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

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-27
• Study First Submitted QC: 2007-02-27
• Study First Posted: 2007-02-28
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-08
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17

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

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

Secondary Outcome Measures

Name	Time	Method
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