Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:9 - Any
Updated:4/21/2016
Start Date:October 2013
End Date:March 2014

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Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Pump Cetaphil® DermaControl™ Moisturizer SPF 30, and Cetaphil® DermaControl™ Foaming Wash Regimen in Patients With Mild to Moderate Acne Vulgaris

This is an open-label, multi-center study to be conducted in the United States. The study
will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in
conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30
(once daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible
for treatment with Epiduo® in accordance with the currently approved product labeling and
who meet other inclusion/exclusion criteria are to be enrolled in the study and receive the
study products for 8 weeks. Efficacy and safety assessments include: complete lesion counts,
cutaneous irritation assessment, end of study treatment questionnaire, photographic
evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function
assessment, treatment compliance, and adverse event assessment.


Inclusion Criteria:

- Men and women of any race, 9 years or older, with a diagnosis of mild to moderate acne,
who are eligible for treatment with adapalene BPO gel in accordance with the currently
approved product labeling.

Exclusion Criteria:

- Subjects with nodules and cysts, pregnant or breastfeeding, with any systemic or
dermatological disorder, or topical condition or facial hair that could interfere with
evaluations.
We found this trial at
5
sites
Boynton Beach, Florida 33437
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Boynton Beach, FL
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Carrolton, Texas 75006
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Carrolton, TX
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College Station, Texas 77845
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College Station, TX
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Nashville, Tennessee 37215
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Nashville, TN
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San Antoinio, TX
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