Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: Phase 2 Study of the First Triple-Combination Drug

James Del Rosso,Linda Stein Gold,David Pariser,Edward Lain,Jonathan Weiss,Hilary Baldwin,; Radhakrishnan Pillai,Leon Kircik,Kenneth Beer,Emil Tanghetti,Michael Gold,Valerie Callender,Varsha Bhatt,Neil Sadick,Zoe Draelos

doi:10.25251/skin.6.supp.17

Abstract

N/A

Highlights

The pathogenesis of acne is multifactorial, involving follicular proliferation of Cutibacterium acnes, increased sebum production and inflammation, and abnormal keratinization1,2
Combining three acne treatments in a once-daily topical polymeric dispersion formulation may provide greater efficacy and tolerability than single or dyad treatments. This is the first study of clindamycin phosphate 1.2%/ benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) gel, which once approved will be the first triple-combination, fixed-dose topical acne treatment
Treatment-emergent adverse events (TEAEs) rates were higher with IDP-126 and BPO/adapalene vs clindamycin/BPO, clindamycin/adapalene, or vehicle at week 12 (Table 2)

Summary

Introduction

The pathogenesis of acne is multifactorial, involving follicular proliferation of Cutibacterium acnes, increased sebum production and inflammation, and abnormal keratinization. There are numerous prescription oral and topical treatments for acne such as benzoyl peroxide (BPO), retinoids, antibiotics, and hormonal therapies[2]. Combining three acne treatments (an antibiotic, antibacterial, and retinoid) in a once-daily topical polymeric dispersion formulation may provide greater efficacy and tolerability than single or dyad treatments. This is the first study of clindamycin phosphate 1.2%/ BPO 3.1%/adapalene 0.15% (IDP-126) gel, which once approved will be the first triple-combination, fixed-dose topical acne treatment

Methods

Results

Conclusion