, while coupling these pathways to glycogenolysis and ATP-dependent phosphorylation, thus ensuring continuing energy supply for these activities.. Our laboratory recently reported correlation of elevated PhK activity with psoriatic activity. This study further evaluates the significance of drug-induced suppression of PhK activity on psoriatic activity.. PhK activity was assayed in four groups, each with 10 patients: (i) active untreated psoriasis; (ii) resolving psoriasis treated by calcipotriol (Dovonex(R), Bristol Myers Squibb, Princeton, NJ, U.S.A. ), a vitamin D3 analogue and an indirect inhibitor of PhK; (iii) curcumin (diferuloylmethane), a selective PhK inhibitor; and (iv) 10 normal non-psoriatic subjects.. PhK activity in units mg-1 protein was highest in active untreated psoriasis (1204 +/- 804.3; mean +/- SD), lower in the calcipotriol-treated group (550.7 +/- 192. 9), lower in curcumin-treated group (207.2 +/- 97.6), and lowest in normal skin (105.4 +/- 44.6). One-way analysis of variance performed on log-transformed PhK activity measure showed significant differences among the four groups, F3,36 = 48.79, P < 0.0001. Decreased PhK activity in curcumin-and calcipotriol-treated psoriasis was associated with corresponding decreases in keratinocyte transferrin receptor (TRR) expression, severity of parakeratosis and density of epidermal CD8+ T cells.. Our results demonstrate that drug-induced suppression of PhK activity is associated with resolution of psoriatic activity as assessed by clinical, histological and immunohistochemical criteria, and support the hypothesis that effective antipsoriatic activity may be achieved through modulation of PhK activity.

Topics: Adult; Aged; Analysis of Variance; Anti-Inflammatory Agents, Non-Steroidal; Calcitriol; CD8-Positive T-Lymphocytes; Cell Division; Curcumin; Dermatologic Agents; Enzyme Inhibitors; HLA-DR Antigens; Humans; Keratinocytes; Ki-67 Antigen; Male; Middle Aged; Parakeratosis; Phosphorylase Kinase; Psoriasis; Receptors, Transferrin

Both tazarotene (a retinoid prodrug) and calcipotriene (a synthetic analog of vitamin D3) are effective in the treatment of plaque psoriasis, but no reports in the literature directly compare the efficacy and tolerability of these 2 drugs. Tazarotene is commonly used in conjunction with a topical corticosteroid. In this study, tazarotene was used with mometasone furoate (a synthetic corticosteroid), and the 2-drug regimen was compared with calcipotriene monotherapy.. This study was conducted to compare the efficacy and tolerability of tazarotene 0.1% gel once daily plus mometasone furoate 0.1% cream once daily with those of calcipotriene 0.005% ointment twice daily in the treatment of plaque psoriasis.. In this multicenter, investigator-blinded, parallel-group study, adult patients with chronic, stable plaque psoriasis affecting 5% to 20% of their body surface area were randomly allocated to receive up to 8 weeks of treatment with either tazarotene 0.1% gel once daily (in the evening) plus mometasone furoate 0.1% cream once daily (in the morning) or calcipotriene 0.005% ointment twice daily. Patients were assessed at baseline and at weeks 2, 4, and 8 of treatment. Patients who demonstrated complete clearance of plaque psoriasis after 2 or 4 weeks of treatment and those whose psoriasis had improved > or = 50% after 8 weeks of treatment entered a 12-week posttreatment follow-up phase during which they applied only moisturizer. Patients were reassessed after 4, 8, and 12 weeks of posttreatment follow-up. Physician-rated measures of efficacy included global improvement, plaque elevation, scaling, erythema, and percentage of body surface area involvement. Patient-rated assessments included efficacy of study treatment compared with previous therapies, comfort of treated skin, outlook for long-term control of psoriasis, and overall impression of treatment.. Of 120 patients with moderate to severe psoriasis enrolled from 3 centers, 106 (88%) completed the study. No significant differences in baseline clinical variables were observed between the 2 groups. Twenty-seven patients (45%) in the tazarotene plus cortico-steroid group achieved marked improvement (> or = 75% global improvement) after 2 weeks of treatment compared with 15 patients (26%) in the calcipotriene group (P < or = 0.05). Between-group comparisons of the percentage of patients achieving complete or almost complete clearance (> or = 90% global improvement) did not reach statistical significance at any time point. When compared with the calcipotriene regimen, the tazarotene plus corticosteroid regimen resulted in significantly greater efficacy on trunk lesions in reducing plaque elevation (at the end of treatment and at week 4 of the posttreatment phase, P < or = 0.05), scaling (week 4 of treatment and week 4 of the posttreatment phase, P < or = 0.05), erythema (week 4 of treatment and at the end of treatment, P < or = 0.05), and percentage of body surface area involvement (weeks 2 and 4 of treatment, P < or = 0.01). In addition, the tazarotene plus corticosteroid regimen was significantly more effective in reducing the percentage of body surface area involvement in upper limb lesions (weeks 2 [P < or = 0.05] and 4 [P < or = 0.01] of treatment). Forty-two of 55 patients (76%) in the tazarotene plus corticosteroid group rated their medication as more or much more effective than previous therapies compared with 30 of 52 patients (58%) in the calcipotriene group (P < or = 0.05). Although adverse events (burning, pruritus, irritation, and erythema) occurred in a significantly greater proportion of patients who received tazarotene plus corticosteroid than in those who received calcipotriene (P < or = 0.05), 47 of 55 patients (85%) in both groups rated the comfort of their treated skin as "somewhat comfortable" or better and both groups had similar discontinuation rates due to treatment-related adverse events (3% and 5%, respectively). CONCL

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Therapy, Combination; Female; Gels; Glucocorticoids; Humans; Male; Middle Aged; Mometasone Furoate; Nicotinic Acids; Ointments; Pregnadienediols; Psoriasis; Treatment Outcome

Phototherapy has been shown to be one of the most effective treatment modalities for patients with psoriasis. Nevertheless, photocombination therapies capable both of reducing cumulative ultraviolet (UV) doses and of accelerating clearance of skin lesions are important and of high interest. There have been no published studies comparing the effect of narrowband UVB irradiation in combination with topical application of tazarotene vs. calcipotriol.. To determine, in a half-side manner, whether a combination of UVB (311 nm) and tazarotene is superior to UVB (311 nm) plus calcipotriol or vice versa.. Ten patients suffering from widespread symmetrical psoriasis were treated for at least 4 weeks with topical calcipotriol and tazarotene in a half-side distribution. Additionally, the whole body was irradiated with narrowband UVB (311 nm) four times a week. Before treatment and once weekly during therapy a modified Psoriasis Area and Severity Index was estimated for each body half. The total treatment time, number of treatment sessions and cumulative UVB dose necessary for clearance of skin lesions were determined in an observer-blind fashion for each patient. Furthermore, all patients completed a quality of life questionnaire.. Clearance of psoriasis was observed after a median of 19 treatment sessions (range 14-28) and a median cumulative UVB dose of 22.98 J cm-2 (range 9.24-58.22) simultaneously for both body halves. On the side treated with topical tazarotene gel, four patients complained of itching and dryness of the skin, and skin irritation was observed in three of them. Six patients preferred the application of tazarotene gel, while four preferred calcipotriol.. Our clinical comparison of narrowband UVB with either topical calcipotriol or topical tazarotene revealed no significant therapeutic difference between both regimens. Although these results need to be confirmed in larger patient groups, we feel that both photocombination therapies can broaden the therapeutic options for moderate to severe psoriasis vulgaris and may reduce the cumulative UVB dose during therapy.

Topics: Administration, Topical; Adult; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Female; Humans; Male; Middle Aged; Nicotinic Acids; Psoriasis; Treatment Outcome; Ultraviolet Therapy

The results of a multicenter, open-label observation study evaluating the use of tazarotene in 1393 patients being treated for plaque psoriasis have been reported recently. The analysis of data from a subset of 166 patients who were switched from calcipotriene therapy, with or without a topical corticosteroid, to receive tazarotene plus a corticosteroid is reported here. This subset of 166 patients showed substantial additional improvements in efficacy and patient satisfaction over and above those already achieved with calcipotriene +/- corticosteroid treatment. The mean scores for overall severity of plaque psoriasis, plaque elevation, scaling, pruritus, and overall discomfort were reduced by 35%, 41%, 44%, 45%, and 40%, respectively, compared with baseline levels at the time of switching therapy. The severity of each of these parameters was reduced from mild-to-moderate at baseline to trace-to-mild after a mean of 10 weeks' treatment with tazarotene plus a corticosteroid.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Calcitriol; Child; Cross-Sectional Studies; Dermatologic Agents; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Nicotinic Acids; Patient Satisfaction; Psoriasis; Severity of Illness Index; Treatment Outcome

Overall results from a multicenter study involving more than 1000 patients with plaque psoriasis treated with tazarotene 0.1% gel plus a topical corticosteroid are soon to be published. This report considers a subgroup of 246 patients from that study who were switched from calcipotriene plus corticosteroid treatment (at baseline) to tazarotene plus corticosteroid for up to 12 weeks. Moderate (> or = 50%) global improvement was achieved in 75% of patients between the baseline visit (when on calcipotriene therapy) and the final visit (when on tazarotene therapy). Considerable additional reductions (38%-50%) in overall severity of plaque psoriasis, plaque elevation, scaling, pruritus, and overall discomfort were achieved over and above improvements already achieved with calcipotriene therapy. Furthermore, 74% of patients were satisfied with their treatment regimen at the final visit (when on tazarotene therapy), compared with 17% at baseline (when on calcipotriene therapy).

Topics: Administration, Topical; Anti-Inflammatory Agents; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Nicotinic Acids; Patient Satisfaction; Psoriasis; Severity of Illness Index; Treatment Outcome

A double-blind, randomized clinical study was conducted to compare the efficacy and tolerability of twice-daily topical calcipotriol treatment with a combination treatment of calcipotriol once a day in the morning and diflucortolone valerate in the evening. Sixty-three patients with a clinical diagnosis of chronic plaque psoriasis and comparable psoriatic lesions on both sides of the body were included. After a washout phase of 1 week, psoriatic lesions were treated for 4 weeks with calcipotriol ointment twice daily on one side of the body and a combination of calcipotriol and diflucortolone valerate ointment on the other side. The treatment period was followed by a period of 4 weeks without any treatment. The psoriasis area and severity index (PASI) was used to compare the 2 groups. Furthermore, the overall therapeutic results were assessed independently by the investigators and by the patients. Both treatment regimens showed a significant, nearly identical, reduction in PASI. The mean PASI for calcipotriol alone was 5.7 at baseline, 1.9 after 4 weeks of treatment and 3.8 at the end of the follow-up period. For combination therapy, these values were 5.7, 1.8 and 3.8, respectively. There was a statistically significant advantage in favor of combined calcipotriol and diflucortolone valerate treatment at weeks 1 and 2 (p < 0.05); however, at the end of the treatment phase the difference between the 2 therapies was not significant. Subjective evaluation of efficacy by both the investigators and the patients revealed no difference between the 2 treatments. The frequency of side effects (e.g. irritation) was low in both groups. In conclusion, both therapies were effective for the treatment of chronic plaque-type psoriatic lesions. The combination of calcipotriol and a topical steroid appeared to produce a more rapid clinical response and was shown to be as effective as calcipotriol therapy alone.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Calcitriol; Dermatologic Agents; Diflucortolone; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Treatment Outcome

Forty-two patients aged between 6 and 61 years (mean: 33.5 years) with psoriasis of the scalp were enrolled in this study. Twenty-seven patients (69%) were males and 15 (31%) were females. The aim of our study was to evaluate the efficacy, safety and tolerability of topical calcipotriol 50 micrograms/g/ml solution vs. betamethasone valerate 1% lotion in the treatment of psoriasis of the scalp. The study was randomized with the twice-daily application of either calcipotriol solution or betamethasone valerate lotion for 6 weeks. Treatment evaluation was clinically based on signs of psoriasis (thickness, redness, scaliness) which were scored from 0 = absent to 4 = severest possible involvement and was performed at the start of treatment and at weeks 2 and 6 of treatment. The results showed a marked improvement and clearance at the end of treatment in 15 (72.8%) of the 24 patients in the calcipotriol group and in 13 of the 18 patients (72%) in the betamethasone group. The mean total sign score at baseline was 5.1 in the calcipotriol group and 5.4 in the betamethasone valerate group. At the end of treatment, this score was decreased to 2.1 and 1.49, respectively. No significant adverse effects were reported in either group except in two patients (8.3%) in the calcipotriol group who developed signs of irritation including itching and erythema. In conclusion, both drugs were effective and well tolerated in the treatment of scalp psoriasis but in some patients calcipotriol had to be given for more prolonged courses.

Topics: Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents; Betamethasone Valerate; Calcitriol; Child; Dermatologic Agents; Female; Humans; Male; Middle Aged; Psoriasis; Scalp Dermatoses; Treatment Outcome

Enkephalins are opioid peptides that can modulate immune responses and inflammatory processes. Furthermore, they inhibit keratinocyte proliferation/differentiation in vitro. Previously, we have shown that enkephalins are present in increased amounts in lesional psoriasis.. To determine the effect of topical treatment with the vitamin D analogue calcipotriol and the corticosteroid mometasone furoate on the level of methionine-enkephalin (enk) in psoriatic lesions.. Twelve psoriatic patients were treated with calcipotriol and mometasone furoate for 14 days without or with hydrocolloid occlusion. Keratome biopsies were obtained from treated and untreated skin, and the extracted enk was quantified by radioimmunoassay. Furthermore, punch biopsies were obtained for immunohistochemical analysis.. Clinically, both calcipotriol and mometasone furoate improved psoriasis to the same degree, the effects being more pronounced after occlusion. Histologically, treatment with mometasone furoate without occlusion decreased both the epidermal thickness/parakeratosis and the number of dermal immunocompetent cells (CD3- and CD68-positive cells). In contrast, treatment with calcipotriol without occlusion reduced the epidermal thickness and the degree of parakeratosis but decreased the number of CD3- and CD68-positive cells only slightly. The mean enk level was decreased by 26 and 86% by calcipotriol without and with occlusion and by 16 and 63% by mometasone furoate without and with occlusion, respectively. The decreases in the enk levels corresponded to the degree of clinical improvement but not to the histological changes.. The increased levels of enk in psoriatic lesions are reduced in parallel with the clinical improvement induced by a topical vitamin D analogue and a corticosteroid. Because enkephalins can modulate epidermal differentiation and inflammatory processes, the findings indicate that enkephalins may play a role in the pathogenesis of psoriasis.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Antigens, CD; Antigens, CD20; Antigens, Differentiation, Myelomonocytic; Calcitriol; CD3 Complex; Dermatologic Agents; Enkephalins; Glucocorticoids; Humans; Immunohistochemistry; Middle Aged; Mometasone Furoate; Occlusive Dressings; Pregnadienediols; Psoriasis; Skin; Treatment Outcome

This study describes the changes in number and distribution of somatostatin- and factor XIIIa-immunoreactive dendritic cells in the epidermis and dermis of psoriatic lesional skin during topical treatment with clobetasol propionate or calcipotriol. Immunohistochemical analysis showed that the number of each cell type was increased in lesional skin as compared to normal skin. Investigation of serial biopsies from psoriasis lesions revealed a significant reduction in the number of somatostatin- and factor XIIIa-positive dendritic cells during the treatments. The reduction rate of the somatostatin-positive cells differed between the two groups and closely paralleled the healing process induced by the two treatments. These findings and the fact that somatostatin has been used in several studies as treatment for psoriasis may indicate that the somatostatin-positive cells are specifically involved in the healing process of psoriasis. The reduction of the factor XIIIa-positive cells was associated with the healing process as a whole, but showed no relation to either treatment.

Topics: Adult; Biopsy; Calcitriol; Clobetasol; Dendritic Cells; Dermatologic Agents; Female; Fluorescent Antibody Technique, Indirect; Glucocorticoids; Humans; Immunohistochemistry; Male; Middle Aged; Psoriasis; Skin; Somatostatin; Transglutaminases

Topics: Adolescent; Adult; Aged; Calcitriol; Coal Tar; Dermatologic Agents; Emulsions; Female; Humans; Keratolytic Agents; Male; Middle Aged; Pilot Projects; Psoriasis; Single-Blind Method

Topics: Adult; Aged; Baths; Calcitriol; Dermatologic Agents; Female; Humans; Male; Middle Aged; Psoriasis; PUVA Therapy

Tacrolimus (FK506) is an effective and well tolerated immunosuppressant used to prevent allograft rejection. We describe the evaluation of two tacrolimus ointment formulations for treatment of chronic plaque-type psoriasis. This was a microplaque assay with randomized, double-blind design. Sixteen patients (15 men, one woman, all white and 28-69 years old) with chronic plaque-type psoriasis participated. Six different ointments were applied to discrete microplaques, 17 mm in diameter, on a descaled psoriasis lesion: these were tacrolimus ointment with diisopropyl adipate as penetration enhancer, tacrolimus ointment without diisopropyl adipate, 0.1% betamethasone 17alpha-valerate ointment, 0.005% calcipotriol ointment and, as controls, the ointment bases for tacrolimus and betamethasone. Ointments were reapplied and the area was sealed every 2-3 days during the 14-day treatment period. After 7 and 14 days, erythema and infiltration were graded on a scale of 0-4, and superficial blood flow was measured with a laser Doppler flowmeter. Epidermal thickness was measured histologically at the end of treatment. Compared with the vehicle controls, sites treated with tacrolimus ointment (with or without penetration enhancer) showed a significant reduction in erythema and infiltration (P < 0. 001), a significant reduction in superficial blood flow (P < 0.01) and a significant decrease in epidermal thickness (P < or = 0.001). Results for betamethasone and calcipotriol, when compared with the vehicle controls, were similar. These results suggest that, under conditions of descaling and occlusion, tacrolimus ointment is effective in the treatment of psoriasis.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Double-Blind Method; Female; Glucocorticoids; Humans; Immunosuppressive Agents; Male; Middle Aged; Ointments; Psoriasis; Skin Tests; Statistics, Nonparametric; Tacrolimus

Calcipotrial has a well-documented effect in the treatment of psoriasis.. To confirm the beneficial effect of the combination of calcipotriol and UVB and to demonstrate that the combination is safe and well tolerated.. Data from two randomized right/left studies were analysed. Patients included in the studies had chronic stable plaque-type psoriasis with symmetrical lesions on the arms, the legs and/or the trunk. In one study, 101 patients were treated with calcipotriol on one side and calcipotriol + UVB on the other side of the body (open study). In the other study, 77 patients were treated with calcipotriol + UVB on one side and vehicle + UVB on the other side of the body (double-blind study). Calcipotriol ointment, 50 microg/g, was applied twice daily and UVB 3 times weekly for 8 weeks. UVB was increased from 0.7 MED before treatment in rapid steps up to the erythema threshold.. In both treatment series the therapeutic effect of the combination of calcipotriol and UVB was enhanced as compared to calcipotriol alone and UVB alone. In the first series there was a significant reduction of the psoriasis area and severity index (PASI) with the combination after 2 weeks as compared to calcipotriol alone. At the end of treatment significantly more sides were cleared after calcipotriol + UVB than after calcipotriol alone. In the other series there was a significantly faster onset of improvement on the sides treated with calcipotriol + UVB than on those treated with vehicle + UVB. After 2 weeks there was a significant difference in PASI in favour of calcipotriol + UVB. At the end of treatment, however, there was no difference between the treatments. There was a similar adverse event profile with either treatment. The addition of UVB to calcipotriol did not alter the tolerability or safety of topically applied calcipotriol.. The result indicates a beneficial effect of combining calcipotriol and phototherapy. The findings are compared to other published studies.

Topics: Administration, Cutaneous; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Female; Folliculitis; Follow-Up Studies; Humans; Male; Phototherapy; Psoriasis; Severity of Illness Index; Skin; Sunburn; Treatment Outcome; Ultraviolet Rays

Sixty-one psoriasis patients, 46 males and 15 females (mean age: 40 years, range: 20-70 years) with baseline PASI score of 7.16 (+/- 3.66 SD) were enrolled in the study. All subjects were advised to apply calcipotriol ointment twice daily for 6 weeks. Six patients dropped out, five after 2 weeks and one after 4 weeks of treatment. PASI scores of fifty five patients were reduced to 2.16 per cent, 46.78 per cent and 55.55 per cent by 2 weeks, 4 weeks and 6 weeks respectively versus the baseline. Overall clinical assessment showed remission in 7.27 per cent marked improvement 74.54 per cent and slight improvement 18.18 per cent. Mild erythema were observed in fourteen patients (22.95%) that were mostly transient except for one patient. Serum creatinine, calcium and phosphate were normal throughout the study.

Topics: Administration, Topical; Adult; Aged; Calcitriol; Chronic Disease; Dermatologic Agents; Female; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Thailand; Time Factors

The aim of this clinical trial was to assess the efficacy and safety of calcipotriol cream associated with oral etretinate compared with etretinate alone in the treatment of moderate-severe psoriasis.. This controlled multicenter trial, within patients (hemiparts), enrolled 86 in- or out-patients (62 males, 24 females), mean (+/-SD) age 57.1 +/- 14.2 years, with psoriasis vulgaris on both sides of the body, and mean (+/-SE) baseline PASI score (Psoriasis Area and Severity Index) 30.7 +/- 0.9. All patients took oral etretinate 50 mg/day and applied calcipotriol cream (50 microg/g) on one half of their body twice a day. Treatment was continued for 9 weeks, and patients were seen every 3 weeks.. At the end of the first 3 weeks the PASI score indicated a significant clinical difference between the two sides of the body (P < 0.001, ANOVA), with a reduction of 50.7% in the score for the calcipotriol-treated half, compared with a 39% reduction for the untreated half. By the 9th week of treatment the PASI score was 81.4% lower on the treated half, and 70.3% on the untreated side (P < 0.001, ANOVA).. These findings suggest that patients with moderate-severe psoriasis might benefit from treatment with etretinate plus calcipotriol, with the aim of achieving a faster response and an overall smaller total dose of etretinate.

Topics: Administration, Oral; Administration, Topical; Adult; Aged; Aged, 80 and over; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Etretinate; Female; Humans; Keratolytic Agents; Male; Middle Aged; Psoriasis

Broad-band UVB phototherapy has appeared to be effective in clearing psoriatic lesions. After the advent of calcipotriol ointment, promising results have been obtained by combining these two therapeutic modalities. Also, an additional effect of narrow-band UVB phototherapy on treatment with calcipotriol ointment has been demonstrated.. Our purpose was to compare treatment with low-dose narrow-band UVB phototherapy both with and without calcipotriol ointment.. We included 53 patients suffering from plaque-type psoriasis. All patients underwent low-dose narrow-band UVB phototherapy. Nearly half of the patients were randomized to apply calcipotriol ointment (50 microg/g) twice daily on the affected skin. The Psoriasis Area and Severity Index (PASI) was used to evaluate psoriatic lesions.. In this study we showed that low-dose narrow-band UVB phototherapy is effective in the treatment of psoriasis and that calcipotriol ointment does not improve treatment outcome.. Calcipotriol ointment does not improve treatment with low-dose narrow-band UVB phototherapy.

Topics: Adolescent; Adult; Aged; Calcitriol; Dermatologic Agents; Female; Humans; Male; Middle Aged; Phototherapy; Psoriasis; Single-Blind Method; Treatment Outcome

Topics: Administration, Topical; Adolescent; Calcitriol; Child; Child, Preschool; Dermatologic Agents; Female; Follow-Up Studies; Humans; Male; Psoriasis; Treatment Outcome

Eighteen patients with symmetric plaque-type psoriasis were recruited for an open, controlled, bilateral half-body comparison study to evaluate the efficacy of calcipotriol/tar/UVB vs. anthralin/tar/UVB in a day care treatment setting. No patient had been on systemic antipsoriatic agents for at least 3 months prior to enrolment. One half-body was arbitrarily assigned to treatment with gradually increasing concentrations of anthralin as tolerated. The other half-body received calcipotriol ointment twice daily. Both sides received UVB and additional coal tar distillate in accordance with our standard day care regimen. Patients who were admitted to the day care program attended the clinic for UVB, anthralin, and calcipotriol on weekdays for two consecutive weeks. Anthralin was applied to psoriatic plaques on one side in the following fashion: anthralin 0.1% with salicylic acid 3% in zinc oxide paste on days 1 and 2; anthralin 0.2% with salicylic acid 3% in zinc oxide paste on days 3-5; anthralin 1% with salicylic acid 3% in hydrophilic petrolatum for 60 min on days 8-10 to thicker lesions; and anthralin 2% with salicylic acid 3% in hydrophilic petrolatum for 60 min on day 11 to thicker lesions. On the contralateral side, calcipotriol ointment 0.05 microgram/mL (Leo Pharmaceuticals, Ajax, Ontario) was applied to lesions twice daily. No anthralin or calcipotriol was applied on weekends. All patients applied coal tar oil 50% (Doak Oil Forte, Trans CanaDerm, St-Laurent, Québec, equivalent to 5% coal tar distillate) with salicylic acid 5% in hydrophilic petrolatum to their lesions at home in the evenings and on weekends. UVB (FSX72T12 lamps, National Biologic Corporation, Twinsburg, Ohio) was administered twice daily on weekdays in increasing doses as tolerated (to erythema) prior to the application of the topical medications. No trial medications were applied to the face, scalp, or genital regions. For clinical evaluation, the standard Psoriasis Activity and Severity Index (PASI) score was modified by splitting the score for area under 10%; the modified score (mPASI) for an area of coverage of 1%-4% was 0.5 and for an area of 5%-9% was 1. The head and neck area was excluded from the analysis since neither anthralin nor calcipotriol was used at these sites. Each half-body was considered to represent 100% in the area score determination. The maximum modified score for each side was 64.8 (vs. 72 in the standard PASI scoring system). Clinical evaluations were comple

Topics: Administration, Topical; Adolescent; Adult; Aged; Ambulatory Care Facilities; Anthralin; Anti-Inflammatory Agents; Body Surface Area; Calcitriol; Chronic Disease; Day Care, Medical; Dermatitis, Irritant; Dermatologic Agents; Dose-Response Relationship, Drug; Drug Therapy, Combination; Erythema; Humans; Middle Aged; Psoriasis; PUVA Therapy; Severity of Illness Index; Time Factors; Treatment Outcome

Our purpose was to find out whether the addition of calcipotriol ointment (50 micrograms/g) to systemic treatment with acitretin produces additional therapeutic effects and thereby an acitretin-sparing effect, and further to investigate the safety and tolerability of this combination. A multicentre, randomized, double-blind placebo-controlled study was designed. Patients were randomized to receive calcipotriol or placebo. All patients were treated with a starting dose of 20 mg acitretin per day and doses were adjusted at 2-weekly intervals with increments of 10 mg per day up to a maximum of 70 mg per day. The dose requirement for acitretin, clinical signs and adverse events were recorded. Seventy-six patients were randomized to treatment with calcipotriol 50 micrograms/g ointment twice daily and 59 patients to treatment with the vehicle only twice daily. Clearance or marked improvement was achieved by 67% of the patients in the calcipotriol group and by 41% of the patients in the placebo group (P = 0.006). Calcipotriol treatment proved to have a statistically significant additional effect to acitretin on the Psoriasis Area and Severity Index, redness, thickness and scaliness as compared with placebo. Clearance or marked improvement was achieved with a statistically significantly lower cumulative dose of acitretin by the patients in the calcipotriol group as compared with the placebo group. The number of patients reporting adverse events was pronounced and largely related to acitretin. No significant differences were observed between the two treatment groups with respect to adverse events. Laboratory assessments were essentially normal. The addition of calcipotriol ointment to acitretin treatment contributes to the efficacy, reduces the cumulative dose of acitretin to reach marked improvement or clearance, and is well-tolerated and safe.

Topics: Acitretin; Adult; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Keratolytic Agents; Male; Middle Aged; Ointments; Psoriasis; Treatment Outcome

Calcipotriene is a synthetic analogue of 1,25-dihydroxyvitamin D3 established to be effective topically in the treatment of psoriasis. We investigated the early cellular and immunological events induced by calcipotriene in psoriasis. Thirty patients with moderate plaque-type psoriasis were randomly assigned to receive twice daily applications of either calcipotriene ointment 0.005% or matching vehicle for 6 weeks. Skin biopsies (6 mm) were performed from designated plaques at baseline and days 3 and 7. On these days and at weeks 2, 4 and 6, complete clinical evaluations were made in a double-blind fashion. Consistent with previous studies, significant clinical improvement (P < 0.05) in psoriasis was observed in patients receiving calcipotriene vs. those receiving vehicle by day 7 for scale and erythema, and by day 14 for thickness. No significant improvement, however, was seen on day 3. None of the immunohistological markers (CD1a, CD4, CD8, ICAM-1, VCAM-1, E-selectin, HLA-DR) semiquantitatively assessed in psoriatic plaques was significantly changed by calcipotriene treatment for 7 days. In the calcipotriene-treated group, interleukin (IL)-10 levels (pg/microgram of protein) increased by 57% from baseline (0.030 +/- 0.006; mean +/- SEM) to day 3 (0.047 +/- 0.011) (P = 0.05 vs. baseline; n = 10) and remained elevated at day 7 (0.046 +/- 0.012). IL-8 levels (pg/microgram of protein), however, declined by 70% from baseline (0.13 +/- 0.06) to day 3 (0.04 +/- 0.01), and remained low at day 7 (0.03 +/- 0.02) (P < 0.05 vs. baseline; n = 10). Both IL-8 and IL-10 were unaffected by vehicle treatment. Calcipotriene-induced clinical improvement of psoriasis is preceded by an increase in IL-10 and a concomitant decrease in IL-8 levels. The changes in the level of these two cytokines provide further evidence for immunological changes as a significant part of the mechanism of action of calcipotriene in psoriasis.

Topics: Adolescent; Adult; Aged; Calcitriol; Dermatologic Agents; Double-Blind Method; Enzyme-Linked Immunosorbent Assay; Female; Humans; Interleukin-10; Interleukin-8; Male; Middle Aged; Psoriasis; Treatment Outcome

The aim of this study was to evaluate the efficacy and tolerability of the association of calcipotriol ointment (50 micrograms/g) plus cyclosporine versus cyclosporine alone in the treatment of moderate psoriasis (mean PASI: 13).. Twenty patients were enrolled in this right-left open study. All the patients admitted were treated with cylosporine at an initial dose of 4.5 mg/kg/day; in case of clinical improvement this dosage was reduced by 0.5 mg/kg/day every 15 days. In each patient we chose two similar, symmetrical lesions and calcipotriol ointment was applied only on the right lesion, twice a day, until the healing of the lesion or for 1 month. Patients were checked at baseline and every 15 days.. Eighteen patients completed the study and 17 of the 18 presented more evident improvement on the side treated with combined therapy, while only one patient showed a better result on the side treated with cyclosporine alone. A significant difference of the total score was already present after 15 days of therapy and was confirmed at the following check-ups.. These results underline the usefulness of the association of calcipotriol and cyclosporine in order to decrease the total dosage of cyclosporine.

Topics: Administration, Oral; Administration, Topical; Adult; Aged; Calcitriol; Cyclosporine; Dermatologic Agents; Dose-Response Relationship, Drug; Drug Interactions; Drug Therapy, Combination; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Psoriasis; Treatment Outcome

Elevated blood and urine calcium levels have been reported with the use of high doses of calcipotriene ointment in patients with psoriasis. The objective of this study was to evaluate key measures of calcium metabolism in patients with psoriasis under supervised dosing conditions in a vehicle-controlled study. Of the 24 patients enrolled, 12 each were administered 15 g of ointment containing calcipotriene or vehicle twice a day for 14 days. Blood and urine samples and 24-hour urine collections were obtained at selected time points. All 24 patients completed the study with no significant differences between treatments in any of the laboratory parameters. Trend analysis failed to show any significant differences over time with the exception of calcium, which showed significant changes common to both the calcipotriene and vehicle groups, suggesting that these changes were unrelated to treatment. The results of this study show that the use of calcipotriene ointment at a dose of 30 g per day for 14 days did not produce any significant alterations in blood or urine calcium concentrations and was well tolerated.

Topics: Adult; Aged; Calcitriol; Calcium; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Psoriasis

A clinical study was conducted to determine whether, in the topical treatment of psoriasis, a combination of calcipotriol and betamethasone valerate after previous treatment with calcipotriol alone was more effective than the continuation of the monotherapy with calcipotriol, especially in 'low responders'. Patients (n = 169) with the clinical diagnosis 'chronic plaque-type psoriasis' were treated twice daily for 2 weeks with calcipotriol, followed by a 4-week treatment with calcipotriol monotherapy in 87 patients or combined calcipotriol/betamethasone valerate in 82 patients; all patients were followed for 8 weeks. The psoriasis area and severity index (PASI) was used to compare the two treatment groups. The overall therapeutic result was also assessed by the investigators and patients. The combination therapy was more effective, as assessed by all evaluated variables; moreover, patients showing insufficient response to calcipotriol alone after 2 weeks showed a regression of psoriatic lesions using the combination regimen. Thus, the combination of calcipotriol and topical steroids is recommended as the therapy of first choice for patients who do not respond well to treatment with 2 weeks of calcipotriol alone. Furthermore, this combination reduces the hazards associated with the long-term use of topical corticosteroids (atrophy and rebound) as well as the irritation associated with calcipotriol.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Betamethasone Valerate; Calcitriol; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index

In a randomized study 30 patients with chronic stationary psoriasis were treated with 3 different topical schemes. Group 1 (n = 10) received monotherapy (dithranol (D) twice a day, D/D), group 2 (n = 10) calcipotriol mornings/dithranol evenings (calcipotriol (C)/dithranol (D) C/D) and 3 (mometasone (M) mornings/dithranol (D) evenings, M/D). During the therapy period of 4 weeks we documented the PASI-Score as well as infiltration, erythema and desquamation weekly. The M/D group revealed in the first week a significantly faster reduction of the PASI-score (5.3) than in the D/D group (PASI 13.22). The C/D group (PASI 10.5) show a not significantly faster reduction. After 4 weeks of treatment and after a follow period of 6 weeks there were similar PASI-Scores in all groups. There were less side-effects in the M/D group than in the others. The beginning, more anti-psoriatic effectiveness was achieved by the mometasone/dithranol combination than the other schemes. In the long term, the effects were similar.

Topics: Administration, Topical; Adult; Aged; Anthralin; Anti-Inflammatory Agents; Calcitriol; Dermatologic Agents; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Prospective Studies; Psoriasis; Recurrence

Psoriasis is a chronic T-cell-mediated inflammatory skin disease which can be treated with topical medication, phototherapy or systemic medication. A subgroup of psoriatic patients does not respond to monotherapy and needs combination therapy. We used low-dose narrow-band UVB phototherapy, combined with balneotherapy, short-contact anthralin, liquor carbonis detergens and calcipotriol for treatment of psoriatic patients in our day care centre.. Our purpose was to study the efficacy, induction of erythema and effect on systemic T-cell activation of this combination therapy.. Skin reflectance spectrophotometry was used to measure skin erythema. The Psoriasis Area and Severity Index (PASI) was used to evaluate psoriatic patients. Serum soluble IL-2 receptor (sIL2-R) levels were measured by an ELISA.. The possible erythematogenic effect of low-dose narrow-band UVB irradiation was studied (skin reflectance spectrophotometer) in a control group of psoriatic patients (n = 11). No induction of skin erythema was seen. Subsequently, this low-dose irradiation regimen was used in combination with topical medication in 26 psoriatic patients. A 90% decrease in the PASI was seen after a mean number of 35 treatment sessions. Seventeen patients (65%) remained in remission during the following 6 months. Serum sIL-2R levels were elevated in all patients (mean 913 U/ml) and did not change during treatment.. Our data indicate that low-dose narrow-band UVB can be used successfully, in combination with topical treatment, in a day care setting to treat psoriatic patients. Since sIL-2R serum levels were not decreased, it can be speculated that this treatment does not induce systemic immunosuppression.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anthralin; Anti-Inflammatory Agents; Balneology; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Dose-Response Relationship, Radiation; Erythema; Humans; Lymphocyte Activation; Middle Aged; Psoriasis; Receptors, Interleukin-2; Severity of Illness Index; Solubility; T-Lymphocytes; Treatment Outcome; Ultraviolet Therapy

Although potent, topical corticosteroids offer effective and rapid healing of psoriatic lesions. Their long term use is limited because of the risk of side effects. Calcipotriol is safe for long-term treatment, but its initial efficacy is lower than with topical corticosteroids.. To investigate whether 2 weeks of treatment with clobetasol propionate 0.05% ointment bd followed by 4 weeks of treatment with calcipotriol 50 microg/g bd would offer therapeutic advantages over 6 weeks of continuous treatment with calcipotriol.. Forty-nine patients with moderate to severe plaque psoriasis were recruited from five centres in Norway. In a randomised, double-blind, right- versus left-side comparison, ointments were applied to two symmetrically-located areas.. Two weeks of treatment with clobetasol propionate produced a significantly greater decrease in total symptom score (combined scores of erythema, induration and scaling) than calcipotriol treatment (P < 0.0001). This improvement on the clobetasol propionate-treated side of the body was maintained throughout a subsequent 4-week treatment period when calcipotriol was applied to both sides of the body (P < 0.0001). The superiority of the clobetasol propionate followed by calcipotriol treatment was maintained during a 4-week, treatment-free, observation period. Treatments were well tolerated with no rebound effect.. Clobetasol propionate ointment bd for 2 weeks followed by treatment with calcipotriol ointment bd for 4 weeks was superior to calcipotriol ointment alone in the treatment of plaque psoriasis.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Calcitriol; Clobetasol; Dermatitis, Irritant; Dermatologic Agents; Double-Blind Method; Drug Therapy, Combination; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Patient Satisfaction; Physician's Role; Program Evaluation; Pruritus; Psoriasis; Purpura; Severity of Illness Index; Skin; Treatment Outcome

Weekend therapy with superpotent topical corticosteroids has been used for the long-term treatment of psoriasis. Recently, calcipotriene ointment has been added to this regimen for use on weekdays, but there are no long-term studies of that combination.. The purpose of this study was to determine whether the addition of weekday calcipotriene to a pulse therapy regimen of weekend superpotent corticosteroids results in a longer duration of remission of plaque psoriasis.. This was a double-blind, placebo-controlled, parallel-group study. Forty-four patients with mild to moderate psoriasis were treated with calcipotriene ointment in the morning and halobetasol ointment in the evening for 2 weeks. Thereafter, 40 patients who were at least moderately (50% or greater) improved were randomized to 2 treatment groups. After 2 weeks of treatment with calcipotriene ointment in the morning and halobetasol ointment in the evening, 20 patients were randomized to receive halobetasol ointment twice daily on weekends and calcipotriene ointment twice daily on weekdays, and 20 patients were randomized to receive halobetasol ointment twice daily on weekends and placebo ointment twice daily on weekdays.. Seventy-six percent of patients applying halobetasol ointments on weekends and calcipotriene ointment on weekdays were able to maintain remission for 6 months compared with 40% of patients applying halobetasol ointment on weekends only with the vehicle on weekdays.. The addition of calcipotriene ointment applied on weekdays to a weekend pulse therapy regimen of superpotent corticosteroids can increase the duration of remission of psoriasis.

Topics: Administration, Topical; Adult; Calcitriol; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Humans; Ointments; Psoriasis; Time Factors

The objectives of the study were to determine whether concurrent treatment with calcipotriol (50 microg/g) and either clobetasone 17-butyrate cream (0.5 mg/g) (moderate potency) or betamethasone 17-valerate cream (1 mg/g) (potent) or placebo (vehicle of calcipotriol) was more effective and/or caused less skin irritation than calcipotriol cream (50 microg/g) used twice daily. It was a multicentre, double-blind, parallel group study. Patients applied calcipotriol cream in the morning and either vehicle (n = 174), calcipotriol (n = 174), clobetasone (n = 175) or betamethasone creams (n = 176) in the evening for up to 8 weeks. Adverse events led to withdrawal in 20 patients (2.9%). The mean percentage change in PASI (psoriasis area and severity index) was -40.6 in the calcipotriol/vehicle group, -48.3 in the calcipotriol/calcipotriol group, -53.7 in the calcipotriol/clobetasone 17-butyrate group and -57.5 in the calcipotriol/betamethasone 17-valerate group. A statistically significant difference was seen between the four treatment groups (P = 0.006) with calcipotriol/vehicle being less effective than the other treatments. A statistically significant difference in favour of calcipotriol/betamethasone 17-valerate was seen between the calcipotriol/calcipotriol group and the calcipotriol/betamethasone 17-valerate group. The majority of adverse events were skin irritations, which were reported for 31.2% of patients treated with calcipotriol/vehicle, 34.3% of patients treated with calcipotriol twice daily and 23.8% vs. 17.1% of patients treated with calcipotriol/clobetasone 17-butyrate and calcipotriol/betamethasone 17-valerate, respectively. Skin irritation was seen statistically significantly less frequently in patients treated with calcipotriol/ clobetasone 17-butyrate or calcipotriol/betamethasone 17-valerate (P = 0.001), whereas no difference was seen between the other groups. In conclusion, calcipotriol applied twice daily was as effective as calcipotriol/clobetasone 17-butyrate, but slightly less effective than calcipotriol/betamethasone 17-valerate. The incidence of skin irritation was less for patients using concurrent corticosteroids, whereas treatment with calcipotriol/vehicle did not reduce the incidence of skin irritation when compared with calcipotriol twice daily.

Topics: Adult; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Psoriasis; Treatment Outcome

This double-blind randomized study was designed to compare the efficacy and safety of calcipotriol ointment (50 microg/g) with betamethasone dipropionate (64 mg/g) and salicylic acid (0.03 g/g) ointment in the treatment of nail bed psoriasis. Fifty-eight patients applied the given drug to the affected nails twice a day for 3-5 months, depending on clinical response. Efficacy was assessed monthly on the basis of nail thickness, measured in millimetres. Photographs of the treated nails were taken at baseline, and after 3 and 5 months. Tolerability was assessed at 3 and 5 months. In patients with fingernail psoriasis, after 3 months of treatment subungual hyperkeratosis was reduced from 2.3 +/- 0.1 mm (mean +/- SEM) to 1.5 +/- 0.1 mm (-26.5%) in the calcipotriol group and from 2.3 +/- 0.1 mm to 1.6 +/- 0.1 mm (-30.4%) in the betamethasone dipropionate and salicylic acid group [not significant (NS) between treatments, analysis of variance (ANOVA)]. After 5 months, responders showed a 49.2% reduction in hyperkeratosis in the calcipotriol group (from 2.8 +/- 0.1 mm to 1.4 +/- 0.2 mm) and 51.7% (from 2.1 +/- 0.1 mm to 1.0 +/- 0.1 mm) in the betamethasone dipropionate and salicylic acid group (P < 0.001 from baseline, NS between treatments, ANOVA). In patients with toenail psoriasis, after 3 months of treatment there was an overall reduction in hyperkeratosis from 2.6 +/- 0.1 mm to 2.1 +/- 0.1 mm (-20.1%) in the calcipotriol group and from 3.0 +/- 0.1 mm to 2.3 +/- 0.1 mm (-22. 9%) in the betamethasone dipropionate and salicylic acid group (P < 0.001 from baseline, NS between treatments, ANOVA). By the end of the fifth month there was a 40.7% reduction in hyperkeratosis in the calcipotriol group (from 2.1 +/- 0.1 mm to 1.2 +/- 0.1 mm) and 51.9% in the betamethasone dipropionate and salicylic acid group (from 2.7 +/- 0.1 mm to 1.3 +/- 0.1 mm; P < 0.0001 from baseline, NS between treatments, ANOVA). The results of the study show that calcipotriol is as effective as a combination of a topical steroid with salicylic acid in the treatment of nail psoriasis and represents a safe alternative in the topical treatment of nail psoriasis.

Topics: Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Middle Aged; Nail Diseases; Ointments; Psoriasis; Salicylates

The aim of this study was to elucidate some of the possible mechanisms of action of the vitamin D analogue calcipotriol in vivo. Calcipotriol is finding increasing use in the treatment of psoriasis, but the primary target cell in vivo has not yet been identified. We treated psoriatic patients and healthy volunteers with calcipotriol and placebo ointment for 4 and 7 days, and obtained epidermal cell suspensions from treated areas. Epidermal cells were cocultured with autologous T cells, isolated from peripheral blood, in the absence or the presence of a classical antigen or a superantigen. In both psoriatic and normal skin, calcipotriol treatment did not alter the capacity of epidermal antigen-presenting cells to stimulate the proliferation of autologous T cells, either in the absence or in the presence of exogenous antigen. Epidermal cell suspensions were analysed further by staining for infiltrating leucocytes (CD45+) and Langerhans cells (CD1a+). Flow cytometric analysis showed that calcipotriol did not alter the number of CD45+ cells or Langerhans cells in psoriatic skin. These results indicate that calcipotriol does not alter either the number of the function of epidermal antigen-presenting cells in psoriatic epidermis. In contrast, we found that calcipotriol significantly inhibited the proliferation of epidermal cells isolated from psoriatic skin after in vivo treatment, as determined by propidium iodide staining and flow cytometry. More specifically, we stained for CD29+ keratinocytes and found an even more significant reduction in proliferative capacity. This cell type contains the population of hyperproliferative keratinocytes in psoriatic epidermis. In conclusion, calcipotriol seems to act via an inhibitory effect on hyperproliferative basal keratinocytes of psoriatic epidermis, rather than via an effect on infiltrating leucocytes, including antigen-presenting cells.

