clobetasol and Psoriasis

Discordance between patient and clinician treatment goals and expectations can present a challenge to implementation of effective therapeutic plans. Because topical treatments are commonly used for plaque psoriasis, both as monotherapy and adjuncts to other treatment modalities, providers need to understand the concerns of patients with psoriasis regarding use of topical products. Psoriasis is a complex and chronic disease with treatment needs that may change over time, influencing patient treatment goals and expectations of efficacy. When these expectations are not met and patient concerns are unaddressed, dissatisfaction may lead to nonadherence, which in turn can prevent patients from achieving relief from the signs and symptoms of psoriasis that affect their quality of life. Here, we detail how current topical treatments meet patient expectations and needs, with particular attention given to combination regimens using corticosteroids. This review shows that once-daily application of halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) not only has a rapid onset of treatment effect and proven efficacy, but also has a remittive effect. In addition, HP/TAZ has a favorable safety profile, with low rates of irritation and local skin reactions in clinical studies. The dual mechanisms of action related to 2 active ingredients, once-daily use, and the favorable clinical findings suggest that HP/TAZ may address patient concerns and promote treatment adherence.J Drugs Dermatol. 2023;22(2):132-138. doi:10.36849/JDD.7367.

Topics: Clobetasol; Dermatologic Agents; Drug Combinations; Emollients; Emulsions; Humans; Motivation; Nicotinic Acids; Psoriasis; Quality of Life; Severity of Illness Index; Skin Cream; Treatment Outcome

Halobetasol propionate foam has been established as an efficacious and easy-to-use topical treatment for adults with plaque psoriasis. Its recent approval in the United States expanded its use for adolescents from ages 12 to 17 years old.. We briefly summarize the chemistry of halobetasol and review clinical trials involving halobetasol propionate 0.05% foam to evaluate its efficacy and safety profile with a specific focus on adolescents with plaque psoriasis.. Halobetasol propionate 0.05% foam is an effective and cosmetically elegant superpotent topical corticosteroid, with a tolerable safety profile in adolescents. The use of this foam offers another option to address patient-specific needs and preferences, adding to the toolbox of currently available treatments for adolescent psoriasis.

Topics: Adolescent; Adult; Child; Clobetasol; Dermatologic Agents; Double-Blind Method; Glucocorticoids; Humans; Psoriasis; Severity of Illness Index; Treatment Outcome; United States

The use of superpotent topical corticosteroids (TCSs) for the treatment of psoriasis is widely practiced, especially for expedient lesion resolution. However, their continued use in managing this chronic condition is limited because of labelling restrictions, concerns of side effects, and a paucity of data to support long-term management strategies. Halobetasol propionate (HP) is an effective short-term superpotent TCS. A novel HP lotion 0.01% formulation has been developed using a polymeric matrix technology that allows for uniform delivery of optimally sized particles onto the skin surface. The polymeric matrix and emulsion help to keep the skin hydrated and provide more efficient delivery of halobetasol into the epidermis.

Topics: Administration, Cutaneous; Clobetasol; Humans; Psoriasis; Treatment Outcome; Vasoconstrictor Agents

Topical corticosteroids (TCS) are the mainstay of psoriasis treatment. Safety concerns may limit use. Combination with tazarotene may optimize efficacy and minimize safety and tolerability concerns.. Investigate safety and efficacy of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis.. Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=418). Subjects randomized (2:1) to HP/TAZ lotion or vehicle once-daily for 8 weeks, 4-week follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in IGA score and 'clear' or 'almost clear'). Safety and treatment emergent AEs evaluated throughout.. HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as week 2 (P equals 0.002). By week 8, 40.6% of subjects were treatment successes compared with 9.9% on vehicle (P less than 0.001). A third of subjects remained treatment successes post-treatment. HP/TAZ lotion was also superior in reducing psoriasis signs and symptoms, and Body Surface Area (BSA) involvement. Most frequently reported treatment related AEs were contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%).. No data were collected beyond the 4-week follow-up.. HP/TAZ lotion provides synergistic efficacy that is both rapid and sustained, with good tolerability and safety over 8 weeks use. J Drugs Dermatol. 2018;17(8):855-861.

Topics: Clinical Trials, Phase III as Topic; Clobetasol; Dermatitis; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Multicenter Studies as Topic; Nicotinic Acids; Pain; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Skin Cream; Treatment Outcome

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

Despite the common prevalence of cutaneous psoriasis, the existence of manifestations in the oral cavity is subject to controversy. In this article, dermatologic psoriasis is reviewed, and a patient with generalized, symptomatic oral mucosal erythema resembling atrophic candidiasis synchronous with flare of chronic skin psoriasis is described. Diagnostic work up and therapeutic response supported that these mucosal findings were the oral counterpart of cutaneous disease. Dental providers should be familiar with the signs and symptoms of oral psoriasis, institute appropriate preventive measures, and provide palliation directed at symptomatic oral changes of psoriasis.

Topics: Aged; Anti-Inflammatory Agents; Clobetasol; Diagnosis, Differential; Female; Humans; Mouth Diseases; Psoriasis

Clobetasol 0.05% spray, a topical clobetasol propionate, is a non-greasy formulation that has shown increased clinical efficacy in a head-to-head comparison with foam formulation. Moreover, available data from randomized, controlled, double-blind trials suggests that clobetasol spray is, in fact, slightly more effective than most, if not all, other preparations of clobetasol. The fact that clobetasol spray is exceptionally easy to comply with may have played a major role in this outcome; however, other factors must be considered. These include vehicle metamorphosis post-application as well as vehicle and excipient effects on stratum corneum permeability. Basic concepts in topical drug delivery and how they apply to this spray vehicle may further explain the greater efficacy of clobetasol spray.

Topics: Anti-Inflammatory Agents; Chemistry, Pharmaceutical; Clobetasol; Humans; Medication Adherence; Pharmaceutical Vehicles; Psoriasis; Skin Absorption

Clobetasol propionate is a super-high potent class 1 topical corticosteroid available in several formulations, including a spray formulation that is approved for use up to 4 weeks in patients aged 18 years and older with moderate to severe plaque psoriasis. The efficacy and safety of clobetasol propionate spray 0.05% has been extensively evaluated in clinical trials in more than 2200 patients with moderate to severe plaque psoriasis. This article reviews the efficacy, safety, and tolerability of clobetasol propionate spray 0.05%. Clobetasol propionate spray 0.05% is a topical product with a documented efficacy and safety profile with good acceptability in patients with moderate to severe plaque psoriasis.

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Clobetasol; Humans; Patient Satisfaction; Psoriasis; Severity of Illness Index; Treatment Outcome

Psoriasis causes significant distress and impairment in health-related quality of life (QOL) in afflicted patients. For this reason, QOL is an essential and important measure of treatment outcome in patients with the disease. Clobetasol propionate is a super-highpotent class I topical corticosteroid. The spray formulation is approved for twice-daily use for up to 4 weeks by patients 18 years and older with moderate to severe plaque psoriasis. Data collected from 2,236 patients enrolled in 5 clinical trials demonstrate consistent improvement in QOL measures using multiple instruments. In a randomized, double-blind trial in patients with scalp psoriasis, treatment with clobetasol propionate 0.05% spray produced significantly greater improvement in QOL compared with vehicle, as measured by the Scalpdex QOL instrument. In another randomized trial in patients with moderate to severe plaque psoriasis, clobetasol propionate 0.05% spray produced significantly greater reductions in mean affected body surface area and significantly greater improvements in QOL, as measured by the Dermatology Life Quality Index (DLQI), compared with a 0.05% foam formulation. When compared with calcipotriene/betamethasone dipropionate ointment, clobetasol propionate 0.05% spray produced greater rates of lesion clearance and similar improvement in QOL scores after 2 or 4 weeks of treatment. When clobetasol propionate 0.05% spray was used as monotherapy or as an add-on therapy for 4 weeks in a large, observational trial, approximately 80% of patients experienced consistent and significant improvement in QOL on 2 separate, validated QOL instruments (DLQI and the Koo-Menter Psoriasis Index). In conclusion, clobetasol propionate 0.05% spray is an efficacious and safe treatment for plaque psoriasis and produces significant improvement in QOL for affected patients.

Topics: Administration, Cutaneous; Betamethasone; Calcitriol; Clobetasol; Drug Combinations; Glucocorticoids; Humans; Psoriasis; Quality of Life; Randomized Controlled Trials as Topic; Scalp; Severity of Illness Index; Treatment Outcome

Topics: Adjuvants, Immunologic; Aged; Aminoquinolines; Anti-Inflammatory Agents; Biopsy; Clobetasol; Humans; Imiquimod; Keratosis, Actinic; Male; Psoriasis; Treatment Outcome; Ultraviolet Therapy

Psoriasis is a chronic immune-mediated disease that appears on the skin. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis is typically a lifelong condition. There is currently no cure, but various treatments can help to control the symptoms. Activated vitamin D3 is the first-line treatment for psoriasis. Psoriasis is often treated with combination therapy of activated vitamin D3 and other treatment. Depending on the severity and location of outbreaks, individuals may experience significant physical discomfort and some disability. Thus, the goal for the treatment of psoriasis is to control the signs and symptoms over a long period and to ameliorate the quality of life of psoriasis patients.

Topics: Administration, Topical; Cholecalciferol; Clobetasol; Dendritic Cells; Drug Therapy, Combination; Humans; Interleukin-23; Nitric Oxide Synthase Type II; Psoriasis; Quality of Life; Retinoids; Th17 Cells; Tumor Necrosis Factor-alpha

Acrodermatitis continua of Hallopeau (ACH) is a rare acropustular eruption, characterized by sterile pustules, paronychia and atrophic skin changes, onychodystrophy and osteolysis of the distal phalanges of the fingers and toes. It is considered to be a variant of pustular psoriasis with a chronic relapsing course and frequent refractoriness to many therapeutic modalities, which can be amenable to successful treatment by tumor necrosis factor alpha antagonists. We report 1 patient with pustular psoriasis and ACH whom we have treated successfully with etanercept (for 30 months) and then adalimumab (for 13 months and ongoing). Blanching was initially achieved with etanercept 50 mg twice a week, but suppression of periungual inflammation then required combination therapy with etanercept 50 mg twice a week and methotrexate 10 mg weekly; lower doses of both drugs did not allow complete control of the disease. Eventually, adalimumab 40 mg every 2 weeks has provided the most cost-effective response in this patient, allowing maintenance of response with partial nail regrowth under monotherapy.

Topics: Acitretin; Acrodermatitis; Adalimumab; Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Betamethasone; Clobetasol; Cyclosporine; Drug Therapy, Combination; Etanercept; Female; Humans; Immunoglobulin G; Methotrexate; Mycophenolic Acid; Nails; Paronychia; Psoriasis; Receptors, Tumor Necrosis Factor; Tumor Necrosis Factor Inhibitors

Psoriasis is a chronic, debilitating disease that commonly involves the scalp. Despite a wide range of therapy options, scalp psoriasis remains difficult to treat, highlighting a long-standing unmet need for the safe and effective treatment of scalp psoriasis. Many topical therapies for scalp psoriasis are also difficult or unpleasant to apply, resulting in decreased adherence and efficacy. In brief, the high level of patient dissatisfaction with currently available treatments for psoriasis supports the need for new, effective and well-tolerated treatment options for scalp psoriasis. This article aims to review the efficacy and safety of new formulations and treatment options available to control scalp psoriasis. For example, a new formulation of calcipotriene/betamethasone scalp solution has a rapid onset of action with once daily dosing that improves compliance. The CalePso study examines the safety profile of otherwise established Clobetasol propionate (CP) shampoo 0.05%, and reports that CP shampoo is safe and efficacious in the long-term management of scalp psoriasis. A new foam formulation of coal tar is shown to be cosmetically acceptable and easier to apply.

Topics: Betamethasone; Calcitriol; Clobetasol; Coal Tar; Drug Combinations; Glucocorticoids; Humans; Keratolytic Agents; Psoriasis; Scalp Dermatoses

Ultrapotent topical corticosteroids are the mainstay of psoriasis treatment, used either alone or in combination with a topical vitamin D analog. Traditionally used in an ointment vehicle for psoriasis, clobetasol propionate 0.05% is also available in spray, foam, lotion, and shampoo formulations, which may provide for improved convenience and acceptance in many patients with similar efficacy, safety, and tolerability as the traditional ointment and cream formulations. To compare newer formulations with traditional ointment and cream formulations, we performed a systematic review of the literature. Search terms included 'clobetasol propionate,' in combination with 'psoriasis,' 'vasoconstriction,' 'vasoconstrictor,' or 'absorption' for each of the four vehicles ('spray,' 'foam,' 'lotion,' and 'shampoo'). While there are very few direct comparison studies between clobetasol propionate in different vehicles, the efficacy rates (with success defined as clear or almost clear of psoriasis) for more recent formulations are high, with most patients achieving success after 2-4 weeks of treatment in well controlled clinical trials, with response rates that are similar to those with the traditional clobetasol propionate ointment. Small differences in vasoconstrictor potency or cutaneous absorption have been noted among the formulations, but the clinical significance of these observations is difficult to discern. Recent research has emphasized the importance of treatment adherence in the management of psoriasis. Adherence to treatment is likely to be a far more important determinant of success than are small differences in drug delivery, especially in actual clinical use as opposed to the well controlled environment of clinical trials. For patients who prefer a less messy vehicle, adherence and outcomes are likely to be better with the more recent formulations compared with the traditionally recommended ointment.

Topics: Administration, Topical; Anti-Inflammatory Agents; Clobetasol; Dosage Forms; Glucocorticoids; Humans; Psoriasis; Skin; Skin Absorption; Vasoconstriction

Topical corticosteroids are the most common treatment modality for patients with psoriasis and atopic dermatitis; however, the efficacy of topical corticosteroids is often hampered by barriers to patient adherence, such as lack of efficacy, side effects and inconvenience. Recently published studies have investigated the safety and efficacy of a novel emollient foam (EF) formulation of clobetasol propionate (CP), a class I topical corticosteroid in psoriasis and atopic dermatitis.. To summarize recent literature on CP EF foam, and to evaluate recent Phase II and III clinical trials of CP EF foam in psoriasis and atopic dermatitis.. The MEDLINE (1950 - January 2008) database was searched using the following terms: 'clobetasol propionate foam', 'topical corticosteroids', 'topical glucocorticoids', 'psoriasis' and 'atopic dermatitis'. Results were evaluated for relevance and quality, and additional references were obtained from bibliographies of selected articles.. CP EF foam appears to be safe and effective for corticosteroid-responsive dermatoses in adults and children > or = 12 years of age. As compared to its hydroethanolic foam predecessor, CP EF presents a potential advance for patients who are less likely to tolerate alcohol-based foam. As alcohol-based foams can be irritating and cause stinging in non-hair-bearing areas, this new emollient formulation has the potential to widen the use of CP foam to more patients with atopic dermatitis and to more non-scalp body sites in patients with psoriasis.

Topics: Administration, Cutaneous; Adult; Anti-Inflammatory Agents; Child; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Clobetasol; Dermatitis, Atopic; Glucocorticoids; Humans; Patient Compliance; Psoriasis

Clobetasol propionate is the most potent of all topical steroids. It is successfully applied in the treatment of various skin diseases such as atopic dermatitis, psoriasis and vulvar lichen sclerosus. The therapy is, however, mainly symptomatic. A preventive effect is only reported in the treatment of the latter. Clobetasol propionate exerts antiinflammatory, immunosuppressive and antimitotic effects influencing the growth, differentiation and function of various cells and inhibiting cytokine production. Seven different dosage forms are available to deliver the drug to the living cells of the skin. Their choice might additionally affect patient compliance. The potency of clobetasol propionate, however, is accompanied by local and systemic side effects, such as skin atrophy and hypothalamic-pituitary-adrenal axis suppression. Patients applying clobetasol propionate must be well instructed in how to use it. Physicians prescribing clobetasol propionate should consider a diversity of factors and be able to answer the questions where, when and why.

Topics: Administration, Cutaneous; Adrenal Cortex Hormones; Anti-Inflammatory Agents; Clobetasol; Dermatitis, Atopic; Female; Humans; Immunosuppressive Agents; Psoriasis; Vulvar Lichen Sclerosus

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

Clobetasol propionate is the most common topical therapy used for psoriasis in the US. Conventional dermatologic wisdom is that ointment preparations provide the highest potency (due to their occlusive nature and moisturizing ability) and are best suited for psoriasis. However, patients often find application of ointment to be messy, raising concerns about both short-term and long-term adherence to treatment. This article reviews the current literature and assesses the relative potency of clobetasol propionate ointment compared to other clobetasol propionate preparations in the treatment of psoriasis. Relevant literature was identified by PubMed and Google searches. We included studies of psoriasis that reported the percentage of subjects that achieved desired efficacy endpoints, as well as studies that reported the subjects' mean change in symptoms from baseline. We excluded studies conducted before 1980 and those that allowed concomitant treatments.. Efficacy rates ranged from 17% to 80% for the different vehicles: ointment, solution, foam, cream, lotion, shampoo, and emollient.. Clobetasol propionate is a very effective treatment for psoriasis. Ointment preparations have similar efficacy to other preparations in clinical trial situations. In clinical practice, a situation in which patient preferences are more likely to affect compliance, it may be best to choose whichever vehicle patients find preferable.

Topics: Administration, Topical; Adult; Clobetasol; Dermatologic Agents; Double-Blind Method; Emollients; Humans; Ointments; Patient Satisfaction; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome

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

Topical corticosteroids have been the mainstay of topical anti-inflammatory therapy of psoriasis and are available in different treatment strengths or doses and various formulations or vehicles. Traditional formulations have included ointments, creams, and lotions. More recently, the mid-potency corticosteroid betamethasone valerate (BMV) and the ultra-high-potency corticosteroid clobetasol propionate (CP) have become available in a novel, thermolabile, low-residue foam vehicle for topical application. This review examines recent clinical studies on efficacy and safety of these two new formulations, BMV 0.12% foam (Luxiq; Connetics Corp, Palo Alto, Calif) and CP 0.05% foam (OLUX, Connetics Corp), as treatments for scalp and nonscalp psoriasis. The studies demonstrated that BMV foam and CP foam are safe and effective treatments for psoriasis affecting scalp and nonscalp regions of the body. BMV foam and CP foam were absorbed more rapidly and demonstrated greater total absorption than their respective comparison formulations, namely BMV lotion and CP solution. The foam vehicle also appears to be associated with better compliance and improvements in quality of life. The unique nature of the foam vehicle, together with the positive findings of in vitro studies suggest these new foam formulations may expand the options currently available for combination therapy.

Topics: Administration, Cutaneous; Adult; Betamethasone Valerate; Clobetasol; Cross-Over Studies; Dermatitis, Atopic; Dosage Forms; Double-Blind Method; Female; Forecasting; Humans; Hydrocortisone; Male; Multicenter Studies as Topic; Ointments; Pharmaceutical Vehicles; Psoriasis; Randomized Controlled Trials as Topic; Scalp Dermatoses; Single-Blind Method; Treatment Outcome

Psoriasis is a common, chronic, distressing skin disorder that frequently affects the scalp, skin, nails and joints. Despite treatment, many patients suffer from unremitting disease and decreased quality of life. Scalp-type psoriasis is particularly difficult to treat. Although topical corticosteroids are the mainstay of therapy for moderate-to-severe disease, patients frequently object to the messiness and unfavourable cosmetic appearance of topical treatments. In this context, foam vehicles, which have the advantage of minimal residue and increased ease of application, have emerged as novel alternatives to traditional creams, ointments and solutions. Clobetasol propionate foam 0.05% (OLUX, Connetics Corporation), a high potency topical steroid, has been shown to alleviate symptoms of several dermatological conditions, including scalp and body psoriasis, improve disease severity and increase quality of life. Dose should be limited to 50 g/week, given the risk of adrenal suppression. Because patient preference is an important determinant of medication efficacy in clinical practice, clobetasol foam is a useful new formulation in the treatment of psoriasis and other skin conditions.

Topics: Administration, Topical; Animals; Clobetasol; Humans; Psoriasis

Topics: Child; Clobetasol; Female; Glucocorticoids; Humans; Psoriasis

Halobetasol propionate (HP) 0.5% ointment and cream are class I topical corticosteroids. We review the efficacy and tolerability of HP for treatment of plaque psoriasis in the English language literature. The efficacy of HP ointment and cream is consistently superior to other super-potent topical corticosteroids. Local adverse events associated with topical HP are similar to those experienced with other super-potent corticosteroids. Combination therapy with calcipotriene (calcipotriol) and tazarotene appears to be superior to monotherapy with topical HP.

Topics: Administration, Topical; Clobetasol; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Maximum Tolerated Dose; Psoriasis; Risk Assessment; Severity of Illness Index; Treatment Outcome

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

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

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

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

The potential for a variety of local and systemic side effects from the use of potent topical corticosteroids has long been recognized. However, adrenal suppression has only rarely been documented. We describe two patients with profound hypothalamic-pituitary-adrenal axis suppression resulting from the unregulated use of super potent topical corticosteroids.

Topics: Administration, Topical; Adrenal Glands; Adult; Anti-Inflammatory Agents; Betamethasone; Chronic Disease; Clobetasol; Depression, Chemical; Female; Glucocorticoids; Humans; Male; Ointments; Psoriasis; Self Medication

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

Clobetasol-17-propionate, the most potent of currently available topical steroids as predicted by the vasoconstrictor assay, has just been approved in the United States. In psoriasis, it has proved significantly more effective than class II steroids and as or more effective than the only marketed class I steroid. In the more steroid-responsive eczemas, the superior efficacy of clobetasol is also apparent, but less striking. Clobetasol prolongs remission rates, making intermittent treatment schedules feasible and minimizing inherent potential steroid side effects. Clobetasol may also be useful in the treatment of a myriad of other skin conditions. A review of the pharmacology, efficacy, and side effects of this addition to our dermatologic armamentarium is presented here.

Topics: Administration, Topical; Betamethasone; Clobetasol; Combined Modality Therapy; Drug Administration Schedule; Eczema; Hypothalamo-Hypophyseal System; Pituitary-Adrenal System; Psoriasis

In mild psoriasis, topical agents remain the mainstay of treatment. However, the available treatments are not satisfactory for a significant proportion of patients in many terms such as efficacy and safety. Because of these deficits, augmentation of therapeutic effect seems desirable.. To evaluate the efficacy of topical cyclosporine cream, delivered by fractional CO. Twenty-two patients with chronic plaque psoriasis involving <10% BSA were included in this study. They were randomly allocated into 2 groups. In Group A, patients were instructed to apply cyclosporine cream twice daily for 5 consecutive days per week immediately after fractional carbon dioxide laser session. While in Group B, clobetasol cream was applied twice daily for 5 consecutive days per week until complete clearance or for a maximum of 10 weeks. The efficacy was objectively assisted clinically and by histopathology by using the scores and skin biopsy.. There was a significant improvement of erythema, plaque elevation, and scaling (p < 0.001) with the use of topical cyclosporine cream delivered by the aid of fractional CO. Laser-assisted delivery of topical cyclosporine can provide comparable clinical and pathological improvement to that of clobetasol in the psoriatic plaques. These findings were apparent in patients with less widespread disease. However, topical steroid showed more improvement.

Topics: Carbon Dioxide; Clobetasol; Cyclosporine; Emollients; Humans; Lasers, Gas; Psoriasis; Severity of Illness Index; 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

The topical corticosteroid halobetasol propionate (HP) and the retinoid tazarotene (TAZ) are effective in psoriasis treatment. To mitigate adverse cutaneous reactions observed with monotherapy, a fixed- combination HP 0.01%/TAZ 0.045% lotion has been developed for the treatment of plaque psoriasis in adults.. To investigate the long-term safety, efficacy and maintenance of response with HP/TAZ lotion.. This was a 1-year, multicentre, open-label study in 555 adults with psoriasis [Investigator's Global Assessment (IGA) score of 3 ('moderate') or 4 ('severe') and body surface area (BSA) of 3-12% at baseline]. HP/TAZ was administered once daily for 8 weeks and then intermittently as needed in 4-week intervals for up to 1 year based on achievement of treatment success [IGA score of 0 ('clear') or 1 ('almost clear')]. Maximum continuous exposure was 24 weeks.. Of 550 participants with postbaseline safety data, 318 (57.8%) achieved treatment success during the study. Of those, 54.4% achieved treatment success within the first 8 weeks; retreatment was not required for >4 weeks in over half (55.3%), and 6.6% did not require any retreatment. Among participants enrolled for the full 52 weeks, 77.5% maintained BSA ≤5% on treatment. There were marked improvements in severity of itching, dryness and burning/stinging over the study course. The most common treatment-related adverse events were application site reactions of dermatitis, pruritus, pain and irritation.. Fixed-combination HP/TAZ lotion provided maintained efficacy with a favourable tolerability and safety profile, supporting its use for the long-term treatment and management of moderate-to-severe plaque psoriasis.

Topics: Administration, Cutaneous; Adult; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Humans; Nicotinic Acids; Propionates; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Psoriasis is a chronic, inflammatory disease that may differ in prevalence and clinical presentation among patients from various racial and ethnic groups. Two phase 3 studies demonstrated efficacy and safety of halobetasol propionate (HP) 0.01% lotion in the treatment of moderate-to-severe plaque psoriasis (NCT02514577, NCT02515097). These post hoc analyses evaluated HP 0.01% lotion in Hispanic participants.. Participants were randomized (2:1) to receive once-daily HP or vehicle lotion for 8 weeks, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in Hispanic participants (HP, n=76; vehicle, n=43) included treatment success (≥2‑grade improvement in Investigator’s Global Assessment and score of ‘clear’ or ‘almost clear’), psoriasis signs, and affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated.. At week 8, 38.8% of participants achieved treatment success with HP versus 10.3% on vehicle (P=0.001). HP‑treated participants achieved greater improvements in psoriasis signs, compared with vehicle (P<0.01 all). HP group had a greater reduction in affected BSA versus vehicle (P=0.001). Treatment-related TEAEs with HP were application site infection and dermatitis (n=1 each).. Once-daily HP 0.01% lotion was associated with significant reductions in disease severity in Hispanic participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks. J Drugs Dermatol. 2021;20(3):252-258. doi:10.36849/JDD.5698.

Topics: Administration, Cutaneous; Adult; Clobetasol; Dermatitis, Contact; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Female; Hispanic or Latino; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Treatment Outcome; Vasoconstrictor Agents

Few studies have examined topical psoriasis therapies in patients with skin of color. Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) was investigated in two phase 3, multicenter, double-blind, vehicle-controlled trials (NCT02462070; NCT02462122). This post hoc analysis evaluated HP/TAZ in subgroups of non-White and White participants, including Hispanic/Latino participants, from these trials.. Adult participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once daily for 8 weeks. Data were pooled and analyzed in non-mutually exclusive subgroups of self-identified non-White or White and Hispanic/Latino participants. Efficacy assessments included treatment success (≥2-grade improvement from baseline in investigator’s global assessment [IGA] and score of clear/almost clear), reduction from baseline in affected body surface area (BSA), and reduction in mean IGA × BSA. Safety was evaluated via treatment-emergent adverse events (TEAEs).. Of 418 participants, 60 and 358 self-identified as non-White and White, respectively; 115 of 418 participants self-identified as Hispanic/Latino. At week 8, a higher percentage of HP/TAZ-treated participants achieved treatment success vs vehicle (non-White, 34.4% vs 19.0%; White, 41.8% vs 8.7%; Hispanic/Latino, 39.3% vs 9.3%); rates for White and Hispanic/Latino participants were statistically significant. Compared with vehicle, HP/TAZ-treated participants in each subgroup experienced numerically greater reductions in affected BSA and IGA × BSA at week 8. The most common TEAEs were contact dermatitis, pruritus, nasopharyngitis, and application-site pain; discontinuations due to TEAEs were few.. HP/TAZ reduced disease severity in non-White, White, and Hispanic/Latino participants with psoriasis, with good tolerability and safety over 8 weeks of treatment. J Drugs Dermatol. 2021;20(7):735-744. doi:10.36849/JDD.6158.

Topics: Adult; Clobetasol; Color; Dermatologic Agents; Drug Combinations; Humans; Nicotinic Acids; Psoriasis; Skin Cream; Skin Pigmentation

Patients with psoriasis and low body surface area (BSA) involvement often experience substantially reduced quality of life and may be candidates for topical therapies. Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) vs vehicle lotion was evaluated in participants with 3% to 5% BSA involvement.. In two phase 3, multicenter, double-blind, vehicle-controlled, 8-week studies (ClinicalTrial.gov identifiers: NCT02462070/NCT02462122), adults with moderate/severe investigator’s global assessment (IGA) score were randomized 2:1 to once-daily HP/TAZ or vehicle. Pooled post hoc analyses included participants with baseline BSA involvement of 3% to 5%. Measures included treatment success (≥2-grade IGA reduction, clear/almost clear score), reduction in affected BSA, and clinically meaningful improvement (reduction) of ≥4 points on dermatology life quality index (DLQI).. Of 418 participants, 232 had baseline BSA involvement of 3% to 5% (HP/TAZ, n=149; vehicle, n=83). At week 8, 42.7% of HP/TAZ-treated participants achieved treatment success, compared with 11.4% of vehicle-treated participants (P< .001). Participants experienced significantly greater reductions in affected BSA at week 8 with HP/TAZ (-36.0%) vs vehicle (-1.6%; P< .001). Larger proportions experienced clinically meaningful DLQI improvements at week 8 with HP/TAZ (64.2%) vs vehicle (47.4%; P< .05). More participants achieved a ≥2-grade improvement in plaque elevation and scaling with HP/TAZ vs vehicle (each comparison, P< .001). Serious adverse events and discontinuations due to treatment-emergent adverse events were rare.. In participants with plaque psoriasis and BSA involvement of 3% to 5%, HP/TAZ provided significantly improved effectiveness after 8 treatment weeks vs vehicle lotion, with clinically meaningful improvements in quality of life. J Drugs Dermatol. 2021;20(8):829-836. doi:10.36849/JDD.6217.

Topics: Body Surface Area; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Humans; Nicotinic Acids; Propionates; Psoriasis; Quality of Life; Severity of Illness Index; Skin Cream; Treatment Outcome

Topics: Administration, Oral; Aerosols; Clobetasol; Drug Therapy, Combination; Female; Humans; Male; Patient Satisfaction; Phosphodiesterase 4 Inhibitors; Pilot Projects; Prospective Studies; Psoriasis; Thalidomide; Treatment Outcome

Background: Plaque psoriasis can occur in all body regions, with the trunk and extremities among the most commonly affected areas. A fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion demonstrated efficacy and safety in patients with moderate-to-severe localized plaque psoriasis. This analysis evaluated patients where a psoriatic target lesion was identified on the leg. Methods: In two phase 3, multicenter, double-blind studies, participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once-daily for 8 weeks. This pooled, post hoc analysis included a subset of participants who had a leg target lesion (HP/TAZ, n=148; vehicle, n=71). Efficacy assessments included treatment success (≥2-grade improvement) in psoriasis signs (erythema, plaque elevation, scaling) on the leg target lesion, and overall treatment outcomes, including overall treatment success (≥2-grade improvement in Investigator's Global Assessment [IGA] score and score of clear/almost clear), affected Body Surface Area (BSA), and IGAxBSA composite score. Results: Psoriasis signs were reduced by week 8, with more HP/TAZ treated participants achieving treatment success for erythema (41.6%), plaque elevation (58.5%), and scaling (59.5%) on the leg compared with vehicle (12.5%, 19.2%, and 21.0%, respectively; P<0.001 all). Significantly more participants achieved overall treatment success at week 8 with HP/TAZ versus vehicle (36.4% vs 10.4%; P<0.001). The HP/TAZ group also had a greater mean reduction in affected BSA and IGAxBSA score versus vehicle (P<0.001, both). The most frequently reported treatment-related adverse event (incidence, ≥3%) with HP/TAZ was contact dermatitis. Conclusions: HP 0.01%/TAZ 0.045% lotion was associated with significant reductions in disease severity and good tolerability following 8 weeks of treatment in patients where a psoriatic target lesion was identified on the leg. J Drugs Dermatol. 2020;19(4):389-396. doi:10.36849/JDD.2020.4958.

