用于治疗痤疮的克林霉素磷酸酯1.2%/阿达帕林0.15%/过氧化苯甲酰3.1%三联组合：一项汇总的3期分析的疗效与安全性

Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis.

作者信息

Kircik Leon H, Stein Gold Linda, Gold Michael, Weiss Jonathan S, Harper Julie C, Del Rosso James Q, Bunick Christopher G, Bhatia Neal, Tanghetti Emil A, Eichenfield Lawrence F, Baldwin Hilary, Draelos Zoe D, Callender Valerie D, Han George, Gooderham Melinda J, Sadick Neil, Lupo Mary P, Lain Edward Ted, Werschler William Philip

机构信息

Icahn School of Medicine at Mount Sinai, New York, NY, USA.

Indiana University School of Medicine, Indianapolis, IN, USA.

出版信息

Dermatol Ther (Heidelb). 2024 May;14(5):1211-1227. doi: 10.1007/s13555-024-01155-7. Epub 2024 May 9.

DOI:10.1007/s13555-024-01155-7

PMID:38724841

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11116301/

Abstract

INTRODUCTION

A three-pronged approach to acne treatment combining an antibiotic, antimicrobial, and retinoid may be more efficacious than single/double treatments while potentially reducing antibiotic resistance. This study evaluated the efficacy and safety of the first fixed-dose, triple-combination topical acne product, clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) using pooled phase 3 data.

METHODS

In two identical phase 3 (N = 183; N = 180), double-blind, 12-week studies, participants aged ≥ 9 years with moderate-to-severe acne were randomized 2:1 to receive once-daily CAB or vehicle gel. Endpoints included ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in acne lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated.

RESULTS

At week 12, 50.0% of participants achieved treatment success with CAB versus 22.6% with vehicle gel (P < 0.001). CAB resulted in > 70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P < 0.001, both). Most TEAEs were of mild-moderate severity, and < 3% of CAB-treated participants discontinued study/treatment because of AEs. Transient increases from baseline in scaling, erythema, itching, burning, and stinging were observed with CAB, but resolved back to or near baseline values by week 12.

CONCLUSIONS

The innovative fixed-dose, triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel was efficacious and well tolerated in children, adolescents, and adults with moderate-to-severe acne. Half of participants achieved clear/almost clear skin by 12 weeks, rates not previously seen in clinical studies of other topical acne products.

TRIAL REGISTRATION

ClinicalTrials.gov identifier NCT04214639 and NCT04214652.

摘要

引言

一种将抗生素、抗菌剂和维甲酸结合起来的三联疗法治疗痤疮，可能比单一或双联疗法更有效，同时有可能降低抗生素耐药性。本研究使用汇总的3期数据，评估了首款固定剂量的三联组合外用痤疮产品克林霉素1.2%/阿达帕林0.15%/过氧化苯甲酰（BPO）3.1%凝胶（CAB）的疗效和安全性。

方法

在两项相同的3期（N = 183；N = 180）、双盲、为期12周的研究中，年龄≥9岁的中度至重度痤疮患者按2:1随机分组，分别接受每日一次的CAB或赋形剂凝胶。终点指标包括与基线相比，评估者整体严重程度评分降低≥2级，皮肤达到清除/几乎清除（治疗成功），以及痤疮皮损计数相对于基线的最小二乘均值百分比变化。评估治疗中出现的不良事件（TEAE）以及皮肤安全性/耐受性。

结果

在第12周时，50.0%使用CAB的参与者治疗成功，而使用赋形剂凝胶的参与者为22.6%（P < 0.001）。CAB在第12周时使炎性和非炎性皮损减少>70%（分别为77.9%和73.0%），显著大于赋形剂凝胶组（57.9%和48.2%；两者P均< 0.001）。大多数TEAE为轻至中度严重程度，接受CAB治疗的参与者中因不良事件而停止研究/治疗的比例<3%。使用CAB观察到脱屑、红斑、瘙痒、灼痛和刺痛较基线有短暂增加，但到第12周时恢复到或接近基线值。