NCT02411942

Study Comparing Adapalene Gel 0.3% to Differin® and Both to a Placebo Control in Treatment of Acne Vulgaris

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Adapalene Gel 0.3% to Differin® (Adapalene Gel 0.3%) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 753 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%).

Detailed description

The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene Gel 0.3%	Adapalene Gel 0.3% applied to the entire face once daily for 84 consecutive days
DRUG	Differin®	Differin® applied to the entire face once daily for 84 consecutive days
DRUG	Placebo	Placebo (vehicle of the test product) applied to the entire face once daily for 84 consecutive days

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2015-04-08
• Last updated: 2017-05-04