Topics: Calcitriol; Cell Division; Dermatologic Agents; Flow Cytometry; Humans; Integrin beta1; Keratinocytes; Langerhans Cells; Leukocyte Common Antigens; Psoriasis; T-Lymphocytes

In a multicentre, randomized, open study, 306 patients of either sex, over 18 years of age with stable chronic plaque psoriasis > 100 cm2 in surface area, and who gave informed consent, applied Dovonex (calcipotriol) ointment (50 micrograms/g) twice daily or Dithrocream (short-contact dithranol) 0.1-2% for up to 3 months. The number of patients 'cleared' or with 'marked improvement' at the end of treatment were: investigators' assessment--calcipotriol 92 of 153 (60.1%); dithranol 67 of 131 (51.1%); odds ratio 1.44 [95% confidence interval (CI) 0.90, 2.31; P = 0.128]; patients' assessment--calcipotriol 93 of 153 (60.8%); dithranol 65 of 131 (49.6%); odds ratio 1.57 (95% CI 0.98, 2.52; P = 0.059). Significant improvement in patients' quality of life as assessed by the Psoriasis Disability Index (PDI) and the Sickness Impact Profile (SIP) were seen in both treatment groups. Reduction in the total mean score for PDI was 6.5 in the calcipotriol group (95% CI 4.4, 8.6; P = 0.001) and 3.7 in the dithranol group (95% CI 1.1, 6.3; P = 0.005). The reduction in the total mean score for SIP was 2.8 in the calcipotriol group (95% CI 1.4, 4.3; P < 0.001) and 1.7 in the dithranol group (95% CI 0.2, 3.1; P = 0.024). Calcipotriol treatment tended to have advantages over treatment with dithranol in improving quality of life.

Topics: Activities of Daily Living; Administration, Topical; Anthralin; Anti-Inflammatory Agents; Calcitriol; Dermatologic Agents; Female; Health Status; Humans; Male; Middle Aged; Ointments; Prospective Studies; Psoriasis; Quality of Life; Self Concept; Treatment Outcome

The use of topical calcipotriol in adults with psoriasis is safe and effective.. Our purpose was to study the efficacy and safety of calcipotriol in children.. A multicenter, prospective, 8-week, double-blind, parallel group study was conducted in 77 children. Response to treatment was assessed by means of the Psoriasis Area and Severity Index (PASI) in that the intensity of redness, thickness, and scaliness as well as the area involved are scored. The children were 2 to 14 years of age and had stable psoriasis, involving less than 30% of the body surface. Forty-three children were assigned to receive calcipotriol ointment and 34 to receive placebo. Nine children dropped out of the study, six in the calcipotriol-treated group and three in the placebo-treated group.. Both treatment groups (calcipotriol and placebo) showed significant improvement in PASI from baseline to the end of treatment, and the difference was not statistically significant. No serious side effects, in particular including those relating to calcium and bone metabolism, were recorded.. Calcipotriol ointment was statistically significantly more effective than its vehicle in terms of the investigator's overall assessment and reduction in redness and scaliness but not in terms of PASI score.

Topics: Administration, Topical; Adolescent; Analysis of Variance; Biomarkers; Calcitriol; Child; Child, Preschool; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Patient Compliance; Peptide Fragments; Procollagen; Prospective Studies; Psoriasis

The efficacy, safety and tolerability of calcipotriol cream was compared with betamethasone 17-valerate cream in the treatment of plaque-type psoriasis in a multicentre double-blind, parallel group study. Patients with stable mild-to-moderate chronic disease were randomized to treatment with either calcipotriol, 50 micrograms/g, in a cream formulation (210 patients) or betamethasone 17-valerate cream, 1 mg/g (211 patients). After a wash-out period of 2 weeks, the treatment was applied twice daily, without occlusion, for 8 weeks or to complete clearing. The severity of psoriasis was assessed using the PASI at baseline and after 4 and 8 weeks treatment. The mean percentage reduction of PASI from baseline to end of treatment was 47.8% in the calcipotriol group and 45.4% in the betamethasone group. The reduction from baseline was highly significant in both groups, but the difference between the groups was not significant. There was a difference in the reduction in thickness of the lesions in favour of calcipotriol. The investigator's as well as the patient's overall assessment of treatment response at end of treatment showed no difference between the two treatment groups. Treatment-related adverse events were more frequent with calcipotriol than betamethasone. Lesional/perilesional irritation was reported in 16% and 9% (P = 0.03), and facial irritation in 10% and 0.5% (P < 0.001), respectively. No change was found in serum levels of calcium. Calcipotriol in a cream formulation was effective, safe, well-tolerated, and equal in effect to betamethasone valerate cream.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Betamethasone Valerate; Calcitriol; Chronic Disease; Dermatologic Agents; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Ointments; Prospective Studies; Psoriasis; Treatment Outcome

Topics: Adult; Aged; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Female; Humans; Male; Middle Aged; Psoriasis; PUVA Therapy

A total of 20 patients with symmetric plaque-type psoriasis were recruited for a controlled, investigator-blinded, right-left study. None of the patients had used any therapy other than emollients for 2 months prior to starting in the trial. All patients had a negative antinuclear antibody. By history, all patients had previously improved upon exposure to sunlight or ultraviolet light. Two symmetrical sites of equal severity were selected as target areas. Each patient was treated on one side with mineral oil twice daily and on the opposite side with calcipotriene 0.005% ointment twice daily. The investigator was blinded as to which site received which topical treatment. Both sides were treated with equal doses of ultraviolet B (UVB) three times weekly in graduated suberythemogenic doses. Ultraviolet B radiation was emitted by a group of 6-ft fluorescent bulbs (Light Sources FS72 T12 UVB HO) in a standard phototherapy unit. The above regimen was continued for a total of 12 weeks. The severity of psoriasis in the target sites was rated by the examiner at baseline and at weekly intervals for the 12 weeks of study. Target sites were rated by severity of erythema, scaling, plaque elevation, and pruritus, with each of these parameters being assigned a score on a four-point scale: 0, clear; 1, mild; 2, moderate; 3, severe. The four scores were added together to arrive at a total severity score for each of the target sites. Statistical analysis was performed using the paired t test, P values less than 0.05 were considered statistically significant. Eleven of the 20 patients (55%) showed a greater decrease in the severity of their psoriasis with UVB plus calcipotriene compared with UVB plus mineral oil. The difference in severity scores between the two groups was statistically significant as early as week 1 (P < 0.05). The difference between the UVB and calcipotriene group versus the UVB and mineral oil group peaked between weeks 3 and 6. The differences then decreased but remained statistically significant through to week 12 (Fig. 1). There were no instances of local cutaneous irritation, but mild photosensitivity occurred symmetrically on both sides in three patients.

Topics: Calcitriol; Combined Modality Therapy; Dermatologic Agents; Humans; Psoriasis; Time Factors; Treatment Outcome; Ultraviolet Therapy

Calcitriol and calcipotriol are effective treatments for psoriasis, although the two have never been directly compared. We compared the efficacy and toxicity of each agent in 24 patients with moderately extensive chronic plaque psoriasis, who were randomized in double-blind fashion to apply 90 g per week of either calcitriol (3 micrograms/g) ointment or calcipotriol (50 micrograms/g) ointment over an 8-week period. Mean PASI in patients applying calcitriol fell from 13 to 8.8 (p < 0.05) and in patients applying calcipotriol from 14.9 to 4.7 (p < 0.005). The reduction was significantly greater in the calcipotriol-treated group (p < 0.05). There was a small increase in serum ionized calcium in the calcipotriol-treated group (from 1.21 mmol/L to 1.25 mmol/L, p < 0.05) but no effect on calcium homeostasis in the calcitriol group.

Topics: Adult; Aged; Calcitriol; Chronic Disease; Dermatologic Agents; Female; Homeostasis; Humans; Male; Middle Aged; Psoriasis

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Patient Compliance; Psoriasis; Salicylates; Salicylic Acid; Treatment Outcome

Topics: Administration, Topical; Calcitriol; Combined Modality Therapy; Dermatitis, Irritant; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Follow-Up Studies; Humans; Ointments; Prognosis; Psoriasis; Risk Assessment; Ultraviolet Therapy

Once daily topical treatment of psoriasis with tacalcitol ointment (4 micrograms/g) was compared with twice daily treatment with calcipotriol ointment (50 micrograms/g) in a double-blind, randomized study over a treatment period of 8 weeks. The severity of pruritus, erythema, infiltration and scaling was scored on a scale from 0 to 4. These features were scored at the initiation of treatment, after 2, 4, 6 and 8 weeks of treatment, and at 4 weeks after discontinuation of treatment. The sum score was the total score for erythema, infiltration and scaling. Serum levels of calcium, phosphate, ionized calcium and intact parathyroid hormone were used as safety parameters. Two hundred and eighty-seven adults with stable plaque psoriasis participated and were treated at least once. Both tacalcitol and calcipotriol ointments effectively reduced the severity of psoriasis. The mean reduction in the sum score in the intention-to-treat population of 287 patients was 4.03 in the group treated with tacalcitol compared with 5.05 in the group treated with calcipotriol. The mean baseline sum scores were 7.64 and 7.15, respectively. The acceptability of both ointments was excellent, and none of the patients had adverse effects in terms of increased serum calcium or other alterations in calcium metabolism. Although less effective than calcipotriol ointment used twice daily, tacalcitol ointment is an effective and useful once daily treatment of chronic plaque psoriasis.

Topics: Adolescent; Adult; Aged; Calcitriol; Calcium; Dermatologic Agents; Dihydroxycholecalciferols; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Patient Satisfaction; Psoriasis; Severity of Illness Index; Treatment Outcome

We studied the effects of combining topical calcipotriol, used at the maximal licensed dose, and narrow-band short wave ultraviolet light (TL01) on systemic calcium homeostasis in the treatment of chronic plaque psoriasis. Patients were randomized in an open fashion to receive either UVB alone, UVB plus 100 g of calcipotriol (50 micrograms/g) ointment per week or calcipotriol ointment alone (100 g/week). With the exception of a slight increase in serum phosphate in the group receiving combination therapy (from 0.92 to 1.22 mmol/l; P = 0.046), no differences were observed between or within the groups. Psoriasis area and severity scores (PASI) improved to a greater extent in those patients receiving both UVB and calcipotriol (P = 0.045). The combination of UVB and calcipotriol is a safe, effective treatment for chronic plaque psoriasis.

Topics: Adolescent; Adult; Aged; Calcitriol; Calcium; Chronic Disease; Dermatologic Agents; Female; Homeostasis; Humans; Male; Middle Aged; Psoriasis; Ultraviolet Therapy

The biologically active form of vitamin D3, calcitriol, is effective in the treatment of psoriasis but can alter calcium metabolism. Calcipotriene is an analog of calcitriol that has low calcemic activity and aids in clearing psoriasis.. The purpose of this study was to determine the safety of topical therapy with calcipotriene particularly in relation to calcium and bone metabolism.. In a double-blind, randomized, parallel, vehicle-controlled trial, 78 adults with plaque psoriasis were treated twice daily with topical calcipotriene ointment (50 microgram/gm, maximum usage, 120 gm per week) or vehicle for 8 weeks. After a screening visit, patients were admitted to the hospital at weeks 0 (baseline), 1,2,4, and 8. Blood and urine chemistry analysis included parathyroid hormone, serum calcium, bone-specific alkaline phosphatase, urinary hydroxyproline, and 24 hour urinary calcium excretion. Bone densitometry measures were performed at baseline and week 8.. No incidences of calcipotriene treatment-related hypercalcemia, calcium mobilization from bone, or clinically significant changes in bone density wer noted during this study.. Topical application of up to 120 gm per week of calcipotriene ointment for 8 weeks is safe and effective for plaque psoriasis. There were no adverse effects on calcium and bone metabolism during this 8 week study.

Topics: Administration, Cutaneous; Adult; Alkaline Phosphatase; Bone and Bones; Bone Density; Calcitriol; Calcium; Densitometry; Dermatologic Agents; Double-Blind Method; Female; Humans; Hydroxyproline; Hypercalcemia; Male; Middle Aged; Ointments; Parathyroid Hormone; Pharmaceutical Vehicles; Psoriasis

Topics: Administration, Cutaneous; Adult; Calcitriol; Clobetasol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Ointments; Psoriasis; Remission Induction; Vasoconstrictor Agents

One hundred and sixty-eight individuals (psoriatic patients treated with calcipotriol with dermatitis due to calcipotriol, psoriatic patients treated with calcipotriol with no dermatitis, psoriatic patients never treated with calcipotriol, patients with eczema and healthy volunteers) were patch-tested (Finn chambers, back, 48 h) with dilutions of calcipotriol ointment (50, 10, 2, 0.4 micrograms/g) and an ointment vehicle. Test evaluation was based on clinical scoring and various non-invasive measuring methods. Doubtful (?+) and weak (1+) reactions were common, irrespective of patient group and history. Moderate (2+) reactions were uncommon and with no increased frequency among psoriatic patients with adverse dermatitis during calcipotriol treatment. The blood flow of test sites measured by laser Doppler flowmetry was, however, increased in psoriatics, who developed dermatitis during calcipotriol treatment as an isolated finding. Furthermore a 1-week repeated open application test (ROAT) was performed on all subjects. None of the persons having a strong reaction in the patch test showed any dermatitis in the ROAT test, indicating that they were not sensitized. Calcipotriol was found to be a mild irritant of the non-corrosive type, i.e. with no influence on the skin barrier. Reactions were dominated by redness (increased laser Doppler flow and chroma a*) and only oedema formation in advanced reactions. The calcipotriol dose-irritation curve was found to be scattered. Calcipotriol induced no increase of transepidermal water loss (TEWL) versus the ointment vehicle, but the ointment vehicle itself increased TEWL. The special ointment vehicle needed for calcipotriol for stability reasons may itself be irritant and cause some impairment of the skin water barrier, with increase in TEWL values. Future patch test studies for calcipotriol allergy should not be done with this vehicle. The non-irritant threshold concentration of calcipotriol in an appropriate test vehicle is still unknown.

Topics: Adult; Aged; Calcitriol; Dermatitis, Allergic Contact; Dermatitis, Contact; Dermatologic Agents; Double-Blind Method; Drug Eruptions; Female; Humans; Male; Middle Aged; Ointments; Patch Tests; Pharmaceutical Vehicles; Psoriasis; Skin

Treatment of psoriasis with vitamin D3 analogues is well established in present dermatological practice. One of the clinical signs of the psoriatic plaque that reduces early and markedly during treatment with the vitamin D3 analogue calcipotriol is scaling. Since scaling is the clinical manifestation of disordered epidermal differentiation, early changes in immunohistochemical markers for differentiation (transglutaminase, involucrin and filaggrin) were studied in patients who had been treated with calcipotriol for 4 weeks. Markers for proliferation (Ki-67 antigen) and inflammation (polymorphonuclear leucocytes and T lymphocytes) were also studied and correlated with the differentiation characteristics. Clinically, a major improvement was seen in all patients. A significant decrease in the percentage of transglutaminase-positive cell layers was observed during the first week of treatment. In contrast, an increase in transglutaminase activity in epidermal cell cultures following incubation with calcipotriol has been reported. Involucrin expression was only slightly modulated in vivo. However, a major restoration of the filaggrin-positive cell layer and significant reduction in the recruitment of cycling epidermal cells characterized the epidermal response to calcipotriol treatment. Markers for inflammation (T11-positive cells and elastase-positive cells) were also reduced substantially during the first week of treatment with calcipotriol. From this study it may be concluded that inhibition of epidermal growth and recovery of the filaggrin-positive cell layer are among the in vivo effects of calcipotriol.

Topics: Adult; Calcitriol; Cell Differentiation; Dermatologic Agents; Epidermis; Female; Filaggrin Proteins; Humans; Ki-67 Antigen; Male; Middle Aged; Pancreatic Elastase; Psoriasis; T-Lymphocytes; Transglutaminases

The long-term safety and effectiveness of calcipotriene 0.005% ointment has been evaluated in the treatment of 397 patients with stable plaque psoriasis. In this multicenter, open-label clinical investigation, the psoriasis characteristics of scaling, erythema, and plaque elevation and overall disease severity were evaluated periodically. Patients were carefully questioned and observed at each visit for adverse events. Laboratory parameters for safety were also evaluated at regular intervals. At the end of the study, 235 subjects were considered assessable. Psoriatic plaques were cleared by week 8 in 25% of the subjects. The median time to initial clearing was between 16 and 17 weeks. Forty-four subjects were prematurely withdrawn from the study due to adverse events, which were considered related to treatment in only 28. This study showed that calcipotriene 0.005% ointment is safe and effective for long-term use in the treatment of plaque psoriasis.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Calcitriol; Calcium; Dermatologic Agents; Drug Monitoring; Female; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Time Factors; Treatment Outcome

The purpose of this study was to examine the effectiveness and side-effects of the vitamin D analogue calcipotriol, applied topically to psoriatic skin lesions in intertriginous areas, in an open and uncontrolled trial. Twelve patients with psoriasis vulgaris who presented with psoriatic lesions in the axilla, and inguinal and anal folds, were treated with calcipotriol ointment (50 micrograms/g) twice daily for 6 weeks. Examination and photographic documentation were performed before treatment, at 3 weeks of treatment, and at 6 weeks of treatment. The mean improvement in the extent and severity of the psoriatic plaques was determined with a semiquantitative grading system closely related to the psoriasis area and severity index (M-PASI). Two of 12 patients showed insufficient response to therapy. Five of 12 patients showed a quick response within 3 weeks or less, and five of 12 patients showed a slow response which could be seen only after 6 weeks of treatment. Minimal burning was reported in one patient, slight lesional and/or perilesional irritation in five patients, and, in the remaining, no side-effects occurred. Topical calcipotriol is an effective and safe treatment for intertriginous psoriasis.

Topics: Adolescent; Adult; Aged; Anal Canal; Axilla; Calcitriol; Chronic Disease; Dermatologic Agents; Female; Groin; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index

Calcipotriol and corticosteroids, two therapy modalities frequently prescribed in the treatment of psoriasis, are often used in combination. The aim of the present study was to determine whether the cell biological response pattern of concurrent use of calcipotriol and corticosteroids is different from calcipotriol monotherapy. Forty patients with chronic plaque psoriasis were divided at random in four parallel groups and treated for 8 weeks with: (1) calcipotriol cream (50 micrograms/g once daily); (2) calcipotriol cream twice daily; (3) calcipotriol and clobetasone 17-butyrate (0.5 mg/g) creams; and (4) calcipotriol and betamethasone 17-valerate (1 mg/g) creams. Before and after treatment keratotome biopsies were taken and single cell suspensions prepared for flow cytometric analysis. Flow cytometric multiparameter quantification of markers for proliferation (TO-PRO-3), differentiation (antikeratin 10) and inflammation (antivimentin) was used to evaluate all four therapy modalities. A statistically significant decrease of the percentage of basal cells in S- and G2M-phase (proliferation) was obtained with all therapy modalities, except for calcipotriol monotherapy applied once daily. A significant reduction of the number of vimentin-positive cells (non-keratinocytes) was observed following combined treatment with calcipotriol and clobetasone butyrate. In contrast, monotherapy with calcipotriol had virtually no effect on the number of vimentin-positive cells. It can be concluded that: (i) calcipotriol monotherapy, applied once daily was less antiproliferative compared with twice daily applications of calcipotriol or the combined treatment with corticosteroids and that (ii) the combination of calcipotriol and corticosteroids proved to have a marked effect on the percentage of non-keratinocytes, in contrast to the modest effect of calcipotriol.

Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone Valerate; Calcitriol; Cell Division; Clobetasol; Dermatologic Agents; DNA; Drug Administration Schedule; Drug Therapy, Combination; Epidermis; Flow Cytometry; Glucocorticoids; Humans; Keratins; Psoriasis; Vimentin

Calcipotriol (Dovonex) ointment has been shown to be an effective, well tolerated, and acceptable treatment for psoriasis vulgaris in adults. This open study was conducted in 16 U.K. centres to assess the safety and efficacy of calcipotriol ointment in treating psoriasis vulgaris in children. Following a 2-week washout, patients were treated with calcipotriol ointment, 50 micrograms/g twice daily, for up to 8 weeks. A blood sample was taken on entry and a second 'on treatment' sample was taken after either 2 or 8 weeks treatment. Sixty-six children (26 boys, 40 girls, age range from 3 to 14 years) entered and 58 completed the study. There was a statistically significant reduction in the mean (+/- SD) Psoriasis Area and Severity Index (PASI) from 6.1 +/- 3.5 at the start of treatment to 2.7 +/- 1.9 at the end of treatment (P < 0.001). Marked improvement or clearance of psoriasis at the end of treatment occurred in 65% of patients as assessed by the investigator and 62% as assessed by the patient. Cosmetic acceptability of calcipotriol ointment was found to be good or excellent in 79% of patients. Eight patients withdrew from the study (four defaulted, two unacceptable responses, two adverse events). Adverse events were reported by 16 patients: the most common being local irritation (seven patients). There was no significant change in the mean serum ionized calcium from baseline to 2 or 8 weeks treatment. Similarly, there were no consistent or clinically important changes in haematological, or other biochemical parameters, measured during the study period. Calcipotriol ointment has been shown to be an effective, well tolerated, and acceptable treatment for psoriasis vulgaris in children.

Topics: Adolescent; Calcitriol; Calcium; Child; Child, Preschool; Chronic Disease; Dermatologic Agents; Female; Humans; Male; Patient Compliance; Prospective Studies; Psoriasis; Treatment Outcome

Topics: Adult; Aged; Calcitriol; Calcium; Dermatologic Agents; Female; Homeostasis; Humans; Male; Middle Aged; Psoriasis

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Calcitriol; Dermatologic Agents; Double-Blind Method; Humans; Middle Aged; Ointments; Pharmaceutical Vehicles; Placebos; Psoriasis

The antipsoriatic effects of two topical antipsoriatic agents, betamethasone valerate (Betnovate) and calcipotriol (Daivonex), and a pure nanocolloid gel were assessed in 10 patients with chronic plaque-type psoriasis in a modified psoriasis plaque test. Three noninvasive bioengineering methods were applied to measure antipsoriatic effects: chromametry for objective evaluation of erythema; visiometry, a method for profilometry, and 20-MHz skin ultrasound for the measurement of skin thickness as a parameter of inflammatory infiltration and psoriatic hyperproliferation of the epidermis. Regarding inflammation parameters such as skin thickness (infiltration) and erythema (dilatation of vessels and hyperperfusion), the steroid preparation Betnovate proved to be significantly most effective in our study. Daivonex showed significant decreases in the skin roughness parameters, underlining its antiproliferative effect. The nanocolloid carrier was significantly effective in thickness reduction, this effect being most probably due to occlusion. 20-MHz ultrasound, chromametry and visiometry proved to provide multiparameter assessment of treated and untreated psoriatic skin and can be recommended as objective and reproducible measurements for further studies.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Betamethasone Valerate; Calcitriol; Colorimetry; Dermatologic Agents; Evaluation Studies as Topic; Female; Glucocorticoids; Humans; Male; Middle Aged; Psoriasis; Single-Blind Method; Skin; Skin Pigmentation; Ultrasonography

Plaque psoriasis of mild to moderate severity is routinely treated with topical steroids and coal tar along with emollients. A safe and convenient new treatment modality would be of value to most patients with psoriasis.. Our purpose was to evaluate the safety and efficacy of a new vitamin D3 analogue, calcipotriene, for the treatment of plaque psoriasis.. Twice-daily dosing of calcipotriene was compared with its vehicle, for up to 8 weeks, in a double-blind study of 277 patients at 10 study centers in the United States. Two hundred forty-seven patients completed the trial. The clinical characteristics of plaque elevation, erythema, scaling, and overall disease severity were evaluated at baseline and after 1, 2, 4, 6, and 8 weeks of treatment. A Physician's Global Assessment of improvement or worsening of the disease was performed after 1, 2, 4, 6, and 8 weeks of treatment. Blood and urine samples, for routine clinical laboratory tests, were collected at baseline and after 1, 2, 4, and 8 weeks of treatment.. As early as the week 1 evaluation, patients treated with calcipotriene ointment 0.005% had significantly lower mean scores (p = 0.043) than the vehicle-treated patients for the disease characteristics of plaque elevation, erythema, and scaling. This trend continued through week 8 of treatment when 70% of the calcipotriene-treated patients showed 75% or more improvement compared with only 19% of vehicle-treated patients. Only minor treatment-related adverse events were observed. There were no abnormal laboratory results judged related to treatment and the rare instances of elevated serum calcium values were equally distributed between active and vehicle treatments.. This study provides evidence that calcipotriene is a safe, effective, and promising new agent for the treatment of moderately severe plaque psoriasis.

Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Calcitriol; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Psoriasis; Time Factors; Treatment Outcome; United States

Scalp psoriasis is associated with hair loss and an increased telogen/anagen ratio. Topical treatment of scalp psoriasis (with corticosteroids, dithranol or tar) results in decreased scaling, induration and erythema of the plaques. Calcipotriol is effective in the treatment of psoriasis vulgaris. However, the potent growth-inhibiting potential of this compound might theoretically induce hair loss. A study was designed to find out to what extent calcipotriol treatment modulates the percentage of anagen and telogen hair during treatment of scalp psoriasis. A group of 26 patients participated in a placebo-controlled dose-finding study on the efficacy of calcipotriol in scalp psoriasis. Hair plucks before and after treatment were taken. The telogen/anagen ratio remained unaffected during 6 weeks of calcipotriol treatment. No correlation was demonstrated between efficacy of treatment and quantification of telogen/anagen ratio. It can be concluded that the growth-inhibiting potential of calcipotriol is not reflected in the in vivo hair growth pattern during calcipotriol treatment.

Topics: Adult; Aged; Alopecia; Calcitriol; Dermatologic Agents; Dose-Response Relationship, Drug; Double-Blind Method; Female; Gels; Hair; Hair Follicle; Humans; Male; Middle Aged; Placebos; Psoriasis; Scalp Dermatoses

The topical vitamin D analogue calcipotriene has been reported to be an effective treatment for patients with psoriasis. Comparative studies with topical steroids are informative in judging this new therapy.. The purpose of this study was to evaluate the efficacy and safety of calcipotriene ointment 0.005% versus fluocinonide ointment 0.05% in the treatment of plaque psoriasis.. This study was a randomized, double-blind, parallel-group, active-controlled trial in adults who had at least mild overall disease severity and plaque elevation of at least moderate severity. Treatments were applied twice daily for 6 weeks, and subjects were evaluated at weeks 0, 2, 4, and 6. Subjects were graded on a 9-point scale (0 to 8) for scaling, erythema, plaque elevation, and for overall disease severity. A physician's global assessment of improvement/worsening was performed at every visit.. A total of 114 subjects were enrolled at six study sites. Ninety-nine subjects completed the trial. Mean scores for signs of scaling and plaque elevation in calcipotriene-treated subjects were significantly lower by week 2 than in the fluocinonide-treated subjects. These scores continued to be significantly lower than fluocinonide through week 6 (p < 0.05). Mean scores for erythema in calcipotriene-treated subjects were significantly lower than those in fluocinonide-treated subjects at weeks 4 and 6 (p < 0.05). Both the physician's global assessment and overall disease severity showed statistically significant treatment differences in favor of calcipotriene at week 4 (p < 0.05). This superior efficacy continued through week 6. Treatment-related adverse events were observed in 12 calcipotriene-treated subjects and 5 fluocinonide-treated subjects; all were considered minor.. Calcipotriene was superior to fluocinonide in the treatment of plaque psoriasis.

Topics: Adult; Aged; Calcitriol; Dermatologic Agents; Double-Blind Method; Female; Fluocinonide; Humans; Male; Middle Aged; Ointments; Psoriasis; Safety; Time Factors

A multi-centre, open, prospective study of 12 months duration was performed to assess safety, efficacy and tolerability of topical calcipotriol in the long-term treatment of psoriasis. One hundred and sixty-seven adults with chronic plaque psoriasis who had previously responded to calcipotriol entered the study. Disease activity was monitored using the psoriasis area and severity index (PASI). Calcipotriol ointment 50 micrograms/g was applied twice daily until remission was attained. Treatment was then stopped but reinstituted in the event of relapses.. Of the 167 recruited patients, 6 patients did not receive any treatment during the trial. A total of 39 patients were withdrawn: 15 due to inadequate control of their psoriasis, 9 due to irritant reactions, 7 due to defaulting and 8 for miscellaneous voluntary reasons. A further 24 patients either reached the study medication limit of 2,500 g or were considered to have completed the study a few weeks prior to the 12-month period. Accordingly, 98 patients were assessable after 12 months of therapy. Complete clearing was obtained in 26% of subjects, who then used the treatment intermittently. The remaining patients required continuous treatment for 12 months. The mean PASI fell from 8.1 (SD +/- 6.67, n = 167) at baseline to 3.90 (+/- 3.50, 136) at 2 months and 2.71 (+/- 2.12, 98) at 12 months. There was no rise in the mean serum total calcium.. Calcipotriol ointment was safe, effective and well tolerated.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Calcitriol; Chronic Disease; Dermatologic Agents; Female; Humans; Male; Middle Aged; Ointments; Patient Compliance; Prospective Studies; Psoriasis

Topical treatment of psoriasis with calcipotriol has been proven effective. The efficacy of calcipotriol has been compared to that of topical corticoids in a number of studies using subjective visual scoring systems such as the PASI index. The purpose of this study was to compare, with objective data, the efficacy of calcipotriol and clobetasol propionate 0.05% in the treatment of plaque type psoriasis. Transepidermal water loss (TEWL) and laser Doppler velocimetry (LDV) were used to monitor restoration of water barrier and normalization of blood flow, respectively, in psoriatic plaques of the limbs of 24 male patients during 3 weeks of treatment. Data were compared to subjective evaluation using the PASI index of the same areas. Significant differences were recorded during treatment in both groups. The results correlated well with the PASI score. Clobetasol was faster in restoring barrier function than calcipotriol. However, no significant differences were detected between the two groups. The use of vitamin analogues may be effective in the topical treatment of psoriasis by normalizing skin biophysical parameters and minimizing the risks of side-effects induced by potent topical corticoids.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Calcitriol; Clobetasol; Dermatologic Agents; Humans; Laser-Doppler Flowmetry; Male; Middle Aged; Psoriasis; Regional Blood Flow; Skin; Water Loss, Insensible

We report that calcipotriol (CPT) is a potent inhibitor of lymphocyte proliferation in mixed epidermal cell lymphocyte reactions. In this model, CPT and cyclosporine A (CsA) have synergistic effects. These results have led to a randomised double-blind therapeutic study protocol in patients with severe psoriasis. In these patients, topical CPT and sub-therapeutic doses of CsA (2mg/kg/d) induce disappearance of cutaneous lesions. This therapeutic association may minimize secondary side effects of both drugs.

Topics: Adult; Calcitriol; Cell Division; Chronic Disease; Cyclosporine; Dermatologic Agents; Dose-Response Relationship, Drug; Double-Blind Method; Drug Synergism; Female; Humans; In Vitro Techniques; Lymphocyte Culture Test, Mixed; Lymphocytes; Male; Psoriasis

The antipsoriatic efficacy, tolerability and safety of calcipotriol ointment was compared with tar in a prospective, right/left randomized, investigator-blinded controlled study. Calcipotriol ointment 50 micrograms/g twice daily was applied to one-half of the body. On the opposite side, white soft paraffin was applied in the morning, and coal tar solution BP 15% v/w in aqueous cream in the evening. Thirty patients with stable chronic plaque-type psoriasis were recruited. Assessments were made at 2, 4 and 6 weeks. Three patients were withdrawn from the study. A decrease in PASI score was seen on both sides at 2, 4 and 6 weeks. The differences from baseline between the two treatments were statistically significant in favour of calcipotriol. Improvement with calcipotriol was rapid in the first 2 weeks of treatment. With tar, significant improvement occurred only after 4 weeks of treatment. The differences in the scores for erythema, induration and desquamation from baseline between the two treatments were also statistically significantly in favour of calcipotriol at all evaluation points. Seven patients developed irritation on the calcipotriol-treated side, but there were no adverse effects on the tar-treated side. In two patients, itching associated with psoriasis was reduced by the calcipotriol. Although the mean serum calcium and phosphate levels remained within the normal ranges after 6 weeks' treatment, there were significant changes in their values compared with baseline.

Topics: Administration, Cutaneous; Adult; Aged; Calcitriol; Calcium; Chronic Disease; Coal Tar; Dermatologic Agents; Female; Humans; Male; Middle Aged; Ointments; Phosphates; Prospective Studies; Psoriasis; Single-Blind Method

The efficacy, tolerability and safety of calcipotriol solution and betamethasone 17-valerate solution were compared in a multicentre, prospective, randomized, double-blind, parallel group study. Four hundred and seventy-four patients with scalp psoriasis were recruited from six European countries and Canada. Following a 2-week washout period, either calcipotriol solution (50 micrograms/ml) or betamethasone 17-valerate solution (1 mg/ml) was applied twice daily for 4 weeks. After this time, patients who required no further active treatment were observed for relapse. Retreatment with calcipotriol was offered to those patients who relapsed, and who were originally in the calcipotriol-treated group. The two treatment groups were well matched at baseline. At the end of treatment, the proportion of patients who had 'cleared' or 'markedly improved' was statistically significantly greater in the betamethasone group (75%) than in the calcipotriol group (58%) (P < 0.001) (95% confidence interval of difference 25.3-->8.6). The decrease in total sign score (sum of scores for erythema, thickness and scaliness) at the end of treatment was also statistically significantly greater in the betamethasone group (61%) than the calcipotriol group (45%) (P < 0.001) (95% confidence interval of difference 9.7-->23.1). Adverse events were reported by 87 patients in the calcipotriol group, and 31 patients in the betamethasone group; the most common was lesional or perilesional irritation, which occurred significantly more frequently with calcipotriol (26%) than with betamethasone (8%) (P < 0.001). Fifteen patients (6%) in the calcipotriol group and four (1%) in the betamethasone group withdrew from the study because of adverse events or unacceptable treatment response (P = 0.017).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Aged; Aged, 80 and over; Betamethasone Valerate; Calcitriol; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Middle Aged; Prospective Studies; Psoriasis; Scalp Dermatoses; Solutions

Recent advances in the treatment of psoriasis include both the topical vitamin D analogue calcipotriol and cyclosporine. Combined treatments have been sought to decrease the incidence of side effects while maintaining efficacy in the treatment of severe chronic plaque psoriasis.. The objective of this study was to evaluate the efficacy and safety of the combination of 2 mg/kg/day of cyclosporine with calcipotriol ointment (50 micrograms/gm) in the treatment of severe plaque psoriasis.. Sixty-nine patients were randomly selected for this double-blind, multicenter study to receive cyclosporine (2 mg/kg/day) combined with calcipotriol ointment (50 micrograms/gm) or cyclosporine (2 mg/kg/day) combined with placebo ointment (vehicle of calcipotriol) for a 6-week period.. Complete clearing or 90% improvement in Psoriasis Area and Severity Index score occurred in 50.0% of patients in the calcipotriol/cyclosporine group in comparison with 11.8% of patients treated with placebo/cyclosporine (p = 0.0019). The confidence interval for the difference ranged from 17.8% to 58.7%. No difference was found between the two groups with respect to side effects.. The calcipotriol/cyclosporine combination was more effective than placebo/cyclosporine. Further studies are needed to establish the long-term efficacy and safety profile of this combination therapy.

Topics: Adult; Aged; Calcitriol; Cyclosporine; Dermatologic Agents; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Ointments; Psoriasis

Calcipotriol, a non-calcemic vitamin D3 analogue, inhibits the proliferation and is necessary for final differentiation of keratinocytes. The aim of the present study was to determine the efficacy and tolerability of calcipotriol ointment in patients treated for 6 weeks. Twenty patients with chronic plaque-type psoriasis were treated twice daily with calcipotriol ointment 50 ng/g. After 6 weeks' treatment there was a marked and statistically significant decrease in the PASI score values for 17 patients, no improvement was seen in 1 patient and local adverse events occurred in 2. Hypercalcemia or other laboratory abnormalities did not develop in any patient.

Topics: Administration, Topical; Adult; Aged; Calcitriol; Dermatologic Agents; Female; Humans; Male; Middle Aged; Ointments; Psoriasis

Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Glucocorticoids; Humans; Psoriasis; Salicylates; Salicylic Acid

The efficacy and safety of calcipotriol solution in the treatment of scalp psoriasis was compared with placebo (vehicle solution), in a multicentre double-blind, randomized, parallel-group study of 49 adult patients. Calcipotriol solution (50 micrograms/ml), or placebo, was applied twice daily over a 4-week period. At the end of the study period 60% of patients on calcipotriol showed clearance or marked improvement of their psoriasis compared with 17% on placebo. Overall assessment of treatment response showed that calcipotriol was superior to placebo in both investigator (P < 0.001; 95% confidence interval for difference 19.0-67.6) and patient (P < 0.001; 95% confidence interval for difference 18.3-68.0) assessments. Total sign score for psoriasis (i.e. the sum of the scores for redness, thickness and scaliness) decreased by 48.9% in the calcipotriol group, and by 18.6% in the placebo group (P = 0.005). Calcipotriol was significantly superior to placebo in reducing redness, thickness, scaliness and extent of psoriasis, and in the patients' assessment in reducing scalp flaking and itching. No statistically significant changes in blood biochemistry were detected during the study, and the solution was generally well tolerated.

Topics: Adult; Calcitriol; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Psoriasis; Scalp Dermatoses; Skin

Combining PUVA with other therapeutic agents which reduce the UVA dose required for clearance of psoriasis may be of benefit by reducing the long-term risk of cutaneous malignancy and by increasing the efficacy of treatment. We have therefore studied the effect of calcipotriol in 13 patients with plaque-type psoriasis who were about to start twice weekly PUVA. In each patient, from the start of PUVA treatment, two plaques on symmetrical body sites were selected for assessment. Calcipotriol ointment was applied to one twice daily, and placebo to the other. Response was assessed weekly for 6 weeks: an investigator, unaware of treatment allocation, compared psoriasis severity within each of the plaques, and blood flux was measured using a scanning laser-Doppler velocimeter. Of the 11 patients who completed the study, in nine the calcipotriol-treated plaque either cleared before the placebo-treated plaque (n = 7), or was consistently judged to be better (n = 2). From the third week of the trial, mean blood flux was significantly lower in the calcipotriol-treated plaques than in those treated with placebo. In the seven patients whose psoriasis was clear in at least one plaque at the end of the study period, there was a median reduction in UVA dose of 26.5% for calcipotriol compared with placebo. With the exception of one patient, the improved response was not associated with earlier relapse.

Topics: Adult; Aged; Calcitriol; Dermatologic Agents; Female; Humans; Male; Middle Aged; Psoriasis; PUVA Therapy; Skin

The purpose of this double-blind, placebo-controlled study was to examine whether the vitamin D analogue calcipotriol, topically applied to psoriatic skin lesions, had any effect on calcium or bone metabolism. Thirty-four outpatients with psoriasis vulgaris were randomized to treatment with either calcipotriol ointment (50 micrograms/g) or vehicle ointment twice daily for 3 weeks. The patients were put on a calcium energy fixed diet and examined once weekly. The mean amount of calcipotriol ointment used was 40.3 g/week (range 8.2-95.4 g/week). The results of biochemical markers on calcium and bone metabolism showed no significant differences between the two groups. No correlation was found between the amount of ointment used and changes in parameters on calcium and bone metabolism during the 3-week treatment. It is concluded that calcipotriol ointment (50 micrograms/g), applied in doses of 8.2-95.4 g/week for 3 weeks to psoriatic skin lesions, has no effect on calcium or bone metabolism.

Topics: Administration, Cutaneous; Adult; Aged; Bone and Bones; Calcitriol; Calcium; Dermatologic Agents; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Psoriasis; Severity of Illness Index; Time Factors

Topics: Adult; Calcitriol; Clobetasol; Colloids; Dermatologic Agents; Female; Humans; Male; Occlusive Dressings; Psoriasis; Single-Blind Method

Topics: Administration, Topical; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Humans; Psoriasis; Ultraviolet Therapy

Forty-eight patients with symmetrical chronic plaque psoriasis affecting the limbs were recruited for a single-blind right/left within patient study to assess the effect of combining occlusion with topical calcipotriol. Subjects were randomized into two groups. Sites of similar severity on opposing limbs were selected as target areas. The first (group A) treated one side with calcipotriol alone and the opposite side with calcipotriol plus occlusion. The second (group B) treated one side with placebo plus occlusion and the opposite side with calcipotriol plus occlusion. In group A the mean improvements were 40% (P < 0.001) for calcipotriol alone and 61% (P < 0.001) for calcipotriol plus occlusion. In group B, occlusion plus calcipotriol resulted in a mean 62% improvement (P < 0.001) while occlusion plus placebo produced no significant change. The combination of calcipotriol plus occlusion was significantly better than calcipotriol alone (P < 0.005). The results indicate that occlusion improves the response to calcipotriol by enhancing its penetration. Indices of calcium metabolism remained unchanged throughout the study.

Topics: Administration, Topical; Adult; Calcitriol; Chronic Disease; Dermatologic Agents; Female; Humans; Leg; Male; Psoriasis; Single-Blind Method

Changes in epidermal immunocytes and cytokeratins were investigated during treatment of psoriasis with calcipotriol and betamethasone valerate. Skin biopsies were obtained from 10 subjects on each treatment from lesional and non-lesional skin at baseline, and from treated lesions after 4 weeks. In each subject, changes in expression of cytokeratins K5, K10 and K16, and changes in epidermal immunocyte counts were assessed. Responses were compared with a separate histological parameter of improvement, epidermal thickness. Both treatments produced a marked normalization of cytokeratins. The reduction of K16 expression was similar on each treatment and correlated significantly with reduction in epidermal thickness. Expression of both K5 and K10 improved less than thickness with betamethasone valerate but more than thickness with calcipotriol, although these differences did not reach statistical significance. With calcipotriol there was an increase in K5 and K10 responses with increasing response of epidermal thickness, which was not seen with betamethasone valerate. T6+ cells, HLA-DR+ dendritic cells and T lymphocytes were all reduced by betamethasone valerate. There was a remarkable similarity in the level of normalization between cell types and also between cellular response and reduction in thickness. Calcipotriol produced a similar consistent reduction in cell numbers and in thickness, with the exception of T6+ cells which increased in some subjects during treatment. Only in subjects in whom thickness had virtually returned to normal was there a marked decrease in T6+ cells.

Topics: Adult; Aged; Antigen-Presenting Cells; Antigens, CD; Antigens, Differentiation, T-Lymphocyte; Betamethasone; Calcitriol; Dendritic Cells; Epidermis; Female; Humans; Keratins; Male; Middle Aged; Psoriasis; T-Lymphocytes

Short-contact treatment with dithranol (anthralin) is a widely used treatment for chronic plaque psoriasis. Although effective, it causes staining and irritation, and is therefore inconvenient. Calcipotriol is a recently developed vitamin D analogue which is effective and easy to use. To evaluate the relative efficacy, safety and acceptability of these treatments a multicentre, open, randomized, parallel-group comparison was performed. Four hundred and seventy-eight patients with chronic plaque psoriasis were randomized to use one of the two treatments for 8 weeks. One group applied calcipotriol ointment (50 micrograms/g) twice daily. The other used a single application for 30 min each day of Dithrocream in the highest concentration tolerated. Severity of psoriasis was assessed by modified PASI score at baseline, and after 2, 4, and 8 weeks of treatment. A five-point scale was used by subjects and by investigators as an additional assessment of overall response, and a similar scale was used by subjects to grade acceptability. Total serum calcium was monitored at baseline and after 2 and 8 weeks on treatment. The mean PASI score fell from 9.1 to 4.7 after 8 weeks on dithranol (P < 0.001), and from 9.4 to 3.4 on calcipotriol (P < 0.001). The difference between the two treatments was significant in favour of calcipotriol at 2 weeks (P < 0.001), and remained so at subsequent assessments. At 8 weeks the difference between mean improvements in scores for the two groups was 1.6 (95% confidence interval 0.5-2.7). Efficacy grading by subjects and investigators, and acceptability grading by subjects, were all significantly better for calcipotriol.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Anthralin; Calcitriol; Calcium; Double-Blind Method; Female; Humans; Male; Observer Variation; Psoriasis; Severity of Illness Index

The discovery of a high-affinity receptor for the bioactive form of vitamin D3, 1,25-dihydroxyvitamin D3 (1,25[OH]D3), in most skin cells has led to the finding of previously unknown effects of vitamin D on epidermal growth and on the skin immune system. 1,25(OH)2D3 inhibits epidermal proliferation and promotes epidermal differentiation. These properties provided the rationale for introducing 1,25(OH)2D3 in the treatment of psoriasis vulgaris. In addition to 1,25(OH)2D3, the synthetic vitamin D3 analogues 1 alpha(OH)D3, 1,24(OH)2D3, and calcipotriol have undergone clinical evaluation. Calcipotriol has been studied most extensively. Compared with 1,25(OH)2D3, calcipotriol is about 200 times less potent in its effects on calcium metabolism, although similar in receptor affinity. In double-blind, placebo-controlled, randomized studies, topical calcipotriol (50 micrograms/gm, up to 100 gm weekly) has been shown to be efficacious and safe for the treatment of psoriasis. A similar therapeutic profile has been seen in long-term studies. In comparative studies topical calcipotriol is slightly more efficacious than betamethasone 17-valerate and dithranol. The mode of action of calcipotriol and other vitamin D3 analogues in psoriasis is not known. Although vitamin D3 analogues affect epidermal growth, their immunosuppressive properties may be equally important for their antipsoriatic effect.

Topics: Administration, Topical; Calcitriol; Dermatologic Agents; Humans; Psoriasis; Vitamin D

The biologically active form of vitamin D3, calcitriol, may offer a new therapeutic approach to psoriasis. Calcipotriol, a new vitamin D3 analogue, is at least 100 times less calcemic than calcitriol.. Our purpose was to study the efficacy and safety of calcipotriol in the treatment of psoriasis vulgaris.. In a right/left comparative, double-blind study, treatment with calcipotriol ointment (50 micrograms/gm) twice daily and placebo was given for 4 weeks. The preferred treatment was continued, without opening the code, for another 4 weeks. Efficacy, as measured by the Psoriasis Area and Severity Index and by the investigator's and patient's global assessment, and safety were assessed every 2 weeks.. The mean Psoriasis Area and Severity Index fell in 4 weeks from 14.2 to 6.3 with calcipotriol and from 14.1 to 9.2 with placebo (p < 0.001; 95% confidence interval for difference: 1.78-->3.94). Local side effects were equally common with calcipotriol and placebo. The mean serum calcium remained unchanged.. Topical application of up to 50 gm of calcipotriol ointment per week was found to be an effective and safe treatment of psoriasis vulgaris.