Topics: Administration, Cutaneous; Adult; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Humans; Leg; Male; Middle Aged; Nicotinic Acids; Psoriasis; Severity of Illness Index; Treatment Outcome; United States

Long-term use of corticosteroids or local use of tazarotene (TAZ) alone for the treatment of psoriasis cause safety issues and low compliance rates. Combining these two may optimize their efficacy and minimize safety concerns. This study aimed to evaluate the clinical efficacy and safety of a fixed combination of TAZ 0.05% and betamethasone dipropionate 0.05% (BM) for psoriasis vulgaris. A multicenter, randomized, single-blinded, controlled phase 3 clinical trial was conducted. A total of 600 Chinese subjects with psoriasis vulgaris were randomized (3:1:1) to TAZ/BM cream, TAZ gel or BM cream groups for 6 weeks with an 8-week follow up. The primary efficacy assessment end-point was 75% improvement in Psoriasis Area and Severity Index (PASI-75) at 6 weeks. Secondary outcome assessments included PASI-90, percentage of PASI decrease and so forth. Safety and treatment-related adverse events were monitored throughout the study. Our results demonstrated that the TAZ/BM group exhibited statistically significant superiority in PASI-75 over TAZ (6.74% vs 1.67%) within 2 weeks. After 6 weeks of treatment, PASI-75 was 44.94% in the TAZ/BM group while 19.17% and 35.00% in the TAZ and BM group, respectively. At the 8-week follow up, the relapse rate of the TAZ/BM group was significantly lower than the BM group (10.62% vs 29.63%, P = 0.0269) though comparable with the TAZ group (10.00%). The most frequently reported treatment-related adverse event was mild to moderate level of skin irritation events. TAZ/BM combination has significant advantages over TAZ, including satisfying efficacy, rapid onset and reduced local stimulation. Meanwhile, compared with BM, it has the advantages of longer relief time and reduced clinical relapse rate. The TAZ/BM combination drug provides psoriatic patients an alternative drug with high efficacy and low relapse rate and safety concerns.

Topics: Betamethasone; Clobetasol; Dermatologic Agents; Double-Blind Method; Humans; Neoplasm Recurrence, Local; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Previous results from two phase 3 studies demonstrated efficacy and safety of fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in participants with moderate-to-severe plaque psoriasis. This post hoc analysis evaluated sex-specific efficacy and safety of HP/TAZ lotion.. In two randomized, double-blind, phase 3 studies, participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once daily for 8 weeks. Male and female participants were evaluated separately in this pooled analysis. Efficacy assessments included treatment success (at least 2‑grade improvement in Investigator's Global Assessment [IGA] score and score of clear/almost clear), impact on individual signs of psoriasis, and affected Body Surface Area (BSA).. The analysis included 272 males (HP/TAZ, n=175; vehicle, n=97) and 146 females (HP/TAZ, n=101; vehicle, n=45). Significantly more participants achieved overall treatment success at week 8 with HP/TAZ versus vehicle in both male (38.4% vs 9.8%) and female (44.5% vs 9.9%) subgroups (P<0.001, both). Erythema, plaque elevation, and scaling were also reduced by week 8 in both males and females, with significantly more HP/TAZ-treated participants achieving at least 2‑grade improvement in each sign of psoriasis than vehicle-treated participants (P<0.001 each, both groups). Mean reductions in affected BSA were significantly greater with HP/TAZ versus vehicle lotion in both males and females (P≤0.001, both). The most frequent treatment-related adverse events were contact dermatitis, pruritis, and application site pain (each 4.0%) in females and contact dermatitis (7.6%) in males.. HP/TAZ lotion was highly effective and safe in both males and females with moderate-to-severe psoriasis over 8 weeks of once-daily use. J Drugs Dermatol. 2020;19(5): doi:10.36849/JDD.2020.5021.

Topics: Adult; Aged; Clobetasol; Dermatitis, Contact; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Nicotinic Acids; Pain; Pruritus; Psoriasis; Severity of Illness Index; Sex Factors; Skin Cream; Treatment Outcome

Introduction: Psoriasis is a chronic, immune-mediated skin disease that is associated with sex-related differences. Two double-blind, vehicle-controlled, phase 3 studies evaluated halobetasol propionate (HP) 0.01% lotion for the treatment of moderate-to-severe localized plaque psoriasis; pooled post hoc analyses investigated efficacy and safety in male and female subgroups. Methods: Participants were randomized (2:1) to once-daily HP or vehicle lotion for 8-weeks of double-blind treatment, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in male (n=253) and female (n=177) subgroups included treatment success (≥2‑grade improvement in Investigator's Global Assessment [IGA] score and score of 'clear' or 'almost clear'), treatment success in psoriasis signs (erythema, plaque elevation, and scaling) at the target lesion, and change in affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated. Results: At week 8, rates of IGA-rated treatment success were significantly greater for HP versus vehicle in males (34.0% vs 6.4%) and females (42.7% vs 14.6%; P<0.001 both). Treatment success in each psoriasis sign approached or exceeded 50% for HP-treated males and females, with all differences versus vehicle statistically significant (P<0.001). Percent reduction in affected BSA was significantly greater for HP versus vehicle in males (34.9% vs 6.7%) and females (35.6% vs 4.6%; P<0.001 both). Five HP treatment-related TEAEs (all application site-related) were reported through week 8. Conclusions: HP lotion was associated with significant reductions in disease severity in male and female participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks of once-daily use. In the overall pooled population, results were similar. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5250.

Topics: Adult; Aged; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Sex Factors; Skin Cream; Treatment Outcome

Gracilaria algae is red macro algae which has demonstrated considerable anti-inflammatory effects. Our objective was to compare the efficacy of Gracilaria algae topical cream 3% vs Clobetasol cream 0.05% in treatment of plaque-type psoriasis. Thirty adult patients with baseline modified Psoriasis Area and Severity Index (PASI) score ≤12 were randomized to receive either Clobetasol or Gracilaria algae cream on right or left-sided symmetric plaques once daily for 8 weeks and follow-up of 4 weeks. Modified PASI score, patient's satisfaction using VAS and global physician assessment score were assessed to evaluate clinical response. Thirty patients with 94 symmetrical psoriasis plaques were enrolled in this trial. The mean baseline modified PASI score of both sides was similar; however, at the end of trial, modified PASI score was reduced more on the sides treated with Gracilaria algae cream (0.80 ± 0.19% vs 0.63 ± 0.25%, P < .05). No significant difference was found regarding mean physician global assessment score between the two groups (P > .05). Patients' satisfaction was significantly higher in favor of algae cream only at week 8 of the intervention (P < .05). Gracilaria algae cream can be an effective and safe alternative of Clobetasol in the treatment of plaque type psoriasis.

Topics: Adult; Clobetasol; Gracilaria; Humans; Psoriasis; Severity of Illness Index; Treatment Outcome

BACKGROUND: A novel foam formulation of halobetasol propionate, 0.05% (HBP-Foam) has been developed to treat plaque psoriasis in patients who prefer a thermostable topical foam with low application shear that allows for easier coverage over large and/or hirsute areas than existing formulations.\ \ OBJECTIVE: To determine the safety and effectiveness of HBP-Foam in subjects with plaque psoriasis.\ \ METHODS: Two randomized, double-blind, vehicle-controlled clinical studies were conducted in 560 adult subjects with moderate to severe plaque psoriasis. Subjects applied the assigned test article to all psoriatic plaques twice daily for 14 days. The key efficacy measures were the proportion of subjects with “treatment success,” defined as those subjects that achieved a score of 0 (clear) or 1 (almost clear) and at least a two-grade improvement compared to baseline for the Investigator’s Global Assessment (IGA) and for the clinical signs of psoriasis (plaque elevation, scaling, and erythema) as well as pruritus. Safety measurements included adverse events and local skin reactions in the treatment area.\ \ RESULTS: HBP-Foam was statistically superior to vehicle in achieving “Treatment Success” in 25.3% and 30.7% vs 3.9% and 7.4% (P<0.001) in Studies 1 and 2, respectively. Pruritus scores statistically improved by over 30% in HBP-Foam treated subjects. In addition, these subjects experienced a significant reduction in the clinical signs of psoriasis (plaque elevation, scaling, and erythema). In contrast, in the vehicle groups the decrease in psoriasis-related signs was generally not observed. Safety outcomes were unremarkable and similar in both the HBP-Foam and vehicle treatment groups.\ \ CONCLUSIONS: These results demonstrate the safety and effectiveness of HBP-Foam in the treatment of plaque psoriasis. Furthermore, this novel foam formulation has demonstrable for its ease of application over large and/or hairy treatment areas.\ \ ClinicalTrials.gov Registration: NCT02742441 NCT02368210

Topics: Adult; Aged; Clobetasol; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Middle Aged; Pharmaceutical Vehicles; Pruritus; Psoriasis; Severity of Illness Index; Skin; Treatment Outcome; Vasoconstrictor Agents

BACKGROUND: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Topical corticosteroids (TCS) are the mainstay of treatment. Long-term safety remains a concern, limiting use and recurrence is common. Tazarotene has also been shown to be effective in psoriasis, with efficacy maintained several weeks posttreatment. Fixed combination therapy with TCS and tazarotene may improve psoriasis signs and maintain efficacy between treatment sessions.\ \ OBJECTIVE: To investigate the maintenance of effect posttreatment with a once-daily application of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in comparison with vehicle in patients with moderate or severe plaque psoriasis.\ \ METHODS: Two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe psoriasis (N=418). Patients randomized (2:1) to receive HP/TAZ lotion or vehicle, once-daily for 8 weeks with a 4 week posttreatment follow-up. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score, and ‘clear’ or ‘almost clear’), impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion, and maintenance of improvements in Body Surface Area (BSA), IGAxBSA and clinically meaningful benefit (IGAxBSA-75).\ \ RESULTS: At week 8, 40.7% of patients achieved treatment success with HP/TAZ lotion, compared with 9.9% treated with vehicle (P<0.001). Four weeks posttreatment, 33.3% of patients achieved treatment success. Two thirds of patients (63%) who were treatment successes at week 8 remained treatment successes posttreatment. In addition, up to 20% of patients who were not treatment successes at week 8 became treatment successes by the end of the study. Three-quarters of patients maintained BSA improvements or reported further reductions in BSA that seemed to be unrelated to baseline BSA severity. At the end of the 4 week posttreatment period, patients who had been treated with HP/TAZ lotion achieved a 46.6% reduction in IGAxBSA, compared with 7.9% on vehicle. 41.7% of patients achieved a clinically meaningful effect at week 8 and this was maintained posttreatment.\ \ LIMITATIONS: The studies only had a 4 week follow-up period.\ \ CONCLUSIONS: In conclusion, HP 0.01%/TAZ 0.045% lotion provides effective maintenance of efficacy over a 4 week posttreatment period.

Topics: Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Follow-Up Studies; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Background: The use of topical therapy is a key component in the management of almost all psoriasis patients. Topicals are considered first-line therapy for mild disease and are having an increasing role in moderate or severe psoriasis as an integral part of combination therapy. Halobetasol has been shown be effective in moderate or severe localized plaque psoriasis, and tazarotene affords important effects on epidermal hyperproliferation that may be important in more severe disease.\ \ Objective: To investigate the efficacy, safety and tolerability of a once-daily application of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion in comparison with its vehicle in patients with severe localized plaque psoriasis (as defined by an Investigator Global Assessment (IGA) of 4 and Body Surface Area (BSA) of 3%-12%.\ \ Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies. Sixty-two patients with severe localized psoriasis (mean BSA 7.4) randomized (2:1) to receive HP/TAZ lotion or vehicle, once-daily for 8 weeks, with a 4-week posttreatment follow-up. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score and a score of ‘clear’ or ‘almost clear’), impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion, BSA, reduction in mean baseline IGAxBSA and achievement of a clinically meaningful response (number of patients who achieved at least a 75% improvement in IGAxBSA). Safety and treatment emergent adverse events (TEAEs) were evaluated throughout.\ \ Results: By week 8, 34.8% of patients were treatment successes compared with 0.0% on vehicle (P=0.004). HP/TAZ lotion was also significantly superior in reducing psoriasis signs and symptoms and improving BSA. At week 8, 47.4% (erythema), 66.4% (plaque elevation), and 65.4% (scaling) subjects achieved at least a 2-grade improvement, compared with 14.0% (P=0.016), 14.8% (P<0.001) and 14.7% (P<0.001) respectively with vehicle. Patients treated with HP/TAZ lotion achieved a 32.8% reduction in baseline mean BSA, compared with a 39.6% increase with vehicle (P=0.013). HP/TAZ lotion achieved a statistically significant superior reduction in mean IGAxBSA compared to vehicle from week 2 (P<0.001 versus vehicle). By week 8, almost half of the patients treated with HP/TAZ lotion achieved a clinically meaningful response (IGAxBSA-75) and

Topics: Adult; Clobetasol; Dermatitis, Contact; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Nicotinic Acids; Pain; Pruritus; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Background: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Topical corticosteroids (TCS) are the mainstay of treatment. Long-term safety remains a concern, limiting use, and posttreatment flare is common. Recently data were reported on the use of halobetasol propionate (HP) 0.01% lotion in moderate or severe localized plaque psoriasis, once-daily for 8 weeks. In addition, a 2-week label-restricted study reported comparable efficacy to HP 0.05% cream. Data evaluating efficacy in specific locations has not been reported and while psoriasis commonly affects lower extremities treatment can be more problematic and burden of disease heightened.\ \ Objective: To investigate the efficacy of a once-daily application of HP 0.01% lotion in comparison with its vehicle in patients with moderate-to-severe plaque psoriasis of the lower extremities.\ \ Methods: A post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in moderate or severe psoriasis. Subjects (N=234) where the leg was identified as the target lesion were randomized (2:1 ratio) to receive HP 0.01% lotion or vehicle, once-daily for 8 weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline) in each individual sign of psoriasis (erythema, plaque elevation, and scaling) at the target lesion (leg) and overall treatment outcomes including at least a 2-grade improvement from baseline in the Investigator Global Assessment (IGA) score, and ‘clear’ or ‘almost clear’, improvement in Body Surface Area (BSA) and reduction in IGAxBSA. Quality of Life (QoL) was assessed using the Dermatology Life Quality Index (DLQI) at baseline, week 4, 8, and 12.\ \ Results: At the end of the 8-week treatment period, more than half of subjects had achieved treatment success, with 52.1%, 55.5%, and 58.2% of subjects achieving at least a 2-grade reduction in erythema, plaque elevation and scaling severity on the leg, compared with 15.7% and 22.9%, and 22.2% of those treated with vehicle (P<0.001). In addition, overall treatment success (IGA) was achieved in 37.1% of these subjects who had been treated with HP 0.01% lotion compared with 8.4% treated with vehicle (P<0.001); with a corresponding 34.2% reduction in baseline BSA and 50.5% change in mean baseline IGAxBSA (both P<0.001 versus vehicle). Overall, a clinically relevant improvement in QoL was achieved by week 4; by week 8 37.7% of subjects wh

Topics: Adult; Aged; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Female; Humans; Lower Extremity; Male; Middle Aged; Psoriasis; Quality of Life; Severity of Illness Index; Skin Cream; Treatment Outcome

Even though the traditional therapy for nail psoriasis has been used for decades, no randomized, controlled trial of such treatment has been conducted to date.. To evaluate the efficacy and safety of intralesional triamcinolone injections compared with 0.05% clobetasol ointment for psoriatic nails.. Psoriasis patients, each with three fingernails with similar degrees of severity, were randomly recruited for intralesional triamcinolone injection group, 0.05% clobetasol ointment group, and a control group. The target Nail Psoriasis Severity Index (NAPSI) score of each finger was evaluated, any adverse effects were recorded, and photographs were taken.. Forty-eight affected nails were analyzed. At the second month, a significantly greater reduction of the target NAPSI score was observed in the injection group compared to the control group (p = .003). There was a greatest reduction of the score in the following two month-period, which showed significant difference from the topical group (p = .003) and the control group (p = < .001). The score of the injection group, however, subsequently rose at the six-month visit so that there was no longer any statistically-significant difference between the three groups.. In spite of its temporary effect, the intralesional triamcinolone injection is an effective and safe treatment for psoriatic nails.

Topics: Adult; Aged; Clobetasol; Female; Humans; Injections, Intralesional; Male; Middle Aged; Nail Diseases; Ointments; Psoriasis; Single-Blind Method; Triamcinolone

Topics: Administration, Cutaneous; Adult; Aged; Clobetasol; Dermatologic Agents; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis; Skin Cream; Treatment Outcome

Topics: Adult; Aged; Aged, 80 and over; Clobetasol; Dermatologic Agents; Drug Therapy, Combination; Humans; Middle Aged; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Time Factors; Young Adult

Potent topical corticosteroids (TCSs) are the mainstay of psoriasis treatment. Safety concerns have limited use to 2 to 4 weeks. The objective of our study was to investigate the safety and efficacy of once-daily halobetasol propionate (HP) lotion 0.01% in moderate to severe plaque psoriasis through 2 multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Participants were randomized (2:1) to HP lotion 0.01% or vehicle once daily for 8 weeks, followed by 4 weeks of follow-up. The primary efficacy assessment was treatment success (at least a 2-grade improvement in baseline investigator global assessment [IGA] score and a score of 0 [clear] or 1 [almost clear]). Additional assessments included improvement in psoriasis signs and symptoms, body surface area (BSA), and a composite score of IGA×BSA. Safety and treatment-emergent adverse events (AEs) were evaluated throughout. We found that HP lotion 0.01% demonstrated statistically significant superiority over vehicle as early as week 2 and also was superior in reducing psoriasis signs and symptoms and BSA involvement.

Topics: Administration, Cutaneous; Adult; Aged; Clobetasol; Dermatologic Agents; Double-Blind Method; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Treatment Outcome

Background: Fixed combinations are commonplace in dermatology, providing significant efficacy and tolerability benefits. In some cases, two active ingredients complement each other providing a cumulative or additive effect. In rarer cases, a synergistic effect may be seen where the sum of the two active ingredients combined action is greater than the sum of the efficacy of the constituent parts.\ \ Objective: To determine whether a novel halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) fixed combination lotion provides a synergistic effect in the treatment of moderate-to-severe plaque psoriasis.\ \ Methods: Post hoc analysis of 212 patients with moderate-to-severe plaque psoriasis randomized (2:2:2:1) to HP/TAZ lotion, HP, TAZ or vehicle once-daily for 8 weeks, with a 4-week posttreatment follow-up. Treatment success was evaluated based on two outcomes: percent of patients achieving at least a 2-grade improvement in Investigator Global Assessment (IGA) and IGA score equating to ‘clear’ or ‘almost clear’; and percent change from baseline in the IGAxbody surface area (BSA) score, an alternative to assessing response to therapy that is more sensitive to area change than the Psoriasis Area Severity Index (PASI). In addition, a clinically meaningful outcome was reported in patients who achieved a 75% reduction in IGAxBSA. Synergy was established when the benefit of combination HP/TAZ lotion was greater than benefit of HP plus TAZ, with a ratio (HP/TAZ divided by HP+TAZ) >1.0.\ \ Results: HP/TAZ lotion was synergistic at week 8, and four weeks posttreatment. At week 8, treatment success with HP/TAZ lotion relative to vehicle was 42.8% compared with 32.5% for HP plus TAZ (ratio 1.3); and percent change from baseline in IGAxBSA score relative to vehicle was 51.6% compared with 40.6% for HP plus TAZ (ratio 1.3). At week 12, treatment success with HP/TAZ lotion relative to vehicle was 31.3% compared with 20.0% for HP plus TAZ (ratio 1.6). Percent change from baseline in IGAxBSA score relative to vehicle was 47.3% compared with 34.2% for HP plus TAZ (ratio 1.4). HP/TAZ lotion also provided synergistic benefits in terms of achieving a clinically meaningful outcome, with a ratio of 1.3 and 2.0 at weeks 8 and 12.\ \ Conclusions: Halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) fixed combination lotion provides a synergistic benefit in the treatment of moderate-to-severe plaque psoriasis. In addition, by combining two agents into one once-daily formulation

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Drug Combinations; Drug Synergism; Follow-Up Studies; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Scalp psoriasis can have a considerable impact on patients' quality of life and is considered difficult to treat. Treatment failure may, however, be due to poor adherence, as application of topical treatments to hair bearing areas is difficult and time consuming and also poor communication between physician and patient.. To assess the efficacy of short-term treatment of scalp psoriasis with topical clobetasol lotion.. Twelve patients with mild to severe scalp psoriasis were recruited for this study. Patients applied clobetasol 0.05% lotion twice daily for seven days. They were followed up with phone calls three days after starting the treatment. Skin hydration, transepidermal water loss (TEWL) and skin erythema were assessed noninvasively at baseline and end of study.. One week after treatment, median PSI score decreased significantly (p = .002). There was also a significant decrease in median TEWL (p = .012) and increase in skin hydration one week after treatment (p = .010). Eighty three percent of patients were satisfied with treatment result and felt convenient with applying clobetasol lotion.. Lack of a long-term follow-up.. Psoriasis is a long-term disease, and improving adherence in the short time could improve patient's adherence to treatment in long time.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Clobetasol; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Patient Satisfaction; Psoriasis; Severity of Illness Index; Skin; Skin Cream; Treatment Outcome; Young Adult

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

Topical corticosteroids are the mainstay of psoriasis treatment, with long-term safety considerations limiting their use. Combining them with tazarotene may optimize their efficacy and minimize safety and tolerability concerns.. To investigate the safety and efficacy of halobetasol propionate 0.01% plus tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis.. Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N = 418) were conducted. Subjects were randomized (2:1) to HP/TAZ lotion or vehicle once daily for 8 weeks with a 4-week follow-up. The primary efficacy assessment end point was treatment success (at least a 2-grade improvement from baseline in Investigator's Global Assessment score and a score of clear or almost clear). Safety and treatment-emergent adverse events were evaluated throughout.. HP/TAZ lotion demonstrated statistically significant superiority over vehicle within as few as 2 weeks. By week 8, 35.8% (study 1) and 45.3% (study 2) of subjects were treatment successes compared with 7.0% and 12.5% of those treated with vehicle (P < .001). HP/TAZ lotion was also superior in reducing signs and symptoms of psoriasis and body surface area affected by psoriasis. The most frequently reported treatment-related adverse events were contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%).. Studies did not include subjects with more than 12% of their body surface area affected by psoriasis.. HP/TAZ lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, with no safety concerns.

Topics: Administration, Cutaneous; Chronic Disease; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Drug Synergism; Female; Humans; Male; Middle Aged; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Topical corticosteroids (TCS) are the mainstay of treatment. Long-term safety remains a concern, limiting use, and posttreatment flare is common. Tazarotene has also been shown to be effective in psoriasis, with efficacy maintained several weeks posttreatment. Fixed combination therapy with TCS and tazarotene may improve psoriasis signs and minimize posttreatment flare or rebound.. To investigate the maintenance of effect posttreatment with a once-daily application of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in comparison with its active ingredients and vehicle in patients with moderate-to-severe plaque psoriasis.. Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Patients randomized (2:2:2:1 ratio) to receive HP/TAZ, individual active ingredients, or vehicle, once-daily for 8 weeks with a 4-week posttreatment follow-up. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score, and 'clear' or 'almost clear'), and impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion.. At the end of the 4-week posttreatment period, 38.2% of patients who had been treated with HP/TAZ were treatment successes; compared with 21.0%, 12.8% and 6.9% of patients who had been treated with HP (P=0.042), TAZ (P=0.004), or vehicle (P=0.002). HP/TAZ lotion was also superior in maintaining reductions in psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. At the end of the 4-week posttreatment period, 49.1%, 54.5%, and 54.5% of patients, respectively, were treatment successes: compared with 38.7% (P=0.26), 48.4% (P=0.51), and 48.4% (P=0.51) of patients who had been treated with HP; 29.8% (P=0.049), 31.9% (P=0.022), and 23.4% (P=0.001) who had been treated with TAZ; and 13.8% (P=0.002), 20.7% (P=0.003), and 20.7% (P=0.003) who had been treated with vehicle. Side effects were minimal and tended to resolve during the posttreatment period.. In conclusion, HP 0.01%/TAZ 0.045% lotion provides synergistic efficacy following 8 weeks' therapy that is sustained after a 4-week posttreatment period. J Drugs Dermatol. 2018;17(7):723-726.

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Drug Synergism; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Psoriasis is a chronic condition often managed with topical therapy. Patients have high expectations about the speed at which improvement is achieved, which then can have a marked impact on the patient's adherence to treatment. Recently, clinical data on a new fixed combination of halobetasol and tazarotene (HP/TAZ) have been presented. HP/TAZ lotion was statistically more effective than individual active ingredients or its vehicle, with a predictable safety profile.. Here we review the efficacy and tolerability data with a specific focus on the first two weeks of therapy.. Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Subjects randomized (2:2:2:1 ratio) to receive halobetasol 0.01%/tazarotene 0.045% (HP/TAZ), individual active ingredients (HP or TAZ), or vehicle, once-daily for 8 weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score and a score of 'clear' or 'almost clear'), and impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion.. As early as 2 weeks, HP/TAZ lotion demonstrated statistically significant superiority for treatment success over vehicle (P equals 0.047) and TAZ (P equals 0.029). By week 2, 47.5% of patients were 'mild', 'almost clear' or 'clear' compared with 33.3%, 16.9%, and 12.9% of patients treated with HP, TAZ, or vehicle, respectively; plaque elevation and scaling were significantly improved compared with HP, TAZ, or vehicle, and erythema was significantly improved compared with TAZ. Improvements in baseline itching (45.6%), dryness (42.2%), burning/stinging (55.9%) with HP/TAZ lotion at 2 weeks were similar to those seen with HP, and greater than that achieved with TAZ (30.8% [P equals 0.099], 35.4%, and 13.3%, respectively).. The HP/TAZ fixed combination lotion provides rapid relief of psoriasis symptoms, with apparent benefits over both HP and TAZ by week 2. J Drugs Dermatol. 2018;17(8):863-868.

Topics: Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Drug Compounding; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Time Factors; Treatment Outcome; Vasoconstrictor Agents

To assess the efficacy, safety, and cost-effectiveness of all-trans retinoic acid/Clobetasol Propionate Compound Ointment and calcipotriol/betamethasone dipropionate ointment in the treatment of mild-to-moderate patients with psoriasis vulgaris. This was a randomized, single-blind, multicenter clinical trial. A total of 240 patients were randomized to receive twice-daily all-trans retinoic acid/Clobetasol Propionate Compound Ointment (treatment group) or once-daily calcipotriol/betamethasone dipropionate ointment (control group) for 4 weeks. The efficacy, safety, and cost-effectiveness were assessed at Weeks 2 and 4. After 4 weeks, both groups showed a significant clinical improvement compared to baseline (88.33% vs. 89.83%, respectively, p = .7112). But PASI 75 response in the treatment group was superior to the control group (44.12% vs. 28.57%, respectively, p = .0200), at Week 4. SSRI improvement rate in the treatment group was also superior to control group (67.11% vs. 59.43%, respectively, p = .0119) at Week 4. All-trans retinoic acid/Clobetasol Propionate Compound Ointment showed a significant clinical improvement in erythema, infiltration, and scales of skin lesions and PASI score compared to baseline. 1.67% of patients (treatment group) reported adverse reactions compared to 2.50% (control group) with no statistical significance. In addition, the cost-effectiveness assessment showed a higher cost-effectiveness of the treatment group compared to the control group in 4 weeks (199.25 vs. 801.51). All-trans retinoic acid/Clobetasol Propionate Compound Ointment was effective and safe in the treatment of psoriasis vulgaris with similar efficacy as calcipotriol/betamethasone dipropionate ointment and lower treatment costs.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Clobetasol; Cost-Benefit Analysis; Dermatologic Agents; Drug Combinations; Female; Humans; Keratolytic Agents; Male; Middle Aged; Ointments; Psoriasis; Severity of Illness Index; Single-Blind Method; Tretinoin; Young Adult

Topical corticosteroids (TCS) are the mainstay of psoriasis treatment; long-term safety concerns limiting consecutive use of potent TCS to 2-4 weeks.. Investigate safety and efficacy of halobetasol propionate 0.01% lotion in moderate-to-severe plaque psoriasis.. Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in Investigator Global Assessment [IGA] score and 'clear' or 'almost clear') at week 8. Safety and treatment emergent adverse events (AEs) evaluated throughout.. Halobetasol propionate 0.01% lotion demonstrated statistically significant superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on vehicle (P less than 0.001). Halobetasol propionate 0.01% lotion was also superior in reducing psoriasis signs and symptoms, body surface area (BSA), and improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated with no treatment-related AEs greater than 1%.. Study did not include subjects with BSA greater than 12.. Halobetasol propionate 0.01% lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, without the safety concerns of a longer treatment course. J Drugs Dermatol. 2018;17(10):1062-1069.

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Skin Cream; Treatment Outcome; United States

Background: A unique fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion has been shown to be effective in psoriasis using Investigator Global Assessment (IGA) tools to assess erythema, plaque elevation, and scaling. However, these do not consider changes in Body Surface Area (BSA). The IGAxBSA composite tool is a simple, effective, validated alternative for measuring improvement in psoriasis severity. It correlates well with the Psoriasis Area and Severity Index (PASI) and demonstrates sensitivity to changes from baseline in patients with both mild and moderately severe disease.\ Objective: To further define the role of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis using the IGAxBSA composite tool.\ Methods: Post hoc analysis of 212 patients with moderate-to-severe plaque psoriasis randomized (2:2:2:1) to HP/TAZ lotion, HP, TAZ, or vehicle once-daily for 8 weeks, with a 4-week posttreatment follow-up. Efficacy assessments using the validated IGAxBSA composite tool.\ Results: HP/TAZ lotion demonstrated statistically significant superiority at week 8 (versus TAZ and vehicle) and week 12 (versus HP, TAZ, and vehicle). By week 8, HP/TAZ lotion achieved a 63.5% reduction in mean IGAxBSA composite score (P<0.001 versus TAZ and vehicle), that was sustained four weeks posttreatment (P<0.001 versus TAZ and vehicle and P=0.003 versus HP). A 25% and 50% improvement in IGAxBSA was achieved within 1.9 and 4.6 weeks, respectively, and 47.5% of patients achieved IGAxBSA-75 by week 8.\ Limitations: This post hoc analysis was limited to patients with moderate-to-severe plaque psoriasis with IGA ≥3 and BSA involvement (3%-12%).\ Conclusions: HP/TAZ lotion was associated with significant and rapid reductions in disease severity as assessed by the IGAxBSA composite tool. The addition of tazarotene affords sustained benefits posttreatment.\ J Drugs Dermatol. 2018;17(12):1290-1296.

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Drug Combinations; Emulsions; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Treatment Outcome

Atopic dermatitis (AD) presents a large unmet need for treatments with better safety and efficacy. To facilitate development of topical therapeutics, we need an efficient model for assessing different formulations and concentrations. The "plaque model" has been successfully implemented in patients with psoriasis, another common inflammatory disease, to assess the efficacy of topical treatments. This model has not been validated for AD, which has higher placebo responses and less stable lesions than psoriasis.. We aimed to assess changes in molecular signatures of intrapatient target lesions treated with topical therapeutics.. We enrolled 30 patients with mild-to-moderate AD in a randomized, double-blind, intraindividual comparison of 3 approved agents applied blindly at the investigator site daily for 14 days: pimecrolimus, betamethasone dipropionate, clobetasol propionate, and a vehicle/emollient control. Changes in total sign scores (TSSs), transepidermal water loss, and tissue biomarkers (determined by using RT-PCR and immunohistochemistry) were evaluated.. TSSs showed improvements of 30%, 40%, 68%, and 76% at 2 weeks with vehicle, pimecrolimus, betamethasone, and clobetasol, respectively, with parallel changes in transepidermal water loss (P < .05). Significant differences versus vehicle values were limited to steroids (P < .0001). Steroids (particularly clobetasol) restored epidermal hyperplasia and terminal differentiation versus minimal changes with vehicle or pimecrolimus (P < .001). Levels of cellular infiltrates and cytokines (IL-13, IL-22, and S100As) were similarly reduced only by steroids (P < .001). TSS improvement correlated with changes in hyperplasia, infiltrates, and differentiation markers.. We detected significant clinical and tissue differences between agents, providing a novel approach to study the differential effects of topical formulations using a limited sample size.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Biomarkers; Cell Differentiation; Clobetasol; Cytokines; Dermatitis, Atopic; Female; Humans; Hyperplasia; Male; Middle Aged; Placebo Effect; Psoriasis; Skin; Tacrolimus; Young Adult

BACKGROUND: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Treatment options focus on relieving symptoms, reducing inflammation, induration, and scaling, and controlling the extent of the disease. Topical corticosteroids are the mainstay of treatment, however long-term safety remains a concern, particularly with the more potent formulations. Combination therapy with a corticosteroid and tazarotene may improve psoriasis signs at a lower corticosteroid concentration providing a superior safety profile.. To investigate the efficacy and safety of a once-daily application of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion in comparison with its monads and vehicle in subjects with moderate-to-severe plaque psoriasis.. Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Subjects randomized (2:2:2:1 ratio) to receive HP/TAZ, individual monads, or vehicle, once-daily for 8 weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score and a score of 'Clear' or 'Almost Clear'), and impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion. Safety and treatment emergent adverse events (TEAEs) were evaluated throughout.. HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as 2 weeks. At week 8, 52.5% of subjects had treatment success compared with 33.3%, 18.6%, and 9.7% in the HP (P=0.033), TAZ (P less than 0.001), and vehicle (P less than 0.001) groups, respectively. HP/TAZ lotion was superior to its monads and vehicle in reducing the psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. At week 8, a 2-grade improvement in IGA was achieved by 54.2% of subjects for erythema, 67.8% for plaque elevation, and 64.4% for scaling. Most frequently reported TEAEs were application site reactions, and were more likely associated with the tazarotene component. Side effects such as skin atrophy were rare.. HP/TAZ lotion was consistently more effective than its monads or vehicle in achieving treatment success and reducing psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. Safety data were consistent with the known safety profile of halobetasol propionate and tazarotene, and did not reveal any new safety concerns with the combination product.

