Official Title: “A Comparison of Differin® Gel, 0.1% vs. Tazorac® Cream, 0.1% vs. Differin® Gel, 0.1% 6-Week Treatment Switched to Tazorac® Cream, 0.1% 6-Week Treatment in Patients With Acne Vulgaris”

To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2006

Same as above.

Intervention(s) in this Clinical Trial

• Drug: Adapalene Gel, 0.1%
  • Apply once daily in the evening for 12 weeks
• Drug: Tazarotene Cream, 0.1%
  • Apply once daily in the evening for 12 weeks
• Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%
  • Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Differin® Gel, 0.1% for 12 weeks
• Active Comparator: 2
  • Tazorac® Cream, 0.1% for 12 weeks
• Active Comparator: 3
  • Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks

Primary Measures

• Efficacy - total lesion counts
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Safety - tolerability assessments and adverse event reporting
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face
• Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

• Subjects with more than 3 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

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

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00469755

Study ID Number: US10026

ClinicalTrials.gov Identifier: NCT00469755

Health Authority: United States: Institutional Review Board