calcipotriene and Skin-Diseases

Although some symptoms of dermatologic diseases, such as pruritus and pain, can be subjectively assessed only by patients, the most commonly used endpoints in dermatology drug research traditionally have been clinician-reported outcomes. Research has found that patient-reported outcomes (PROs) were included in only one-quarter of 125 trials conducted between 1994 and 2001. Our objective was to characterize the impact of PROs in dermatology drug development from the patient, prescriber, regulator, payer, and manufacturer perspectives using a case study approach. We conducted a structured literature review for pivotal clinical trials using PROs for six dermatologic products (MAS063DP, onabotulinumtoxinA, calcipotriene hydrate plus betamethasone dipropionate, pimecrolimus, tacrolimus, and ustekinumab). We also searched regulatory websites to identify product labeling and the UK National Institute for Health and Care Excellence website to identify submissions for the products of interest. A total of 32 articles illustrating the various perspectives were selected for inclusion. Clinical trials that include PROs allow patients to differentiate among treatments based on the experience of other patients participating in trials and enable prescribers to understand the benefit-risk profile of new treatments. The inclusion of PROs enables regulators to evaluate product benefits with a patient-centered perspective; five of the products of interest obtained eight total product labeling statements. PRO data supported manufacturers' dissemination of product benefits in the form of publications and PRO labeling for the product. For payers, PRO data were used in an analysis of cost effectiveness of new treatments. Inclusion of PROs in dermatology drug development programs benefits patients, prescribers, regulators, manufacturers, and payers.

Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Dermatologic Agents; Female; Humans; Male; Middle Aged; Patient Reported Outcome Measures; Patient Satisfaction; Quality of Life; Self Report; Skin Diseases; Surveys and Questionnaires

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

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

A 7-year-old otherwise healthy girl presented with a 2-year history of an ILVEN (inflammatory linear verrucous epidermal nevus) located on the inner part of her right upper arm. The diagnosis was histologically confirmed. Different conservative therapeutic strategies with corticosteroids, antibiotics and antimycotics produced little or no improvement. Because of encouraging reports describing the successful use of 0.005% calcipotriol ointment in patients with ILVEN, we treated our patient with this regimen. After 4 weeks we could recognize a impressive improvement and after 8 weeks the ILVEN had nearly completely disappeared. 25 weeks after withdrawal of calcipotriol, no relapse had occurred. The dramatic response to calcipotriol suggests some pathological links between ILVEN and psoriasis.

Topics: Administration, Topical; Calcitriol; Child; Dermatologic Agents; Female; Hamartoma; Humans; Skin Diseases

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

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

Topics: Calcitriol; Dermatologic Agents; Humans; PUVA Therapy; Retinoids; Skin Diseases

A number of important therapeutic agents have recently become available for the treatment of infectious and inflammatory skin diseases. Five of these drugs, calcipotriol, EMLA (eutectic mixture of local anesthetics), interferon-alpha 2a, cyclosporine, and acyclovir, are reviewed. Calcipotriol, a vitamin D analogue, has been shown to be useful but not curative in chronic stable plaque psoriasis in adults. Its use in children is being studied. EMLA is proving to be useful in the prevention of pain prior to minor procedures. The use of interferon-alpha 2a promises to be highly effective in the treatment of the complications of vascular lesions. Cyclosporine is a powerful immunomodulating agent. It has been used in the treatment of atopic dermatitis and psoriasis. Adverse effects limit its widespread use as a systemic agent. Topical cyclosporine has limited efficacy due to its poor penetration. Acyclovir has revolutionized the treatment of herpes simplex virus infections, particularly in reducing the morbidity and mortality of neonatal herpes. Whether it is indicated in varicella infection in normal children is questionable.

