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2%超分子水杨酸与5%过氧化苯甲酰/0.1%阿达帕林治疗痤疮的疗效和安全性比较:一项随机、半脸、开放标签、单中心研究。

Efficacy and safety of 2% supramolecular salicylic acid compared with 5% benzoyl peroxide/0.1% adapalene in the acne treatment: a randomized, split-face, open-label, single-center study.

作者信息

Zheng Yue, Yin Songchao, Xia Yue, Chen Jian, Ye Congxiu, Zeng Quanrong, Lai Wei

机构信息

a Department of Dermatology , The Third affiliated Hospital of Sun Yat-sen University , Guangzhou , China.

b Department of Dermatology , The Third affiliated Hospital of Sun Yat-sen University Yuedong Hospital , Meizhou , China.

出版信息

Cutan Ocul Toxicol. 2019 Mar;38(1):48-54. doi: 10.1080/15569527.2018.1518329. Epub 2018 Dec 20.

Abstract

BACKGROUND

Topical drugs for mild to moderate acne include adapalene (ADA) and benzoyl peroxide(BPO). Supramolecular salicylic acid (SSA), a modified SA preparation, is considered as a new effective therapeutic scheme.

OBJECTIVES

To compare the safety and efficacy of 2% supramolecular SA (2% SSA) with 0.01% adapalene plus 5% benzoyl peroxide (5%BPO +0.1%ADA) for treatment of facial acne.

MATERIALS AND METHODS

This was an open-label, split face, randomized and single-centre clinical trial. Subjects with mild to moderate acne were enrolled. Two percent SSA cream were randomly applied on one side of the face while 5%BPO +0.1%ADA gel was applied on the opposite side for 28 days. The numbers of acne lesions, along with side effects of the targeted area were evaluated by the investigators at day 0, day 14, and day 28. Skin water content, TEWL and skin lightening indexes were measured at the same time.

RESULTS

A total of 31 of acne patients completed the trial. Dates showed that 2% SSA had similar effects to 5%BPO +0.1%ADA in reducing papules/pustules (47.9% vs. 49.8%), non-inflammatory lesions (43.1% vs. 42.7%) and total lesions (44.1% vs. 45.6%; all p > 0.05) at day 28. The skin barrier (skin hydration value and TEWL value), skin brightness (L* value) and erythema (a* values) indicators showed no statistical differences in the left and right sides of the face (p > 0.05).

CONCLUSION

This study demonstrated that 2% SSA has a similar efficacy with 5%BPO +0.1%ADA in mild to moderate acne treatment. This might be a useful pilot study that could be used to support further larger clinical trials.

摘要

背景

用于治疗轻至中度痤疮的外用药物包括阿达帕林(ADA)和过氧化苯甲酰(BPO)。超分子水杨酸(SSA)是一种改良的水杨酸制剂,被认为是一种新的有效治疗方案。

目的

比较2%超分子水杨酸(2% SSA)与0.01%阿达帕林加5%过氧化苯甲酰(5%BPO +0.1%ADA)治疗面部痤疮的安全性和有效性。

材料与方法

这是一项开放标签、半脸、随机、单中心的临床试验。纳入轻至中度痤疮患者。将2% SSA乳膏随机涂于一侧面部,而将5%BPO +0.1%ADA凝胶涂于另一侧,持续28天。研究人员在第0天、第14天和第28天评估痤疮皮损数量以及目标区域的副作用。同时测量皮肤含水量、经皮水分流失(TEWL)和皮肤美白指数。

结果

共有31名痤疮患者完成试验。数据显示,在第28天,2% SSA在减少丘疹/脓疱(47.9%对49.8%)、非炎性皮损(43.1%对42.7%)和总皮损(44.1%对45.6%;所有p>0.05)方面与5%BPO +0.1%ADA效果相似。皮肤屏障(皮肤水合值和TEWL值)、皮肤亮度(L值)和红斑(a值)指标在面部左右两侧无统计学差异(p>0.05)。

结论

本研究表明,2% SSA在治疗轻至中度痤疮方面与5%BPO +0.1%ADA疗效相似。这可能是一项有用的初步研究,可用于支持进一步的大型临床试验。

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