Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Participants With Moderate-to-Severe Acne: The Patient Journey.

IF 1.5 4区 医学 Q3 DERMATOLOGY
Hilary Baldwin, Julie C Harper, Joshua A Zeichner, Zoe D Draelos, Lawrence F Eichenfield, Michael Gold, Linda Stein Gold, Leon H Kircik
{"title":"Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Participants With Moderate-to-Severe Acne: The Patient Journey.","authors":"Hilary Baldwin, Julie C Harper, Joshua A Zeichner, Zoe D Draelos, Lawrence F Eichenfield, Michael Gold, Linda Stein Gold, Leon H Kircik","doi":"10.36849/JDD.8639","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for acne treatment. In 3 clinical studies of participants with moderate-to-severe acne, CAB demonstrated superior efficacy to vehicle and component dyads, with good safety and tolerability. Detailed efficacy/safety data from individual clinical study participants are presented.</p><p><strong>Methods: </strong>In two phase 3 (NCT04214652, NCT04214639) randomized, double-blind, 12-week studies, participants aged at least 9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Descriptive data - including lesion count changes, treatment success (at least 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin), compliance, treatment-emergent adverse events (AEs), and cutaneous safety/tolerance assessments - were summarized from 6 CAB-treated cases.</p><p><strong>Results: </strong>By week 12, all cases achieved &gt;70% lesion reductions, 4/6 achieved treatment success, and 1/6 achieved a 2-grade reduction in severity. All cases were compliant with CAB treatment. No cases reported serious AEs. Transient increases occurred on cutaneous safety and tolerability assessments, with scores generally decreasing back to/below baseline levels by week 12.</p><p><strong>Conclusions: </strong>In two phase 3 clinical trials, fixed-dose, triple-combination CAB demonstrated good efficacy/safety. All 6 CAB-treated cases achieved substantial (&gt;70%) lesion reductions, with 5/6 achieving treatment success or 2-grade reduction in severity by week 12. Transient cutaneous safety/tolerability severity increases generally resolved to baseline values by week 12. These clinical study cases reinforce the importance of patient education regarding adherence, expectations, and AEs. J Drugs Dermatol. 2024;23(11):1017-1024. doi:10.36849/JDD.8639.</p>","PeriodicalId":15566,"journal":{"name":"Journal of Drugs in Dermatology","volume":"23 11","pages":"1017-1024"},"PeriodicalIF":1.5000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Drugs in Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.36849/JDD.8639","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Introduction: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for acne treatment. In 3 clinical studies of participants with moderate-to-severe acne, CAB demonstrated superior efficacy to vehicle and component dyads, with good safety and tolerability. Detailed efficacy/safety data from individual clinical study participants are presented.

Methods: In two phase 3 (NCT04214652, NCT04214639) randomized, double-blind, 12-week studies, participants aged at least 9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Descriptive data - including lesion count changes, treatment success (at least 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin), compliance, treatment-emergent adverse events (AEs), and cutaneous safety/tolerance assessments - were summarized from 6 CAB-treated cases.

Results: By week 12, all cases achieved >70% lesion reductions, 4/6 achieved treatment success, and 1/6 achieved a 2-grade reduction in severity. All cases were compliant with CAB treatment. No cases reported serious AEs. Transient increases occurred on cutaneous safety and tolerability assessments, with scores generally decreasing back to/below baseline levels by week 12.

Conclusions: In two phase 3 clinical trials, fixed-dose, triple-combination CAB demonstrated good efficacy/safety. All 6 CAB-treated cases achieved substantial (>70%) lesion reductions, with 5/6 achieving treatment success or 2-grade reduction in severity by week 12. Transient cutaneous safety/tolerability severity increases generally resolved to baseline values by week 12. These clinical study cases reinforce the importance of patient education regarding adherence, expectations, and AEs. J Drugs Dermatol. 2024;23(11):1017-1024. doi:10.36849/JDD.8639.

克林霉素磷酸酯 1.2%/阿达帕林 0.15%/过氧化苯甲酰 3.1%凝胶在中重度痤疮患者中的应用:患者之旅。
简介局部使用克林霉素磷酸酯 1.2%/阿达帕林 0.15%/过氧化苯甲酰 3.1%(CAB)凝胶是唯一获准用于痤疮治疗的固定剂量三合一配方。在对中度至重度痤疮患者进行的 3 项临床研究中,CAB 的疗效优于载体和双组分,同时具有良好的安全性和耐受性。本文介绍了个别临床研究参与者的详细疗效/安全性数据:在两项为期12周的3期(NCT04214652、NCT04214639)随机双盲研究中,年龄至少9岁的中度至重度痤疮患者被随机分配使用每日一次的CAB或载体凝胶。研究总结了6例CAB治疗病例的描述性数据,包括皮损数量变化、治疗成功率(评价者总体严重程度评分和透明/几乎透明皮肤比基线至少降低2级)、依从性、治疗突发不良事件(AEs)和皮肤安全性/耐受性评估:结果:截至第 12 周,所有病例的皮损均减少了 70%,4/6 的病例治疗成功,1/6 的病例严重程度降低了 2 个等级。所有病例都坚持接受 CAB 治疗。无严重不良反应报告。在皮肤安全性和耐受性评估中,评分出现短暂上升,到第12周时,评分普遍降至/低于基线水平:在两项 3 期临床试验中,固定剂量、三联 CAB 显示出良好的疗效/安全性。所有 6 例 CAB 治疗病例的皮损均大幅减少(70%),其中 5/6 在第 12 周前达到治疗成功或严重程度降低 2 级。一过性皮肤安全性/耐受性严重程度的增加一般在第 12 周前恢复到基线值。这些临床研究病例强化了对患者进行依从性、期望值和不良反应教育的重要性。J Drugs Dermatol.2024;23(11):1017-1024. doi:10.36849/JDD.8639.
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
CiteScore
2.20
自引率
13.30%
发文量
289
审稿时长
3-6 weeks
期刊介绍: The Journal of Drugs in Dermatology (JDD) is a peer-reviewed publication indexed with MEDLINE®/PubMed® that was founded by the renowned Dr. Perry Robins MD. Founded in 2002, it offers one of the fastest routes to disseminate dermatologic information and is considered the fastest growing publication in dermatology. We present original articles, award-winning case reports, and timely features pertaining to new methods, techniques, drug therapy, and devices in dermatology that provide readers with peer reviewed content of the utmost quality. Our high standards of content are maintained through a balanced, peer-review process. Articles are reviewed by an International Editorial Board of over 160 renowned experts.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信