Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma Laboratories, L.P.
• Treatments: Adapalene; Benzoyl Peroxide

Criteria

Inclusion Criteria:

• Male or female subjects, aged 16 to 25 years inclusive;

• Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3;

• A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose);

• Subjects who agree to be photographed at each visit;

• Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study

Exclusion Criteria:

• Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;

• Subjects with a wash-out period for topical acne treatment on the face less than 30 days

• Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months;

• Subjects who are currently being treated with antibiotics;

• Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, etc.);

• Subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials