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  

Information obtained from ClinicalTrials.gov on July 02, 2009

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