Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2009

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

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
• Placebo Comparator: 2
  • Vehicle Gel

Primary Measures

• Maintenance rate for total lesions at Week 24 : defined as the percentage of subjects maintaining at least 50% of the improvement obtained with prior combination therapy, in terms of total lesion counts.
  • Time Frame: Week 24
    Safety Issue?: No

Secondary Measures

• Maintenance rate for total lesions: at each intermediate visits, Maintenance rate for inflammatory lesions: at each post Baseline visit, Maintenance rate for non-inflammatory lesions: at each post Baseline visit
  • Time Frame: Weeks 4, 8, 12, 16, 20 and 24
    Safety Issue?: No
• Incidence of Adverse Events, Local tolerance Worst-score post Baseline, Postinflammatory Hyperpigmentation Worst-score post Baseline.
  • Time Frame: All along the study
    Safety Issue?: Yes

Inclusion Criteria:

• Subjects who completed the previous study (RD.03.SPR29074)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3)

Exclusion Criteria:

• Female Subjects who are pregnant, nursing or planning a pregnancy during the study
• Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Galderma

Overall Clinical Trial Officials and Contacts

Diane Thiboutot, MD Principal Investigator Penn State College of Medicine, Hershey, PA  

Overall Contact: Jean-Charles Dhuin, BSc 33-4-9295-2921 jean-charles.dhuin@galderma.com

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00687908

Study ID Number: RD.03.SPR.29075

ClinicalTrials.gov Identifier: NCT00687908

Health Authority: United States: Food and Drug Administration