Department of Dermatology, University of Kiel, Kiel, Germany. tschwarz@dermatology.uni-kiel.de
BACKGROUND: Perioral dermatitis (POD) is a common dermatosis without standard therapy. OBJECTIVE: We sought to evaluate pimecrolimus cream 1% in POD. METHODS: We conducted a multicenter, randomized, double-blind, parallel-group study in adult patients with POD treated twice daily with pimecrolimus cream 1% or vehicle until clearance for up to 4 weeks. Follow-up took place 4 and 8 weeks after treatment. RESULTS: Patients treated with pimecrolimus had an average POD Severity Index score of 2.6 compared with 3.5 for patients treated with vehicle. Both groups had baseline scores of 5.2. The between-group difference was 0.9 (95% confidence level 0.4, 1.4, P = .0011). Patients with history of topical corticosteroids benefited most. Pimecrolimus-treated patients reported greater improvement in quality of life. There were no group differences regarding safety. LIMITATIONS: Pimecrolimus vehicle is not a true placebo. CONCLUSIONS: Pimecrolimus rapidly improves clinical symptoms and quality of life of patients with POD, being most effective in corticosteroid-induced POD.