A Randomized, Open-Label, Multicenter Trial of Topical Tacrolimus for the Treatment of Pruritis in Patients with Atopic Dermatitis.

Satoshi Takeuchi; Hidehisa Saeki; Shoji Tokunaga; Makoto Sugaya; Hanako Ohmatsu; Yuichiro Tsunemi; Hideshi Torii; Koichiro Nakamura; Tamihiro Kawakami; Yoshinao Soma; Eiichi Gyotoku; Michihiro Hide; Rikako Sasaki; Yukihiro Ohya; Makiko Kido; Masutaka Furue

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A Randomized, Open-Label, Multicenter Trial of Topical Tacrolimus for the Treatment of Pruritis in Patients with Atopic Dermatitis.

Author: Satoshi TAKEUCHI ¹ ; Hidehisa SAEKI ; Shoji TOKUNAGA ; Makoto SUGAYA ; Hanako OHMATSU ; Yuichiro TSUNEMI ; Hideshi TORII ; Koichiro NAKAMURA ; Tamihiro KAWAKAMI ; Yoshinao SOMA ; Eiichi GYOTOKU ; Michihiro HIDE ; Rikako SASAKI ; Yukihiro OHYA ; Makiko KIDO ; Masutaka FURUE
Author Information

1. Department of Dermatology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. takeuchs@dermatol.med.kyushu-u.ac.jp
Publication Type:Multicenter Study ; Original Article ; Randomized Controlled Trial
Keywords: Atopic dermatitis; Maintenance therapy; Pruritis; Randomized trial; Tacrolimus
MeSH: Dermatitis, Atopic; Emollients; Humans; Pruritus; Recurrence; Steroids; Tacrolimus
From:Annals of Dermatology 2012;24(2):144-150
CountryRepublic of Korea
Language:English
Abstract: BACKGROUND: Pruritis caused by atopic dermatitis (AD) is not always well controlled by topical corticosteroid therapy, but use of tacrolimus often helps to soothe such intractable pruritis in clinical settings. OBJECTIVE: To determine the anti-pruritic efficacy of topical tacrolimus in treating AD in induction and maintenance therapy. METHODS: Prior to the study, patients were randomly allocated into two groups, induction therapy followed by tacrolimus monotherapy maintenance, and induction therapy followed by emollient-only maintenance. In the induction therapy, the patients were allowed to use topical tacrolimus and emollients in addition to a low dose (<10 g/week) of topical steroids. Patients showing relief from pruritis were allowed to proceed to maintenance therapy. Recurrence of pruritis in maintenance therapy was examined as a major endpoint. RESULTS: Two-thirds of patients (44/68; 64.7%) showed relief from pruritis after induction therapy. Pruritis recurred in 23.8% (5/21) of the tacrolimus monotherapy group and in 100% (21/21) of the emollient group during maintenance period, a difference that was statistically significant. CONCLUSION: Use of topical tacrolimus is effective in controlling pruritis of AD compared to emollient.