Efficacy and Safety Study of GK530G Versus CD0271 0.1% Gel and CD1579 2.5% Gel in the Treatment of Acne Vulgaris.

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to demonstrate the superiority in efficacy of the GK530G (fixed combination of CD0271 0.1% and CD1579 2.5%) versus each of the monads (CD0271 0.1% and CD1579 2.5%) in the treatment of acne vulgaris for up to 12 weeks, in the Japanese patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Men and women at the age of 12 or older at the Screening visit.

• Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion Criteria:

• Those with more than two nodular acne lesions or any cysts.

• Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.

• Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment.