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

IF 1.5 4区医学 Q3 DERMATOLOGY Journal of Drugs in Dermatology Pub Date : 2024-12-01 DOI:10.36849/jdd.8643

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

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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.

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三联克林霉素磷酸1.2%/阿达帕烯0.15%/过氧化苯甲酰3.1%凝胶用于儿童和青少年中重度痤疮

背景：外用克林霉素磷酸1.2%/阿达帕烯0.15%/过氧化苯甲酰3.1% （CAB）凝胶是唯一被批准用于痤疮的固定剂量三联疗法（适用于12岁及以上患者）。由于儿科患者局部痤疮治疗可能因耐受性和/或认为缺乏疗效而复杂化，因此采用事后分析来调查儿童和青少年使用CAB的疗效/安全性。方法：数据来自2项为期12周的3期双盲研究(NCT04214639；NCT04214652)。年龄在9岁及以上的中重度痤疮患者被随机分配（2:1）至每日一次的CAB或载体凝胶组。终点包括治疗成功（评估者的总体严重程度评分比基线降低至少2级，皮肤清晰/几乎清晰）和炎症/非炎症性病变较基线的最小二乘平均百分比变化。评估治疗出现的不良事件（teae）和皮肤安全性/耐受性。对12至17岁的青少年进行事后分析(CAB, n=123；车辆，n=50)， 10至11岁儿童的描述性数据(CAB, n=3；车,n = 2)。结果：在第12周，51.5%的cab治疗青少年获得了治疗成功，而24.9%的vehicle治疗成功（P<0.01）。CAB还提供了78.3%/73.7%的炎症/非炎症病变减少，而对照组为50.5%/42.9% （P<均为0.001）。大多数teae的严重程度为轻至中度，2.5%的参与者因不良事件而停药。只有3名接受CAB治疗的儿童获得了治疗成功，病变减少幅度从76%到100%不等。一名接受caba治疗的儿童经历了teae，没有人停止治疗。结论：在两项合并的3期研究中，每日一次的CAB凝胶对患有痤疮的儿科参与者具有良好的耐受性和有效性，超过一半的患者在第12周获得治疗成功。皮肤医学杂志，2024;23(12):1049-1057。doi: 10.36849 / JDD.8643。

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来源期刊

Journal of Drugs in Dermatology DERMATOLOGY-

CiteScore

2.20

自引率

13.30%

发文量

289

审稿时长

3-6 weeks

期刊介绍： The Journal of Drugs in Dermatology (JDD) is a peer-reviewed publication indexed with MEDLINE®/PubMed® that was founded by the renowned Dr. Perry Robins MD. Founded in 2002, it offers one of the fastest routes to disseminate dermatologic information and is considered the fastest growing publication in dermatology. We present original articles, award-winning case reports, and timely features pertaining to new methods, techniques, drug therapy, and devices in dermatology that provide readers with peer reviewed content of the utmost quality. Our high standards of content are maintained through a balanced, peer-review process. Articles are reviewed by an International Editorial Board of over 160 renowned experts.

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