Results of a randomized, double-blind, vehicle-controlled efficacy trial of pimecrolimus cream 1% for the treatment of moderate to severe facial seborrheic dermatitis - 19/08/11
, Ross Jon Wohlhuter a, b, An Liu, MS a, Sarah A. Zeller, MD, MPH c, Rachel A. Wenner, MD a, b, Sacharitha Bowers, MD a, b, d, Julie C. Schultz, MD b, H. Irving Katz, MD b, Calogera L. McCormick, BA e, Anne Parneix-Spake, MD e
Correspondence to: Erin M. Warshaw, MD, MS, University of Minnesota, Dermatology Section, Minneapolis Veterans Affairs Medical Center, Department 111K, 1 Veterans Dr, Minneapolis MN 55417.Minneapolis, Minnesota; Oklahoma City, Oklahoma; Springfield, Illinois; and East Hanover, New Jersey
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.
Le texte complet de cet article est disponible en PDF.Abbreviations used : CI, FDA, IGA, IL, ITT, PP
Plan
| 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. Disclosure: Anne Parneix-Spake, MD, and Calogera L. McCormick are employees of Novartis Pharmaceuticals Corporation. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs. Reprints not available from the authors. |
Vol 57 - N° 2
P. 257-264 - août 2007 Retour au numéro
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