Topics: Acyclovir; Anesthetics, Local; Calcitriol; Child; Cyclosporine; Dermatologic Agents; Drug Combinations; Humans; Interferon alpha-2; Interferon-alpha; Lidocaine; Lidocaine, Prilocaine Drug Combination; Prilocaine; Recombinant Proteins; Skin Diseases

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

Topics: Aminolevulinic Acid; Antibodies, Monoclonal, Humanized; Calcitriol; Dermatologic Agents; Humans; Skin Diseases

Topics: Aged; Anti-Inflammatory Agents; Betamethasone; Calcitriol; Diagnosis, Differential; Drug Combinations; Humans; Male; Psoriasis; Skin Diseases

Low level laser or light treatment on the various clinical condition is getting considerable attention now. However, there has been no report about the clinical effect of low level polarized polychromatic noncoherent light (LPPL) on the inflammatory skin disease. We experienced a case of acrodermatitis continua in a pregnant woman refractory to any conventional treatment including the most potent topical steroid. She was successfully treated with LPPL. LPPL could be a possible treatment modality producing substantial clinical result in inflammatory skin condition without any side-effect.

Topics: Acrodermatitis; Adult; Calcitriol; Female; Humans; Inflammation; Light; Phototherapy; Pregnancy; Pregnancy Complications; Psoriasis; Skin Diseases

Topics: Anti-Inflammatory Agents; Betamethasone; Biological Products; Calcitriol; Dermatologic Agents; Drug Administration Routes; Humans; Psoriasis; Severity of Illness Index; Skin Diseases; Treatment Outcome

Topics: Administration, Topical; Adolescent; Anti-Inflammatory Agents; Bandages; Calcitriol; Dermatologic Agents; Drug Therapy, Combination; Edema; Fibrosis; Humans; Kidney Failure, Chronic; Kidney Transplantation; Male; Methotrexate; Methylprednisolone; Peritoneal Dialysis; Skin Diseases; Treatment Outcome; Triamcinolone

MC903 (calcipotriol) is a synthetic, low calcemic analog of the nuclear hormone 1alpha,25-dihydroxyvitamin D3 and used in the treatment of psoriasis. The beneficial effects of MC903 on psoriasis are based on gene regulatory events. The genomic actions of 1alpha,25-dihydroxyvitamin D3 and its analogs are primarily mediated by a complex of the vitamin D3 receptor and the retinoid X receptor bound to a 1alpha,25-dihydroxyvitamin D3 response element that can be considered as the molecular switch of 1alpha,25-dihydroxyvitamin D3 signaling. In this study, the interaction of MC903 and two new analogs, GS1500 and EB1213, with this molecular switch was compared with that of 1alpha,25-dihydroxyvitamin D3. In DNA-dependent limited protease digestion assays, ligand-dependent gel shift assays and mammalian-one-hybrid assays, all four ligands appeared to be equally sensitive VDR agonists that activated vitamin D3 receptor-retinoid X receptor-1alpha,25-dihydroxyvitamin D3 response element complexes at a concentration of approximately 0.2 nM. The analyzed VDR agonists, however, also showed individual molecular properties, such as a reduced sensitivity in HaCaT cells (MC903), a selectivity for DNA-bound vitamin D3 receptor-retinoid X receptor heterodimers (GS1500) and a long-lasting stabilization of vitamin D3 receptor-retinoid X receptor-1alpha,25-dihydroxyvitamin D3 response element complexes (EB1213). This molecular evaluation demonstrated that the sensitivity in activating the vitamin D3 receptor is already optimal for MC903, but the analog may not be ideal in keeping the receptor active and in selectively triggering 1alpha,25-dihydroxyvitamin D3 signaling pathways.

Topics: Administration, Topical; Calcitriol; Cell Line; Dermatologic Agents; Drug Evaluation, Preclinical; Drug Stability; HeLa Cells; Humans; Receptors, Calcitriol; Receptors, Retinoic Acid; Response Elements; Retinoid X Receptors; Skin Diseases; Technology, Pharmaceutical; Transcription Factors

Topics: Arm Injuries; Burns, Electric; Calcitriol; Dermatologic Agents; Diagnosis, Differential; Female; Hamartoma; Humans; Middle Aged; Skin Diseases

Topics: Administration, Cutaneous; Calcitriol; Child; Dermatitis; Dermatologic Agents; Female; Foot Dermatoses; Hamartoma; Humans; Infant; Leg Dermatoses; Male; Skin Diseases

Topics: Calcitriol; Dermatologic Agents; Humans; Skin Diseases

Topics: Administration, Topical; Calcitriol; Child, Preschool; Dermatologic Agents; Hamartoma; Humans; Male; Skin Diseases