Early Acne Improvements With Fixed-Combination Topical Therapy: Analysis of the First 4 Weeks of Treatment

January 2025 | Volume 24 | Issue 1 | 79 | Copyright © January 2025


Published online December 31, 2024

doi:10.36849/JDD.8712

Steven R. Feldman MD PhDa, Katie Lovell BSa, Robin Yi BSa, Julie Harper MDb, Hilary Baldwin MDc,d, Ted Lain MDe, Linda Stein Gold MDf, Leon Kircik MDg-i, Emil Tanghetti MDj, Eric Guenin PharmD PhD MPHk

aWake Forest University School of Medicine, Winston-Salem, NC
bDermatology & Skin Care Center of Birmingham, Birmingham, AL
cThe Acne Treatment and Research Center, Brooklyn, NY
dRobert Wood Johnson University Hospital, New Brunswick, NJ
eAustin Institute for Clinical Research, Austin, TX
fHenry Ford Hospital, Detroit, MI
gIcahn School of Medicine at Mount Sinai, New York, NY
hIndiana University School of Medicine, Indianapolis, IN
iPhysicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY
jCenter for Dermatology and Laser Surgery, Sacramento, CA
kOrtho Dermatologics*, New Brunswick, NJ
*Ortho Dermatologics is a division of Bausch Health US, LLC

Abstract
Background: Acne treatment can take weeks to deliver noticeable improvements, which may diminish patients' perception of treatment effectiveness and undermine treatment adherence. Combination topical treatments that target multiple acne pathophysiological pathways are more efficacious than topical monotherapies, and simplifying combination treatment by delivering multiple active ingredients as fixed combinations may improve adherence.
Methods: This review provides an overview of efficacy with 4 weeks of treatment in pivotal trials of fixed-combination topical treatments for acne. Outcomes assessed were reductions from baseline in inflammatory (IL) and noninflammatory lesions (NIL) and treatment success (≥2-grade reduction in global acne severity score and clear/almost clear skin).
Results: Data were compiled for 7 acne topicals, comprising fixed combinations of adapalene (ADAP), benzoyl peroxide (BPO), clindamycin phosphate (CLIN), and tretinoin (TRET). At week 4, lesion reductions from baseline ranged from 32 to 54% (IL) and 25 to 45% (NIL), while rates of treatment success ranged from 3 to 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%).
Conclusions: In clinical trials of topical fixed-combination formulations, 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 combinations. Even greater differences may be expected with real-world world use, as early improvements may bolster treatment adherence and long-term outcomes.

J Drugs Dermatol. 2025;24(1):79-87. doi:10.36849/JDD.8712

INTRODUCTION

Acne vulgaris is a chronic inflammatory skin disease affecting approximately 85% of individuals aged 12 to 24 years.1-3 Even mild acne can result in long-lasting dyspigmentation and scarring, which may be more bothersome than the acne itself and have profound impacts on psychosocial functioning and quality of life.4-6 Early and aggressive treatment can be initiated with the twin goals of reducing lesion count and preventing the formation of new lesions in the near term, and mitigating long-term sequelae and associated morbidity.1,7,8

Acne treatment can take many weeks before any improvement is observed, and maximal improvement may take several months. This delay presents a frustrating challenge; prolonged time to visible improvement can diminish patients’ perception of treatment effectiveness and undermine treatment adherence, further impairing treatment efficacy.9-11 Medications that deliver rapid initial improvements may encourage continued use, providing the best opportunity for acne resolution.

Efficacy in acne treatment can be enhanced by combining active ingredients to target multiple pathophysiological mechanisms. Combination therapy is more efficacious than monotherapy12,13 and is recommended by the American Academy of Dermatology (AAD).2 In addition to improving long-term efficacy, combination treatment yields greater lesion
Close Menu