Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide

Criteria

Inclusion Criteria:

• subject has a clinical diagnosis of acne vulgaris with facial involvement

• the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face

Exclusion Criteria:

• subject has a severe acne form or secondary acne form

• the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face

• the subject has a known allergy or sensitivity to any of the components of the study products

• subject is not willing to respect wash-out periods for topical and/or systemic treatments