A randomized, double-blind, vehicle-controlled study of 1% pimecrolimus cream in adult patients with perioral dermatitis

被引：28

作者：

Schwarz, Thomas ^{[1
]}

Kreiselmaier, Inga ^{[1
]}

Bieber, Thomas ^{[2
]}

Thaci, Diamant ^{[3
]}

Simon, Jan C. ^{[4
]}

Meurer, Michael ^{[5
]}

Werfel, Thomas ^{[6
]}

Zuberbier, Torsten ^{[7
]}

Luger, Thomas A. ^{[8
]}

Wollenberg, Andreas ^{[9
]}

Braeutigam, Matthias ^{[10
]}

机构：

[1] Univ Kiel, Dept Dermatol, D-24105 Kiel, Germany

[2] Univ Bonn, Dept Dermatol, D-5300 Bonn, Germany

[3] Goethe Univ Frankfurt, Dept Dermatol, D-6000 Frankfurt, Germany

[4] Univ Leipzig, Dept Dermatol, Leipzig, Germany

[5] Univ Dresden, Dept Dermatol, Dresden, Germany

[6] Leibniz Univ Hannover, Dept Dermatol, D-30167 Hannover, Germany

[7] Univ Berlin, Dept Dermatol, Berlin, Germany

[8] Univ Munster, Dept Dermatol, D-4400 Munster, Germany

[9] Univ Munich, Dept Dermatol, D-80539 Munich, Germany

[10] Novartis Pharma GmbH, Nurnberg, Germany

来源：

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY | 2008年 / 59卷 / 01期

关键词：

D O I：

10.1016/j.jaad.2008.03.043

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

Backgroun: 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.

引用

页码：34 / 40

页数：7

共 16 条

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