J Drugs Dermatol. 2017;16(3):197-204.

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Glucocorticoids; Humans; Male; Nicotinic Acids; Pharmaceutical Vehicles; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

BACKGROUND: A novel lotion formulation of halobetasol propionate, 0.05% (HBP Lotion) with enhanced vehicle characteristics of a cream while preserving the ease of use and cosmetic elegance of a lotion has been developed to treat plaque psoriasis.. Determine the safety and effectiveness of HBP Lotion in patients with plaque psoriasis.. Two prospective, randomized, vehicle-controlled clinical studies were conducted in 443 adult subjects with moderate-severe plaque psoriasis. Subjects applied the test article to psoriatic plaques within the treatment area twice daily for 14 days. Efficacy data are based upon treatment "success" defined as those subjects that achieved scores of 0=clear or 1=almost clear with at least a two-grade improvement relative to baseline for an Investigator's Global Assessment (IGA) and clinical signs (plaque elevation, erythema, scaling). Safety data are presented as adverse events and local skin reactions.. After two weeks of treatment with HBP Lotion, 44.5% of the HBP Lotion treated subjects in each study achieved (a) treatment "success" (ie, an IGA score of 0=clear or 1=almost clear and >2 grade improvement compared to baseline) and (b) a notable reduction in plaque elevation, erythema, scaling, and pruritus. In contrast, only 6.3% and 7.1% of VEH subjects in Studies 1 and 2, respectively, achieved treatment success and the reduction of disease related signs was materially lower. Statistically, at day 15 in both Phase 3 studies, treatment success with HBP Lotion was superior to VEH (P less than 0.001). From a safety perspective the outcomes were in general unremarkable with similar findings in the HBP Lotion and VEH treatment groups.. The results demonstrate the safety and effectiveness of HBP Lotion in the treatment of plaque psoriasis. Furthermore, this novel HBP lotion formulation is also distinguished by its moisturization qualities and ease of use.

J Drugs Dermatol. 2017;16(3):234-240.

Topics: Administration, Cutaneous; Adult; Clobetasol; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Pharmaceutical Vehicles; Prospective Studies; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Attempts to use topical cyclosporine in treatment of psoriasis have failed because of unfavorable physicochemical properties and inappropriate formulation design of the conventional dosage forms.. To evaluate the efficacy of topical cyclosporine using liposomal nanocarriers (lipogel) in limited chronic plaque psoriasis.. A single-center randomized clinical trial was conducted using a 3-arm parallel group, double-blind, vehicle and active comparator design and included 38 patients with chronic plaque psoriasis measuring less than or equal to 100 cm2 performed in a tertiary care hospital.. In the first arm, a total of 24 patients were randomized to receive either cyclosporine lipogel, 2.0% weight by weight (w/w), or placebo lipogel. In the second arm, 7 patients were randomized to receive cyclosporine lipogel, 2.0%, or conventional cyclosporine cream, 2.0% w/w. The third arm comprised 7 patients randomized with cyclosporine lipogel, 2.0% or standard clobetasol propionate cream, 0.05% w/w. Patients were examined twice weekly for 14 weeks, or until total lesional clearance was observed, whichever was earlier.. The primary outcome measure was the dermatological sum score (DSS) assessing erythema, scaling, and plaque elevation on a 4-point scale (0, absent; 1, minimal; 2, moderate; 3, severe).. In 38 patients (23 men and 15 women with a mean [SD] age range from 35 [8] to 40 [13] years), a 19% decrease in DSS score from a mean (SD) of 8.45 (0.67) to 6.82 (0.77) compared with baseline was observed after 2 weeks of treatment with cyclosporine lipogel, 2.0% w/w (P < .001; 95% CI, 13.77-24.51) in 59% of psoriasis lesional sites. At the end of the eighth week, a significant reduction (approximately 83%) in DSS was seen in all sites treated with cyclosporine lipogel, (P < .001; 95% CI, 77.48-88.22). At the end of the study period, complete clearance (ie, DSS = 0) was observed in 16 (41%) psoriasis lesional sites treated with cyclosporine lipogel, 85.7% of sites treated with clobetasol propionate cream, and none of the sites treated with conventional cyclosporine cream or placebo gel.. Topical liposomal formulation of cyclosporine, 2.0% w/w, is effective in treatment of limited chronic plaque psoriasis with a satisfactory safety profile. Future clinical trials should assess liposomal cyclosporine in larger study populations.. Clinical Trials Registry-India Identifier: CTRI/2011/12/002307.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Clobetasol; Cyclosporine; Dermatologic Agents; Double-Blind Method; Female; Gels; Humans; Liposomes; Male; Middle Aged; Nanostructures; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome; Young Adult

The combination of phototherapy and topical therapy is one of the most widely used treatment modalities for moderate to severe psoriasis. The development of targeted phototherapy with excimer laser and new topical spray formulations has made these therapies both more convenient and more effective. In this open label pilot study, we aim to assess the efficacy of combination therapy using 308-nm excimer laser, clobetasol propionate spray and calcitriol ointment for the treatment of moderate to severe generalized psoriasis.. In this 12-week study, patients with moderate to severe psoriasis received twice weekly treatment with XTRAC® Velocity 308-nm excimer laser combined with clobetasol propionate twice daily followed by calitriol ointment twice daily.. To date, 21 patients have completed the protocol. By week 12, 76% of the patients had a reduction in Psoriasis Area and Severity Index by at least 75% (PASI-75) and 52% had a Physicians Global Assessment of "clear" or "almost clear".. Excimer laser therapy combined with an optimized topical regimen that includes clobetasol spray followed by calictriol ointment appears to be an effective treatment for moderate to severe generalized psoriasis that avoids the risk of serious internal side effects associated with many systemic agents.

Topics: Administration, Cutaneous; Adult; Calcitriol; Clobetasol; Combined Modality Therapy; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Lasers, Excimer; Male; Ointments; Phototherapy; Pilot Projects; Psoriasis; Treatment Outcome

Topical corticosteroids are the most common first-line treatment for psoriasis. Tachyphylaxis, a decreased response to treatment with repetitive application of the drug, is a controversial phenomenon associated with topical corticosteroid treatment.. We sought to prove or disprove tachyphylaxis to occluded halobetasol 0.05% versus vehicle.. Patients with plaque psoriasis were recruited to this study. The study involved 3 phases (1, 2A, and 2B) with each phase being separated by a treatment vacation period. In phases 1 and 2A, 2 plaques were randomized to either halobetasol 0.05% or vehicle ointment application. In phase 2B, halobetasol 0.05% was applied to both. Target Lesion Severity Scale was used for clinical assessment.. Twenty patients were enrolled. No difference in time to clearance (P=.88) or time to recurrence (P=.92) of the treated plaques was found between phases 1 and 2A. Percentage of improvement was higher in phase 2A compared with phase 1 (89.4%, P<.05 vs 71%, P<.05), as a result of reduction of vehicle effect. In phase 2B, a greater improvement was found for previously corticosteroid-treated plaques.. Limitations are small sample size and 1 corticosteroid tested.. No evidence of tachyphylaxis to the topical corticosteroid halobetasol 0.05% ointment treatment in patients with plaque psoriasis was found.

Topics: Administration, Cutaneous; Adult; Clobetasol; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Pilot Projects; Psoriasis; Severity of Illness Index; Tachyphylaxis; Young Adult

Few clinical trials have evaluated the combination of topical corticosteroids plus systemic therapies for psoriasis.. We sought to evaluate efficacy and safety of etanercept plus topical clobetasol propionate (CP) foam versus etanercept monotherapy for treatment of moderate to severe plaque psoriasis.. Adults with Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 and psoriasis-affected body surface area greater than or equal to 10% were randomized to etanercept with CP as needed to clear (2 up-to-2-week courses, weeks 11-12 and 23-24) or etanercept alone (each arm at 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks).. A total of 592 patients enrolled (295 etanercept + CP arm; 297 etanercept arm). At week 12, significant differences were observed for response of 75% improvement in PASI score (primary end point, 65.2% vs 48.3% in the etanercept + CP vs etanercept arms, respectively; P < .001), response of 90% improvement in PASI score (29.7% vs 19.4%; P = .009), percentage PASI score improvement (76.5% vs 68.2%; P < .001), static physician global assessment of clear/almost clear (63.1% vs 47.3%; P < .001), and patient satisfaction with treatment (P = .006). Response of 75% improvement in PASI score and static physician global assessment of clear/almost clear were not significantly different between arms at week 24. Patient satisfaction with treatment (P = .001) and percentage improvement in PASI score (P = .031) were also greater in the etanercept + CP arm compared with etanercept only at week 24. Comparable numbers of adverse events occurred in each arm.. No placebo for CP foam was provided in the etanercept arm.. Addition of CP to etanercept yielded increased efficacy compared with etanercept alone at week 12 without an increase in treatment-related adverse events.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Body Surface Area; Clobetasol; Drug Therapy, Combination; Etanercept; Female; Humans; Immunoglobulin G; Male; Middle Aged; Patient Satisfaction; Psoriasis; Receptors, Tumor Necrosis Factor; Severity of Illness Index; Young Adult

One of the hurdles to effectively managing plaque psoriasis is lack of adherence to prescribed treatments. Up to 40% of subjects report they do not adhere to their medication for a variety of reasons. Earlier response to treatment may be a motivator for subjects to better adhere to treatment. Clobetasol propionate 0.05% spray (CPS) is a highly potent topical corticosteroid indicated for the treatment of moderate to severe plaque psoriasis that has efficacy as early as 1 week after initiating therapy. Using data from the 2 CPS pivotal trials, a post hoc analysis was performed to determine the relationship between week 1 improvements and week 4 treatment success (defined as a score of 0 [clear] or 1 [almost clear] in overall disease severity [ODS]). Improvements in week 1 ODS and pruritus were predictive of week 4 treatment success. Subjects who had ODS or pruritus scores of moderate or better at week 1 tended to be treatment successes at week 4 whereas no relationship between week 1 scores and week 4 treatment success was observed for those treated with vehicle spray. The results of this post hoc analysis indicate that early improvement correlates to treatment success.

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Double-Blind Method; Glucocorticoids; Humans; Pruritus; Psoriasis; Severity of Illness Index; Time Factors; Treatment Outcome

Clobetasol propionate 0.05% spray (CPS) is a topical, super-high-potent corticosteroid indicated for the treatment of moderate to severe plaque psoriasis. Two pivotal trials of CPS investigated the efficacy and safety of treatment in subjects with moderate to severe plaque psoriasis. Overall disease severity (ODS), erythema, plaque elevation, scaling, and pruritus were assessed on a 5-point scale of 0 (clear) to 4 (severe/very severe). Overall disease severity treatment success was de!ned as achieving a score of %2 at week 2 and a score of %1 at week 4. Treatment success for all other parameters was de!ned as achieving a score of %1 at all time points. Based on Cochran-Mantel-Haenszel analysis, treatment success was achieved in the CPS group in both studies compared with vehicle after 2 weeks, but not after 1 week. Only subjects who achieved treatment success were considered for analysis. Thus, subjects who did not meet the criteria for treatment success were not examined for improvement. A post hoc analysis was conducted using all the data and the median as the measure of central tendency. It was shown that ODS, erythema, plaque elevation, scaling, and pruritus improved by 1 grade from baseline at week 1 in subjects given CPS. The data presented here suggest CPS is effective in improving the signs and symptoms of plaque psoriasis 1 week after initiating treatment.

Topics: Administration, Topical; Adolescent; Adult; Aerosols; Aged; Anti-Inflammatory Agents; Clobetasol; Double-Blind Method; Female; Humans; Male; Middle Aged; Pruritus; Psoriasis; Skin; Treatment Outcome; Young Adult

Psoriasis is a hyperproliferative and inflammatory skin disorder that affects roughly 2 percent of the worldwide population. Clobetasol propionate is the most common corticosteroid used to treat moderate-to-severe psoriasis but the potential for side effects limits its long-term use. Topical vitamin D, which is used to treat mild-to-moderate psoriasis, has been shown to be safe when used daily for up to 52 weeks. To date, very few studies exist evaluating the use of clobetasol propionate in a regimen with calcitriol to manage moderate-to-severe disease over time.. To evaluate the efficacy and assess safety of a regimen of sequential topical treatments with clobetasol propionate 0.05% spray for up to four weeks followed by calcitriol 3 μg/g ointment for eight weeks in the management of moderate-to-severe plaque psoriasis.. This was a multi-center, open-label study in subjects aged 18-80 years with moderate-to-severe plaque psoriasis at baseline. Subjects applied clobetasol propionate 0.05% spray twice daily for up to four weeks. At the end of four weeks, if the subject's overall disease severity (ODS) was assessed as clear, almost clear, mild or moderate, subjects started treatment with calcitriol 3 μg/g ointment twice daily. Twice-daily treatment with calcitriol 3 μg/g ointment continued for eight weeks (until week 12) or unless the subject's ODS was assessed as severe or returned to the baseline score, at which time it was discontinued. Subjects were evaluated at baseline and at weeks 2, 4, 8 and 12.. Of the 305 subjects enrolled, 170 subjects completed the full 12-week study with no major protocol deviations and comprised the per-protocol (PP) study population. Treatment success, defined as at least one grade improvement in ODS at week 12 compared to baseline, was achieved in 84.1 percent of subjects. The percent body surface area affected (% BSA) decreased from 7.1 percent at baseline to 3.9 percent at week 12 (P<0.001). The sequential treatment regimen was well tolerated with no unexpected adverse events. Most reported adverse events and cutaneous irritations were mild in severity.. The results of this study indicate that the 12-week regimen of clobetasol propionate 0.05% spray treatment for four weeks immediately followed by an eight-week treatment phase with calcitriol 3 μg/g ointment is efficacious and safe for the management of moderate-to-severe plaque psoriasis.

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Calcitriol; Clobetasol; Disease Progression; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Psoriasis; Time Factors; Treatment Outcome; Vitamins

Palmoplantar psoriasis (PPP) produces significant morbidity and requires prompt treatment. Topical agents form the mainstay of therapy. We compared the efficacy and side-effect profile of a steroid/coal-tar combination with topical psoralen and solar ultraviolet A (PUVAsol) in PPP.. In total, 52 patients with PPP were randomized to receive either a combination of clobetasol propionate cream and coal tar daily (group 1) or topical PUVAsol on alternate days (group 2) for 16 weeks. Response was assessed as change in Psoriasis Activity and Severity Index (PASI) and Patient Global Assessment (PGA).. Of the 52 patients, 43 completed the treatment phase. There was a reduction in PASI for the palms and soles in both treatment groups throughout the treatment period until week 16. There was a greater reduction in PASI in palmar psoriasis with topical PUVAsol, and a greater reduction in psoriasis of the soles with the steroid/coal-tar combination. In both groups, patients perceived 'good improvement'. Improvement or cure in palmar lesions was observed in 90% of cases in the topical steroid/coal-tar group and in 75% of cases in the topical PUVAsol group; for the soles, these figures were 76% and 79%, respectively. No adverse effects were experienced with the steroid/coal-tar combination, whereas for the topical PUVAsol, phototoxicity occurred in 22% of cases.. Both treatments had comparable efficacy. In both groups, patients experienced 'good improvement' after 16 weeks of therapy.

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Child; Clobetasol; Coal Tar; Drug Therapy, Combination; Female; Foot Dermatoses; Hand Dermatoses; Humans; Keratolytic Agents; Male; Middle Aged; Psoriasis; PUVA Therapy; Severity of Illness Index; Young Adult

Clobetasol propionate 0.05% spray is available for treating moderate-to-severe plaque psoriasis; however, there is limited information with plaque psoriasis of the scalp.. Evaluate the efficacy, safety, and quality-of-life impact of clobetasol propionate 0.05% spray in patients with moderate to severe plaque psoriasis of the scalp.. Multicenter, randomized, double-blind, vehicle-controlled study involving 81 men and women with moderate-to-severe (Global Severity Score [GSS] = 3 or 4) plaque psoriasis of the scalp. Eligible patients were treated with clobetasol propionate 0.05% spray or vehicle spray, which was applied twice daily for up to four weeks. The primary efficacy end point was the GSS of psoriasis of the scalp after four weeks. Safety assessments included local tolerability, presence of Cushing's syndrome, and adverse events.. At the end of treatment, 85 percent (35/41) of patients in the clobetasol propionate 0.05% spray group achieved success (GSS clear or almost clear), compared with 13 percent (5/40) in the vehicle spray group (P is less than .001). The proportion of patients treated with clobetasol propionate 0.05% spray who achieved a rating of clear (GSS = 0) after two weeks and at the end of treatment was 12 percent and 51 percent, respectively. Clobetasol propionate 0.05% spray was well tolerated, and there were no serious adverse events or reported cases of folliculitis or Cushing's syndrome.. Treatment with clobetasol propionate 0.05% spray for up to four weeks is effective and well tolerated for moderate-to-severe plaque psoriasis of the scalp.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Clobetasol; Cushing Syndrome; Disease Progression; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis; Quality of Life; Scalp; Treatment Outcome

Psoriasis is a chronic condition with serious quality-of-life ramifications. Dermatologists seek alternative treatments of patients with plaque psoriasis that provide both efficacy and safety while minimizing exposure to high-potency steroids that can have adverse effects following long-term use. We report an open-label, multicenter study designed to evaluate a morning/evening (AM/PM) treatment regimen involving clobetasol propionate spray 0.05% and calcitriol ointment 3 microg/g for moderate plaque psoriasis. Participants applied clobetasol propionate spray 0.05% in the morning and calcitriol ointment 3 microg/g in the evening for up to 4 weeks. Participants were evaluated at baseline, week 2, and week 4. The results of this study indicate that a 4-week regimen of clobetasol propionate spray 0.05% treatment in the morning and calcitriol ointment 3 microg/g in the evening is efficacious and without unexpected safety issues for the management of moderate plaque psoriasis.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Calcitriol; Clobetasol; Drug Administration Schedule; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Ointments; Psoriasis; Treatment Outcome; Vitamins; Young Adult

High-potency topical corticosteroids are the cornerstone of psoriasis therapy. Although highly effective, long-term use of topical steroids can cause adverse side effects. Additionally, steroids alone do not address the multiple pathophysiologic factors that cause the disease. Psoriasis regimens that utilize high-potency steroids combined with nonsteroid-containing products such as vitamin D analogs have been used for many years to manage the disease, not only for the short-term treatment of the disease but also for long-term treatment to minimize the recurrence of symptoms. We report an open-label, multicenter study designed to evaluate a weekday/ weekend treatment regimen involving calcitriol ointment 3 microg/g and clobetasol propionate spray 0.05% for moderate plaque psoriasis. Participants applied calcitriol ointment 3 microg/g twice daily on the weekdays and clobetasol propionate spray 0.05% twice daily on the weekends for up to 4 weeks. Participants were evaluated at baseline, week 2, and week 4. The results of this study demonstrate that a 4-week regimen of calcitriol ointment 3 microg/g treatment on weekdays and clobetasol propionate spray 0.05% on weekends is effective and well-tolerated for the treatment of moderate plaque psoriasis.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Calcitriol; Clobetasol; Drug Administration Schedule; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Ointments; Patient Satisfaction; Psoriasis; Treatment Outcome; Vitamins; Young Adult

Safety and clinical effectiveness of clobetasol-17 propionate 0.05% shampoo have been shown in patients with scalp psoriasis.. First, to evaluate treatment satisfaction, user convenience safety and effectiveness of clobetasol-17 propionate 0.05% shampoo treatment in daily clinical practice. Second, to identify subgroup variables that may predict treatment success or failure.. A total of 56 patients with scalp psoriasis were treated with short-contact clobetasol-17 propionate 0.05% shampoo once daily for 4 weeks. Data on treatment satisfaction, user convenience, safety and effectiveness were assessed on a 7-point Likert scale using postal questionnaires. Subgroup analyses were performed to identify variables that may predict treatment outcome.. A total of 41 patients returned both questionnaires (73%). Positive treatment satisfaction and user convenience were reported by 66% and 79% of patients respectively. Patient-rated indicators for disease severity improved by 39-46% (P < 0.05%). No major side-effects were reported. Subgroup analyses did not reveal any statistically significant patient variable that may predict treatment outcome. However, a tendency towards improved treatment satisfaction was observed in patients who had received fewer topical antipsoriatic treatments previously (P > 0.05).. Short-contact treatment with clobetasol-17 propionate 0.05% shampoo has high user convenience and patient satisfaction rates. Moreover, the treatment is well-tolerated and efficacious from patients' perspective. Subgroup analyses did not reveal factors predicting treatment outcome, although treatment success tended to be more evident in patients who had received fewer treatments previously.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Clobetasol; Cross-Sectional Studies; Drug Administration Schedule; Female; Hair Preparations; Humans; Male; Patient Satisfaction; Psoriasis; Scalp Dermatoses; Severity of Illness Index; Surveys and Questionnaires

We evaluated in this study the efficacy and safety of an alternate regimen using clobetasol propionate 0.05% shampoo (CP shampoo) for long-term control of scalp psoriasis. Patients with moderate scalp psoriasis (Global Severity Score [GSS] of 3 on a 0-5 scale) first received CP shampoo once daily for 4 weeks. Patients with a GSS 2) occurred, patients received the 4-week daily CP shampoo treatment. Patients who had a GSS

Topics: Administration, Cutaneous; Adult; Clobetasol; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug-Related Side Effects and Adverse Reactions; Female; Follow-Up Studies; Hair Preparations; Humans; Long-Term Care; Male; Middle Aged; Patient Satisfaction; Probability; Psoriasis; Reference Values; Risk Assessment; Scalp Dermatoses; Severity of Illness Index; Treatment Outcome; Young Adult

Clobetasol propionate (CP) shampoo 0.05% is an efficacious and safe treatment for scalp psoriasis. The aim of this double-blind, randomized, placebo-controlled study was to determine if CP shampoo is suitable for long-term disease control. Participants with moderate to severe scalp psoriasis (global severity score [GSS] of 3 or 4 on a scale of 0 [clear] to 5 [very severe]) first received once daily CP shampoo treatment for up to 4 weeks. Responders were subsequently randomized to receive the CP shampoo or vehicle twice weekly maintenance regimen for up to 6 months. When relapse occurred (defined as GSS > 2), participants resumed once daily CP shampoo treatment; when symptoms diminished (GSS < or = 2), they readopted the twice weekly maintenance regimen. At all visits significantly more participants treated with CP shampoo did not relapse compared with participants treated with vehicle (P < .001). Only approximately one-third of participants treated with vehicle remained relapse free at 1 month, while this rate was observed approximately 3.5 months later (4.5 months after baseline of maintenance phase) in the CP shampoo group. After 6 months 31.1% (33/106) of participants in the CP shampoo group were still relapse free versus 8.1% (9/111) of participants in the vehicle group. There was no greater incidence of skin atrophy, telangiectasia, or hypothalamic-pituitary-adrenal (HPA) axis suppression in the CP shampoo group compared with the vehicle group. Clobetasol propionate shampoo is efficacious and safe for acute management and long-term maintenance of moderate to severe scalp psoriasis.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Clobetasol; Double-Blind Method; Female; Glucocorticoids; Hair Preparations; Humans; Male; Middle Aged; Psoriasis; Recurrence; Scalp Dermatoses; Severity of Illness Index; Time Factors; Treatment Outcome; Young Adult

Clobetasol propionate shampoo is effective and safe in treatment of scalp psoriasis (SP). Gene expression profiling of psoriatic skin biopsies led to the identification of numerous disease-related genes. However, it remained unknown whether the gene expression profile of hair follicles of SP patients was also affected.. To determine whether psoriasis-related genes are differentially regulated in the hair follicles of SP patients and whether the modulation of these genes can be correlated with clinical severity scores.. A single arm, open study was conducted in three centres. SP patients received daily treatment with clobetasol propionate shampoo. At Baseline, Weeks 2 and 4, investigators assessed clinical severity parameters and collected scalp hair follicles in anagen phase. Total RNA extracted from hair follicles was used to determine the expression level of 44 genes, which were reported previously to be upregulated in the skin of psoriasis patients.. RNA of good quality and sufficient quantity was obtained from hair follicles of psoriasis patients and healthy volunteers (HV). The expression level of 10 inflammation-related genes was significantly increased in psoriatic hair follicles. The patient's exploratory transcriptomic score, defined as the mean fold modulation of these 10 genes compared with HV, correlated with clinical severity scores. Clobetasol propionate shampoo was effective in decreasing both the exploratory transcriptomics and the clinical severity scores.. Hair follicles of SP patients are affected by the inflammatory process. The change in the expression level of inflammation-related genes correlates with the severity of the disease.

Topics: Adult; Biomarkers; Clobetasol; Dermatitis; Drug Resistance; Gene Expression; Gene Expression Profiling; Glucocorticoids; Hair Follicle; Hair Preparations; Humans; Psoriasis; Scalp; Severity of Illness Index

Alefacept has an established efficacy and safety profile for 12 weeks of treatment of severe chronic plaque type psoriasis. The effectiveness and safety of longer-term continuous use is not well characterized.. Fifteen subjects with moderate-to-severe chronic plaque type psoriasis were given weekly 15 mg alefacept injections for 16 consecutive weeks followed by monthly 15 mg injections for up to eight consecutive months, along with clobetasol propionate spray 0.05% twice daily for the first four weeks. Disease severity was measured using the Psoriasis Area and Severity Index (PASI) and the Investigator Global Assessment (IGA).. Mean PASI scores improved 33 percent overall during the first month with combination treatment. There was an overall 21 percent worsening in PASI scores after the transition from weekly to monthly medication administration. Of the 15 initially enrolled patients, 27 percent achieved PASI 75 by end of study. No patients achieved an IGA of 0 or 1 by end of study. Two major adverse events were reported: low CD4 count and severe allergic dermatitis.. Topical clobetasol propionate 0.05% was only partially effective at augmenting the early treatment effect of alefacept. The authors did not observe marked benefit or major side effects by continuing additional monthly alefacept treatments beyond 16 weeks of weekly treatment.

Topics: Alefacept; Anti-Inflammatory Agents; Clobetasol; Dermatologic Agents; Drug Administration Schedule; Female; Humans; Male; Pilot Projects; Psoriasis; Recombinant Fusion Proteins; Severity of Illness Index; Time Factors; Treatment Outcome

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

Scalp psoriasis has a considerable impact on the quality of life (QOL) of patients, and most patients are dissatisfied with available treatments. Clobetasol propionate shampoo 0.05% has been shown to be effective and safe for moderate to severe scalp psoriasis. We evaluated the effect of clobetasol propionate shampoo on QOL and the degree of participant satisfaction with the product. Participants received once-daily treatment for up to 4 weeks. Their QOL and degree of satisfaction were evaluated by questionnaires. The mean (standard deviation) Dermatology Life Quality Index (DLQI) score decreased significantly from 7.0 (4.9) at baseline to 3.2 (3.2) at week 4 (P<.001). Participants who considered the disease as having a small effect or no effect on their QOL increased from 45.6% at baseline to 81.7% at week 4. Most participants were satisfied with the cosmetic acceptability and the efficacy and safety aspects of the product, considered it better than prior treatments, and would use it again in the future. Therefore, we conclude that treatment with clobetasol propionate shampoo improved the QOL of participants and resulted in high satisfaction.

Topics: Administration, Cutaneous; Clobetasol; Double-Blind Method; Female; Glucocorticoids; History, 17th Century; Humans; Male; Patient Satisfaction; Psoriasis; Quality of Life; Scalp Dermatoses; Surveys and Questionnaires; Treatment Outcome

This study compared the efficacy of a novel, topical class I synthetic, 0.10% fluocinonide corticosteroid with two other class I corticosteroids and placebo for the treatment of plaque psoriasis.. A 0.5 gram dose of fluocinonide 0.1% cream, clobetasol propionate 0.05% cream, halobetasol propionate 0.05% cream, and placebo ointment were applied to test sites on one psoriatic plaque per patient (n=5). Test sites were outlined according to the Scholtz-Dumas bioassay. Test sites were assessed by a blinded evaluator (1 = psoriasis worsened to 5 = psoriasis clear or almost clear), cleaned and medications were reapplied on days 3, 5, 7, 10 and 12.. The three class I corticosteroid products were comparably effective, numerically and statistically, in clearing the psoriatic plaques. Upon completion of treatment, 60-80% of active-treated sites were clear or almost clear of psoriasis compared to zero with the placebo.

Topics: Administration, Cutaneous; Aged, 80 and over; Biological Assay; Clobetasol; Dermatologic Agents; Female; Fluocinonide; Glucocorticoids; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Single-Blind Method; Treatment Outcome

The aim of the present study was to evaluate through ultrasound imaging the response to treatment of twice and once daily application of clobetasol propionate 0.05% foam on psoriatic skin as well as the atrophogenic potential of once daily application of the foam on healthy skin. The study included a total of 40 participants, 30 affected by Psoriasis vulgaris and 10 healthy volunteers. Patients with psoriasis were branched in two groups of 15 subjects: in the first group, clobetasol propionate 0.05% foam was applied twice daily for up to 2 weeks on targeted plaques, in the second group, it was applied once daily for up to 4 weeks. Ten healthy adult volunteers were instructed to apply the foam to a 4 x 4 cm area on the volar aspect of the forearm once daily for 4 weeks. Ultrasound evaluation was performed in all treated areas using a 20-MHz B-mode high-resolution system (EasyScan Echo), Business Enterprise, Trapani, Italy). At the end of the study, ultrasound showed a reduction of psoriatic skin thickness, with values equal to those of adjacent healthy skin, in all treated plaques. No differences in treatment efficacy between the two groups of patients with psoriasis were observed. As regards the healthy group, no ultrasound variations in skin thickness were observed at the end of the study. Ultrasound imaging, allowing an objective and reproducible measurement of skin thickness, is a useful technique for a noninvasive evaluation both of the efficacy of psoriasis treatment and of the potential side effects of topical corticosteroids.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Clobetasol; Female; Humans; Male; Middle Aged; Pilot Projects; Psoriasis; Skin; Treatment Outcome; Ultrasonography; Young Adult

Moderate to severe psoriasis often requires systemic treatment, but even biologic medications do not always induce complete clearing in patients. In many instances, physicians supplement biologic treatment with topical agents as adjunctive therapy to obtain additional clearing of plaques. To evaluate the effectiveness of the addition of a superpotent corticosteroid--clobetasol propionate spray 0.05%--to various psoriasis treatments, a phase 4, multicenter, open-label, community-based trial was conducted. In this study, clobetasol propionate spray 0.05% applied twice daily was added on to a variety of existing stable treatments including systemic biologic agents in participants with moderate, severe, or very severe plaque psoriasis. The decision to add clobetasol propionate spray 0.05% to stable psoriasis therapy was determined by each investigator based on his/her evaluation of a participant's needs. A total of 159 participants from the trial adhered to stable (> or = 3 months' duration) therapeutic regimens that included a biologic treatment. In this population, at the end of the study period, 81.0% of participants with moderate disease at baseline, 79.5% of participants with severe disease at baseline, and 58.8% of participants with very severe disease at baseline were rated as clear or almost clear (target plaque severity [TPS]). Worst skin tolerability response was assessed postbaseline and included erythema (20.3% mild, 8.9% moderate, 1.9% severe), peeling (26.6% mild, 7.0% moderate, 1.3% severe), dryness (34.8% mild, 8.9% moderate, 1.3% severe), and stinging (25.3% mild, 3.8% moderate, 0.6% severe). Telangiectasia and skin atrophy were reported in 1.3% of participants each at some point during the study (postbaseline). Pruritus was reported in 7.6% of participants and folliculitis was reported in 1.9% of participants. Eight participants experienced adverse events (AEs) that were regarded as probably related to the study medication (clobetasol propionate spray 0.05%). Because those participants who entered the study already were receiving one medication (the biologic agent), it is believed that most of the reported AEs were due to the addition of clobetasol propionate spray 0.05%, and those AEs associated with the biologic agent and/or the combination of the two may be underreported. Although the results of this study are intriguing, further research is needed to evaluate if the addition of topical therapies, such as superpotent corticosteroids, are

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Biological Products; Clobetasol; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Psoriasis; Quality of Life; Severity of Illness Index; Young Adult

Clobetasol propionate 0.05% emulsion foam was recently developed for use on multiple body sites.. We sought to evaluate safety and efficacy of clobetasol emulsion foam 0.05% to treat steroid-responsive dermatoses in multiple age groups.. A phase II open-label study evaluated the effect of clobetasol foam on the hypothalamic-pituitary-adrenal axis in 52 participants aged 6 years or older with mild-to-severe atopic dermatitis (AD). Cosyntropin stimulation test was used to determine the effect of clobetasol foam on hypothalamic-pituitary-adrenal axis, with a normal response considered to be a postinjection serum cortisol level greater than 18 mug/dL. Another phase II open-label pharmacokinetic safety study was conducted in 32 participants aged 12 years or older with mild-to-moderate plaque-type psoriasis. Pharmacokinetic parameters evaluated included maximal plasma concentration of clobetasol propionate, time to achieve maximum concentration, and area under the curve. Two phase III, randomized controlled studies assessed treatment success in participants aged 12 years or older with moderate-to-severe AD (N = 377) or mild-to-moderate plaque-type psoriasis (N = 497). In all studies, participants received study drug for 2 weeks. In the AD study, treatment success was determined using a composite end point requiring an Investigator's Static Global Assessment (ISGA) score of 0 or 1, erythema score of 0 or 1, induration/papulation score of 0 or 1, and improvement in the ISGA score of at least two grades from baseline. Likewise, the study in plaque-type psoriasis used a composite end point requiring an ISGA score of 0 or 1, erythema score of 0 or 1, scaling score of 0 or 1, plaque thickness score of 0, and improvement in the ISGA score of at least two grades from baseline.. Significantly more participants achieved treatment success on clobetasol foam than vehicle foam (P < .0001 and P = .0005 for each study). Reversible hypothalamic-pituitary-adrenal axis suppression was observed in 27% of participants aged 18 years or older and 47% in participants aged between 6 and younger than 12 years, but 0% in participants aged between 12 and younger than 18 years.. The studies evaluated short-term use only.. Clobetasol emulsion formulation foam is safe and effective for treatment of moderate-to-severe AD and mild-to-moderate plaque-type psoriasis in patients aged 12 years or older.

