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 |
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.
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.
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