1. Tacrolimus 0.1% versus ciclopiroxolamine 1% for maintenance therapy in patients with severe facial seborrheic dermatitis: A multicenter, double-blind, randomized controlled study.
- Author
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Joly, Pascal, Tejedor, Ines, Tetart, Florence, Cailleux, Hélène Collas, Barrel, Alice, De Preville, Paul Arnaud, Mion-Mouton, Nathalie, Gabison, Germaine, Baricault, Sophie, Tordeur, Catherine Girardin, Dore, Martin Xavier, Rossi, Bernard, Bourseau-Quetier, Catherine, Chamaillard, Mélanie, Ly, Sandra, Chosidow, Olivier, Richard-Lallemand, Marie-Aleth, Rzeznik, Jean-Claude, Amici, Jean-Michel, and Lair, Guillaume
- Abstract
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. [ABSTRACT FROM AUTHOR]- Published
- 2021
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