克林霉素磷酸酯 1.2%/阿达帕林 0.15%/过氧苯甲酰 3.1%凝胶治疗男女痤疮：3 期分析。

Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis.

出版信息

J Drugs Dermatol. 2024 Oct 1;23(10):873-881. doi: 10.36849/JDD.2024.8484.

DOI:10.36849/JDD.2024.8484

Abstract

BACKGROUND

Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) is the only fixed-dose triple-combination treatment approved for acne. This post hoc analysis assessed the impact of sex on efficacy and safety/tolerability of CAB.

METHODS

In two multicenter, double-blind, phase 3 studies (NCT04214639 and NCT04214652), participants aged ≥9 years with moderate-to-severe acne were randomized (2:1) to 12 weeks of once-daily treatment with CAB or vehicle gel. Pooled data were analyzed by sex. Assessments included treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of 0 [clear] or 1 [almost clear]), inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability.

RESULTS

At week 12, treatment success rates were significantly greater with CAB versus vehicle irrespective of sex (females: 53.7% vs 23.0%; males: 43.1% vs 24.6%; P<0.05, both). CAB-treated female and male participants both experienced greater reductions from baseline versus vehicle in inflammatory (females: 77.7% vs 57.9%; males: 77.5% vs 57.1%; P<0.001, both) and noninflammatory lesions (females: 72.5% vs 45.6%; males: 72.3% vs 49.6%; P<0.001, both). Acne-QoL improvements from baseline to week 12 were significantly greater with CAB than vehicle. No significant differences in any efficacy measures between CAB-treated males and females were observed. Most TEAEs were of mild-to-moderate severity; no sex-based trends for safety/tolerability were observed.

CONCLUSIONS

CAB demonstrated comparable efficacy, quality-of-life improvements, and safety in female and male participants with moderate-to-severe acne. As the first fixed-dose, triple-combination topical formulation, CAB represents an important new treatment for acne. J Drugs Dermatol. 2024;23(10):873-881. doi:10.36849/JDD.8484.

摘要

背景

克林霉素磷酸酯 1.2%/阿达帕林 0.15%/过氧苯甲酰 3.1%凝胶（CAB）是唯一一种获得批准用于治疗痤疮的固定剂量三联组合治疗药物。本事后分析评估了性别的差异对 CAB 疗效和安全性/耐受性的影响。

方法

在两项多中心、双盲、3 期研究（NCT04214639 和 NCT04214652）中，年龄≥9 岁的中重度痤疮患者按 2:1 的比例随机分配至接受为期 12 周的每日一次 CAB 或赋形剂凝胶治疗。对数据进行了按性别分层的汇总分析。评估包括治疗成功（与基线相比，评估者整体严重程度评分至少改善 2 级和评分 0 [痊愈] 或 1 [几乎痊愈]）、炎症/非炎症性皮损计数、痤疮特异性生活质量（Acne-QoL）问卷、治疗期间出现的不良事件（TEAEs）和皮肤安全性/耐受性。

结果

在第 12 周，与赋形剂相比，CAB 治疗在无论性别均显著提高了治疗成功率（女性：53.7% vs 23.0%；男性：43.1% vs 24.6%；均 P＜0.05）。与赋形剂相比，CAB 治疗的女性和男性患者的炎症性皮损（女性：77.7% vs 57.9%；男性：77.5% vs 57.1%；均 P＜0.001）和非炎症性皮损（女性：72.5% vs 45.6%；男性：72.3% vs 49.6%；均 P＜0.001）均有更大的基线改善。与基线相比，CAB 治疗在第 12 周时对 Acne-QoL 的改善也显著优于赋形剂。未观察到 CAB 治疗的男性和女性患者之间在任何疗效指标上有显著差异。大多数 TEAEs 为轻度至中度严重程度；未观察到安全性/耐受性的性别趋势。