Topics: Adult; Calcitriol; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Ointments; Psoriasis

Topical vitamin D analogues have been reported to be an effective treatment in patients with psoriasis. Comparative studies with existing treatments are required.. Our purpose was to compare the effectiveness of calcipotriol (50 micrograms/gm) and betamethasone 17-valerate (1 mg/gm) ointments twice daily in the treatment of stable plaque psoriasis.. This study was a randomized, double-blind comparison over 6 weeks in 409 patients. Efficacy, as measured by the Psoriasis Area and Severity Index (PASI), and safety were assessed at 2, 4, and 6 weeks.. Reduction of PASI was statistically significant at all time points for both treatments but there were no significant between-treatment differences. At the completion of 6 weeks of treatment, the mean PASI reduction was 5.50 for calcipotriol and 5.32 for betamethasone (95% confidence interval [CI] -0.40 to 0.78). Analysis of patient assessment at 6 weeks showed clearance or marked improvement in 61.2% of the calcipotriol patients and 50.5% with betamethasone (95% CI 1.4 to 20.8). Calcipotriol produced significantly more local side effects (19.5% compared with 3.9%, p less than 0.001); however, these were minimal leading to withdrawal in only 3 of 205 patients.. Calcipotriol ointment was as effective as betamethasone 17-valerate ointment as measured by the PASI and superior as measured by self-assessment in patients with stable plaque psoriasis. Both treatments were well tolerated.

Topics: Betamethasone Valerate; Calcitriol; Canada; Dermatologic Agents; Double-Blind Method; Drug Tolerance; Female; France; Humans; Ireland; Male; Ointments; Patient Dropouts; Psoriasis; United Kingdom

The therapeutic efficacy and tolerability of calcipotriol ointment and betamethasone valerate ointment in psoriasis were compared in a multicentre, prospective, randomised, double-blind, right/left trial. 345 inpatients and outpatients with psoriasis vulgaris of symmetrical distribution were treated twice daily for 6 weeks with calcipotriol ointment 50 micrograms/g and betamethasone ointment 0.1% randomly assigned to opposite sides of the body. The main outcome measures--the psoriasis area and severity index (PASI), the investigators' assessments of erythema, thickness, and scaling, and the patients' own assessments of the overall response to treatment--were sought at weeks 2, 4, and 6. Both treatments significantly reduced the PASI scores and the investigator's assessment scores, but at each visit the PASI score was significantly (p less than 0.001) lower with calcipotriol than with betamethasone. At 6 weeks the mean PASI reduction was 68.8% with calcipotriol and 61.4% with betamethasone (95% confidence interval for difference 5.1-9.8, p less than 0.001). The scores for erythema, thickness, and scaling were significantly (p less than 0.001) lower with calcipotriol than with betamethasone at the end of treatment. The patients considered that 82.1% of calcipotriol-treated sides and 69.3% of betamethasone-treated sides had improved greatly or cleared up by the end of treatment (p less than 0.001). 57 adverse events were reported by 52 patients (15.1%). The most common adverse event, lesional/perilesional skin irritation, was slightly but not significantly (p = 0.12) more common with calcipotriol treatment. 15 (4.3%) patients were withdrawn from the study, 3 because of local adverse events. There were no changes in serum calcium during the study. Thus, calcipotriol ointment was superior to betamethasone valerate ointment in psoriasis vulgaris. Though long-term results are not yet available, calcipotriol holds great promise as an antipsoriatic agent.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Betamethasone Valerate; Calcitriol; Double-Blind Method; Drug Administration Schedule; Drug Evaluation; Female; Follow-Up Studies; Humans; Male; Middle Aged; Ointments; Prospective Studies; Psoriasis; Severity of Illness Index

Topics: Betamethasone; Calcitriol; Double-Blind Method; Humans; Psoriasis

Calcipotriol is a non-calcaemic vitamin D3 analogue. In short-term studies, topically applied calcipotriol is both efficacious and safe for the treatment of psoriasis vulgaris. The purpose of the present study was to determine the efficacy and safety of calcipotriol ointment in patients treated for approximately 6 months. Fifteen patients with plaque-type psoriasis were treated daily with calcipotriol ointment 50 micrograms/g. After treatment for 6 weeks there was a significant alleviation of erythema, infiltration and scaling. This degree of improvement was maintained throughout the study, except in one patient, who was withdrawn at week 15 because of minimal improvement. At the end of treatment, 80% of the patients showed a moderate improvement at least. Local adverse events occurred in 3 patients. These were mild and transient. Hypercalcaemia or other laboratory abnormalities did not develop in any patient. Morphometric examination of biopsies taken from perilesional skin (i.e. skin exposed to calcipotriol) at the end of treatment did not show signs of epidermal or dermal atrophy compared with uninvolved psoriatic skin. Although only a limited number of patients participated in the study, these results indicate that calcipotriol ointment 50 mu/g is both efficacious and safe for the long-term treatment of psoriasis.

Topics: Administration, Cutaneous; Adult; Aged; Calcitriol; Calcium; Female; Humans; Male; Middle Aged; Ointments; Prospective Studies; Psoriasis; Treatment Outcome

Topics: Betamethasone Valerate; Calcitriol; Double-Blind Method; Humans; Ointments; Prospective Studies; Psoriasis

The efficacy of MC903, a vitamin D3 analogue, in reducing hyperproliferation as determined by levels of ornithine decarboxylase (ODC) was investigated in a double-blind study of 15 patients with chronic plaque psoriasis. The lesions of psoriasis were treated for 8 weeks with MC903 in one of two different cream bases or with a placebo cream. Biopsies were taken before and after treatment. In addition an uninvolved area of skin was treated during the last 3 weeks and this as well as control areas were then sellotape stripped and biopsied after 8 h. Clinical improvement was seen in eight out of 11 patients treated with MC903 but there was no reduction in the level of ODC in psoriatic lesions after 8 weeks of treatment. The levels of ODC in the tape-stripped uninvolved skin after 3 weeks of treatment with MC903 averaged 22.5 +/- 4.2 pmol/min/mg protein as compared to 58.6 +/- 12.6 pmol/min/mg protein (P = 0.004). The trauma-induced induction of ODC activity was markedly inhibited by the application of MC903.

Topics: Adult; Calcitriol; Chronic Disease; Double-Blind Method; Enzyme Induction; Epidermis; Female; Humans; Male; Ornithine Decarboxylase; Psoriasis

The influence of topical application of MC903, an analogue of 1 alpha,25-dihydroxyvitamin D3, on psoriatic plaques was investigated during a long-term treatment study. The parameters for epidermal growth and for inflammation were assessed on frozen sections using immunohistochemical methods to elucidate their modulations in time and the interrelations between the different cell types involved during treatment with MC903. Biopsies were taken before and after 1, 2, 4 and 12 weeks of treatment. Monoclonal antibodies against the hyperproliferation-associated keratin 16, against cycling nuclei, and against T lymphocytes, B lymphocytes, Langerhans cells and CD14-positive cells were used in combination with a polyclonal antibody against polymorphonuclear leucocyte (PMN)-elastase. The earliest change was a statistically significant decrease in PMN after 1 week of treatment followed by a decline of cycling nuclei after 2 weeks. These changes preceded a decrease of T lymphocytes which occurred after 4 weeks. Keratin 16 content tended to diminish after 4 weeks of treatment. CD14+ cells decreased slightly during the observation period, whereas Langerhans cells tended to increase. No B lymphocytes were found. These results suggest that MC903 influences the number of PMN and epidermal growth rather than the number of T lymphocytes.

Topics: Adult; Aged; Aged, 80 and over; Calcitriol; Cell Division; Epidermis; Humans; Immunoenzyme Techniques; Inflammation; Middle Aged; Neutrophils; Psoriasis

Twenty patients with psoriasis were treated with the vitamin D3 analogue MC903 and betamethasone ointment in a double-blind trial with a left-right comparison. In addition to the clinical severity scores, Ks8.12 binding which detects keratin 16 expression and the DNA synthesis were quantified using flow cytometry. Both markers decreased significantly with treatment, but remained above the normal range even in those who had total clearance of the lesions. Treatment with MC903 with regard to Ks8.12 binding was significantly better than with betamethasone.

Topics: Adult; Aged; Antibodies, Monoclonal; Betamethasone; Calcitriol; DNA; Double-Blind Method; Female; Fluorescent Antibody Technique; Humans; Keratins; Male; Middle Aged; Psoriasis; Skin

The synthetic compound MC 903 (calcipotriol) is a structural analogue of the naturally occurring, biologically active 1,25-dihydroxyvitamin D3 [1,25-(OH)2-D3]. MC 903 and 1,25-(OH)2-D3 show similar receptor binding and comparable effects on cell differentiation. However, MC 903 appears to be at least 100 times less potent in its effects on calcium metabolism. In previous double-blind placebo-controlled studies, topical MC 903 has been shown to have a therapeutic effect in psoriasis. The present open study involving 20 patients with psoriasis vulgaris was a right/left comparison of the efficacy and tolerability of MC 903 ointment (50 micrograms/g) alone or with UVB radiation. After treatment for 8 weeks, topical MC 903 alone resulted in marked improvement in 66% of the patients and in clearance in 17%. Combination of topical MC 903 with UVB resulted in marked improvement in 50% of the patients and in clearance in 39%. These differences were not statistically significant. No significant change in serum calcium levels was detected. Two patients developed a facial dermatitis which disappeared spontaneously during continued treatment. These results show that the combination of topical MC 903 and UVB radiation is well tolerated. Larger-scale studies are warranted to answer the question whether UVB radiation induces a significant improvement of the antipsoriatic effect of topical MC 903.

Topics: Adult; Aged; Calcitriol; Combined Modality Therapy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Psoriasis; Ultraviolet Therapy

Calcipotriol (the synthetic compound MC 903) is a structural analogue of naturally occurring, biologically active calcitriol. Calcipotriol and calcitriol (1,25-dihydroxy vitamin D3) show similar receptor binding and comparable effects on cell differentiation. However, calcipotriol seems to be at least 100 times less potent in its effects on calcium metabolism. In a double-masked study involving 50 patients with psoriasis vulgaris, the efficacy and tolerability of ointments containing various calcipotriol concentrations (25, 50, or 100 micrograms/g) or the vehicle alone were compared in a study involving a right-left, within-patient randomized design. Patients were treated twice daily for 8 weeks. Marked improvement was seen in 40% of the patients treated with the 25-micrograms/g concentration of calcipotriol in 63% of patients treated with the 50-micrograms/g concentration, and in 88% treated with the 100-micrograms/g concentration. No patient treated with placebo had more than slight improvement. Five patients developed facial dermatitis during the study. The serum levels of ionized calcium were unchanged. This study demonstrates that calcipotriol ointment provides an effective and well-tolerated treatment of psoriasis vulgaris.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Calcitriol; Double-Blind Method; Drug Eruptions; Female; Humans; Male; Middle Aged; Psoriasis; Random Allocation

In 10 in-patients with chronic plaque psoriasis, the antipsoriatic effect of MC903, a new synthetic analogue of vitamin D was evaluated. In each patient two symmetrical located psoriatic plaques were selected for the study. Topical treatment with MC903 cream (containing 1.2 mg MC903 per g cream) was compared with placebo cream in a double-blind, controlled, left-right, randomized way during 6 weeks of therapy. Compared with baseline, the clinical (erythema, scaling and infiltration) improvement was significant after 1 week of therapy with MC903 cream, while lateral comparison showed MC903 cream significantly better than cream base after 4 weeks of therapy (p less than 0.05). Measurements of skin blood flow by the laser Doppler technique in evaluating the disease activity was not superior to the clinical assessments. In 3 patients the psoriatic lesions treated with MC903 cream cleared completely during 6 weeks of therapy. No essential adverse reactions were observed. MC903 has a potent effect on cell proliferation and cell differentiation, but has minimal effect on calcium metabolism. It is concluded that this synthetic vitamin D analogue is potentially useful in the treatment of psoriasis.

Topics: Administration, Topical; Adult; Aged; Calcitriol; Clinical Trials as Topic; Double-Blind Method; Humans; Middle Aged; Psoriasis; Random Allocation; Regional Blood Flow; Skin

Skin biopsies from 5 patients with chronic plaque psoriasis were examined to test the effect of topical treatment with a new synthetic vitamin D3 analogue, MC 903, on epidermal interleukin 6 (IL-6) and tumour necrosis factor alpha (TNF alpha). Skin biopsies, taken before therapy and after one and 2 weeks of therapy were examined immunohistologically. IL-6 was visualized using a partially purified polyclonal antiserum to crude supernatants of activated human blood monocytes before and after absorption with recombinant human IL-6. TNF alpha was demonstrated using a specific polyclonal antiserum to human recombinant TNF alpha. Both the intensity and extension of staining for IL-6, but not for TNF alpha, were increased in lesions compared with unaffected skin. During therapy with MC 903 a decline in the staining intensity for IL-6, but not for TNF alpha, was observed in both lesional and unaffected skin. Placebo-treated lesions, however, remained unchanged.

Topics: Adult; Biopsy; Calcitriol; Epidermis; Humans; Interleukin-6; Middle Aged; Ointments; Psoriasis; Skin; Tumor Necrosis Factor-alpha

Topics: Administration, Topical; Adolescent; Adult; Aged; Calcitriol; Calcium; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis; Skin

Topics: Calcitriol; Combined Modality Therapy; Dermatologic Agents; Humans; Psoriasis; Treatment Outcome; Ultraviolet Therapy; Vitamin D; Vitamins

Topics: Aged; Betamethasone; Dermatologic Agents; Drug Combinations; Humans; Medicare Part D; Psoriasis; Treatment Outcome; United States

Clinical trials have demonstrated the efficacy of fixed-dose combination calcipotriol/betamethasone (Cal/BD) aerosol foam for the treatment of patients with scalp psoriasis. However, data on the real-world effectiveness of Cal/BD aerosol foam in this subgroup of patients are lacking. Therefore, this study investigated the effectiveness and tolerability of 4 weeks' treatment with Cal/BD aerosol foam in patients with scalp psoriasis in everyday clinical practice.. This prospective, non-interventional multicenter study involved 217 adults with scalp psoriasis who were treated with Cal/BD aerosol foam for 4 weeks. Primary endpoints included the proportion of patients with <10% of the scalp area affected (Scalp-BSA) plus a Scalp-PGA of "mild" after 4 weeks, as well as the proportion of patients with an absolute PSSI ≤2 points after 4 weeks. Secondary endpoints included patient reported changes in erythema, itching, flaking, and thickness at baseline, 3 days, 1 week, 2 weeks, and 4 weeks.. After 4 weeks, 53.4% of patients treated with Cal/BD aerosol foam had achieved a Scalp-BSA of <10% and a mild Scalp-PGA. Furthermore, 47.6% of patients achieved a PSSI ≤2. Improvements in pruritus and other symptoms (induration, erythema, and scaling) were seen already within 3 days. The proportion of patients who reported that scalp psoriasis had no influence on their quality of life (Dermatology Quality of Life Index 0/1 points) increased from 3.2% at baseline to 47.9% at study end. Patient satisfaction with treatment was high (Treatment Satisfaction Questionnaire-9 scores of 74.5 ± 27.1 for effectiveness, 72.0 ± 25.2 for ease of use, and 77.8 ± 24.2 for general satisfaction). Overall, 97.4% of HCPs assessed the tolerability of Cal/BD aerosol foam as good/very good with no new safety concerns.. This study demonstrated the effectiveness, rapid onset of action, good tolerability, and good safety profile of the Cal/BD aerosol foam in patients with scalp psoriasis treated in a real-world setting.

Topics: Adult; Aerosols; Betamethasone; Dermatologic Agents; Drug Combinations; Humans; Prospective Studies; Pruritus; Psoriasis; Quality of Life; Scalp; Treatment Outcome

Nail psoriasis has a major negative impact on the physical and psychological aspects of the patient's life. Treatment is often unsatisfactory because of the difficult penetration of the drug into the nail.. To compare the efficacy of fractional CO 2 laser monotherapy versus combined fractional CO 2 laser and calcipotriol/betamethasone ointment preparation in treatment of nail psoriasis.. Thirty patients with nail psoriasis with at least 2 affected fingernails were recruited for this study. Target NAPSI (tNAPSI) score was calculated at the start of the study and at 3 months after the last laser session. One affected fingernail of each patient received 6 sessions of fractional CO 2 laser with 4-week intervals. Another affected fingernail of each patient received topical betamethasone/calcipotriol ointment once daily in addition to the 6 fractional CO 2 laser sessions.. In the monotherapy group, there was significant improvement in the nail matrix score, nail bed score, and tNAPSI score. In the combined therapy group, there was significant improvement in nail bed score and tNAPSI score, but nail matrix score showed no statistically significant improvement. Overall, there was no statistically significant difference between the 2 studied groups.. Fractional CO 2 laser can be an effective and promising new treatment for nail psoriasis.

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Humans; Nail Diseases; Ointments; Psoriasis; Treatment Outcome

Many patients with moderate-to-severe psoriasis may not achieve complete skin clearance with recalcitrant lesions despite being on biologics. We aimed to evaluate the real-world effectiveness and safety of combining topical calcipotriene/betamethasone dipropionate (Cal/BD) foam with biologic therapy for the treatment of recalcitrant psoriatic lesions over the scalp or lower legs. We retrospectively reviewed the medical charts of psoriasis patients receiving adjunctive topical Cal/BD foam with biologics for at least 16 weeks on recalcitrant psoriatic lesions of the scalp or lower legs between 2020 and 2021 at a tertiary referral medical center in southern Taiwan. Among the 18 recruited patients, the severity outcomes of body surface area (BSA), Physician's Global Assessment (PGA), and BSA × PGA of the recalcitrant areas decreased by approximately 31%, 48%, and 50%, respectively, after 4 weeks of once-daily adjunctive Cal/BD foam use. Thereafter, the effect remained nearly constant after dose reduction to twice weekly until week 16. The Dermatology Life Quality Index and the nine-item Treatment Satisfaction Questionnaire for Medication questionnaire revealed improved life quality and a high level of satisfaction, with only a few mild adverse effects reported. In conclusion, adjunctive topical Cal/BD foam might be an effective and safe option for patients with recalcitrant lesions on the scalp and lower legs despite biologics use.

Topics: Betamethasone; Biological Products; Biological Therapy; Dermatologic Agents; Drug Combinations; Humans; Leg; Psoriasis; Retrospective Studies; Scalp; Treatment Outcome

Most patients with plaque psoriasis exhibit mild-to-moderate disease and topical therapies remain the mainstay treatment option for these patients. The use of topical steroids in combination with vitamin D analogs can produce synergistic effects and minimize adverse effects. However, due to the incompatible pH ranges of topical steroids and vitamin D analogs, combination formulations can be difficult to manufacture. Until recently, only anhydrous formulations of these 2 agents were developed as foam, gel/suspension, and ointment. However, anhydrous vehicles can often result in greasy or oily skin, thus limiting treatment adherence. Recently, Polyaphron Dispersion (PAD) technology presents a new, more cosmetically appealing vehicle that allows for both topical steroids and vitamin D analogs to coexist in an aqueous environment, such as a cream formulation. The calcipotriene/betamethasone dipropionate (CAL/BDP) cream enhances drug delivery by reducing the greasy and oily side effects of anhydrous formulations. Phase 3 clinical trials have demonstrated CAL/BDP cream’s superior efficacy in treating psoriasis over gel/suspension, and the clinical trials have also shown significantly improved patient satisfaction with the cream formulation.   .

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Emollients; Excipients; Humans; Psoriasis; Treatment Outcome

Topical medications are commonly used to manage mild-to-moderate psoriasis and serve as adjunct therapies used in combination with phototherapy and systemic treatments. Fixed-dose calcipotriene (Cal) 0.005%/betamethasone dipropionate (BD) 0.064% aerosol foam is a safe, efficacious topical therapy approved for the treatment of psoriasis vulgaris in the United States and European Union. Several investigator-initiated studies (IISs) have been conducted to provide real-world evidence related to the safety, effectiveness, and therapeutic indications of Cal/BD foam and are relevant to clinicians' every-day practice. This paper summarizes the findings of the IISs around the globe published to date and presents the real-world data related to the effectiveness and clinical considerations of Cal/BD foam as a treatment for psoriasis.

Topics: Aerosols; Betamethasone; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Treatment Outcome

Psoriasis is a common immune-mediated skin disorder manifesting in abnormal skin plaques, and phosphodiesterase 4 (PDE4) is an effective target for the treatment of inflammatory diseases such as psoriasis. Toddacoumalone is a natural PDE4 inhibitor with moderate potency and imperfect drug-like properties. To discover novel and potent PDE4 inhibitors with considerable druggability, a series of toddacoumalone derivatives were designed and synthesized, leading to the compound (2

Topics: Administration, Topical; Animals; Cyclic Nucleotide Phosphodiesterases, Type 4; Mice; Phosphodiesterase 4 Inhibitors; Psoriasis; Skin

To examine the effectiveness and safety of adjunctive treatment with calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam in adult patients with chronic plaque psoriasis who have localized residual plaques after ≥24 weeks of treatment with ixekizumab biologic therapy.. This study was a prospective, open-label, single-arm study of adult patients with moderate-to-severe chronic plaque psoriasis who had suboptimal response after ≥24 weeks of treatment with ixekizumab (residual 3–8% body surface area [BSA] involvement). All patients continued treatment with ixekizumab and received once-daily Cal/BD foam for 4 weeks, followed by every other day for weeks 8 to 12. The primary endpoint was treat-to-target BSA ≤1% at week 4. Additional endpoints included the Physician’s Global Assessment (PGA) score, PGA×BSA, and the patient-reported Dermatology Life Quality Index (DLQI). Safety evaluations included assessments of adverse events (AEs) and local skin reactions.. Among 25 enrolled patients, 36% were female, and the mean age was 50 years. After 4 weeks of daily Cal/BD foam, 56% of patients achieved the treat-to-target goal of ≤1% BSA. Mean % BSA involvement, mean PGA score, and composite PGA×BSA score decreased 4 weeks after the addition of Cal/BD foam. Improvements in disease severity outcomes were maintained after reducing Cal/BD dosing frequency. Cal/BD was generally safe and well-tolerated, with no serious AEs reported.. In real-world clinical practice, for patients with moderate-to-severe plaque psoriasis who had residual plaques following ≥24 weeks of ixekizumab monotherapy, adjunctive treatment with Cal/BD foam was associated with notable and sustained improvements in disease control. J Drugs Dermatol. 2022;21(3): 235-240. doi:10.36849/JDD.6396.

Topics: Adult; Antibodies, Monoclonal, Humanized; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Middle Aged; Prospective Studies; Psoriasis; Treatment Outcome

Fixed combination calcipotriol/betamethasone (Cal/BD) aerosol foam has been shown to be effective in psoriasis treatment in clinical trials, but real-world evidence is currently sparse. The real-world CELSUS study in Greece found that Cal/BD aerosol foam treatment was effective and associated with satisfaction in psoriasis patients. Patients from the CELSUS study (N = 400) were stratified by baseline disease severity according to physician's global assessment (PGA) score (mild vs. moderate vs. severe) and by previous psoriasis treatment (naïve vs. treatment-experienced). Proportions of patients achieving treatment success (clear/almost clear [PGA 0/1]) after 4 weeks' treatment with Cal/BD aerosol foam were reported for each subgroup. Psoriasis area and severity index (PASI) and patient-reported itch, itch-related sleep loss, scaling, dry skin, and erythema numerical rating scores were reported by subgroup. At baseline, 216 (54%) patients were systemic-or-topical psoriasis treatment-naïve and 184 (46%) were treatment experienced. By disease severity, there were 135 versus 89 patients with mild, 69 versus 83 with moderate and 12 versus 12 with severe disease in the treatment-naïve versus treatment-experienced groups, respectively. In the treatment-naïve group, treatment success was achieved by 72.6%, 56.5%, and 66.7% of patients with mild, moderate, and severe disease, respectively, while the proportions in the treatment-experienced group were 60.7%, 42.2%, and 25%, respectively. Reduction from baseline in psoriasis symptoms was observed in all patient groups. The greatest reductions were observed in treatment-naïve patients with severe disease. Clinically relevant benefits were observed with Cal/BD aerosol foam in psoriasis patients, regardless of prior treatment-experience and disease severity at baseline.

Topics: Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Greece; Humans; Patient Satisfaction; Psoriasis; Severity of Illness Index; Treatment Outcome

Even in light of significant recent therapeutic advancements, many patients with psoriasis will use a combination of treatments at some point in the disease course. Despite the frequency with which combinations are used in clinical practice, there are few large-scale, randomized controlled trials investigating the use of various combination therapies in psoriasis. Twice-weekly maintenance application of topical Cal/BD aerosolized foam has recently been shown to prolong time to remission and is associated with fewer relapses in patients initially treated with standard dosing of the formulation. Data from a small number of pilot studies suggest potential benefits from the combined used topical Cal/BD foam with oral apremilast. This pilot study assesses the effect of twice-weekly maintenance doses of Cal/BD foam after 4 weeks of standard once-daily treatment in combination with apremilast. The combination of apremilast plus Cal/BD achieved the primary endpoint, with 95% of subjects rated clear or almost clear on PGA at week 4. Subject’s global assessment scores showed similar improvement to PGA scores at week 4 (47% of subjects clear or almost clear). Ten subjects (53%) achieved PASI 75 at week 4, and 12 (63%) achieved PASI 75 at week 16. Maintenance dosing of Cal/BD foam in combination with apremilast is safe and effective for the management of moderate psoriasis. J Drugs Dermatol. 2022;21(4):381-386. doi:10.36849/JDD.6622.

Topics: Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Pilot Projects; Psoriasis; Thalidomide; Treatment Outcome

A convergent approach for the total synthesis of calcipotriol (brand name: Dovonex), a proven vitamin D analog used for the treatment of psoriasis, and medicinally relevant synthetic analogs is described. A complete approach, not wedded to semisynthesis, toward both the A-ring and CD-ring is reported. From a retrosynthetic standpoint, hidden symmetry within the decorated A-ring is disclosed, which allowed for scalable quantities of this advanced intermediate. In addition, a radical retrosynthetic approach is described, which highlights an electrochemical reductive coupling as well as an intramolecular hydrogen atom transfer Giese addition to establish the 6,5-transcarbon skeleton found in the vitamin D family. Finally, a late-stage decarboxylative cross-coupling approach allowed for the facile preparation of various C20-arylated derivatives that show promising biological activity in an initial bioassay.

Topics: Calcitriol; Humans; Psoriasis; Vitamin D; Vitamins

Topics: Calcitriol; Dermatologic Agents; Humans; Ointments; Psoriasis; Skin Diseases; Treatment Outcome

Topics: Animals; Calcitriol; Dermatologic Agents; Humans; Mice; Mice, Transgenic; Psoriasis; Vascular Endothelial Growth Factor A

Although long-term management of psoriasis is paramount, this approach is challenging in clinical practice. In the recent PSO-LONG trial, a fixed-dose combination of betamethasone dipropionate (BD) and calcipotriol (Cal) foam applied twice a week on non-consecutive days for 52 weeks (proactive treatment) reduced the risk of relapse. However, the role of Cal/BD foam in the long-term management of psoriasis needs further clarifications. The ProActive Management (PAM) program, a nationwide Italian project, aims at reaching a consensus on the role of proactive management of psoriasis.. A steering committee generated some statements through the nominal group technique (NGT). The statements were voted by an expert panel in an adapted Delphi voting process.. Eighteen statements were proposed, and the majority of them (14/18) reached a consensus during the Delphi voting. The need to provide long-term proactive topical treatment to reduce the risk of relapse for the treatment of challenging diseases sites or in patients where phototherapy or systemic therapies are contraindicated/ineffective was widely recognized. A consensus was reached about the possibility to associate the proactive treatment with systemic and biological therapies, without the need for dose intensification, thus favoring a prolonged remission. Moreover, the proactive treatment was recognized as more effective than weekend therapy in increasing time free from relapses. Approaches to improve adherence, on the other hand, need further investigation.. The inclusion in guidelines of a proactive strategy among the effective treatment options will be a fundamental step in the evolution of a mild-moderate psoriasis therapeutic approach.

Topics: Aerosols; Betamethasone; Consensus; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Recurrence; Treatment Outcome

Oxidative stress due to excessive reactive oxygen species (ROS) production in the skin microenvironment is one of the main mechanisms in psoriasis pathogenesis. A nano drug delivery system based on ROS-responsive release can enhance drug release at the target site. In this study, a ROS-sensitive material methoxypolyethylene glycol-thioether-thiol (mPEG-SS) was synthesized using mPEG as the parent structure with sulfide structural modification. An mPEG-SS-calcipotriol (mPEG-SS-CPT, PSC) nano-micelle percutaneous delivery system was prepared by encapsulating CPT. A small animal imaging system was used to study PSC's the ROS-sensitive drug release process. It is shown that endogenous ROS mainly affects PSC and releases drugs. Finally, the therapeutic effect of PSC on psoriasis was explored by animal experiments. Ultimately, it ameliorates imiquimod-induced psoriasis-like inflammation. Overall, PSC is an effective ROS-sensitive transdermal drug delivery system that is expected to provide a new strategy for treating psoriasis.

Topics: Animals; Calcitriol; Drug Carriers; Drug Delivery Systems; Micelles; Polyethylene Glycols; Polymers; Psoriasis; Reactive Oxygen Species

An innovative foam formulation for the fixed-dose combination of calcipotriol and betamethasone dipropionate (Cal/BD) has recently become available for the treatment of psoriasis vulgaris. Observational studies of patients treated with Cal/BD foam in routine practice have been conducted in several Western countries, but there are limited data on outcomes in Asian patients. We performed a prospective, open-label, noncomparative, noninterventional study to investigate treatment outcomes and satisfaction in adult patients receiving Cal/BD foam for psoriasis vulgaris in dermatological centers and outpatient clinics in Korea. Data were collected at the time of enrollment (Visit 1) and at a routine clinic visit ~4 weeks later (Visit 2). In total, 218 patients were enrolled, of whom 175 were included in the safety analysis set (58.9% male; mean age ± standard deviation 46.7 ± 15.1 years; use of Cal/BD foam at least once daily 74.3%). Of the safety analysis set, 166 patients had at least mild psoriasis (Investigator Global Assessment [IGA] ≥ 2) and were analyzed for treatment outcomes and satisfaction. Of the 166 patients, 71.7% had mild psoriasis (IGA 2) at baseline. The majority (57.8%) achieved an IGA of 0/1 (clear/almost clear) at Visit 2. The Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) showed significant improvements from Visit 1 to Visit 2 (PASI -2.4 ± 3.0, DLQI -4.5 ± 5.2, both P < 0.0001). Most of the patients were satisfied with the Cal/BD foam treatment; 77.0%, 60.0%, and 73.9% were satisfied in terms of effectiveness, ease of use, and global satisfaction, respectively. In the safety analysis set, adverse events were reported in 13 patients (7.4%). In conclusion, this first Korean real-world study of Cal/BD foam shows improvement of lesions and health-related quality of life after 4 weeks of treatment, with high global satisfaction and good overall tolerability and safety.

Topics: Adult; Aerosols; Betamethasone; Dermatologic Agents; Drug Combinations; Female; Humans; Immunoglobulin A; Male; Patient Satisfaction; Prospective Studies; Psoriasis; Quality of Life; Republic of Korea; Treatment Outcome

The natural course of psoriasis is characterized by the long-term persistence of lesions and a predilection for relapse in the same area. It is caused by the inherence of TRM (tissue resident memory T cells) in apparently healthy skin. These cells are able to initiate an inflammatory cascade and induce relapse of the disease. These cells are characterized by high resistance to damaging factors and apoptosis, which determines their longevity.. The aim of our study was to evaluate the presence of TRM in psoriatic plaques before, during and after 12 weeks of therapy in patients treated with topical calcipotriol and betamethasone dipropionate (Cal/BD) foam.. TRM markers (CD4, CD8, CD103, CD69, CD49, CXCR6) and tissue expression of cytokines (IL-17A, IL-22) in the lesional psoriatic skin from 10 patients compared to 10 healthy skin samples were estimated by immunohistochemistry. Biopsy samples from the area of the same psoriatic plaque were collected three times: before the initiation of therapy, 4 and 12 weeks after its initiation.. The presence of TRM markers in the epidermis and dermis of psoriatic lesions was significantly higher when compared to the skin of control group patients. A reduction in the expression of the characteristic TRM markers (CD8, CD4, CD103, CD69, CXCR6, IL-17A and IL-22) was observed in the epidermis on week 12 of therapy, while a depletion in the expression of TRM in the dermis was demonstrated only in CD4 and IL-22.. Topical treatment with Cal/BD foam significantly decreased the expression of TRM markers mainly in the epidermis, and to a lesser extent in the dermis, during the 12-week observation period. It probably results from a worse penetration of the drug into the dermis and the effect of the preparation mainly on the epidermis. The persistence of a high expression of TRM markers in the dermis may result in the rapid recurrence of lesions after discontinuation of topical treatment.

Topics: Betamethasone; Calcitriol; Humans; Immunologic Memory; Interleukin-17; Psoriasis; Recurrence

To undertake a comparison of Cal/BDP cream versus foam for the treatment of plaque psoriasis, with cross-trial population differences accounted for.. An anchored matching-adjusted indirect comparison was undertaken, using individual patient data for Cal/BDP cream and published aggregated data for Cal/BDP foam. Altogether, 11 outcomes were analyzed, including PGA success, mPASI75, DLQI-related outcomes and treatment satisfaction across numerous domains. For each outcome an odds ratio or mean difference was calculated to represent the relative efficacy of Cal/BDP cream versus foam. Methods were guided by NICE Decision Support Unit recommendations.. After adjustment, baseline characteristics were balanced across treatment arms in each analysis. There were no statistically significant differences in PGA success, mPASI75 or DLQI outcomes between Cal/BDP cream and foam when they were compared after their recommended treatment durations (8 weeks for cream and 4 weeks for foam). For treatment satisfaction after 1 week of treatment, Cal/BDP cream was significantly superior to the Cal/BDP foam in all but one domain of the questionnaire.. Cal/BDP cream and Cal/BDP foam have equivalent efficacy and HRQoL (measured in DLQI) outcomes when used for the topical treatment of plaque psoriasis at their recommended treatment durations. A comparison of treatment satisfaction assessments after 1 week of treatment demonstrated that patients find Cal/BDP cream to be more convenient than foam.

Topics: Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Treatment Outcome

Psoriasis Vulgaris is a common immune-mediated skin disease. Its high prevalence, disability, chronicity, disfiguration, and associated comorbidities make it a challenge for physicians. Topical agents remain the mainstay of treatment for patients with mild to moderate psoriasis.. To evaluate the efficacy and tolerability of topical methotrexate 1% gel (MTX) versus topical calcipotriol 0.005% cream (CPL) in the treatment of localized plaque psoriasis.. This prospective comparative study included 40 patients with localized plaque psoriasis instructed to apply MTX to one side (group A) and CPL to the other side lesions (group B) twice daily for 12 weeks. Clinical and dermoscopic evaluations before, weekly during and after 3 months of treatment were done. The immunohistopathological assessment was done for skin biopsies from 10 patients in each group before and after treatment.. At the end of 12 weeks, there was marked-complete improvement in 97.5% of group A lesions treated with MTX 1% gel compared with 37.5% of group B lesions treated with calcipotriol 0.005% cream (p < 0.001). There was a very high statistically significant improvement in erythema that was cleared totally in 67.5% vs 22.5%, scaling in 75% vs 17.5%, and infiltration in 72.5% vs 27.5% in group A vs B, respectively (p < 0.001). These results were confirmed by dermoscopic and immunohistopathological findings.. Methotrexate 1% gel is a marvelous promising well-tolerated effective topical agent that can be used safely in the treatment of localized plaque psoriasis.

Topics: Dermatologic Agents; Emollients; Humans; Hydrogels; Methotrexate; Ointments; Prospective Studies; Psoriasis; Treatment Outcome

PD-1 is an immunoregulatory receptor that can bind PD-L1 or PD-L2 expressed on stimulated antigen-presenting cells. In this study, isolated antigen-presenting cells (macrophages and dendritic cells) were cultured with IFN-γ, IL-4, or IL-17A, and the expression of PD-L1 and PD-L2 was compared by flow cytometry. Strong upregulation of PD-L1 expression was observed on IFN-γ stimulation of both antigen-presenting cells as well as in response to IL-17A stimulation of macrophages compared with the expression in unstimulated controls. In contrast, only stimulation with IL-4 could upregulate PD-L2 expression on both antigen-presenting cells. Therefore, experiments were performed in murine models, including DNFB-induced contact hypersensitivity, calcipotriol-induced atopic dermatitis-like skin inflammation, and imiquimod-induced psoriasis-like dermatitis models, to trigger IFN-γ‒mediated T helper type (Th)1-, IL-4‒mediated Th2-, and IL-17A‒mediated Th17-type responses, respectively. In both Th1- and Th17-type immunity models, changes in ear thickness were more severe in Pd-l1‒deficient mice than in wild-type or Pd-l2‒deficient mice. In the Th2-type immunity model, changes in thickness in Pd-l2‒deficient mice were more severe than that in wild-type or Pd-l1‒deficient mice. Collectively, PD-L1 has predominant roles in Th1 and Th17 type immunity, whereas PD-L2 is involved in Th2-type immunity.

Topics: Animals; Antigen Presentation; B7-H1 Antigen; Calcitriol; Cells, Cultured; Cytokines; Dendritic Cells; Dermatitis, Atopic; Dermatitis, Contact; Dinitrofluorobenzene; Disease Models, Animal; Humans; Imiquimod; Inflammation; Macrophages; Mice; Mice, Inbred C57BL; Mice, Knockout; Programmed Cell Death 1 Ligand 2 Protein; Psoriasis; Skin; Th1 Cells; Th17 Cells; Th2 Cells

Topics: Calcitriol; Chemokine CCL27; Dermatologic Agents; Humans; Inflammation; Psoriasis

To compare the short-term cost and effectiveness of calcipotriol/betamethasone dipropionate (Cal/BD) cutaneous foam against nonbiologic systemics in psoriasis patients for whom oral systemic or topical therapy is considered appropriate in seven European countries.. Matching-adjusted indirect comparisons of four-week PASI-75 responses of Cal/BD foam were performed versus 12-week responses of methotrexate, acitretin, fumaric acid esters (FAE) and 16-week responses of apremilast. Analyses took a payer perspective and included drug, physician visit and monitoring costs.. In all countries, Cal/BD foam generated the lowest cost per responder (CPR). Against methotrexate, apremilast and acitretin, Cal/BD foam generated response for less than €190 in Italy, €195 in Portugal, €216 in Greece, £218 in the United Kingdom, €250 in Belgium, €319 in Spain, and €359 in the Netherlands. Relative to treatment with FAE, Cal/BD foam resulted in response for less than €298, €430, €382 and £262 in Belgium, the Netherlands, Spain and the United Kingdom, respectively. For Cal/BD foam, apremilast and FAE, total costs were driven by drug costs; for methotrexate and acitretin, by monitoring.. Driven by its lower costs and high response rates, Cal/BD foam is likely to be a cost-effective option over the short-term in the investigated psoriasis population.

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Treatment Outcome

Psoriasis (PsO) is a chronic skin disease. This study aims to evaluate clinical and subclinical response to calcipotriol+betamethasone foam, in patients with PsO, comparing, for the first time, data from microvascular ultrasound (MicroV) and shear wave elastography (SWE) with Psoriasis Area and Severity Index (PASI).. Between November 2018 and April 2019 in Tor Vergata Hospital (Roma, Italy), we enrolled 26 patients with PsO who were ageds 20-75 years, with PASI score ≥4, candidated for calcipotriol+betamethasone foam treatment. They underwent MicroV and SWE evaluation at baseline (T. At T. Calcipotriol+betamethasone foam is a very effective topical treatment in a short-medium term follow-up in patients with PsO. MicroV and SWE evaluate response to treatment (in term of plaque vascularisation and stiffness), so they could represent promising early indicators of therapeutic response and help the physician to establish a better clinical-therapeutic management of patients with PsO.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Elasticity Imaging Techniques; Feasibility Studies; Female; Humans; Male; Middle Aged; Psoriasis; Treatment Outcome; Ultrasonography; Young Adult

Topics: Adolescent; Adult; Aerosols; Calcitriol; Child; Dermatologic Agents; Humans; Psoriasis; Scalp; Treatment Outcome

Topics: Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Pemphigus, Benign Familial; Psoriasis; Treatment Outcome

The fixed-dose combination calcipotriol (Cal; 50 µg/g) plus betamethasone dipropionate (BD; 0.5 mg/g) ointment and gel formulations have well-established efficacy profiles in the treatment of psoriasis vulgaris (chronic plaque psoriasis); this combination has been shown to produce favourable outcomes versus either monotherapy. To improve upon the efficacy and cosmetic acceptability of these treatments Cal/BD foam was developed, demonstrating superior efficacy in Phase II/III studies compared with either of its monocomponents, Cal/BD ointment, Cal/BD gel and various other therapies for the treatment of psoriasis. Multiple outcome measures were evaluated in the clinical studies, including physician's global assessment of disease severity and modified psoriasis area and severity index. Of note, 38-55% of patients across studies achieved a physician's global assessment of 'clear' or 'almost clear' after 4 weeks of Cal/BD treatment. This superior efficacy was not associated with an increased frequency or severity of adverse events, and there was no evidence for dysregulation of the hypothalamic-pituitary-adrenal axis or calcium homeostasis. Overall, Cal/BD foam was efficacious, with a good tolerability profile consistent with established Cal/BD formulations.

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Hypothalamo-Hypophyseal System; Pituitary-Adrenal System; Psoriasis; Treatment Outcome

The physical symptoms of psoriasis vulgaris (chronic plaque psoriasis), such as itch and itch-related sleep loss, and the psychological impact of visible plaques on the body, all contribute to significantly reduced health-related quality of life (HRQoL) in patients with psoriasis. In fact, the deterioration of HRQoL in patients with psoriasis is similar to patients with other chronic conditions, such as cancer and cardiovascular diseases. Rapid and effective improvements in HRQoL and itch-related outcomes would therefore be highly valued by patients and may even improve adherence to treatment. In this article, we summarise previously published data assessing the impact of fixed-dose combination calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) on itch relief, quality of sleep, onset of action and HRQoL. Findings across multiple analyses indicate that Cal/BD foam provides significant improvements in itch, itch-related sleep loss and HRQoL compared with vehicle foam or Cal/BD gel comparators. Additionally, the benefits of Cal/BD foam were recorded earlier than these comparators, often within 1 week of treatment, indicating a rapid onset of action. With the published data to hand, it is clear that Cal/BD foam provides significant improvements in the outcomes that matter most to patients and should be considered an effective topical treatment for psoriasis.

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Quality of Life; Treatment Outcome

Topical therapy is the mainstay of treatment for the majority of patients with psoriasis vulgaris (chronic plaque psoriasis), with combinations of vitamin D analogues and glucocorticoids having been shown to negate many of the negative effects associated with either monocomponent individually. Following the established efficacy of fixed-dose combination calcipotriol (Cal; 50 µg/g) plus betamethasone dipropionate (BD; 0.5 mg/g) ointment and gel formulations, a novel Cal/BD foam formulation was developed. When applied, Cal/BD foam forms a supersaturated solution on the skin, increasing the penetration and bioavailability of Cal and BD. Early data indicate that this results in improved efficacy outcomes versus Cal/BD ointment, without negatively affecting safety outcomes (such as the incidence/severity of side effects or impacted calcium homeostasis or hypothalamic-pituitary-adrenal axis). This article discusses the potency and absorption of fixed-dose combination Cal/BD foam, as well as the positive early efficacy and safety data associated with its utilisation in the treatment of psoriasis vulgaris.

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Hypothalamo-Hypophyseal System; Pituitary-Adrenal System; Psoriasis; Treatment Outcome

Real-world evidence studies are becoming increasingly important in providing insight into clinical effectiveness and safety, economic outcomes, patient-reported outcomes and health-related quality of life of treatments in the clinical setting. These studies also help to complement data reported in clinical studies. Fixed-dose combination calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) is a topical agent used for the treatment of psoriasis vulgaris. In clinical studies, Cal/BD foam has demonstrated a significantly greater efficacy and rapid onset of action compared with both single and combination formulations such as ointments and gels. To date, three observational studies have examined the real-world efficacy and safety of Cal/BD foam in clinical practice in the United States, Germany and Spain. Data gathered from these studies reinforce the positive findings reported in clinical studies assessing Cal/BD foam for the treatment of psoriasis and demonstrate improved patient satisfaction with Cal/BD foam. Using Cal/BD foam has been shown to be cost-effective based on results from randomised clinical trials and cost-effective analysis. As such, Cal/BD foam has the potential to lower treatment costs by reducing the need for some patients to progress to more expensive treatments, such as phototherapy and biologics. Cal/BD foam is therefore a cost-effective solution for the treatment of psoriasis vulgaris that should be considered when prescribing topicals.

