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

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.) to Epiduo® (Galderma Laboratories, L.P., Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) and Both Active Treatments to a Placebo in the Treatment of Acne Vulgaris.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2,008 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%	Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days.
DRUG	Epiduo® Gel	Epiduo® (Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) (Galderma Laboratories, L.P.)applied topically once daily for 84 consecutive days.
DRUG	Placebo	Placebo (vehicle of test product) (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days.

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2012-12-05
• Last updated: 2017-05-04