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Tacrolimus 0.1% versus ciclopiroxolamine 1% for maintenance therapy in patients with severe facial seborrheic dermatitis: A multicenter, double-blind, randomized controlled study

2020; Elsevier BV; Volume: 84; Issue: 5 Linguagem: Inglês

10.1016/j.jaad.2020.09.055

1097-6787

P. Joly, I. Tejedor, F. Tétart, Hélène Collas Cailleux, Alice Barrel, Paul Arnaud De Preville, Nathalie Mion-Mouton, G. Gabison, Sophie Baricault, Catherine Girardin Tordeur, Martin Xavier Dore, Bernard Rossi, Catherine Bourseau‐Quetier, Mélanie Chamaillard, Sandra Ly, O. Chosidow, Marie-Aleth Richard-Lallemand, Jean-Claude Rzeznik, Jean‐Michel Amici, G Lair, Sylvie Bechu, Jacques Bénichou, Caroline Thill, M. Beylot‐Barry,

Antifungal resistance and susceptibility

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.