Topics: Betamethasone; Calcitriol; Cost-Benefit Analysis; Dermatologic Agents; Drug Combinations; Germany; Humans; Patient Satisfaction; Psoriasis; Quality of Life; Spain; Treatment Outcome

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Ointments; Psoriasis; Treatment Outcome

Topics: Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Greece; Humans; Psoriasis; Treatment Outcome

Topics: Adult; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Drug Evaluation; Humans; Psoriasis; Treatment Outcome

Topical treatment is the mainstay for mild or moderate psoriasis, but patients are generally little satisfied. Calcipotriol/betamethasone dipropionate (Cal/BD) cutaneous foam has shown to improve signs and symptoms in plaque psoriasis patients. This study assessed patient's satisfaction with Cal/BD foam in a real-life Italian dermatological clinical practice. A multicenter, 4-week observational prospective cohort study enrolled, in 17 Italian dermatology clinics, adult patients with plaque psoriasis on the body and/or scalp. Treatment satisfaction was assessed by 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9), preference over previous treatments by Patient Preference Questionnaire (PPQ), and change in disease state by Psoriasis Area Severity Index (PASI). Overall 256 patients were eligible, with a mean (SD) age of 55.6 (15.4) years, 59.4% were males. Psoriasis severity was mild in 52.0% of patients, moderate in 43.3%, and severe in 4.7%. Scalp involvement was present in 36.7% of patients. Previous antipsoriatic treatments had been received by 80.5% of patients. TSQM-9 median (25th-75th percentile) scores were 83.3 (66.7-88.9) for effectiveness, 77.8 (66.7-88.9) for convenience, and 78.6 (64.3-92.9) for global satisfaction. Mean (SD) PASI value decreased from 7.3 (4.8) to 2.1 (2.7) after 4 weeks. More than 90% of patients previously treated for psoriasis evaluated the Cal/BD foam more effective, easier to use and better tolerated compared to previous topical treatments at PPQ. This observational study provides real-life evidence of a high level of satisfaction with effectiveness and convenience of the Cal/BD foam in a cohort of plaque psoriasis patients, with an objective improvement in PASI.

Topics: Adult; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Male; Middle Aged; Patient Satisfaction; Prospective Studies; Psoriasis; Treatment Outcome

Topics: Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Greece; Humans; Patient Reported Outcome Measures; Psoriasis; Treatment Outcome

Psoriasis vulgaris is not easy to manage, even when mild. Knowledge of the efficacy of most topical therapies in this population is limited.. To assess the efficacy of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam in patients with mild psoriasis.. Post hoc analysis was performed on pooled data for subjects with mild psoriasis at baseline from 2 Phase 3 and 1 Phase 2 clinical trials. All subjects applied Cal/BD foam or vehicle foam once daily for at least 4 weeks. Efficacy assessments included treatment success (defined as IGA=0), mPASI, BSA, and the composite IGA BSA score.. Of the 848 subjects, 164 had mild psoriasis at baseline. Within this subpopulation of mild subjects, Cal/BD foam demonstrated significant efficacy over vehicle at week 4 in terms of the proportion of subjects achieving complete clearance of visible lesions (IGA=0). Significant improvements were also observed for mPASI, BSA, and IGA BSA score.. These post hoc analyses need to be confirmed with prospective studies.. Once-daily Cal/BD foam for 4 weeks demonstrated effectiveness in treating subjects with mild psoriasis, a population in which demonstration of treatment success can be difficult, because of the requirement for complete clearance of visible disease. Clinicaltrials.gov: NCT02132936, NCT01866163, and NCT01536938 J Drugs Dermatol. 2021;20(8):822-828. doi:10.36849/JDD.5743.

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Dosage Forms; Drug Combinations; Humans; Prospective Studies; Psoriasis; Randomized Controlled Trials as Topic; Treatment Outcome

Topics: Administration, Topical; Calcitriol; Dermatologic Agents; Female; Humans; Male; Middle Aged; Psoriasis

Topics: Administration, Cutaneous; Animals; Betamethasone; Calcitriol; Cytokines; Dermatologic Agents; Disease Models, Animal; Drug Synergism; Drug Therapy, Combination; Female; Gene Expression Regulation; Glucocorticoids; Humans; Imiquimod; Mice; Ointments; Psoriasis; Skin; Th1 Cells; Th17 Cells

This study evaluates the effectiveness of the topical use of an aerosol foam combination of calcipotriol 50 μg/g plus betamethasone dipropionate 0.5 mg/g (Cal/BD foam, Enstilar®) in adults with moderate plaque psoriasis. A total of 120 male and female adult psoriasis patients (53.3% male) from two Italian dermatological units were enrolled in an 8-week prospective study performed between November 2018 and January 2019. Psoriasis Area and Severity Index (PASI) was evaluated at baseline (T0) and 4 weeks (T4) of daily application, and a further evaluation was carried out 4 weeks after suspension (T8). Furthermore, the Dermatology Life Quality Index (DLQI) was evaluated at baseline and after 4 weeks of treatment (T4). At baseline, patients presented a mean PASI of 7 (7.0 ± 2.1). After 4 weeks (T4) of once-daily application, an important improvement in PASI was observed (1.1 ± 0.3). At Week 4, DLQI was reduced by 5.5 points from baseline (mean: 12 ± 3.1 at T0 vs 6.5 ± 1.8 at T4). Four weeks after suspension (T8), mean PASI was 2.6 ± 1.9, which was stable compared to the previous evaluation; only 8.3% of the treated patients showed worsening of plaque psoriasis. This study suggested that the Cal/BD aerosol foam is an effective topical therapy to treat plaque psoriasis.

Topics: Administration, Cutaneous; Adult; Aerosols; Aged; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Italy; Male; Middle Aged; Prospective Studies; Psoriasis; Severity of Illness Index; Treatment Outcome

We compared results of in vitro performance testing with results of therapeutic equivalence study for calcipotriol/betamethasone ointment, to evaluate their sensitivity and in vivo relevance.. Different in vitro methods were used to evaluate drug release and permeation from the test and reference ointment. Moreover, 444 psoriasis patients were randomized in the therapeutic equivalence study and the parameters of efficacy and safety were compared with in vitro results.. In vitro release and permeation rate of calcipotriol and betamethasone from the test formulation was higher than from the reference product for all methods used (p ≤ 0.05 for calcipotriol and p < 0.01 for betamethasone). Observed batch-to-batch variability of reference product confirmed high sensitivity and discriminatory power of in vitro methods. Higher release and permeation rate of calcipotriol and betamethasone from test product was reflected in the efficacy assessment (mean response difference 4.78 mPASI percentage points), but the observed difference was within the equivalence margins. Systemic exposure to calcipotriol and betamethasone was similar in both treatment groups.. The results of in vitro experiments rank orderly correlated with the results of clinical study. In vitro methods are more sensitive and highly discriminatory when compared to in vivo performance.

Topics: Adult; Betamethasone; Calcitriol; Dermatologic Agents; Drug Evaluation; Drug Liberation; Female; Humans; In Vitro Techniques; Male; Ointments; Psoriasis; Random Allocation; Therapeutic Equivalency

Topics: Administration, Oral; Aged; Betamethasone; Calcitriol; Cyclosporine; Dermatologic Agents; Drug Combinations; Drug Resistance; Female; Gels; Humans; Male; Middle Aged; Nail Diseases; Ointments; Psoriasis; Severity of Illness Index; Thalidomide; Treatment Outcome

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Lasers, Dye; Prospective Studies; Psoriasis; Treatment Outcome

Poor adherence to treatment makes achievement of expected therapeutic outcomes more difficult, especially in chronic disorders like psoriasis. There are several critical factors that affect adherence, including therapeutic efficacy, patient satisfaction, patient treatment preferences and ease of application, especially in topical therapy. The fixed combination of calcipotriol plus betamethasone dipropionate in a gel formulation (Cal/BDP gel) has been recommended as a first-line topical treatment for mild to moderate plaque. To examine whether Cal/BDP gel can effectively improve treatment adherence, we investigated the effects of once-daily Cal/BDP gel on factors affecting adherence at weeks 4, 8 and 12 in patients with plaque psoriasis who had poor adherence. A total of 46 subjects were enrolled and 41 subjects (26 men, 15 women; mean age, 50.5 years) were included in the analysis. The following items were evaluated: Patient Preference Questionnaire, nine-item Treatment Satisfaction Questionnaire for Medication, Physician's Global Assessment (PGA), modified Psoriasis Area and Severity Index (m-PASI), body surface area (BSA), pruritus, medication adherence and application time. In patients with poor adherence, many preferred treatment with Cal/BDP gel and evaluated its convenience as "excellent" at weeks 4 and 12. At week 12, the proportion of "clear"/"very mild" ratings using PGA reached 20.5%, the change from baseline on m-PASI was -61.3% and the change from baseline on BSA was -39.8%, suggesting that the skin symptoms of psoriasis had improved greatly. In most patients, the longer they used Cal/BDP gel, the greater their preference and satisfaction and the higher the therapeutic effect, which increased markedly over 12 weeks. These results suggest that Cal/BDP gel can effectively improve treatment adherence. Conversely, high adherence to Cal/BDP gel must enhance the therapeutic effect. Therefore, we expect that Cal/BDP gel could become the mainstay of topical psoriasis treatment in patients with poor adherence.

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Patient Satisfaction; Psoriasis; Treatment Outcome

Topics: Acantholysis; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Ichthyosis; Ointments; Psoriasis

Topics: Betamethasone; Calcitriol; Clobetasol; Humans; Nicotinic Acids; Psoriasis

Topics: Betamethasone; Calcitriol; Clobetasol; Humans; Nicotinic Acids; Psoriasis

Many exopolysaccharides (EPS) have significant emulsifying activity. Some EPS produced by the marine bacterial strain FYS have stronger emulsifying activity in the form of nanoparticles, suggesting that they could potentially form Pickering emulsions. We prepared novel EPS/CT Pickering nanoemulsions (ECPN) with EPS as emulsifiers and assessed their ability to ameliorate the poor permeability of calcipotriol (CT) in skin affected by psoriasis vulgaris.. A strain of marine bacterium FYS was identified. Molecular weight, monosaccharide composition and microstructure of EPS were determined by gel permeation chromatography, high-performance liquid chromatography and scanning electron microscopy. EPS nanoparticles were prepared by adjusting the pH, and the emulsifying activity was studied at different pH. ECPN were prepared by ultrasound and optimized by the response surface method. The size distribution, microstructure, stability and in vitro drug release of ECPN were studied. The therapeutic effect of ECPN on psoriasis vulgaris was explored by animal experiments and characterizing histomorphology in vivo.. A phylogenetic tree revealed that FYS was a. EPS is highly possible to have the potential Pickering emulsification mechanism. The stability of the nanoemulsion was high. ECPN also showed potential for use in the treatment of psoriasis vulgaris. This study provides new insight into the medical applications of EPS and the treatment of psoriasis.

Topics: Animals; Bacillus; Calcitriol; Dermatologic Agents; Drug Delivery Systems; Drug Liberation; Emulsifying Agents; Emulsions; Hydrogen-Ion Concentration; Mice; Molecular Weight; Nanoparticles; Phylogeny; Polysaccharides, Bacterial; Psoriasis; Skin

Topics: Administration, Oral; Administration, Topical; Adult; Blister; Calcitriol; Dermatologic Agents; Female; Humans; Photochemotherapy; Practice Guidelines as Topic; Psoriasis; Retinoids; Smokers; Steroids; Treatment Outcome

Topics: Administration, Cutaneous; Animals; Bacillus amyloliquefaciens; Calcitriol; Dermatologic Agents; Emulsifying Agents; Male; Mice; Polysaccharides, Bacterial; Psoriasis

The reported real-life use of prescribed topical antipsoriatic drugs is conflicting and based on heterogeneous data sources.. To describe the utilization of topical antipsoriatic drugs among patients with psoriasis in Denmark.. A drug utilization study was performed based on nationwide Danish health registry data. We identified patients who received a first-time hospital diagnosis of psoriasis and redeemed at least one topical drug prescription in the period 2005-2015 (n = 7743). Patients were followed for 3 years from the time of diagnosis. Use of topical and systemic antipsoriatic drugs was described, specified by the type of treatment.. The total use of topical drugs was divided between corticosteroids with calcipotriol (31%), calcipotriol (6·5%), very potent corticosteroids (24%), potent corticosteroids (30%), moderate corticosteroids (7·2%) and corticosteroids with antimicrobials (1·6%). There was a 19% reduction in the overall use of topical drugs during the study period. Use increased around the time of diagnosis and the majority of patients redeemed more than two packages of topical drugs during the first year after being diagnosed. Regional differences in patients' use of topical drugs varied considerably. The distribution of use of topical drugs was uneven, with a minority of all patients (25%) using 70% of the total amount of topical treatment. There was a 70% increase in the use of methotrexate over the study period. Biologics were used by up to 6%.. The study provides further evidence that the use of topical antipsoriatic drugs shows considerable heterogeneity over time and regional practices, and differences between patients.

Topics: Administration, Cutaneous; Adult; Anti-Infective Agents; Calcitriol; Denmark; Dermatologic Agents; Drug Prescriptions; Drug Utilization; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Psoriasis; Registries

Plaque psoriasis has significant impact on patients' quality of life. Topical therapy is considered the treatment mainstay for mild-to-moderate disease according to guidelines. Calcipotriol/betamethasone dipropionate (Cal/BD) [0.005%/0.05%] aerosol foam is indicated for psoriasis vulgaris treatment in adults. Cal/BD foam trials demonstrated improved efficacy and similar safety in this population. Psoriasis treatment is complicated by the broad range of disease presentation, variability and therapeutic options; particularly decisions on transition from topical to non-biologic systemic treatment are difficult. Assessing comparative effectiveness of treatment options provides meaningful value to treatment decisions.. To compare efficacy of Cal/BD foam individual patient data from pooled trials with efficacy of non-biologic systemic treatments based on aggregated patient characteristics and treatment outcomes.. Individual data from four Cal/BD foam trials in 749 psoriasis patients were pooled to conduct matching-adjusted indirect comparisons. Literature review identified non-biologic systemic treatment trials where methods, populations and outcomes align with Cal/BD foam trials. Of 3090 screened publications, four studies of apremilast, methotrexate, acitretin or fumaric acid esters (FAE) were included.. After baseline matching, patients treated with 4 weeks of Cal/BD foam had greater Physician's Global Assessment 0/1 response compared to those treated with 16 weeks of apremilast (52.7% vs. 30.4%; P < 0.001). Patients treated with Cal/BD foam had significantly greater Psoriasis Area and Severity Index (PASI) 75 response at Week 4 compared to 16 weeks of apremilast treatment (51.1% vs. 21.6%; P < 0.001). Cal/BD foam patients demonstrated significantly greater PASI 75 response improvements at Week 4 vs. 12 weeks of methotrexate (50.8% vs. 33.5%; P < 0.001) or acitretin (50.9% vs. 31.7%; P = 0.009), and comparable response to FAE (42.4% vs. 47.0%; P = 0.451).. Despite recent treatment advances, unmet needs for psoriasis patients remain. Cal/BD foam offers improved efficacy in baseline matched psoriasis patients compared to apremilast, methotrexate or acitretin, and comparable efficacy to FAE.

Topics: Acitretin; Administration, Cutaneous; Aerosols; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Esters; Female; Fumarates; Humans; Male; Methotrexate; Middle Aged; Psoriasis; Thalidomide; Treatment Outcome

Itch is common in psoriasis, adversely affecting health-related quality of life (HRQoL) and sleep.. We evaluated the efficacy of topical fixed-dose combination calcipotriol 50 μg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) on itch, itch-related sleep loss and HRQoL vs. foam vehicle.. We pooled data from three Phase II/III trials (NCT01536886/NCT01866163/NCT02132936) of Cal/BD foam vs. foam vehicle in adults with mild-severe psoriasis. For itch-related analyses, patients with baseline itch visual analogue scale (VAS) >40 (range 0-100) were analysed. Outcomes included the following: itch VAS reduction >40, ≥70% improvement in itch (Itch70) or itch-related sleep loss, 75% improvement in modified Psoriasis Area and Severity Index (excluding head; mPASI75) and Dermatology Life Quality Index (DLQI) scores 0/1 through 4 weeks.. Compared with foam vehicle, Cal/BD foam offers more rapid and effective itch relief, with associated significant improvements in sleep and DLQI.

Topics: Administration, Cutaneous; Adult; Aged; Betamethasone; Calcitriol; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Drug Combinations; Dyssomnias; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Pruritus; Psoriasis; Quality of Life; Randomized Controlled Trials as Topic; Single-Blind Method; Visual Analog Scale

Psoriasis is a chronic inflammatory disorder that imposes a substantial economic burden. We conducted a cost-utility analysis from a Swedish healthcare payers perspective using a decision-tree model with a 12-week time horizon. Patients with psoriasis vulgaris could have two 4-week cycles of topical treatment with calcipotriol 50 µg/g and betamethasone 0.5 mg/g as dipropionate (Cal/BD) foam or Cal/BD ointment before progressing to phototherapy/methotrexate. In the base-case analysis, Cal/BD foam dominated over Cal/BD ointment. The increased efficacy of Cal/BD foam resulted in fewer consultations and a decreased risk of progressing to phototherapy/methotrexate. Although Cal/BD foam costs more than Cal/BD ointment, this was offset by lower costs for phototherapy/methotrexate or consultation visits. Sensitivity analyses revealed that the base-case net monetary benefit was robust to plausible variations in key parameters. In conclusion, Cal/BD foam was predicted to be more cost-effective than Cal/BD ointment in the treatment of psoriasis vulgaris.

Topics: Administration, Cutaneous; Aerosols; Betamethasone; Calcitriol; Clinical Decision-Making; Clinical Trials, Phase II as Topic; Cost-Benefit Analysis; Decision Support Techniques; Decision Trees; Dermatologic Agents; Disease Progression; Drug Compounding; Drug Costs; Glucocorticoids; Humans; Models, Economic; Office Visits; Ointments; Phototherapy; Psoriasis; Quality of Life; Quality-Adjusted Life Years; Randomized Controlled Trials as Topic; Sweden; Time Factors; Treatment Outcome

Although 40% of psoriasis patients reported skin pain, this symptom is often underestimated. A new formula of calcipotriol plus betamethasone dipropionate (Cal/BD) has been recently approved for psoriasis treatment. Therefore, we aimed to evaluate the efficacy of Cal/BD aerosol foam on skin pain of patients with plaque psoriasis.. A real-life 4-week prospective, open study on Cal/BD aerosol foam (not compared to vehicle or emollient cream) was performed in adult psoriasis patients attending three Dermatology units located in Campania region, Italy, between March and October 2018. Inclusion criteria were a history of skin pain over the last week and psoriatic involvement of the palmar area. Before (t0) and after a course of once daily application of Cal/BD aerosol foam for 4 weeks (t1), the following items were evaluated: Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA) index of target plaque on palmar region, subjective skin pain features through Pain Qualities Assessment Scale questionnaire and skin pain threshold measured by pressure digital algometer at palmar psoriatic plaques.. Seventy-five patients (43 male, mean age of 43.2 years) were enrolled. After 4 weeks of therapy with Cal/BD aerosol foam, a significant improvement in both PASI (mean: 6.5 ± 2.1 at t0 vs. 2.3 ± 1.6 at t1) and palmar plaques PGA (mean: 3.6 at t0 vs. 1.7 at t1) was observed (P < 0.001). The mean intensity score of skin pain decreased from 7.6 to 1.3 (P < 0.001); among skin pain qualities, intense, sensible, aching and unpleasant showed the highest rate of reduction (t0-t1: 6.3, 6.3, 6.1 and 5.8, respectively). Pain threshold of palmar skin lesions increased at t1.. Our real-life study suggested that Cal/BD aerosol foam may represent a valid topical anti-psoriatic treatment, not only improving skin lesions, but also relieving cutaneous pain, thus contributing to ameliorate patients' quality of life.

Topics: Administration, Topical; Adult; Aerosols; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Hand; Humans; Male; Middle Aged; Pain; Pain Measurement; Pain Threshold; Prospective Studies; Psoriasis; Severity of Illness Index; Young Adult

The effectiveness of topical therapies in psoriasis is dependent on, amongst other factors, patient adherence. Together with treatment effectiveness and reduction of symptoms, speed of onset and health-related quality of life (HRQoL) are important influencers of adherence.. This pooled analysis of three Phase II/III trials evaluated the efficacy of topical fixed-dose combination calcipotriol 50 μg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) vs. foam vehicle at early timepoints in mild-to-severe psoriasis using clinically meaningful modified Psoriasis Area and Severity Index (mPASI) and Dermatology Life Quality Index (DLQI) targets.. A greater proportion of Cal/BD-foam- vs. foam-vehicle-treated patients achieved absolute mPASI targets 0 (15.1% vs. 1.0%), ≤1 (41.4% vs. 5.2%), ≤3 (78.5% vs. 29.2%) and ≤5 (90.2% vs. 62.5%) at week 4 (P < 0.001; all targets). Significant differences between Cal/BD-foam- vs. foam-vehicle-treated patients were observed as early as week 1 in those achieving mPASI ≤1 (6.8% vs. 1.5%; P < 0.01), ≤3 (40.4% vs. 22.8%; P < 0.001) and ≤5 (69.7% vs. 50.8%; P < 0.001). In patients with more severe psoriasis (baseline mPASI >10), a greater proportion of Cal/BD-foam- vs. foam-vehicle-treated patients achieved mPASI ≤1 (20.2% vs. 5.9%; P < 0.05), ≤3 (49.2% vs. 8.8%; P < 0.001) and ≤5 (63.7% vs. 26.5%; P < 0.001) at week 4. In patients with severely impaired HRQoL (baseline DLQI >10), a greater proportion of Cal/BD-foam- vs. foam-vehicle-treated patients achieved target DLQI ≤1 or 0 (week 4: DLQI ≤1, 25.0% vs. 4%; P = 0.001; DLQI 0, 17.4% vs. 2.0%; P = 0.006).. We report rapid onset of action and greater efficacy with Cal/BD foam vs. foam vehicle, even in patients with more severe psoriasis, manageable with topical treatments. This may support physician management of patient expectations and improve patient adherence, translating into overall topical treatment effectiveness.

Topics: Administration, Cutaneous; Betamethasone; Calcitriol; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Dermatologic Agents; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Patient Compliance; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome

Although the active ingredients of the most frequently used topical therapy for psoriasis have remained the same for many years, the introduction of new vehicles and fixed-dose combination products has increased ease of patient use as well as, in some cases, efficacy and safety. Topical therapies with novel mechanisms of action are under study.

Topics: Administration, Cutaneous; Biological Products; Calcitriol; Dermatologic Agents; Drug Combinations; Drug Therapy, Combination; Glucocorticoids; Humans; Nicotinic Acids; Psoriasis

Topics: Adiponectin; Administration, Cutaneous; Aerosols; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Chemokine CCL22; Dermatologic Agents; Drug Therapy, Combination; Female; Humans; Interleukin-17; Male; Middle Aged; Psoriasis; Treatment Outcome

A better understanding of the means by which topical vitamin D analogues exert their therapeutic effect on psoriasis is of theoretical and practical importance.. We sought to clarify whether and how the topical vitamin D analogue calcipotriol (CAL) controls the IL-17A-mediated pathogenesis of murine psoriasis-like dermatitis in vivo.. Psoriasis-like dermatitis was induced by the topical application of an imiquimod (IMQ)-containing cream on the murine ear for 4 to 6 consecutive days. For topical CAL treatment, mice were treated daily with CAL solution on the ear before IMQ application.. Mice treated topically with CAL exhibited much milder IMQ-induced psoriasis-like dermatitis compared with vehicle-treated mice, with impaired accumulation of IL-17A-committed T (T17) cells in the lesional skin. The IMQ-induced upregulation of Il12b and Il23a was marked in the epidermis and was abrogated by CAL application, suggesting CAL-mediated suppression of IL-23 expression. CAL inhibited Il12b and Il23a expression by Langerhans cells ex vivo stimulated with IMQ and CD40 cross-linking. Topical CAL also inhibited T17 cell expansion in the draining lymph nodes of IMQ-treated skin, implying a possible effect on T17 cell-mediated dermatitis at distant sites. In fact, topical CAL application on the IMQ-treated left ear resulted in amelioration of T17 cell accumulation and psoriasis-like dermatitis in the right ear subsequently treated with IMQ.. Topical CAL can exert its antipsoriatic effect on CAL-treated lesions and, concomitantly, distant lesions by attenuating the T17 cell accumulation in both CAL-treated lesions and draining lymph nodes.

Topics: Animals; Calcitriol; Disease Models, Animal; Gene Expression Regulation; Humans; Imiquimod; Interleukin-12 Subunit p40; Interleukin-17; Interleukin-23 Subunit p19; Mice; Psoriasis; Th17 Cells

Topical active vitamin D3 application alone or in combination with topical steroid application is widely used to treat psoriasis. In Japan, combined calcipotriol hydrate/betamethasone dipropionate ointment has been used for patients with psoriasis vulgaris since September 2014. Current evidence regarding the incidence of hypercalcemia due to the use of this combination product, however, is insufficient. We evaluated the incidence of hypercalcemia following combined calcipotriol hydrate/betamethasone dipropionate ointment in patients with severe psoriasis vulgaris.. Japanese patients (n = 22) with extensive plaque psoriasis (body surface area: 20-30%) applied the combined calcipotriol hydrate/betamethasone dipropionate ointment once daily for 8 weeks, and their serum Ca concentrations were measured periodically.. The mean serum Ca concentration changed only marginally, from 9.04 ± 0.34 mg/dL before treatment to 9.08 ± 0.39 mg/dL after 8 weeks of treatment. None of the patients had an elevated serum Ca concentration throughout the study. No cases of hypercalcemia were reported as an adverse event. No correlation was detected between the amount of the combined calcipotriol hydrate/betamethasone dipropionate ointment applied and changes in the serum Ca concentration.. The incidence of hypercalcemia due to topical application of a combined calcipotriol hydrate/betamethasone dipropionate ointment is low in Japanese patients with severe psoriasis vulgaris.

Topics: Adult; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Calcium; Drug Therapy, Combination; Female; Humans; Hypercalcemia; Incidence; Japan; Male; Middle Aged; Ointments; Psoriasis; Severity of Illness Index; Treatment Outcome

Calcipotriol 50 µg/g and betamethasone 0.5 mg/g dipropionate (Cal/BD) aerosol foam formulation provides greater effectiveness and improved patient preference compared with traditional Cal/BD formulations for the topical treatment of plaque psoriasis.. To determine the cost-effectiveness of Cal/BD foam compared with Cal/BD gel from the Australian perspective.. A Markov model was developed to evaluate the cost-effectiveness of topical Cal/BD foam and gel for the treatment of people with plaque psoriasis. Treatment effectiveness, safety, and utilities were based on a randomized control trial, resource use was informed by expert opinion, and unit costs were obtained from public sources. Outcomes were reported in terms of 1-year costs, quality-adjusted life years, and incremental cost-effectiveness ratios. All costs were reported in 2017 Australian Dollars.. The model showed that patients using Cal/BD foam had more QALYs and higher costs over 1 year compared with patients using Cal/BD gel, resulting in a cost of $13,609 per QALY gained at 4-weeks. When 4 weeks of Cal/BD foam was compared with 8 weeks of Cal/BD gel treatment, Cal/BD foam was $8 less expensive and resulted in 0.006 more QALYs gained. Sensitivity analyses showed that, compared with Cal/BD ointment, Cal/BD foam was associated with an incremental cost of $15,091 per QALY gained.. Cal/BD foam is the most cost-effective Cal/BD formulation for the topical treatment of patients with plaque psoriasis.

Topics: Aerosols; Betamethasone; Calcitriol; Cost-Benefit Analysis; Dermatologic Agents; Humans; Ointments; Psoriasis; Quality-Adjusted Life Years

IL-17C is a functionally distinct member of the IL-17 family that was believed to play a role in the pathogenesis of psoriasis. Here we confirmed that IL-17C is involved in psoriasis and explored potential roles for IL-17C in atopic dermatitis (AD). An anti-IL-17C antibody, MOR106, was generated that potently and selectively binds to human and mouse IL-17C, thereby inhibiting the binding of IL-17C to its IL-17RE receptor. The antibody inhibited cutaneous inflammation in an IL-23-induced psoriatic-like skin inflammation model. In lesional skin of patients with AD, IL-17C expression levels were increased and localized to keratinocytes and infiltrating immune cells. To determine the contribution of IL-17C to AD pathogenesis, MOR106 was tested in two distinct in vivo models. In the calcipotriol-induced AD model, ear skin inflammation, TSLP, and IL-33 protein production in ears was suppressed by MOR106. Consistently, in the flaky tail strain mouse model, spontaneous development of AD-like skin inflammation was reduced by MOR106. Moreover, serum IgE levels, number of mast cells in skin and T helper type 2-related cytokines IL-4 and CCL17 in serum were all reduced. Overall, our results indicate that IL-17C is a central mediator of skin inflammation beyond psoriasis and is relevant in particular in AD.

Topics: Animals; Antibodies, Neutralizing; Biopsy; Calcitriol; Cells, Cultured; Dermatitis, Atopic; Disease Models, Animal; Female; Humans; Injections, Intraperitoneal; Interleukin-17; Interleukin-23; Keratinocytes; Mice; Mice, Inbred BALB C; Mice, Inbred C57BL; Primary Cell Culture; Psoriasis; Signal Transduction; Skin

Optimizing combinations for psoriasis means asking patients to take control of their disease. It means balancing potency of steroids for the short-run to put out the fire and bring relief and maintaining the clearance for the long-run to reduce recurrence potential. Successful combinations are built on tolerability, ease of application, and the efficacy demonstrated by the synergy of the sum of the parts over being used separately.

J Drugs Dermatol. 2018;17(3):342-346.

Topics: Administration, Cutaneous; Adult; Aged; Anti-Inflammatory Agents; Calcitriol; Clobetasol; Dermatologic Agents; Drug Delivery Systems; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Middle Aged; Psoriasis; Single-Blind Method; Treatment Outcome

Topics: Abatacept; Administration, Cutaneous; Adult; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Autoimmunity; Biopsy; Calcitriol; Graft Rejection; Humans; Immunosuppressive Agents; Kidney Failure, Chronic; Kidney Transplantation; Male; Psoriasis; Rituximab; Skin; Treatment Outcome

VEGF and EGF are assumed to be involved in the pathogenesis of psoriasis, while the impacts of their polymorphisms on psoriasis are inconsistent. Therefore, we hope to clarify these relationships in the Chinese Han population.. A total of 131 patients with psoriasis vulgaris and 176 controls were enrolled. The polymorphisms rs833061 (T > C), rs10434 (G > A) in VEGFA, and rs4444903 (G > A), rs2237051 (A > G) in EGF of each participant were detected. The patients were treated with calcipotriol plus acitretin 30 mg/day for 8 weeks.. No SNPs of rs833061, rs10434, rs4444903 and rs2237051 were found to be associated with psoriasis susceptibility and efficacy. Although the mutation of rs10434A was associated with baseline disease severity (p = 0.026), and rs2237051G allele was associated with increased erythema during treatment (p = 0.015).. The allele of rs2237051 G increased the erythema during the treatment, and no polymorphism of VEGF and EGF gene was found to be associated with the susceptibility and efficacy in psoriasis.

Topics: Acitretin; Adult; Calcitriol; China; Drug Administration Schedule; Epidermal Growth Factor; Female; Genetic Association Studies; Genetic Predisposition to Disease; Genotype; Humans; Male; Middle Aged; Polymorphism, Single Nucleotide; Psoriasis; Vascular Endothelial Growth Factor A

Psoriasis is a chronic, immune-mediated inflammatory disease characterized by localized scaling and plaques associated with itching and pain. In some cases, topical therapies are effective to treat mild to moderate psoriasis. Topical agents can be used concomitantly with other treatments for moderate and severe or treatment-resistant psoriasis. Patient adherence to medication regimens remains a major challenge in therapy, especially with topical agents, for which adherence can be affected by the amount of time needed for application, the treatment formulation, cost, and cosmetic characteristics. This study was conducted to obtain feedback from patients clinically diagnosed with psoriasis regarding their satisfaction following once-daily topical application of the fixed combination calcipotriene (Cal) 0.005% and betamethasone dipropionate (BD) 0.064% foam for 15 days. Patients completed a 13-question online survey. In this community-based setting of patients with mild to severe psoriasis, patients were satisfied with Cal/BD foam after 15 days of use; 94% were satisfied or highly satisfied with symptom relief. Most of the patients (88%) were satisfied with how Cal/BD foam felt on their skin. After 15 days of use, 94% of patients would recommend Cal/BD foam to other patients with psoriasis, with 73% being very likely to do so. These findings may have important implications for optimizing medical decision-making, treatment adherence, and health outcomes in clinical practice. The cosmetic acceptability of the fixed combination Cal/BD foam formulation and patient satisfaction may make Cal/BD aerosol foam a more acceptable topical treatment than other currently available vehicles for patients with plaque psoriasis. J Drugs Dermatol. 2018;17(8):880-884.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Patient Satisfaction; Psoriasis; Self Report; Treatment Outcome; Young Adult

Our patient's pruritic rash was spreading throughout his trunk and arms. An acute infection 10 days earlier shed light on the diagnosis.

Topics: Calcitriol; Child; Exanthema; Humans; Male; Penicillin G Benzathine; Pharyngitis; Psoriasis; Streptococcal Infections; Treatment Outcome

Stacey Croney, Clinical Nurse Lead Dermatology, Medway NHS Foundation Trust, Kent discusses the care of patients with psoriasis, including the latest drug treatments.

Topics: Acitretin; Administration, Cutaneous; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Cyclosporine; Dermatologic Agents; Disease Management; Emollients; Humans; Immunosuppressive Agents; Keratolytic Agents; Methotrexate; Phototherapy; Psoriasis; Thalidomide

Poor adherence to topical therapy, defined as the degree to which patients use medication as prescribed by their healthcare provider, represents a frequent cause of poor treatment outcomes.. To evaluate the impact of individualized medication training on efficacy, adherence and patient satisfaction to 4 weeks of a topical therapy in psoriasis.. All enrolled psoriatic patients were given a prescription for calcipotriol/betamethasone dipropionate gel once daily and were randomly assigned to one of the two following groups with a 1:1 allocation ratio. Patients in group 1 and group 2 underwent an initial visit, including the physical examination and provision of information by the dermatologist. Patients in group 2 also received an additional 20 min of individualized medication training. Efficacy, adherence and patient satisfaction were evaluated after 4 weeks of treatment.. We enrolled 104 consecutive patients with psoriasis: patients in group 2, who were trained, had a significant improvement at week 4 in BSA, PASI, dPGA and higher PPQ score, and were more adherent compared to those in group 1 who were not trained.. Individualized medication training on the correct application of a topical therapy from a healthcare professional may improve patients' adherence, treatment tolerability and clinical outcomes.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Female; Humans; Linear Models; Male; Middle Aged; Patient Compliance; Patient Education as Topic; Patient Satisfaction; Psoriasis; Quality of Life; Severity of Illness Index; Surveys and Questionnaires; Young Adult

The aim of this study was to assess the psychometric properties of the five-level (EQ-5D-5L) in comparison with the standard three-level (EQ-5D-3L) classification systems of the EQ-5D in a sample of psoriatic patients. Psoriatic subjects (n = 396) recruited from 16 private practicing centers from various areas of Greece self-completed the two EQ-5D versions and the Dermatology Life Quality Index, while information was also collected on socio-demographics, clinical characteristics and comorbidities. The EQ-5D-5L and EQ-5D-3L were evaluated in terms of agreement, feasibility, ceiling effects, redistribution properties, inconsistency, informativity, and convergent and known-groups validity. Missing values were negligible in both versions. The agreement between the EQ-5D-5L and the EQ-5D-3L was very high (ICC = 0.94), while the largest differences were identified for subjects with moderate health status. Ceiling effects decreased in the EQ-5D-5L system by 14.08% (p < 0.05), with "anxiety/depression" showing the highest relative reduction (-10.31%; p < 0.05). Overall inconsistency was rather low (1.7%) and respondents preferred to report milder problems in the EQ-5D-5L. Absolute informativity improved by 56.42% in the EQ-5D-5L, while relative informativity declined by 9.24%, with only "anxiety/depression" demonstrating a small increase (6.77%). Both instruments demonstrated good convergent and known-groups validity, with evidence of a slightly better convergent performance and discriminatory efficiency of the EQ-5D-5L. In conclusion, both instruments demonstrated consistency, valid redistribution and good construct validity. The EQ-5D-5L system may be preferable to the EQ-5D-3L in psoriatic patients, as it demonstrated a marginally better performance in terms of reduced ceiling effects, increased informativity, and improved convergent and known-groups validity efficiency, particularly in the domain of "anxiety/depression".

Topics: Adolescent; Adult; Aged; Anxiety; Betamethasone; Calcitriol; Depression; Dermatologic Agents; Female; Health Status; Health Surveys; Humans; Male; Middle Aged; Outcome Assessment, Health Care; Prospective Studies; Psoriasis; Psychometrics; Quality of Life; Young Adult

To develop a budget impact model (BIM) for estimating the financial impact of formulary adoption and uptake of calcipotriene and betamethasone dipropionate (C/BD) foam (0.005%/0.064%) on the costs of biologics for treating moderate-to-severe psoriasis vulgaris in a hypothetical US healthcare plan with 1 million members.. This BIM incorporated epidemiologic data, market uptake assumptions, and drug utilization costs, simulating the treatment mix for patients who are candidates for biologics before (Scenario #1) and after (Scenario #2) the introduction of C/BD foam. Predicted outcomes were expressed in terms of the annual cost of treatment (COT) and the COT per member per month (PMPM).. At year 1, C/BD foam had the lowest per-patient cost ($9,913) necessary to achieve a Psoriasis Area and Severity Index (PASI)-75 response compared with etanercept ($73,773), adalimumab ($92,871), infliximab ($34,048), ustekinumab ($83,975), secukinumab ($113,858), apremilast ($47,960), and ixekizumab ($62,707). Following addition of C/BD foam to the formulary, the annual COT for moderate-to-severe psoriasis would decrease by $36,112,572 (17.91%, from $201,621,219 to $165,508,647). The COT PMPM is expected to decrease by $3.00 (17.86%, from $16.80 to $13.80).. Drug costs were based on Medi-Span reference pricing (January 21, 2016); differences in treatment costs for drug administration, laboratory monitoring, or adverse events were not accounted for. Potentially confounding were the definition of "moderate-to-severe" and the heterogeneous efficacy data. The per-patient cost for PASI-75 response at year 1 was estimated from short-term efficacy data for C/BD foam and apremilast only.. The introduction of C/BD foam is expected to decrease the annual COT for moderate-to-severe psoriasis treatable with biologics by $36,112,572 for a hypothetical US healthcare plan with 1 million plan members, and to lower the COT PMPM by $3.00.

Topics: Betamethasone; Biological Products; Budgets; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Models, Econometric; Psoriasis; Severity of Illness Index; United States

Vitamin D analogues and NBUVB phototherapy are both well-established modalities of treatment in psoriasis. The objective of this open label, intraindividual, left right study was to compare two different vitamin D analogues, calcipotriol and tacalcitol, in combination with NBUVB phototherapy in chronic stable plaque psoriasis.. Thirty patients with stable plaque psoriasis were enrolled for a 12-week clinical trial. The target lesion on left side was treated topically with tacalcitol ointment once daily, while that on the right side was treated with calcipotriol ointment twice daily. NBUVB phototherapy was given thrice weekly. Efficacy was assessed by target plaque scoring.. Both therapies resulted in statistically significant reduction in erythema, scaling, thickness and target plaque score, seen as early as 2 weeks into therapy. However, calcipotriol combination led to an earlier clearance of plaques and a lesser relapse rate than tacalcitol combination. The number of treatment sessions and cumulative NBUVB doses were significantly lower in the calcipotriol-treated group.. Both vitamin D analogues appear to be safe, effective and cosmetically acceptable, calcipotriol being more efficacious, well tolerated with a rapid onset of action and a better maintenance of response.

Topics: Adult; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Dihydroxycholecalciferols; Female; Humans; Male; Ointments; Prospective Studies; Psoriasis; Severity of Illness Index; Ultraviolet Therapy; Young Adult

Inverse or intertriginous psoriasis commonly involves skin fold areas including the axillae, perianal skin, intergluteal cleft, inframammary, genital/inguinal, abdominal, and retroauricular folds. After reviewing the literature for new treatments, a task force was convened to update a consensus on inverse psoriasis therapy. Short-term treatment continues to be low-potency topical steroids. In order to avoid steroid-induced adverse effects, long-term therapy includes topical immunomodulators, calcitriol, and calcipotriene. Second and third-line therapies include antimicrobials, emollients, and tar-based products. Inverse psoriasis resistant to topical therapy has been shown to respond to botulinum toxin injections, excimer laser therapy, and certain systemic agents (such as anti-TNF and anti-IL12/IL23 therapy). Based on promising results from case reports and prior clinical experience, these systemic agents should be strongly considered in inverse psoriasis resistant to topical therapy. However, they need further evidence-based evaluation. The use of randomized trials and objective severity indices may allow for more robust therapeutic data.

J Drugs Dermatol. 2017;16(8):760-766.

Topics: Administration, Cutaneous; Calcitriol; Dermatologic Agents; Humans; Immunologic Factors; Psoriasis; Randomized Controlled Trials as Topic; Tumor Necrosis Factor-alpha

Psoriasis is a chronic inflammatory skin disorder that greatly affects the patient's quality of life. Photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) has recently been applied for inflammatory dermatoses including psoriasis. However, the therapeutic effect of ALA-PDT is yet to be validated, and the underlying mechanisms remain unclear.. In this study, a psoriatic model was established by treating HaCaT cells with 250 U/ml IFN-γ for 48 h. The effect of ALA-PDT treatment on HaCaT cell viability was assessed using MTT assay. The levels of p38, JNK, and ERK, as well as their phosphorylation status (P-p38, P-JNK, P-ERK), were assessed by immunoblotting.. Our data indicate that ALA-PDT can significantly inhibit the proliferation of IFN-g-treated HaCaT cells and the expression of keratin 17, both in a dose- and time-dependent manner. Furthermore, ALA-PDT can activate the MAPK pathway, and promote the expression of p38, JNK, and ERK. ALA-PDT showed pro-apoptotic effects by enhancing cell apoptosis and upregulating the apoptotic genes PARP and caspase 3.. Taken together, these findings indicate the possible pathways involved in ALA-PDT-mediated effects and highlight the potential of ALA-PDT in the development of novel therapeutic strategies.

Topics: Aminolevulinic Acid; Apoptosis; Calcitriol; Caspase 3; Cell Line; Cell Survival; Extracellular Signal-Regulated MAP Kinases; Gene Expression; Humans; Interferon-gamma; JNK Mitogen-Activated Protein Kinases; Keratin-17; MAP Kinase Signaling System; p38 Mitogen-Activated Protein Kinases; Photochemotherapy; Photosensitizing Agents; Poly(ADP-ribose) Polymerases; Psoriasis

BACKGROUND Calcipotriol ointment has been demonstrated to be a very safe and effective topical drug for psoriasis. This study aims to investigate the effect of calcipotriol on IFN-γ-induced keratin 17 (K17) expression in a human keratinocyte cell line (HaCaT), which is a widely accepted as a mimic in vitro model for psoriasis. MATERIAL AND METHODS We used Western blot, immunofluorescence staining, and luciferase reporter system assays to evaluate the expression of K17 and the possible underlying mechanisms. RESULTS Administration of IFN-γ (125-1000 U) increased K17 expression in a dose-dependent manner, and 250 U/ml IFN-γ significantly elevated K17 expression. The experimental results showed that calcipotriol at concentrations of 10^-7 M and 10^-5 M suppressed the IFN-γ-induced K17 expression by 58.10% and 70.68%, respectively. Through immunofluorescence staining and luciferase reporter assay, we found that Vitamin D Response Element (VDRE) affected IFN-activated site (Gamma-activated sequence, GAS) function at the transcriptional level and was involved in the inhibition of K17 expression. CONCLUSIONS Our data suggest that calcipotriol downregulates IFN-γ-mediated K17 expression in keratinocytes in a dose-dependent manner via VDRE effect GAS function. The inhibitory effect of calcipotriol on K17 expression may be a potential mechanism and function in the treatment psoriasis.

Topics: Calcitriol; Cell Line; Dose-Response Relationship, Drug; Drug Interactions; Epidermis; Humans; Interferon-gamma; Keratin-17; Keratinocytes; Psoriasis; Up-Regulation

To assess the efficacy and tolerability of the new aerosol foam of calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g (Cal/BD foam, Enstilar®) in psoriasis vulgaris under daily practice conditions.. 410 adult psoriasis patients (56% male) from 87 German sites were enrolled in a 4-week, open-label, prospective, non-controlled, observational, non-interventional study.. At baseline, patients presented with a psoriasis severity of mild (41.81%), moderate (49.63%), and severe (8.31%) assessed by an investigator global assessment (IGA). After 4 weeks of treatment, 49% of the patients achieved an IGA of clear/almost clear. The mean affected body surface area was reduced from 12.91 to 7.55%, the PASI from 10.4 to 5.2 (p < 0.0001). 43% of the patients with severe IGA achieved treatment success (IGA = 0/1 and ≥2-step improvement). 93% of the patients did not show any adverse events.. The new Cal/BD foam showed a convincing efficacy and tolerability profile in daily practice, particularly in patients with severer disease manifestations.

Topics: Adult; Aerosols; Aged; Anti-Inflammatory Agents; Betamethasone; Body Surface Area; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Prospective Studies; Psoriasis; Severity of Illness Index; Treatment Outcome

Current work reports the development and optimization of clobitasol propionate (CP) and calcipotriol (CT) loaded nanoemulsion based gel for topical treatment of psoriasis. Components of nanoemulsion viz., oil and surfactant/co-surfactant were selected depending upon solubility and emulsification potential respectively. The optimized ratio of 5:3:2 of Capmul MCM C8 EP, Cremophor RH 40 and Labrafil 1944 CS was selected. Carbopol 980 was used as gelling agent to achieve final drug concentration of 0.05% w/w and 0.005% w/w respectively for CP and CT. HaCaT cell lines showed higher uptake of drug from nanoemulsion in correlation with the enhancement in penetration of both drugs in stratum corneum (SC) and viable layer from nanoemulsion and gel as compared to free drugs. Imiquimod induced psoriatic BALB/c mice revealed significantly higher anti-psoriatic activity of nanoemulsion gel as compared to free drugs and marketed formulation. The developed formulation showed negligible skin irritation despite increased penetration into the skin.