Topics: Administration, Cutaneous; Adolescent; Adrenal Insufficiency; Adult; Age Factors; Aged; Area Under Curve; Biological Availability; Child; Clobetasol; Cosyntropin; Dermatitis, Atopic; Emulsions; Humans; Hydrocortisone; Immunosuppressive Agents; Middle Aged; Pituitary-Adrenal Function Tests; Psoriasis; Treatment Outcome

Two advanced formulations of clobetasol propionate (CP) 0.05% (Clobex Spray; Galderma Laboratories, L.P., Fort Worth, TX, USA and Olux Foam; Stiefel/Connetics Corp., Coral Gables, FL, USA) were compared in a study of 77 randomized patients with moderate to severe plaque psoriasis. At the end of the treatment period (2 weeks for CP foam or up to 4 weeks for CP spray per product labeling), patients treated with CP spray had a median 64% reduction in affected body surface area (BSA) compared to a median 25% reduction in patients treated with the CP foam (p = 0.004). Also at the end of the treatment period, 22% of CP spray-treated patients were completely clear compared to 5% of CP foam-treated patients (p = 0.04). Improvements in quality of life as determined by the Dermatology Life Quality Index were statistically significantly greater at all time points for patients treated with CP spray compared to patients treated with CP foam (p<0.04 for all). The majority of adverse events for both products were mild in severity. Thus, while both of these formulations contain the same active ingredient at the same concentration, differences in their efficacy were observed when each treatment was used within its approved labeling guidelines.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; California; Chemistry, Pharmaceutical; Clobetasol; Dermatologic Agents; Drug Compounding; Drug Delivery Systems; Female; Glucocorticoids; Humans; Male; Middle Aged; Patient Satisfaction; Prospective Studies; Psoriasis; Severity of Illness Index; Time Factors; Treatment Outcome

Topics: Administration, Topical; Clobetasol; Dermatologic Agents; Double-Blind Method; Humans; Keratolytic Agents; Nail Diseases; Nicotinic Acids; Psoriasis

To establish the efficacy of clobetasol propionate foam 0.05% in patients with plaque-type psoriasis and scalp psoriasis.. We conducted an open-label study on 24 patients. Twelve patients affected by plaque-type psoriasis (group 1) and 12 patients with scalp psoriasis (group 2) applied clobetasol propionate foam 0.05% twice daily for 4 weeks.. Clobetasol propionate foam 0.05% led to a reduction of the disease severity. After 2 weeks the PASI score decreased from 7.5 at baseline to 2.5 (range: 0.8-4.6, SD: 1.1) in group 1 and from 5.7 to 1.7 (range: 0.2-4.8, SD: 1.1) in group 2. At week 4, the mean PASI was 2 (range: 0.6-4, SD: 1) and 1.1 (range: 0.2-2.2, SD: 0.6) in groups 1 and 2, respectively. In particular, at week 2, 83.3% of patients with plaque psoriasis and 75% with scalp psoriasis achieved an improvement of the PASI score from baseline> or =50% (PASI-50). At week 4, 91.6% of patients from group 1 and 100% from group 2 achieved or maintained PASI-50, while 41.6% in group 1 and 58.3% in group 2 demonstrated a further improvement, reaching PASI-75.. The rapidity of effect and the good safety profile suggest a role for clobetasol propionate foam 0.05% in the management of both plaque-type and scalp psoriasis.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Chemistry, Pharmaceutical; Clobetasol; Female; Humans; Male; Middle Aged; Psoriasis; Scalp; Severity of Illness Index; Treatment Outcome

The goal of psoriasis therapy is shifting from an emphasis on the short-term management of severe outbreaks to the maintenance of continuous long-term control. Topical corticosteroids play an important role in all of the therapeutic strategies used. The Clobex Spray Community-Based Research Assessment (COBRA) trial involved 455 community dermatologists throughout the United States who participated in a multicenter, 4-week, open-label, observational, community-based trial of twice-daily clobetasol propionate spray 0.05% as monotherapy or as an addition to a treatment regimen present at the time of study entry. Dermatologists were allowed to select study participants based on their own professional judgment, which resulted in the largest number of study participants ever enrolled in a psoriasis community-based trial, with 2488 subjects enrolled from 455 investigational sites. Of the total population, 1254 subjects with moderate to severe plaque psoriasis treated with clobetasol propionate spray 0.05% twice daily as monotherapy and 731 subjects treated with clobetasol propionate spray 0.05% twice daily in addition to an existing regimen were evaluated for efficacy with at least one follow-up visit. Data from this trial suggest that superpotent topical corticosteroids are appropriate for use as monotherapy and when added to existing therapeutic regimens. The effectiveness and tolerability results from this study suggest that clobetasol propionate spray 0.05% is a potent, well-tolerated, and versatile topical therapy for moderate to severe plaque psoriasis that may be used in a diverse range of settings to help dermatologists optimize response to therapy.

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

The Clobex Spray Community-Based Research Assessment (COBRA) trial, a large, 4-week, open-label, observational trial, evaluated the use of twice-daily clobetasol propionate spray 0.05% in subjects with moderate to severe plaque psoriasis affecting 3% to 20% body surface area (BSA). The study was designed to augment existing phase 3 clinical trial data. In this trial, 1254 subjects in the effectiveness-evaluable (EE) population were treated with clobetasol propionate spray 0.05% as monotherapy. Clinical effectiveness was evaluated at weeks 2 and 4 using a 6-point target plaque severity (TPS) scale and 7-point investigators' global assessment of improvement (GAI) scale. Psoriasis TPS at week 0 (baseline) was rated as moderate to severe in more than 90% of subjects. After 2 weeks of clobetasol propionate spray 0.05% monotherapy, statistically significant improvement in TPS was seen at weeks 2 and 4 (P < .001). In addition, statistically significant improvement was seen at week 4 versus week 2 (P < .001) using the GAI scale. Clobetasol propionate spray 0.05% monotherapy was well-tolerated as assessed by erythema, peeling/scaling, dryness, stinging/burning, telangiectasia, skin atrophy, pruritus, and folliculitis. Skin and subcutaneous tissue disorders as well as general disorders and application-site conditions defined as possibly or probably related to therapy occurred in 1.0% and less than 1.0% of subjects, respectively. In addition, more than 90% of subjects were reported by investigators as being very satisfied or somewhat satisfied with their treatment at week 4. Based on these data, clobetasol propionate spray 0.05% is an effective and convenient topical monotherapy for moderate to severe plaque psoriasis.

Topics: Administration, Topical; Adult; Aged; Clobetasol; Female; Glucocorticoids; Humans; Male; Middle Aged; Patient Satisfaction; Psoriasis; Quality of Life; Severity of Illness Index; Skin; Treatment Outcome

Controlled clinical trials provide important information about medications. However, although controlled clinical trials typically assess the use of a medication by itself or in a single combination, combinations and adjunctive use of multiple medications frequently are used in the care of patients with psoriasis. The Clobex Spray Community-Based Research Assessment (COBRA) trial, a large, 4-week, open-label, observational, community-based trial, assessed the use of twice-daily clobetasol propionate spray 0.05% as an add-on therapy to an existing therapeutic regimen in subjects (n = 731) with moderate to severe plaque psoriasis affecting 3% to 20% body surface area (BSA). The key outcome measures were the change in target plaque severity (TPS) and investigators' global assessment of improvement (GAI) at week 4. Tolerability, quality of life (QOL), and subject satisfaction also were assessed. After 4 weeks of treatment, 80.0% of subjects in the add-on therapy group were clear or almost clear, according to the TPS scale, or had an improvement in severity from baseline by 2 grades (P < .001); 62.0% of subjects were completely cleared or almost completely cleared at week 4 according to the GAI scale (P < .001). Tolerability ratings of severe for erythema, peeling/ scaling, dryness, and stinging/burning occurred in less than 1.0% of subjects at week 4, and a rating of moderate occurred in only 1.6% to 4.1% of subjects. In addition, 94.0% of subjects in the add-on therapy group were reported as being very satisfied or somewhat satisfied with their therapy at week 4. Clobetasol propionate spray 0.05% was highly effective and well-tolerated as part of a wide range of therapeutic strategies.

Topics: Administration, Topical; Adult; Aged; Clobetasol; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Patient Satisfaction; Psoriasis; Quality of Life; Severity of Illness Index; Skin; 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

Studies show that pulsed dye laser (PDL) has some clinical benefits on psoriasis with a low clearance rate. In addition, it has been suggested that applying keratolytics before treatment might be helpful in PDL therapy. Topical corticosteroids remain the most commonly prescribed agents for psoriasis.. This study was designed to compare the efficacy of the PDL treatment with that of PDL treatment after salicylic acid on psoriatic plaques. The other goal of this study was to compare the efficacy of the PDL treatment with that of clobetasol propionate treatment.. Twenty-two patients with chronic, stable psoriatic plaques that involved less than 20% of their body were included in the study. Three similar-appearing psoriasis plaques in these patients were selected. Whereas the first plaque received only PDL, the second plaque received PDL after salicylic acid, and the third plaque received clobetasol propionate ointment and salicylic acid. Evaluation of the study plaques was carried out by the modified Psoriasis Area and Severity Index (mPASI) score and by measuring the area of the plaques.. Of the 21 patients, 19 completed the study. Although the decrease in mPASI scores was determined to be maximum for clobetasol propionate + salicylic acid-treated plaques and minimum for only PDL-treated plaques, the decrease was statistically significant in all groups when compared with baseline (p < .003). At the 3- and 6-week evaluations, there was a statistically significant difference between clobetasol propionate + salicylic acid-treated plaques and the two PDL-treated plaques (p < .003); however, the difference observed at the 9-, 12-, and 15-week evaluations was statistically significant only between clobetasol propionate + salicylic acid-treated plaques and PDL-treated plaques (p < .003). When the baseline and 15-week evaluations were compared, there was no statistically significant increase in the mean lesion areas of clobetasol propionate + salicylic acid-treated psoriatic plaques (p > .003), but there was a statistically significant increase in the mean lesion areas of two PDL-treated psoriatic plaques (p < .003).. The results of this study showed that the effect of PDL could be increased when salicylic acid was added to treatment, although there was no statistically significant difference between both treatment protocols. However, clobetasol propionate + salicylic acid treatment is more effective than both PDL and PDL + salicylic acid treatment.

Topics: Adult; Aged; Clobetasol; Combined Modality Therapy; Drug Therapy, Combination; Female; Follow-Up Studies; Glucocorticoids; Humans; Keratolytic Agents; Low-Level Light Therapy; Male; Middle Aged; Prospective Studies; Psoriasis; Salicylic Acid; Treatment Outcome

Clobetasol propionate is known to be a very effective treatment for psoriasis; however, its use is limited by potent corticosteroid class related side effects such as hypothalamic-pituitary-adrenal (HPA) axis suppression and atrophogenicity. The aim of this single-center, parallel group, randomized study was to assess the HPA axis suppression potential, atrophogenicity, and ocular tolerability of clobetasol propionate shampoo in 26 patients with scalp psoriasis. Suitable subjects were treated once daily for 4 weeks with clobetasol propionate shampoo, to be rinsed off after 15 minutes or with a leave-on clobetasol propionate gel. The study demonstrated that clobetasol propionate shampoo did not lead to HPA axis suppression or to skin atrophy. Conversely, the gel led to HPA axis suppression and a decrease in skin thickness. Neither formulation had an impact on ocular safety. Despite the short contact application time, the clobetasol propionate shampoo provides similar efficacy results to the gel.

Topics: Administration, Cutaneous; Adult; Atrophy; Clobetasol; Drug Administration Schedule; Female; Hair Preparations; Humans; Hypothalamo-Hypophyseal System; Male; Middle Aged; Ocular Physiological Phenomena; Pituitary-Adrenal System; Psoriasis; Scalp Dermatoses; Skin; Time Factors; Treatment Outcome

Plaque psoriasis affects about 2% of the US population. A new and unique spray formulation of clobetasol propionate (CP) 0.05% was developed to provide advantages over the currently available treatment formulations.. To evaluate the efficacy and safety of CP 0.05% spray compared to its vehicle in the treatment of moderate to severe plaque psoriasis.. A 4-week, single-center, randomized, double-blind, vehicle-controlled, intra-individual study in subjects with plaque psoriasis. Each of 2 target lesions per subject were randomized to receive either CP 0.05% spray or its vehicle twice daily over 4 weeks. Efficacy parameters included overall target plaque severity score, scaling, erythema, and plaque elevation at all visits. Adverse events were reported throughout the study.. A total of 27 subjects were enrolled in the study. At all visits there was a significant intra-individual treatment effect for the overall target plaque severity (P < .001) in favor of CP spray. Throughout the study, results for scaling, erythema, and plaque elevation were significantly (P < .001) in favor of CP spray. After 4 weeks of treatment, all intra-individual response measures, with the exception of erythema, showed an average difference in severity scores of more than 4 points (based on a 9-point scale) between the lesions treated with CP 0.05% spray and the lesions treated with vehicle. No serious adverse event occurred during the course of the study. One local adverse event at the application site (5%) was considered probably related to study medication.. CP 0.05% spray was effective and safe in reducing overall plaque severity, scaling, erythema, and plaque elevation from the first week of treatment continuing throughout the trial.

Topics: Adult; Aged; Anti-Inflammatory Agents; Clobetasol; Double-Blind Method; Drug Administration Schedule; Drug Delivery Systems; Female; Humans; Male; Middle Aged; Psoriasis; Skin; Time Factors; Treatment Outcome

The clinical benefit of currently available tar blend shampoos for the treatment of scalp psoriasis is restricted due to their limited efficacy, low cosmetic appeal and potential for carcinogenicity. This 4-week multicentre, randomized, parallel-group, investigator-masked study included 162 subjects and aimed to compare the efficacy, safety and cosmetic acceptability of clobetasol propionate 0.05% shampoo versus a currently marketed tar blend 1% shampoo in subjects with moderate to severe scalp psoriasis. Clobetasol propionate shampoo was superior to tar blend shampoo with respect to all efficacy variables tested (p<0.001): Total and Global Severity Score; erythema; plaque thickening; desquamation; pruritus; total scalp area involved; and the subject's global assessment of clinical improvement. Both treatments were safe and well-tolerated. Furthermore, more subjects indicated that clobetasol propionate shampoo was more cosmetically acceptable than tar blend shampoo. Clobetasol propionate 0.05% shampoo is a good alternative to tar blend shampoo in the treatment of moderate to severe scalp psoriasis.

Topics: Administration, Cutaneous; Clobetasol; Double-Blind Method; Female; Hair Preparations; Humans; Keratolytic Agents; Male; Middle Aged; Psoriasis; Scalp Dermatoses; Severity of Illness Index; Tars; 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

Treatment of the inflammatory component of plaque psoriasis is an important part of psoriasis management. A new and unique spray formulation of clobetasol propionate 0.05% may provide advantages over the currently available formulations through easy application to hard-to-reach areas and the ability to deliver a fixed dose of corticosteroid per spray. The purpose of this study was to evaluate the efficacy and safety of clobetasol propionate spray 0.05% in the treatment of moderate to severe plaque-type psoriasis. This study was conducted as a multicenter, randomized, double-blinded, vehicle-controlled, parallel-group, comparative study in subjects with plaque psoriasis. Subjects were randomized to receive either clobetasol propionate spray 0.05% (n=60) or vehicle spray (n=60) twice daily for 4 weeks, followed by a 4-week treatment-free follow-up period. Efficacy evaluations at all visits included assessment of scaling, erythema, plaque elevation, pruritus, and overall disease severity. Success rates for each of the signs and symptoms evaluated, as well as for the overall disease severity assessment, were significantly in favor of clobetasol propionate (P<.001). The additional 2 weeks of treatment from weeks 2 to 4 increased the number of cleared subjects from 2% to 25%; treatment success was still in favor of clobetasol propionate (P<.001) at week 8 (4 weeks post-treatment). No treatment-related serious adverse events occurred during the course of the study. Mild application site burning/stinging was the most common treatment-related adverse event, with similar frequency and severity for both active and vehicle groups. There were no reports of skin atrophy, telangiectasia, folliculitis, or hypothalamus-pituitary-adrenal axis suppression. Overall, clobetasol propionate spray 0.05% administered twice daily for 4 weeks was effective and safe in reducing scaling, erythema, plaque elevation, and overall disease severity and demonstrates durable clinical response up to 4 weeks after treatment end.

Topics: Administration, Cutaneous; Adult; Aged; Anti-Inflammatory Agents; Clobetasol; Dosage Forms; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; 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

Various formulations of clobetasol propionate are currently used to treat psoriasis due to its anti-inflammatory, anti-pruritic, vasoconstrictive and immunomodulating properties.. To assess the efficacy, safety and remission profile of clobetasol propionate lotion compared to that of clobetasol propionate emollient cream and lotion vehicle in subjects with moderate to severe plaque-type psoriasis.. Multicentre, investigator-blind, randomized, active- and vehicle-controlled, parallel-group study.. A total of 192 subjects were treated: 82 with clobetasol propionate lotion, 81 with clobetasol propionate cream and 29 with the vehicle. Clobetasol propionate lotion was significantly more effective than vehicle lotion and was comparable in efficacy to the emollient cream after 4 weeks of treatment. Treatment success was higher for subjects in the clobetasol propionate lotion group than in the emollient cream group after 4 weeks of a treatment-free follow-up period. Clobetasol propionate lotion was safe and well tolerated.. The present study demonstrates that clobetasol propionate lotion is an efficacious, safe and well-tolerated alternative to the currently available emollient cream formulation, while showing a better remission profile after 4 weeks of treatment-free follow-up period.

Topics: Administration, Topical; Adult; Aged; Analysis of Variance; Clobetasol; Dermatologic Agents; Emollients; Female; Humans; Male; Middle Aged; Psoriasis; Quality of Life; Treatment Outcome

Owing to its anti-inflammatory, antipruritic, vasoconstrictive, and immune-modulating properties, clobetasol propionate is used to treat psoriasis. This study was conducted to evaluate the efficacy, safety, and cosmetic acceptability of clobetasol propionate lotion compared with its vehicle and with clobetasol propionate cream in the treatment of moderate to severe plaque-type psoriasis. A total of 222 patients were treated. After 4 weeks of treatment, clobetasol propionate lotion was more efficient than vehicle lotion and of equivalent efficacy as clobetasol propionate cream. Cosmetic acceptability was significantly better with clobetasol propionate lotion than with clobetasol propionate cream. Clobetasol propionate lotion was efficient, safe, and well tolerated and offers a significantly higher cosmetic advantage in the treatment of moderate to severe plaque-type psoriasis compared with clobetasol propionate cream.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Clobetasol; Female; Humans; Male; Middle Aged; Psoriasis; Skin; Telangiectasis; 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

It was discovered that Skin Cap (Cheminova Internacional S.A., Madrid, Spain), an over-the-counter psoriasis therapy with zinc pyrithione, contained clobetasol propionate and it was withdrawn from the market by the US Food and Drug Administration review. Some suggested that there might be a synergistic effect of zinc pyrithione with clobetasol propionate.. We sought to evaluate the efficacy of clobetasol propionate 0.05% foam with and without the coadministration of a topical 0.25% zinc pyrithione spray in treating psoriasis involving sites other than the scalp.. We conducted a randomized, double-blind, right/left study of patients with mild to moderate, generally symmetric, plaque-type psoriasis. Patients were assigned to treatment with clobetasol propionate foam on all psoriatic lesions and then randomly assigned to use zinc pyrithione spray to either the right or left side of their body (vehicle spray to be applied to the opposite side). There was a 2-week treatment phase (visits at baseline, week 1, and week 2) and a follow-up phase (visit at week 4), and all treatments were administered twice daily for 2 weeks. The primary outcome measure was the change from baseline to week 2 in the composite score of the signs of psoriasis (erythema, scaling, plaque thickness) for symmetric target lesions.. A total of 25 patients were enrolled; 24 completed the trial and 1 was lost to follow up. Of those who completed the study, 63% (15 of 24) were men, and the mean age (+/-SD) was 50 years (+/-12.2). After 2 weeks of therapy, the average decline in the composite score was 3.5 (+/-1.8) for monotherapy (clobetasol propionate foam and vehicle) and, similarly, 3.3 (+/-1.8) for clobetasol propionate foam plus zinc pyrithione spray (P =.5).. Zinc pyrithione spray does not appear to enhance the efficacy of clobetasol propionate foam after 2 weeks of therapy.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Clobetasol; Double-Blind Method; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Organometallic Compounds; Psoriasis; Pyridines; Treatment Outcome; Zinc

For topical medications commonly used to treat dermatologic conditions, outcomes may be affected by the choice of delivery vehicles. The aim of this study was to compare quality of life (QOL), effectiveness, user satisfaction, and cost-effectiveness of 2 clobetasol regimens for the treatment of psoriasis over 14 days. In a single-blind design, 32 patients randomized into 2 groups applied either clobetasol foam 0.05% to the skin and scalp or combination clobetasol cream 0.05% to the skin and clobetasol solution 0.05% to the scalp. Psoriasis severity was measured using the standardized Psoriasis Area and Severity Index (PASI) and self-administered PASI (SAPASI). QOL was assessed via the EuroQoL-5D (EQ-5D) questionnaire and Dermatology Life Quality Index (DLQI). Cost-effectiveness was measured by the amount of medication used per body surface area (BSA) treated and by cost per point improvement in PASI score. In this study, a foam formulation performed better than a cream/solution combination by several measures. A greater absolute improvement in psoriasis severity was seen in the group using the foam than in the group using the cream/solution (mean decrease in PASI=5.0 vs 3.3, P=.05). The PASI score in the foam group decreased by 41% versus 35% in the cream/solution group (P=.17). In scalp psoriasis, the group using the foam had greater improvement in both absolute (P=.03) and percentage (P=.03) terms and than the solution group. When measuring global QOL, foam users had a significantly greater increase in EQ-5D than those using the cream/solution in absolute (P=.05, P=.02) and percentage (P=.04, P=.02) terms (first and second survey components, respectively). Differences in improvement of skin-specific QOL, quantified by DLQI scores between groups, were suggested but not statistically significant. Patients using foam spent less time applying medication compared with previous topical medications (P<.001). No significant difference in cost was appreciated between foam and cream/solution over the period after controlling for BSA (8.18 dollars vs 7.05 dollars per percentage BSA affected, P=.30).

Topics: Administration, Cutaneous; Chemistry, Pharmaceutical; Clobetasol; Cost-Benefit Analysis; Dermatologic Agents; Female; Humans; Male; Middle Aged; Psoriasis; Quality of Life; Severity of Illness Index; Single-Blind Method; Surveys and Questionnaires; Treatment Outcome

To investigate the effects of honey, olive oil and beeswax mixture on patients with atopic dermatitis (AD) or psoriasis vulgaris (PV).. Twenty-one patients with dermatitis and 18 patients with psoriasis were entered for patient-blinded, partially controlled study; 11 patients with dermatitis used topical betamethasone esters and 10 patients with psoriasis used clobetasol propionate. Honey mixture contained honey, beeswax and olive oil (1:1:1). Mixtures A, B, and C contained honey mixture with the corticosteroids ointment in a ratio of 1:1, 2:1, and 3:1 respectively. Patients with dermatitis were subjected to controlled bilateral half-body comparison to evaluate the efficacy of honey mixture against Vaseline, or mixture A against Vaseline-betamethasone esters mixture (1:1) in patients using topical corticosteroid treatment. In patients with psoriasis, the effect of honey mixture was compared with paraffin in an individual right/left-sites comparison, or mixture A against paraffin-clobetasol propionate mixture (1:1) in patients using corticosteroid topical therapy. In dermatitis, body lesions on right or left half-body were assessed for erythema, scaling, lichenification, excoriation, indurations, oozing and itching on a 0-4 points scale. In psoriasis, lesions of selected site were assessed for redness, scaling, thickening and itching, on a 0-4 points scale.. In honey mixture group, 8/10 patients with dermatitis showed significant improvement after 2 weeks, and 5/11 patients pretreated with betamethasone esters showed no deterioration upon 75% reduction of corticosteroid doses with use of mixture C. In psoriasis, 5/8 patients showed a significant response to honey mixture. In patients using clobetasol propionate, 5/10 patients showed no deterioration upon 75% reduction of corticosteroid doses with use of mixture C.. Honey mixture appears useful in the management of dermatitis and psoriasis vulgaris.

Topics: Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents; Betamethasone; Child; Child, Preschool; Clobetasol; Dermatitis, Atopic; Female; Honey; Humans; Male; Middle Aged; Olive Oil; Plant Oils; Psoriasis; Single-Blind Method; Waxes

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

Since its introduction, the effectiveness of dithranol in treating psoriasis has been unequalled by other topical treatments. Out-patient short-contact dithranol treatment is effective with regard to clinical response rate and relapse rate after 1 year. A drawback, however, is the relatively long treatment duration.. To study a dithranol regimen combined with a potent topical corticosteroid with regard to clinical response rate, treatment duration and remission period after clearance.. Twelve patients with stable psoriasis vulgaris participated in this study. We treated three comparable psoriasis lesions on the extremities for 39 consecutive days. The first lesion was treated daily with short-contact dithranol cream followed by clobetasol-17-propionate ointment 5 days per week. The second lesion was treated daily with short-contact dithranol cream followed by the vehicle of clobetasol-17-propionate ointment. The third lesion was treated with clobetasol-17-propionate ointment 5 days per week. The patients attended on days 1, 4, 9, 12, 15, 18, 22, 25, 32 and 39 during treatment. We assessed lesional severity scores at each visit and registered the baseline area at the first visit. During the follow up at weeks 2, 4, 6, 10, 14, 19 and 23 we assessed lesional sum scores. We also estimated the area involved in recurrence of the lesion as a percentage of the baseline area. The overall differences between the three treatment curves for the treatment period and follow-up period separately were tested with a likelihood ratio test.. Differences between the curves of the sum scores during treatment (P < 0.001) were mainly due to the different time-course of dithranol monotherapy, which showed a slower decrease in sum score. Differences between the linear trends of the sum score (P < 0.001) and the area score P < 0.001) during follow up were due to a different time-course of the combination therapy, which started lower and increased more slowly, suggesting a slower relapse rate with combination therapy. When comparing the follow-up data, it must be kept in mind that the three treatments showed an overall significantly different sum and area score at the start of follow up.. Intermittent addition of clobetasol-17-propionate ointment enhanced the antipsoriatic efficacy of short-contact, high-dose dithranol therapy in terms of clearing capacity and treatment duration, without shortening remission duration.

Topics: Administration, Topical; Adult; Aged; Anthralin; Anti-Inflammatory Agents; Clobetasol; Drug Administration Schedule; Drug Therapy, Combination; Glucocorticoids; Humans; Middle Aged; Psoriasis; Recurrence; Severity of Illness Index; Time Factors

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

Topical corticosteroids are the primary treatment for mild to moderate psoriasis. Foam preparations of corticosteroids offer potential cosmetic and pharmacodynamic advantages over cream and ointment vehicles. A clobetasol propionate foam product is as effective as clobetasol propionate solution in the treatment of scalp psoriasis.. To evaluate the safety and efficacy of clobetasol propionate foam in the treatment of psoriasis involving sites other than the scalp.. Eighty-one subjects with mild to moderate psoriasis were randomized in a 3 : 1 ratio to receive clobetasol propionate foam vs. placebo foam treatment in this double-blind study of psoriasis involving nonscalp sites. The investigator's and subject's global assessment of the response at week 2 (or at the end of treatment) and at week 4 (follow-up) and the severity of erythema, scaling, and plaque thickness were assessed. Safety was assessed from reported adverse events.. After 2 weeks of treatment, there was significantly greater improvement with clobetasol propionate foam compared with placebo foam in both investigator's and subject's global assessment of the response (P < 0.0005). The improvement with clobetasol propionate foam was still present at the 4-week follow-up visit. Adverse effects were generally limited to mild to moderate application site reactions. No subjects withdrew because of adverse events.. Clobetasol propionate foam is more effective than placebo in the treatment of nonscalp psoriasis. Twice-daily applications are well tolerated, compliance exceeds 90%, cosmetic characteristics are acceptable, and the medication may eliminate the need for separate scalp and body prescriptions.

Topics: Administration, Topical; Adolescent; Adult; Anti-Inflammatory Agents; Clobetasol; Double-Blind Method; Drug Compounding; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Outcome Assessment, Health Care; Psoriasis; Severity of Illness Index; Time Factors

Many studies have shown the clinical efficiency of occlusion therapy for psoriasis, particularly corticosteroids used under hydrocolloid dressings. However, there are no data from comparative clinical studies evaluating the remission and relapse characteristics of such occlusion therapy compared with orthodox topical steroid monotherapy.. In a randomised, open-label, parallel group study from three centres, the remission and relapse characteristics were investigated for the use of a hydrocolloid dressing (HCD) over clobetasol propionate 0.05% lotion once a week compared with the same steroid in ointment formulation used unoccluded twice a day in 61 patients with stable chronic plaque psoriasis.. There was a pronounced treatment difference in favour of the HCD + clobetasol propionate lotion group with respect to time to clearance, but there was little evidence for a difference with respect to time to relapse.. The combination of the HCD + clobetasol propionate lotion provides a fast and highly effective remission induction.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Chronic Disease; Clobetasol; Colloids; Combined Modality Therapy; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Middle Aged; Occlusive Dressings; Psoriasis; Recurrence; Remission Induction

Topics: Administration, Topical; Anti-Inflammatory Agents; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Therapy, Combination; Gels; Glucocorticoids; Humans; Middle Aged; Nicotinic Acids; Ointments; Psoriasis; Severity of Illness Index; Skin; Time Factors; Treatment Outcome

Dithranol (anthralin) has been known to be effective in the treatment of psoriasis for more than 80 years. However, perilesional and uninvolved skin often show irritation during dithranol treatment, which limits its use. As the relapse rate of psoriasis is worsened by adding corticosteroids to a dithranol regimen, the use of topical corticosteroids to reduce dithranol irritation is controversial.. The aim of the present study was to investigate the clinical and cell biological effect of clobetasol-17-propionate 0.05% ointment on dithranol-treated lesional and perilesional skin.. For 17 consecutive days, 2% dithranol cream was applied on two test sites. A third site was left untreated on all participating patients (n = 8). All sites consisted of a psoriasis lesion as well as a 3-cm zone of perilesional skin localized on the back. After 1 h, the cream was washed off, and subsequently one of the dithranol-treated sites was treated once a day with clobetasol-17-propionate 0.05% ointment. The second site was treated once daily with the vehicle. On day 17, punch biopsies were taken from all three lesions and from the perilesional zone of all test sites in order to perform an immunohistochemical investigation, using markers to assess proliferation, differentiation and inflammation.. The SUM score (erythema + induration + scaling) of the lesion treated with dithranol/clobetasol showed a pronounced reduction, which was significantly greater than the SUM score of the lesion treated with dithranol/vehicle. However, the scores of both sites were equal by 6 weeks of follow-up. Comparing the two treated lesions, we observed a lower number of cycling epidermal cells in the dithranol/clobetasol lesion and a significantly lower perivascular dermal score of T lymphocytes. Comparing the perilesional skin of the two treated sites we observed less cycling epidermal cells in the dithranol/clobetasol-treated site. Regarding perilesional differentiation, the interpapillary involucrin expression was higher in the dithranol/clobetasol-treated site. With respect to perilesional inflammation the expression of dermal polymorphonuclear leucocytes, monocytes, macrophages and T lymphocytes in the dermal infiltrate were significantly lower in the dithranol/clobetasol-treated site.. The addition of clobetasol-17-propionate enhanced the antipsoriatic efficacy of dithranol by interfering with T-cell accumulation and epidermal proliferation. The addition of a corticosteroid reduced perilesional dithranol inflammation at the cellular level, although clinically detectable dithranol erythema was not reduced.

