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

Phase 3
Completed
Conditions
Acne Vulgaris
Registration Number
NCT00441415
Lead Sponsor
Galderma R&D
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 vulgaris after a 12-week treatment period.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
272
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.
Secondary Outcome Measures
NameTimeMethod
Global severity assessment at each post Baseline visit
Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit

Trial Locations

Locations (4)

Paul YAMAUCHI

🇺🇸

Santa Monica, California, United States

Steven E. KEMPERS

🇺🇸

Fridley, Minnesota, United States

Dr Alicia BUCKO

🇺🇸

Albuquerque, New Mexico, United States

Elisabeth ARTHUR

🇺🇸

Rochester, New York, United States

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