阿达帕林/过氧化苯甲酰凝胶0.3%/2.5%：无论年龄或性别，均为有效的痤疮治疗药物。

Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: Effective Acne Therapy Regardless of Age or Gender.

作者信息

Stein Gold Linda, Werschler William P, Mohawk Jennifer

出版信息

J Drugs Dermatol. 2017 Jun 1;16(6):582-589.

Abstract

BACKGROUND: Acne vulgaris affects a diverse group of people, and there is an increasingly wide variety of acne treatments. Because of the many options, clinicians have a better ability to individualize treatment; however, achieving optimal results relies on understanding how various agents perform in specific population segments. Fixed-combination adapalene plus benzoyl peroxide (A/BPO) is a first-line recommended acne therapy and is available in two adapalene concentrations (0.1% and 0.3%) combined with BPO 2.5%. This analysis investigated whether gender and age have an impact on either the efficacy or safety of topical A/BPO 0.3%.

METHODS: A post-hoc subanalysis was performed on data from a multicenter, randomized, double-blind, parallelgroup, 12-week study of A/BPO gel 0.3%/2.5% or vehicle gel in subjects ≥ 12 years old with moderate to severe acne vulgaris (Investigator global assessment [IGA] of 3 or 4). Efficacy measurements included achievement of an IGA of clear (0) or almost clear (1), and change in lesion counts from baseline to week 12. Safety measures included adverse events and cutaneous tolerability. The intent to treat (ITT) and safety populations were analyzed.

RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 217 subjects. Among the subjects, 111 were 12-17 years old and 106 were ≥ 18 years old; 104 were male and 113 were female. A/BPO 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle in success rates (IGA 0 or 1) and reduction of inflammatory/noninflammatory lesions (P≤0.05) across both age groups and genders.

CONCLUSIONS: A/BPO 0.3%/2.5% treatment achieved success and was equally effective and safe in younger vs older subjects and in males vs females. These results support the use of A/BPO 0.3%/2.5% in all subjects 12 and older.

Clinicaltrials.gov registry: (NCT01880320)

J Drugs Dermatol. 2017;16(6):582-589.

摘要

背景

寻常痤疮影响着不同人群，痤疮治疗方法也日益多样。由于有多种选择，临床医生有更强的能力实现个体化治疗；然而，要取得最佳效果，依赖于了解各种药物在特定人群中的表现。固定复方阿达帕林加过氧化苯甲酰（A/BPO）是一线推荐的痤疮治疗药物，有两种阿达帕林浓度（0.1%和0.3%）与2.5%的BPO组合剂型。本分析研究了性别和年龄对局部用0.3%A/BPO的疗效或安全性是否有影响。

方法

对一项多中心、随机、双盲、平行组、为期12周的研究数据进行事后亚组分析，该研究纳入年龄≥12岁、患有中度至重度寻常痤疮（研究者整体评估[IGA]为3或4）的受试者，比较0.3%/2.5%A/BPO凝胶与赋形剂凝胶。疗效指标包括达到IGA清除（0）或几乎清除（1），以及从基线到第12周皮损计数的变化。安全性指标包括不良事件和皮肤耐受性。分析意向性治疗（ITT）人群和安全性人群。

结果

0.3%/2.5%A/BPO凝胶治疗组包括217名受试者。其中，111名年龄在12 - 17岁，106名年龄≥18岁；104名男性，113名女性。0.3%/2.5%A/BPO安全、耐受性良好，在成功率（IGA为0或1）以及炎症性/非炎症性皮损减少方面，在两个年龄组和不同性别中均显著优于赋形剂（P≤0.05）。