Official Title: “Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Compared to Clindamycin 0.1% / Benzoyl Peroxide 5% Gel in the Treatment of Acne Vulgaris”

The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: Adapalene BPO

Primary Measures

• Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.

Secondary Measures

• Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit
• Global severity assessment at each post Baseline visit

• Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/exclusion criteria.

Main inclusion criteria:

• 1. Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris, 2. Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, 3. Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose.

Main exclusion criteria:

• 1. Subjects with acne cystic lesions, 2. Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Galderma

Overall Clinical Trial Officials and Contacts

Elisabeth ARTHUR, MD Principal Investigator Helendale Dermatology - Rochester NY - 585-266-5420  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00441415

Study ID Number: RD.03.SPR.29058

ClinicalTrials.gov Identifier: NCT00441415

Health Authority: United States: Food and Drug Administration