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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.
Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Adherence to Study Medication
Adherence will be reported as percentage of prescribed doses taken as measured electronically by a Medication Event Monitoring System (MEMS®) cap.
Time frame: Baseline to 6 weeks
Change in Acne Global Assessment
Change in the physician's global assessment of acne severity on a validated 0-5 scale (0=clear to 5=very severe) from baseline to Week 6 visit.
Time frame: Baseline and 6 weeks
Change in Acne Lesion Count
Change in total count of acne lesions from baseline visit to Week 6 visit
Time frame: Baseline and 6 weeks
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