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 (ACCESS II)

NCT00687908 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Galderma R&D
Phase	Phase 3
Status	COMPLETED
Enrolment	243
Start date	2008-11
Completion	2009-07

Conditions

• Acne

Interventions

• Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
• Vehicle Gel

Primary outcomes

• Maintenance Success for Total Lesions at Week 24 — Week 24
  Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.

Countries

United States, Canada, Puerto Rico