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Pimecrolimus cream (1%) efficacy in perioral dermatitis - results of a randomized, double-blind, vehicle-controlled study in 40 patients.

BACKGROUND: Perioral dermatitis (POD) is a common skin disease and difficult to treat. Pimecrolimus cream (1%) successfully controls atopic eczema.

OBJECTIVE: Our aim was to investigate its efficacy in POD.

STUDY DESIGN: Single-centre, randomized, double-blind, vehicle-controlled study including 40 POD patients with a 4-week treatment and a 4-week follow-up. Efficacy was assessed by a novel Perioral Dermatitis Severity Index (PODSI) and Finlay's Dermatology Life Quality Index (DLQI).

SETTING: Outpatient clinics of a large dermatological hospital in Munich, Germany.

RESULTS: During treatment, the PODSI was significantly lower in the pimecrolimus group compared with vehicle (P = 0.005-0.02) whereas at follow-up, no significant differences were observed. At week 2, the responder rates (> or = 50% PODSI improvement) were 50% with pimecrolimus cream (1%) and 25% with vehicle (P = 0.095). DLQI was improved in pimecrolimus group compared with vehicle.

CONCLUSION: Results suggest that pimecrolimus cream (1%) effectively treats acute-stage POD.

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