复方克林霉素磷酸酯 1.2%/过氧化苯甲酰 3.1%/阿达帕林 0.15%凝胶治疗儿童和青少年中重度痤疮的随机 2 期研究。

Triple-combination clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel for moderate-to-severe acne in children and adolescents: Randomized phase 2 study.

机构信息

Departments of Dermatology and Pediatrics, University of California, San Diego School of Medicine, La Jolla, California, USA.

Division of Pediatric and Adolescent Dermatology, Rady Children's Hospital, San Diego, California, USA.

出版信息

Pediatr Dermatol. 2023 May-Jun;40(3):452-459. doi: 10.1111/pde.15283. Epub 2023 Mar 22.

DOI:10.1111/pde.15283

PMID:36949579

Abstract

BACKGROUND/OBJECTIVES: Topical clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel (IDP-126) is the first fixed-dose triple-combination formulation in development for acne. This post hoc analysis investigated efficacy and safety of IDP-126 in children and adolescents with moderate-to-severe acne.

METHODS

In a randomized, double-blind phase 2 study (NCT03170388), participants ≥9 years of age with moderate-to-severe acne were eligible for randomization (1:1:1:1:1) to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. This post hoc analysis of pediatric participants (n = 394) included children and adolescents up to 17 years of age. Assessments included treatment success, inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability.

RESULTS

At Week 12, treatment success rates were significantly greater with IDP-126 (55.8%) than with vehicle (5.7%; p < .001) or any of the dyad combinations (range: 30.8%-33.9%; p < .01, all). Lesion reductions with IDP-126 were also significantly greater than with vehicle (inflammatory: 78.3% vs. 45.1%; noninflammatory: 70.0% vs. 37.6%; p < .001, both) and 9.2%-16.6% greater than with any of the dyad combinations. Increases (improvements) from baseline in Acne-QoL domain scores were generally greater with IDP-126 than in any other treatment group. The most common treatment-related TEAEs across treatment groups were application site pain and dryness. Most treatment-related TEAEs were of mild-to-moderate severity.

CONCLUSION

IDP-126 gel-a novel fixed-dose, triple-combination topical formulation for acne-demonstrated superior efficacy to vehicle and three dyad component gels and was well tolerated in children and adolescents with moderate-to-severe acne.

摘要

背景/目的：克林霉素磷酸酯 1.2%/过氧化苯甲酰 3.1%/阿达帕林 0.15%凝胶（IDP-126）是首款开发用于治疗痤疮的固定剂量三联复方制剂。本事后分析研究了 IDP-126 在中重度痤疮儿童和青少年中的疗效和安全性。

方法

在一项随机、双盲 2 期研究（NCT03170388）中，年龄≥9 岁、中重度痤疮患者有资格按 1:1:1:1:1 比例随机分配至每日 1 次 IDP-126、三种二联组合凝胶中的一种或赋形剂凝胶，治疗 12 周。本项儿科参与者（n=394）事后分析包括 9-17 岁的儿童和青少年。评估包括治疗成功率、炎性/非炎性皮损计数、痤疮特异性生活质量（Acne-QoL）问卷、治疗中出现的不良事件（TEAEs）以及皮肤安全性/耐受性。

结果

在第 12 周，IDP-126 的治疗成功率显著高于赋形剂（5.7%；p<0.001）或任何二联组合（范围：30.8%-33.9%；p<0.01，均），分别为 55.8%和 5.7%。IDP-126 治疗的皮损减少也显著大于赋形剂（炎性：78.3% vs. 45.1%；非炎性：70.0% vs. 37.6%；p<0.001，均），比任何二联组合分别高 9.2%-16.6%。IDP-126 组在痤疮特异性生活质量（Acne-QoL）问卷各维度评分的改善也普遍大于其他治疗组。各治疗组中最常见的与治疗相关的 TEAEs 为用药部位疼痛和干燥。大多数治疗相关的 TEAEs 为轻中度。