RESUMEN
BACKGROUND: No long-term maintenance therapy has been tested in patients with seborrheic dermatitis (SD). OBJECTIVE: We sought to compare the efficacy and tolerance of tacrolimus 0.1% ointment versus ciclopiroxolamine 1% cream as maintenance therapy for severe SD. METHODS: This double-blind randomized controlled study was conducted from 2014 to 2017 in 5 Dermatology Departments and 15 dermatology practices in France. Consecutive patients with severe and chronic facial SD were included. Patients were initially treated with desonide 0.05% cream twice daily for 7 days. Patients cleared after this open phase were randomized to receive tacrolimus 0.1% or ciclopiroxolamine 1% cream 2 times a week 24 weeks. The primary endpoint was disease-free-duration, defined as the time from randomization to first relapse. RESULTS: One hundred fourteen patients were randomized (tacrolimus, n = 57; ciclopiroxolamine, n = 57). Twelve patients relapsed in the tacrolimus group after a median delay of 91.5 days (range 15-195 days) versus 23 patients in the ciclopiroxolamine group (median delay, 27 days [range 13-201 days]). Comparison of disease-free duration curves showed that patients in the tacrolimus group had a longer duration of complete remission than those in the ciclopiroxolamine group (P = .018), corresponding to a hazard ratio of relapse of 0.44 (95% confidence interval 0.22-0.89; P = .022). LIMITATIONS: The theoretical sample size was not reached. CONCLUSION: Tacrolimus 0.1% is more effective than ciclopiroxolamine 1% as maintenance therapy for patients with facial SD.
Asunto(s)
Ciclopirox/administración & dosificación , Dermatitis Seborreica/tratamiento farmacológico , Dermatosis Facial/tratamiento farmacológico , Quimioterapia de Mantención/métodos , Tacrolimus/administración & dosificación , Adulto , Dermatitis Seborreica/diagnóstico , Método Doble Ciego , Esquema de Medicación , Dermatosis Facial/diagnóstico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Treating dermatological pathologies with topical corticosteroids under occlusion is often more effective than nonocclusive therapy, especially in the treatment of psoriasis. Betamethasone valerate medicated plaster provides a controlled and localized method of dosing betamethasone valerate, a well-established corticosteroid with vasoconstrictive, anti-inflammatory, immunosuppressive, and antiproliferative properties. This self-adhesive plaster is approved for the treatment of inflammatory skin disorders that do not respond to treatment with less potent corticosteroids. As a patch, it offers all the clinical benefits of occlusive therapy such as increased penetration of topical agent into the area requiring treatment, enhanced skin hydration, and protection from local trauma or scratching. This translates into improved patient compliance, which is notoriously low in patients with dermatological conditions. This review presents the available clinical data from studies with betamethasone valerate medicated plaster in the treatment of psoriasis and other dermatoses and discusses its place in therapy for dermatological conditions.