Effect of Samples on Acne Treatment With Epiduo® Gel



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:9/14/2018
Start Date:December 2011
End Date:November 2012

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Effect of Sample Medication Use and Application Instructions on Adherence to and Efficacy of Treatment of Patients With Mild to Moderate Acne With Epiduo(R) Gel

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.

Adapalene Topical Gel is a Vitamin A type product in a water-based gel that is applied to the
skin. It is approved by the United States Food and Drug Administration (FDA) for the
treatment of acne. Benzoyl Peroxide is a medication applied to the skin that is also approved
by the FDA for the treatment of acne and has anti-bacterial properties.

The purpose of this study is to evaluate the safety and effectiveness of a drug called
Epiduo® Gel 0.1%/2.5% for the treatment of acne vulgaris.Epiduo® is a combination of
adapalene and benzoyl peroxide. This combination drug is approved by the FDA for sale in the
United States for use in individuals with acne who are over the age of 12.

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.
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
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