Topics: Administration, Topical; Anthralin; Anti-Inflammatory Agents; Cell Division; Clobetasol; Drug Administration Schedule; Drug Therapy, Combination; Epidermis; Follow-Up Studies; Glucocorticoids; Humans; Immunoenzyme Techniques; Psoriasis; Severity of Illness Index; T-Lymphocytes; Treatment Outcome

Leukotriene B4 (LTB4) receptor antagonists have been the subject of several studies in the treatment of inflammatory diseases, including psoriasis. A novel oral LTB4 antagonist, VML 295 (LY-293111) has recently been developed and has a pronounced effect on epidermal inflammatory parameters. However, oral treatment of psoriasis for 4 weeks did not result in a decrease in disease severity. The present study was performed in order to investigate whether prolonged treatment with VML 295 up to 8 weeks has a beneficial effect on the overall severity of psoriasis. Moreover, we studied to what extent VML 295 is able to prevent relapse in psoriasis. In the present study, 35 patients with stable chronic plaque psoriasis were included. A representative plaque of at least 16 cm2 was initially treated with clobetasol-17-propionate lotion under hydrocolloid occlusion in all patients. Clearance was achieved within 6 weeks in 31 patients. After clearance, the patients were randomized to treatment and received oral VML 295 capsules 200 mg twice daily or placebo for 8 weeks. Twenty-five patients completed the study. The psoriasis area and severity index (PASI) was assessed before treatment, at clearance, and on days 15, 29, 43 and 5 7 of the treatment period. Biopsies were taken from the treated lesion before treatment, after clearance and at relapse, and cells were analysed by flow cytometry with markers for differentiation (keratin 10), inflammation (vimentin), and proliferation (DNA content). After 8 weeks of treatment, 14 of 15 VML 295-treated patients had relapsed and 11 of 16 placebo-treated patients had relapsed. A total of six patients were withdrawn. The time to relapse and the number of relapsed patients was not significantly different comparing the treatment groups. There was no significant difference in PASI scores between VML 295-treated patients and placebo-treated patients after 8 weeks of treatment. Flow cytometric parameters for differentiation, inflammation and proliferation did not show significant differences between VML 295- and placebo-treated patients. We conclude that oral VML 295 (LY-293111) is not effective in preventing relapse in psoriasis, either clinically or at the cellular level, and that in our group of patients VML 295 had no beneficial effect on overall psoriasis severity. Moreover, we conclude that further development of LTB4 modulating drugs for the treatment of psoriasis is not indicated.

Topics: Administration, Topical; Anti-Inflammatory Agents; Benzoates; Clobetasol; Drug Therapy, Combination; Flow Cytometry; Glucocorticoids; Humans; Leukotriene Antagonists; Leukotriene B4; Psoriasis; Recurrence; Severity of Illness Index

Topics: Administration, Topical; Anti-Inflammatory Agents; Chemistry, Pharmaceutical; Clobetasol; Double-Blind Method; Drug Delivery Systems; Female; Glucocorticoids; Humans; Male; Pharmaceutical Vehicles; Psoriasis; Scalp Dermatoses; Solutions; 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

It is a well-established fact that very potent corticosteroids are highly effective in the treatment of psoriatic plaques, and that the addition of a hydrocolloid occlusive dressing (HCD) enhances its efficacy. It is known that topical steroids induce normal differentiation and diminish hyperproliferation during treatment of psoriatic plaques. These changes are reflected by an increase in keratin 10 (K10) and a decrease in keratin 6 (K6), respectively. However, the influence of class IV corticosteroids under HCD on K10 and K6 subpopulations has never been studied.. The present study was performed to study quantitatively the influence of a class IV topical steroid under HCD on the dynamics of K10 and K6 subpopulations.. In the present study, we treated moderately severe stable psoriatic plaques with clobetasol-17-propionate under HCD until clearance was achieved. We took biopsies prior to treatment, after clearance and at relapse. Using flow cytometry, we studied the dynamics of K10 and K6 subpopulations.. Prior to treatment, 41.8% of all cells expressed K6. After treatment-induced clearance, this proportion decreased to 1.2%, which is below the normal range. At relapse, pre-treatment levels were observed again. A trend to an increasing number of basal cells and an increase in the proliferative activity of these basal cells at relapse compared to the stable situation prior to treatment was observed.. We conclude that clobetasol under hydrocolloid occlusion induces virtually a total block of proliferation of the basal cell population and decreases hyperproliferation-associated keratins dramatically. Furthermore, based upon epidermal cell characteristics, we conclude that a rebound phenomenon occurs following discontinuation of therapy with clobetasol under hydrocolloid occlusion.

Topics: Administration, Topical; Anti-Inflammatory Agents; Clobetasol; Colloids; Flow Cytometry; Glucocorticoids; Humans; Keratin-10; Keratins; Occlusive Dressings; Psoriasis; Recurrence; Skin; Time Factors; Treatment Outcome

The aim of the present study has been to analyse remission and relapse characteristics in psoriasis vulgaris. In 15 patients, two different psoriatic lesions (clinical and flow cytometric study) were treated with clobetasol propionate until clearance for maximally 23 days. In the clinical study only cleared lesions were divided into three test sectors with different post-clearance treatment: (1) alcoholic solution under occlusion, (2) occlusion only, and (3) no treatment. In the flow cytometric study, biopsies were taken from the test lesion before clobetasol therapy (i), at clearance (ii), and at relapse from both visibly affected and unaffected skin (iii, iv). Epidermal proliferation, differentiation and inflammation were quantified by multiparameter flow cytometry. The clinical evaluation worked well and could discriminate between the different therapy modalities. After 28 days, 80% of untreated sectors showed a relapse. Occlusion decreased this percentage to 50%. Application of the alcoholic solution further decreased this percentage to 30%. The flow cytometric analysis demonstrated a very low proliferative activity of the basal compartment at clearance. This activity was higher in the visibly unaffected skin at relapse, whereas highest values were assessed in the affected skin at relapse. Interestingly, at relapse the proliferative activity in the suprabasal compartment of the visibly unaffected skin had increased to values identical to the affected skin. The present model allows standardized comparison of different approaches for maintenance therapy in psoriasis vulgaris. We demonstrate that occlusion has an inhibitory effect on the tendency to relapse after successful treatment with clobetasol propionate. Quantitative information on remission and relapse of psoriasis can be obtained by multiparameter flow cytometry.

Topics: Administration, Topical; Adolescent; Adult; Aged; Alcohols; Anti-Inflammatory Agents; Biopsy; Clobetasol; Combined Modality Therapy; Female; Flow Cytometry; Glucocorticoids; Humans; Male; Middle Aged; Occlusive Dressings; Psoriasis; Recurrence; Remission Induction; Severity of Illness Index; Skin

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

Two clinical trials were conducted to evaluate the safety and antipsoriatic efficacy of a new 0.05 percent emollient formulation of clobetasol propionate (CP). In a crossover study of hypothalamic-pituitary-adrenal (HPA)-axis effects in 12 patients with psoriasis or eczema, 1.5 gm of CP emollient, applied to lesions twice daily for seven consecutive days, resulted in fewer patients with serum cortisol concentrations < 10 micrograms/100 mL than CP cream 0.05 percent (1vs 4); such concentrations were seen in two other patients during both treatment phases. A double-blind, randomized, parallel-group clinical trial in patients with moderate to severe plaque-type psoriasis showed that four weeks' treatment with CP emollient 0.43 to 0.5 gm twice daily (n = 35) was significantly more effective than emollient vehicle (n = 39) in reducing total signs/symptoms and scaling by Day 4, erythema and skin thickening by Day 8, and pruritus by Day 15. CP emollient was rated superior to vehicle by Day 4 in physician's gross assessment ratings and by Day 15 in patient's self-assessment ratings. In all assessments, CP emollient continued to be superior to vehicle during the remainder of the treatment period and two-week posttreatment period. No significant differences were observed in tolerability or serum cortisol effects during the course of the study.

Topics: Adult; Aged; Aged, 80 and over; Burns, Chemical; Clobetasol; Cross-Over Studies; Dermatologic Agents; Double-Blind Method; Drug Evaluation; Eczema; Emollients; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Outcome Assessment, Health Care; Pituitary-Adrenal System; Pruritus; Psoriasis; Skin; Skin Physiological Phenomena; Time Factors; Treatment Outcome

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

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

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

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

Topics: Betamethasone; Clobetasol; Double-Blind Method; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Pituitary-Adrenal System; Psoriasis

Twenty-two consecutive patients with nummular psoriasis were treated with a 0.05% clobetasol propionate stick on the right side of the body and with 0.05% clobetasol propionate ointment (Dermovate, Glaxo) on the left according to an intermittent application schedule. The trial was open and lasted for 3 weeks. The patients were assessed at the beginning and at the end of the trial. The variables studied included: an overall clinical assessment, assessment of the lesion area, scaling, erythema and thickness and the amount of clobetasol propionate used during the trial, and a questionnaire on patients' opinions about hygienic and cosmetic qualities of the stick. No significant difference was found between the stick and corresponding ointment. From a hygienic and cosmetic point of view, the patients preferred the stick formulation.

Topics: Adolescent; Adult; Aged; Clobetasol; Dosage Forms; Female; Humans; Male; Middle Aged; Ointments; Psoriasis

The purpose of this study was to compare the therapeutic efficacy of a hydrocolloid dressing (Actiderm) over a medium strength corticosteroid (triamcinolone acetonide (TAA) 0.1% cream) with that of a highly potent corticosteroid (clobetasol propionate 0.05% cream) in palmo-plantar pustulosis and localized pustular psoriasis. It was a randomized, open, prospective, right-left comparative trial in 19 patients. The Actiderm dressing and the TAA cream were applied every third day, whereas the clobetasol cream was applied twice daily for 4 weeks. Both treatments resulted in a significant improvement. On completion of treatment, complete clearance was found in 13 patients (63%) with Actiderm plus TAA, but in only 3 patients (21%) with clobetasol (p = 0.001). Four weeks after stopping therapy, the clinical parameters had returned to their pre-treatment level, except for erythema on the Actiderm plus TAA treated lesions (p less than 0.05). No clinically important adverse effects were reported or observed; in particular there was no sign of skin atrophy at the end of study. The results of this study demonstrate that Actiderm applied over a medium strength corticosteroid every third day is highly effective against palmoplantar pustulosis and localized pustular psoriasis. However, it is necessary to develop treatment regimens to maintain the improvement achieved.

Topics: Adolescent; Adult; Aged; Bandages, Hydrocolloid; Clobetasol; Colloids; Drug Therapy, Combination; Female; Foot Dermatoses; Hand Dermatoses; Humans; Male; Middle Aged; Occlusive Dressings; Prospective Studies; Psoriasis; Triamcinolone Acetonide

In a double-blind, parallel-group, multicenter trial in 134 patients with severe, localized, plaque psoriasis, the success rate (described as "healed" or "marked improvement") at the end of the study was 96% in the halobetasol propionate group and 91% in the clobetasol propionate group. A significantly larger proportion of patients treated with halobetasol had no disease or mild disease after 14 days compared with those treated with clobetasol (86% versus 70%, p = 0.023). Healing within 24 days of starting treatment was noted in 69% and 56% of patients treated with halobetasol and clobetasol, respectively. Adverse effects were reported in a smaller percentage of patients treated with halobetasol propionate ointment than in those treated with clobetasol propionate ointment (7% versus 12%). Cosmetic acceptability and ease of application were recorded as "very good" in a larger percentage of patients treated with halobetasol propionate ointment than in the group treated with clobetasol propionate (90% versus 80%).

Topics: Adult; Aged; Chronic Disease; Clobetasol; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Patient Satisfaction; Psoriasis; Remission Induction; South Africa; Vasoconstrictor Agents; Wound Healing

In a double-blind, parallel-group, multicenter comparative trial on 104 evaluable patients with severe, localized plaque psoriasis, 0.05% halobetasol propionate ointment demonstrated an 88.7% success rate assessed as "healed" or "marked improvement" compared with 78.5% for 0.05% betamethasone dipropionate ointment. Healing was observed within 24 days of the start of treatment in 40% and 25% of the patients who received halobetasol propionate and betamethasone dipropionate ointments, respectively. After 4 weeks' treatment, tolerability of both ointments was good. Neither skin atrophy nor systemic adverse effects were observed. Patient acceptance of halobetasol propionate ointment, based on cosmetic acceptability and ease of application, was significantly better (p = 0.02) than that of betamethasone dipropionate ointment.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Betamethasone; Chronic Disease; Clobetasol; Double-Blind Method; Female; Germany; Glucocorticoids; Humans; Male; Middle Aged; Ointments; Patient Satisfaction; Psoriasis; Remission Induction; Vasoconstrictor Agents; Wound Healing

In a double-blind, parallel-group, multicenter comparative trial in 84 evaluable patients with severe, localized plaque psoriasis, 0.05% halobetasol propionate ointment proved significantly superior (p = 0.02) to 0.1% betamethasone valerate ointment with respect to the success rate, as indicated by ratings of "healed" or "marked improvement" (88.1% versus 64.3%). The therapeutic effect was observed within 5 days of the start of treatment in 76% and 67% of the patients treated with halobetasol propionate and betamethasone valerate ointments, respectively. Both preparations were well tolerated. Minor adverse effects at the site of application were reported in only 2% of the patients in each treatment group. Neither skin atrophy nor systemic adverse effects were observed.

Topics: Adult; Aged; Betamethasone Valerate; Chronic Disease; Clobetasol; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Patient Satisfaction; Psoriasis; Remission Induction; Switzerland; Vasoconstrictor Agents; Wound Healing

In a multicenter, 14-day pediatric study in 81 evaluable patients with severe, localized corticosteroid-susceptible dermatoses, the combined treatment with halobetasol propionate cream once during the day and halobetasol propionate ointment once at night produced a very satisfactory therapeutic effect. The success rates, as indicated by ratings of "healed" and "marked improvement," were 100% and 90.9% in patients with atopic dermatitis and psoriasis vulgaris, respectively. Healing was reported in 86.8% and 72.7% of patients treated for atopic dermatitis and psoriasis, respectively. Both the cream and ointment preparations were well tolerated. Adverse effects at the site of application were reported in only 3 of 81 patients. Mild skin atrophy was observed in one patient. No systemic adverse effects were observed.

Topics: Administration, Cutaneous; Adolescent; Child; Child, Preschool; Chronic Disease; Clobetasol; Dermatitis, Atopic; Drug Tolerance; Female; Humans; Male; Ointments; Psoriasis; Remission Induction; Switzerland; Vasoconstrictor Agents; Wound Healing

The results of two studies are presented that reveal the efficacy and safety of 0.05% halobetasol ointment in the treatment of patients with plaque psoriasis of at least moderate severity. Both multicenter studies were randomized, double-blind, and vehicle controlled, and study medications were applied twice daily for 2 weeks. One study was a paired-comparison (PC); the other study was of parallel-group (PG) design. Both studies called for evaluations at entry (week 0) and after 1 and 2 weeks of treatment. The PC study enrolled 100 patients; the PG study enrolled 110 patients; 204 patients provided efficacy data over both studies. In the PC study, plaque elevation, erythema, and scaling, at least moderately severe at entry, showed at the end of treatment both statistical (p less than or equal to 0.0003) and clinical significance (all greater than 1-unit difference on the rating scale) favoring 0.05% halobetasol ointment over vehicle. Pruritus (initially mild) and total score also showed statistically significant treatment differences favoring halobetasol at the final evaluation. Patient global responses for "effectiveness" and "overall rating" favored 0.05% halobetasol ointment over vehicle. In the PG study, induration, erythema, and scaling, at least moderately severe at entry, showed at the end of treatment both statistically and clinically significant differences favoring 0.05% halobetasol ointment over vehicle. Physician's global evaluation favored 0.05% halobetasol ointment over vehicle after 2 weeks of use. No patients were released from either study because of adverse events. No systemic adverse events or findings of skin atrophy were reported in these studies. Reports of "stings" or "burns" were equally divided between halobetasol and its vehicle.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Aged; Aged, 80 and over; Clobetasol; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Pharmaceutical Vehicles; Psoriasis; Remission Induction; United States; Vasoconstrictor Agents; Wound Healing

The efficacy and safety of halobetasol propionate 0.05% cream, an ultra high-potency corticosteroid preparation, was evaluated in a double-blind, vehicle-controlled, paired comparison study. Patients' psoriatic lesions were evaluated before treatment and after 1 and 2 weeks of twice-daily treatment with halobetasol propionate and vehicle. Response measures (plaque elevation, erythema, scaling, and pruritus) were evaluated with a 4-point severity scale whereby the sum provided a total score. Patient self-assessment measures were obtained at the 2-week visit by categorizing his or her global responses to queries about each treatment's "effectiveness" and "overall rating." All efficacy parameters, as judged by the physician, showed statistically significant (p = 0.0001) treatment differences favoring halobetasol propionate at both week 1 and week 2 evaluations. Patient global responses for "effectiveness" and "overall rating" favored halobetasol propionate 0.05% cream over vehicle after 2 weeks of use. No systemic adverse drug effects were reported during the study. No patient was discontinued from the study because of an adverse event, and there was no evidence of skin atrophy after 2 weeks of treatment with either agent. Patient reports of "stings" or "burns" were equally distributed between the active and vehicle treatment groups. This trial demonstrates that halobetasol propionate 0.05% cream is clinically beneficial and without evidence of significant risk in the treatment of plaque psoriasis.

Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Clobetasol; Double-Blind Method; Female; Humans; Male; Middle Aged; Pharmaceutical Vehicles; Pruritus; Psoriasis; Safety; United States; Vasoconstrictor Agents

The efficacy and safety of clobetasol propionate 0.05% scalp application was evaluated in 378 patients with moderate to severe scalp psoriasis in a double-blind vehicle-controlled parallel group study. After 2 weeks of twice-daily applications, 81% receiving active drug versus 22% receiving vehicle had clearing of 50% or greater. Complete clearing was seen in 26% with active drug and 1% with vehicle. Local side effects were primarily burning or stinging in 11% and 10% of patients treated on an active or a vehicle regimen, respectively. The morning cortisol levels of 168 patients were checked at baseline and again after 2 weeks of drug therapy. Subnormal morning plasma cortisol values were seen in 5% of the patients receiving active drug and in 5% receiving vehicle; 13% of those taking active drug versus 5% taking vehicle had a 50% or greater decrease in morning cortisol at the 2-week visit compared with baseline values. Clobetasol propionate 0.05% scalp application appears to be a safe and an effective treatment for scalp psoriasis.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Clobetasol; Double-Blind Method; Female; Humans; Hydrocortisone; Male; Middle Aged; Psoriasis; Scalp Dermatoses; United States

Clobetasol-17-propionate (CP) and crude coal tar (CT) have an anti-inflammatory potential. Both agents have been advocated to suppress irritation of the skin during dithranol treatment. The effect of CP and CT on dithranol-induced irritation was studied by the assessment of erythema and measurement of alkaline phosphatase (ALP) as a direct reflection of the metabolic activity of the endothelial cells. Dithranol was applied for 2 h in the relatively high concentration of 10%, which resulted in a marked inflammation of the skin in all volunteers. Neither CP nor CT influenced the erythema. In contrast, CP and CT had a synergistic effect on the dithranol-induced induction of ALP. In conclusion, the present study indicates that CP and CT are not indicated for the treatment of dithranol-induced irritation.

Topics: Adolescent; Adult; Alkaline Phosphatase; Anthralin; Clobetasol; Coal Tar; Drug Therapy, Combination; Erythema; Female; Humans; Male; Psoriasis

In 10 patients with chronic plaque type psoriasis one or two plaques affected equally with psoriasis were chosen for study. Five punched out rings of a hydrocolloid dressing were applied to the psoriasis plaque(s). In each circular test area 20 mg of one of the following creams was applied: base, 1% hydrocortisone (DAK), 0.1% triamcinolone acetonide (Kenalogue), 0.1% betamethasone-17-valerate cream (Betnovate), and 0.05% clobetasol proprionate cream (Dermovate). The areas were occluded with a thin film of transparent hydrocolloid dressing (Comfeel Transparent Dressing), for 1 week. Non-invasive measurements (ultrasound skin thickness, laser-Doppler flowmetry, colorimetry) were performed before and after treatment. Therapeutic response was evaluated blindly by clinical score. The measurements showed a decline in blood flow, a decrease in skin thickness, and normalization of colour approaching that of normal skin, the more potent the corticosteroid used. The clinical scores showed the same: the more potent a corticosteroid used, the closer to the score of normal skin. Data on variability and applications of the methods are presented. The study concludes that potent corticosteroids occluded with a hydrocolloid dressing can clear psoriasis in 1 week. Short-course corticosteroid therapy appears harmless and relevant for clinical dermatology.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Bandages, Hydrocolloid; Betamethasone Valerate; Clobetasol; Colloids; Female; Glucocorticoids; Humans; Hydrocortisone; Male; Middle Aged; Occlusive Dressings; Psoriasis; Skin; Time Factors; Triamcinolone Acetonide

Topics: Betamethasone; Clobetasol; Double-Blind Method; Humans; Ointments; Psoriasis

Overt iatrogenic cutaneous atrophy is easily recognized; however, the earliest signs of such an adverse event may be covert. Preatrophy is proposed as a term to describe the subtle unmasking or normally covert subpapillary vascular channels found by the use of enhanced skin surface magnification techniques. We conducted a randomized double-blind, bilaterally paired comparison clinical trial in patients with chronic plaque psoriasis treated with twice-daily (nonoccluded) superpotent topical steroids for 2 weeks. Occult reversible delicate networks of horizontally oriented vascular channels were found within and surrounding 20% (23/118) of the involved psoriatic plaques during the course of the study. The use of a hand-held magnifying lens (8X), mineral oil, a coverglass, and adequate illumination allow recognition of preatrophy. Preatrophy was more frequently found in women than in men.

Topics: Adult; Aged; Atrophy; Betamethasone; Clinical Trials as Topic; Clobetasol; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Prospective Studies; Psoriasis; Random Allocation; Skin

Ten patients with chronic plaque-type psoriasis were treated topically with the group IV corticosteroid clobetasol propionate cream (Dermovate) with and without occlusion with a semipermeable hydrocolloid dressing (Comfeel Coloplast, Denmark). The effect of treatment was compared with untreated skin and evaluated in terms of (a) O2-consumption as measured by the TCM-2-oxygen monitor from Radiometer, Denmark, (b) blood flow as measured by a laser-Doppler flowmeter (Perimed, Sweden), (c) temperature measurements using thermo-couples and (d) a clinical score. While steroid + occlusion had a very pronounced effect measured by all parameters and apparent after 24 h, the steroid alone was only marginally effective after 7 days. No placebo effect was detectable in untreated skin with the laboratory methods used. It is suggested that the methods described can be used to evaluate other treatment schedules. Recently it has been shown that measurement of oxygen consumption by transcutaneous O2 electrodes might reflect disease activity in psoriatic plaques. Transcutaneous O2 decreases when a tourniquet is applied around the extremity investigated and the decrease per minute has been used as a measure of the metabolism of normal and psoriatic skin. In a later study it was shown that stripping of the skin prior to measuring was essential as a diffusion barrier was present in the horny layer. It has been previously shown that occlusion of an area to which corticosteroid has been applied increases absorption as estimated by the intensity of blanching. In the present study the effect of occlusion and non-occlusion of corticosteroid treated sites in psoriasis has been compared using clinical and laboratory parameters.

Topics: Adolescent; Adult; Aged; Bandages, Hydrocolloid; Betamethasone; Clinical Trials as Topic; Clobetasol; Colloids; Female; Humans; Male; Middle Aged; Occlusive Dressings; Oxygen Consumption; Psoriasis; Skin; Skin Temperature

Twenty-three patients with resistant psoriasis vulgaris were evaluated clinically and histologically before and after treatment with potent topically administered steroids. It was shown that psoriatic plaques are comprised of clinically and histologically distinct acute and chronic areas, each responding differently to treatment. Chronic areas, characterized by chronic inflammation, respond well to therapy; acute areas, characterized by acute inflammation, are resistant to therapy. It is suggested that the psoriagenic stimulus is greater within the therapy-resistant "hot spots." Future therapy aimed at hot spots may aid in the better control of psoriasis.

Topics: Administration, Topical; Betamethasone; Biopsy; Clobetasol; Drug Resistance; Humans; Hypertrophy; Psoriasis; Steroids; Triamcinolone

A prospective randomized trial of anthralin in Lassar's paste compared with anthralin in 0.0125% clobetasol propionate in the treatment of chronic plaque psoriasis was undertaken. The psoriatic skin of patients treated with the corticosteroid-anthralin combination cleared significantly more quickly than those treated with anthralin alone, with a mean time to clearance of 14.9 days compared with 18.5 days, and with lower concentrations of anthralin. No significant difference was found in the rate of relapse of the two treatment groups, with relapse occurring in over 80% of patients within one year. Anthralin in 0.0125% clobetasol propionate was found to be an effective agent in the treatment of chronic plaque psoriasis, and one that was cosmetically acceptable to patients and nursing staff. An important disadvantage, however, was the development of a staphylococcal folliculitis in four of the 35 patients in which it was used. Because of this, anthralin in Lassar's paste remains our standard inpatient therapy, although the ease of use and cosmetic acceptability of anthralin in clobetasol propionate make it a useful remedy for outpatient use.

Topics: Adolescent; Adult; Aged; Anthralin; Betamethasone; Chronic Disease; Clobetasol; Coal Tar; Combined Modality Therapy; Drug Combinations; Female; Humans; Male; Middle Aged; Prospective Studies; Psoriasis; Random Allocation; Staphylococcal Skin Infections; Ultraviolet Therapy

Multiple clinical and laboratory evaluations, including morning plasma cortisol levels, were done in forty patients having moderate to severe psoriasis vulgaris prior to and during treatment with either betamethasone dipropionate in optimized vehicle or clobetasol-17-propionate ointment. The study was randomized, double-blind, and of parallel group design, lasting 3 weeks. Both drugs were effective (3 of 4 achieving at least 75% or more improvement). Temporary reversible suppression of the hypothalamic-pituitary-adrenal axis, as reflected by low morning plasma cortisol determinations, was found in eight of forty patients (20%). The clinician should respect the potential for superpotent topical steroids to cause laboratory evidence of adrenal suppression.

Topics: Administration, Topical; Adolescent; Adrenal Glands; Adult; Aged; Betamethasone; Clinical Trials as Topic; Clobetasol; Double-Blind Method; Female; Humans; Hydrocortisone; Male; Middle Aged; Psoriasis; Random Allocation

A double-blind study was carried out in 12 hospitalized patients with symmetrical eruptions of psoriasis to evaluate the effectiveness of treatment with 0.05% clobetasol propionate ointment, applied once daily, to one side for 2 weeks compared with 1 week of active treatment and 1 week of vehicle alone to the other side. The results of clinical assessments of scaling, redness, and induration before and after each week of treatment showed only a very slight difference in favour of 2-weeks' continuous treatment when analyzed using a one-tailed Student's t-test (p = 0.047) but not when two-tailed testing was used (p = 0.094). Although it would appear that there was no clear preference for continuous therapy, other studies involving larger numbers of patients are needed to determine whether intermittent therapy with a potent corticosteroid such as clobetasol propionate is equally as effective in psoriasis.

Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Betamethasone; Clobetasol; Double-Blind Method; Drug Administration Schedule; Drug Evaluation; Female; Humans; Male; Middle Aged; Psoriasis; Random Allocation

A multicenter, double-blind study compared the effectiveness of two highly potent topical corticosteroids in patients with moderate to severe signs of psoriasis. Left/right paired comparisons of clobetasol propionate ointment 0.05 percent, and an optimized formulation of betamethasone dipropionate ointment 0.05 percent, were made in 130 patients with roughly symmetrical psoriatic lesions. The ointments were applied by the patients twice daily, without occlusion, for two weeks. Both drugs were shown to be highly effective and were well tolerated. Significantly more patients showed greater improvement on the side treated with clobetasol propionate. Follow-up evaluation two weeks after the treatment period showed statistically significant (p less than 0.001) longer remissions resulting from the use of clobetasol propionate.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Betamethasone; Clinical Trials as Topic; Clobetasol; Double-Blind Method; Drug Tolerance; Follow-Up Studies; Glucocorticoids; Humans; Ointments; Psoriasis; Time Factors

Topics: Administration, Topical; Adrenal Insufficiency; Anti-Inflammatory Agents; Betamethasone; Clinical Trials as Topic; Clobetasol; Costs and Cost Analysis; Glucocorticoids; Humans; Psoriasis; Skin Diseases

Topics: Betamethasone; Clinical Trials as Topic; Clobetasol; Consumer Behavior; Double-Blind Method; Evaluation Studies as Topic; Halcinonide; Humans; Ointments; Pregnenediones; Psoriasis; Random Allocation

Fifty patients with plaque psoriasis were treated with dithranol and UVB 5 days per week. Twenty-six of these patients also received 13 treatments (once daily in the 1st week, every other day in the 2nd week, twice in the 3rd week and once in the 4th week) with topical clobetasol propionate. The median time for clearance was 2.5 weeks for those on the clobetasol propionate-dithranol-UVB combination compared with 4 weeks when only dithranol-UVB was used. Scaling and induration of the lesions disappeared during the first 2 weeks of treatment with clobetasol propionate-dithranol-UVB which was a significant improvement compared with dithranol-UVB alone. The time of remission in patients completely cleared was the same in the two groups. Relapses occurred slightly more often in the clobetasol propionate treated than in the control group (during treatment 5 of 26 versus 2 of 24; after 6 months 7 of 18 versus 4 of 15) but the differences were not statistically significant. The study shows that addition of topical clobetasol propionate according to our schedule to the traditional dithranol-UVB regimen of psoriasis results in a more rapid clearance of lesions without undesirable side effects.

Topics: Administration, Topical; Adult; Anthracenes; Anthralin; Betamethasone; Clobetasol; Combined Modality Therapy; Drug Therapy, Combination; Female; Humans; Male; Psoriasis; Recurrence; Time Factors; Ultraviolet Therapy

A double-blind, parallel comparison was made of the short-term efficacy and safety of three times daily regimens of 0.05% clobetasol propionate cream and 0.05% fluocinonide cream in 114 adolescent and adult patients with psoriasis and 113 with eczema. After 2 weeks of topical applications, patients were assessed according to (1) investigators' overall judgment of clinical response, (2) degree of severity of specific signs and symptoms, and (3) patients' evaluation of improvement. In all three response categories in psoriasis, and in two of three in eczema, clobetasol was statistically significantly superior to fluocinonide (p less than 0.05-p less than 0.001). Healing commenced more rapidly with clobetasol and there was no indication of tachyphylaxis. In contrast, the healing rate with fluocinonide slowed noticeably after the first week, and there was a greater tendency to relapse following fluocinonide treatment. Both regimens were safe: drug-related side effects were generally mild and occurred most commonly with fluocinonide therapy in eczema patients. Overall, drug-related effects occurred in 4% of patients receiving clobetasol and 12% receiving fluocinonide (p less than 0.05). Transient morning plasma cortisol reductions below 5 micrograms/dl occurred in 6% of clobetasol-treated patients, reverting to normal within 1 week of the end of treatment.

Topics: Administration, Topical; Adolescent; Adult; Aged; Betamethasone; Clinical Trials as Topic; Clobetasol; Double-Blind Method; Eczema; Female; Fluocinolone Acetonide; Fluocinonide; Humans; Male; Middle Aged; Psoriasis; Random Allocation; Time Factors

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

A study has been carried out to compare the effect of a combination of clobetasol propionate and UVB versus placebo/UVB. No significant reduction in time to healing was observed. However, symptoms abated more rapidly in the steroid/UVB group. Recurrences occurred at an earlier stage following the steroid UVB combination for long periods. A third group, treated solely with clobetasol propionate has also been investigated, but results were poorer than those described above. It is concluded that steroids in combination with UVB should be used only during the initial period in order to achieve a more rapid alleviation of symptoms and to avoid the side effects.

