Early Acne Improvements With Fixed-Combination Topical Therapy: Analysis of the First 4 Weeks of Treatment
Main Article Content
Keywords
Acne, Topical Therapy
Abstract
Background: Acne treatment can take weeks to result in noticeable improvements, which may diminish patients’ perception of treatment effectiveness and negatively affect treatment adherence. Acne treatments that deliver early visible improvements may encourage treatment adherence and bolster overall treatment effectiveness. Combination topical treatments that target multiple acne pathophysiological pathways are more efficacious than monotherapies and simplifying the treatment regimen by delivering multiple active ingredients as fixed combinations may improve adherence.
Objective: To evaluate early acne improvements in clinical trials of fixed-combination acne topicals.
Methods: Week 4 efficacy data for fixed-combination topical treatments were gathered from US Food and Drug Administration medical reviews, prescribing information, and/or publications of pivotal phase 2 and phase 3 clinical trials of 7 acne topicals, comprising fixed combinations of adapalene (ADAP), benzoyl peroxide (BPO), clindamycin phosphate (CLIN), and tretinoin. For the triple-combination formulation (CLIN 1.2%/ADAP 0.15%/BPO 3.1% gel), data from a nonpivotal phase 2 study with dyad combination treatment arms were also included. Outcomes included reductions from baseline in inflammatory lesions (ILs) and noninflammatory lesions (NILs) and treatment success (≥2-grade reduction in global acne severity score and clear/almost clear skin).
Results: At week 4, IL reductions from baseline ranged from 32-54% while NIL reductions ranged from 25-45%. Rates of treatment success ranged from 3-12%. Overall, efficacy was greatest with triple-combination CLIN 1.2%/ADAP 0.15%/BPO 3.1% gel (IL: 54-55%; NIL: 43-45%; treatment success: 8-12%), followed by combinations of ADAP/BPO (IL: ~42-48%; NIL: ~38%; treatment success: 4-~7%). None of the branded topical products were evaluated in a head-to-head study.
Conclusions: In pivotal clinical trials of topical fixed-combination formulations for acne, triple-combination CLIN 1.2%/ADAP 0.15%/BPO 3.1% gel yielded greater lesion reductions and rates of treatment success after 4 weeks of treatment than dyad formulations. Even greater differences may be expected with real-world world use, as early improvements may foster better long-term outcomes by increasing patients’ confidence in and adherence to the treatment.
Funding: Ortho Dermatologics
References
2.Yentzer BA, et al. Cutis. 2010;86:103-108.
3.Tan J, et al. J Drugs Dermatol. 2017;16:97-102.
4.Huang CY, et al. Ann Fam Med. 2023;21:358-369.
5.Feldman SR, et al. J Drugs Dermatol. 2024;23:42-49.
6.Kircik LH, et al. Dermatol Ther (Heidelb). 2024;14:1211-1227.
7.Stein Gold L, et al. Am J Clin Dermatol. 2022;23:93-104.
8.Stein Gold L, et al. Am J Clin Dermatol. 2016;17:293-303.
9.Stein Gold L, et al. Cutis. 2009;84:110-116.
10.Thiboutot DM, et al. J Am Acad Dermatol. 2007;57:791-799.
11.Thiboutot D, et al. J Am Acad Dermatol. 2008;59:792-800.
12.Pariser DM, et al. J Drugs Dermatol. 2014;13:1083-1089.
13.Leyden JJ, et al. Am J Clin Dermatol. 2001;2:33-39.
14.Del Rosso J, et al. J Am Acad Dermatol. 2023;89:719-727.
15.DUAC [package insert]. Research Triangle Park, NC: Stiefel; 2015.
16.Center for Drug Evaluation and Research (CDER). Medical review of NDA 050803Orig1s000. Silver Spring, MD, USA: United States Food and Drug Administration; 2010.
17.ZIANA [package insert]. Scottsdale, AZ: Medicis; 2006.
18.Center for Drug Evaluation and Research (CDER). Medical review of NDA 50-802. Silver Spring, MD, USA: United States Food and Drug Administration; 2006.
19.Benzamycin [package insert]. Berwin, PA, USA: Aventis Pharmaceuticals, Inc.; 2003.
20.Aktipak [package insert]. Wayne, PA, USA: Demarc, LLC, a subsidiary of Cutanea Life Sciences, Inc.; 2018.
21.Center for Drug Evaluation and Research (CDER). Medical review of NDA 50-769. Silver Spring, MD, USA: United States Food and Drug Administration; 2000.
22.Ortho Dermatologics. [Data on file].
23.Tschen EH, et al. Cutis. 2001;67:165-169
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution 4.0 International License.
Creative Commons Attribution (CC BY): lets others distribute and copy the article, to create extracts, abstracts, and other revised versions, adaptations or derivative works of or from an article (such as a translation), to include in a collective work (such as an anthology), to text or data mine the article, even for commercial purposes, as long as they credit the author(s), do not represent the author as endorsing their adaptation of the article, and do not modify the article in such a way as to damage the author's honor or reputation.
Authors retain copyright in their work and license the publisher to publish the content. The publisher is the National Society for Cutaneous Medicine, with production and publishing support provided by OJS, Open Journal Systems,see https://pkp.sfu.
Prior to January 2022, authors transferred copyright to the National Society for Cutaneous Medicine. However, all articles are freely available to anyone in the world. There are no subscription fees, page charges, or article processing charges.