NCT00421993

A 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: 1,670 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be 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 subject should remain the same during the study. The primary objective is 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	Topical Gel, One application daily in the evening for 12 weeks
DRUG	Adapalene	Topical Gel,One application daily in the evening for 12 weeks
DRUG	Benzoyl Peroxide	Topical Gel, one application daily in the evening for 12 weeks
DRUG	Topical Gel Vehicle	Topical Gel Vehicle,one application daily in the evening for 12 weeks

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-10-01
• Completion: 2007-12-01
• First posted: 2007-01-15
• Last updated: 2021-02-18
• Results posted: 2009-03-11

Locations

62 sites across 5 countries: United States, Canada, Germany, Hungary, Poland