A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Galderma Galderma R&D
Treatments:
Adapalene Adapalene, Benzoyl Peroxide Drug Combination Benzoyl Peroxide