Results of a randomized, double-blind, vehicle-controlled efficacy trial of pimecrolimus cream 1% for the treatment of moderate to severe facial seborrheic dermatitis

Erin M Warshaw, Ross Jon Wohlhuter, An Liu, Sarah A. Zeller, Rachel A. Wenner, Sacharitha Bowers, Julie C. Schultz, H. Irving Katz, Calogera L. McCormick, Anne Parneix-Spake

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56 Scopus citations

Abstract

Background: Seborrheic dermatitis is commonly treated with anti-inflammatory products, including topical corticosteroids. Pimecrolimus cream 1% also exerts anti-inflammatory activity by inhibiting T-cell cytokine production. Objective: We sought to compare the efficacy and safety of twice-daily pimecrolimus for treatment of moderate to severe facial seborrheic dermatitis. Methods: This double-blind, vehicle-controlled, 4-week trial randomized patients with seborrheic dermatitis to pimecrolimus or vehicle (1:1). Clinical assessments (erythema [0-3] and scaling [0-3] combined for a total area score [0-6]) were performed at weeks 0, 2, and 4. Inclusion criteria included total area score 4 or greater and erythema 2 or greater. The prespecified primary variable, change from baseline in total area score at week 4, was analyzed using a two-sample t test for intent-to-treat and per protocol populations. Results: In all, 96 adults of mean age 59.6 years, 88.5% male, were randomized (n = 47 pimecrolimus; 49 vehicle). At week 4, the mean change from baseline in total area score was 3.7 versus 3.3 for pimecrolimus and vehicle groups, respectively (intent-to-treat: P = .1913; 95% confidence interval (CI) for difference [-0.195, 0.961]). Per protocol analysis (n = 41 pimecrolimus; 46 vehicle) indicated a significant difference between groups (mean change 3.9 pimecrolimus vs 3.2 vehicle; P = .0156; CI [0.129, 1.197]). The superiority of pimecrolimus was observed as early as week 2 (intent-to-treat: P = .0062; CI [0.132, 0.777]; per protocol: P = .0012; CI [0.410, 1.593]). No drug-related serious adverse events occurred. The most frequent drug-related adverse events were local, mild, and transient (pimecrolimus = 26%; vehicle = 12%). Limitations: Generalizability is limited by the elderly male study population. Conclusion: This study suggests that pimecrolimus cream 1% is an effective and well-tolerated treatment for moderate to severe facial seborrheic dermatitis.

Original languageEnglish (US)
Pages (from-to)257-264
Number of pages8
JournalJournal of the American Academy of Dermatology
Volume57
Issue number2
DOIs
StatePublished - Aug 2007

Bibliographical note

Funding Information:
This investigator-initiated study was supported by Novartis Pharmaceuticals Corporation. During this study, Dr Warshaw was supported by a Department of Veterans Affairs Cooperative Studies Clinical Research Career Development Award.

Copyright:
Copyright 2011 Elsevier B.V., All rights reserved.

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