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

Authors: Oppel, T; Pavicic, T¹; Kamann, S¹; Bräutigam, M²; Wollenberg, A¹

Source: Journal of the European Academy of Dermatology & Venereology, Volume 21, Number 9, October 2007 , pp. 1175-1180(6)

Publisher: Wiley-Blackwell

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Abstract:

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 (≥ 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.

Keywords: calcineurin inhibitor; PODSI score; quality of life; randomized double-blind placebo-controlled clinica

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1468-3083.2007.02191.x

Affiliations: 1: Department of Dermatology and Allergy, Ludwig-Maximilians University, Munich, Germany 2: Novartis Pharma GmbH, Nürnberg, Germany

Publication date: 2007-10-01