NCT00422240

Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,668 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a participant should remain the same during the study. The primary objective was to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene/Benzoyl Peroxide	Adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
DRUG	Adapalene Gel, 0.1%	0.1% of adapalene gel topically daily in the evening for 12 Weeks.
DRUG	Benzoyl Peroxide Gel 2.5%	2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
DRUG	Gel Vehicle	Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Timeline

• Start date: 2006-06-27
• Primary completion: 2007-07-12
• Completion: 2007-07-12
• First posted: 2007-01-15
• Last updated: 2024-04-15
• Results posted: 2024-04-15

Locations

1 site across 1 country: United States