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

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.

Squamous cell carcinomas are associated with verrucokeratotic cutaneous lesions but not with common warts in organ-transplant patients. A case-control study.

BACKGROUND: Warts are thought to be associated with the development of squamous cell carcinoma (SCC) in organ transplant patients. We investigated the association between the different types of warts and SCC in organ transplant patients. METHODS: A prospective multicenter case-control study was conducted. Cases were patients with a kidney or heart transplant who were referred for a SCC. Controls were organ transplant patients without SCC, individually matched for age, gender, type of organ transplant (heart or kidney), skin phototype, time from transplantation, and center. Four types of warts: flat warts, verrucae vulgares (including palmo-plantar warts and common warts), verrucous papilloma, and verrucokeratotic lesions were compared between cases and controls using conditional logistic regression. RESULTS: Ninety-nine cases and 169 controls were included. In multivariate analysis, number of rejections, azathioprine, prednisolone and anti-lymphocyte anti-serum or anti-CD3 monoclonal antibodies use, cumulative sun exposure, actinic keratosis, and verrucokeratic lesions (odds ratio [OR] 16.50; 95% confidence interval [CI] 2.82-96.80) were independently associated with SCC, whereas the association with verrucous papilloma was borderline significant (OR 2.21; 95% CI 0.97-8.15). The association between the presence of at least one of these two types of warts (verruco-keratotic lesions and verrucous papilloma) and the occurrence of SCC was highly significant (OR 18.36; 95% CI 3.03-111) when these warts were located in the same area than SCC, whereas no significant association was evidenced when these warts were located in another area (OR 1.02; 95% CI 0.13-5.79). CONCLUSION: Verrucous papilloma and mainly verrucokeratotic lesions are strongly associated with the risk of SCC in organ transplant patients, whereas the most typical types of warts: verrucae vulgares and flat warts, are not.