NCT00687908

Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance

Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel as a 6-month Acne Maintenance Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 243 (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 demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.

Detailed description

This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel	Topical Gel to the face, once daily in the evening for 24 weeks.
DRUG	Vehicle Gel	Topical Gel to the face, once daily in the evening for 24 weeks.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-06-02
• Last updated: 2021-02-18
• Results posted: 2010-09-24

Locations

33 sites across 3 countries: United States, Canada, Puerto Rico