Topics: Betamethasone; Clinical Trials as Topic; Clobetasol; Double-Blind Method; Female; Humans; Male; Photochemotherapy; Psoriasis; Recurrence; Time Factors; Ultraviolet Therapy

The efficacy of Diprolene ointment 0.05 percent (betamethasone dipropionate in a glycol formulation) and Dermovate ointment 0.05 percent (clobetasone propionate) and their effects on adrenal function were evaluated in two double-blind, parallel group studies. A fixed dose of 7 gm of ointment a day was applied topically for fourteen days (Study 1) or twenty-one days (Study 2) to the skin of patients with psoriasis or other resistant dermatoses. To evaluate the adrenal effect of the treatments, plasma cortisol levels were determined for twenty of the sixty-one patients in Study 1 and for all of the twenty patients in Study 2. Efficacy and adverse experience data were evaluated for all patients. At the initial visit and at weekly follow-up visits, the selected lesions were graded for the severity of the signs and symptoms of disease. Most of the patients in these studies experienced a complete clearing of all the signs and symptoms of their disease by the end of the treatment with either Diprolene or Dermovate. The two treatments were equally effective. No adverse experiences were seen in the Diprolene group, but one patient with psoriasis in the Dermovate group had an exacerbation of the disease and the treatment was discontinued. In Study 1, reduction in plasma cortisol levels during treatment was observed in both groups, but to a distinctly lesser degree in the Diprolene than in the Dermovate group; levels below the normal range (184 to 767 nmol/l) were observed in one patient in the Diprolene group and in four patients in the Dermovate group.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Aged; Betamethasone; Clinical Trials as Topic; Clobetasol; Double-Blind Method; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Ointments; Pituitary-Adrenal System; Psoriasis; Random Allocation

Topics: Adolescent; Adult; Aged; Betamethasone; Clinical Trials as Topic; Clobetasol; Dermatitis, Atopic; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Psoriasis

Topics: Clinical Trials as Topic; Clobetasol; Dermatitis; Halcinonide; Humans; Pregnenediones; Psoriasis

In a double-blind controlled trial, we have compared the therapeutic effectiveness of Diflorason-Diacetate and Clobetasol-17-propionate with 50 PUVA-resistent psoriatics. Both externals resulted in a highly significant decline of psoriatic symptoms. The difference in therapeutic achievement between the two respective groups was statistically not significant. According to the physician's overall judgement, however, Clobetasol was favored significantly over Diflorasone-Diacetate, while the patients only showed a slight preference for Clobetasol. Based on these findings and previously published results, Diflorasone-Diacetate may be classified as one of the most effective skin corticosteroids, ranging just behind Clobetasol.

Topics: Betamethasone; Clinical Trials as Topic; Clobetasol; Double-Blind Method; Humans; Photochemotherapy; Psoriasis; PUVA Therapy

Topics: Betamethasone; Clinical Trials as Topic; Clobetasol; Double-Blind Method; Drug Administration Schedule; Humans; Psoriasis; Random Allocation; Time Factors

In an open multi-centre trial, 316 psoriasis patients were treated with clobetasol propionate intermittently over a 14-day period. The treatment gave rapid clinical healing of the psoriasis infiltration in 62% of the patients. A total of 132 of these patients was subsequently put on maintenance treatment with two applications per week. This regimen kept the disease in remission throughout the observation period, which exceeded 4 months on average, in 75% of the patients. Only 5 patients experienced side-effects.

Topics: Administration, Topical; Betamethasone; Clinical Trials as Topic; Clobetasol; Drug Administration Schedule; Humans; Psoriasis

In a parallel group design, and using a 'blind evaluator' technique, alclometasone cream 0.05% and clobetasone butyrate cream 0.5% applied twice a day for 21 days were compared in thirty-one patients presenting with psoriasis. Erythema, induration and scaling were assessed at the start of treatment. Seven, 14 and 21 days later, effects of the two treatments were assessed and recorded together with the physician's global evaluation of overall improvement. Both drugs had similar beneficial effects on the clinical signs. No adverse experience was reported and the overall results indicate that alclometasone and clobetasone have comparable efficacy and safety.

Topics: Adult; Anti-Inflammatory Agents; Betamethasone; Clobetasol; Drug Evaluation; Humans; Methylprednisolone; Psoriasis

A double-blind comparison was made between Diprosalic and Dermovate lotions in fifty-one patients with psoriasis of the scalp. Both preparations were highly effective. No significant difference in efficacy between the preparations could be demonstrated after 3 weeks treatment except for antipruritic effect, in this respect Diprosalic being superior to Dermovate. Only three patients (two in the Dermovate group, and one in the Diprosalic group) experienced minor adverse reactions. Plasma cortisol levels were determined in seventeen of the patients and no significant influence on the adrenal function could be shown on the part of either of the preparations.

Topics: Anti-Inflammatory Agents; Betamethasone; Clobetasol; Drug Evaluation; Female; Humans; Hydrocortisone; Male; Psoriasis; Salicylates; Scalp Dermatoses; Suspensions

Clobetasone butyrate 0.05% (Eumovate), a halogenated topical steroid, was compared with hydrocortison butyrate 0.1% (Locoid) which does not contain any halogen atoms. In the treatment of eczema there was not difference between the preparations, but in that of psoriasis the halogen-containing steriod was significantly more effective. Under normal circumstances neither preparation had any detectable effect on adrenal function, but with large doses under total-body polythene occlusion, circulating cortisol levels were reduced less by the halogenated than by the non-halogenated preparation. Corticosteroids which contain a halogen atom are often considered to cause more adverse effects than the non-halogenated preparations with similar clinical efficacy. This study shows that this cannot be assumed for their ability to suppress cortisol levels.

Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone; Clinical Trials as Topic; Clobetasol; Double-Blind Method; Eczema; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Pituitary-Adrenal System; Psoriasis

90 patients suffering from chronic skin diseases-mainly psoriasis vulgaris-were treated in a double-blind-study for two weeks with topical Clobetasol-17-propionate compared with other topical corticoids. In 81% was seen a better therapeutical effect on the Clobetasol-17-propionate treated skin area.

Topics: Administration, Topical; Adolescent; Adrenal Cortex Hormones; Adult; Aged; Betamethasone; Child; Clinical Trials as Topic; Clobetasol; Desoximetasone; Diflucortolone; Double-Blind Method; Eczema; Humans; Middle Aged; Neurodermatitis; Psoriasis

Topics: Adolescent; Adult; Aged; Betamethasone; Clinical Trials as Topic; Clobetasol; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Psoriasis; Skin Diseases; Solutions; Triamcinolone Acetonide

Comparable lesions in 16 patients with chronic plaque psoriasis were treated with clobetasol propionate or placebo ointments for 1 week before beginning photochemotherapy. The greater improvement of the steroid treated lesions was maintained after the ointment was withdrawn and there was a mean period of 31 days before those treated with placebo showed a comparable response to photochemotherapy. By the end of the study 8 patients were completely free of psoriasis, healing being achieved after a mean of 7.2 photochemotherapy treatments on the steroid treated lesions compared with 13.5 where a placebo ointment was used. No patient had any adverse reaction to treatment.

Topics: Adult; Betamethasone; Clinical Trials as Topic; Clobetasol; Drug Therapy, Combination; Female; Humans; Methoxsalen; Photochemotherapy; Placebos; Psoriasis

Topics: Administration, Topical; Betamethasone; Betamethasone Valerate; Clinical Trials as Topic; Clobetasol; Double-Blind Method; Drug Evaluation; Humans; Hydrocortisone; Pituitary-Adrenal System; Psoriasis

Three hundred and fifty-four patients with symmetrical dermatoses took part in a multicentre, doubleblind, half-side study in order to compare the efficacy of a new topical steroid, diflucortolone valerate 0.3% (Nerisone Forte) against that of an established, potent topical steroid, clobetasol propionate 0.05% (Dermovate). The assessment of overall response, as judged by the physicians' preference for one side or another, showed no difference between the two compounds. However, when the results were examined by separate diagnostic category, the number of preferences was greater for diflucortolone valerate 0.3% in eczema, and for clobetasol propionate 0.05% in psoriasis, although neither of these differences reached levels of statistical significance. The graded assessments of response indicated that both compounds were highly effective, potent, topical steroids. Eighty-one percent of all patients showed marked improvement or healing with diflucortolone valerate 0.3%, and 84% showed marked improvement or healing with clobetasol propionate 0.05%. This difference was not statistically significant. Analysis of response, either by diagnosis or grade of severity, showed no statistically significant differences between the two compounds. No significant differences in the incidence of severity of side-effects were observed. It was concluded that the two compounds were of equal clinical efficacy.

Topics: Adrenal Cortex Hormones; Adult; Betamethasone; Clinical Trials as Topic; Clobetasol; Dermatitis, Atopic; Double-Blind Method; Eczema; Female; Humans; Male; Middle Aged; Psoriasis

A double-blind randomized study to compare the plasma cortisol values at both 9.00 a.m. and 12 midnight following topical application fo 10 g daily for 7 days of either diflucortolone valerate 0.3% (Nerisone Forte) ointment or clobetasol propionate 0.05% (Dermovate) ointment in 20 hospital inpatients suffering from severe psoriasis, showed that clinically both compounds behaved as potent, highly active topical preparations and caused rapid clinical improvement. Diflucortolone valerate 0.3% caused only slight and non-significant depression of mean plasma cortisols. On the other hand, clobetasol caused an immediate, persistent and statistically significant depression of the 9.00 a.m. coritsol values, which appeared to recover towards normality only on the third day after therapy had been withdrawn. the difference between these 2 compounds was found to be statistically significant (P less than 0.05). From these observations, it is concluded that diflucortolone valerate 0.3% ointment suppresses adreno-cortical function to a significantly lesser extent than clobetasol propionate 0.05% ointment.

Topics: Adrenal Cortex Hormones; Betamethasone; Clinical Trials as Topic; Clobetasol; Depression, Chemical; Double-Blind Method; Humans; Hydrocortisone; Psoriasis

Clobetasone butyrate ointment has been shown to be more effective in treating psoriasis and eczema than flurandrenolone ointment yet to cause less epidermal thinning in a human experimental model. This is an indication that the clinical activity of topical glucocorticoids may not necessarily be inseparable from their propensity to cause atrophy of the skin.

Topics: Betamethasone; Cell Count; Clinical Trials as Topic; Clobetasol; Eczema; Flurandrenolone; Humans; Psoriasis; Skin

Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone Valerate; Clinical Trials as Topic; Clobetasol; Eczema; Fluocinonide; Glucocorticoids; Humans; Pregnenediones; Psoriasis

A double-blind evaluation was carried out in 40 patients with moderate to severe psoriasis of the scalp to assess the effectiveness of a 0.05% alcoholic solution of clobetasol propionate as compared with a 0.05% alcoholic solution of betamethasone-17,21-dipropionate. Patients were treated on a non-selective basis with a twice a day application for 2 weeks. When comparing the effects on the parameters scaling, induration, erythema and itching it was concluded that clobetasol propionate was superior to betamethasone-17,21-dipropionate as an antipsoriatic compound. Clobetasol propionate did not cause any side-effects, while 2 of the patients using betamethasone-17,21-dipropionate developed a forehead folliculitis during the second week of treatment.

Topics: Betamethasone; Clinical Trials as Topic; Clobetasol; Humans; Psoriasis; Scalp Dermatoses

Copy: Palmoplantar psoriasis is a chronic, difficult-to-treat localized variant of psoriasis that affects the palms and soles, significantly affecting patient's quality of life.. To evaluate the synergistic effect of a fixed-combination topical lotion composed of halobetasol propionate 0.01% and tazarotene 0.045% in the treatment of palmoplantar psoriasis.. This was an open-label investigator-initiated trial involving 21 patients with moderate-to-severe palmoplantar plaque-type psoriasis who underwent treatment with halobetasol propionate 0.01% and tazarotene 0.045%. Subjects were assessed for disease severity using the palmoplantar Physician Global Assessment and the mean difference over time was compared using the Wilcoxon signed-rank test.. 5 patients (24%) achieved a palmoplantar Physician Global Assessment of 0 or 1 after week 24 or last observation carried forward. The mean palmoplantar Physician Global Assessment significantly decreased from baseline (3.57) to week 24/last observation carried forward (2.38) (P<0.001).. Halobetasol propionate 0.01% and tazarotene 0.045% lotion demonstrated efficacy in adult patients with moderate-to-severe palmoplantar plaque-type psoriasis through significant improvement in palmoplantar Physician Global Assessment. The complementary mechanisms of action of the corticosteroid and tazarotene may be of benefit compared to monotherapeutic agents. J Drugs Dermatol. 2023;22(2): 223-225. doi:10.36849/JDD.7067.

Topics: Adult; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Emulsions; Humans; Nicotinic Acids; Psoriasis; Quality of Life; Severity of Illness Index; Skin Cream; Treatment Outcome

A novel topical corticosteroid, halobetasol propionate (HP) 0.01% lotion (Bryhali™), has recently been introduced for the treatment of plaque psoriasis and corticosteroid-responsive dermatoses in adults. Once daily application of HP 0.01% lotion is indicated for use up to 8 weeks. Treatment success for plaque psoriasis in the pivotal phase 3 clinical trials (defined as an Investigator Global Assessment [IGA] of clear/almost clear [IGA 0/1] with ≥2-grade improvement from baseline) occurred in over one-third of patients by week 8. Treatment-emergent adverse events were typically mild-to-moderate in intensity and usually limited to the application site(s). No treatment-related cases of skin atrophy have been reported from the studies. Counselling should be considered to optimize treatment outcomes.

Topics: Administration, Cutaneous; Adult; Clobetasol; Drug Combinations; Emollients; Emulsions; Glucocorticoids; Humans; Immunoglobulin A; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Not all patients with psoriasis achieve a satisfactory response to their initial biologic monotherapy. Switching to a new biologic may be associated with new safety issues and additional costs. In this study, we assessed the effectiveness and safety of adjunctive halobetasol propionate (HP) 0.01%-tazarotene (TAZ) 0.045% lotion in adult patients with moderate to severe plaque psoriasis who had been receiving biologic monotherapy for 24 weeks or more but had inadequate responses. All participants received HP-TAZ lotion once daily for 8 weeks, then once every other day for 4 weeks, in addition to their ongoing biologics. This real-world study demonstrated that HP-TAZ lotion adjunctive to ongoing biologics is safe and effective and potentially a more economical alternative to switching biologics for patients with psoriasis with inadequate responses to biologic monotherapy.

Topics: Administration, Cutaneous; Adult; Biological Products; Clobetasol; Dermatologic Agents; Drug Combinations; Emollients; Humans; Nicotinic Acids; Propionates; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Develop a platform for co-delivering clobetasol propionate (CP) and cyclosporine (CyA) to the epidermis and dermis to treat psoriasis.. The transfersomes were prepared by thin-film hydration method. Transfersomes were characterised by dynamic light scattering and transmission electron microscope (TEM). Then, the gel stability, viscosity, pH, and spreadability were measured. Cytotoxicity of the CyA-loaded transfersome embedded in CP-dispersed gel (TEG-CyA-CP) was assessed on both human keratinocyte cell line (HaCaT) and Jurkat cells.. Nanoscale (<150 nm) transferosomes with high CyA encapsulation efficiency (>86%) were made. TEG-CyA-CP demonstrated higher viscosity (4808.8 ± 12.01 mPas), which may help control dual drug release.. The developed TEG-CyA-CP represents a promising fit-to-purpose delivery platform for the dual-site co-delivery of CyA and CP in treating psoriasis.

Topics: Clobetasol; Cyclosporine; Humans; Lymphocytes; Pharmaceutical Preparations; Psoriasis; Tumor Necrosis Factor-alpha

Topics: Alcoholism; Antirheumatic Agents; Arthritis, Rheumatoid; Clobetasol; Diagnostic Errors; Glucocorticoids; Humans; Hydroxychloroquine; Male; Middle Aged; Pellagra; Psoriasis

Up to 80% of individuals with plaque psoriasis have scalp involvement, which can have a significant impact on the quality of life of affected individuals. Despite advancements in psoriasis therapeutics, management of scalp involvement remains a challenge. This12-week, open-label pilot study assessed the safety and efficacy of fixed combination tazarotene 0.045% and halobetasol propionate 0.01% lotion for the treatment of patients with mild-to-moderate plaque psoriasis with scalp involvement. Among 20 patients who were followed through 12 weeks, there were significant improvements in the primary endpoint (Investigator’s Global Assessment (IGA)) and most secondary endpoints (Psoriasis Scalp Severity Index (PSSI), body surface area (BSA), and scalp IGA (sIGA)). Treatment was well-tolerated. Further placebo-controlled double-blinded study for confirmation of our results is recommended. J Drugs Dermatol. 2021;20(11): 1191-1194. doi:10.36849/JDD.0102.

Topics: Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Humans; Nicotinic Acids; Pilot Projects; Psoriasis; Quality of Life; Scalp; Severity of Illness Index; Skin Cream; Treatment Outcome

A novel fixed combination lotion containing the super-potent corticosteroid halobetasol propionate 0.01% and retinoid tazarotene 0.045% (Duobrii™) has recently been introduced and indicated for the treatment of moderate to severe plaque psoriasis in adults. Studies have shown that there is synergy between the ingredients and that the product can be safely used intermittently for up to 1 year. Treatment success (i.e., Investigator Global Assessment [IGA] of clear/almost clear [IGA 0/1] and at least a 2-grade improvement from baseline) occurred in 58.8% of participants at some point in a 1-year clinical trial. Persistence of treatment success is common after treatment discontinuation. Most treatment-emergent adverse events are application site reactions, mild to moderate in intensity, and occur primarily during the first 12 weeks. Counselling should be considered to optimize treatment outcomes.

Topics: Administration, Cutaneous; Adult; Clobetasol; Dermatologic Agents; Drug Combinations; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream

Successful clinical data on halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis are published. This article charts its formulation development.. Dermal deposition, clinical efficacy, and synergistic effect of HP and TAZ delivered by polymeric emulsion technology was compared to HP 0.05% cream (Ultravate) and TAZ 0.1% cream (Tazorac); skin hydration and barrier maintenance with vehicle lotion through Trans Epidermal Water Loss (TEWL) and corneometry using human cadaver tissue; and steroid potency by vasoconstrictor assay (VCA) in healthy volunteers. Safety and tolerability evaluated in clinical studies and patient preference questionnaire.. HP/TAZ lotion, using polymeric emulsion technology demonstrated better active ingredient delivery than HP 0.05% or TAZ 0.1% creams; supported by synergistic clinical data, with high HP potency outcome. Efficacy was rapid and sustained posttreatment. Layering TAZ 0.1% cream onto HP 0.05% cream had a negative effect on receptor phase levels. HP/TAZ lotion provided rapid and sustained increases in skin moisturization and gradually decreases in TEWL. Most subjects responded favorably to questions on the physical attributes of the vehicle lotion.. Fixed combination HP 0.01%/TAZ 0.045% lotion formulation utilizing innovative polymeric emulsion technology and optimal selection of solvents/emollients/humectants, has recently been developed. Features inherent in technology translate into rapid, sustained efficacy, low irritation, and good patient acceptance.

Topics: Clobetasol; Dermatologic Agents; Drug Combinations; Emulsions; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Treatment Outcome

Psoriasis is an autoimmune disease of the skin with lapsing episodes of hyperkeratosis, irritation, and inflammation. Numerous traditional and novel drug delivery systems have been used for better penetration through psoriatic barrier cells and also for retention in the skin. As there is no effective remedy for better penetration, and retention is there because of the absence of an ideal carrier for effective and safe delivery of antipsoriatic drugs.. The main objective of this project is to develop a Squalene integrated NLC based carbopol 940 gel to create a local drug depot in the skin for improved efficacy against psoriasis.. Homogenization method is used for the formulation of Nanostructured Lipid Carrier, which was characterized on the basis of size, entrapment efficiency, polydispersity index (PDI), viscosity, spreadability, DSC, zeta potential, % in vitro release, in vitro skin permeation and retention studies, physical storage stability studies. In vivo studies can use other alternative models for induction of psoriasis by severe redness, swelling macroscopically, and microvascular dilation edema lasting for 10 days. Furthermore, histopathology study was done to asses changes in the skin.. The optimized formulation of nanostructured lipid carrier-based gel has shown significant and sustained release of clobetasol propionate. Furthermore, this formulation has also shown retention in skin because of squalene as it is a sebum derived lipid, which shows an affinity towards the sebaceous gland.

Topics: Clobetasol; Drug Carriers; Humans; Lipids; Nanostructures; Psoriasis

Clobetasol propionate (CP), a superpotent topical corticosteroid, holds great promise for psoriasis treatment. However, common side effects like skin atrophy, steroidal acne, hypopigmentation and allergic contact dermatitis associated with it, hamper its utility for topical application. Taking this into consideration, the current work was aimed to fabricate CP loaded cyclodextrin nanosponge (CDNS) based hydrogel, to alleviate the aforementioned side effects, while controlling drug release. Nanosponges were crafted employing β-cyclodextrin (polymer) and diphenyl carbonate (cross linker) and evaluated appropriately. The selected formulation augmented 45 folds water solubility, with respect to pure CP. The formulation possessed entrapment efficiency (56.33 ± 0.94%), particle size (194.27 ± 49.24 nm) with polydispersitive index (0.498 ± 0.095), surface charge (-21.83 ± 0.95 mV) and drug release (86.25 ± 0.28%). Selected CP-CDNS were found crystalline and uniform in size. Further, in vitro cell viability analysis has been performed using THP1 cells to evaluate cytocompatibility of CP nanosponges. The chosen CP nanosponges were then embedded into Carbopol hydrogel, and characterized for rheological behaviour, spreadability, and texture profile. The developed nanoformulations were also assessed in vivo using mouse tail model. Histological and biochemical assessments have been conducted to explore their antipsoriatic activity via oxidative stress biomarkers. The degree of orthokeratosis was observed remarkably (p < 0.001) amplified by CP-CDNS14 hydrogel as compared to untreated group (control) and CP hydrogel. In addition, drug activity and change in epidermal thickness were found significant. Our findings altogether advocated the profound potential of prepared CP nanogel in the topical treatment of psoriasis, with improved patient compliance.

Topics: Administration, Topical; Animals; Clobetasol; Drug Liberation; Hydrogels; Mice; Psoriasis; Skin

Targeting the nuclear receptor RORγt is thought to be effective in autoimmune disorders. Tertiary sulfonamide 1 was found to be a potent RORγt inverse agonist previously. However, the high hepatic clearance value limits its druggability. In this study, we designed and synthesized a series of N-sulfonamide-tetrahydroquinolines by molecular modeling and scaffold hopping strategy, aiming at improving the metabolic stabilities. Detailed SAR exploration led to identification of potent RORγt inverse agonists such as 13 with moderate binding affinity and inhibitory activity of Th17 cell differentiation. Binding mode of 13 with RORγt-LBD was revealed by molecular docking. Moreover, 13 showed lower intrinsic clearance in mouse liver microsomes compared with 1 and potent in vivo efficacy and safety in psoriasis models, which can be used as a good starting point for the further optimization.

Topics: Animals; Cell Differentiation; Disease Models, Animal; Dose-Response Relationship, Drug; Drug Discovery; Female; Fluorescence Resonance Energy Transfer; Imiquimod; Mice; Mice, Inbred BALB C; Microsomes, Liver; Molecular Docking Simulation; Molecular Structure; Nuclear Receptor Subfamily 1, Group F, Member 3; Psoriasis; Quinolines; Structure-Activity Relationship; Sulfonamides; Th17 Cells

Topics: Administration, Cutaneous; Animals; Clobetasol; Disease Models, Animal; Drug Carriers; Drug Liberation; Female; Gels; Lipids; Male; Microscopy, Electron, Scanning; Nanoparticles; Particle Size; Psoriasis; Rats; Rats, Wistar; Rheology; Sebaceous Glands; Skin; Skin Absorption; Temperature

Lipid-polymer hybrid nanoparticles (LPNs) exhibit several advantages over polymeric and non-polymeric systems in terms of improved drug loading, controlled release, stability, and cellular uptake. Herein we report a scalable and stable monolithic lipid-polymer hybrid nanoparticles (LPNs) consisting of a combination of lipids (solid and liquid) and an amphiphilic copolymer, mPEG-PLA. Clobetasol propionate, a topical corticosteroid, was encapsulated in the hydrophobic core of these LPNs that showed spherical shaped particles with a z-average size of 94.8 nm (PDI = 0.213) and encapsulation efficiency of 84.3%. These clobetasol loaded LPNs (CP/LPNs) were formulated into a topical hydrogel using carbopol 974P. CP/LPNs gel showed a sustained in vitro clobetasol release for 7 days with no burst release and 6 month stability at 2-8°C and room temperature. Further, CP/LPNs showed an improved cellular uptake with significant growth inhibition of HaCaT cells. In ex vivo studies, these LPNs penetrated into the viable epidermis and dermis region of the psoriatic skin with undetectable quantities leaching to the reservoir. Further, the topical application of CP/LPNs gel on Swiss albino mice with psoriasis-like inflammation showed negligible leaching of clobetasol into the systemic circulation. Efficacy assessment showed significantly improved PASI score, reduced skin damage and proliferation after treatment with CP/LPNs gel as compared to marketed product (Clobetamos™). Collectively, the enhanced cellular uptake, high skin penetration with increased skin retention, and improved efficacy demonstrate the potential of these LPNs for future clinical application.

Topics: Animals; Clobetasol; Imiquimod; Inflammation; Lipids; Mice; Nanoparticles; Polymers; Psoriasis

Skin of color patients with psoriasis face unique challenges related to disease characteristics and treatment. Dyspigmentation, including postinflammatory hypo- and hyperpigmentation, more frequently and severely affects patients with skin of color and remains a challenge in psoriasis management. We present the case of a 58-year-old Black male with moderate psoriasis who was treated for 8 weeks with a fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion during a phase 3 study (NCT02462070). HP/TAZ was efficacious in this patient, whose Investigator’s Global Assessment score decreased from 3 (moderate) at baseline to 1 (almost clear) within 4 weeks, with maintenance of & "almost clear"; through week 12 (4 weeks posttreatment). Affected body surface area decreased by 50% and quality of life greatly improved from baseline to week 8. The patient experienced dyspigmentation of the affected skin during the trial; hypopigmentation was primarily experienced from weeks 2-8, with the greatest degree at week 4. By week 12, the affected skin area had returned to normal, with only small regions of hyperpigmentation, primarily around the periphery of the lesion. These results indicate that HP/TAZ may be a treatment option for patients with skin of color, who are disproportionally affected by postinflammatory dyspigmentation. \ \ J Drugs Dermatol. 2020;19(10):1000-1004. doi:10.36849/JDD.2020.5347.

Topics: Administration, Cutaneous; Black or African American; Clobetasol; Drug Combinations; Esthetics; Humans; Hypopigmentation; Male; Middle Aged; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Skin Pigmentation; Treatment Outcome

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

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

Topics: Aged; Antibodies, Monoclonal, Humanized; Biopsy; Clobetasol; Dermatologic Agents; Drug Eruptions; Glucocorticoids; Humans; Male; Psoriasis; Skin; Treatment Outcome

Recently, clinical data on 8 weeks’ once-daily treatment of localized moderate-to-severe psoriasis with a novel fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion were published.1,2 HP/TAZ lotion was significantly more effective than individual active ingredients or vehicle, based on improvements in Investigator’s Global Assessment (IGA), body surface area (BSA) involvement, and signs and symptoms of psoriasis (erythema, plaque elevation, and scaling) at the target lesion as well as a synergistic benefit over individual active ingredients, and good tolerability.

Topics: Administration, Cutaneous; Clinical Trials, Phase III as Topic; Clobetasol; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Humans; Multicenter Studies as Topic; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Topics: Administration, Topical; Aged; Clobetasol; Diagnosis, Differential; Female; Glucocorticoids; Granuloma, Giant Cell; Herpes Zoster; Humans; Psoriasis; Skin Diseases

Topics: Adrenocorticotropic Hormone; Adult; Clobetasol; Cushing Syndrome; Cyclosporine; Dermatologic Agents; Female; Glucocorticoids; Humans; Iatrogenic Disease; Prescription Drug Overuse; Psoriasis

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Drug Combinations; Humans; Nicotinic Acids; Psoriasis

Novel effective and cosmetically acceptable formulations are needed for the treatment of scalp psoriasis, due to the poor efficacy of the current products. The challenge in developing safe, efficient, and convenient delivery systems for this drug was addressed in the present work by formulating clobetasol propionate-loaded W/O microemulsions (MEs). Pseudo-ternary phase diagrams were constructed by using a combination of biocompatible and biodegradable excipients. Characterization studies demonstrated that selected MEs had suitable technological features such as being Newtonian fluids, possessing low viscosity, and high thermodynamic stability. Photomicrographs showed a significant alteration of the skin structure after treatment with MEs, and a preferential concentration of these in the stratum corneum and epidermis. These data, together with ex vivo permeation results, suggested an enhanced topical targeted effect due to an increased drug retention efficacy in the upper skin layers, as desired. Moreover, the bio-based excipients selected could contribute to the healing of the psoriatic scalp. In this way, the improvement of clobetasol efficacy is combined with the useful properties of the microemulsion components and with environmental safety.

Topics: Administration, Cutaneous; Animals; Biocompatible Materials; Chemistry, Pharmaceutical; Clobetasol; Emulsions; Epidermis; Excipients; Particle Size; Permeability; Psoriasis; Scalp; Skin; Skin Absorption; Swine

Topics: Administration, Cutaneous; Adolescent; Adult; Anti-Inflammatory Agents; Clobetasol; Female; Humans; Male; Middle Aged; Nail Diseases; Pilot Projects; Psoriasis; Severity of Illness Index; Young Adult

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

Despite the important nail alterations caused by onychomycosis and psoriasis few studies have characterized the microstructure of the diseased nail plate and the diffusion and penetration of drugs through this altered structure. This work aimed to characterize the microstructure of the healthy, onychomycotic and psoriatic human nail using Raman spectroscopy, scanning electron microscopy, optical microscope profilometry and mercury intrusion porosimetry followed by analysis of the structure with PoreCor® software. The results showed that onychomycotic nails have higher porosity and lower amounts of disulphide bonds compared to healthy nails. This suggests that the presence and action of fungi on the nail plate makes this structure more permeable to water and drugs. Psoriatic nails had increased porosity compared to healthy nails but lower than fungal infected specimens. In vitro permeation studies showed that diseased nails were more permeable to ciclopirox (onychomycosis) and clobetasol (psoriasis) although drug permeation was highly variable and likely to be influenced by the degree of alteration of the nail structure. On the whole, this work provides new and valuable information about the microstructure and porosity of diseased nails and a plausible explanation of the increased drug permeability observed in this work and elsewhere.

Topics: Administration, Topical; Adult; Antifungal Agents; Ciclopirox; Clobetasol; Foot Dermatoses; Healthy Volunteers; Humans; Image Processing, Computer-Assisted; Microscopy, Electron, Scanning; Middle Aged; Nails; Onychomycosis; Permeability; Porosity; Psoriasis; Pyridones; Software; Spectrum Analysis, Raman

Topics: Aged; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Clobetasol; Enzyme-Linked Immunosorbent Assay; Female; Glucocorticoids; Humans; Pemphigoid, Bullous; Psoriasis

Topics: Clobetasol; Dermatologic Agents; Diagnosis, Differential; Eosinophilia; Humans; Hydroxyzine; Isotretinoin; Male; Middle Aged; Pityriasis Rubra Pilaris; Psoriasis; Severity of Illness Index; Skin; Treatment Outcome; Urea

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Drug Combinations; Glucocorticoids; Humans; Male; Minoxidil; Psoriasis; Striae Distensae; Young Adult

In the present study chitin nanogel loaded with anti-psoriatic drug clobetasol was developed (CLCNG) for its topical delivery in psoriasis. CLCNG had the particle size of 132±14nm, with gel like consistency, stability in refrigerator, having higher drug release properties at acidic pH. CLCNG exhibited significant toxicity towards HaCaT and THP-1cell lines by MTT assay. The uptake of nanogel by HaCaT cell lines was confirmed by fluorescent microscopy. CLCNG at 0.35mg/ml exhibited significant anti-inflammatory activity with an average of 65% and 70% inhibition in COX and LOX activities expressed in THP-1 cells. In vitro skin permeation studies revealed the increased transdermal flux with fragmented stratum corneum and loosened epidermal layers in CLCNG treated samples, compared with control drug solution. The in vivo anti-psoriatic studies done on imiquimod model confirmed the potential benefits of the nanogel for the topical delivery of clobetasol in psoriasis.

