固定剂量三合一磷酸克林霉素 1.2%/阿达帕林 0.15%/过氧化苯甲酰 3.1%凝胶治疗儿童和青少年中重度痤疮的有效性和安全性

L. Eichenfield, Adelaide A. Hebert, Julie C Harper, Hilary Baldwin, Neal Bhatia, L. Stein Gold, L. Kircik, Emmy Graber, Emil Tanghetti, Andrew F. Alexis, James Q Del Rosso
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引用次数: 0

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)凝胶是首个获准用于治疗寻常痤疮的固定剂量三合一配方,适用于 12 岁及以上的患者。由于儿童患者的局部痤疮治疗可能会因耐受性问题和/或认为缺乏疗效而变得复杂,因此本研究旨在调查 CAB 在儿童和青少年中的疗效和安全性。研究方法汇总两项为期 12 周的 3 期双盲随机研究(NCT04214639;NCT04214652)的数据。年龄≥9岁、患有中度至重度痤疮的合格参与者被随机(2:1)分配到每日一次的CAB或载体凝胶中。这项分析评估的是 12-17 岁的青少年(CAB:123 人;载体:50 人)。终点包括评价者总体严重程度评分和透明/几乎透明皮肤(治疗成功)比基线降低≥2级、炎性/非炎性皮损比基线变化的最小二乘平均百分率以及治疗突发不良事件(TEAEs)。此外,还总结了参与研究的五名 10-11 岁儿童的描述性疗效和安全性数据(CAB:3 人;药物:2 人)。研究结果第 12 周时,51.5% 接受 CAB 治疗的≥12 岁参试者取得了治疗成功,而 24.9% 接受车辆凝胶治疗的参试者取得了治疗成功(青少年炎症和非炎症病变计数的 P70%(分别为 78.3% 和 73.7%)与车辆(50.5% 和 42.9%;任何治疗的 P3%)),治疗相关的 TEAE 是涂抹部位疼痛。不到 2.5% 的参与者因 AEs 而退出。在 5 名年龄小于 12 岁的儿童中,接受 CAB 治疗的 3 名儿童都取得了治疗成功,炎症/非炎症病变的减少率在 76%-100% 之间;接受车辆治疗的两名参与者均未取得治疗成功。只有一名接受过 CAB 治疗的小患者出现了 TEAEs(涂抹部位疼痛/干燥和红斑 [均为轻度/中度]),没有人中止研究。结论:在两项合并的三期研究中,每日一次的CAB凝胶--首个获批的用于治疗寻常型痤疮的固定剂量三合一外用制剂--对患有中度至重度痤疮的儿童患者具有良好的耐受性和疗效,超过半数的患者在第12周时取得了治疗成功。资金来源:Ortho DermatologicsOrtho Dermatologics
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Efficacy and Safety of Fixed-Dose Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne Vulgaris in Children and Adolescents
Background: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the first fixed-dose triple-combination formulation approved for acne vulgaris and is indicated for use in patients aged 12 years and older. As topical acne treatment in pediatric patients may be complicated by tolerability issues and/or a perceived lack of efficacy, the objective of this post hoc analysis was to investigate the efficacy and safety of CAB in children and adolescents. Methods: Data were pooled from two phase 3 double-blind, randomized, 12-week studies (NCT04214639; NCT04214652). Eligible participants ≥9 years of age with moderate-to-severe acne were randomized (2:1) to once-daily CAB or vehicle gel. This analysis evaluated adolescents aged 12-17 years (CAB: n=123; vehicle: n=50). Endpoints included ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success), least-squares mean percent change from baseline in inflammatory/noninflammatory lesions, and treatment-emergent adverse events (TEAEs). Descriptive efficacy and safety data for five children aged 10-11 years enrolled in the study are also summarized (CAB: n=3; vehicle: n=2). Results: At week 12, 51.5% of CAB–treated participants aged ≥12 years achieved treatment success vs 24.9% with vehicle gel (P<0.01). CAB treatment resulted in significant reductions of >70% in inflammatory and noninflammatory lesion counts in adolescents (78.3% and 73.7%, respectively) vs vehicle (50.5% and 42.9%; P<0.001, both). Most TEAEs were of mild-to-moderate severity, and the most common (>3% in any treatment) treatment-related TEAE was application site pain. Less than 2.5% of participants withdrew due to AEs. For the 5 children aged <12 years, all 3 treated with CAB achieved treatment success, with reductions in inflammatory/noninflammatory lesions ranging from 76%-100%; neither vehicle-treated participant achieved treatment success. Only one CAB–treated younger participant experienced TEAEs (application site pain/dryness, and erythema [all mild/moderate]) and none discontinued the study. Conclusions: In two pooled phase 3 studies, once-daily CAB gel—the first approved fixed-dose, triple-combination topical formulation for acne vulgaris—was well tolerated and efficacious in pediatric participants with moderate-to-severe acne, with over half achieving treatment success at week 12. Funding: Ortho Dermatologics
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