Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity.

IF 4.2 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-07-01 Epub Date: 2025-05-16 DOI:10.1007/s13555-025-01440-z

Michael Gold, Ted Lain, Julie C Harper, Hilary Baldwin, Eric Guenin, Linda Stein Gold

{"title":"Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity.","authors":"Michael Gold, Ted Lain, Julie C Harper, Hilary Baldwin, Eric Guenin, Linda Stein Gold","doi":"10.1007/s13555-025-01440-z","DOIUrl":null,"url":null,"abstract":"Introduction: Clindamycin phosphate (CLIN) 1.2%/adapalene (ADAP) 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) is the only triple-combination topical approved for acne. These post hoc analyses assessed efficacy and safety of CAB gel compared with component dyads and branded ADAP 0.3%/BPO 2.5% gel in participants stratified by baseline acne severity.Methods: Data were pooled from two phase 2 and two phase 3 12-week studies. Participants were randomized to once-daily CAB or vehicle; one phase 2 study included dyad combinations of CAB active ingredients (ADAP/BPO, CLIN/BPO, and CLIN/ADAP) and the other included a head-to-head comparison with branded ADAP 0.3%/BPO 2.5%. Assessments included percent changes from baseline in inflammatory/noninflammatory lesions (IL/NIL) and treatment success (≥ 2-grade reduction from baseline in Evaluator's Global Severity Score [EGSS] and clear/almost clear skin). Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were assessed.Results: At week 12, IL reductions in moderate participants (EGSS = 3; n = 1557) were significantly greater with CAB vs vehicle, dyads, and branded ADAP/BPO (77.1% vs 54.1%, 64.4-69.4%, and 72.8%, respectively; P < 0.05, all). IL reductions in severe participants (EGSS = 4; n = 230) were significantly greater with CAB vs vehicle, ADAP/BPO, and CLIN/BPO (74.5% vs 44.4%, 63.9%, and 61.3%; P < 0.05, all), and similar to CLIN/ADAP and branded ADAP/BPO (73.7%/75.4%). IL reductions were greater than NIL. Moderate participants achieved greater treatment success rates with CAB vs vehicle, dyads, or branded ADAP/BPO (53.9% vs 19.5%, 31.5-35.3%, and 38.1%; P ≤ 0.001, all); only CAB- and CLIN/ADAP-treated severe participants had significantly greater rates vs vehicle (30.9% and 34.0% vs 9.0%; P < 0.05). Most TEAEs were of mild to moderate severity. All mean cutaneous safety/tolerability scores were ≤ 1 (1 = mild).Conclusions: CAB demonstrated superior efficacy to three dyads and branded ADAP 0.3%/BPO 2.5% in moderate acne participants, and generally numerically greater efficacy in severe acne participants. To our knowledge, these analyses include data from the only double-blind, vehicle-controlled, head-to-head study.Trial registration: ClinicalTrials.gov identifier NCT03170388, NCT04892706, NCT04214639, and NCT04214652.","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"1867-1882"},"PeriodicalIF":4.2000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12126431/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01440-z","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/5/16 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction: Clindamycin phosphate (CLIN) 1.2%/adapalene (ADAP) 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) is the only triple-combination topical approved for acne. These post hoc analyses assessed efficacy and safety of CAB gel compared with component dyads and branded ADAP 0.3%/BPO 2.5% gel in participants stratified by baseline acne severity.

Methods: Data were pooled from two phase 2 and two phase 3 12-week studies. Participants were randomized to once-daily CAB or vehicle; one phase 2 study included dyad combinations of CAB active ingredients (ADAP/BPO, CLIN/BPO, and CLIN/ADAP) and the other included a head-to-head comparison with branded ADAP 0.3%/BPO 2.5%. Assessments included percent changes from baseline in inflammatory/noninflammatory lesions (IL/NIL) and treatment success (≥ 2-grade reduction from baseline in Evaluator's Global Severity Score [EGSS] and clear/almost clear skin). Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were assessed.

Results: At week 12, IL reductions in moderate participants (EGSS = 3; n = 1557) were significantly greater with CAB vs vehicle, dyads, and branded ADAP/BPO (77.1% vs 54.1%, 64.4-69.4%, and 72.8%, respectively; P < 0.05, all). IL reductions in severe participants (EGSS = 4; n = 230) were significantly greater with CAB vs vehicle, ADAP/BPO, and CLIN/BPO (74.5% vs 44.4%, 63.9%, and 61.3%; P < 0.05, all), and similar to CLIN/ADAP and branded ADAP/BPO (73.7%/75.4%). IL reductions were greater than NIL. Moderate participants achieved greater treatment success rates with CAB vs vehicle, dyads, or branded ADAP/BPO (53.9% vs 19.5%, 31.5-35.3%, and 38.1%; P ≤ 0.001, all); only CAB- and CLIN/ADAP-treated severe participants had significantly greater rates vs vehicle (30.9% and 34.0% vs 9.0%; P < 0.05). Most TEAEs were of mild to moderate severity. All mean cutaneous safety/tolerability scores were ≤ 1 (1 = mild).

Conclusions: CAB demonstrated superior efficacy to three dyads and branded ADAP 0.3%/BPO 2.5% in moderate acne participants, and generally numerically greater efficacy in severe acne participants. To our knowledge, these analyses include data from the only double-blind, vehicle-controlled, head-to-head study.

Trial registration: ClinicalTrials.gov identifier NCT03170388, NCT04892706, NCT04214639, and NCT04214652.

查看原文本刊更多论文

克林霉素磷酸1.2%/阿达帕林0.15%/过氧化苯甲酰3.1%凝胶的疗效和安全性：基线疾病严重程度的事后分析

克林霉素磷酸（CLIN） 1.2%/阿达帕烯（ADAP） 0.15%/过氧化苯甲酰（BPO） 3.1%凝胶（CAB）是唯一被批准用于治疗痤疮的三联用药。这些事后分析评估了CAB凝胶在按基线痤疮严重程度分层的参与者中与成分双组和品牌ADAP 0.3%/BPO 2.5%凝胶相比的疗效和安全性。方法：数据来自两项为期12周的2期和3期研究。参与者被随机分配到每天一次的CAB或车辆；一项2期研究包括CAB活性成分的双组合（ADAP/BPO、clini /BPO和clini /ADAP），另一项研究包括与品牌ADAP 0.3%/BPO 2.5%的正面比较。评估包括炎性/非炎性病变（IL/NIL）与基线相比的百分比变化和治疗成功率（评估者的整体严重程度评分[EGSS]与皮肤清洁/几乎清洁比基线降低≥2级）。评估了治疗出现的不良事件（teae）和皮肤安全性/耐受性。结果：在第12周，中度参与者IL减少(EGSS = 3；n = 1557)， CAB与车辆、双牌和品牌ADAP/BPO的差异显著(分别为77.1%比54.1%、64.4-69.4%和72.8%；结论：CAB在中度痤疮患者中对三组患者和品牌ADAP （0.3%/BPO 2.5%）表现出卓越的疗效，在重度痤疮患者中通常表现出更高的疗效。据我们所知，这些分析包括了唯一一项双盲、车辆对照、面对面研究的数据。试验注册：ClinicalTrials.gov识别码NCT03170388、NCT04892706、NCT04214639和NCT04214652。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.