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一项双盲、随机、赋形剂对照研究,旨在评估一种抗炎保湿剂联合0.1%阿达帕林凝胶治疗痤疮的皮肤耐受性和疗效。

A double-blinded, randomized, vehicle-controlled study to access skin tolerability and efficacy of an anti-inflammatory moisturizer in treatment of acne with 0.1% adapalene gel.

作者信息

Chularojanamontri Leena, Tuchinda Papapit, Kulthanan Kanokvalai, Varothai Supenya, Winayanuwattikun Waranaree

机构信息

a Department of Dermatology , Faculty of Medicine Siriraj Hospital, Mahidol University , Bangkok , Thailand.

出版信息

J Dermatolog Treat. 2016;27(2):140-5. doi: 10.3109/09546634.2015.1079298. Epub 2015 Sep 2.

DOI:10.3109/09546634.2015.1079298
PMID:26293170
Abstract

INTRODUCTION

Topical retinoids are considered to be the first-line agents and maintenance therapy of acne; however, irritation side effects are major concern issues. Noncomedogenic moisturizers are sometimes added to relieve cutaneous irritations. This study aimed to compare tolerability and efficacy of moisturizers containing licochalcone A, l-carnitine and 1,2-decanediol (active formulation) with a placebo in mild to moderate severe acne in Asian subjects.

METHODS

This was an 8-week double-blind, prospective, randomized controlled study. All patients (n = 120) were randomized equally into three groups: (A) adapalene gel, (B) adapalene gel with the active formulation and (C) adapalene gel with the placebo. The severity of acne, skin bioengineering measurements and skin tolerability were recorded during the study.

RESULTS

Compared to baseline, the active formulation group showed significant reductions in inflammatory lesions and total lesions at the end of the study without flare-up. Moreover, skin irritations were less detected than in the other two groups by corneometer and transepidermal water loss measurements.

CONCLUSIONS

The concomitant usage of adapalene gel and the moisturizer containing licochalcone A, l-carnitine and 1,2-decanediol could reduce undesirable side effects without interfering the efficacy of adapalene. This moisturizer may be superior to placebo to prevent cutaneous irritations and enhance patients' adherence to acne medications.

摘要

引言

外用维甲酸类药物被认为是痤疮的一线治疗药物和维持治疗药物;然而,刺激副作用是主要关注的问题。有时会添加非致粉刺性保湿剂来缓解皮肤刺激。本研究旨在比较含光甘草定、左旋肉碱和1,2 - 癸二醇的保湿剂(活性配方)与安慰剂对亚洲轻至中度重度痤疮患者的耐受性和疗效。

方法

这是一项为期8周的双盲、前瞻性、随机对照研究。所有患者(n = 120)被平均随机分为三组:(A)阿达帕林凝胶组,(B)含活性配方的阿达帕林凝胶组,(C)含安慰剂的阿达帕林凝胶组。在研究期间记录痤疮严重程度、皮肤生物工程测量结果和皮肤耐受性。

结果

与基线相比,活性配方组在研究结束时炎症性皮损和总皮损显著减少,且无病情加重。此外,通过角质层水合测定仪和经表皮水分流失测量发现,该组皮肤刺激比其他两组更少。

结论

阿达帕林凝胶与含光甘草定、左旋肉碱和1,2 - 癸二醇的保湿剂联合使用可减少不良副作用,且不影响阿达帕林的疗效。这种保湿剂在预防皮肤刺激和提高患者对痤疮药物的依从性方面可能优于安慰剂。

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