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

Condition(s) targeted: Acne Vulgaris

Intervention: Adapalene/Benzoyl Peroxide (Drug)

Phase: Phase 3

Status: Completed

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 weeks.

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

Primary outcome:

Success rate on the Investigator's Global Assessment

Change in inflammatory lesion counts

Change in noninflammatory lesion counts

Secondary outcome:

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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Miller MD, San Antonio, Texas 78229, United States

Related publications:

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