Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
Information source: Galderma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Adapalene/Benzoyl Peroxide (Drug)
Phase: Phase 3
Sponsored by: Galderma
Official(s) and/or principal investigator(s):
Michael Graeber, MD, Study Director, Affiliation: Galderma
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
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Success rate on the Investigator's Global Assessment
Change in inflammatory lesion counts
Change in noninflammatory lesion counts
Percent change in lesion counts (inflammatory, noninflammatory, total)
Change in Investigator's Global Assessment (IGA)
Subject's assessment of acne
Minimum age: 12 Years.
Maximum age: N/A.
- A clinical diagnosis of acne vulgaris with facial involvement.
- A minimum of 20 but not more than 50 inflammatory lesions
- A minimum of 30 but not more than 100 noninflammatory lesions
- A score of 3 (Moderate) on the Investigator's Global Assessment Scale
Locations and Contacts
Miller MD, San Antonio, Texas 78229, United States
Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. Review.
Starting date: June 2006
Ending date: July 2007
Last updated: September 10, 2007