Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.

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

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Adapalene; Benzoyl Peroxide; Doxycycline

Criteria

Inclusion Criteria:

• Male or female Subjects of any race, aged 12 to 35 years inclusive

• Subjects with severe facial acne (global severity score of 4)

• Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose

• Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

• Subjects with more than 3 nodules or cysts on the face,

• Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)