Official Title: “A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris”

This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2008

Same as above.

Intervention(s) in this Clinical Trial

• Drug: adapalene gel, 0.3%
  • Applied once daily at bedtime
• Drug: clindamycin/benzoyl peroxide gel
  • Applied once daily in the morning

Primary Measures

• Percent change from baseline in total lesion counts at Week 12
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Percent change from baseline in total lesion counts at Week 6
  • Time Frame: 6 weeks
    Safety Issue?: No
• Percent change from baseline in inflammatory and non-inflammatory lesion counts at Weeks 6 and 12
  • Time Frame: 6 and 12 weeks
    Safety Issue?: No
• Global severity assessment at Weeks 6 and 12
  • Time Frame: 6 and 12 weeks
    Safety Issue?: No
• Global assessment of Improvement from baseline at Week 12
  • Time Frame: 12 weeks
    Safety Issue?: No
• Tolerability assessments and incidence of adverse events
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Subjects with a minimum of 20 inflammatory lesions on the face;
• 2. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
• 3. Subject has a Global Severity Assessment

Exclusion Criteria:

• 1. Subjects with more than three nodulo-cystic lesions

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 Laboratories, L.P.

Overall Clinical Trial Officials and Contacts

Ron W Gottschalk, MD Study Director Galderma Laboratories, L.P.  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00671749

Study ID Number: US10066

ClinicalTrials.gov Identifier: NCT00671749

Health Authority: United States: Institutional Review Board