Effect of Samples on Acne Treatment With Epiduo® Gel

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare adherence to treatment and efficacy with Epiduo® Gel in patients with mild to moderate acne who receive a medication sample and instructions on proper application with their stock size medication tube versus patients who receive only the stock size medication tube.

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

Details

• Lead Sponsor: Wake Forest University
• Collaborator: Galderma Laboratories, L.P.
• Treatments: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide

Criteria

Inclusion Criteria:

• Male or female subject with mild to moderate acne, aged 12 and older, who agrees to participate and provides written consent.

• Have an Acne Global Assessment (AGA) of mild to moderate acne (an AGA score of 2 or 3)

Exclusion Criteria:

• Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.

• Subjects with known allergy or sensitivity to Epiduo® Gel (or Benzoyl Peroxide Gel) or components therein, including adapalene or benzoyl peroxide

• Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, intrauterine device (IUD), Depo-Provera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.