用于儿童和青少年中重度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%三联凝胶

Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne in Children and Adolescents.

作者信息

Eichenfield Lawrence F, Hebert Adelaide A, Harper Julie C, Baldwin Hilary, Bhatia Neal, Gold Linda Stein, Kircik Leon H, Graber Emmy, Tanghetti Emil A, Alexis Andrew F, Del Rosso James Q

出版信息

J Drugs Dermatol. 2024 Dec 1;23(12):1049-1057. doi: 10.36849/jdd.8643.

DOI:10.36849/jdd.8643

PMID:39630680

Abstract

BACKGROUND

Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose triple-combination approved for acne (indicated in patients 12 years and older). As topical acne treatment in pediatric patients may be complicated by tolerability and/or a perceived lack of efficacy, post hoc analyses were used to investigate efficacy/safety of CAB in children and adolescents.

METHODS

Data were pooled from 2 phase 3, double-blind, 12-week studies (NCT04214639; NCT04214652). Participants aged 9 years and older with moderate-to-severe acne were randomized (2:1) to once-daily CAB or vehicle gel. Endpoints included treatment success (at least 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesions. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated. Post hoc analyses were conducted in adolescents aged 12 to 17 years (CAB, n=123; vehicle, n=50) with descriptive data shown for children aged 10 to 11 (CAB, n=3; vehicle, n=2).

RESULTS

At week 12, 51.5% of CAB-treated adolescents achieved treatment success vs 24.9% with vehicle (P<0.01). CAB also provided inflammatory/noninflammatory lesion reductions of 78.3%/73.7% vs 50.5%/42.9% with vehicle (P<0.001, both). Most TEAEs were of mild-to-moderate severity, and <2.5% of participants discontinued due to adverse events. Only the 3 children treated with CAB achieved treatment success, with lesion reductions ranging from 76% to 100%. One CAB-treated child experienced TEAEs and none discontinued.

CONCLUSIONS

In 2 pooled phase 3 studies, once-daily CAB gel was well tolerated and efficacious in pediatric participants with acne, with over half achieving treatment success at week 12. J Drugs Dermatol. 2024;23(12):1049-1057. doi:10.36849/JDD.8643.

摘要

背景

外用克林霉素磷酸酯1.2%/阿达帕林0.15%/过氧化苯甲酰3.1%（CAB）凝胶是唯一获批用于治疗痤疮的固定剂量三联组合药物（适用于12岁及以上患者）。由于儿科患者外用痤疮治疗可能因耐受性和/或疗效欠佳而变得复杂，因此进行了事后分析以研究CAB在儿童和青少年中的疗效/安全性。

方法

数据来自2项3期、双盲、为期12周的研究（NCT04214639；NCT04214652）。年龄在9岁及以上的中度至重度痤疮患者被随机分组（2:1），分别每日一次使用CAB凝胶或赋形剂凝胶。终点指标包括治疗成功（评估者整体严重程度评分较基线降低至少2级且皮肤清除/几乎清除）以及炎症性/非炎症性皮损较基线的最小二乘均值百分比变化。对治疗中出现的不良事件（TEAE）以及皮肤安全性/耐受性进行评估。对12至17岁的青少年进行了事后分析（CAB组，n = 123；赋形剂组，n = 50），并给出了10至11岁儿童的描述性数据（CAB组，n = 3；赋形剂组，n = 2）。

结果

在第12周时，接受CAB治疗的青少年中有51.5%取得了治疗成功，而使用赋形剂凝胶的这一比例为24.9%（P<0.01）。CAB还使炎症性/非炎症性皮损分别减少了78.3%/73.7%，而赋形剂凝胶组为50.5%/42.9%（两者P均<0.001）。大多数TEAE为轻度至中度严重程度，且因不良事件停药的参与者不到2.5%。仅3名接受CAB治疗的儿童取得了治疗成功，皮损减少幅度在76%至100%之间。1名接受CAB治疗的儿童出现了TEAE，但无人停药。