Topics: Administration, Cutaneous; Animals; Anti-Inflammatory Agents; Cell Line; Chitin; Clobetasol; Drug Carriers; Humans; Mice; Mice, Inbred BALB C; Nanogels; Organ Culture Techniques; Polyethylene Glycols; Polyethyleneimine; Psoriasis; Skin Absorption; Skin Cream; Swine

Dillenia indica Linn. (Dilleniaceae) is traditionally used to treat skin inflammation.. This study evaluated the healing effect of Dillenia indica fruit extracts on induced psoriasis-like wounds in Wistar rats.. Extracts were standardized to betulinic acid, including an aqueous ethanolic extract (AEE), ethyl acetate extract (EAE) and petroleum ether extract. Effects against lipid peroxidation were assessed in vitro. Wounds were created at rat tails (n = 12). Topical treatments were applied once daily for 7 days (1 mL of AEE or EAE at 5 or 50 mg/mL). Maximal dose was defined by the extract solubility. A 10-fold lower dose was also tested. Positive and negative controls were treated with clobetasol (0.5 mg/mL) or excipient. Half of each group was euthanized for histology. The remaining animals were observed for 20 days for wound measurements.. Yields of AEE and EAE were 4.3 and 0.7%, respectively. Betulinic acid concentrations in AEE and EAE were 4.6 and 107.6 mg/g. Extracts neutralized lipid peroxidation in vitro at 0.02 μg/mL, accelerating healing at 50 mg/mL. Complete healing in mice treated with AEE occurred 16 days after wound induction. This time was 14 and 12 days in mice treated with EAE and clobetasol. Compared to orthokeratosis, parakeratosis was reduced by AEE (25%), EAE (45%) and clobetasol (55%). EAE caused superior protection against biomolecules oxidation of skin compared to AEE.. EAE exhibited activity closer to that of clobetasol. Betulinic acid may be an active constituent, which should be assessed in future studies.

Topics: Animals; Anti-Inflammatory Agents; Antioxidants; Betulinic Acid; Biomarkers; Clobetasol; Dermatologic Agents; Dilleniaceae; Disease Models, Animal; Fruit; Lipid Peroxidation; Male; Malondialdehyde; Oxidative Stress; Pentacyclic Triterpenes; Phytotherapy; Plant Extracts; Plants, Medicinal; Protein Carbonylation; Psoriasis; Rats, Wistar; Skin; Solvents; Time Factors; Triterpenes; Ultraviolet Rays; Wound Healing

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

A common therapeutic modality for psoriasis includes the combination of phototherapy with topical treatments. The recent development of targeted phototherapy with the excimer laser and spray formulations for topical treatments has increased the efficacy and convenience of these combinational therapies. Herein, we aim to assess the efficacy of a novel combination of therapies using the 308 nm excimer laser, clobetasol propionate spray and calcitriol ointment for the treatment of moderate to severe generalized psoriasis. In this 12-week study, patients with moderate to severe psoriasis received twice weekly treatments with a 308-nm excimer laser combined with clobetasol proprionate twice daily for a month followed by calcitriol ointment twice daily for the next month. Of the 30 patients enrolled, 83% of patients (25/30) achieved PASI-75 [65-94%, 95% confidence interval (CI)] at week 12. For PGA, there was an estimated decrease of 3.6 points (3.1-4.1, 95% CI, p < 0.0005) by week 12. In conclusion, the combination of excimer laser with alternating clobetasol and calcitriol application has shown to be a promising combination of therapies for the treatment of moderate to severe generalized psoriasis. Further evaluation may be conducted with a larger study inclusive of control groups and head-to-head comparisons against topical steroid and UVB therapy as monotherapies.

Topics: Administration, Topical; Adult; Calcitriol; Calcium Channel Agonists; Chemistry, Pharmaceutical; Clobetasol; Combined Modality Therapy; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Lasers, Excimer; Low-Level Light Therapy; Male; Middle Aged; Nebulizers and Vaporizers; Ointments; Pilot Projects; Psoriasis

A 45-year-old man who had psoriasis had applied topical clobetasol 17 propionate ointment on his whole body 2-3 times a week after the bath for 20 years. Physical examination showed abdominal distension, atrophy all over the skin, psoriatic plaques on the trunk, and extremities and multiple striae on the shoulders and legs. Morning plasma cortisol level and ACTH stimulation test confirmed the diagnosis of hypothalamic insufficiency. Bone mineral densitometry showed severe osteoporosis. Multiple bone fractures in the vertebrae and costa were detected on lumbar magnetic resonance imaging, the (99)Tc MDP whole-body bone scan, and thoracoabdominal computerized tomography imaging. Topical corticosteroid therapies have possible local and/or systemic side effects such as atrophy, telangiectasia, hypertricosis, and suppression of pituitary-adrenal axis. We present an interesting case with multiple bone fractures caused by long-time topical corticosteroid use.

Topics: Administration, Topical; Clobetasol; Dermatologic Agents; Fractures, Bone; Glucocorticoids; Humans; Male; Middle Aged; Pituitary-Adrenal System; Psoriasis

Ubiquitous electronic devices, such as smartphones and tablets, have the potential to enable a fundamental shift in the paradigm of healthcare as these devices may allow patients and health care providers (HCPs) to rapidly and remotely communicate with each other. Once fully realized, these devices may facilitate interactions between patients and HCPs. While these devices hold much promise, much work remains in assessing their viability in various diseases. A pilot study was conducted to investigate the use of a tablet-based numeric rating scale to assess improvements in a plaque psoriasis target lesion treated with clobetasol propionate 0.05% spray (CPS). Twenty-eight subjects with plaque psoriasis enrolled and were treated with CPS twice daily for 15 days. Target lesion severity (scale of 0 [no psoriasis] to 10 [very severe psoriasis]) and effectiveness scores (scale of 0 [none] to 3 [severe]) were recorded using a tablet-based system by the investigator and subjects. The tablet was also used to take photos of the target lesion to capture photographic evidence of improvement. Investigator and subject assessed target lesion severity and effectiveness scores improved during the study from baseline to day 15; in addition subjects indicated a high level of satisfaction with CPS treatment. Very few technological failures were reported and captured photographs were consistent visit to visit and of high quality. Taken together, this study supports the use of a tablet-based system to measure and track plaque psoriasis disease progression and also confirmed that CPS is an effective and safe treatment for plaque psoriasis.

Topics: Administration, Cutaneous; Adult; Aged; Anti-Inflammatory Agents; Clobetasol; Computers, Handheld; Female; Humans; Male; Middle Aged; Pilot Projects; Prospective Studies; Psoriasis; Reproducibility of Results; Treatment Outcome

Sarcoidosis is a multisystem disease characterized by non-caseating granulomas present in the involved organ systems. The disease is believed to result from an interaction among genetic factors, antigens, and the immune response. Environmental exposures and infectious agents have been implicated as potential causes. Cutaneous sarcoidosis presents clinically in many forms and the lesions are classified as either specific or non-specific. Non-specific lesions show a nondescript inflammatory process whereas specific lesions display typical, non-caseating granulomas. There are many different forms of specific lesions with some being more common than others. Psoriasiform lesions are uncommon. The literature suggests that as few as 0.9% of patients display this type of cutaneous sarcoidosis. Some of these patients present solely with cutaneous sarcoidosis, but others have systemic involvement with pulmonary involvement being the most common concomitant presentation. Plaques appear as round or oval, brownish, red infiltrated lesions, frequently involving the extensor surface of the extremities, face, scalp, back, and buttocks. Multiple configurations, including discrete, confluent, annular, and polycyclic, have been reported. Despite the clinical resemblance to psoriasis, on histological examination, only non-caseating granulomas are seen in the dermis. In rare cases both psoriasiform sarcoidosis and psoriasis were present.

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Diagnosis, Differential; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Infliximab; Middle Aged; Psoriasis; Rituximab; Sarcoidosis; Skin Diseases

Topics: Aged; Clobetasol; Diagnosis, Differential; Foot Diseases; Glucocorticoids; Humans; Male; Pagetoid Reticulosis; Psoriasis; Skin Neoplasms

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

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

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

Although topical corticosteroid ointments were once viewed as the best vehicle for treating inflammatory skin diseases, the recognition of the problem of poor compliance and patients' preferences for other vehicles has led to the development of corticosteroid products in alternative formulations.. To describe patterns of use of newer vehicle formulations including foams, shampoos, sprays, and lotions for the treatment of psoriasis and other dermatoses.. The use of non-traditional vehicles was identified using visit with diagnoses for psoriasis and other dermatoses from the National Ambulatory Medical Care Survey 2000-2010 data. Trends in corticosteroid vehicles mentions were evaluated over the study period to determine how the use of non-traditional vehicles has changed. The odds ratios of being prescribed a nontraditional vehicle were reported for patient and office-based characteristics of visits.. Approximately 2.3% and 1.9% of visits mentioned foam and other non-traditional vehicles (shampoo, lotion, spray), respectively. The use of corticosteroids in shampoo, lotion, or spray preparations increased by 0.5% annually (p=0.008) but did not significantly change for corticosteroids in a foam preparation (p=0.10). Psoriasis and seborrheic dermatitis were the leading diagnoses at visits prescribed corticosteroids in nontraditional vehicles. Dermatologists were more likely than non-dermatologists to prescribe foam products [OR: 8.4 (3.6, 19.9)] or clobetasol in another non-traditional vehicle [OR: 49.7 (10.3, 240.5)].. Product vehicle was not specified for all corticosteroids.. Although there was increasing use of non-traditional vehicles, the rate of use has remained low. Dermatologists appear to have greater familiarity with the use of these newer vehicle formulations than do physicians in other specialties.

Topics: Adrenal Cortex Hormones; Anti-Inflammatory Agents; Clobetasol; Dermatitis; Dermatitis, Seborrheic; Dermatologic Agents; Female; Humans; Male; Medication Adherence; Pharmaceutical Vehicles; Psoriasis; Skin Cream

Effective treatments for moderate to severe psoriasis are phototherapy and biologics. These treatments are similar in that they both decrease cutaneous immune system hyperactivity yet do so via different mechanisms. Our patient, a 63 year old Asian male had a rapid response to treatment with the high dose excimer laser, having previously failed treatment with 28 weeks of ustekinumab therapy. A pre-treatment biopsy of a psoriatic plaque was found to contain relatively low levels of IFN-γ (Th1) and IL-17 (Th17) secreting T cells. Following treatment with the excimer laser, the patient had a quick improvement in PASI that was reflected by a 3-fold reduction in the number of live T cells found in the post-treatment biopsy. Although ustekinumab and the excimer laser both result in decreased levels of these cytokines, the excimer laser directly causes apoptosis of T cells and induces DNA damage in antigen presenting cells. Thus, the broader effects of phototherapy on immune cells compared to the targeted inhibition of IL-12 and IL-23 by ustekinumab likely account for the superior response observed.

Topics: Administration, Cutaneous; Calcitriol; Clobetasol; Combined Modality Therapy; Dermatologic Agents; Glucocorticoids; Humans; Lasers, Excimer; Male; Middle Aged; Ointments; Psoriasis; Treatment Failure; Ustekinumab

Topics: Administration, Topical; Adolescent; Clobetasol; Cushing Syndrome; Female; Glucocorticoids; Humans; Psoriasis

Psoriasis is a chronic, immune-mediated inflammatory and refractory disease. The koebner phenomenon, which can be induced by trauma, is common in psoriasis patients. Herein, we report a patient with psoriasis who was treated by cupping therapy and subsequently developed the koebner phenomenon (KP) at the cupped sites. To our knowledge, it is the first report about cupping therapy leading to KP in a psoriasis patient.

Topics: Adult; Clarithromycin; Clobetasol; Ecchymosis; Humans; Male; Medicine, Chinese Traditional; Nicotinic Acids; Psoriasis; Purpura; Skin; Vacuum

Many factors, including patients' methods of payment, may influence psoriasis treatment decisions.. To characterize psoriasis treatments by patients' types of payment in the US outpatient office setting.. Using the National Ambulatory Medical Care Survey (NAMCS), a large survey that samples outpatient office visits to US non-federally funded physicians, visits linked with sole diagnoses for psoriasis (ICD-9-CM: 696.1) were identified. There were 545 unweighted records. The types and number of treatments prescribed at these visits were categorized by expected major payment type to be used for the visit.. Mainstay psoriasis therapies such as vitamin D analogs and clobetasol were prescribed regardless of payment type. Retinoids were also within the most frequently prescribed psoriasis medications for all payment types, however they were less frequently prescribed than vitamin D analogs. Payment type did not have a significant effect on the number of medications prescribed at psoriasis visits.. Data on treatment adherence and filling of prescriptions are not included in the NAMCS database.. Prescribing patterns for psoriasis medications are similar across payment type. Additional factors appear to modulate therapy choice for patients with psoriasis.

Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Age Factors; Aged; Aged, 80 and over; Clobetasol; Drug Utilization; Health Care Surveys; Humans; Insurance, Health; Male; Medicaid; Medicare; Middle Aged; Outpatients; Psoriasis; Retinoids; Triamcinolone Acetonide; United States; Vitamin D; Vitamins; Young Adult

Hypertrophic lichen planus (LP), also known as LP verrucosus, is a rare disorder that presents as verrucous plaques, typically on the lower extremities and ankles. This variant differs from the common presentation of LP, which appears as flat, polygonal, pink-purple papules spread diffusely on the flexor wrists, trunk, shins, and dorsal aspects of the feet, frequently involving the oral mucosa. Clinically, hypertrophic LP can be confused with psoriasis and usually does not respond to therapy with biologics. We present a case of hypertrophic LP in a 42-year-old woman who had been treated extensively for psoriasis. Although the morphology and location of the hyperkeratotic plaques mimicked psoriasis, biopsy results exhibited characteristic features of hypertrophic LP, and the lesions responded to treatment with acitretin, clobetasol propionate ointment, hydroxychloroquine, and simple wound care. The hypertrophic variant of LP can be extremely challenging to differentiate from psoriasis. Physicians who treat patients with scaly plaques should think beyond psoriasis and consider the hypertrophic variant of LP as a potential diagnosis.

Topics: Acitretin; Adult; Biopsy; Clobetasol; Dermatologic Agents; Female; Humans; Hydroxychloroquine; Lichen Planus; Psoriasis; Treatment Outcome

Scalp psoriasis is a difficult to treat and usually chronic manifestation of psoriasis. The CalePso study showed that CPS (Clobex(®) Shampoo) in maintenance therapy of scalp psoriasis (twice weekly) significantly increases the probability of keeping patient under remission during 6 months, compared with vehicle (40.3% relapses vs. 11.6% relapses, ITT).. The objective of the study was to assess the cost-effectiveness of a maintenance therapy with CPS vs. its vehicle in nine European countries.. A 24-week decision tree model was developed with 4-weekly time steps. The considered population has moderate scalp psoriasis successfully treated with a daily application of CPS up to 4 weeks. Data were taken from the CalePso study and from national experts' recommendations for alternative treatment choices, with their probabilities of success taken from literature to develop country-specific models. Health benefits are measured in disease-free days (DFD). The economic analysis includes drug and physician costs. A probabilistic sensitivity analysis (PrSA) assesses the uncertainty of the model.. Depending on the country, the mean total number of DFDs per patient is 21-42% higher with CPS compared with vehicle, and the mean total cost is 11-31% lower. The mean costs per DFD are 30-46% lower with CPS compared with the vehicle. The PrSA showed in 1000 simulations that CPS is more effective vs. vehicle in 100% of the cases and less expensive than its vehicle in 80-99% of the cases.. This model suggests that CPS is cost-effective in maintaining the success achieved in moderate scalp psoriasis patients.

Topics: Anti-Inflammatory Agents; Clobetasol; Cost-Benefit Analysis; Europe; Hair Preparations; Humans; Psoriasis; Scalp

Protease-activated receptor 2 (PAR2) is a G protein-coupled receptor which mediates a variety of functions in the skin including cutaneous inflammation. SLIGKV-NH(2) , an agonist peptide for PAR2, enhanced the interleukin (IL)-17-induced production of two CXC chemokines, CXCL1 (GRO-α) and CXCL8 (IL-8), in normal human epidermal keratinocytes (NHEK) in a concentration-dependent manner. The enhanced production of those chemokines was suppressed by a PAR2-specific siRNA. The SLIGKV-NH(2) -induced production of both CXCL1 and CXCL8 was markedly reduced by cyclosporine A. The enhanced production of CXCL1 was suppressed by 1α, 24R-dihydroxyvitamin D(3) , an active form of vitamin D(3) , and weakly by glucocorticoids, dexamethasone and clobetasol propionate, whereas production of CXCL8 was not altered by any of those receptor agonists. In psoriatic skin, the thickened upper spinous layer of the epidermis was positive for PAR2 protein and the expression of the IL17A mRNA was increased. These results suggest that the IL-17-induced pro-inflammatory reaction is enhanced by the activation of PAR2 in keratinocytes, and that the effect of PAR2 is differentially modulated by cyclosporine A, the active form of vitamin D(3) and glucocorticoids.

Topics: Cells, Cultured; Chemokine CXCL1; Clobetasol; Cyclosporine; Dexamethasone; Dihydroxycholecalciferols; Glucocorticoids; Humans; Inflammation Mediators; Interleukin-17; Interleukin-8; Keratinocytes; Oligopeptides; Psoriasis; Receptor, PAR-2; RNA, Messenger; RNA, Small Interfering

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

Psoriasis is a chronic, inflammatory skin condition with negative impacts both physical and psychological. Scalp psoriasis, especially around the hairline, can cause significant impairment in quality of life due to its visibility. Options for treatment of facial psoriasis, including hairline involvement, are the use of low potency topical steroids, calcineurin inhibitors, and vitamin D analogues. Though the use of excimer laser for scalp psoriasis has been reported, there are no cases or studies specifically examining excimer laser phototherapy for the treatment of hairline psoriasis. We present a case of rapid improvement of hairline psoriasis using a regimen of 308 nm excimer laser with clobetasol spray and recommend an algorithm for the optimal treatment of scalp psoriasis utilizing currently available antipsoriatic therapies.

Topics: Aged; Algorithms; Clobetasol; Combined Modality Therapy; Female; Follow-Up Studies; Glucocorticoids; Humans; Lasers, Excimer; Psoriasis; Quality of Life; Scalp; Treatment Outcome

A 59-year-old Caucasian gentleman presented with malaise, fatigue and proximal muscle weakness. He had history of long-standing roseate psoriasis treated with topical clobetasol propionate (dermovate). On admission, he had significant postural hypotension, and hypercalcaemia. Endocrinological investigation revealed hypercalcaemia, a serum cortisol of <30 nmol/l, a flat short synacthen test and undetectable adrenocorticotropic hormone. He was treated with hydrocortisone. The abrupt withdrawal of the topical steroids by the patient precipitated the addisonian crisis. Further enquiry documented inappropriate oral administration of clobetasol for more than 10 years in addition to prescribed topical usage.

Topics: Adrenal Insufficiency; Clobetasol; Glucocorticoids; Humans; Hydrocortisone; Hypercalcemia; Male; Middle Aged; Psoriasis; Self Medication

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

Psoriasis is a chronic inflammatory skin disease that is characterized by thickened red plaques covered with silvery scales. Excimer laser therapy is a cutting-edge advancement in UVB phototherapy. In contrast to traditional phototherapy, the 308 nm excimer laser only targets psoriasis plaques, while it spares uninvolved skin. It allows for treatment with a supra-erythmogenic dose of UVB irradiation. Targeted UVB therapy is a possible treatment especially for many who have failed topical treatments, systemic therapy, and traditional phototherapy. For safe and effective psoriasis treatment, a combination of therapies may be used, including a combination of laser treatment with topical medications. We present two cases demonstrating effective treatment with excimer laser in conjunction with clobetasol spray and calcitriol ointment for 12 weeks. Long-term near-clearance of psoriasis was sustained after 6 months and one-year follow up periods without further therapy.

Topics: Adult; Calcitriol; Clobetasol; Combined Modality Therapy; Glucocorticoids; Humans; Laser Therapy; Maintenance Chemotherapy; Male; Psoriasis; Severity of Illness Index; Ultraviolet Therapy; Vitamins

Alopecia areata (AA) is a tissue-specific, T-cell-mediated autoimmune disease characterized by non-scarring hair loss. Ustekinumab is a human immunoglobulin monoclonal antibody that binds with the p40-subunit of interleukin-12 (IL-12) and IL-23 and has been licensed for the treatment of moderate to severe plaque psoriasis. The exact pathogenesis of AA remains unclear. However, increased Th1 serum cytokine levels have been associated with this condition. Thus, IL-12 inhibitors (ustekinumab) would be expected to treat or at least to prevent hair loss. We report two cases of acute AA occurring while on ustekinumab administration.

Topics: Alopecia Areata; Anti-Inflammatory Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Betamethasone; Clobetasol; Humans; Male; Middle Aged; Psoriasis; Treatment Outcome; Ustekinumab

The term Pseudoainhum is used in medical literature to elaborate the presence of constricting bands around the digits of hands and feet due to variety of etiologies. This phenomenon can lead to irreversible damage to the supplying neurovasculature and sequential autoamputation of the affected digits. The report herein, describes the rare presentation of pseudoainhum occurring concomitantly in acute psoriasis. Timely recognition of such rare disease entities by physicians is imperative to avoid unnecessary complications.

Topics: Acitretin; Acute Disease; Aged; Ainhum; Anti-Inflammatory Agents; Biopsy; Clobetasol; Constriction, Pathologic; Female; Fingers; Humans; Keratolytic Agents; Male; Psoriasis; Treatment Outcome

Psoriasis is a chronic, autoimmune skin disease affecting approximately 2% of the world's population. Clobetasol propionate which is a superpotent topical corticosteroid is widely used for topical treatment of psoriasis. Conventional dosage forms like creams and ointments are commonly prefered for the therapy. The purpose of this study was to develop a new topical delivery system in order to provide the prolonged release of clobetasol propionate and to reduce systemic absorption and side effects of the drug. Clobetasol propionate loaded-poly(D,L-lactic-co-glycolic acid) (PLGA) microspheres were prepared by oil-in-water emulsion-solvent evaporation technique. Particle size analysis, morphological characterization, DSC and XRD analyses and in vitro drug release studies were performed on the microparticle formulations. Emulgel formulations were prepared as an alternative for topical delivery of clobetasol propionate. In vitro drug release studies were carried out from the emulgel formulations containing pure drug and drug-loaded microspheres. In addition, the same studies were performed to determine the drug release from the commercial cream product of clobetasol propionate. The release of clobetasol propionate from the emulgel formulations was significantly higher than the commercial product. In addition, the encapsulation of clobetasol propionate in the PLGA microspheres significantly delayed the drug release from the emulgel formulation. As a result, the decrease in the side effects of clobetasol propionate by the formulation containing PLGA microspheres is expected.

Topics: Administration, Topical; Anti-Inflammatory Agents; Clobetasol; Delayed-Action Preparations; Excipients; Humans; Lactic Acid; Microspheres; Particle Size; Polyglycolic Acid; Polylactic Acid-Polyglycolic Acid Copolymer; Psoriasis; Technology, Pharmaceutical

Topics: Adalimumab; Adult; Alopecia Areata; Antibodies, Monoclonal, Humanized; Biological Therapy; Clobetasol; Humans; Immunosuppressive Agents; Male; Psoriasis

A man, 58 years of age, presented with a 4 year history of painful lesions of his nails. His previous history included hypertension, diabetes mellitus and hyperlipidaemia. These were treated with enalapril, metformin and simvastatin respectively. He also had asymptomatic skin lesions for over 15 years that had worsened in the past 4 years. His father had similar nail lesions that had been diagnosed as onychomycosis.

Topics: Clobetasol; Dermatologic Agents; Glucocorticoids; Humans; Male; Methotrexate; Middle Aged; Nail Diseases; Onycholysis; Pain; Psoriasis; PUVA Therapy

Topics: Acquired Hyperostosis Syndrome; Adult; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Clobetasol; Diagnosis, Differential; Drug Eruptions; Eczema, Dyshidrotic; Female; Foot; Hand; Humans; Impetigo; Manubrium; Osteitis; Psoriasis; Radionuclide Imaging; Sternoclavicular Joint

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

Topics: Administration, Topical; Adult; Aerospace Medicine; Clobetasol; Glucocorticoids; Gravitation; Humans; Male; Psoriasis; Unconsciousness

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

Psoriasis plaques that have very thick adherent scale (so-called coral reef or rupioid psoriasis) tend to be resistant to topical treatment. We present a case of coral reef psoriasis that responded to topical clobetasol 0.05% spray without concomitant use of moisturizers or keratolytic agents. We propose that coral reef psoriasis is resistant to topical corticosteroids because of poor adherence to treatment, not because of poor penetration of applied agents.

Topics: Administration, Topical; Adult; Clobetasol; Glucocorticoids; Humans; Male; Medication Adherence; Psoriasis

Topics: Anti-Inflammatory Agents; Child, Preschool; Clobetasol; Female; Glucocorticoids; Humans; Psoriasis; Substance Withdrawal Syndrome

A 49-year-old woman presented with a seven-year history of pruritic, erythematous, scaling plaques on sun-exposed skin that localized only to pre-existing depigmented patches. Histopathologic examination showed changes consistent with cutaneous lupus erythematosus with lichenoid features and confirmed contiguous vitiligo. Diagnosis of chronic cutaneous lupus erythematosus localized to areas of vitiligo was determined by clinicopathologic correlation and may reflect an autoimmune diathesis. Consequently, hydroxychloroquine and topical glucocorticoids therapy were initiated with reported improvement in pruritus, erythema, and scale. Clinical monitoring for development of squamous-cell carcinoma in areas of chronic inflammation and sun-exposure is imperative.

Topics: Autoimmunity; Carcinoma, Squamous Cell; Clobetasol; Diabetes Complications; Diagnostic Errors; Drug Therapy, Combination; Female; Fluocinolone Acetonide; Humans; Hydroxychloroquine; Lupus Erythematosus, Discoid; Middle Aged; Photosensitivity Disorders; Pruritus; Psoriasis; Skin Neoplasms; Sunlight; Ultraviolet Rays; Vitiligo

A case of psoriasis and psoriatic arthritis in a 38-year-old white male patient infected with human immunodeficiency virus (HIV) treated safely and effectively with mycophenolate mofetil (MMF) is reported. Treatments for psoriasis and psoriatic arthritis are manifold, including topical, oral, intramuscular, intravenous, and subcutaneous therapies. These indicated treatments for psoriasis and psoriatic arthritis result in suppression of the immune system.

Topics: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Antiretroviral Therapy, Highly Active; Arthritis, Psoriatic; Clobetasol; HIV Infections; Humans; Male; Middle Aged; Mycophenolic Acid; Psoriasis; Skin

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Clinical Trials as Topic; Clobetasol; Drug Industry; Ethics, Clinical; Humans; Marketing; Physician's Role; Practice Patterns, Physicians'; Psoriasis; Research Design; United States

Nail involvement is a common and distressing feature in the course of psoriasis. Although much progress has been made in the treatment of the disease, the presence of psoriasis in the nail continues to pose a challenge. In recent years, vitamin D3 analogs and a new formulation containing 8% clobetasol-17-propionate in a colourless nail lacquer vehicle have produced good results for the control of nail psoriasis.. To determine the efficacy and safety of the combined treatment of 8% clobetasol-17-propionate in a lacquer vehicle and tacalcitol ointment in nail psoriasis.. Fifteen patients with both nail bed and nail matrix psoriasis were included in the study. They were treated with a colourless nail lacquer containing 8% clobetasol-17-propionate applied at bedtime at the weekend, and with tacalcitol ointment under occlusion on the remaining days, for 6 months.. All 15 patients responded well to treatment. The therapeutic effect was very fast and directly related to the length of therapy. All nail alterations, including nail pain, were reduced, and the modified target Nail Psoriasis Severity Index fell by an average of 78% compared to baseline levels (+/-59.6, P < 0.0001).. Combined treatment with tacalcitol ointment and 8% clobetasol-17-propionate in a nail lacquer is a safe, effective treatment for nail bed and nail matrix psoriasis.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Clobetasol; Dihydroxycholecalciferols; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Nail Diseases; Ointments; Psoriasis; Treatment Outcome

Two hundred and two patients with clinically typical or biopsy-confirmed vulval lichen sclerosus were reviewed either at consultation (75%) or by retrospectively examining their chart. At diagnosis, 79% were 50 years or older. Ninety-six per cent complained of itching, pain and/or dyspareunia. Lichen sclerosus most often affected the labia minora and perineum but 50% had perianal and 13% had extragenital disease. Thirty-five patients gave a history of psoriasis (17%), which affected the vulval area in 10. Thyroid disease was reported in 39 patients (19%), and 33 gave a family history of thyroid disease. Of those tested (142), 20% had elevated thyroid antibodies. Topical clobetasol propionate was very effective but at least intermittent treatment was required long term in 85%. At follow up, 101 of 185 patients (56%) were asymptomatic but 22 (12%) continued to have moderate-to-severe symptoms. Thyroid disease and psoriasis are common associated conditions.

Topics: Administration, Cutaneous; Adolescent; Adult; Age Distribution; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Child; Child, Preschool; Clobetasol; Female; Humans; Infant; Interviews as Topic; Lichen Sclerosus et Atrophicus; Medical Records; Middle Aged; New Zealand; Psoriasis; Retrospective Studies; Severity of Illness Index; Vulvar Diseases

Topics: Clobetasol; Humans; Ointments; Pharmaceutical Vehicles; Psoriasis

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

[corrected] Prorokeratosis of Mibelli is a chronic disorder characterised by slightly atrophic plaques surrounded by keratotic border.. A 45-year-old with clobetazole propionate ointment for psoriasis over 15 years developed characteristic lesions of porokeratosis Mibelli on the elbows. Histopathological examination revealed the cornoid lamellae located on the edges of the specimen and psoriasiform acanthosis and a spongiotic pustule formation in the center of the specimen; thus, it was suggested as 'psoriasis encircled by porokeratosis'.. Development of porokeratosis may be explained by the local immunosuppressive effect of the prolonged application of the topical steroid.

Topics: Acanthosis Nigricans; Catheter Ablation; Clobetasol; Glucocorticoids; Humans; Immunocompromised Host; Male; Middle Aged; Porokeratosis; Psoriasis; Treatment Outcome

In psoriasis, T-cell infiltration and epidermal hyperproliferation are key phenomena which are closely related. Our aim was to investigate the dynamics among T-cell subsets in relation to epidermal proliferation and clinical severity in psoriasis during treatment with an ultra-potent corticosteroid. Seven psoriasis patients were treated twice daily for 14 days with clobetasol-17 propionate ointment. Punch biopsies were taken at day 0, 3, 7 and 14. Epidermal proliferation marker Ki-67 and CD4+, CD8+, CD45RO+, CD2+ T cells were quantified by immunohistochemical techniques and image analysis. The clinical score declined significantly (60%; p<0.01) and a 47% reduction of Ki-67+ nuclei was observed after only 3 days (p<0.01). In the epidermis all investigated T-cell subsets were significantly reduced at day 14 (p<0.05). In the dermis, treatment resulted in a significant decrease of CD4+, CD45RO+ and CD2+ T cells, but dermal CD8+ T cells persisted. In psoriasis, reduction of clinical severity and epidermal proliferation during the early phase of topical corticosteroid therapy cannot primarily be the result of decreased T-cell subsets. Furthermore, selective persistence of dermal CD8+ T cells was observed, which might be associated with disease relapse.

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; CD8-Positive T-Lymphocytes; Clobetasol; Drug Administration Schedule; Female; Humans; Immunohistochemistry; Male; Middle Aged; Psoriasis; Severity of Illness Index; T-Lymphocyte Subsets

Treatment of nail psoriasis is difficult. Several topical therapies have been employed with poor results because drug penetration is limited in this localization. Recently, a new formulation containing 8% clobetasol-17-propionate in a colourless nail lacquer vehicle has shown good results in the control of nail psoriasis.. To determine the efficacy and safety of 8% clobetasol-17-propionate in a lacquer vehicle in nail psoriasis.. Ten patients with both nail bed and matrix psoriasis were included in the study. They were treated with a colourless nail lacquer containing 8% clobetasol-17-propionate that was applied once daily for 21 days and then twice weekly for 9 months.. Within 4 weeks of therapy there was a reduction of all the nail alterations, including nail pain. Therapeutic response was directly related to the length of therapy. The nail parameters that responded best to therapy were onycholysis, pitting and salmon patches. Subungual hyperkeratosis and splinter haemorrhages on the other hand had moderate and poor improvement, respectively. The treatment was well tolerated in all of the patients and there were no local (i.e. atrophy and sobreinfection) or systemic secondary effects.. The formulation containing 8% clobetasol-17-propionate is a safe, effective and cosmetically highly acceptable treatment for nail bed and matrix psoriasis.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Clobetasol; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Hand Dermatoses; Humans; Male; Middle Aged; Nails; Prospective Studies; Psoriasis; Treatment Outcome

Topical therapy is one of the foundations of dermatology. The vehicles used to deliver topical therapy have considerable impact on efficacy. The vehicle can have direct effects on disease; it can impact the delivery of the active drug, and its characteristics affect patient compliance. While the physical chemistry of vehicles has been studied in great detail, there has been very little study of patients' preferences for different vehicles and even less on the effect of these preferences on patient compliance. Such study is essential, as noncompliance with topical therapy is very common, and likely impacts the response to topical therapy observed in clinical practice. This manuscript discusses information on patients' preferences for different vehicles, focussing on the treatment of scalp psoriasis. Significant vehicle characteristics such as ease or difficulty of use, messiness, odors, and staining are recognized to affect patients' preferences. An instrument based on these characteristics has been used to compare patients' preferences for different vehicles. Patients with psoriasis generally prefer less messy vehicles, such as foam and solution preparations, to traditional cream and ointment vehicles. These preferences have the potential to impact patient compliance. Studies directly measuring patient compliance have not yet been performed. In conclusion, the choice of vehicles impacts both the potency of the medication and patients' acceptance of the treatment. Actual effects of different vehicles on compliance are important but have not yet been adequately studied.