Topics: Animals; Anti-Inflammatory Agents; Calcitriol; Cell Line; Clobetasol; Dermatologic Agents; Drug Combinations; Drug Liberation; Emulsions; Gels; Humans; Interleukin-6; Mice, Inbred BALB C; Nanoparticles; Psoriasis; Skin Absorption; Swine; Tumor Necrosis Factor-alpha

Fixed combination calcipotriol 50 µg/g (Cal; as hydrate) plus betamethasone 0.5 mg/g (as dipropionate; BD) has been formulated in an innovative aerosol foam.. To assess systemic safety of Cal/BD aerosol foam.. In a multicentre, single-arm, open-label, maximal-use systemic-exposure trial, adult patients with moderate to severe, extensive psoriasis (15%-30% of body surface area, including ≥30% of scalp) applied Cal/BD foam once daily. Endpoints were week 4 abnormal adrenocorticotropic hormone (ACTH) challenge test and change in albumin-corrected serum calcium, 24-hour urinary calcium excretion, and urinary calcium-creatinine ratio.. 35 patients reaching week 4 exhibited normal ACTH responses. At week 4, changes in calcium homeostasis were minor and not clinically relevant; no patients experienced elevations above normal. Disease severity generally improved, and 49% of patients achieved treatment success according to the Physician's Global Assessment of Disease Severity.. No clinically relevant HPA axis or calcium homeostasis impact was observed with 4 weeks of once-daily Cal/BD foam in patients with extensive psoriasis vulgaris.

Topics: Aerosols; Betamethasone; Calcitriol; Calcium; Dermatologic Agents; Drug Combinations; Female; Homeostasis; Humans; Hypothalamo-Hypophyseal System; Male; Middle Aged; Pituitary-Adrenal System; Psoriasis

Topical calcipotriol is a widely used treatment for plaque-type psoriasis worldwide, and has been shown to improve psoriatic plaques as well as very potent corticosteroids. However, there remains the practical question of whether calcipotriol application should continue on healed pigmentation/depigmentation associated with psoriatic plaques. Therefore, we conducted a pilot clinical study to answer this question. Plaque-type psoriatic patients not receiving systemic treatment were enrolled and treated with calcipotriol for 8 weeks (stage I) to achieve maximum effect. The patients were then divided into two groups: group A continued to apply calcipotriol to the entirety of the previous lesion (including pigmentation/depigmentation) regardless of whether skin was healed or not, while group B applied calcipotriol to the remaining lesion only. Patients were followed for 12 weeks (stage II) and dates of plaque recurrence were recorded. A total of 29 patients (13 men, 16 women) were enrolled. During stage I, reductions in scores for redness, induration and scale occurred in 40%, 47% and 55% of patients, respectively. After stage II was completed, group A (n = 19) showed a significantly better Kaplan-Meier curve of non-recurrence than group B (n = 8, P < 0.01). The mean non-recurrence duration was 76.8 ± 11.8 in group A and 35.0 ± 12.0 in group B. Our study showed that applying topical calcipotriol on seemingly healed psoriatic plaque lesions suppresses recurrence better than applying it only on remaining plaques. This finding may be important for instructing psoriatic patients on topical calcipotriol treatment.

Topics: Administration, Topical; Aged; Calcitriol; Dermatologic Agents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Pilot Projects; Psoriasis; Random Allocation; Secondary Prevention; Severity of Illness Index; Treatment Outcome

To evaluate patients' assessment of therapy, efficacy, quality of life and treatment adherence in patients with scalp psoriasis treated with non-alcoholic mometasone emulsion or calcipotriol/betamethasone gel.. Prospective, open-label, multicentre, non-interventional study. Patients with non-severe scalp psoriasis were treated with mometasone emulsion or calcipotriol/betamethasone gel. Evaluations included patient's global assessment of treatment, physician's global assessment of disease severity, quality of life (Dermatology Life Quality Index), physician's subjective evaluation of therapy, treatment adherence and adverse events.. Ninety-five patients treated with mometasone emulsion and 88 treated with calcipotriol/betamethasone gel were included in the intention-to-treat analysis. Patients' global assessment of treatment favoured mometasone emulsion over calcipotriol/betamethasone gel (p = 0.008), with treatment rated as good/very good by 91% versus 82.5%. Patients were less likely to report irritation of fingers' skin with mometasone than with calcipotriol/betamethasone (p = 0.0015). Severity of scalp psoriasis and quality of life improved in both groups. Adherence to treatment was similar in both groups. Physicians' perception of efficacy, tolerability and compliance was better for mometasone emulsion.. Non-alcoholic mometasone emulsion achieved greater acceptability to patients and physicians than calcipotriol/betamethasone gel for the treatment of scalp psoriasis. Both topical treatments were similarly effective in terms of disease severity and quality of life.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Emulsions; Female; Glucocorticoids; Humans; Male; Middle Aged; Mometasone Furoate; Patient Acceptance of Health Care; Patient Compliance; Patient Preference; Prospective Studies; Psoriasis; Quality of Life; Scalp Dermatoses

Psoriasis vulgaris is characterised by epidermal hyper-proliferation and infiltration of immune cells including dendritic cells (DCs) and T cells. The inflammation is driven by a complex interplay between immune and skin cells involving interleukin (IL)-17A, IL-23 and TNF-α as key drivers. The calcipotriol/betamethasone dipropionate two-compound fixed combination product is widely used for topical treatment of psoriasis. However, the mechanism behind its high efficacy has not been elucidated in detail.. Here, we investigated and compared the immune modulatory effects of betamethasone, calcipotriol and the combination in ex vivo cultures of psoriatic skin and in vitro cultures of primary human cells that recapitulate key cellular activities of psoriatic inflammation.. The immune modulatory effect of the treatments on psoriatic skin and on in vitro differentiated Th1/Th17 cells, Tc1/Tc17 cells, monocyte-derived inflammatory dendritic cells and primary keratinocytes was assessed by a panel of inflammatory and phenotypic related transcription factors and cytokines. The expression was evaluated by both gene and protein analysis.. Compared to vehicle control or mono-treatments, the effect of calcipotriol/betamethasone combination was significantly better in inhibiting the secretion of IL-17A and TNF-α in psoriatic skin. Additionally, the two components showed additive inhibitory effects on secretion of IL-23 and TNF-α by DCs, of IL-17A and TNF-α by both CD4(+) and CD8(+) T cells and reduced inflammatory responses in Th17-stimulated keratinocytes. Furthermore, calcipotriol was found to enhance IL-10 secretion in psoriatic skin and in human T cells, to induce secretion of type 2 cytokines by T cells and, lastly, to significantly modulate the differentiation of DCs and T cells.. In summary, we demonstrate a unique and supplementary immune modulatory effect of calcipotriol/betamethasone combination on TNF-α and IL-23/Th17 immune axis, supporting the superior clinical efficacy of the combination product compared to the respective mono-treatments in psoriasis patients.

Topics: Adrenal Cortex Hormones; Betamethasone; Calcitriol; Cell Communication; Cell Differentiation; Cells, Cultured; Cytokines; Drug Therapy, Combination; Gene Expression Regulation; Humans; Immunologic Factors; Inflammation Mediators; Keratinocytes; Langerhans Cells; Phenotype; Psoriasis; Receptors, Calcitriol; Signal Transduction; Th17 Cells; Tissue Culture Techniques

Calcipotriol ameliorates psoriasis through inducing keratinocyte apoptosis and inhibiting nuclear factor kappa B (NF-κB) activation, while zinc finger protein A20 exhibits an anti-apoptotic effect on various types of cells.. To understand the potential role of A20 in calcipotriol function.. The A20 levels were evaluated in the psoriatic skins from both human patients and K14-vascular endothelial growth factor (VEGF) transgenic mice that received or did not receive topical calcipotriol treatment. The in vitro effect of calcipotriol on A20 expression and the downstream NF-κB pathway was studied using a model of human foreskin keratinocytes (HFKs) that were stimulated with psoriatic cytokines [M5, a cocktail of interleukin (IL)-1a, IL-17A, IL-22, Oncostatin M and tumour necrosis factor-α, each at 10 ng mL(-1) ].. A20 expression was enhanced in both psoriatic tissues and keratinocytes when compared with controls, but decreased on calcipotriol treatment. The transfection of A20 small interfering RNA (siRNA) improved cell differentiation, and inhibited psoriatic inflammation in a HFK model. Moreover, the nuclear expression of NF-κB p65 decreased on A20 downregulation in psoriatic tissues and keratinocytes. Interestingly, calcipotriol enhanced the binding of A20 to ring finger protein 114 (RNF114) and A20-binding inhibitor of NF-κB-1 (ABIN-1) in HFKs, two negative regulators of the NF-κB pathway.. Calcipotriol exhibits its antipsoriatic function through suppressing A20 expression and stabilizing negative regulators of the NF-κB pathway.

Topics: Administration, Cutaneous; Animals; Apoptosis; Calcitriol; Cell Differentiation; Cells, Cultured; Cytokines; Dermatitis; Dermatologic Agents; Down-Regulation; Female; Humans; Keratinocytes; Mice, Transgenic; NF-kappa B; Protein Binding; Psoriasis; RNA, Small Interfering; Signal Transduction; Skin; Transfection; Tumor Necrosis Factor alpha-Induced Protein 3

Topics: Administration, Cutaneous; Aerosols; Animals; Calcitriol; Chemistry, Pharmaceutical; Dermatologic Agents; Drug Administration Schedule; Humans; Psoriasis; Treatment Outcome

Immunomodulatory agents that target PD-1 and its ligand (PD-L1) are being increasingly used in the management of lung cancer. Potential immune-related adverse events include dermatological complications which mostly are of low grade severity. The use of immune checkpoint inhibitors may lead to the exacerbation of autoimmune conditions. We report a case of a documented psoriasis flare with anti-PD-1 treatment for lung cancer.

Topics: Adenocarcinoma; Aged; Antibodies, Monoclonal; Antineoplastic Agents; B7-H1 Antigen; Calcitriol; Carcinoma, Non-Small-Cell Lung; Cigarette Smoking; Disease Progression; ErbB Receptors; Exons; Humans; Male; Mometasone Furoate; Neoplasm Metastasis; Phototherapy; Psoriasis; Sequence Deletion

In relation to Th17 cell actions, interferon (IFN)-α production by plasmacytoid dendritic cells (pDCs) are involved in the pathogenesis of psoriasis. Vitamin D3 analogues are widely used in the treatment of psoriasis, however, their actions on pDCs are not well understood.. To investigate the effects of Vitamin D3 analogue calcipotriol (CAL) on pDCs, focusing on the cytokine production and chemotactic activity.. We compared in mice the effects of CAL, cyclosporine A (CyA), and triamcinolone acetonide (TA) on the cytokine production by pDCs (IFN-α), conventional DCs (TNF-α), and γd T cells (IL-17A). pDCs isolated from mouse spleen cells were stimulated with CpG-ODN in the presence or absence of each drug for 48h. Purified splenic conventional DCs (cDCs) and lymph node γδ T cells were stimulated with CpG-ODN or with anti-CD3/CD28 antibody, respectively. IFN-α, TNF-α and IL-17A in the 48-h culture supernatants were quantified by ELISA. We also studied the ability of CAL to inhibit the chemotaxis of freshly isolated pDCs toward chemerin and VEGF-A, representative chemoattractants of pDCs, by a real-time monitoring method, EZ-Taxiscan. To assess the effect of CAL on pDC accumulation in vivo, we painted CAL ointment to the mouse skin inflamed by topical application of imiquimod cream (IMQ) for 4 consecutive days. In the skin samples, we enumerated 440c. CAL significantly inhibited CpG-enhanced pDC IFN-α production at a comparable level to T cell IL-17A production, whereas its effect on cDC TNF-α production was minimal. Accordingly, CAL suppressed the CpG-augmented expression of TLR9 and MyD88. On the contrary, CyA strongly suppressed the production of TNF-α and IL-17A, but not IFN-α. TA inhibited the production of all the cytokines tested. The effect of CAL on the chemotactic activity of pDCs was also evaluated, demonstrating a significant downmodulation by exposure to the reagent. CAL depressed chemerin receptor CMKLR1 expression in pDCs. The in vivo mouse study showed that simultaneous application of CAL to the imiquimod-applied skin reduce both the recruitment of pDCs and the expression of IFN-α2 in the skin.. Our findings suggest that CAL uniquely downmodulates the cytokine production and chemotactic activity of pDCs. The CAL suppression of the in vivo pDC accumulation to the skin suggests that these actions are therapeutically relevant.

Topics: Animals; Calcitriol; Chemotaxis; Cholecalciferol; CpG Islands; Dendritic Cells; Dermatologic Agents; Down-Regulation; Female; Flow Cytometry; Humans; Immunohistochemistry; Interferon-alpha; Interferon-gamma; Interleukin-17; Mice; Microscopy, Fluorescence; Oligonucleotides; Psoriasis; Receptors, Antigen, T-Cell, gamma-delta; Skin; Spleen; Tumor Necrosis Factor-alpha; Vascular Endothelial Growth Factor A

Topics: Calcitriol; Dermatologic Agents; Humans; Psoriasis; Ubiquitin

Evidence on efficacy and safety of topical treatments for paediatric scalp psoriasis is lacking.. This study aims to evaluate the effectiveness and safety of calcipotriene/betamethasone dipropionate scalp formulation for paediatric scalp psoriasis in daily clinical practice. The influence of this formulation on the quality of life (QoL) was assessed as well.. Data of children treated with the scalp formulation were extracted from a prospective observational daily clinical practice registry of children with psoriasis, called Child-Continuous Assessment of Psoriasis Treatment Use Registry. Severity was expressed by Psoriasis Scalp Severity Index (PSSI) and the impact on the QoL was reflected by the validated Children's Scalpdex in Psoriasis (CSP).. Eighty-four treatment episodes were analysed. Significant improvements of PSSI score (18.7 ± 11.8 to 12.7 ± 9.4) were demonstrated in the first 12 weeks and this result was well maintained during 48 weeks of follow-up. Three patients (4.1%) developed striae of the skin (arms, trunk and legs), which are possibly related to the scalp formulation. CSP scores (79.0-46.3) declined significantly after 3 months.. In a daily clinical practice cohort of children with scalp psoriasis, calcipotriene/betamethasone dipropionate scalp formulation was effective with a 32.1% improvement of PSSI at week 12 and a maintenance of this effect until 48 weeks of follow-up, in combination with improvement of QoL.

Topics: Administration, Cutaneous; Adolescent; Betamethasone; Calcitriol; Child; Child, Preschool; Drug Combinations; Female; Humans; Male; Prospective Studies; Psoriasis; Quality of Life; Scalp Dermatoses; Severity of Illness Index

Diminished suppressive capacity of regulatory T cells (Treg) has been demonstrated in blood and in lesional skin of psoriatic patients. Treatment with anti-TNFα restored the number and function of circulating Treg in psoriasis. We aimed to study Treg in the skin of psoriatic patients undergoing topical treatment with calcipotriol-betamethasone dipropionate (CBD) ointment (n = 12) or systemic treatment with anti-TNFα agent adalimumab (n = 10). Skin biopsies were collected from patients with chronic plaque psoriasis who responded to the above-mentioned treatments with a SUM-score improvement of at least 50% (at the end of treatment). Biopsies were processed for immunohistochemistry. As Treg function is associated with a numerical balance between Treg and effector T cells, Foxp3/CD4 ratios were calculated. It appeared that both treatments cause a significant decrease in the presence of Foxp3+ cells. However, in patients that were treated with CBD ointment, we observed lower Foxp3/CD4 ratios after 8 weeks of treatment compared to baseline (t = 0: 0.41 ± 0.08; t = 8: 0.22 ± 0.04, P = 0.033), whereas in patients who were treated with adalimumab we observed an increase of the Foxp3/CD4 ratios after 1.5 and 16 weeks of treatment compared to baseline (t = 0: 0.25 ± 0.04; t = 1.5: 0.32 ± 0.06; t = 16: 0.49 ± 0.10, P = 0.15). Based on Foxp3/CD4 ratios, we can conclude that adalimumab treated skin differs from CBD treated skin with regard to the anti-inflammatory/inflammatory balance. We suggest that, in contrast to CBD ointment, adalimumab favours local Treg function in the skin.

Topics: Adalimumab; Administration, Topical; Aged; Anti-Inflammatory Agents; Antibodies, Monoclonal, Humanized; Betamethasone; Biopsy; Calcitriol; CD4-Positive T-Lymphocytes; Female; Forkhead Transcription Factors; Humans; Immunohistochemistry; Inflammation; Male; Middle Aged; Ointments; Psoriasis; Skin; T-Lymphocyte Subsets; T-Lymphocytes, Regulatory; Tumor Necrosis Factor-alpha

Topical corticosteroids and the vitamin D analogue calcipotriol are the cornerstone of therapy for patients with mild-to-moderate plaque psoriasis. Lack of patients' adherence leads to suboptimal effectiveness of topical therapy in real-life practice. The fixed combination betamethasone/calcipotriol gel is more effective and safe than the administration of single components and may enhance patients' adherence. We aimed at evaluating the pattern of care and dermatologists' expert opinion toward the available topical treatments for the management of mild-to-moderate psoriasis in Italy.. We enrolled 242 Italian dermatologists and collected information related to their practice pattern and opinion toward available topical treatments with a face-to-face structured interview. We evaluated dermatologists' ratings of therapy with 16 items tapping their opinion toward the relevance and satisfaction toward 8 therapy attributes in clinical practices which tapped aspects of real-life effectiveness, adherence promotion, toxicity, convenience of use. Ratings occurred along a 10-point scale. We compared single-attribute and weighted overall therapy ratings across alternative treatment options with random-intercept linear models to account for ratings clustering within dermatologists.. There was a wide variation in practice patterns: 1/3 of dermatologist had seen more than 30 patients with psoriasis while around 1/4 had seen less than 10 patients. The fixed combination betamethasone/calcipotriol gel was considered superior to monotherapies in all the eight attributes considered which tapped aspects of real-life effectiveness, adherence promotion, toxicity, convenience of use.. Participant dermatologists' strongly preferred the fixed betamethasone/calcipotriol combination gel over both the fixed combination ointment formulation and corticosteroid or vitamin D analogues monotherapies. Such findings are in line with evidence from randomized controlled trials and few observational studies demonstrating superior clinical outcomes, quality of life, tolerability and lower risk of side effect in patients treated with the fixed combination of betamethasone/calcipotriol gel.

Topics: Administration, Cutaneous; Attitude of Health Personnel; Betamethasone; Calcitriol; Dermatologic Agents; Dermatology; Drug Combinations; Glucocorticoids; Health Care Surveys; Humans; Italy; Medication Adherence; Practice Patterns, Physicians'; Psoriasis; Quality of Life

Topics: Acitretin; Adult; Calcitriol; Calcium; Dermatologic Agents; Drug Therapy, Combination; Female; Genotype; Humans; Keratolytic Agents; Male; Middle Aged; Ointments; Polymorphism, Single Nucleotide; Psoriasis; Receptors, Calcitriol; Severity of Illness Index

Topical therapies are the mainstay of treatment for psoriasis vulgaris. The fixed combination of calcipotriol (Cal) 50 μg/g plus betamethasone 0.5 mg/g (as dipropionate; BD) is a first-line topical treatment and available as a gel or ointment. The use of these fixed combination products was compared in PRO-long, a long-term noninterventional study, for which interim results (4 and 12 weeks) have previously been reported.. To describe and compare patients' perspectives on the fixed combination gel and ointment formulations; to include efficacy, adherence behaviour, treatment satisfaction and health-related quality of life (HRQoL) aspects during long-term real-life psoriasis management.. PRO-long was a multicentre, prospective, observational, 52-week study of patients prescribed fixed combination Cal/BD gel or ointment in clinical practice. For final analysis the following were assessed at weeks 24, 36 and 52: differences in the proportion of patients with 'mild'/'very mild' disease according to patient's global assessment of disease severity, adherence behaviour, treatment satisfaction (nine-item treatment satisfaction questionnaire for medication) and HRQoL (Skindex-29).. Patients (n = 328) were prescribed once-daily Cal/BD gel (n = 152) or ointment (n = 176). At week 52, a higher proportion of patients reported that the severity of their psoriasis was 'mild'/'very mild' vs. baseline (gel: 60.2 vs. 47.1%; ointment: 58.8 vs. 42.4%), with greater treatment satisfaction reported in patients using gel vs. those using ointment. A higher proportion of patients found the gel 'easy' to use compared with the ointment (66.7 vs. 45.2%). Daily application of treatment took ≤ 5 min for 86.1% of patients using gel and 71.0% of patients using ointment.. This real-life study has demonstrated similar effectiveness between the Cal/BD formulations. However, over a 52-week treatment period, patients reported greater treatment satisfaction with the gel, which was considered easier to use, faster to apply and overall a more convenient product.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Child; Dermatologic Agents; Drug Combinations; Female; Gels; Humans; Male; Medication Adherence; Middle Aged; Ointments; Patient Satisfaction; Prospective Studies; Psoriasis; Quality of Life; Severity of Illness Index; Time Factors; Young Adult

Variably considered as a localized subtype of pustular psoriasis, palmoplantar pustulosis (PPP) is commonly treated with topical steroids, acitretin, and local phototherapy with oral or topical psoralen (PUVA). The utility of acitretin for PPP is limited by adverse effects such as myalgias and an extended risk of teratogenicity in female patients. Isotretinoin is a more tolerable retinoid with a shorter teratogenic window, but to date its effectiveness in PPP has not been reported. Herein we present two patients with PPP who responded well to isotretinoin treatment.. Two patients with PPP refractory to topical therapies were started on acitretin. Both patients developed adverse effects (including headache, myalgias, and mood alterations) leading to acitretin discontinuation. Isotretinoin monotherapy was started in one patient resulting in significant clearing of palmar plaques and scale, and the addition of isotretinoin to UVA therapy resulted in near-complete clearing of recalcitrant plantar plaques in the second patient.. Acitretin represents an important treatment for PPP, but is limited by adverse effects and extended teratogenicity. Our experience supports the utility of isotretinoin as a potential therapeutic alternative, which may be particularly beneficial in patients who are poor candidates for or unable to tolerate acitretin therapy.

Topics: Acitretin; Anti-Inflammatory Agents; Biopsy; Calcitriol; Ceramides; Cholesterol; Clobetasol; Combined Modality Therapy; Diagnostic Errors; Drug Combinations; Drug Substitution; Eczema; Emollients; Fatty Acids; Female; Humans; Isotretinoin; Male; Middle Aged; Psoriasis; Ultraviolet Therapy

Topics: Administration, Topical; Antistreptolysin; Calcitriol; Dermatologic Agents; Diagnosis, Differential; Humans; Male; Pharyngitis; Phototherapy; Prognosis; Psoriasis; Streptococcal Infections; Treatment Outcome; Triamcinolone Acetonide; Young Adult

Angiogenesis represents a key phenomenon in psoriasis. Insights in the microcirculation within psoriatic lesions in a whole field are lacking. Recently, the Twente Optical Perfusion Camera (TOPCam) was developed, which provides the possibility of evaluating the superficial cutaneous microcirculation in a whole field.. This pilot study aims to examine whether the TOPCam can be used to visualize the microcirculation within and around psoriatic lesions, and whether it is capable of revealing vascular changes during topical treatment.. Five patients with chronic plaque psoriasis were included. The superficial microcirculation and clinical local scores (SUM score) were analyzed in two comparable lesions within one patient. At baseline and after 2, 4, 6, and 8 weeks the disease's natural course was evaluated in one plaque versus topical treatment in the other.. The TOPCam was able to visualize an increased microcirculation within psoriatic lesions and perfusion variability due to the heartbeat. Whole field images demonstrated heterogeneity in perfusion intensity (hot and cold spots) within clinically homogeneous-looking plaques. Topical therapy induced a decrease in overall perfusion and a significant decrease in SUM score.. The TOPCam is the first noninvasive technique to visualize the microcirculation of psoriatic lesions in a whole field, to correct images for the heartbeat, and to reveal heterogeneity in perfusion intensity.

Topics: Aged; Betamethasone; Calcitriol; Dermatologic Agents; Female; Heart Rate; Humans; Laser-Doppler Flowmetry; Male; Microcirculation; Middle Aged; Pilot Projects; Psoriasis; Skin; Treatment Outcome

Topics: Adalimumab; Antibodies, Monoclonal, Humanized; Calcitriol; Dermatitis, Exfoliative; Dermatologic Agents; Drug Therapy, Combination; Humans; Male; Middle Aged; Psoriasis; Salicylic Acid

The interleukin-23/interleukin 17A (IL-23/IL-17A) cytokine axis plays a critical role in the pathogenesis of psoriasis. In this study, we report the effects of topical calcipotriol, camptothecin, clobetasol and tazarotene on the treatment of imiquimod (IMQ)-induced psoriasis-like inflammation, the development of which is dependent on the IL-23/IL-17A axis. IMQ-induced epidermal hyperplasia and inflammation in the BALB/c mouse ear were significantly inhibited following clobetasol treatment but not calcipotriol, camptothecin or tazarotene treatments. Real-time polymerase chain reaction showed that the mRNA levels of IL-17A, IL-17F, IL-22, IL-1β, IL-6 and TNF-α in ear skin were significantly decreased by clobetasol. In addition, we observed that calcipotriol, camptothecin and tazarotene failed to show any inhibitory effects on the IL-23/IL-17A/IL-22 axis. We also found that clobetasol treatment inhibited the proliferation of γδ T cells and C-C chemokine receptor type 6 (CCR6) expression induced by IMQ. Calcipotriol, camptothecin and tazarotene not only failed to inhibit this proliferation but also enhanced retinoic acid-related orphan receptor γ (RORγ) expression in IMQ-induced psoriasis-like inflammation. In conclusion, we suggest that clobetasol induces the relief of IMQ-induced psoriasis-like inflammation in a mouse model but that calcipotriol, camptothecin and tazarotene cannot. Therefore, we suggest that more in-depth studies on pharmacological effects of tazarotene, camptothecin and calcipotriol should be carried out.

Topics: Adjuvants, Immunologic; Administration, Topical; Aminoquinolines; Animals; Anti-Inflammatory Agents; Calcitriol; Camptothecin; Clobetasol; Dermatologic Agents; Disease Models, Animal; Humans; Imiquimod; Mice; Mice, Inbred BALB C; Nicotinic Acids; Psoriasis; Topoisomerase I Inhibitors

Topical application of the vitamin D (VitD) analog calcipotriol is a highly effective standard treatment modality of psoriatic skin lesions. However, the immune modulatory effects of the treatment are incompletely understood. VitD is well known to induce tolerogenic responses in conventional dendritic cells (cDCs). Plasmacytoid DCs (pDCs) comprise a specialized, naturally occurring DC subset known to be important in autoimmune diseases including psoriasis. pDCs from the blood rapidly infiltrate psoriatic skin and are key to the initiation of the immune-mediated pathogenesis of the disease. We now demonstrate that pDCs express various proteins of the VitD receptor (VDR) pathway, including the VitD-metabolizing enzymes Cyp27B1 and Cyp24A1, and that VDR is transcriptionally active in pDCs. Moreover, VitD impairs the capacity of murine and human pDCs to induce T-cell proliferation and secretion of the T-helper 1 cytokine IFNγ. The inhibitory effect of VitD is dependent on the expression of the VDR in the DCs. This study demonstrates that VitD signaling can act as a natural inhibitory mechanism on both cDCs and pDCs, which may instigate the development of VitD-based therapeutic applications for psoriasis and other inflammatory skin diseases.

Topics: Animals; Calcifediol; Calcitriol; Dendritic Cells; Dermatologic Agents; Humans; Interferon-gamma; Mice; Mice, Inbred BALB C; Mice, Inbred C57BL; Mice, Knockout; Psoriasis; Receptors, Calcitriol; Signal Transduction; Th1 Cells; Vitamin D

Psoriasis is most often treated using topical therapies such as the once-daily fixed combination of calcipotriol and betamethasone dipropionate, which is available as a gel and an ointment. To date, there have been no direct comparisons of patient perspectives on the two formulations.. To describe and compare patients' perspectives on calcipotriol and betamethasone gel and ointment formulations, including real-life effectiveness, adherence behaviour, treatment satisfaction and health-related quality of life (QoL), during long-term psoriasis vulgaris management, according to interim findings from the PRO-long study.. PRO-long is a multicentre, prospective, observational, 52-week cohort study in patients prescribed fixed-combination calcipotriol (50 μg/g) and betamethasone (0.5 mg/g; as dipropionate) gel or ointment for long-term psoriasis management. Difference in effectiveness at 4 and 12 weeks was assessed by comparing the proportion of patients with controlled (mild or very mild) disease, according to the Patient's Global Assessment. Additional patient questionnaires were used to assess adherence behaviour, treatment satisfaction (nine-item Treatment Satisfaction Questionnaire for Medication) and health-related QoL (Skindex-29).. A total of 156 patients were included in the analysis. In single items of the adherence behaviour and treatment satisfaction questionnaires, patients preferred the gel over the ointment as convenient, easy to use and fast to apply. Post hoc analysis demonstrated significant differences between gel and ointment for convenience and application time. More patients had controlled disease at week 12 with gel (71.9%) vs. ointment (65.7%); however, the difference was not statistically significant (primary end point; P = 0.40).. This interim analysis supports fixed-combination calcipotriol and betamethasone gel as more convenient, easier to use and faster to apply than the ointment formulation in real-life conditions according to patients with psoriasis vulgaris. Furthermore, a numerical difference in patient-reported real-life effectiveness was seen in favour of the gel, although this was not statistically significant.

Topics: Adolescent; Adult; Aged; Betamethasone; Calcitriol; Drug Administration Schedule; Female; Gels; Humans; Male; Middle Aged; Ointments; Patient Satisfaction; Prospective Studies; Psoriasis; Quality of Life; Young Adult

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Attitude of Health Personnel; Betamethasone; Calcitriol; Clobetasol; Dihydroxycholecalciferols; Dose-Response Relationship, Drug; Drug Prescriptions; Gels; Humans; Immunosuppressive Agents; Medication Adherence; Practice Patterns, Physicians'; Psoriasis

Psoriasis in children has a significant negative impact on the quality of life (QoL) and effective treatment can improve this. The two-compound ointment calcipotriol 50 μg g(-1) and betamethasone dipropionate 0·5 mg g(-1) is an effective treatment option for moderate-to-severe psoriasis in adults.. To study prospectively the effectiveness and safety of calcipotriol/betamethasone dipropionate ointment in paediatric patients with mild-to-moderate plaque psoriasis in daily clinical practice and to investigate the influence on QoL.. Data were obtained from a prospective, longitudinal paediatric psoriasis registry, called Child-CAPTURE. Severity was assessed using the Psoriasis Area and Severity Index (PASI) and body surface area (BSA). The Children's Dermatology Life Quality Index (CDLQI) was used to assess QoL and visual analogue scores (VAS) for pain and itch were collected. For safety data the number of (serious) adverse events was recorded.. Seventy-three patients (mean age 10·8 years, range 3-18) were treated for a median time of 35·0 weeks (range 1·0-176·0). At week 12, mean PASI decreased 15·4% (from 5·2 to 4·4), BSA barely changed, and median CDLQI decreased significantly from 5·5 to 4·0. VAS scores for pain and itch declined. At week 24, mean PASI decreased to 4·3 (17·3%). No related serious adverse events were observed.. In this daily clinical practice study in paediatric psoriasis, calcipotriol/betamethasone dipropionate ointment initially improved mild-to-moderate psoriasis and then maintained its effect. In addition, it improved QoL, with few adverse events.

Topics: Adolescent; Betamethasone; Calcitriol; Child; Child, Preschool; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Ointments; Prospective Studies; Psoriasis; Quality of Life; Treatment Outcome

Current data from daily practice show that vitamin D₃ analogues, corticosteroids and their fixed combination products are used heterogeneously for topical long-term treatment of psoriasis.. To evaluate scientific evidence about topical long-term therapy with vitamin D3 analogues, corticosteroids and their two-compound-products in psoriasis vulgaris and scalp psoriasis and to develop daily practice recommendations.. Systematic literature review via PubMed and Embase and informal expert consensus.. The search strategy identified 21 relevant clinical trials. Best evidence regarding topical long term treatment was available for the two-compound-formulation containing calcipotriene and betamethasone. In a comparative trial in psoriasis vulgaris the two-compound-formulation showed superior tolerability and cost effectiveness compared to monotherapy. In scalp psoriasis the two-compound-gel was superior compared to calcipotriene monotherapy. Standardized and simplified treatment application modes resulted in a better clinical outcome comparing to on-demand therapies.. Patients should be proactively involved in the choice of treatment, formulation and mode of application. Besides long-term treatment with the two-compound-formulation other treatment regimens including calcipotriene monotherapy can also be considered. Due to a favorable risk-benefit ratio in maintenance trials and due to better cost-effectiveness the application of two-compound-products once or twice a week after initial therapy is recommended.

Topics: Administration, Topical; Adrenal Cortex Hormones; Betamethasone; Calcitriol; Cholecalciferol; Clinical Trials as Topic; Drug Combinations; Evidence-Based Medicine; Guideline Adherence; Humans; Long-Term Care; Psoriasis

Psoriasis is a multifactorial process associated with immunologic dysregulation. Chronic plaque psoriasis (PP) is the most common clinical presentation. Plaque psoriasis is characteristically a chronic disease associated with periods of persistence and episodes of flaring; therefore, intermittent use of topical corticosteroid (TC) therapy along with concurrent or sequential use of a nonsteroidal topical agent is commonly employed to achieve and sustain control of the disorder. Calcipotriene 0.005%-betamethasone dipropionate 0.064% topical suspension (C/Bd-TS) is a rational option for the treatment of PP in patients with localized disease or in patients treated systemically or with phototherapy for more extensive disease who exhibit persistence or recurrence of scattered areas of PP. This article provides a review of a patented topical suspension combination formulation of C/Bd-TS, including formulation characteristics, perspectives on modes of action, outcomes from pivotal trials, and efficacy and safety data reported from additional studies.

Topics: Administration, Cutaneous; Betamethasone; Calcitriol; Dermatologic Agents; Dermatology; Drug Combinations; Evidence-Based Medicine; Humans; Psoriasis; Suspensions; Treatment Outcome

Treatment with calcipotriene plus betamethasone dipropionate (CBD) fixed-combination topical suspension has been shown to be effective and well tolerated in patients with psoriasis vulgaris.. To document experiences with CBD topical suspension in a US clinical dermatology setting using patient-reported outcomes (PROs).. In total, 147 patients were enrolled in this 8-week, prospective, noninterventional, multicenter, one-arm study. Data were collected at baseline and week 8 at the office, and at one time at home (week 2). PROs were assessed using the Dermatology Life Quality Index (DLQI), Patient's Global Assessment of disease severity (PtGA) using a 5-point Likert scale, patient-reported level of itching using a 0-100 graduated visual analog scale, and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Treatment adherence and adverse events (AEs) were assessed at week 8.. After 8 weeks of treatment, DLQI score significantly improved compared with baseline (-5.5 ± 5.93; P<.0001), starting as early as week 2 (-4.2 ± 5.28; P<.0001). The level of itching was significantly reduced from baseline to week 2 (-19% ± 25.94%; P<.0001) and week 8 (-28.6% ± 29.14%; P<.0001). The percentage of patients with "controlled disease" (PtGA score of "clear" or "very mild") was 34.1% at week 2 and 60.2% at week 8. At the end of treatment, mean TSQM-9 scores for effectiveness, convenience, and satisfaction domains ranged from 68 to 74. Patients reported the need to use CBD topical suspension for an average of 53.62 ± 8.05 days. Treatment-emergent AEs occurred in 3 patients.. The results of this noninterventional study are consistent with previously reported data from interventional trials and suggest that treatment with CBD topical suspension is efficacious and well tolerated and improves quality of life in patients with psoriasis vulgaris.

Topics: Administration, Cutaneous; Adult; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Patient Satisfaction; Prospective Studies; Pruritus; Psoriasis; Quality of Life; Severity of Illness Index; Surveys and Questionnaires; Suspensions; Treatment Outcome

It has been indicated that the sphingolipid sphingosine-1-phosphate (S1P) restrains the ability of dendritic cells to migrate to lymph nodes. Furthermore S1P has been demonstrated to inhibit cell growth in human keratinocytes. However, only little is known about the effect of S1P in hyperproliferative and inflammatory in vivo models.. In this study, locally acting S1P was explored in different experimental mouse models of psoriasis vulgaris.. S1P and FTY720 were tested in the imiquimod-induced psoriasis mouse model, the mouse tail assay and a pilot study of the severe combined immunodeficiency mice (SCID).. In the imiquimod model the positive control diflorasone diacetate and S1P, but not FTY720 reduced the imiquimod-induced epidermal hyperproliferation of the ear skin. This effect was confirmed in the SCID model, where S1P treated skin from patients suffering from psoriasis showed a decrease in epidermal thickness compared to vehicle. In the imiquimod model, there was also significant inhibition of ear swelling and a moderate reduction of inflammatory cell influx and oedema formation in ear skin by S1P treatment. The inflammatory response on the back skin was, however, only reduced by diflorasone diacetate. In the mouse tail assay, the influence of S1P and FTY720 in stratum granulosum formation was tested compared to the positive control calcipotriol. Whereas topical administration of calcipotriol led to a low but significant increase of stratum granulosum, S1P and FTY720 lacked such an effect.. Taken together, these results imply that topical administration of S1P might be a new option for the treatment of mild to moderate psoriasis lesions.

Topics: Administration, Cutaneous; Aminoquinolines; Animals; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Cell Differentiation; Cell Proliferation; Dermatologic Agents; Disease Models, Animal; Female; Fingolimod Hydrochloride; Humans; Imiquimod; Keratinocytes; Local Lymph Node Assay; Lysophospholipids; Mice; Mice, Inbred BALB C; Mice, SCID; Propylene Glycols; Psoriasis; Receptors, Lysosphingolipid; Skin; Skin Transplantation; Sphingosine; Sphingosine-1-Phosphate Receptors; Time Factors

Psoriasis is treated with several classes of treatments that may be used in combination, but the ways combination therapies are used are not well characterized.. To determine the frequency of prescribing calcipotriene and other psoriasis drugs in combination.. Visits with a sole diagnosis of psoriasis were selected from 1990-2010 data from the National Ambulatory Medical Care Survey. The number of combination therapies used, the leading therapies in each class of medications, and the leading types used in combination were analyzed.. About 10.2 million of 20.3 million psoriasis visits used multiple treatments. The mean number of prescribed medications increased over time (P=.0003). The top 10 treatments included 6 topical steroids, calcipotriene, 2 other topicals, and methotrexate. The most common combinations were topical steroid plus other topical (15.0%), multiple topical steroids (11.5%), topical steroid plus vitamin D analogue (9.7%), and topical steroid plus systemic treatment (6.9%). Vitamin D analogues and systemic treatments were prescribed with increasing frequency over time, while fewer topical steroids were used, and use of other topicals did not change significantly.. Visits with multiple diagnoses had to be excluded to ensure that the medications listed were for psoriasis.. Combination therapy is the most common way to treat psoriasis in the United States. The wide range of combination therapies prescribed may reflect increased attention to individualization of treatment to match patients' diverse preferences.

Topics: Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Glucocorticoids; Health Care Surveys; Humans; Methotrexate; Practice Patterns, Physicians'; Psoriasis; Time Factors; United States

A 38-year-old man presented with whitish nail changes on all fingers as the sole symptom. The condition had developed within a few days and led to dystrophy of the proximal part of the nail plates. As microscopic examination of nail scrapings demonstrated budding hyphae and the patient working as a teacher reported frequent use of a wet sponge, antifungal therapy was initiated. Subsequent cultures and molecular typing identified Rhodotorula mucilaginosa (formerly R. rubra). This environmental yeast was repeatedly isolated despite of therapy with itraconazole. As no improvement was achieved and testing of the biological activity of the fungus revealed only marginal keratolytic activity, it was considered as a coloniser of a destructed nail matrix. Finally, a biopsy of the nail bed confirmed the diagnosis of nail psoriasis, which rapidly responded to treatment with acitretin and topical calcipotriol/betamethasone cream. Fungal growth in destructed nails masqueraded the underlying disease and may have triggered the psoriatic nail reaction.

Topics: Acitretin; Adult; Anti-Inflammatory Agents; Antifungal Agents; Betamethasone; Calcitriol; Coinfection; Dermatologic Agents; Humans; Itraconazole; Keratolytic Agents; Male; Microbiological Techniques; Molecular Diagnostic Techniques; Nails; Onychomycosis; Psoriasis; Rhodotorula; Treatment Outcome

As defensins are dysregulated in psoriasis, the present work is aimed at the assessment of the impact of topical betamethasone with and without calcipotriol on human beta-defensin 2 (hBD-2) expression and serum level in a cohort Egyptian psoriatic patients.. A biopsy was performed at the site of psoriatic plaque for all patients participating in the study before application of any treatment. The first group of patients (n = 25) used an ointment containing a combination of calcipotriol and betamethasone dipropionate for 4 weeks while the second group (n = 25) used an ointment containing betamethasone valerate for the same period. For all patients, human beta defensin-2 expression and serum level was assayed before and after either treatment course.. No statistically significant difference way detected between both groups as regards PASI score, hBD-2 expression or serum level before application of either treatment regimen, while those who used the combined regimen showed lower expression and serum level of hBD-2 associated with lower PASI score on comparison with those who followed the mono-therapy.. Psoriasis treatment using the combined calcipotriol and betamethasone therapy is superior in effect to monotherapy using betamethasone alone. In addition, serum hBD-2 might be a useful marker for disease activity in psoriasis that can help assess the patient's clinical condition.

Topics: Adult; Betamethasone; Calcitriol; Defensins; Humans; Middle Aged; Psoriasis

Psoriasis is a chronic disease that significantly impacts patients' quality of life. It most commonly manifests as localized disease, for which there are various treatment options.. To determine the prescription patterns of topical corticosteroids and vitamin D analogs for the treatment of psoriasis in the United States and how their use has changed over time.. Data from the National Ambulatory Medical Care Survey (NAMCS) from 1994 to 2010 were queried for visits linked with a psoriasis diagnosis. Prescriptions for topical corticosteroids and vitamin D analogs were described. Vitamin D analogs usage was compared across physician specialties. For each sampled visit reported in the NAMCS, visits meeting our inclusion criteria that also mentioned the following medications were identified: topical calcipotriene, topical calcipotriene/betamethasone or any topical corticosteroid indicated for the treatment of psoriasis.. There were an estimated 2.05 million psoriasis visits per year over the 1994-2010 interval. Dermatologists were responsible for 67% of these encounters followed by family practice (14%) and internal medicine (11%). Dermatologists prescribed a vitamin D product at 15% of psoriasis visits, followed by family physicians at 12%, and internists at 5%. Dermatologists prescribed calcipotriene, calcipotriene/betamethasone, and topical corticosteroids in 15%, 4% and 59% of psoriasis visits, respectively. Over time, there was no significant change in the use of topical steroids or vitamin D products by physicians.This study is limited by the inability to determine the severity of psoriasis from the data collected, and the lack of data on the length of treatment with different medications.. Despite their demonstrated efficacy and safer side effect profile, vitamin D analogs are used less often than topical corticosteroids for the treatment of psoriasis. These findings suggest that vitamin D products may not be utilized to their fullest potential as effective topical therapy or adjuncts to therapy for localized plaque psoriasis.

Topics: Administration, Cutaneous; Betamethasone; Calcitriol; Cross-Sectional Studies; Dermatologic Agents; Female; Glucocorticoids; Health Care Surveys; Humans; Male; Practice Patterns, Physicians'; Psoriasis; Time Factors; United States; Vitamin D

Topical corticosteroids and vitamin D analogs are well established as safe and effective first-line treatments for mild to moderate plaque psoriasis. They act via distinct and complementary mechanisms of action: vitamin D analogs primarily counter epidermal dysregulation, inhibiting epidermal hyperproliferation and inducing keratinocyte differentiation, whereas corticosteroids act primarily as immunosuppressors, targeting pro-inflammatory cytokines and chemokines. Furthermore, both agents have additional activity that may complement their main effects: vitamin D analogs have some immunomodulatory properties and corticosteroids may impact on keratinocyte differentiation. Based on their dominant mechanisms of action, there is a strong scientific rationale for the combination of corticosteroids and vitamin D analogs in the treatment of plaque psoriasis. Indeed, the combination has been shown to have a greater effect on the immune-mediated mechanisms of psoriasis than either monotherapy used alone. There is also a strong biological rationale for decreased side effects with the combination. Vitamin D may restore epidermal barrier function, which is impaired with corticosteroid use, and counteract steroid-induced skin atrophy. Corticosteroids may reduce perilesional skin irritation induced by vitamin D analogs. Although clinical data strongly support improved efficacy and tolerability with a combination of calcipotriol and betamethasone dipropionate, additional studies are needed to further investigate their underlying mechanisms.

Topics: Administration, Cutaneous; Animals; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Glucocorticoids; Humans; Psoriasis; Vitamin D

Tinea incognito is a dermatophyte infection of the skin that presents atypically because it has previously been treated with imunnosuppresive medication. Herein we present a case of a middle-aged man who was initially clinically diagnosed to have plaque-type psoriasis on his arms. Over the course of two months of topical hydrocortisone and calciptriol treatment as well as phototherapy, the rash worsened. At the time of presentation to hospital the patient had a pruritic, widespread, sloughing, erythematous rash with areas of eschar. A punch biopsy skin confirmed dermatophyte fungal infection of the skin. Fungal culture was positive for Trichophyton Rubrum and the eruption resolved with systemic anti-fungal therapy. Patient specific risk factors for atypical presentation included poor hygiene and hepatatic disease.

Topics: Antifungal Agents; Biopsy; Calcitriol; Combined Modality Therapy; Diagnostic Errors; Exanthema; Fluconazole; Humans; Hydrocortisone; Immunocompromised Host; Immunosuppressive Agents; Liver Cirrhosis, Alcoholic; Male; Middle Aged; Psoriasis; Skin; Tinea; Trichophyton; Ultraviolet Therapy

The efficacy and safety of calcipotriol plus betamethasone dipropionate ointment in the treatment of psoriasis vulgaris has consistently been demonstrated in several clinical trials. For treatment of scalp psoriasis, more convenient formulations are required. Therefore, new lipophilic alcohol-free gel formulations containing calcipotriol (50 µg/g) and betamethasone (0.5 mg/g; as dipropionate) (two-compound gels) for treatment of scalp psoriasis were developed.. To identify the optimal gel formulation by evaluating the antipsoriatic effect in a psoriasis plaque test model.. The use of a psoriasis plaque test enables investigation of the antipsoriatic effect of several formulations and compounds in a limited number of patients, and is a useful method for predicting treatment efficacy in psoriasis vulgaris. Five different gel vehicles were investigated in two plaque test studies.. The optimised two-compound gels showed superior antipsoriatic effect over marketed betamethasone dipropionate solution. The results suggest that use of the psoriasis plaque test early in the development process can improve the development of topical formulations for dermatological use and can be a beneficial tool for selecting the most promising formulations for further clinical studies in psoriasis vulgaris.

