A Long-Term Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
|ClinicalTrials.gov Identifier: NCT00446043|
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : March 12, 2007
This is a multi-centre, open-label, non-comparative study to evaluate the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.
Subjects are evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.
Safety is evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (haematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy is evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject’s Assessment of Acne.
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Adapalene/Benzoyl Peroxide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||452 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Long-Term Safety and Efficacy Study of a Fixed Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% (Adapalene and Benzoyl Peroxide Topical Gel) Gel in Subjects With Acne Vulgaris|
|Study Start Date :||February 2004|
|Estimated Study Completion Date :||May 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446043
|United States, Oregon|
|Phoebe Rich, MD|
|Portland, Oregon, United States, 97210|
|Study Director:||Michael Graeber, MD||Galderma|