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
J Drugs Dermatol. 2024 Dec 1;23(12):1049-1057. doi: 10.36849/jdd.8643.
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.
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).
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.
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.
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。
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）。
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。
在2项汇总的3期研究中，每日一次使用CAB凝胶在患有痤疮的儿科参与者中耐受性良好且有效，超过一半的患者在第12周时取得了治疗成功。《药物皮肤病学杂志》。2024；23(12):1049 - 1057。doi:10.36849/JDD.8643。