Topics: Anti-Inflammatory Agents; Betamethasone; Calcitriol; Chemistry, Pharmaceutical; Dermatologic Agents; Drug Combinations; Drug Compounding; Female; Gels; Humans; Male; Ointments; Psoriasis; Scalp; Treatment Outcome; Young Adult

A few studies in psoriasis vulgaris patients have reported changes suggesting red blood cell (RBC) damage is linked to neutrophil activation, oxidative stress, and psoriasis worsening.. The aim of this study was to evaluate erythroid disturbances in Portuguese psoriasis vulgaris patients, before, during, and after treatment.. A cross-sectional study (n = 73 patients vs 40 healthy control subjects) followed by a longitudinal study (n = 47 patients) was performed, with assessments before, and at 3, 6, and 12 weeks of therapy (10 patients started topical treatment, 17 narrow-band UVB, and 20 photochemotherapy [psoralen plus UVA; PUVA]). Evaluations included hematologic data, total bilirubin levels, membrane-bound hemoglobin (MBH), membrane protein band 3 profile, total plasma antioxidant status (TAS), lipid peroxidation (thiobarbituric acid [TBA] assay), elastase, lactoferrin, and C-reactive protein (CRP).. Before treatment, patients presented with higher leukocyte/neutrophil and reticulocyte counts, elastase, lactoferrin, TBA, TBA/TAS, reticulocyte production index, total bilirubin and MBH values, lower RBC and hematocrit, higher percentages of high-molecular-weight aggregates, and lower percentages of band 3 monomer. After treatment, we observed a reversal in most of the parameters. However, patients still presented with values suggestive of accelerated RBC damage, removal, and production, as most of the parameters were still higher than those in the control group; the same occurred with CRP.. Our data suggest that psoriasis vulgaris triggers an inflammatory response, with release of acute-phase reactants, reactive oxygen species, cationic proteins, and proteases, leading to enhanced RBC damage/aging and, ultimately, to enhanced RBC removal. These assumptions were strengthened by the observation that, with treatment, all of these changes were reversed, the inflammation was reduced, the production of reticulocytes was increased, and the RBCs presented changes usually observed in younger/less damaged RBCs. These erythroid changes were enhanced with PUVA therapy, probably due to the more pronounced clearing of the lesions, as suggested by Psoriasis Area and Severity Index (PASI) scores. Finally, after treatment, a residual inflammation still persisted that might contribute to the observed erythroid disturbances.

Topics: Adult; Betamethasone; Calcitriol; Cross-Sectional Studies; Dermatologic Agents; Erythroid Cells; Female; Humans; Longitudinal Studies; Male; Middle Aged; Neutrophil Activation; Oxidative Stress; Photochemotherapy; Psoriasis; Ultraviolet Therapy

Topics: Adrenal Cortex Hormones; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antibody Specificity; Calcitriol; Compassionate Use Trials; Drug Resistance; Humans; Immunosuppressive Agents; Interleukin-12 Subunit p40; Keratoderma, Palmoplantar; Male; Middle Aged; Psoriasis; PUVA Therapy; Remission Induction; Ustekinumab

Topics: Adrenal Cortex Hormones; Adrenocorticotropic Hormone; Arthroplasty, Replacement, Hip; Calcitriol; Clobetasol; Cyclosporine; Dermatologic Agents; Drug Therapy, Combination; Femur Head; Hip; Humans; Male; Middle Aged; Osteonecrosis; Psoriasis; Quality of Life; Range of Motion, Articular; Severity of Illness Index; Treatment Outcome

Topics: Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Diagnosis, Differential; Drug Combinations; Humans; Male; Psoriasis; Skin Diseases

Psoriasis is a chronic inflammatory skin disease of unknown aetiology, and an active form of vitamin D(3) (1α,25-dihydroxyvitamin D(3)) and its analogues (VD3As) are widely used topical reagents for psoriasis treatment. Besides their well-known calcium homeostasis functions, VD3As have been shown to have various immune-modulating effects including the induction of thymic stromal lymphopoietin (TSLP), a master cytokine for inducing Th2 inflammation, in mouse models, but not yet in human psoriasis. VD3As also have been shown to induce cathelicidin, an antimicrobial peptide and strong inducer of innate immunity. Cathelicidin is overexpressed in psoriatic skin lesions; however, its role in this disease seems as yet inconclusive.. To clarify whether topical VD3As induce TSLP and cathelicidin, and to examine the modulation of expression patterns of related cytokines in human psoriatic lesions.. Skin biopsy samples from psoriatic lesions with or without VD3A treatment were subjected to immunohistochemical staining and quantitative reverse transcription-polymerase chain reaction analyses to measure the expression levels of various cytokines.. Significantly higher levels of TSLP, thymus and activation-related chemokine and CCR4 expression were observed in VD3A+ skin samples than in VD3A- samples. In contrast, significantly lower levels of interleukin (IL)-12/23 p40, IL-1α, IL-1β and tumour necrosis factor (TNF)-α expression were observed in the VD3A+ samples than in the VD3A- samples. Expression of cathelicidin was elevated in VD3A+ samples.. Topical VD3As induce TSLP and cathelicidin in psoriatic lesions, resulting in suppression of IL-12/23 p40, IL-1α, IL-1β and TNF-α, thereby ameliorating psoriatic plaques.

Topics: Administration, Cutaneous; Adult; Aged; Antimicrobial Cationic Peptides; Blotting, Western; Calcitriol; Cathelicidins; Cholecalciferol; Cytokines; Dermatologic Agents; Dihydroxycholecalciferols; Drug Therapy, Combination; Female; Humans; Interleukins; Male; Middle Aged; Psoriasis; Thymic Stromal Lymphopoietin; Tumor Necrosis Factor-alpha

The antimicrobial peptides (AMP) psoriasin (S100A7) and koebnerisin (S100A15) are differently induced in psoriatic skin. They act synergistically as chemoattractants and "alarmins" to amplify inflammation in psoriasis. Th17 cytokines are key players in psoriasis pathogenesis and vitamin D analogs feature anti-psoriatic effects; both of these activities could be mediated through epidermal AMP regulation. We show that supernatants of cultured psoriatic T cells induce and release psoriasin and koebnerisin from keratinocytes and the Th17 cytokines IL-17A, tumor necrosis factor-α, and IL-22 differently regulate psoriasin and koebnerisin reflecting their distinct expression pattern in normal and psoriatic skin. IL-17A is the principal inducer of both S100 and their expression is further amplified by cooperating Th17 cytokines in the micromilieu of psoriatic skin. Increased extracellular psoriasin and koebnerisin also synergize as "alarmins" to prime epidermal keratinocytes for production of immunotropic cytokines that further amplify the inflammatory response. Treatment of psoriatic plaques with the vitamin D analog calcipotriol interferes with the S100-mediated positive feedback loop by suppressing the increased production of psoriasin and koebnerisin in psoriatic skin and their Th17-mediated regulation in epidermal keratinocytes. Thus, targeting the S100-amplification loop could be a beneficial anti-inflammatory approach in psoriasis and other inflammatory skin diseases.

Topics: Antimicrobial Cationic Peptides; Calcitriol; Cells, Cultured; Dermatologic Agents; Humans; Inflammation; Interleukin-17; Interleukin-22; Interleukins; Keratinocytes; Psoriasis; S100 Calcium Binding Protein A7; S100 Proteins; Th17 Cells; Tumor Necrosis Factor-alpha

Psoriasis (Pso) in children may be confused clinically with atopic dermatitis (AD) and, indeed, the two conditions may co-exist. The aim of this study was to determine historical and clinical features that are different in paediatric Pso and AD and to describe children who have features of both: psoriasis-dermatitis overlap (PD).. Children with features of psoriasis or eczema, or both, who were referred to paediatric outpatients and/or private rooms were evaluated. Data were collected from 170 consecutive children aged less than 12 years between July 2011 and November 2011. Participants were classified by described criteria as having Pso (n = 64), AD (n = 62) or PD (n = 44).. Only 9.4% of children with Pso were correctly diagnosed by the referring doctor. Children with Pso relative to AD were more likely to have had a history of scaly scalp and nappy rash in infancy, a family history of psoriasis, current scalp and periauricular rashes, defined, patchy plaque morphology and papulosquamous rashes not typical of adult psoriasis on extensor elbows and knees. Children with PD had features of both but presented most often as typical paediatric psoriasis combined with flexural eczema. Children with Pso and PD responded well to specific treatment strategies for psoriasis, including potent topical corticosteroids (TCS), calcipotriol and phototherapy. Both Pso and PD tended to require more potent TCS than AD to achieve disease suppression.. We found that Pso and PD in children both differ clinically from AD and have identified historical and clinical features that characterise childhood Pso.

Topics: Anti-Inflammatory Agents; Betamethasone; Calcitriol; Child; Child, Preschool; Dermatitis, Atopic; Dermatologic Agents; Diagnosis, Differential; Female; Humans; Infant; Male; Psoriasis; Ultraviolet Therapy

Psoriasis is among the top dermatologic diagnoses for older adult patients, and the number of older adult psoriasis patients is expected to rise.. To characterize trends in older adult psoriasis health care practices of US ambulatory physician offices from 1993 to 2009.. We used data from the National Ambulatory Medical Care Survey to assess demographics, specialties seen, and treatment in visits by older adult patients, 55 years of age and older.. There were approximately 14.1 million outpatient visits for psoriasis among the older adult population during the study period. Older adult psoriasis patients were 52.4% female and 47.6% male. The most frequent older adult age group seen for psoriasis was the 55 to 64 year age group. Dermatologists saw 69.3% of patients, internists saw 14.5%, and general and family practitioners saw 11.6%. Topical corticosteroids were the most frequently prescribed medications. Dermatologists preferred clobetasol whereas non-dermatologists more commonly prescribed betamethasone. For both the 18 to 54 year age group and the 55 and older group, the leading 7 out of 10 medications prescribed were topical corticosteroids and calcipotriene. However, etanercept, coal tar, and fluocinolone were among the leading medications in the younger group but not in the 55 and older group.. Treatment approach for older adult psoriasis patients showed some differences among medical specialties and among the younger and older age groups. Further research specific to older adult psoriasis patients is needed to determine optimal treatment strategies for this patient population.

Topics: Administration, Cutaneous; Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Ambulatory Care; Betamethasone; Calcitriol; Clobetasol; Coal Tar; Dermatologic Agents; Dermatology; Etanercept; Family Practice; Female; Fluocinolone Acetonide; Glucocorticoids; Health Care Surveys; Humans; Immunoglobulin G; Immunologic Factors; Internal Medicine; Keratolytic Agents; Male; Middle Aged; Practice Patterns, Physicians'; Psoriasis; Receptors, Tumor Necrosis Factor; United States; Young Adult

Calcipotriol, a vitamin D analogue, and betamethasone dipropionate, a high potency corticosteroid, are complementary agents for the topical treatment of psoriasis vulgaris. Robust evidence on the efficacy and safety of their fixed combination has been provided by randomized, double-blind, controlled clinical trials involving more than 7000 patients with the ointment formulation in psoriasis of the body and more than 4000 patients with the gel formulation in scalp psoriasis. These trials have shown that the fixed combination ointment is more effective and better tolerated, not only than placebo, but also than calcipotriol and tacalcitol monotherapies. In addition, it has proved, in most instances, to be more effective than betamethasone and at least as well tolerated. The same applies to the gel for scalp and body psoriasis. Safety studies have excluded that repeated courses of treatment with the fixed combination for up to one year produce systemic effects. Studies have also shown that the fixed combination treatment improves quality of life to a significantly greater extent than calcipotriol, with the once daily regimen most appreciated by patients, in both active disease and recurrency. Because of the extensive evidence, American and European guidelines recommend the calcipotriol/betamethasone dipropionate fixed combination as first line topical treatment for mild to moderate plaque psoriasis of the body and scalp.

Topics: Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Gels; Humans; Psoriasis; Quality of Life; Scalp Dermatoses; Time Factors

Topics: Administration, Topical; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Middle Aged; Psoriasis; Th17 Cells; Treatment Outcome

Psoriasis is a common chronic inflammatory skin disease and many patients require lifelong treatment. Characteristic scaly, itchy, unsightly psoriatic lesions affect many body areas and most patients commonly experience scalp involvement. The cosmetic embarrassment of visible body lesions, inaccessibility of scalp skin to application of therapies and proximity of sensitive facial skin add to the challenges of most patients managing their psoriasis long term. Psoriasis can severely impact patients' quality of life. This can impact significantly on the patient. In economic terms patients may incur increased out-of-pocket expenditure or extended time away from work as a direct consequence of psoriasis, particularly in severe cases; In many countries, specialist review of patients provides pressures on hard-pressed services and the costs of psoriasis care are substantial, particularly in patients with severe recalcitrant psoriasis which may require lengthy inpatient admission. Around 80% of patients with psoriasis have mild to moderately severe disease and the majority are treated with topical medicines by their physician in primary care. Despite the availability of a wide range of treatment options, regimens have been unsatisfactory, associated with patient dissatisfaction, poor compliance and often safety concerns with long-term use. Evidence-based clinical guidelines aim to improve healthcare of patients and while there are such guidelines for psoriasis, to date the challenges of (and recommendations for) managing scalp psoriasis are often limited or missing from these treatment guidelines. In the following in-journal supplement, a connected suite of five papers focus on the use of topical therapies for the treatment of the person afflicted with psoriasis. This work harnesses robust evidence from randomised clinical trials (RCTs) of topical therapies commonly used in psoriasis patients and translates this into recommendations for the most appropriate treatment of patients with body or scalp psoriasis, from an efficacy, safety and cost-effectiveness perspective. Based upon systematic review and harnessing 'state of the art' evidence assessment methodologies, the modelling work suggests that the use of a two-compound formulation (TCF) product of calcipotriol and betamethasone dipropionate is the most appropriate treatment option for both body and scalp psoriasis. This Editorial acknowledges the results of any modelling exercise have limitations; indeed such

Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Chemistry, Pharmaceutical; Drug Combinations; Humans; Psoriasis; Scalp Dermatoses; Severity of Illness Index; Treatment Outcome

The remission period of psoriasis vulgaris following narrowband ultraviolet B (NB-UVB) light therapy with topical vitamin D(3) application was evaluated retrospectively to investigate the therapeutic efficacy. Fifty-two patients (60 cases) were treated with a 5-day/week protocol of NB-UVB light irradiation plus topical vitamin D ointment application for 1 month and followed up for at least 12 months. We considered re-exacerbation as the time when the patients needed treatment other than topical therapy. The remission period was defined as the duration from the end of treatment until re-exacerbation. Twenty-seven cases (56%) of psoriasis showed a remission period longer than 12 months. The patients with a past history of systemic therapy or phototherapy had a significantly shorter remission period than those without such a history. No statistically significant differences were observed in sex, age, period before treatment, Psoriasis Area and Severity Index score and total irradiation dose. A previous history of systemic therapy or phototherapy may mean that the disease is severe and sufficiently active to form multiple new lesions requiring these treatments. Our results suggest that the 5-day/week NB-UVB light protocol for 4 weeks is an effective and safe treatment for psoriasis vulgaris and can induce long-term remission.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Female; Humans; Male; Middle Aged; Psoriasis; Remission Induction; Retrospective Studies; Time Factors; Treatment Outcome; Ultraviolet Therapy; Young Adult

Low level laser or light treatment on the various clinical condition is getting considerable attention now. However, there has been no report about the clinical effect of low level polarized polychromatic noncoherent light (LPPL) on the inflammatory skin disease. We experienced a case of acrodermatitis continua in a pregnant woman refractory to any conventional treatment including the most potent topical steroid. She was successfully treated with LPPL. LPPL could be a possible treatment modality producing substantial clinical result in inflammatory skin condition without any side-effect.

Topics: Acrodermatitis; Adult; Calcitriol; Female; Humans; Inflammation; Light; Phototherapy; Pregnancy; Pregnancy Complications; Psoriasis; Skin Diseases

Topics: Acitretin; Adalimumab; Adrenal Cortex Hormones; Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Calcitriol; Cyclosporine; Dermatologic Agents; Drug Therapy, Combination; Etanercept; Female; Humans; Immunoglobulin G; Infliximab; Methotrexate; Psoriasis; Receptors, Tumor Necrosis Factor; Tacrolimus; Treatment Outcome; Ustekinumab

Quality of life of patients with scalp psoriasis is greatly impaired due to itch and scaling. To control the disease long-term therapy is necessary and treatment success is greatly dependent on compliance.. In a prospective, non-interventional trial in German dermatological practices 721 patients with scalp psoriasis received Xamiol(®) gel (calcipotriol 50 μg/g, betamethasone 0,5 mg/g) topically for 4 weeks. Severity was assessed by physician's global assessment (PGA) and quality of life by using a scalp-specific questionnaire at the beginning of the study and after 4 weeks of treatment.. The mean disease severity of scalp psoriasis (PGA) improved from 4.26 to 2.49 (-41.8 %, p < 0.0001) during 4 weeks of treatment and quality of life improved from 10.57 to 3.22 (-69.5 %, p < 0.0001). Among patients with pre-treatment 89.5 % of patients and 87.9 % of dermatologists judged treatment response to Xamiol(®) gel as better/much better compared to previous therapy. Tolerability of Xamiol(®) gel was rated good/very good by 98 % of dermatologists and patients, respectively. The use of Xamiol(®) gel was found easy/very easy by 90.4 % of the patients.. Due to the major improvement of quality of life and quick onset of improvement together with the high acceptance by the patients Xamiol(®) gel may be regarded as the topical treatment of choice for scalp psoriasis.

Topics: Administration, Topical; Adult; Aged; Betamethasone; Calcitriol; Cohort Studies; Dermatologic Agents; Drug Combinations; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Psoriasis; Quality of Life; Scalp Dermatoses; Surveys and Questionnaires

The synthesis of the clinically important drug calcipotriol (2, MC903) is described as an example of a new and efficient approach to C24-hydroxylated analogs and metabolites of vitamin D3 (1). The key step of the process is the generation of the C24 stereocenter by DAIB [(-)-3-exo-(dimethylamino)isoborneol]-catalyzed addition of the alkenylzinc derivative of alkyne 3 to cyclopropylcarboxaldehyde.

Topics: Alcohols; Calcitriol; Catalysis; Cell Differentiation; Chemistry, Pharmaceutical; Dihydroxycholecalciferols; Drug Design; Humans; Models, Chemical; Molecular Conformation; Psoriasis; Stereoisomerism

Psoriatic patients present with an increased frequency of cardiovascular events.. To study the impact of psoriasis duration and therapy on traditional and new cardiovascular risk factors.. A longitudinal study performed between 2005 and the first trimester of 2008. Each patient was followed up for 12 weeks, and was observed before and 3, 6, and 12 weeks after starting therapy.. Patients attending the Dermatology Service, University Hospital of Coimbra, Coimbra, Portugal were enrolled.. Thirty-four patients with psoriasis vulgaris and 37 healthy volunteers as controls.. Psoriasis Area and Severity Index (PASI); lipid profile, oxidized low-density lipoprotein (oxLDL), oxLDL/low-density lipoprotein (LDL), total antioxidant status, lipid peroxidation, C-reactive protein (CRP), and circulating levels of adiponectin.. Ten patients started therapy with topical treatment, 11 with narrow-band UVB radiation (NB-UVB), and 13 with psolaren plus UVA (PUVA).. Before starting therapy, psoriatic patients presented with several risk changes in their lipid profiles, and significantly higher CRP, oxLDL, and oxLDL/LDL, and lower adiponectin levels (vs control subjects), which may further contribute to inflammation and atherogenesis. After treatment of the patients, although no significant differences were observed in the lipid profile compared with baseline, some changes suggested that the treatment could somehow alter lipid metabolism, as the reduction in high-density lipoprotein cholesterol (HDL-C) and apolipoprotein A and the increase in the atherogenic index cholesterol/HDL-C maintained an even higher significance (as shown by p-values) when compared with the control group. After topical therapy, there was a significant reduction in thiobarbituric acid reactivity only, suggesting that the reduction in the hyperproliferative process within the lesions is important for lipid peroxidation. After NB-UVB therapy, oxLDL/LDL, cholesterol/HDL-C, lipoprotein (a) [Lp(a)], and CRP remained higher than in the control subjects, reflecting persistent inflammation and atherogenic risk. After PUVA treatment, there was a significant reduction in Lp(a), associated with an almost significant increase in apolipoprotein-B (p = 0.054); these changes were not observed after NB-UVB treatment. However, after PUVA and NB-UVB treatment, CRP and, in the NB-UVB group, oxLDL/LDL were persistently higher than controls.. Our data show that psoriatic patients present with several lipid profile changes that seem to be related to the severity of the disease and/or the treatment used. Mild psoriasis patients receiving topical treatment presented before starting therapy with a lipid profile similar to controls, whereas those undergoing NB-UVB and PUVA, who had higher PASI scores, presented with several risk factors. Moreover, PUVA therapy seems to interact in a different way with lipids that might result from an interaction of psoralen with plasma lipids, namely Lp(a). Inflammation, a hallmark of psoriasis, also seems to be related to psoriasis severity. Both NB-UVB and PUVA were effective, as shown by the reduction in PASI score, as well as in the oxidative and inflammatory stress markers. However, after NB-UVB and PUVA, a low-grade inflammatory process still persisted, which might be related to the duration of remission of the disease.

Topics: Adiponectin; Adult; Betamethasone; Biomarkers; C-Reactive Protein; Calcitriol; Cardiovascular Diseases; Combined Modality Therapy; Dermatologic Agents; Follow-Up Studies; Glucocorticoids; Humans; Lipid Metabolism; Lipids; Longitudinal Studies; Male; Middle Aged; Oxidative Stress; Psoriasis; PUVA Therapy; Risk Factors; Severity of Illness Index; Ultraviolet Therapy

Topics: Calcitriol; Dermatitis, Phototoxic; Dermatologic Agents; Female; Humans; Middle Aged; Psoriasis; PUVA Therapy

Topics: Administration, Cutaneous; Calcitriol; Coal Tar; Cost-Benefit Analysis; Dermatologic Agents; Follow-Up Studies; Humans; Insurance, Health, Reimbursement; Massachusetts; Nonprescription Drugs; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Single-Blind Method; Treatment Outcome

Topics: Adolescent; Calcitriol; Clobetasol; Dermatologic Agents; Humans; Male; Ointments; Psoriasis

Topics: Acitretin; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Clobetasol; Dermatologic Agents; Friends; Glucocorticoids; Humans; Male; Middle Aged; Prednisone; Prescription Drugs; Psoriasis

Psoriasis therapy has evolved during the past 25 years as newer and more effective medications become available. Furthermore, various combination regimens and approaches have been advocated.. We sought to describe patterns of psoriasis treatment from 1986 to 2005.. Visits to dermatologists for treatment of psoriasis were identified using National Ambulatory Medical Care Survey data, a representative survey of visits to physician offices in the United States. We focused on medications listed at these visits during the 1986-to-2005 interval to determine how treatment for psoriasis has changed.. There were an estimated 23.9 million visits for psoriasis during the 20-year study period. As a category, the most common medications used for psoriasis were topical steroids. Dermatologists are prescribing more potent topical steroids compared with nondermatologists. The use of these potent drugs has increased from 1986 to 2005. There has been growing use of systemic treatments, with biologic therapies introduced in the 2001-to-2005 time period.. National Ambulatory Medical Care Survey data represent national trends in psoriasis treatment and cannot be used to evaluate smaller subpopulations of patients with psoriasis. These data are used to speculate why certain trends in treatment are seen.. The primary treatment for psoriasis in the late 1980s and early 1990s was mid-potency corticosteroids. Since then, the primary therapies for psoriasis have evolved to include class I ultrapotent topical corticosteroids, vitamin-D analogs, and systemic medications such as methotrexate and biologic agents. These changes in psoriasis management are consistent with patient desire for better disease control.

Topics: Adrenal Cortex Hormones; Adult; Biological Products; Calcitriol; Dermatologic Agents; Drug Utilization; Female; Humans; Male; Methotrexate; Middle Aged; Nonprescription Drugs; Practice Patterns, Physicians'; Psoriasis

Involvement of areas of the skin fold is common in patients with psoriasis although the exact incidence is unknown. This report summarizes studies regarding the therapy of intertriginous psoriasis.. A task force of the National Psoriasis Foundation Medical Board was convened to evaluate treatment options. Our aim was to arrive at a consensus on therapy for intertriginous or inverse psoriasis.. Reports in the literature were reviewed regarding psoriasis affecting the skin-fold areas and its therapy.. There are few evidence-based studies on the treatment of intertriginous psoriasis.. The recommended short-term (2-4 weeks) therapy for inverse psoriasis is low- to mid-potency topical steroids. For long-term therapy, topical calcipotriene (calcipotriol) or one of the immunomodulating agents, pimecrolimus or tacrolimus, is favored.. Low- to mid-potency topical steroids are recommended as first-line, short-term treatment. It is recommended that their use should either be of limited duration (less than 2-4 weeks) or that the lowest effective strength be used intermittently for long-term care to minimize the potential for risks. Calcipotriene (calcipotriol), pimecrolimus, and tacrolimus, while not as highly efficacious as topical steroids, are associated with fewer long-term risks and are therefore recommended for long-term therapy when feasible.

Topics: Adrenal Cortex Hormones; Algorithms; Calcitriol; Dermatologic Agents; Humans; Immunologic Factors; Psoriasis

The scalp is the most commonly affected part of the body in patients with psoriasis. Signs and symptoms of scalp psoriasis vary significantly for individual patients.. A task force of the National Psoriasis Foundation was convened to evaluate treatment options. Our aim was to achieve a consensus for scalp psoriasis therapy.. Reports in the medical literature were reviewed regarding scalp psoriasis therapy.. There is a paucity of evidence-based and double-blind studies in the treatment of scalp psoriasis particularly for long-term therapy. Many of the studies in scalp psoriasis were designed to attain Food and Drug Administration approval for a medication and not to provide treatment guidance.. The recommended short-term or intermittent therapy for scalp psoriasis is topical corticosteroids. The primary alternatives are topical retinoids, vitamin D analogues, and salicylic acid. Combination therapy has many advantages. The choice of an appropriate vehicle is crucial to increase patient compliance. While scalp psoriasis can often be adequately treated with topical therapy, recalcitrant disease may require more aggressive approaches, including systemic agents.

Topics: Administration, Topical; Adrenal Cortex Hormones; Calcitriol; Drug Combinations; Evidence-Based Medicine; Humans; Psoriasis; Scalp Dermatoses; Ultraviolet Therapy

Numerous consumer products, including medicines, can be bought over the Internet. Previous reports indicate that patients are able to purchase the current available treatments, including expensive systemic and biological agents with side-effects, available for use on an outpatient basis. In France, as in most industrialized countries, these drug treatments are available only by prescription. Objective To evaluate whether psoriatic outpatients can buy the full range of psoriasis medications, including biological therapies, without a prescription, via the Internet.. One investigator acted as a consumer to purchase psoriasis treatments and complementary medicines over the Internet. The website search was limited to a 4-h period. All products had to be available for delivery in France, without a prescription, and be suitable for outpatient use. Key words for the Internet search were combinations of medicinal product names, 'psoriasis', 'shopping', 'pharmacy', 'parapharmacy', entered into two major search engines, Google and Yahoo.. The investigator identified 47 websites offering a total of 340 products. All treatments, including biological therapies (etanercept, adalumimab and efaluzimab), were available for purchase with the exception of calcitriol and alefacept, with median prices being higher than the French price.. This study shows that it is possible for consumers to purchase the majority of treatments for psoriasis via the Internet, including systemic therapies and even the most recent and expensive products such as biological agents, without a prescription.

Topics: Acitretin; Adalimumab; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Calcitriol; Commerce; Dermatologic Agents; Etanercept; France; Humans; Immunoglobulin G; Internet; Nonprescription Drugs; Psoriasis; Receptors, Tumor Necrosis Factor; Self Medication

Topical therapy continues to be one of the pillars of psoriasis management. Topical corticosteroids and vitamin D analogs are the drugs of choice during the induction phase, and vitamin D analogs continue to be drugs of choice for maintenance therapy. Tazarotene and dithranol are suitable options in patients with certain, specific characteristics. The calcineurin inhibitors can be considered to be second-line treatment for psoriasis of the face and flexures. The efficacy and safety of the fixed-dose combination of betamethasone and calcipotriol in the induction phase is greater than that of either drug alone. The combination of corticosteroids with salicylic acid achieves better results than corticosteroids in monotherapy. None of the drugs evaluated stands out over the others in all clinical situations, and their use must therefore be individualized in each patient and adjusted according to the course of the disease.

Topics: Administration, Topical; Betamethasone; Calcitriol; Drug Therapy, Combination; Humans; Psoriasis

Patients who respond only partially to etanercept may require additional treatments that act synergistically to improve their therapeutic response while at the same time reducing the dose required and the risk of side-effects. The aim of this study was to evaluate the effecti veness of topical calcipotriol in etanercept partial responder patients. We enrolled 120 patients affected by psoriasis vulgaris and psoriatic arthritis. A 50 mg dose of etanercept was administered twice weekly for the first 12 weeks, followed by a 25 mg dose twice weekly for an additional 12 weeks. At week 12, for 45 patients who had not achieved PASI 50, calcipotriol cream was also prescribed twice daily for 4 weeks and then once daily for a further 8 weeks. At week 24, of the 45 patients in the group treated with etanercept plus calcipotriol, 14 (31.1%) had achieved PASI 75, and 23 PASI 50, while 8 (17.7%) had dropped out of therapy; of the 75 patients who continued etanercept in monotherapy with a 25 mg dose twice weekly for another 12 weeks, 71 (94.6%) had achieved PASI 50 and 57 (76.0%) PASI 75. The application of calcipotriol in etanercept partial responder patients had therefore helped 37 out of 120 patients (31%) achieve at least PASI 50. This is the first report about the controlled combination of topical calcipotriol and etanercept in a large group of psoriatic patients. The efficacy and cost-effectiveness of the combined treatment is evidenced by the good response shown at week 24 by a group of etanercept low-responder patients using drugs sparingly and limiting likely toxicity.

Topics: Administration, Oral; Administration, Topical; Adolescent; Adult; Antirheumatic Agents; Arthritis, Psoriatic; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Etanercept; Female; Humans; Immunoglobulin G; Male; Middle Aged; Psoriasis; Receptors, Tumor Necrosis Factor; Treatment Outcome

Scalp psoriasis occurs in 50%-75% of patients with plaque psoriasis. It may be the only area of the body affected, or it may be associated with disease elsewhere, including psoriatic arthritis. Most cases are treated topically, usually with steroids and/or calcipotriol. In 2008, Health Canada and the US FDA approved a stable, once-daily 2-compound gel containing calcipotriol and betamethasone dipropionate (Xamiol, LEO Pharma; Taclonex Scalp, Warner Chilcott). This once-daily therapy improves patient quality of life with a quick onset of action and greater efficacy than monotherapy with either ingredient or twice daily treatment with calcipotriol 0.005% (Dovonex, LEO Pharma) scalp solution. The gel vehicle was developed for ease of use, improved cosmetic acceptability and absorption on the scalp. By 2 weeks, approximately 60%, and by 8 weeks, approximately 70% of patients have controlled disease (i.e., absent or very mild disease). At 8 weeks, the calcipotriol and betamethasone dipropionate gel formulation has a safety profile comparable with betamethasone dipropionate and is associated with significantly fewer adverse events than calcipotriol. Xamiol may be safely used for up to 52 weeks. No cases of atrophy, striae, or steroid purpura were noted in two 52-week studies.

Topics: Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Gels; Humans; Psoriasis; Scalp Dermatoses; Treatment Outcome

Psoriasis is a very common dermatological disease affecting a large part of the world population. In its most common form, psoriasis vulgaris, many topical drugs are available to treat the localized forms, and the recurrence of the dermatosis. Among topicals, tacalcitol has been proven to be effective and devoid of side effects which are typical of Vitamin-D3 analogues or derivates. The aim of this retrospective study was to evaluate the efficacy of topical tacalcitol vs. calcipotriol and emollient treatment of the first recurring lesion in order to induce a longer remission period before the retreatment with nb-UVB phototherapy in a population of 90 psoriatic patients. In this trial, the time between the first relapsing plaque appearance and retreatment with nb-UVB resulted in 25, 16 and 11 days for tacalcitol, calcipotriol and emollient respectively, with a statistically significant difference for tacalcitol (p < 0.0001). These results proved that tacalcitol treatment is effective in increasing the time interval in consecutive phototherapy cycles and in reducing the total amount of UV exposure.

Topics: Administration, Topical; Adult; Calcitriol; Cohort Studies; Dermatologic Agents; Dihydroxycholecalciferols; Female; Humans; Male; Middle Aged; Psoriasis; Retrospective Studies; Treatment Outcome; Ultraviolet Therapy

In recent years, vitamin D3 analogues have become one of the most widely prescribed topical treatments for mild or moderate chronic plaque psoriasis. These molecules are effective and safe, but their exact mechanism of action is not completely understood. In vitro studies have shown that D3 analogues decrease proliferation and induce differentiation of keratinocytes, and have strong immunomodulating effects, but there are no conclusive data about apoptosis. The aim of this study was to evaluate differences in apoptotic response between lesional and perilesional keratinocytes of patients with psoriasis before and after treatment with calcipotriol, a synthetic vitamin D3 analogue. Keratinocytes were isolated from psoriatic plaques including lesional and perilesional skin, and cultured. Cells were treated with calcipotriol for 20 h and examined under confocal microscopy after staining with propidium iodide. The number of apoptotic cells after incubation with calcipotriol was significantly higher in lesional than in perilesional keratinocytes (P < 0.05) or non-treated psoriatic keratinocytes (P < 0.05). In conclusion, calcipotriol seems to induce apoptosis in psoriatic keratinocytes.

Topics: Adolescent; Adult; Aged; Apoptosis; Calcitriol; Dermatologic Agents; Female; Humans; Keratinocytes; Male; Middle Aged; Prospective Studies; Psoriasis; Young Adult

According to data received in recent years, abnormality of phosphorous-calcium metabolism is revealed in patients with psoriasis. The combination of hypocalcemia and hypophosphatemia is considered as an indication of the relative deficiency of vitamin D. The aim of this study was the assessment of therapeutic efficacy of domestic drugs Ergobat and Daivonex in the treatment of patients with psoriasis. Under observation were 25 patients with psoriasis. Patients with lesion area less than 25% of body surface have been selected for study. Progressive stage of Dermatosis has been revealed in all patients. They were divided into 2 groups. Both groups were comparable by sex, age, onset of the disease, its duration and clinical forms and the value of PASI. The application of Daivonex ointment was included in the therapy of both groups of patients. After 28 days of therapy the reliable improvement in the skin processes was achieved in the group of patients, in which along with local application of Daivonex ointment the treatment with Ergobat was used. Active regressing of psoriatic rash and jump into the stationary phase began at 2,1+/-0,1 days earlier than in the group of patients taking just Ergobat. The contents of total calcium and inorganic phosphorus in the blood serum by the end of treatment reached the normal level in the patients taking Ergobat, such a trend in the control group we have not observed. Thus, our clinical observations allow recommending the prescription of a consistent scheme of Daivonex and Ergobat treatment in order to stabilize the psoriatic process.

Topics: Adolescent; Adult; Aged; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Psoriasis; Treatment Outcome; Young Adult

(1) Plaque psoriasis is the most common form of psoriasis in children. Topical agents should be tried first, especially well-tolerated products such as emollients. Topical corticosteroids are sometimes useful during exacerbations but, given adverse effects, they should only be used for short periods; (2) UVB phototherapy is an option for extensive psoriasis refractory to local treatments, but it carries a long-term risk of skin cancer. Immunosuppressants have not been well assessed in this setting, but methotrexate has been better evaluated than the others.

Topics: Acitretin; Administration, Topical; Anthralin; Calcitriol; Child; Cyclosporine; Dermatologic Agents; Emollients; Etanercept; Humans; Immunoglobulin G; Immunosuppressive Agents; Methotrexate; Nicotinic Acids; Plant Extracts; Psoriasis; Receptors, Tumor Necrosis Factor; Salicylates; Steroids; Tars; Treatment Outcome; Ultraviolet Therapy

Psoriasis requires lifelong treatments that depend on the extent, clinical forms and associated conditions.. To retrospectively analyze which topical treatments were used, their efficacy, and potential advantages and disadvantages.. A total of 666 patients admitted for the first time over 15 years who were topically treated were retrospectively reviewed and subdivided using clinical forms and PASI into four groups and four subgroups for the applied treatments. For each treatment the mean PASI was calculated daily: on the first, third and sixth day. An X sample statistical analysis and Mann--Whitney U-test were performed. The hospitalization time and correlation with the response to treatment were analyzed.. A statistically significant response was recorded for every regimen. The best combination was clobetasol propionate plus eosin on alternate days with eosin plus cade oil. The highest score was recorded for the 'en plaques' psoriasis. The average length of treatment was of 7.5 days in the best combination. No statistically significant difference among the groups was recorded with respect to the length of hospitalization and PASI.. The statistically significant response for all the topical treatments analyzed and recorded in this study does not exclude a potential benefit due to hospitalization per se.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Calcitriol; Clobetasol; Dermatologic Agents; Drug Therapy, Combination; Eosine Yellowish-(YS); Female; Humans; Male; Middle Aged; Plant Extracts; Psoriasis; Retrospective Studies; Severity of Illness Index; Skin; Statistics, Nonparametric; Treatment Outcome

Topics: Acitretin; Acute Disease; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Body Surface Area; Calcitriol; Dermatologic Agents; Diagnosis, Differential; Drug Monitoring; Female; Humans; Immunosuppressive Agents; Keratolytic Agents; Middle Aged; Nurse Practitioners; Nursing Assessment; Patient Education as Topic; Phototherapy; Physical Examination; Primary Health Care; Psoriasis; Tacrolimus

To investigate the effect of weekly alefacept monotherapy 15 mg i.m. on epidermal hyperproliferation, keratinization, T-cell subsets and cells expressing NK receptors during 12 weeks of treatment. Furthermore, the addition of calcipotriol cream to alefacept treatment was studied and compared with alefacept monotherapy.. Five patients participated in this study, and used weekly alefacept 15 mg i.m. combined with calcipotriol cream up to a maximum of 100 g per week. Biopsies from two lesions (one treated and another lesion not treated with calcipotriol cream) were taken at week 0 and week 12. We investigated the number of T-cell subsets (CD4, CD8, CD45RO, CD45RA, CD2, CD25), cells expressing NK receptors (CD94 and CD161), the proliferation marker Ki-67 and the keratinization marker keratin-10.. Alefacept monotherapy induced a statistically significant reduction of CD4+, CD45RO+ and CD2+ cells in dermis and epidermis and CD8+ cells in epidermis at week 12. Furthermore, the keratin-10 positive epidermal surface was significantly increased at week 12. The combination of alefacept and calcipotriol cream induced a statistically significant reduction of only CD4+ and CD45RO+ cells at week 12.. The number of memory effector T-cells in the psoriatic lesion is significantly decreased by alefacept, and calcipotriol cream does not seem to have an additional effect on this reduction. Cells expressing NK receptors are virtually not targeted by alefacept monotherapy or the combination.

Topics: Administration, Cutaneous; Alefacept; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Humans; Psoriasis; Receptors, Neurokinin-1; Recombinant Fusion Proteins; T-Lymphocyte Subsets; Treatment Outcome

Topics: Betamethasone; Calcitriol; Female; Humans; Middle Aged; Nail Diseases; Psoriasis; Ultrasonography

Topics: Adult; Aged; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Psoriasis; Scalp Dermatoses; Treatment Outcome

Topics: Anti-Inflammatory Agents; Betamethasone; Biological Products; Calcitriol; Dermatologic Agents; Drug Administration Routes; Humans; Psoriasis; Severity of Illness Index; Skin Diseases; Treatment Outcome

Selective photothermolysis of diseased capillaries by pulsed dye laser (PDL) treatment has been described as a mechanism for long-lasting clearance of psoriatic plaques.. To evaluate PDL and a two-compound formulation of calcipotriol/betamethasone dipropionate ointment for the treatment of localized, recalcitrant plaque psoriasis.. Eight psoriatic patients were treated for 4 weeks with both PDL and topical calcipotriol/betamethasone dipropionate in an open, intra-patient, left-right comparison. Biopsies were analyzed for T-cell subsets, cells expressing NK-receptors, epidermal proliferation, differentiation and epidermal thickness.. After active treatment, both treatments showed statistically significant but comparable improvements of T-cell subsets, epidermal proliferation, differentiation and epidermal thickness. In line with the clinical results, after an 8-week follow-up period statistically significant further reductions were observed for dermal CD3(+), CD4(+), CD45RO(+), CD2(+) T cells, epidermal CD3(+), CD8(+), CD45RO(+), CD2(+), CD25(+) T cells and the epidermal parameters for the PDL-treated plaques, in contrast to the topically treated plaques.. After 8 weeks of follow-up, PDL treatment for localized and recalcitrant plaque psoriasis resulted in persistent reductions of activated and memory effector T-helper cells in the dermis, cytotoxic T cells in the epidermis, and normalization of epidermal proliferation and keratinization, in contrast to treatment with calcipotriol/betamethasone dipropionate ointment.

Topics: Administration, Cutaneous; Adult; Anti-Inflammatory Agents; Antigens, CD; Betamethasone; Biopsy; Calcitriol; Cell Proliferation; Dermatologic Agents; Drug Therapy, Combination; Epidermis; Female; Humans; Keratinocytes; Low-Level Light Therapy; Male; Ointments; Psoriasis; Skin; T-Lymphocytes; T-Lymphocytes, Cytotoxic; T-Lymphocytes, Helper-Inducer; Treatment Outcome

Topics: Administration, Topical; Adrenal Cortex Hormones; Betamethasone; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Humans; Ointments; Psoriasis

Topics: Administration, Topical; Animals; Animals, Domestic; Calcitriol; Dogs; Fatal Outcome; Human-Animal Bond; Humans; Ointments; Poisoning; Psoriasis

The histopathologic changes characteristic of psoriasis might be related to suppressed apoptosis. The P53 and Bcl-2 proteins play a central role in the regulation of apoptosis. This study aimed to evaluate P53 and Bcl-2 expression and apoptotic cells in the psoriatic skin before and after topical calcipotriol therapy.. Skin biopsies were obtained from nonlesional and lesional skin of 10 patients with generalized plaque psoriasis before and after treatment with topical calcipotriol ointment. The P53 and Bcl-2 expression was evaluated using immunoperoxidase technique and apoptotic cells by the terminal deoxynucleotide transferase (TdT) mediated deoxyuridine triphosphate nick end labeling (TUNEL) method.. After topical calcipotriol therapy, keratinocytes of psoriatic skin showed significant decrease of P53 (P = 0.002) and increase of Bcl-2 (P = 0.01) expression. On the other hand lymphocytes showed significant decrease of Bcl-2 (P = 0.01). There were no apoptotic cells before treatment but after calcipotriol therapy, apoptosis was more detectable in keratinocytes than in lymphocytes.. The results of the study suggested that one of the actions of calcipotriol in psoriasis might be exerted through induction of apoptosis, especially of keratinocytes, through a P53-independent pathway. Meanwhile, suppression of Bcl-2 expression in lymphocytes may promote apoptosis of dermal lymphocytes leading to healing of psoriasis.

Topics: Adult; Aged; Apoptosis; Biopsy; Calcitriol; Dermatologic Agents; Female; Humans; Immunohistochemistry; In Situ Nick-End Labeling; Male; Middle Aged; Proto-Oncogene Proteins c-bcl-2; Psoriasis; Skin; Tumor Suppressor Protein p53

To determine the cost-effectiveness of calcipotriol/betamethasone dipropionate (Dovobet) in the initial treatment of moderate severity plaque psoriasis vulgaris in Scotland.. An economic model was developed to simulate the costs and benefits of the most commonly used topicals in the management of plaque psoriasis. This was informed by an indirect unadjusted comparison of the effectiveness data to determine the relative efficacy of commonly used topicals. The model estimated their impact on costs and utility gain over a 1-year period. We accounted for direct medical costs from a health payer perspective. The cost-utility analysis included pharmacy costs and costs of failure of topicals in primary care in terms of secondary-care referrals for phototherapy. Extensive sensitivity analyses were undertaken to address areas of uncertainty in the parameters of the model.. Patients treated with the two-compound formulation (TCF) of calcipotriol and betamethasone dipropionate (BDP) experienced better control of their psoriasis. In our model, this translated into reduced costs, as patients were less likely to be referred for phototherapy, and increased quality adjusted life years (QALYs) relative to other commonly used topicals. The TCF was estimated to generate annual savings ranging from 96 to 276 pounds per patient per year compared to the other commonly used alternative topicals. With reduced costs and superior outcomes, the TCF 'dominated' these other treatments since the latter were associated with higher cost and lower utility or QALY gain. The model findings were not influenced by changes to a range of model input parameters within plausible limits.. Use of the TCF in patients with plaque psoriasis represents excellent value for money by delivering savings to the National Health Service (NHS) in Scotland. Similar findings are predicted for the management of psoriasis patients elsewhere in the UK.

Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Cost-Benefit Analysis; Dermatologic Agents; Drug Combinations; Humans; Psoriasis; Quality-Adjusted Life Years; Scotland; State Medicine; Treatment Outcome

To investigate the efficacy of treating acrodermatitis continua of Hallopeau (ACH) with a new two-compound ointment.. ACH is a rare pustular eruption on the distal portions of the fingers and less often, on the toes. It is nowadays classified as a form of acropustular psoriasis that tends to be resistant to treatment.. A 75-year old woman presented with pustules and hyperkeratotic erythematous papules, coalescing in plaques on the dorsal aspect of both great toes and on the perionychium of their nails. Diagnosis of ACH was based on clinical and histologic findings. We treated the patient with application of an ointment containing calcipotriol and betamethasone dipropionate twice daily for a month.. Therapeutic effect of the applied agent was impressively rapid with complete recovery of the lesions. In our patient, calcipotriol/ betamethasone dipropionate ointment was an efficacious regimen in the treatment of ACH. In the era of biologics, old topical agents in combined forms remain valuable. Although calcipotriol alone or its combination with betamethasone have been reported to aggravate the disease in some cases, their beneficial role is important and they are worth considering as first line therapeutic agents in the management of various forms of pustular psoriasis.

Topics: Acrodermatitis; Administration, Topical; Aged; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Psoriasis; Skin

Topics: Administration, Cutaneous; Aged; Calcitriol; Calcium; Clinical Trials as Topic; Dermatologic Agents; Dose-Response Relationship, Drug; Humans; Hypercalcemia; Male; Ointments; Psoriasis

The effect of the established antipsoriatic treatment with topical calcipotriol (with a maximum of 100 g per week) in addition to systemic treatment with alefacept, a new biological agent for psoriasis, on epidermal cell populations in the psoriatic lesion was investigated using a combination of the Zenon labelling technique and microscopic image analysis. Epidermal cell populations were measured quantitatively with this sensitive method.. Frozen sections of non-treated psoriatic epidermis and psoriatic epidermis treated with either alefacept intramuscular or alefacept intramuscular in combination with topical calcipotriol for 12 weeks were compared immunohistochemically. Antibodies against keratin 6, 10 and 15 were labelled with the Zenon technique, whereas antibodies against the Ki-67 antigen and beta-1 integrin were covalently Fluorescein Isothiocyanate (FITC)-labelled. Using image analysis, these markers were measured in the epidermis in a standardized manner.. Treatment of psoriasis with alefacept resulted in a good clinical response in several patients and in a normalization of epidermal expression of the immunohistochemical parameters for differentiation and proliferation. The addition of topical calcipotriol resulted in a faster clinical improvement with a similar overall clinical response and a similar response of epidermal cell populations as compared to treatment with alefacept monotherapy after 12 weeks of treatment. This study also suggests that the appearance of keratin 15 has a predictive value for the duration of remission. It can be concluded that the addition of a low-dose calcipotriol treatment does not contribute to the clinical efficacy of alefacept, both at the clinical level and with respect to markers for epidermal proliferation and differentiation.

Topics: Administration, Topical; Alefacept; Biomarkers; Calcitriol; Dermatologic Agents; Epidermis; Female; Fluorescent Dyes; Humans; Immunohistochemistry; Integrin beta1; Keratins; Ki-67 Antigen; Male; Middle Aged; Psoriasis; Recombinant Fusion Proteins; Staining and Labeling; Treatment Outcome

Calcipotriol and betamethasone dipropionate are both proven products in the topical treatment of psoriasis. The efficacy and tolerability of a new ointment containing these two compounds has been assessed in six phase III clinical studies.. To compare the results obtained in the clinical studies of the new calcipotriol/betamethasone dipropionate ointment.. A total of 6050 patients with psoriasis took part in the six randomized, double-blind studies. The two-compound product was compared with each of the active constituents, either in the new ointment vehicle or in the marketed formulation.. After 4 weeks of treatment the mean reduction in the Psoriasis Area and Severity Index (PASI) ranged from 65 to 74% with the two-compound product applied once or twice daily, from 46 to 59% with calcipotriol alone and from 57 to 63% with betamethasone dipropionate alone. The tolerability profile of the two-compound product was similar to betamethasone dipropionate monotherapy and better than calcipotriol alone.. The new two-compound product containing calcipotriol and betamethasone dipropionate was found to consistently provide rapid, highly effective treatment of psoriasis vulgaris.

Topics: Adult; Betamethasone; Calcitriol; Clinical Trials, Phase III as Topic; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Prospective Studies; Psoriasis; Randomized Controlled Trials as Topic; Reproducibility of Results; Treatment Outcome

Psoriasis of the hands and feet is a chronic disease which is often resistant to the usual topical therapies. It has considerable morbidity and seriously affects the quality of life of patients.. We sought to prospectively evaluate the efficacy and safety of pulsed dye laser (PDL) treatment of psoriasis of the hands and feet.. In all, 41 patients with therapy-resistant psoriasis of the hands and feet were treated once every 4 to 6 weeks with PDL at 585-nm wavelength, 450-microsecond pulse duration, 7-mm spot diameter, and 5- to 6.5-J/cm2 fluence. Calcipotriol ointment and salicylic acid 5% to 10% ointment were used as keratolytic agents. Treatment efficacy was evaluated by blinded comparison of photographs of the lesions taken before and after PDL treatment in each patient.. A good to very good improvement in the lesions was observed in 76% of the patients after treatment. An average duration of remission was 11 months. Side effects were transient purpura, moderate discomfort during the treatment, transient hyperpigmentation or hypopigmentation, and incidental transient crustae.. This was an open prospective study with a limited number of patients who were concomitantly treated with calcipotriol and salicylic acid ointment. Patients with photointolerance, on medication with phototoxic or photoallergic drugs, and with widespread psoriasis were excluded.. Concomitant treatment with PDL and topical calcipotriol, salicylic acid, or both was a satisfactory modality for treating psoriasis of the hands and feet. There was a subjective improvement in the symptoms and quality of life in all patients.

Topics: Adolescent; Adult; Aged; Calcitriol; Child; Combined Modality Therapy; Dermatologic Agents; Female; Humans; Keratolytic Agents; Laser Therapy; Male; Middle Aged; Ointments; Prospective Studies; Psoriasis; Remission Induction; Salicylic Acid; Treatment Outcome

Psoriasis presents many management complexities. A cornerstone of therapy has been topical corticosteroids, although over the past 10 years there have been many additions to the medication armamentarium. Furthermore, various combination regimens and approaches have been advocated.. We sought to characterize various patterns of psoriasis health care delivery and the changes associated with these patterns from 1990 to 2001.. Visits for psoriasis were identified using National Ambulatory Medical Care survey data, a representative survey of visits to physician offices in the United States. We determined basic demographic characteristics, specialty of the physician provider and medications listed at these visits over the 1990-2001 interval.. There were more than 13.5 million visits for psoriasis during the 12-year study period. Dermatologists were responsible for the majority of the visits over the study interval (82%) although there was an overall decline in the proportion of psoriasis visits to dermatologists. As a category, the most common medications used for psoriasis were topical steroids. Topical calcipotriene was the single-most listed medication. There was no observed use of non-corticosteroid topical agents at visits to non-dermatologists. Non-dermatologists were as likely as dermatologists to list a systemic medication at a visit as well as use a systemic as monotherapy.. In conclusion, the primary topical therapies for psoriasis remain clobetasol and calcipotriene. The decreasing role of dermatologists in the treatment of psoriasis is probably a complex issue, but may relate in part to the difficulty of obtaining access to dermatology care.

Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Aged; Calcitriol; Clobetasol; Dermatologic Agents; Drug Therapy, Combination; Drug Utilization; Female; Health Care Surveys; Humans; Male; Methotrexate; Middle Aged; Office Visits; Psoriasis; Triamcinolone; United States

An expensive combunation of familiar components. Is it worth it?

Topics: Anti-Inflammatory Agents; Betamethasone; Calcitriol; Clinical Trials as Topic; Dermatologic Agents; Drug Combinations; Humans; Psoriasis

A variety of approaches (in vitro-/ex vivo studies, animal models, human studies and clinical trials) are available to assess compounds with potential antipsoriatic properties. Over the past few years various rodent models that mirror aspects of psoriasis phenotypes and/or pathogenesis have been created (e. g. knockout rodents, xenotransplantation models). Unfortunately these animal models do not reflect the complete pathogenesis of psoriasis. Therefore, screening procedures involving psoriatic lesions in humans are necessary. Even in the era of biologicals, the psoriasis plaque test (PPT) remains an important in vivo tool. In addition to screening potential antipsoriatic substances, the PPT can help answer other questions (frequency of use, dose-response relationship). A prerequisite for correct performance of PPT is knowledge of the toxicological and pharmacological data of the investigational compounds. The PPT is relatively simple, not time-consuming and allows the simultaneous testing of multiple substance. All the results from PPT must be confirmed by controlled clinical trials.

Topics: Administration, Topical; Animals; Anti-Inflammatory Agents; Biological Products; Calcineurin Inhibitors; Calcitriol; Cholecalciferol; Dermatologic Agents; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Evaluation, Preclinical; Humans; Psoriasis; Rodentia; Skin

Dovobet is a compounded combination of calcipotriol [also calcipotriene] and betamethasone diproprionate, and is used for psoriasis vulgaris once daily. For this photo case presentation, Dovobet was used once daily in combination with UVB phototherapy 3 times a week. Light therapy was increased by 10% increments at each visit or as tolerated by the patient. Results show the combination of light therapy plus Dovobet may be an effective and convenient option in the treatment of psoriasis.

Topics: Administration, Cutaneous; Adult; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Humans; Male; Middle Aged; Ointments; Patient Education as Topic; Patient Selection; Photochemotherapy; Psoriasis; Severity of Illness Index; Treatment Outcome; Ultraviolet Therapy

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Humans; Male; Middle Aged; Psoriasis; Respiratory Distress Syndrome

Combination treatment with topical vitamin D(3) and narrow-band ultraviolet B (UVB) radiation is effective against psoriasis vulgaris. We compared the efficacy of the topical vitamin D(3) derivatives calcipotriol and maxacalcitol in combination therapy.. In this retrospective observational study, 21 patients admitted to Nagoya City University Hospital between April 2001 and September 2004 were enrolled.. Combination treatment with calcipotriol or maxacalcitol and narrow-band UVB was effective against psoriasis vulgaris. Calcipotriol induced a more rapid improvement and required lower levels of narrow-band UVB irradiation to be effective. Serum calcium levels were slightly increased after 4 weeks of treatment, but there was no significant difference between the two groups. No other adverse effects were observed in either of the two groups.. The findings of this retrospective observational study indicated that combination treatment with topical vitamin D(3) derivatives and narrow-band UVB is effective against psoriasis without any obvious side-effects. These findings provide further evidence that calcipotriol has advantages over maxacalcitol regarding the narrow-band UVB-accumulated treatment dose and improvement rate of psoriasis area and severity index (PASI) scores.

Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Female; Hospitals, University; Humans; Japan; Male; Middle Aged; Psoriasis; Retrospective Studies; Severity of Illness Index; Treatment Outcome; Ultraviolet Therapy

Following its introduction in 1994, calcipotriene quickly became the single most prescribed medication for psoriasis according to National Ambulatory Medical Care Survey (NAMCS) data. Primarily through regulation of cellular differentiation, calcipotriene may be effective in dermatoses other than psoriasis. We characterize the clinical trends in the utilization of calcipotriene by analyzing a representative sample of visits to US physicians. Demographic characteristics, specialty of the provider, and off-label uses are reported. Calcipotriene was mentioned at 5.8 million of all NAMCS visits during the study period. Nearly 57% of mentions of calcipotriene were not linked to a diagnosis of psoriasis. Adjusted use for gender and race were relatively stable; there was a rise in non-psoriasis uses and use among non-dermatologists in 1997. Our findings support previous reports of the utility of calcipotriene in treating other dermatoses as witnessed by the numerous conditions for which its use was observed. Physicians and policy-makers should be aware of the role that this medication plays in the delivery of dermatologic care.

Topics: Calcitriol; Dermatologic Agents; Female; Health Care Surveys; Humans; Male; Middle Aged; Practice Patterns, Physicians'; Psoriasis; United States

Psoriasis is a clinical conundrum that affects an estimated 1-3% of the world's population. The psoriatic disease process, characterized by a type 1 cytokine pattern, is supposed to be maintained by a continuing immune response in a "peripheral lymphoid tissue" that forms in lesional skin and is composed of T cells, dendritic cells, and vessels arranged like a T-dependent zone in lymph nodes. Dehydroepiandrosterone (DHEA), produced from dehydroepiandrosterone sulfate (DHEAS) through the enzymatic activity of DHEA-sulfatase, plays a pivotal role in the development of the type 1 immune response generated in peripheral lymphoid organs. Taken together, it could be reasoned that DHEA-sulfatase inhibitors may have utility in the treatment of psoriasis. Furthermore, the addition of DHEA-sulfatase inhibitors to calcipotriol, which encourages type 2 immune response, may provide an additive or synergistic inhibition of the type 1 immune response underlying psoriasis. It has been shown that topical application of cholesterol sulfate in the hairless mouse causes epidermal hyperkeratosis, which can be prevented by co-application of topical cholesterol. Therefore, as the inhibition of conversion of cholesterol sulfate to cholesterol can induce epidermal hyperkeratosis and may thus abbreviate the benefit obtained by inhibition of DHEAS to DHEA conversion, topical sulfatase inhibitors should preferably be co-applied with topical cholesterol, though it is also possible that the beneficial immunological effects of steroid sulfatase inhibitors outweigh their possible hyperkeratosis stimulation. Alternatively, the production of specific DHEA-sulfatase inhibitors can resolve the above concern. DHEA-sulfatase inhibitors may prove invaluable in the treatment of psoriasis.

Topics: Animals; Calcitriol; Cytokines; Dehydroepiandrosterone; Dermatologic Agents; Drug Interactions; Enzyme Inhibitors; Mice; Mice, Inbred Strains; Models, Biological; Psoriasis; Steryl-Sulfatase

Nuclear factor-kappaB (NF-kappaB) is an inducible nuclear transcription factor regulating a range of cellular processes. An imbalance of the DNA binding activity of NF-kappaB may, therefore, be part of the pathophysiological mechanisms in psoriasis. The purpose of this study was to determine the NF-kappaB DNA binding activity in psoriatic skin using three different kappaB sites and to determine how DNA binding activity was modulated by the anti-psoriatic drug calcipotriol. By electrophoretic mobility shift assay, we demonstrated that the NF-kappaB DNA binding to the p53 kappaB site was decreased, whereas the NF-kappaB DNA binding to the interleukin-8 (IL-8) kappaB site was increased in lesional psoriatic skin compared with non-lesional psoriatic skin. No regulation was seen on the NF-kappaB DNA binding to the major histocompatibility complex class I kappaB site. These changes were paralleled by a similar decrease in p53 expression and an increase in IL-8 expression in involved psoriatic skin compared with uninvolved skin as determined by quantitative RT-PCR. The alteration in NF-kappaB DNA binding activity was neither accompanied by any change in the expression of the inhibitor kappaB (IkappaB) kinases, IKKalpha, IKKbeta, and IKKgamma nor in the expression of the NF-kappaB inhibitor proteins, IkappaBalpha and IkappaBbeta. Immunofluorescence analysis revealed that p65 was sequestered in the cytoplasm of keratinocytes, whereas p50 exhibited a cytoplasmic as well as a nuclear localization. Interestingly, this distribution of p50 and p65 was similar in lesional and non-lesional psoriatic skin. Topical application of calcipotriol to lesional psoriatic skin for 4 d resulted in increased NF-kappaB binding to the p53 kappaB site and decreased NF-kappaB binding to the IL-8 kappaB site. Taken together, our data demonstrate that the NF-kappaB DNA binding activity is regulated in a specific manner in psoriatic skin depending on the kappaB sites investigated, and that topical treatment of psoriatic skin normalizes the abnormal NF-kappaB binding activity seen in lesional psoriatic skin.

Topics: Administration, Cutaneous; Adult; Blotting, Western; Calcitriol; Cells, Cultured; Dermatologic Agents; DNA; Electrophoretic Mobility Shift Assay; Fluorescent Antibody Technique; Gene Expression Regulation; Humans; I-kappa B Kinase; I-kappa B Proteins; Interleukin-8; Keratinocytes; NF-kappa B; Protein Isoforms; Protein Serine-Threonine Kinases; Psoriasis; Response Elements; Reverse Transcriptase Polymerase Chain Reaction; RNA, Messenger; Skin; Tumor Suppressor Protein p53

Compared with the original Goeckerman therapy devised by Dr Goeckerman in the 1930s, modern modified Goeckerman therapy in the second millennium shows significantly enhanced efficacy by improvements in technology (e.g. narrowband UVB) and the possibility of adding other relatively safe therapeutic options for more resistant cases to enhance efficacy without compromising the basic safety profile.. For approximately 6 months, psoriasis patients undergoing Goeckerman therapy at the UCSF Psoriasis Center were followed from admission to discharge. A total of 25 consecutive psoriasis patients were treated with the Goeckerman regimen until (near-) clearance or for a maximum period of 3 months, and their weekly improvements in terms of PASI (psoriasis area and severity index) were recorded.. In all, 100% reached PASI 75 by 12 weeks of treatment. In fact, by 8 weeks, 95% reached PASI 75 and most of the patients were discharged within 2 months.. The onset of treatment effect was rapid. Goeckerman therapy is still a valuable and important part of the psoriatic armamentarium.

Topics: Acitretin; Anthralin; Calcitriol; Coal Tar; Combined Modality Therapy; Female; Humans; Keratolytic Agents; Male; Methotrexate; Middle Aged; Nicotinic Acids; Phototherapy; Psoriasis; Salicylic Acid; Severity of Illness Index; Time Factors; Ultraviolet Therapy

Topics: Administration, Cutaneous; Calcitriol; Dermatologic Agents; Humans; Male; Middle Aged; Ointments; Patch Tests; Psoriasis

Interleukin (IL)-20 and IL-19 are recently discovered members of the IL-10 family of cytokines. The skin of transgenic mice overexpressing IL-20 shows histological changes resembling some of those seen in psoriasis, i.e. thickened epidermis, hyperkeratosis and a compact stratum corneum. IL-19 and IL-20, as well as their receptor complexes, IL-20Ralpha/IL-20Rbeta and IL-22Ralpha/IL-20Rbeta, are expressed in human skin.. To study the dynamics of IL-19 and IL-20 gene expression as well as the expression of their receptor subunits in psoriatic skin lesions.. Punch biopsies from patients with plaque-type psoriasis were collected before, during and after 28 days of treatment with either calcipotriol or ciclosporin (CsA). IL-20, IL-19, IL-20Ralpha, IL-20Rbeta and IL-22Ralpha mRNA expression were determined by quantitative reverse transcriptase-polymerase chain reaction.. We found IL-19 and IL-20 mRNA expression in lesional psoriatic skin to be strongly upregulated compared with nonlesional psoriatic skin by a factor of 65 and 22, respectively. In contrast to previous reports, IL-20Ralpha and IL-20Rbeta mRNA levels showed a modest but statistically significant decrease in lesional psoriatic skin compared with nonlesional psoriatic skin. During treatment with calcipotriol or CsA, IL-19 and IL-20 mRNA levels decrease in accordance with the clinical improvement of psoriasis. Neither IL-19, IL-20, nor receptor subunit mRNA expression in lesional psoriatic skin reaches the levels of nonlesional skin during this short-term treatment. These findings are in line with the residual disease activity observed at the end of treatment.. The increased IL-19 and IL-20 mRNA expression levels in lesional psoriatic skin suggest that these two cytokines play a role in the pathogenesis of psoriasis. An imbalance in the receptor complexes for IL-19 and IL-20 might contribute to their suspected pathogenic effects.

Topics: Adult; Aged; Calcitriol; Chronic Disease; Cyclosporine; Dermatologic Agents; Female; Gene Expression Regulation; Humans; Immunosuppressive Agents; Interleukin-10; Interleukins; Male; Middle Aged; Psoriasis; Receptors, Interleukin; Reverse Transcriptase Polymerase Chain Reaction; RNA, Messenger; Skin

Acrodermatitis continua of Hallopeau (ACH) is a rare type of pustular psoriasis affecting the digits. We report on a 43-year-old female patient who had been suffering from ACH for more than 20 years. Despite the fact that the disease was localized on one finger during the whole period, several topical and systemic treatments resulted in only temporary or partial improvement of the lesion. Although the monotherapies with calcipotriol and tacrolimus ointments gave no satisfying results in the long-term management of the disease, the combination of both agents led to a continuous improvement of the patient's skin condition.

Topics: Acrodermatitis; Administration, Cutaneous; Adult; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Hand Dermatoses; Humans; Immunosuppressive Agents; Ointments; Psoriasis; Tacrolimus

Topics: Betamethasone; Calcitriol; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Humans; Psoriasis

We report a case of guttate psoriasis in a 28-year-old woman who had been suffering from scalp psoriasis from the age of 14. After an upper respiratory infection she presented with the typical exanthema of guttate psoriasis. Despite initial treatment with antibiotics and emollients, the rash continued to spread. Two months after the flare of psoriasis we decided to treat the patient with calcipotriol and betamethasone dipropionate ointment applied once daily, using an intermittent treatment modality. The lesions disappeared and despite two small recurrences on the legs we managed to maintain clearance after a 2-year follow-up. Although the application of calcipotriol and betamethasone dipropionate ointment was cumbersome, due to the extent of the eruption, the result was highly effective and safe without any lesional/perilesional adverse reaction during application and with normal blood examinations.

Topics: Adult; Betamethasone; Calcitriol; Dermatologic Agents; Drug Combinations; Female; Humans; Ointments; Psoriasis

Topics: Calcitriol; Dermatologic Agents; Humans; Hyperpigmentation; Male; Melanoma; Middle Aged; Psoriasis; Skin Neoplasms

Topics: Aged; Aged, 80 and over; Calcitriol; Dermatologic Agents; Female; Humans; Hypercalcemia; Hypernatremia; Ointments; Psoriasis

Topics: Betamethasone; Calcitriol; Clinical Trials as Topic; Dermatologic Agents; Humans; Ointments; Psoriasis; Treatment Outcome

Topics: Betamethasone; Calcitriol; Clinical Trials as Topic; Dermatologic Agents; Drug Design; Humans; Placebos; Psoriasis; Treatment Outcome

Calcipotriol and corticosteroids are commonly used treatments for psoriasis vulgaris, each with different mechanisms of action. The two agents have shown combined action, but current formulations do not permit simultaneous application. Daivobet (LEO Pharma, Denmark) ointment contains calcipotriol and the corticosteroid, betamethasone dipropionate. Such a formulation may provide convenience and enhanced activity compared with separate applications, but it is essential that the biological activity and bioavailability of either active agent is not adversely affected by the other component.. His study was designed to determine whether the bioavailability of the corticosteroid component of Daivobet was equivalent to that in a corticosteroid-only formulation (Diprosone, Schering-Plough Laboratories, France).. A vasoconstrictor assay measuring skin blanching was used to determine bioequivalence.. Skin blanching measured either by objective chromametric measurement or visual assessment showed Daivobet to be equivalent to Diprosone.. The data indicate that the steroid component of Daivobet is not unfavorably affected by the calcipotriol.

Topics: Adolescent; Adult; Anti-Inflammatory Agents; Betamethasone; Biological Availability; Calcitriol; Dermatologic Agents; Drug Combinations; Drug Interactions; Humans; Male; Middle Aged; Pilot Projects; Psoriasis

Psoriasis is a common benign skin disease characterized by hyperproliferation and abnormal differentiation of keratinocytes. The transcription factor activator protein 1 (AP-1) is known to play an important role in cell proliferation and differentiation.. To investigate AP-1 DNA binding activity in psoriatic skin.. Keratome biopsies were taken from patients with plaque-type psoriasis. Electrophoretic mobility shift assays were used to determine the AP-1 DNA binding activity, whereas Western and Northern blotting was used to determine Jun and Fos protein and mRNA expression.. We found that AP-1 DNA binding activity was almost completely abolished in lesional psoriatic skin compared with nonlesional psoriatic skin. Furthermore, experiments revealed that the protein and mRNA expression of the AP-1 subunits c-Fos, Fra-1 and c-Jun was reduced in lesional psoriatic skin compared with nonlesional psoriatic skin, whereas the protein and mRNA expression of the subunit JunB was increased. Topical application of the vitamin D analogue calcipotriol under occlusion to involved psoriatic skin for 4 days resulted in an increase in AP-1 DNA binding activity, and an increase in the protein and mRNA expression of c-Fos, Fra-1 and c-Jun, together with a decrease in JunB protein and mRNA expression.. Together, these results suggest that the activity of the transcription factor AP-1 is impaired in lesional psoriatic skin and that this impairment may be important for the disturbed epidermal growth observed in psoriasis.

Topics: Adult; Aged; Blotting, Northern; Blotting, Western; Calcitriol; Dermatologic Agents; DNA-Binding Proteins; Electrophoretic Mobility Shift Assay; Female; Gene Expression Regulation; Humans; Male; Middle Aged; Proto-Oncogene Proteins c-fos; Proto-Oncogene Proteins c-jun; Psoriasis; RNA, Messenger; Skin; Transcription Factor AP-1

Topics: Betamethasone; Calcitriol; Clinical Trials as Topic; Dermatologic Agents; Drug Combinations; Humans; Ointments; Psoriasis

Topics: Administration, Topical; Calcitriol; Dermatologic Agents; Female; Humans; Immunosuppressive Agents; Middle Aged; Psoriasis; Tacrolimus

Interleukin-19, 20, and 24 are new members of the IL-10 family binding and signaling through the IL-20R1/IL-20R2 heterodimer, while IL-20 and 24 also bind to the IL-20R2/IL-22R1 heterodimer. Using in situ hybridization we have studied mRNA expression of IL-19, 20, and 24 and their related receptor chains in skin from psoriatic patients before and during short-term treatment with either oral cyclosporine A or topical calcipotriol. In untreated lesions IL-19 and IL-20 mRNA was expressed focally in epidermis above the dermal papillae, whereas IL-24 was expressed in mononuclear cells in the dermal infiltrate. The expression of IL-19 and 20 mRNA was confined to the basal and suprabasal keratinocytes. No expression of IL-19 and 20 mRNA could be detected in uninvolved psoriatic skin. Treatment with cyclosporine A and calcipotriol resulted in disappearance of the IL-19 and 20 mRNA. Expression of mRNA for the receptor chains IL-20R1 and IL-20R2 was found throughout the psoriatic epidermal layer, whereas IL-22R1 mRNA was predominantly expressed in the superficial part of the psoriatic epidermis. These findings show that IL-19 and IL-20 are synthesized by a distinct population of keratinocytes. It remains to be clarified whether IL-19 and IL-20 are implicated in the pathogenesis of psoriasis.

Topics: Calcitriol; Cyclosporine; Dermatologic Agents; Epidermal Cells; Epidermis; Gene Expression; Genes, Tumor Suppressor; Humans; Interleukin-10; Interleukins; Keratinocytes; Psoriasis; Receptors, Interleukin; RNA, Messenger; T-Lymphocytes

This new compound product containing 50 micrograms/gram calcipotriol and 0.5 milligrams/gram betamethasone dipropionate was recently introduced in Canada for the treatment of psoriasis. Clinical trials demonstrated that this compound was more active than either agent used alone. Recent changes in the product monograph involving the reduction in dose to once daily use has raised questions about the relevance of some previous comparisons of twice daily Dovobet. Pooling the available data from 5,500 patients in clinical trials for Dovobet will allow an inter-trial comparison of the various treatment arms, demonstrating that Dovobet, when applied once daily is significantly more effective than with twice daily applications of either its individual components used alone.

Topics: Adult; Betamethasone; Calcitriol; Confidence Intervals; Data Interpretation, Statistical; Dermatologic Agents; Double-Blind Method; Drug Combinations; Humans; Multicenter Studies as Topic; Patient Compliance; Prospective Studies; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Time Factors

Little attention is given to accurate dosage of topical medication which is a potential source of side-effects and treatment failure. There are studies on the dosage for 'sparing' application relevant to topical steroids but not for 'liberal' application. Though calcipotriol is a first line topical treatment for psoriasis, approximately one-third of patients do not respond adequately. The aims of the present study were to define liberal dosage, to develop a method of calculation of area of involved skin and to evaluate the efficacy of calcipotriol in optimized liberal dosages, based on preliminary studies, in calcipotriol treatment failures. Weight/unit area of ointment and cream base, constituting liberal application, was determined in six normal volunteers. The area of psoriatic involvement in 24 calcipotriol non-responders was estimated by a 'fill-up' method and a modified 'hand' method. The results of the two methods were similar (Pearson correlation coefficient 0.68, P < 0.0001) but the 'hand' method proved easier in use and was the preferred method for the rest of the study. The patients applied calcipotriol at their accustomed rates for at least 2 weeks and then at the calculated liberal rates, using cream in the morning and ointment at night, for 4 weeks. The efficacy measures were Psoriasis Area and Severity Index (PASI) (primary measure), a four-point efficacy score and a visual analogue scale. As a result of the preliminary study and the actual amounts used by the patients in the psoriasis treatment study reported below, liberal application has been defined as 50 g/m2 per application for ointment base and 40 g/m2 per application for cream. At this dosage, an average individual would use approximately 100 g of medication/week to treat 10% of the body surface. During the 4-week treatment study, the psoriasis patients used an average of 39 g (SD 17 g)/m2 per application of cream and 52 g (SD 13 g)/m2 per application of ointment. All efficacy measures showed marked improvement (P < 0.0001). The frequency distribution of the PASI reduction defined responsive (70% of patients) and poorly responsive groups (30%), with mean PASI reduction of 60% and 17%, respectively.

Topics: Administration, Topical; Adult; Aged; Analysis of Variance; Anthropometry; Body Mass Index; Calcitriol; Dermatologic Agents; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Middle Aged; Probability; Prospective Studies; Psoriasis; Sampling Studies; Severity of Illness Index; Statistics, Nonparametric; Treatment Failure; Treatment Outcome; United Kingdom

Topics: Adult; Biopsy, Needle; Calcitriol; Dermatitis, Allergic Contact; Follow-Up Studies; Humans; Immunohistochemistry; Male; Patch Tests; Psoriasis; Risk Assessment

Calcipotriol ointment and calcipotriol cream have both been shown to be effective in the treatment of psoriasis.. To find out the patient compliance, efficacy and tolerance to a regimen of a calcipotriol cream application in the morning and a calcipotriol ointment application in the evening.. In order to obtain data relevant to daily practice, information was obtained from patients and dermatologists on the treatment of psoriasis with a combination of calcipotriol ointment and calcipotriol cream. In total, three assessments were carried out: at the beginning, after 3 weeks and after 8 weeks. The first assessment comprised general demographics, localization of the lesions, the percentage body surface involved, and details on other antipsoriatic medications. The second and third assessments were an evaluation of compliance and efficacy in comparison with calcipotriol ointment monotherapy, provided that the patients had experience with this treatment. In total, 976 patients were included by 170 dermatologists in The Netherlands and Belgium.. Compliance with the combined use of calcipotriol cream in the morning and calcipotriol ointment in the evening was optimal in 60-70% of the patients. The highest compliance was shown at the second visit but dropped at the third visit. Those patients with previous experience of calcipotriol ointment indicated that the calcipotriol cream/ointment regimen was a better principle. Response to the calcipotriol cream/ointment regimen was considered good in 67-76% of the patients.. The present study indicates that the combined use of calcipotriol cream in the morning and ointment in the evening is useful as a principle for mild to severe psoriasis. A total of 67-68% of the patients stated that this regimen was the most preferred topical treatment of psoriasis.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Calcitriol; Child; Dermatologic Agents; Dosage Forms; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Ointments; Patient Compliance; Psoriasis; Treatment Outcome

Broad-band UVB alone or in combination with different topical drugs (anthralin, calcipotriol), systemic PUVA and bath-PUVA therapy are very effective and well-established treatment modalities for psoriasis.. The aim of this retrospective study was to assess which of these routinely applied phototherapeutic modalities might be most effective and safe for the treatment of plaque-type psoriasis.. Patients (n = 203) with moderate to severe (pretreatment Psoriasis Area and Severity Index score between 12 and 35) chronic plaque-type psoriasis treated between 1992 and 1998 at our department with either UVB (with/without anthralin or calcipotriol; n = 97), systemic PUVA (n = 19) or bath-PUVA therapy (n = 87) were evaluated for efficacy, duration of treatment, number of treatments necessary for complete remission (CR), cumulative light dose, side effects of therapy and duration of remission after therapy.. No statistically significant difference comparing the efficacy of bath-PUVA (CR in 72.4%), PUVA (CR in 89.5%) and UVB phototherapy (CR in 69.1%) was found. Although the duration of therapy was significantly longer for bath-PUVA (66 +/- 42 days) as compared to UVB treatment (50 +/- 27 days), the mean number of treatments did not differ significantly between bath-PUVA (28 +/- 12), UVB therapy (30 +/- 12) and PUVA (26 +/- 13). Significantly fewer side effects of phototherapy were observed with bath-PUVA (14.9%) therapy compared to UVB treatment (30.9%). Also, the duration of remission after successful therapy was significantly longer for bath-PUVA (8.4 +/- 3.5 months) as compared to UVB phototherapy (5.1 +/- 4.2 months).. Bath-PUVA therapy has some advantages over UVB phototherapy in the treatment of psoriasis: fewer UV-related acute side effects and a longer period of remission after therapy. However, the choice of treatment with either UVB, bath-PUVA or systemic PUVA should also be based on a history of previous response to treatment and patient considerations, including compliance and responsibility for following the precautions to avoid potential side effects.

Topics: Administration, Topical; Adult; Anthralin; Anti-Inflammatory Agents; Baths; Calcitriol; Dermatologic Agents; Female; Humans; Male; Methoxsalen; Middle Aged; Psoriasis; PUVA Therapy; Retrospective Studies; Treatment Outcome; Ultraviolet Therapy

Pustular psoriasis of the nail apparatus is a common disease that greatly influences the quality of life because of its chronic course and poor response to treatment.. To review the clinical and histopathological features, the response to treatment and the long-term follow-up of 46 patients with pustular psoriasis of the nail unit.. Treatments utilized included oral retinoids (n = 12), oral nimesulide (n = 13), topical calcipotriol (n = 15) and topical steroids (n = 18). Retinoids were utilized as first choice in seven patients with involvement of several digits and in five patients with severe relapses, whereas topical calcipotriol, oral nimesulide or topical steroids were utilized in patients with involvement of a single nail. Topical calcipotriol was also prescribed as maintenance therapy in patients who responded to oral treatment. Twenty-five patients were followed for more than 5 years.. Improvement or regression of the lesions was obtained in 23 of 46 patients. Retinoids were effective in six of 12 patients, nimesulide in four of 13, topical calcipotriol in nine of 15 and topical steroids in four of 18. The long-term follow-up showed a complete remission of the disease in only two patients, both affected by pustular psoriasis involving multiple nails. All other patients experienced periodic relapses which were in most cases controlled by regular use of topical calcipotriol.. Severe cases of pustular psoriasis of the nail are best treated with systemic retinoids. Topical calcipotriol is effective in about 50% of patients with localized disorder and is also useful as maintenance therapy after retinoid treatment.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Calcitriol; Child; Dermatologic Agents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Nail Diseases; Psoriasis; Retinoids; Treatment Outcome

The data from a questionnaire-based study of 5,739 members of the psoriasis associations of Denmark, Finland, Iceland, Norway, Sweden and the Faeroe Islands showed that the two most commonly used active agents were topical steroids (89.7% total use and 49.4% present use) and calcipotriol (73.1% total use and 35.8% present use), with only small variations between the countries. Marked differences between the countries were, however, found within all other types of psoriasis therapy, including the so-called alternative treatments. Significant priorities varied between the different countries. The use of dithranol in Finland was almost twice the average. While 14.2% of Danish members had received grenz-rays within the last week only 0.1% of the Finns had been given the same treatment. Psoralen plus ultraviolet A (PUVA) was being used by 13.1% of the Finnish psoriatics compared with 3.8% of Danes, while PUVA was almost non-existent on the Faeroe Islands. The use of non-PUVA phototherapy was highest in Norway and Sweden. Almost 10% of the Danes were presently on methotrexate, which was used far more than etretinate/acitretin or cyclosporine. In contrast, Finnish patients more often received etretinate than other systemic agents, and in Iceland there was a higher present use of cyclosporine than of etretinate. The popularity of alternative therapies was highest in Iceland, where 26.6% had taken such medication during the last week. The results of the study suggest that different treatment patterns should be taken into consideration when discussing the prognosis of psoriasis in different countries.

Topics: Administration, Topical; Analysis of Variance; Anthralin; Anti-Inflammatory Agents; Calcitriol; Complementary Therapies; Cyclosporine; Dermatologic Agents; Europe; Female; Health Care Surveys; Humans; Male; Methotrexate; Middle Aged; Psoriasis; PUVA Therapy; Steroids; Surveys and Questionnaires

Topics: Adult; Calcitriol; Dermatologic Agents; Hirsutism; Humans; Male; Psoriasis

Psoriasis in infancy is often more therapeutically challenging than atopic and seborrheic dermatitis. The generalized nature of psoriasis and the intensity of inflammation often reduce the efficacy of topical corticosteroids. Furthermore, involvement of intertriginous skin and the presence of scalp disease limit the potency of the topical steroids that can be prescribed. We report on an infant treated with topical calcipotriene for infantile psoriasis who experienced greater benefit than he had with standard corticosteroid medications. Laboratory testing for calcium metabolism was normal during the course of therapy. We conclude that calcipotriene can be a safe and effective therapy for psoriasis in early infancy.

Topics: Calcitriol; Dermatologic Agents; Humans; Infant; Infant Welfare; Male; Ointments; Psoriasis; Treatment Outcome

Sphingomyelin hydrolysis seems to be a ubiquitous pathway generating ceramide, an important cell response modifier. Upon agonist-stimulation this pathway is linked to biological responses as inhibition of proliferation, promotion of differentiation and induction of apoptosis. One of the agonists described is 1alpha,25-dihydroxyvitamin D3. Recently, we could demonstrate the existence of sphingomyelin hydrolysis in human primary keratinocytes as well as in the human keratinocyte cell line HaCaT after treatment with 1alpha,25-dihydroxyvitamin D3. In the present study we tested four vitamin D analogues on HaCaT keratinocytes for their ability to inhibit cell proliferation and to induce sphingomyelin hydrolysis. These analogues, calcipotriol, EB 1213, GS 1500 and tacalcitol inhibit cell growth after 48 hrs. of incubation and trigger the hydrolysis of sphingomyelin. Moreover, all analogues tested induce apoptotic cell death in HaCaT keratinocytes after 24 hrs. of incubation. This study indicates that sphingomyelin hydrolysis, subsequently leading to the elevation of cellular ceramide levels, may represent an important signal transduction pathway for 1alpha,25-dihydroxyvitamin D3 and its analogues in human keratinocytes. Possible differences of the mechanism underlying vitamin D-induced sphingomyelin hydrolysis has to be studied in more detail and may contribute to the antipsoriatic action of these analogues.

Topics: Apoptosis; Calcitriol; Cell Division; Cell Line; Dihydroxycholecalciferols; Humans; Keratinocytes; Psoriasis; Sphingomyelins; Vitamin D

Tazarotene is the first receptor-selective retinoid indicated for the topical treatment of plaque psoriasis. It is being used clinically in combination with other topical antipsoriatic treatments, although its stability in the presence of these products has not been examined extensively. This study examines the compatibility of tazarotene 0.05% gel with 17 other topical products used in the treatment of psoriasis, assessed over a 2-week period. Tazarotene showed minimal degradation (<10%) at 0, 8, 24, and 48 hours after compounding with each of the 17 products. In addition, after 1 and 2 weeks, degradation of tazarotene remained less than 10% for 15 of the 17 products tested. Tazarotene appeared to have minimal impact on the stability of the other products. These results suggest that tazarotene gel can be successfully coprescribed with a range of commonly used topical psoriasis treatments without adversely affecting the chemical stability of either agent.

Topics: Administration, Topical; Betamethasone; Calcitriol; Clobetasol; Dermatologic Agents; Drug Evaluation, Preclinical; Drug Incompatibility; Fluocinonide; In Vitro Techniques; Mometasone Furoate; Nicotinic Acids; Pregnadienediols; Psoriasis

Topics: Calcitriol; Dermatologic Agents; Humans; Psoriasis

The combination of UVB phototherapy with topical application of vitamin D analogs is frequently used for treating psoriasis. This regimen is not only very effective but also has only minimal side effects. Pronounced, persistent hyperpigmentation developed in the psoriatic plaques in a patient who was treated with combined UVB (311 nm) radiation and topical calcipotriol.

Topics: Aged; Aged, 80 and over; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Female; Humans; Hyperpigmentation; Psoriasis; Ultraviolet Therapy

Topics: Calcitriol; Chronic Disease; Dermatologic Agents; Drug Therapy, Combination; Glucocorticoids; Humans; Psoriasis; Vitamin D

New treatments are available for psoriasis that complement or replace the use of topical corticosteroids.. The purpose of this article is to assess the relative overall cost difference between regimens based on topical steroids and those using the nonsteroidal anti- psoriasis medication, topical calcipotriene.. Retrospective data on the cost of therapy of psoriasis were attained through analysis of claims from a national pharmaceutical-and-medical-visit claims-database. Episodes of psoriasis treatment were defined and analyzed for patients whose therapy was initiated with either topical calcipotriene or topical corticosteroids of different potency classes.. The average medication cost per episode was greater for topical calcipotriene ($111/episode) compared to ultra-high potency ($70/episode), high potency ($57/episode), mid potency ($47/episode), and low-potency, ($75/episode) topical corticosteroids (p <.05). The average total cost of therapy for the topical calcipotriene regimen ($218) fell within the range for the cost of therapy for topical steroid base regimens ($197 to $457); there were no significant differences in the total cost of therapy between topical calcipotriene monotherapy and other treatment groups.. The per-gram cost of medication is by itself a poor indicator for comparing the cost of different psoriasis treatment regimens. Given the greater safety and efficacy of combination regimens in terms of both short-term improvement and long-term control, initiating psoriasis treatment with a combination regimen of topical calcipotriene combined with an ultrapotent corticosteroid appears to be the most cost-effective approach to psoriasis treatment.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Calcitriol; Cohort Studies; Cost-Benefit Analysis; Dermatologic Agents; Drug Costs; Economics, Pharmaceutical; Female; Glucocorticoids; Humans; Male; Middle Aged; Psoriasis; Retrospective Studies

Topics: Calcitriol; Chronic Disease; Confounding Factors, Epidemiologic; Dermatologic Agents; Humans; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome

To examine the relative cost effectiveness of topical calcipotriol and short-contact dithranol in the treatment of mild to moderate plaque psoriasis.. This was a modelling study from the perspective of the UK National Health Service as payer.. The interventions were compared using 2 decision-analytic models: one using a short term horizon (12 weeks) and the other using a longer term horizon (up to 1 year). Clinical success of treatment and relapse rates were obtained from the results of randomised controlled trials.. The outcome measure used was the degree of improvement in psoriasis as judged by the patient. In the short term comparison, calcipotriol was the most effective treatment (60.8% success), but it was also the most expensive (96.03 Pounds; 2000 values). The incremental cost per success was 577.50 Pounds using a 12-week course of calcipotriol compared with short-contact dithranol. Over the long term horizon, first-line treatment with calcipotriol still had the highest expected cost per successful treatment (164.91 Pounds), but the incremental cost using this strategy was 38.66 Pounds compared with short-contact dithranol. In terms of cost per successful day's treatment (i.e. the cost for a day in which the patient reported a marked improvement or cleared lesions), the cost of each additional successful day's treatment was 19.93 Pounds when using calcipotriol as first-line treatment rather than short-contact dithranol.. The combination of differences in drug acquisition costs and relapse rates can lead to large differences in the comparative cost effectiveness of topical treatments for plaque psoriasis. From the perspective of the prescriber, the results of this analysis suggest that selecting short-contact dithranol as first-line treatment was the most cost-effective strategy.

Topics: Administration, Topical; Anthralin; Anti-Inflammatory Agents; Calcitriol; Cost-Benefit Analysis; Decision Trees; Dermatologic Agents; Humans; Models, Economic; Psoriasis; Randomized Controlled Trials as Topic

To describe the clinical characteristics and treatments of children with psoriasis.. Retrospective, descriptive.. The medical records were studied of all 38 children with psoriasis who visited the outpatient clinic for Dermatology of the University Hospital/Wilhelmina Children's Hospital Utrecht, the Netherlands, for the first time between 1 January 1995 and 31 December 1997.. The 38 children accounted for 3.6% of all children in whom a diagnosis was made. There were 19 boys and 19 girls. 79% had psoriasis vulgaris and 11% psoriasis guttata. Average age of onset was 6.8 years for girls and 9.3 years for boys. Family history was positive in 42%. The limbs were affected most. Nail changes were seen in 11%. Provoking factors were stress, infections, summertime and injuries of the skin. In almost all patients in the outpatient department local mono- and/or combination therapy of corticosteroids in cream or ointment with salicylic acid and tar was given.

Topics: Adolescent; Adrenal Cortex Hormones; Anthralin; Anti-Inflammatory Agents; Aspirin; Calcitriol; Child; Cyclosporine; Dermatologic Agents; Female; Genetic Predisposition to Disease; Humans; Male; Phototherapy; Psoriasis; Retrospective Studies; Tars; Treatment Outcome; Tretinoin

Topics: Administration, Topical; Aged; Calcitriol; Calcium; Dermatologic Agents; Dose-Response Relationship, Drug; Humans; Hypercalcemia; Male; Psoriasis

Calcipotriol (Daivonex R; Leo Pharmaceuticals, Zurich, Switzerland) may cause irritation of the skin, whereas allergic reactions are less common. In the present study we describe two patients with different types of reaction patterns, one presenting as an allergic, the other as an irritant contact dermatitis. Irritative skin reactions were observed only at higher testings doses, in contrast to the allergic type of reaction, which occurred at a lower testing dose. The present observation suggests, that a batch of different testing doses, including lower testing doses may help to differentiate between an allergic type of contact dermatitis and an irritant type of reaction after treatment with calcipotriol.