Topics: Administration, Topical; Anti-Inflammatory Agents; Clobetasol; Glucocorticoids; Humans; Patient Acceptance of Health Care; Patient Satisfaction; Pharmaceutical Vehicles; Psoriasis; Scalp

A 72-year-old woman developed manifestations of Cushing's syndrome after long-term topical steroid therapy for psoriasis. Shortly after tapering the dose of topical steroids she developed signs of adrenal insufficiency (provoked by a urinary tract infection) requiring intravenous administration of a stress dose of hydrocortisone. There have only been a few reports of systemic side effects of topically applied corticosteroids in adults. Considering their serious consequences physicians should be alert to signs of Cushing's syndrome in patients on long-term topical steroid therapy. Furthermore, clobetasol propionate ointment doses exceeding 50 g a week should not be prescribed and use of occlusive dressings should be avoided.

Topics: Administration, Topical; Adrenal Insufficiency; Aged; Anti-Inflammatory Agents; Clobetasol; Cushing Syndrome; Female; Glucocorticoids; Humans; Psoriasis

The aim of this study was to evaluate the efficacy of 5 locally made clobetasol propionate creams compared with a brand name product. The study was divided into 3 parts 1) pharmacological study, 2) vasoconstriction test, and 3) double blind clinical trial. The results showed that the pharmacological properties of the locally made products were not different from the brand name product. Product C and D could diffuse through cellulose acetate membrane 3 fold more than the brand name product. Product D and E caused less vasoconstriction than the brand name product. This double blind study showed that all locally made products could improve psoriasis to the same extent as the brand name product, but there was more recurrence of psoriasis while using all the locally made products. It was concluded that locally made products were as effective as the brand name product in the treatment of psoriasis evaluated over a 2 week peroid, but more recurrence was observed with locally made products.

Topics: Administration, Topical; Anti-Inflammatory Agents; Clobetasol; Drugs, Generic; Glucocorticoids; Humans; Psoriasis

Topics: Administration, Topical; Anti-Inflammatory Agents; Clobetasol; Colloids; Combined Modality Therapy; Glucocorticoids; Humans; Occlusive Dressings; Psoriasis

Topics: Clobetasol; Drug Contamination; Humans; Keratolytic Agents; Organometallic Compounds; Psoriasis; Pyridines; Triamcinolone

The present study assesses the applicability of human skin-SCID (severe combined immunodeficiency) mouse chimeras in testing antipsoriatic therapeutics. Three agents were examined: (1) a monoclonal antibody to the alpha subunit of leukocyte function associated antigen-1 integrin (CD11a); (2) Cyclosporin A; and (3) clobetasol propionate (Temovate), a potent topical corticosteroid used clinically in the treatment of psoriasis. Skin transplanted to SCID mice from normal human volunteers or from psoriatic lesional skin was allowed to heal for 3 to 5 weeks before application of test reagents. During this period, psoriatic skin, which was 3.8-fold thicker than the corresponding normal skin before transplantation, maintained its phenotype (ie, increased epidermal thickness, rete ridges with blunted ends, and intralesional presence of T lymphocytes). Transplanted normal human skin, however, underwent a hyperplastic response during this period, resulting in a 2.4-fold increase in epidermal thickness. After the healing period, animals transplanted with normal or psoriatic skin were treated for 14 days by daily intraperitoneal injection of either Cyclosporin A or a monoclonal antibody to human CD11a, or by topical application of clobetasol propionate. At the end of the treatment period, the mice were killed and the tissue evaluated morphometrically for changes in epidermal thickness and immunohistologically for the presence of T lymphocytes. Both Cyclosporin A and anti-CD11a reduced the epidermal thickness of transplanted psoriatic skin, whereas neither reagent significantly reduced the thickness of transplanted normal skin. T lymphocytes were detected in the skin from treated animals; there did not seem to be any reduction in the number of T lymphocytes. Clobetasol propionate reduced the epidermal thickness of both normal and psoriatic skin. These data indicate that, in this model, therapies directed against pathophysiologic mechanisms that contribute to psoriasis can be distinguished from treatments that block epidermal hyperplasia occurring as a consequence of xenografting. Our observations provide evidence for the activity of anti-CD11a in an animal model of human psoriasis.

Topics: Administration, Topical; Animals; Anti-Inflammatory Agents; Antibodies, Monoclonal; Clobetasol; Cyclosporine; Dermatologic Agents; Glucocorticoids; Humans; Lymphocyte Function-Associated Antigen-1; Mice; Mice, SCID; Psoriasis; Reference Values; Skin; Skin Transplantation; Transplantation, Heterologous

Topics: Administration, Topical; Anti-Inflammatory Agents; Clobetasol; Combined Modality Therapy; Glucocorticoids; Humans; Psoriasis; Remission Induction; Ultraviolet Therapy

Topics: Administration, Topical; Anti-Inflammatory Agents; Clobetasol; Diagnosis, Differential; Follow-Up Studies; Glucocorticoids; Humans; Infant; Male; Psoriasis; Warts

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

The mature psoriatic lesion does not necessarily demonstrate changes relevant to early phases of the lesion.. In a model for relapsing psoriasis we examined the epidermal phenotype by means of a panel of immunohistochemical parameters: keratins 14 and 16, epidermal growth factor receptor (EGFR), Ki-67 antigen, and Tdt-mediated Unscheduled Nick End Labeling to detect apoptosis.. In 9 patients, we cleared psoriatic plaques by topical treatment with clobetasol-17-propionate under hydrocolloid occlusion. Relapse (defined as a clinical sum score > or = 6) was awaited. Biopsy specimens of the psoriatic lesion, the cleared skin, the relapsed plaque, and its clinically normal margin were assessed.. Psoriasis recurred after 19+/-6 weeks (mean +/- SEM). During treatment all parameters improved considerably; however, the number of apoptotic cells was not affected. Ki-67 values decreased well below the normal range. At initial relapse, the symptomless skin adjacent to the relapsing lesion (margin) showed a marked expression of keratin 16 and EGFR. Ki-67 expression was increasing in the margin but was below values of the mature lesion. The localization of cycling cells in the first suprabasal layers was a remarkable feature. Keratin 14 expression was increased in the recurrent lesion itself, but not in the symptomless margin.. Keratin 16 and EGFR expression are early phenomena in the evolution of the lesion, and they anticipate epidermal proliferation. The expression of keratin 14 follows overt epidermal hyperproliferation. The present observation in incipient psoriasis lends support to the hypothesis that the basal cell compartment does not have a primary involvement in the initiation of epidermal abnormalities in psoriasis, but that a coordinated sequence of events involving proliferation and differentiation markers in the first suprabasal layers of the epidermis could be the key to the pathogenesis of this puzzling disease.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Apoptosis; Clobetasol; ErbB Receptors; Glucocorticoids; Humans; Immunohistochemistry; In Situ Nick-End Labeling; Keratins; Ki-67 Antigen; Middle Aged; Psoriasis; Recurrence

Topical vitamin D3 therapy is one of the mainstays of psoriasis treatment. However, the effectiveness of combination therapy with topical vitamin D3 and corticosteroids is still controversial. It has been reported that topical vitamin D3 treatment following topical corticosteroids is less effective than that without preceding corticosteroid treatment. We hypothesized that vitamin D receptor (VDR) in the skin is down-regulated by topical corticosteroids. To obtain support for this hypothesis, we determined VDR protein levels in cultured keratinocytes and fibroblasts after corticosteroid treatment. VDR levels were quantified by Western blot analysis with a Fluorolmager. Keratinocytes and fibroblasts were obtained from four psoriasis patients and four normal controls. VDR levels were altered in neither normal nor psoriatic keratinocytes by 2-day incubation with dexamethasone (1x10(-9)-1x10(-6) M) or clobetasol propionate (1x10(-9)-1x10(-6) M). Similarly, VDR levels in normal and psoriatic fibroblasts were not affected by 2-day incubation with dexamethasone (1x10(-6) M). These findings suggest that down-regulation of VDR by topical corticosteroids in keratinocytes and fibroblasts of psoriasis is unlikely.

Topics: Administration, Topical; Adult; Aged; Anti-Inflammatory Agents; Blotting, Western; Cells, Cultured; Clobetasol; Dexamethasone; Down-Regulation; Female; Fibroblasts; Glucocorticoids; Humans; Keratinocytes; Male; Middle Aged; Psoriasis; Receptors, Calcitriol; Skin

Topics: Child; Clobetasol; Diagnosis, Differential; Fluocinonide; Humans; Male; Psoriasis; Tinea

Steroids have been discovered previously in oral "herbal" preparations. Using liquid chromatography, we have now confirmed the presence of the potent topical steroid, clobetasol proprionate, in a Chinese herbal cream.

Topics: Administration, Topical; Anti-Inflammatory Agents; Chromatography, Liquid; Clobetasol; Drug and Narcotic Control; Drug Contamination; Drug Costs; Drugs, Chinese Herbal; Female; Glucocorticoids; Humans; Middle Aged; New Zealand; Psoriasis

Topics: Administration, Topical; Clobetasol; Complementary Therapies; Drug Labeling; Humans; Keratolytic Agents; Organometallic Compounds; Psoriasis; Pyridines

Topics: Administration, Topical; Anti-Inflammatory Agents; Clobetasol; Glucocorticoids; Humans; Internet; Keratolytic Agents; Nonprescription Drugs; Organometallic Compounds; Psoriasis; Publishing; Pyridines; Zinc

Topics: Administration, Topical; Anti-Inflammatory Agents; Clobetasol; Dermatology; Glucocorticoids; Humans; Information Services; Internet; Keratolytic Agents; Nonprescription Drugs; Organometallic Compounds; Psoriasis; Pyridines; Zinc

Topics: Administration, Topical; Anti-Inflammatory Agents; Clobetasol; Fraud; Glucocorticoids; Humans; Keratolytic Agents; Nonprescription Drugs; Organometallic Compounds; Psoriasis; Pyridines; Triamcinolone; Zinc

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Clobetasol; Cushing Syndrome; Dermatitis, Exfoliative; Glucocorticoids; Humans; Iatrogenic Disease; Male; Ointments; Psoriasis; Self Medication; Uric Acid

PA-FABP (psoriasis-associated fatty acid-binding protein) is a new member of a group of low-molecular-weight proteins that are highly up-regulated in psoriatic skin and that share similarity to fatty acid-binding proteins. In this study we demonstrate that PA-FABP transcripts are expressed in human skin in vivo and that topical application of 0.05% retinoic acid (RA) cream results in a rapid induction of PA-FABP transcripts following treatment for 16 hours and persists at increasing levels after 48 and 96 h of RA treatment. The PA-FABP mRNA response to RA was reduced by approximately 50% when patients concurrently were treated with RA and 0.025% clobetasol propionate (CLO) for 48 and 96 h, whereas treatment with CLO alone resulted in PA-FABP transcript levels not significantly different from vehicle-treated skin. When comparing the effects of a well-known irritant, sodium lauryl sulfate (SLS), to those of RA and its vehicle, 0.05% RA cream but not 2% SLS in RA vehicle caused PA-FABP mRNA induction after 16 h. SLS treatment of human skin for 96 h caused a slight increase in PA-FABP transcripts, but markedly less than that observed in response to RA treatment. Incubation of cultured human keratinocytes or skin fibroblasts with RA for up to 48 h did not significantly induce PA-FABP transcripts. Expression of PA-FABP message in keratinocytes was observed to be induced by calcium and fetal calf serum (FCS), while tetra-decanoyl phorbol acetate (TPA) caused little or no induction.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Base Sequence; Carrier Proteins; Cells, Cultured; Clobetasol; Fatty Acid-Binding Protein 7; Fatty Acid-Binding Proteins; Gene Expression; Humans; Keratinocytes; Molecular Probes; Molecular Sequence Data; Neoplasm Proteins; Psoriasis; RNA, Messenger; Skin; Skin Physiological Phenomena; Sodium Dodecyl Sulfate; Tissue Distribution; Tretinoin; Tumor Suppressor Proteins

Topics: Buttocks; Cell Count; Clobetasol; Humans; Hydrocortisone; Immunohistochemistry; Langerhans Cells; Microscopy, Immunoelectron; Psoriasis; Triamcinolone Acetonide

The effects on the hypothalamic-pituitary-adrenal axis of the ultra-high potency corticosteroid halobetasol in the treatment of psoriasis were evaluated in seven patients with extensive, long-standing plaque psoriasis. Each patient applied 3.5 g halobetasol 0.05% ointment in the morning and evening for 7 days. Morning plasma cortisol levels and 24-hour urinary excretion of 17-hydroxycorticosteroid were determined before and on the last 2 days of treatment; plasma cortisol levels were also determined 4 and 5 days after completion of therapy. Morning plasma cortisol concentrations did not decrease significantly during treatment, and no values were below the normal range. Mean 24-hour urinary 17-hydroxycorticosteroid excretion fell from 6.6 +/- 1.4 mg to 5.1 +/- 1.4 mg. Two patients had mild, localized pruritus and stinging with the initial ointment application. No other adverse cutaneous effects were observed. Halobetasol was also clinically efficacious over the 7 days of treatment, based on evaluation of pruritus, erythema, scaling, and plaque elevation. These results demonstrate no adverse effects of the drug on the hypothalamic-pituitary-adrenal axis at doses that are clinically effective in the management of plaque psoriasis.

Topics: 17-Hydroxycorticosteroids; Adult; Aged; Betamethasone; Clobetasol; Drug Evaluation; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Ointments; Pituitary-Adrenal System; Psoriasis; Time Factors

Topics: Administration, Topical; Betamethasone; Clobetasol; Eczema; Humans; Psoriasis

It is now well established that epidermis, like many other tissues, contains a phospholipase A2 that is responsible for the initiation of the arachidonic acid cascade. Here we report that human epidermis also contains a second, quite distinct enzyme of the phospholipase A2 group, which is unique in its extreme activity against phospholipids in true solution. It also differs from the classic cutaneous enzyme in that (a) its activity is not reduced by pretreatment of the skin with corticosteroids in vivo nor by treatment of the epidermal homogenate with alkaline phosphatase in vitro, and (b) its activity is reduced, rather than increased, in the lesions of inflammatory diseases such as psoriasis. The enzyme seems to occur mainly in fully differentiated keratinocytes, its level being low in the basal cell layer of epidermis and in keratinocytes cultured in vitro. On the basis of these observations, we suggest that this new phospholipase A2 is responsible for the degradation of phospholipids that accompanies the terminal keratinization process.

Topics: Alkaline Phosphatase; Cells, Cultured; Clobetasol; Eczema; Epidermis; Humans; Keratins; Lichen Planus; Phospholipases; Phospholipases A; Phospholipases A2; Psoriasis; Skin Diseases; Trypsin

Topics: Administration, Cutaneous; Administration, Oral; Betamethasone; Cell Nucleus; Clobetasol; Deoxyribonucleases; Drug Evaluation; Etretinate; Humans; Immunoenzyme Techniques; Mitosis; Mitotic Index; Psoriasis; PUVA Therapy; Skin

In conclusion, there can be no doubt that CP is a remarkable local steroid with potency greater than anything previously available to the dermatologist. It may be useful for short-term (less than 2 weeks) and intermittent treatment of widespread inflammatory dermatoses. It is excellent for treating some stubborn localized inflammatory dermatoses before moving on to more dilute preparations. When prescribing CP, it is important to warn the patient of common side effects, such as atrophy and striae, and to instruct the patient carefully in its use, mentioning body areas that should be spared its application. CP should not be applied to flexural, scrotal, or, with a few exceptions such as discoid lupus erythematosus and actinic reticuloid, facial skin. Its use is contraindicated in infants, toddlers, and children under 12 years of age. In addition, adult patients must be told never to use more than 50 gm per week (the manufacturer's recommendation). The prescribing physician must monitor and regularly review the amount used per unit time. Treatment with CP beyond 2 weeks is not recommended in the product information on CP listed in the Physicians' Desk Reference (1988). Those few patients taking CP for a long period should be managed as though they are on systemic steroids. Episodes of acute stress, such as surgery and intercurrent infection, should be managed with supplemental, if necessary parenteral, glucocorticoid administration.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Topical; Betamethasone; Clobetasol; Eczema; Humans; Psoriasis; Skin Diseases

We have investigated the mechanisms by which topical corticosteroids modulate cutaneous immune reactions in man. Volunteers applied clobetasone butyrate 0.05% (Eumovate; EV), betamethasone valerate 0.1% (Betnovate; BV), clobetasol propionate 0.05% (Dermovate; DV), and control vehicles twice daily to forearm skin for 7 days. Steroid therapy significantly decreased the number of HLA-DR/T6 (CD1a) positive Langerhans cells (LCs) per mm2 in suction blister-derived epidermal sheets, expressed as a mean percentage of controls, as follows: EV 69.2%; BV 67.3%; DV 37.8%. LC antigen presenting capacity was determined in the allogeneic and autologous epidermal cell-lymphocyte reactions. The LC-dependent allostimulatory capacity of epidermal cells, expressed as a mean percentage of controls, was also significantly reduced by steroid therapy: EV 45.1%; BV 41.9%; DV 23.4%. Following therapy with clobetasol propionate 0.05%, the capacity of epidermal cells to present tetanus toxoid to, and to augment concanavalin A mediated lymphocyte stimulation of, autologous lymphocytes was reduced to 33.6% and 19.7% respectively of controls. Depression of epidermal cell allostimulatory capacity was not the result of a steroid-induced decrease in the production of epidermal cell-derived thymocyte activating factor (ETAF)/interleukin 1 by keratinocytes, since it could not be reversed by addition of exogenous interleukin 1. Indomethacin, added to block any potential prostaglandin synthesis during the culture period, did not restore the allostimulatory capacity of epidermal cells from steroid-treated sites. Addition of epidermal cells from DV-treated sites depressed the capacity of control epidermal cells to stimulate lymphocytes in the allogeneic epidermal-lymphocyte reaction. Our results demonstrate that the anti-inflammatory action of topical corticosteroids in man is associated not only with a reduction in the number of HLA-DR/T6 positive LCs, but also with a marked decrease in Langerhans cell-dependent T lymphocyte activation. The effects of the different steroids on both of these parameters correlated with their potency as determined in the standard occlusive vasoconstrictor assay. Topical corticosteroids are widely used for the treatment of inflammatory skin disorders, and inhibit not only the elicitation phase, but also the induction phase, of allergic contact dermatitis reactions.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Antigen-Presenting Cells; Betamethasone; Betamethasone Valerate; Clobetasol; Fluorescent Antibody Technique; HLA-D Antigens; HLA-DR Antigens; Humans; Langerhans Cells; Psoriasis

Topics: Administration, Topical; Betamethasone; Clobetasol; Cushing Syndrome; Humans; Male; Middle Aged; Psoriasis

Topics: Clobetasol; Creatinine; Cyclosporins; Drug Evaluation; Drug Therapy, Combination; Humans; Hypertension; Psoriasis

Topics: Administration, Oral; Betamethasone; Clobetasol; Cyclosporins; Drug Evaluation; Drug Therapy, Combination; Humans; Psoriasis

Topics: Administration, Topical; Betamethasone; Clobetasol; Humans; Psoriasis

The use of topical steroids is associated with adverse systemic effects such as suppression of the hypothalamic-pituitary-adrenal (HPA) axis, and application of more than 50 g per week of clobetasol propionate cream has been shown to cause secondary adrenal failure. We describe 4 patients who used clobetasol propionate cream over a prolonged period; 3 patients used less than 50 g per week (7.5, 25 and 30 g per week) and yet all developed secondary adrenal failure for up to 4 months after cessation of therapy. Adrenal insufficiency following prolonged use of clobetasol propionate in moderate dosages may therefore be more common than previously recognized. It is suggested that the metyrapone test, which conveniently examines the entire HPA axis, should be employed in patients receiving long-term topical clobetasol propionate cream and that glucocorticoid supplementation should be given during episodes of stress, such as infections and surgery, for up to 4 months after cessation of therapy.

Topics: Administration, Topical; Adrenal Glands; Adrenal Insufficiency; Adult; Aged; Betamethasone; Clobetasol; Depression, Chemical; Female; Humans; Male; Middle Aged; Psoriasis

Topics: Administration, Topical; Betamethasone; Clobetasol; Cushing Syndrome; Female; Humans; Middle Aged; Ointments; Psoriasis

Topical clobetasol propionate or vehicle ointment was applied daily for 3 days to psoriatic plaques on eight patients. Skin chamber exudates from untreated, steroid and vehicle treated lesions were assayed for arachidonic acid (AA), leukotriene B4 (LTB4), prostaglandin E2 (PGE2) and 12-hydroxy-5,8,10,14-eicosatetraenoic acid (12-HETE) before, and at 24 h and 72 h after treatment. Significant reductions in AA and LTB4 were observed at 72 h in steroid treated lesions. The reduction in 12-HETE levels observed after steroid treatment was not statistically significant. PGE2 levels in lesional psoriatic skin were unaltered. The reduction of AA, and LTB4 was associated with clinical improvement of psoriasis.

Topics: 12-Hydroxy-5,8,10,14-eicosatetraenoic Acid; Adult; Arachidonic Acid; Arachidonic Acids; Betamethasone; Clobetasol; Dinoprostone; Exudates and Transudates; Female; Humans; Hydroxyeicosatetraenoic Acids; Leukotriene B4; Male; Middle Aged; Prostaglandins E; Psoriasis; Skin

Topics: Betamethasone; Clobetasol; Femur Head Necrosis; Humans; Male; Middle Aged; Psoriasis

We describe the effects of treatment with topical steroids or dithranol on T and dendritic cells in the skin of patients with chronic plaque psoriasis. Resolution of lesions by both types of topical treatments was accompanied by a marked decrease in epidermal T cells. In steroid treated lesions there was also a reduction in DR+ dendritic cells to normal numbers during treatment and the rate of disappearance of both cell types correlated with the rate of resolution. However, a significant reduction of dendritic cells was not usually observed until after the T cells had almost disappeared from the epidermis and substantial healing of lesions had taken place. Dendritic cells in steroid-treated uninvolved skin had decreased to a lower level than in normal skin. In contrast, dithranol did not affect dendritic cells, either in lesional or in unaffected psoriatic epidermis. The decrease in dermal T cells observed with both treatments was more marked in steroid-treated lesions and correlated with resolution. However, blood T cells were unaffected by both treatments. The findings provide further support for the role of T cells in the pathogenesis of psoriasis.

Topics: Administration, Topical; Anthracenes; Anthralin; Antigen-Presenting Cells; Clobetasol; Histocompatibility Antigens Class II; HLA-DR Antigens; Humans; Leukocyte Count; Psoriasis; Skin; T-Lymphocytes; T-Lymphocytes, Helper-Inducer; T-Lymphocytes, Regulatory

Topics: Adult; Betamethasone; Clobetasol; Eczema; Humans; Male; Psoriasis

Five patients with widespread plaque-type psoriasis were treated continuously with clobetasol under occlusion. Clinical healing was seen after 6-10 days of treatment. All plaques treated in this way clinically relapsed approximately 12 days later. During the period of remission, sequential biopsies were taken and prepared for light and electron microscopy. Histologically, the earliest indications of relapse were endothelial alterations (swelling, intercellular widening) followed by the appearance of mast cells around the postcapillary venules; these mast cells showed signs of degranulation. Hours later, activated macrophages showing pericellular edema were present, and these migrated into the epidermis soon after. Associated with the presence of macrophages, there was a complete loss of desmosome-tonofilament complexes. Later, lymphocytes and neutrophils were seen. Under these experimental conditions, the psoriatic-tissue alterations appear to have been initiated by degranulating mast cells as well as by macrophages which later invaded the epidermis.

Topics: Clobetasol; Cytoplasmic Granules; Humans; Inflammation; Macrophages; Mast Cells; Psoriasis; Recurrence; Skin

Topics: Adolescent; Adult; Anti-Inflammatory Agents; Betamethasone; Child; Child, Preschool; Clobetasol; Eczema; Female; Humans; Male; Middle Aged; Ointments; Psoriasis; Skin Diseases

Three marker enzymes were measured during treatment of psoriatic plaques with two different therapies. During treatment with clobetasol propionate the epidermal enzymes (acid phosphatase and glucose-6-phosphate dehydrogenase) returned to normal within 14 days whereas capillary alkaline phosphatase remained at the original level. By contrast, all three marker enzymes reverted to normal at the same tempo during PUVA therapy, reaching the control range after 4-8 weeks.

Topics: Acid Phosphatase; Alkaline Phosphatase; Betamethasone; Clobetasol; Epidermis; Glucosephosphate Dehydrogenase; Humans; Photochemotherapy; Psoriasis; PUVA Therapy; Time Factors

Topics: Adult; Betamethasone; Clobetasol; Humans; Male; Photochemotherapy; Psoriasis; PUVA Therapy

The effect of several steroid creams on epidermal phospholipase A2 (PLA2) activity in symptomless psoriatic and normal epidermis was studied. The magnitude of PLA2 inhibition produced by the steroids was directly proportional to the initial level of the enzyme activity. This differential inhibition resulted in PLA2 activity approaching or attaining the normal range regardless of its initial level. Clobetasol propionate 0.05% (Dermovate) produced more enzyme inhibition than betamethasone valerate 0.1% (Betnovate) but there was no difference in inhibition between this latter steroid and clobetasone butyrate 0.05% (Eumovate). All were more inhibitory than hydrocortisone I% (Efcortelan).

Topics: Administration, Topical; Anti-Inflammatory Agents; Betamethasone Valerate; Clobetasol; Fluocinolone Acetonide; Glucocorticoids; Humans; Hydrocortisone; Phospholipases; Phospholipases A; Phospholipases A2; Psoriasis; Skin; Time Factors

The proliferation of fibroblasts cultured from psoriatic and normal skin was compared following addition of clobetasol propionate to the culture medium. Proliferation was stimulated at 0.1 microgram/ml and progressively inhibited at 1-10 micrograms/ml. A differential sensitivity to the drug was demonstrated: the fibroblasts from involved psoriatic skin were more stimulated than normal fibroblasts at 0.1 microgram/ml and then more inhibited at 10 micrograms/ml. The fibroblasts from uninvolved psoriatic skin displayed intermediate responses. There was some cytotoxicity in cultures of the psoriatic cells at 10 micrograms/ml. The results demonstrate a further abnormality of fibroblasts from psoriatic skin.

Topics: Betamethasone; Cell Division; Cells, Cultured; Clobetasol; Fibroblasts; Humans; Male; Psoriasis

Topics: Administration, Oral; Administration, Topical; Adrenal Cortex; Adult; Anti-Inflammatory Agents; Betamethasone; Budesonide; Clobetasol; Diflucortolone; Dose-Response Relationship, Drug; Eczema; Female; Humans; Hydrocortisone; Male; Middle Aged; Ointments; Pregnenediones; Psoriasis

Topics: Administration, Topical; Adolescent; Adult; Aged; Anti-Inflammatory Agents; Betamethasone; Clobetasol; Eczema; Female; Humans; Hydrocortisone; Kinetics; Male; Middle Aged; Ointments; Psoriasis; Radioimmunoassay

Absolute values of both cAMP and cGMP leves were measured in the involved and uninvolved skin of psoriatic patients, and also the effect of topical therapy on these levels in the involved skin was studied. The mean cGMP level in the untreated psoriatic plaque was increased by 300% compared to the non-involved skin (which did not differ from normal skin), but no significant difference in cAMP levels was found. Epidermal stripping of uninvolved skin, which stimulates cell proliferation, did not change the cGMP level. Treatment of the psoriasis with dithranol caused the cGMP levels to return to normal, but a potent topical glucocorticoid, in contrast, produced no such decrease. This may imply that the two drugs act at different levels in suppressing cell replication, and dithranol may be a useful tool for the further investigation of cyclic nucleotide metabolism.

Topics: Anthracenes; Anthralin; Clobetasol; Cyclic AMP; Cyclic GMP; Epidermis; Humans; Psoriasis; Skin

Topics: Adolescent; Adult; Alopecia; Betamethasone; Child; Child, Preschool; Clobetasol; Dermatitis, Seborrheic; Female; Humans; Male; Middle Aged; Neurodermatitis; Pharmaceutical Vehicles; Pityriasis; Psoriasis; Scalp Dermatoses; Switzerland

The risk of systemic effects of high doses of potent topical corticosteroids was evaluated in 6 psoriatics with lesions on more than 50% of the body surface. Before the examinations the patients had been treated for 3-4 months with 35-65 g fluorinated corticosteroids daily. General clinical examination, plasma cortisol determinations, and tetracosactrin tests were carried out. One patient showed clinical signs of Cushing's syndrome including diabetes mellitus, another had a slight Cushingoid appearance. The plasma cortisol levels were depressed in 5 of the 6 patients on the first post-treatment day. A subnormal plasmacortisol response to tetracosactrin stimulation was noted in 3 of the patients. In these cases the potent corticosteroid therapy was discontinued. One month later a follow-up was performed, which showed a clinical and laboratory normalization except for the tetracosactrin test in one case. The study emphasizes the risk of serious systemic effects of the absorbed corticosteroids, if high doses are used for long periods.

Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Betamethasone; Clobetasol; Cushing Syndrome; Desoximetasone; Female; Flumethasone; Humans; Male; Middle Aged; Psoriasis; Time Factors

A study to demonstrate methods of using topical preparations to control chronic skin conditions is described. 25 patients with atopic eczema or psoriasis were followed for an average of 10 months. Both self-assessment using a diary card and clinical assessment were used to evaluate the treatment. The study shows that, when used correctly, topical corticosteroids can provide an effective means of controlling these intractable conditions without producing the side-effects associated with their misuse.

Topics: Administration, Topical; Betamethasone; Butyrates; Chronic Disease; Clobetasol; Drug Evaluation; Eczema; Humans; Patient Education as Topic; Propionates; Psoriasis

Clobetasol propionate cream, applied intermittently for 2 weeks, induced a rapid clinical and histological clearing of psoriatic infiltrates. The serum cortisol level was transiently lowered. By maintenance therapy, with the corticosteroid given only one day a week, 8 of 12 patients were kept in remission for an average period of 5 months.

Topics: Administration, Topical; Adolescent; Adult; Aged; Betamethasone; Clobetasol; Female; Humans; Male; Middle Aged; Psoriasis

Topics: Betamethasone; Clobetasol; Humans; Psoriasis; Recurrence

Topics: Adult; Aged; Animals; Clobetasol; Fatty Acids, Essential; Female; Humans; Linoleic Acids; Male; Middle Aged; Psoriasis; Rats; Skin; Water

Topics: Betamethasone; Clobetasol; Humans; Psoriasis; Skin Absorption

Confluent cultures of normal primary human skin fibroblasts were incubated with various glucocorticosteroids which are in current use clinically for the treatment of various skin disorders. For all steroids concentrations were found at which collagen hydroxyproline formation was inhibited, while total protein synthesis was little affected. The concentration effective for inhibition was highest for hydrocortisone and lowest for clobetasol-17-propionate. All other steroids (hydrocortisone-17-butyrate, triamcinolone acetonide and betamethasone-17-valerate) showed medium effectiveness. Fluorination as such was not a factor in the degree of inhibition. The inhibition observed was shown to be independent of concomitant specific effects on cell proliferation or cell turnover. The possible implications of these findings on the therapeutic effects in psoriasis and the frequently occurring atrophic side-effects of these steroids are discussed.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Betamethasone Valerate; Cell Division; Cells, Cultured; Clobetasol; Collagen; Depression, Chemical; Fibroblasts; Glucocorticoids; Humans; Hydrocortisone; Hydroxyproline; Protein Biosynthesis; Psoriasis; Skin; Triamcinolone Acetonide

Topics: Administration, Topical; Adult; Betamethasone; Child; Clobetasol; Female; Humans; Psoriasis; Skin Diseases

Clobetasone butyrate is a new corticosteroid, selected for study because of its combination of good activity in the vasoconstriction test and low systemic activity in animals. Formulated as an 0.05% ointment and cream (Molivate) it was clinically effective in patients with eczema, its activity being significantly greater than that of hydrocortisone 1% or fluocortolone 0.2% (Ultradil). Under conditions that predispose to maximal percutaneous absorption clobetasone butyrate ointment had minimal effect on hypothalamic-pituitary-adrenal function. In an animal model of cutaneous atrophy it caused less thinning of the epidermis than steroids other than hydrocortisone. Clobetasone butyrate 0.05% ointment and cream gave every indication of offering clinically effective topical anti-inflammatory activity with a wide margin of safety.

Topics: Administration, Topical; Animals; Betamethasone; Clobetasol; Cosyntropin; Eczema; Fluocortolone; Humans; Insulin; Pituitary-Adrenal Function Tests; Pituitary-Adrenal System; Psoriasis; Skin; Swine