A Long-term Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-centre, open-label, non-comparative study to evaluate the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.

Subjects are evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.

Safety is evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (haematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy is evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.

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

Details

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

Criteria

Inclusion Criteria:

• A clinical diagnosis of acne vulgaris with facial involvement

• A minimum of 20 but not more than 50 Inflammatory lesions

• A minimum of 30 but not more than 100 Noninflammatory lesions

Exclusion Criteria:

• Subjects with presence of nodules or cysts.

• Acne conglobata, acne fulminans, secondary acne, or severe acne.

• Underlying diseases that require the use of interfering topical or systemic therapy.

• Use of prohibited medications prior to the study unless appropriate washout period is documented