Tacrolimus 0.1% versus ciclopiroxolamine 1% for maintenance therapy in patients with severe facial seborrheic dermatitis: A multicenter, double-blind, randomized controlled study.
J Am Acad Dermatol
; 84(5): 1278-1284, 2021 May.
Article
in En
| MEDLINE
| ID: mdl-33010323
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Tacrolimus
/
Dermatitis, Seborrheic
/
Facial Dermatoses
/
Maintenance Chemotherapy
/
Ciclopirox
Type of study:
Clinical_trials
/
Diagnostic_studies
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
J Am Acad Dermatol
Year:
2021
Type:
Article