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

Abstract

No long-term maintenance therapy has been tested in patients with seborrheic dermatitis (SD). We sought to compare the efficacy and tolerance of tacrolimus 0.1% ointment versus ciclopiroxolamine 1% cream as maintenance therapy for severe SD. 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 7days. Patients cleared after this open phase were randomized to receive tacrolimus 0.1% or ciclopiroxolamine 1% cream 2 times a week 24weeks. The primary endpoint was disease-free-duration, defined as the time from randomization to first relapse. One hundred fourteen patients were randomized (tacrolimus, n=57; ciclopiroxolamine, n=57). Twelve patients relapsed in the tacrolimus group after a median delay of 91.5days (range 15-195days) versus 23 patients in the ciclopiroxolamine group (median delay, 27days [range 13-201days]). 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). The theoretical sample size was not reached. Tacrolimus 0.1% is more effective than ciclopiroxolamine 1% as maintenance therapy for patients with facial SD.