The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2007

Intervention(s) in this Clinical Trial

• Drug: IDP-110
  • Topical application for 12 weeks
• Drug: Clindamycin
  • Topical application for 12 weeks
• Drug: Benzoyl peroxide
  • Topical application for 12 weeks
• Drug: Vehicle
  • Topical application for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2
• Active Comparator: 3
• Placebo Comparator: 4

Primary Measures

• Change from baseline in number of lesions
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Change from baseline in global severity
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria:

• Dermatological conditions of the face other than acne that could interfere with clinical evaluations
• Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dow Pharmaceutical Sciences

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00664248

Study ID Number: DPSI-06-22-2006-012

ClinicalTrials.gov Identifier: NCT00664248

Health Authority: United States: Food and Drug Administration