Kircik Leon H, Harper Julie C, Gold Michael, Gold Linda Stein, Draelos Zoe D, Guenin Eric, Choi Su Yong, Wroblewski Karol, Baldwin Hilary, Callender Valerie D, Hebert Adelaide A, Weiss Jonathan S
J Drugs Dermatol. 2025 Aug 1;24(8):803-809. doi: 10.36849/JDD.9212.
Truncal acne is underdiagnosed and undertreated, and it can lead to scarring and postinflammatory hyperpigmentation. However, applying topical treatments to larger skin surface areas introduces additional safety/tolerability concerns. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination topical for acne and has demonstrated favorable efficacy/safety in participants with facial acne.
Data were pooled from one phase 2 (NCT04892706) and two phase 3 (NCT04214639, NCT04214652), double-blind, 12-week studies. Participants aged ≥9 years (≥12 years, phase 2) with moderate to severe facial acne were randomized to once daily CAB or vehicle gel. Truncal acne treatment was optional, and efficacy was not the main outcome. Truncal treatment-emergent adverse events (TEAEs) and truncal cutaneous safety/tolerability were evaluated through week 12. Only participants treating both face and trunk were included in this post hoc analysis (CAB, n=118; vehicle, n=101).
Through week 12, TEAE rates on the trunk were higher with CAB vs vehicle (5.9% vs 1.0%). Most TEAEs were mild, none were serious, and only 1 participant (CAB-treated) discontinued due to TEAEs. Mean truncal cutaneous safety/tolerability scores with CAB were <0.5 (1=mild) at all visits. Severe (grade 3) ratings postbaseline occurred in <1% of CAB-treated participants for erythema, hyperpigmentation, and burning (n=1 each).
In this pooled analysis, fixed-dose CAB gel was well tolerated over 12 weeks in participants treating their truncal acne. The lack of safety signals combined with the favorable safety/tolerability profile of CAB shows that it is a safe treatment option for truncal and facial acne.
躯干痤疮的诊断和治疗不足，且可能导致瘢痕形成和炎症后色素沉着。然而，在较大面积的皮肤表面应用局部治疗会引发更多安全性/耐受性问题。1.2%磷酸克林霉素/0.15%阿达帕林/3.1%过氧化苯甲酰（CAB）凝胶是唯一一种用于治疗痤疮的固定剂量三联复方局部用药，并且已在面部痤疮患者中显示出良好的疗效/安全性。
数据来自一项2期（NCT04892706）和两项3期（NCT04214639、NCT04214652）双盲、为期12周的研究。年龄≥9岁（2期为≥12岁）的中度至重度面部痤疮患者被随机分配至每日一次使用CAB凝胶或赋形剂凝胶。躯干痤疮的治疗为可选方案，且疗效并非主要观察指标。在第12周时评估躯干治疗出现的不良事件（TEAE）以及躯干皮肤的安全性/耐受性。仅对同时治疗面部和躯干的患者进行了此项事后分析（CAB组，n = 118；赋形剂组，n = 101）。
至第12周时，CAB组躯干的TEAE发生率高于赋形剂组（5.9%对1.0%）。大多数TEAE为轻度，无严重事件，且仅有1名患者（CAB治疗组）因TEAE停药。在所有访视中，CAB组的平均躯干皮肤安全性/耐受性评分均<0.5（1 = 轻度）。基线后出现的严重（3级）红斑、色素沉着和烧灼感在接受CAB治疗的患者中均<1%（各1例）。
在此项汇总分析中，固定剂量的CAB凝胶在治疗躯干痤疮的患者中12周内耐受性良好。缺乏安全性信号以及CAB良好的安全性/耐受性表明，它是治疗躯干和面部痤疮的一种安全治疗选择。
