Back issues No.1 - 2004 / Original Study  

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Efficacy and Safety of Tacrolimus Ointment for Patients of Atopic Dermatitis in Taiwan
Yu-Hsin Wu, Hsi-Ching Wang, Tien-Yi Tzung, Ding-Dar Lee, Jui-Lung Shen
Dermatol Sinica 22 : 15-22, 2004

Tacrolimus ointment is a topical non-steroid immunomodulator formulated for patients of atopic dermatitis. In this multi-center, open-labeled, single-drug, 4-week clinical trial, 78 patients of moderate to severe atopic dermatitis in Taiwan were enrolled. During this study, we used 0.03% or 0.1% tacrolimus ointment to assess its efficacy and safety. Significant improvement in physician’s global evaluation of clinical response, eczema area and severity index, percent body surface affected and the patient’s/parent’s assessment of pruritus was observed in the first week. The effectiveness could be maintained through the study. In evaluation of safety, the concentration of tacrolimus in serum was mostly lower than the limit of quantification(1.5 ng/ml). The most common side effects observed included burning sensation, pruritus and stinging sensation, but the symptoms usually subsided in the first three days(52%). In conclusion, tacrolimus ointment is effective and safe for patients of atopic dermatitis.

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