Status:
COMPLETED
Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Lead Sponsor:
Galderma R&D
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-35 years
Phase:
PHASE3
Brief 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 vulg...
Eligibility Criteria
Inclusion
- 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:
- Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris,
- Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,
- 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:
- Subjects with acne cystic lesions,
- Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT00441415
Start Date
February 1 2007
End Date
October 1 2007
Last Update
February 17 2021
Active Locations (4)
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1
Paul YAMAUCHI
Santa Monica, California, United States, 90404
2
Steven E. KEMPERS
Fridley, Minnesota, United States, 55432
3
Dr Alicia BUCKO
Albuquerque, New Mexico, United States, 87106
4
Elisabeth ARTHUR
Rochester, New York, United States, 14609