NCT00883233

Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris

Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	Adapalene BPO Gel standard daily overnight application	Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
DRUG	Adapalene-BPO 3-hour daily application before bedtime	Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
DRUG	Adapalene-BPO Gel every other day application	Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
DRUG	Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion	Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-04-17
• Last updated: 2021-02-18
• Results posted: 2010-12-08

Locations

2 sites across 1 country: Canada