drugset / Trial / NCT01742637

Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% to Epiduo® and Both to a Placebo Control in the Treatment of Acne Vulgaris

NCT01742637

Phase 1 Completed 2008 enrolled Sun Pharmaceutical Industries, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to evaluate the therapeutic equivalence and safety of Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel (Taro Pharmaceuticals Inc.) and Epiduo® (Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel) (Galderma Laboratories, L.P.) in the treatment of acne vulgaris, and to demonstrate the superiority of the efficacy of the test and reference products over the vehicle (placebo) control in the treatment of acne vulgaris.

Timeline

Start
2012-10
Primary completion
2014-02
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Adapalene Other / unclassified 0.1 % Topical
Subject Benzoyl Peroxide Other / unclassified 2.5 % Topical

Indications