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NCT00441415 Clinical Trial

Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00441415
Other study ID # RD.03.SPR.29058
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2007
Est. completion date October 2007

Study information
Verified date August 2008
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 272
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender All
Age group 12 Years to 35 Years
Eligibility 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.).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Adapalene BPO

Locations
Country Name City State
United States Dr Alicia BUCKO Albuquerque New Mexico
United States Steven E. KEMPERS Fridley Minnesota
United States Elisabeth ARTHUR Rochester New York
United States Paul YAMAUCHI Santa Monica California

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.
Secondary Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit
Secondary Global severity assessment at each post Baseline visit
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