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Safety and Efficacy of Tacrolimus 0.03% Ointment in the Treatment of Atopic Dermatitis: A Randomized, Double-Blind, Placebo Controlled Clinical Trial

Author(s): Parvin Mansouri | Soheila Hasouri | Alireza Firooz | Alireza Khatami | Asal Atarod | Hamed Zartab | Reza Chalangari | Katalin Martits Chalangari | Faribroz Sadeghi

Journal: Dermatology and Cosmetic
ISSN 2008-7470

Volume: 2;
Issue: 3;
Start page: 143;
Date: 2011;
Original page

Keywords: Atopic Dermatitis | Treatment | Corticosteroid | Calcineurin Inhibitor

Background and Aim: Atopic dermatitis (AD) is a chronic, relapsing, pruritic skin disease more common in infancy and childhood. Emollients, topical corticosteroids, and avoidance of irritating factors are the mainstay of its treatment, but fear of side effects has limited the use of topical corticosteroids. The objective of this study was to evaluate the safety and efficacy of topical tacrolimus 0.03% ointment in the treatment of AD. Methods: In this randomized, double-blind, clinical trial, 76 patients with AD older than 2 years were randomly allocated in two groups and treated with either tacrolimus 0.03% ointment (Abu-Rayhan Co., Iran) or placebo, twice a day for 6 weeks. Responses to treatment were compared every 2 weeks using SCORAD. Results: Twenty-nine patients in tacrolimus group and 26 in placebo group completed the trial. The reduction in SCORAD after 2 and 4 weeks in tacrolimus group was significantly higher than placebo group (P
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