Topics: Administration, Topical; Aged; Calcitriol; Dermatologic Agents; Drug Eruptions; Female; Humans; Middle Aged; Patch Tests; Psoriasis

Microbiological aspects are considered to be of pathophysiological importance in psoriasis, but there has so far been no information regarding cytomegalovirus (CMV) infection. This is of interest due to the high prevalence of latent infection in the general population, the frequent reactivation in inflammatory diseases, and the immunomodulating capacity of CMV. To detect active infection we analysed CMV antigen expression of peripheral blood mononuclear cells (PBMC) from psoriatic patients (n = 30) in comparison with healthy volunteers (n = 65). Using three monoclonal antibodies and immunocytological staining (alkaline phosphatase-antialkaline phosphatase technique), we frequently found CMV antigenaemia in psoriasis (43%) compared with healthy laboratory staff (12%, P < 0. 01) and blood donors (6%, P < 0.001). Clearance of CMV antigenaemia was observed with antipsoriatic treatment. CMV antigenaemia was symptomless, and was associated with seropositivity for anti-CMV IgG but not IgM antibodies, indicating subclinical activation of latent infection. Serological investigations in 85 psoriatic patients gave no evidence for a higher prevalence of latent CMV infection. In psoriatic lesions, CMV DNA was only rarely detected by polymerase chain reaction. As it has been shown that tumour necrosis factor (TNF)-alpha can induce CMV reactivation, we determined TNF-alpha plasma concentrations and mRNA expression in PBMC from psoriatic patients. Elevated TNF-alpha levels were found and correlated with the frequency of CMV antigen-expressing PBMC, suggesting a critical role of TNF-alpha in CMV activation. We speculate that active, subclinical CMV infection may be of pathophysiological importance in psoriasis.

Topics: Administration, Topical; Adult; Anthralin; Anti-Inflammatory Agents; Antigens, Viral; Calcitriol; Case-Control Studies; Chi-Square Distribution; Cytomegalovirus; Dermatologic Agents; DNA, Viral; Humans; Leukocytes, Mononuclear; Phototherapy; Prevalence; Psoriasis; Skin; Statistics, Nonparametric; Tumor Necrosis Factor-alpha; Virus Latency

Topics: Calcitriol; Dermatologic Agents; Humans; Polymorphism, Genetic; Psoriasis; Receptors, Calcitriol

Seven patients with chronic plaque psoriasis were treated with topical calcipotriol for 8 to 24 weeks; the lesions improved in 5 patients. Immunohistochemistry was performed on frozen sections, to evaluate the expression of adhesion molecules and extracellular matrix components before and after therapy. Changes in expression and topography of beta1 and beta4 integrins were found on psoriatic lesions before therapy and a reduction in the expression of tenascin was detected as well. Moreover, several activation markers such as ICAM-1, HLA-DR, CD26 were focally positive, with a diffuse cytoplasmic reactivity, in basal and suprabasal layers in untreated lesions. In the 5 patients in whom lesions regressed after topical calcipotriol treatment, we observed a histological normalization of the epidermis and the inflammatory infiltrate was reduced. Moreover, not only was there a normalization in the expression and topography of adhesion molecules, but also the integrin pattern observed after therapy was superimposable to that of normal skin.

Topics: Administration, Topical; Adult; Aged; Calcitriol; Calcium; Cell Adhesion Molecules; Dermatologic Agents; Dipeptidyl Peptidase 4; Female; HLA-DR Antigens; Humans; Immunohistochemistry; Integrins; Intercellular Adhesion Molecule-1; Male; Middle Aged; Psoriasis; Severity of Illness Index; Skin; Treatment Outcome

Topics: Administration, Topical; Calcitriol; Dermatologic Agents; Drug Combinations; Drug Stability; Humans; Ointments; Psoriasis

During the last decade important innovations in the topical treatment of psoriasis have been accomplished, and important investments in new drug development for psoriasis are planned.. A survey was conducted among psoriatic patients in order to quantify the present mode of use of topical drugs by the patients, the mode of prescription by their doctors and the compatibility of actual use and instructions to the patients.. Major observations are: The distribution of lesions, in particular on the scalp and soles, justifies major investments in the development of a treatment at these locations. calcipotriol and topical corticosteroids (classes III and IV) are by far the most frequently prescribed topical drugs. Although at the time of investigation, Calcipotriol was only available as ointment in the Netherlands, it is prescribed twice as often as clobetasol which is both available as an ointment and cream. Dermatologists are responsible for approximately 2/3 and general practitioners for 1/3 of the prescriptions. The prescription by general practitioners also comprises the continuation of prescriptions by the dermatologist. The duration of topical treatment is unrestricted in the majority of patients. However, use of up to 8 weeks is only seldom practised. Therefore, long-term safety and efficacy data of these drugs are mandatory for any topical treatment. Although twice daily treatment was advised in 50% of all patients, this treatment frequency was followed in only 33% of them. Greasiness accounted for non-compliance in 11% of the patients. Less frequent applications were desired by 38% of the patients, including patients on a once-a-day regimen. Most patients preferred the cream formulation. However, the variability of the expression of psoriasis (dry cracked exudative or superficially scaling lesions) required the availability of both cream and ointment formulations.. An optimal treatment of psoriasis requires a spectrum of topical drugs and their formulations in different vehicles.

Topics: Administration, Cutaneous; Adolescent; Adrenal Cortex Hormones; Adult; Aged; Aged, 80 and over; Calcitriol; Chemistry, Pharmaceutical; Child; Child, Preschool; Dermatologic Agents; Female; Humans; Male; Middle Aged; Netherlands; Pharmaceutical Vehicles; Psoriasis; Surveys and Questionnaires

The vitamin D3 analogue calcipotriol (calcipotriene) is an effective topical treatment for psoriasis. In combination with other antipsoriatic agents, such as ultraviolet radiation, calcipotriol is reported to improve the overall efficacy of the treatment. Here we describe two patients treated with a combination treatment of calcipotriol and bath psoralens and ultraviolet A who developed hyperpigmentation at the lesional sites where calcipotriol ointment was applied.

Topics: Adult; Calcitriol; Dermatologic Agents; Drug Eruptions; Female; Humans; Hyperpigmentation; Male; Middle Aged; Photochemotherapy; Psoriasis

We have previously reported the effectiveness of high-dose calcipotriol in extensive psoriasis. We now report the long-term outcome in patients following this treatment. Twenty-eight patients with severe psoriasis were treated as in-patients with high-dose topical calcipotriol for 2 weeks. There was a mean reduction in the psoriasis area and severity index of 65%. Sixty-nine per cent were controlled for 3 months and 42% for 6 months. The relapse rate was comparable with that following Ingram's regimen, the in-patient stay was shorter and the treatment more acceptable. Careful monitoring of calcium homeostasis is mandatory.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Calcitriol; Chronic Disease; Dermatologic Agents; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Middle Aged; Psoriasis; Retrospective Studies; Treatment Outcome

The lack of a quantitative method for assessing psoriasis severity poses a problem for quality control in dermatology. Quantitative estimation of involved surface area is important, as in the psoriasis area and severity index (PASI), but the reliability of many methods is poor. The purpose of this study was to assess the involved surface area of 15 psoriasis patients before and after different anti-psoriasis treatments using the human eye method and a computer image analysis (CIA) system based on colour segmentation. The human eye assessments were compared with the results of the CIA system and the resulting effects on the PASI score were also compared. The human eye estimates were higher than those obtained by the CIA method and, as a consequence, the values of the PASI by the human eye method were also higher than those by CIA. The human eye estimates differed most in cases where the PASI was under 15. The changes in the PASI by the human eye method before and after treatments differed significantly from those by CIA. The CIA system offers a possibility to quantify actual surface in patients with psoriasis, and will be an alternative for developing quality control when evaluating different treatment efficacies.

Topics: Acitretin; Administration, Topical; Adult; Aged; Anthralin; Anti-Inflammatory Agents; Calcitriol; Color; Dermatologic Agents; Eye; Female; Humans; Image Processing, Computer-Assisted; Keratolytic Agents; Male; Middle Aged; Photography; Psoriasis; PUVA Therapy; Quality Control; Reproducibility of Results; Severity of Illness Index; Skin; Tars

The biologically active vitamin D analog calcipotriol is effective and safe in the topical treatment of psoriasis, but its exact mechanism of action is unknown.. We investigated expression of 1,25-dihydroxyvitamin D3 receptors, markers for inflammation (CD1a, CD4, CD8, CD11b, CD15; NAP-1/interleukin-8; 55 kd tumor necrosis factor-receptor; intercellular adhesion molecule-1; HLA-DR), proliferation (proliferating cell nuclear antigen, Ki-67), and differentiation (transglutaminase K; involucrin; cytokeratin 16) in psoriatic skin during topical calcipotriol treatment.. For immunohistochemical staining we used the labeled avidin-biotin technique on cryostat-cut sections.. We found a significant increase of 1,25-dihydroxyvitamin D3 receptor expression in epidermal basal keratinocytes of lesional psoriatic skin during calcipotriol treatment. In all patients analyzed, effects on proliferation and differentiation of epidermal keratinocytes were stronger than effects on dermal inflammation. Effects on inflammation were more pronounced in the epidermal than in the dermal compartment.. Our findings indicate that analogs of 1,25-dihydroxyvitamin D3 upregulate their corresponding receptor in human keratinocytes in vivo. This mechanism may be important in the therapeutic efficacy of vitamin D analogs in psoriasis. The differential therapeutic effects in the epidermal and dermal skin compartments may be due to a reduced bioavailability of calcipotriol in the dermal compartment.

Topics: Administration, Cutaneous; Antigens, CD; Antigens, CD1; Biological Availability; Calcitriol; CD11 Antigens; CD4 Antigens; CD8 Antigens; Cell Differentiation; Cell Division; Dermatologic Agents; Epidermis; Gene Expression Regulation; HLA-DR Antigens; Humans; Immunoenzyme Techniques; Immunohistochemistry; Intercellular Adhesion Molecule-1; Interleukin-8; Keratinocytes; Keratins; Lewis X Antigen; Male; Proliferating Cell Nuclear Antigen; Protein Precursors; Psoriasis; Receptors, Calcitriol; Receptors, Interleukin; Receptors, Interleukin-8A; Receptors, Tumor Necrosis Factor; Skin; Transglutaminases; Tumor Necrosis Factor-alpha; Up-Regulation

Topics: Calcitriol; Combined Modality Therapy; Dermatologic Agents; Humans; Psoriasis; Ultraviolet Therapy

Calcipotriol, 1,25(OH)2D3 and 1,24(OH)2D3 are potent drugs for the treatment of psoriasis. It has recently been published that these compounds induce epidermal hyperproliferation in hairless mouse skin.. The aim of our study was to examine the effect of vitamin D3 derivatives on epidermal growth, keratinization and permeability barrier function in vivo.. Calcipotriol, 1,25(OH)2D3 and 1,24(OH)2D3 in isopropanol or in an ointment formula were applied to normal hairless mouse skin. Transepidermal water loss (TEWL), a marker of cutaneous barrier function, and epidermal proliferation were determined at different time points 0-264 h after treatment. In addition, light and electron microscopy studies were performed.. A single treatment in solution led to a transient (2- to 3-fold) increase in TEWL after application of calcipotriol or 1,25(OH)2D3 and to a 3- to 6-fold increase in epidermal proliferation after application of each of the compounds. Repeated applications also resulted in an up to 3-fold increase in TEWL which persisted for 3 days after the end of the treatment. By light microscopy an increase in epidermal thickness was observed. There was no sign of inflammation. Electron microscopy studies showed the formation of a transitional cell zone as a sign of a premature keratinization.. These results demonstrate that in normal mouse skin vitamin D3 and its analogues disrupt the epidermal permeability barrier by induction of epidermal proliferation and premature keratinization but without morphological signs of inflammation.

Topics: 1-Propanol; Administration, Cutaneous; Animals; Calcitriol; Cell Division; Cholecalciferol; Dermatologic Agents; Dihydroxycholecalciferols; Epidermis; Keratins; Male; Mice; Mice, Hairless; Microscopy, Electron; Ointments; Permeability; Psoriasis; Skin; Time Factors; Water Loss, Insensible

Topics: Administration, Oral; Administration, Topical; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Etretinate; Humans; Keratolytic Agents; Ointments; Psoriasis

Calcipotriene is often used with UVB or PUVA, but interactions between UV radiation and calcipotriene have not been examined extensively.. Our purpose was to examine interactions between calcipotriene and UV light.. Minimal erythema doses (MEDs) were determined with UVB and immediate pigment darkening was measured for UVA. The effect of calcipotriene ointment applied before phototesting was examined. Thick and thin applications of calcipotrience were compared. Calcipotriene ointment was applied to a small area on the skin before phototherapy. Patients received either UVB, PUVA, UVA, or no phototherapy. After phototherapy, the ointment was collected and assayed by reverse-phase, high-performance liquid chromatography.. MEDs for UVB and immediate pigment darkening for UVA were unaffected by calcipotriene. Thick application of calcipotriene, however, increased the MED, UVA caused substantial reductions in the concentration of detectable calcipotriene.. When used in conjunction with PUVA, calcipotriene should be applied after exposure to UVA.

Topics: Calcitriol; Dermatologic Agents; Female; Humans; Male; Psoriasis; PUVA Therapy; Ultraviolet Therapy

Topics: Calcitriol; Dermatologic Agents; Drug Resistance; Female; Humans; Male; Polymorphism, Genetic; Psoriasis; Receptors, Calcitriol

Topics: Animals; Calcitriol; Dermatologic Agents; Dog Diseases; Dogs; Humans; Poisoning; Psoriasis

A woman developed a pruritic exacerbation of her methotrexate-dependent psoriasis after applying topical calcipotriene ointment. Patch test reactions were positive to propylene glycol 1 percent and white petrolatum, but to none of the other ingredients of the medication. Physicians would be advised to patch test patients to both the therapeutic medication and the excipients of topical substances to which patients have adverse reactions. By so doing, an allergic reaction to one or more of the excipients may be found, thus the patient may be provided the benefit of the topical medication by using it in a form that does not contain the allergenic substance.

Topics: Aged; Antioxidants; Calcitriol; Dermatitis, Allergic Contact; Dermatologic Agents; Female; Humans; Methotrexate; Ointments; Patch Tests; Propylene Glycol; Propylene Glycols; Psoriasis

It has been shown that 1,25-dihydroxyvitamin D3 has a photoprotective effect against UVB injury in mouse skin and cultured rat keratinocytes by induction of metallothionein (MT). Calcipotriol is a synthetic analogue of 1,25-dihydroxyvitamin D3 with equipotent cell regulating properties, but with a lower risk of calcium-related side effects. The aim of the present study was to see whether calcipotriol has a photoprotective property both in vitro and in vivo. We examined the effect of calcipotriol on UV-induced damage of cultured human keratinocytes through a cell viability assay, and measurement of DNA synthesis by cultured keratinocytes, on UV-induced damage of mouse skin and on minimal erythema dose (MED). We found that calcipotriol was protective against UVB-induced reduction in DNA synthetic activity of cultured keratinocytes in relatively low doses (20 and 40 mJ/cm2) of UVB. With phototesting following application of calcipotriol, five subjects among 10 healthy volunteers and three among six psoriasis patients showed an increase in MED compared with the vehicle-treated site. These findings imply that calcipotriol may be photoprotective and that more extensive studies with various doses of UV irradiation and modes of calcipotriol delivery are required.

Topics: Administration, Cutaneous; Adult; Animals; Calcitriol; Cell Survival; Cells, Cultured; Dermatologic Agents; DNA; Erythema; Female; Humans; Keratinocytes; Male; Mice; Mice, Inbred ICR; Pharmaceutical Vehicles; Psoriasis; Radiation Dosage; Radiation-Protective Agents; Rats; Skin; Skin Tests; Ultraviolet Rays

Topics: Administration, Topical; Calcitriol; Cross Reactions; Dermatitis, Allergic Contact; Dermatologic Agents; Dihydroxycholecalciferols; Humans; Hypersensitivity, Delayed; Male; Middle Aged; Patch Tests; Psoriasis

Calcipotriol is an effective treatment of chronic plaque psoriasis. We have previously demonstrated that it has a small effect on systemic calcium homeostasis even at recommended doses.. We attempted to determine the mechanism of the effect of calcipotriol on systemic calcium homeostasis so we could assess the possible consequences of long-term use.. Sixteen patients with extensive chronic plaque psoriasis were hospitalized and treated with high-dose topical calcipotriol. Up to 360 gm of calcipotriol (50 micrograms/gm) ointment was applied per week for 2 weeks under controlled conditions.. There was a dose-dependent rise in intestinal absorption of calcium. No effect on bone turnover was demonstrated over this short period. Five patients became hypercalcemic, and there was a dose-dependent rise in serum total adjusted calcium, serum ionized calcium, serum phosphate, urine calcium, and urine phosphate. There was a dose-dependent fall in serum parathyroid hormone and serum 1,25 dihydroxyvitamin D3.. Calcipotriol exerts its effects on systemic calcium homeostasis by increasing intestinal absorption of calcium and probably phosphate. This results in suppression of parathyroid hormone and 1,25 dihydroxyvitamin D3.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Bone and Bones; Calcitriol; Calcium; Chronic Disease; Dermatologic Agents; Dose-Response Relationship, Drug; Female; Homeostasis; Hospitalization; Humans; Hypercalcemia; Intestinal Absorption; Longitudinal Studies; Male; Middle Aged; Ointments; Parathyroid Hormone; Phosphates; Psoriasis

Topics: Adult; Aged; Aged, 80 and over; Calcitriol; Dermatologic Agents; Drug Evaluation; Female; Humans; Male; Middle Aged; Ointments; Psoriasis; Remission Induction

Topics: Artifacts; Calcitriol; Chromatography, High Pressure Liquid; Dermatologic Agents; Humans; Psoriasis; Radioimmunoassay

Topics: Calcitriol; Dermatologic Agents; Filtration; Humans; Ointments; Plastics; Psoriasis; PUVA Therapy; Skin Pigmentation; Sunscreening Agents; Ultraviolet Rays

In this case report a patient with therapeutically recalcitrant erythrodermic psoriasis is presented. After various attempts with several major therapies in this patient, the first substantial improvement was achieved using the combination of cyclosporine and calcipotriol, followed by the combination of UVB and calcipotriol. The therapeutic options for severe psoriasis are discussed, and since combined approaches seem to be an attractive alternative for severe psoriasis, mechanisms of synergy of combined therapeutic approaches are hypothesised.

Topics: Aged; Calcitriol; Combined Modality Therapy; Cyclosporine; Dermatitis, Exfoliative; Dermatologic Agents; Drug Therapy, Combination; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Psoriasis; Ultraviolet Therapy

Topics: Administration, Topical; Aged; Calcitriol; Dermatitis, Irritant; Dermatologic Agents; Drug Eruptions; Humans; Male; Psoriasis; Ultraviolet Therapy

Topics: Adrenal Cortex Hormones; Calcitriol; Cyclosporine; Dermatologic Agents; Humans; Immunosuppressive Agents; Keratolytic Agents; Methotrexate; Psoriasis; PUVA Therapy; Retinoids

Electron microscopic details in psoriatic skin during calcipotriol application are reported. Ten psoriatic patients (PASI score 3-14) were punch-biopsied on typical lesions before treatment and 2, 4 and 8 weeks after it. Two patients dropped out after 1 month because of lack of clinical response. Skin blocks were processed routinely for transmission electron microscopy and freeze-fracture techniques. The first modifications were the disappearance of fine intercellular granular material and the restoration of the granular layer. After 4 weeks desmosomes appeared in greater amounts than at baseline. Horny layer lipid vacuoles and remnants of nuclei as well as multilayering of the basal lamina were only focally observed. Dilatation of dermal capillaries was still seen even after 8 weeks. Freeze-fracture confirmed the data about the desmosomes and revealed a marked decrease of the gap junctions. Calcipotriol basically seems to act similarly to other antipsoriatic agents, though faster. The persistence of microvasculature dilatation could imply the need for long-term therapy.

Topics: Adult; Aged; Biopsy; Calcitriol; Dermatologic Agents; Freeze Fracturing; Humans; Microscopy, Electron; Middle Aged; Psoriasis; Skin; Time Factors

Topics: Animals; Calcitriol; Dermatologic Agents; Humans; Psoriasis; Rats; Skin

Topics: Calcitriol; Cholecalciferol; Dermatologic Agents; Humans; Psoriasis

Topics: Calcitriol; Calcium; Dermatologic Agents; Drug Eruptions; Humans; Psoriasis

Ultraviolet B phototherapy is an effective agent for the treatment of psoriasis; its most frequent acute side effect is burning of the skin. It has been combined with various other topical or systemic agents to augment therapeutic effect. Recently, UV-B therapy has been used with calcipotriene ointment (Dovonex, Westwood-Squibb, Buffalo, NY), a new vitamin D analogue.. We report four cases of chronic plaque psoriasis that developed in patients who used UV-B phototherapy for a substantial period without ill effects and in whom photosensitivity reactions within psoriatic plaques developed after calcipotriene ointment was added, without changes in their UV-B dosage or frequency of treatment. The time from starting calcipotriene therapy to the development of photosensitivity ranged from 4 to 28 days, and the number of UV-B exposures during this period varied between one and 12 treatments. The mean UV-B dose at burning was 1114mJ/cm2. Twenty-two patients had used calcipotriene in combination with UV-B therapy of a total of 103 UV-B-treated patients during the period when the adverse events occurred. Half these patients started calcipotriene therapy prior to starting treatment with UV-B. However, cases of photosensitivity occurred only in the remaining half of the patients in whom calcipotriene therapy was added during UV-B therapy. Combined therapy was able to be continued or resumed in two patients by reduction of the UV-B dose. In three cases, phototesting, confirmed greater photosensitivity to calcipotriene-treated skin than to skin to which hydrated petrolatum was applied.. Calcipotriene ointment should be introduced with caution in patients already receiving UV-B phototherapy, particularly those receiving high doses of UV-B. The mechanism of this photosensitivity reaction is unknown. This increased sensitivity to UV-B may be a result of the effect of calcipotriene on stratum corneum thickness, epidermal melanization, a result of its effect on the inflammatory reaction to UV-B irradiation, or, possibly, because it is a phototoxic agent.

Topics: Adult; Aged; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Humans; Incidence; Male; Middle Aged; Photosensitivity Disorders; Psoriasis; Ultraviolet Therapy

Topics: Calcitriol; Dermatologic Agents; Humans; Psoriasis

Topics: Calcitriol; Clinical Trials as Topic; Dermatologic Agents; Humans; Psoriasis

The vitamin D3 derivative calcipotriol (Daivonex) is an efficient topical treatment of psoriasis. When applied at a dose of about 25 g/week over a mean body surface of 16%, it is not associated with any detectable change in calcium metabolism.. Our purposes were (i) to analyze the effects of calcipotriol on various parameters of calcium metabolism when applied on a large body surface and (ii) to evaluate the usefulness of an oral calcium tolerance test in monitoring psoriatic patients under topical calcipotriol.. In group 1, 10 patients with psoriasis affecting 67.0 +/- 2.7% of total body surface (range 55-80%) were treated with calcipotriol for 6.5 weeks (mean 383 g/month). In group 2, 19 patients with psoriasis involving 15% of body surface were treated with calcipotriol for 9 weeks (mean 105 g/month). In group 3, 7 patients without topical calcipotriol for at least 1 week were given 1.5 micrograms of oral calcitriol for 7 days. An extended survey of blood and urinary parameters of calcium metabolism was performed before and after 45 days of treatment (group 1). Since one of the actions of vitamin D is to stimulate intestinal calcium absorption, an oral calcium-loading test (groups 1, 2 and 3) was done in order to detect more subtle changes possibly induced by calcipotriol.. We did not detect any significant change in various parameters of calcium metabolism in group 1 (large body surface treated) patients. The urinary calcium responses to the oral calcium load were identical to controls in both group 1 (large body surface treated) and group 2 (limited body surface treated), whereas in group 3 (oral calcitriol therapy) an increased urinary calcium response to the calcium load was identified.. No significant changes in calcium metabolism were detectable when calcipotriol was administered once a day over a large body surface with doses up to 100 g/week. The oral calcium tolerance test appears to be a cheap, simple and sensitive test to monitor patients exposed to high doses of calcipotriol as it detects increased intestinal calcium absorption induced by 1.5 micrograms of oral calcitriol.

Topics: Administration, Topical; Adult; Aged; Calcitriol; Calcium; Dermatologic Agents; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Psoriasis; Sensitivity and Specificity

Calcipotriol is a synthetic analogue of vitamin D, used in the treatment of psoriasis. Until now no specific sid-effects have been described after combined therapy with calcipotriol and UV. We describe 3 patients, who in the summer of 1993, after a combined treatment of calcipotriol and heliotherapy, developed hyperpigmentation in the site where the ointment had been applied. Hyperpigmentation healed spontaneously in less than 7 months. To the best of our knowledge there are no other reports of this side-effect due to calcipotriol. In our opinion the fact that the 3 patients presented the hyperpigmentation only on the treated lesions and that, in the past, they had not presented similar lesions after exposure to sunlight confirms the relationship between the hyperpigmentation and the combined treatment used.

Topics: Adult; Aged; Calcitriol; Combined Modality Therapy; Dermatologic Agents; Female; Heliotherapy; Humans; Hyperpigmentation; Male; Middle Aged; Psoriasis

It is well known that UVB therapy of psoriasis vulgaris is potentiated by the association with topical and oral drugs, while till now there have been very few reports on the association between UVB and calcipotriol. In order to evaluate the efficacy and tolerance of this association, we studied 19 patients with psoriasis vulgaris of mild severity (PASI: 5-10). Each patient was treated with UVB and invited to apply calcipotriol 50 micrograms/g ointment twice a day on one lesion usually on elbows or knees in order to compare it with the opposite side. The evaluation of each lesion was performed before and after 4 weeks of therapy. Our data show that the association between UVB and calcipotriol is significantly more effective than UVB therapy alone: 17 out of 19 patients (89%) showed a greater improvement with UVB plus calcipotriol as compared to UVB alone.

Topics: Adult; Aged; Calcitriol; Dermatologic Agents; Drug Tolerance; Female; Follow-Up Studies; Humans; Male; Middle Aged; Photochemotherapy; Psoriasis; Ultraviolet Therapy

Topics: Calcitriol; Case-Control Studies; Dermatitis, Allergic Contact; Dermatologic Agents; Drug Eruptions; Humans; Male; Middle Aged; Psoriasis

The aim of the present study was to investigate the distribution of Langerhans cells and T cells in the lesions and also the phenotypic expression of markers of activation on lesional T cells and keratinocytes, before and after 2 weeks of topical treatment of 7 psoriatic patients with calcipotriol. Before treatment, the infiltrate was composed mainly of T cells and there was decreased expression of CD1 on the intra-epidermal Langerhans cells. ICAM-1 and EGF receptor were present throughout the epidermis, but keratinocytes expressing Transferrin receptor were detected only in the basal layer. After 14 days of calcipotriol therapy, there were significantly fewer CD4T cells in the dermis and an increased number of intraepidermal CD1 + Langerhans cells. ICAM-1 expression on lesional keratinocytes was reduced in all patients, but the expression of EGF receptor was decreased in 3 patients only, and Transferrin receptor expression on keratinocytes had not changed. All these changes were concurrent with moderate clinical improvement of the lesions. The results suggest that in the early stages of the clinical response to calcipotriol there is an immunomodulating effect of the drug associated with variable decreases in keratinocyte expression of markers of activation.

Topics: Administration, Topical; Adult; Calcitriol; Cell Adhesion Molecules; Dermatologic Agents; Epidermal Growth Factor; HLA-DR Antigens; Humans; Immunohistochemistry; Intercellular Adhesion Molecule-1; Keratinocytes; Langerhans Cells; Middle Aged; Ointments; Psoriasis; Skin; T-Lymphocyte Subsets

Topics: Administration, Topical; Adolescent; Calcitriol; Dermatitis, Allergic Contact; Dermatologic Agents; Female; Humans; Psoriasis

Topics: Calcitriol; Calcium; Dermatologic Agents; Female; Humans; Middle Aged; Psoriasis

Calcipotriol is a vitamin D analogue which is an effective topical treatment for chronic plaque psoriasis. It has been reported to have no effect on systemic calcium homeostasis provided the manufacturer's guidelines are adhered to (maximum 100 g of calcipotriol ointment (50 micrograms/g) per week). However, there have been reports of hypercalcaemia in patients using topical calcipotriol even at recommended doses. The purpose of this study was to investigate the effects of topical calcipotriol in vivo using the recently developed 'intact' PTH assay as a more sensitive index of systemic calcium homeostasis.. Seven patients with extensive psoriasis were recruited for the study. Each patient was admitted to hospital and applied 200 g of calcipotriol (50 micrograms/g) ointment over the first week followed by 300 g over the second week. In the third week of treatment, patients were treated with 2% crude coal tar which served as a biochemical washout phase.. Serum total adjusted calcium was measured at baseline and three times a week during the study. Twenty-four-hour urinary calcium excretion was measured at baseline and twice a week throughout the study. Peak (0400 h) and trough (0900 h) PTH levels were measured at baseline and at the ends of weeks 2 and 3.. Serum PTH levels were reduced in every patient after 2 weeks' treatment with calcipotriol and rose after withdrawal. Mean 0400 h PTH fell by 2.58 pmol/l (95% confidence interval 1.45-3.70) from 5.11 to 2.53 pmol/l (P < 0.01) and mean 0900 h PTH fell by 2.08 pmol/l (0.84-3.36) from 4.04 to 1.96 pmol/l (P < 0.01). Mean serum and urine calcium rose during treatment with calcipotriol and fell after withdrawal. Mean adjusted total calcium rose by 0.14 mmol/l (95% confidence interval 0.10-0.16) from 2.25 to 2.39 mmol/l (P < 0.01). Mean 24 hour urine calcium excretion rose by 2.09 mmol/24 h (0.51-3.26) from 3.40 to 5.49 mmol/24 h (P < 0.05). No patient developed hypercalcaemia at any stage of the study although hypercalcaemia was recorded transiently in three patients.. Topical calcipotriol is likely to have a dose dependent effect on systemic calcium homeostasis.

Topics: Administration, Cutaneous; Adult; Aged; Calcitriol; Calcium; Dermatologic Agents; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Parathyroid Hormone; Psoriasis

Topics: Aged; Calcitriol; Female; Humans; Hypercalcemia; Psoriasis

Topics: Adult; Calcitriol; Dermatitis, Allergic Contact; Dermatologic Agents; Drug Eruptions; Female; Humans; Leg Dermatoses; Patch Tests; Psoriasis

Topics: Calcitriol; Clinical Trials as Topic; Dermatologic Agents; Humans; Ointments; Psoriasis

Recent research has demonstrated the activity of calcipotriol, effective as a potent inhibitor of cellular proliferation and known to increase differentiation in a number of cell lines in the topical treatment of psoriasis. Vit D3 receptors are expressed in keratinocytes and vascular endothelial cells. We studied the alterations in basal keratinocytes (stem cells or anchoring cells) and endothelial cell modification in 6 patients with psoriasis treated with calcipotriol ointment twice a day for 4 weeks. The samples were embedded in Epon resin for thin section and ultrathin section examination by electron microscopy. A normal pattern of distribution of the two different types of basal keratinocytes was observed before treatment. After treatment, only anchoring cells were detected. The alterations of endothelial cells in capillary loop disappeared after treatment, presenting normal aspects. Our morphological findings suggest that calcipotriol is therapeutically effective, due principally to an inhibition of cellular proliferation.

Topics: Calcitriol; Capillaries; Dermatologic Agents; Endothelium, Vascular; Humans; Keratinocytes; Psoriasis; Skin

Calcipotriol is demonstrably efficacious for the treatment of psoriasis by virtue of its effects on the skin's immune system and on epidermal growth. We performed this study to emphasize the difference in the expression of certain cell adhesion molecules (CAMs) (ICAM-1, ELAM-1, LFA-1, VLA-3, VLA-6) in lesional and perilesional skin of 10 patients with psoriasis, before and after treatment with topical Calcipotriol. We took two biopsies of lesional and perilesional skin from each patient before and after treatment and then performed an immunohistochemical study to observe the expression of these CAMs, utilizing monoclonal antibodies against these adhesion molecules. We noticed reduced levels of infiltrating cells along with the expression of ICAM-1, LFA-1, ELAM-1 and of CAMs VLA-3, VLA-6 in basal and suprabasal keratinocytes. On the basis of these data we hypothesize that, besides epidermal keratinocytes, another target for Calcipotriol may be the skin's own immune system, suggesting that Calcipotriol can modify T lymphocyte activity (IL-1 dependent) through a down-regulation of CAMs.

Topics: Administration, Topical; Adult; Calcitriol; Cell Adhesion Molecules; Dermatologic Agents; Down-Regulation; Female; Humans; Male; Middle Aged; Psoriasis; Skin

Interleukin-8 is assumed to play a central role in the pathogenesis of psoriasis. Since an increased expression of the interleukin-8 receptor has been observed both in polymorphonuclear leukocytes and in affected psoriatic epidermis, we were interested in whether the interleukin-8 receptor could be a molecular target of antipsoriatic compounds. Cyclosporine, calcitriol, calcipotriol or dithranol caused a dose-dependent decrease in interleukin-8 binding to cultured human keratinocytes, while interleukin-8 binding to granulocytes was not affected. In addition, the interleukin-8-induced human leukocyte antigen-DR (HLA-DR) expression of keratinocytes was nearly completely blocked by treatment of the cells with these substances. The inhibition of the keratinocyte interleukin-8 receptor and its function by antipsoriatic drugs may contribute to their therapeutic action.

Topics: Anthralin; Calcitriol; Cells, Cultured; Cyclosporine; Flow Cytometry; HLA-DR Antigens; Humans; Interleukin-8; Keratinocytes; Neutrophils; Psoriasis; Receptors, Interleukin; Receptors, Interleukin-8A; Recombinant Proteins

Calcipotriol (MC903) is a side chain analog of the vitamin D hormone calcitriol, containing a 22-23 double bond, a 24(S)-hydroxyl function, and carbons 25, 26, and 27 incorporated into a cyclopropane ring which has been developed for treating psoriasis. The in vitro metabolism of calcipotriol was studied in two keratinocyte cell models, HPK1A and HPK1A-ras. Calcipotriol was initially converted into the 24-ketone (MC1046) and its 22,23-hydrogenated derivative (MC1080), metabolites observed in osteosarcoma, kidney, and hepatoma cell lines. We also observed the formation of further metabolites, identified as the two 23-hydroxylated derivatives of MC1080 (MC1439 and MC1441), the two 23,24-dihydroxylated compounds (MC1575 and 1577), and the side chain-cleaved compounds, tetranor-1,23-(OH)2D3 and calcitroic acid, the end products of catabolism of calcitriol. These findings suggest that calcitriol and calcipotriol may share catabolic enzymes. The biological activity of each of the principal metabolites of calcipotriol, assessed using a growth hormone reporter gene transcriptional activation system and a vitamin D receptor assay, was found to be lower than that of calcipotriol. If the extensive in vitro metabolism of calcipotriol is also found in normal and psoriatic keratinocytes in vivo, then this may explain the lack of systemic calcemic activity of topically applied drug.

Topics: Animals; Biotransformation; Calcitriol; Cell Line; Cell Line, Transformed; Chromatography, High Pressure Liquid; Dermatologic Agents; Gas Chromatography-Mass Spectrometry; Genes, ras; Humans; Keratinocytes; Molecular Structure; Psoriasis; Structure-Activity Relationship; Tumor Cells, Cultured

Topics: Anthralin; Calcitriol; Coal Tar; Cyclosporins; Humans; Methotrexate; Phototherapy; Psoriasis; Retinoids

In the human hair follicle, outer root sheath (ORS) cells constitutively express the hyperproliferation-associated keratins 6, 16 and 17 instead of keratins 1 and 10 found in interfollicular epidermis. In organotypic cultures. ORS cells form a stratified epithelium which in many respects resembles psoriatic skin: it has a hyperplastic tissue architecture and a poorly developed granular layer, and expresses hyperproliferation-associated keratins. Therefore, we studied the effects of the antipsoriatic compounds 1 alpha,25-dihydroxy-vitamin D3 (1 alpha,25-(OH)2-D3) and its synthetic derivative calcipotriol on cultured ORS cells. In monolayer cultures, 10(-6) M 1 alpha,25-(OH)2-D3 or calcipotriol completely blocked ORS cell proliferation. This inhibitory effect was substantially reduced at 10(-8) M. Incubation of organotypic ORS cultures with both vitamin D analogues resulted in a marked thinning of the living cell compartment concomitant with a thickening of the horny layer. A reduced expression of differentiation markers such as keratins 10, 16 and 17, involucrin and filaggrin paralleled the thinning of the stratum Malpighi. As determined by quantification of BrdU-positive cells, ORS cell proliferation was apparently not affected by the vitamin D analogues, indicating that these compounds mainly operate by accelerating the differentiation pathway within the suprabasal living cell compartment. No alteration in the expression of the alpha 6- and beta 1-integrin chains was found.

Topics: Adult; Calcitriol; Cell Differentiation; Cell Division; Dermatologic Agents; Filaggrin Proteins; Hair; Humans; Keratins; Models, Biological; Organ Culture Techniques; Psoriasis

Urine calcium excretion is a very sensitive method of detecting vitamin D intoxication, and may rise in the absence of any apparent change in the serum level. Little attention has been paid to urine calcium levels during the large trials performed to assess the efficacy and safety of calcipotriol in psoriasis vulgaris. There are some urine calcium data from short-term studies of average dose rates of calcipotriol. However, there are no published data on long-term usage, nor on the use of dose rates at the upper end of the licensed range (100 g/week). In a group of 20 patients, who were using typical quantities of calcipotriol ointment (50 micrograms/g) to treat psoriasis vulgaris, urine calcium excretion was measured prior to treatment, and then monthly for 12 months. There was no significant change in urine calcium over the year. In a separate group of 10 patients, who were using calcipotriol in the same concentration, at the maximum recommended rate of 100 g/week, urine calcium was measured at baseline, and after 2 and 4 weeks. There was a statistically significant rise in calcium excretion. This is the first trial to demonstrate that topical calcipotriol affects calcium homeostasis when used within the recommended dose range. Further studies are necessary to determine more precisely the magnitude and variability of this effect in a large group of individuals. For the present, caution is required when prescribing calcipotriol for any patient with known hypercalciuria or a history of renal stone formation. Consideration should be given to monitoring urine calcium excretion during prolonged use at dose rates approaching the recommended maximum.

Topics: Administration, Topical; Adolescent; Adult; Calcitriol; Calcium; Dermatologic Agents; Female; Humans; Male; Psoriasis; Time Factors

Topics: Calcitriol; Dermatologic Agents; Humans; Psoriasis

A new topical treatment for psoriasis was introduced in 1992 when the vitamin D analogue calcipotriol was registered in Norway. This is a new therapeutic principle for psoriasis. Calcipotriol induces differentiation and inhibits proliferation of the keratinocytes. Application twice daily for 6-8 weeks gives a 60-70% improvement in plaque type psoriasis. No serious side effects have been reported when using up to 100 grams of the ointment weekly.

Topics: Administration, Topical; Calcitriol; Dermatologic Agents; Humans; Psoriasis

Numerous clinical studies have demonstrated the efficacy of calcipotriol, a synthetic vitamin D3 analogue, in the treatment of mild to moderate chronic psoriasis.. Report on clinical experience of 40 psoriasis patients treated with calcipotriol, alone or in combination with phototherapy.. After four weeks of treatment, the condition had largely cleared up in eleven out of 18 patients (61%) receiving calcipotriol alone, and in 20 out of 22 patients (91%) receiving combination treatment with UVB or UVA plus UVB. The new anti-psoriasis agent was well tolerated and readily accepted by the patients.. Calcipotriol represents a valuable addition to the available therapy spectrum in chronic psoriasis.

Topics: Administration, Topical; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Humans; Psoriasis; PUVA Therapy

Ten patients with extensive plaque psoriasis were treated with calcipotriol ointment (50 micrograms/g) for 2 weeks (200 g for 1 week, followed by 300 g during the second week). Mean improvement in psoriasis area and severity index (PASI) was 71%. Mean 24 h urine calcium rose from 4.79 mmol/24 h to 7.27 mmol/24 h (P < 0.0001). Urine calcium returned towards baseline after stopping calcipotriol. Mean serum calcium also rose slightly, but significantly, from 2.26 mmol/l to 2.32 mmol/l (P < 0.005), and fell again in the washout phase. Individual serum calcium values remained within the normal range throughout the study. Topical calcipotriol is an effective, rapidly acting and safe in-patient treatment for extensive plaque psoriasis.

Topics: Administration, Topical; Calcitriol; Calcium; Chronic Disease; Dermatologic Agents; Drug Administration Schedule; Humans; Psoriasis; Severity of Illness Index

Topics: Calcitriol; Dermatologic Agents; Humans; Psoriasis; Vitamin D

The efficacy of 1,25-dihydroxyvitamin D3 [1,25(OH)2D3] and the new analogue calcipotriene (MC 903) in the treatment of psoriasis was investigated. Eight patients with psoriasis were enrolled in a pilot study with systemically administered vitamin D3 and were given 1,25(OH)2D3 (Rocaltrol; Hoffmann-La Roche) in dosages from 0.5 microgram to 2 micrograms/day for a 6-month trial. In one patient, the psoriatic plaques resolved within 2 months after treatment (0.5 microgram/day) was initiated. Moderate improvement was noted in one other patient (1 microgram/day). The serum level of 1,25(OH)2D before treatment was not less than the normal range of the adult population. Side effects of systemically administered 1,25(OH)2D3 included a dose-dependent increase in the 24-hour urinary calcium excretion and a decrease in the total number of platelets. Seven patients with symmetric plaque-type psoriasis were treated topically with 2 micrograms/g of 1,25(OH)2D3 in petrolatum. During 3 months of follow-up, mild improvement was noted in three patients. Five patients in the calcipotriene study were part of a nationwide double-blind placebo-controlled trial by Bristol-Myers Squibb. Moderate to marked improvement was noted in the two patients who received 50 micrograms/g of calcipotriene topically. The three patients who received placebo showed no response. We conclude that a subset of patients with psoriasis responds well to 1,25(OH)2D3. Calcipotriene is efficacious and an excellent alternative to topically applied corticosteroids.

Topics: Administration, Oral; Administration, Topical; Adult; Aged; Calcitriol; Cholecalciferol; Dermatologic Agents; Female; Humans; Male; Middle Aged; Pilot Projects; Psoriasis

Topics: Administration, Topical; Calcitriol; Dermatologic Agents; Humans; Hypercalcemia; Psoriasis

Topics: Administration, Topical; Calcitriol; Dermatologic Agents; Humans; Psoriasis

Topics: Administration, Topical; Aged; Aged, 80 and over; Calcitriol; Dermatologic Agents; Female; Humans; Psoriasis

We report the case of a 28-year-old homosexual man with advanced HIV disease (CDC classification group IV A) who developed erythrodermic psoriasis which responded to calcipotriol, a topical vitamin D analogue. We believe this to be the first reported case of HIV-related psoriasis responsive to this form of treatment. Systemic therapy for HIV-related psoriasis is limited because of immunosuppressive effects. We suggest that calcipotriol may prove to be a useful therapeutic option in these patients.

Topics: Adult; Calcitriol; Dermatologic Agents; HIV Infections; Humans; Male; Psoriasis

Topics: Betamethasone Valerate; Calcitriol; Humans; Psoriasis

Topics: Calcitriol; Dermatologic Agents; Humans; Multicenter Studies as Topic; Ointments; Psoriasis

Topics: Calcitriol; Dermatitis, Contact; Female; Humans; Middle Aged; Patch Tests; Psoriasis

Topics: Calcitriol; Humans; Psoriasis

Topics: Calcitriol; Calcium; Humans; Hypercalcemia; Occlusive Dressings; Ointments; Psoriasis

Topics: Calcitriol; Humans; Psoriasis

Topics: Aged; Calcitriol; Female; Humans; Hypercalcemia; Psoriasis

Topics: Anthralin; Antibodies, Monoclonal; Biomarkers; Calcitriol; Frozen Sections; Gene Expression; Humans; Immunohistochemistry; Keratins; Psoriasis; Skin

The analogue of calcitriol, calcipotriol (MC 903, Daivonex) has been proven effective in the treatment of psoriasis, when given topically. However, the possible influence of cutaneously absorbed MC 903 on calcium metabolism is still unclear. We evaluated various parameters of calcium metabolism in 17 psoriatic patients treated for 5.4 +/- 2.3 (mean +/- SD) weeks with MC 903, on 16 +/- 6% of the body surface. The dose administered (100 g of Daivonex corresponding to 5 mg of MC 903) decreased the PASI score by 40.9 +/- 20.0% (p less than 0.001). Among these patients, 12 were studied before and after MC 903 therapy. In none could be detected any change in protein-adjusted calcium, ionized Ca, plasma levels of creatinine, alkaline phosphatase, osteocalcin, intact parathyroid hormone (PTH), calcidiol and calcitriol, or in daily or fasting urinary excretion of Ca or cAMP. After an MC-903-free period, 9 patients received 1.5 micrograms/day of calcitriol orally for 7 days. Whereas this treatment did not control the skin relapse in most of the patients, it induced a significant increase in plasma levels of protein-adjusted Ca and calcitriol, and in 24-hour urinary Ca excretion, as well as a significant fall in PTH as compared with pretreatment values. These results indicate that 150 micrograms/day of MC 903, despite a possible 1% absorption, i.e. a systemic dose of 1.5 micrograms, did not produce any detectable alteration of Ca metabolism, whereas an equivalent dose of oral calcitriol was associated with significant changes. The threshold dose of topical calcipotriol that might induce alterations similar to 1.5 micrograms/day of oral calcitriol remains to be evaluated.

Topics: Administration, Oral; Administration, Topical; Adolescent; Adult; Calcitriol; Calcium; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Psoriasis; Time Factors

Topics: Acute Disease; Administration, Cutaneous; Aged; Calcitriol; Dermatitis, Contact; Female; Humans; Patch Tests; Psoriasis; Recurrence

Topics: Administration, Topical; Calcitriol; Psoriasis

Topics: Calcitriol; Humans; Pharmaceutical Vehicles; Psoriasis; Time Factors