Clinical End Point Study of Generic Adapalene and Benzoyl Peroxide Gel Versus Epiduo® Forte Gel in Treatment of Acne Vulgaris

Summary

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of adapalene and benzoyl peroxide gel, 0.3%/2.5% (Actavis Laboratories UT, Inc.) to Epiduo® Forte (adapalene and benzoyl peroxide) gel 0.3%/2.5% (Galderma) in the treatment of Acne Vulgaris

Timeline

Start

2015-11

Primary completion

2016-04

Completion

2016-10

Outcome

Met primary endpoint

registry analysis (equivalence test); Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w vs Epiduo® Forte Gel 0.3%/2.5% w/w; Bioavailability 100.28 (90% CI 96.78 to 103.91) NCT02651220 ↗

registry analysis (equivalence test); Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w vs Epiduo® Forte Gel 0.3%/2.5% w/w; Bioavailability 99.73 (90% CI 96.04 to 103.56) NCT02651220 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adapalene	Other / unclassified	0.3 %	Topical
Subject	Benzoyl Peroxide	Other / unclassified	2.5 %	Topical

Indications