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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
81
Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30 (once daily)
Foam Wash (twice daily)
Study Protocol, Inc.
Boynton Beach, Florida, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Stephens & Associates
Carrollton, Texas, United States
J&S Studies, Inc.
College Station, Texas, United States
The Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Total Lesion Count
The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.
Time frame: Baseline, 2, 4, and 8 weeks
Inflammatory Lesions
The change in inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.
Time frame: Baseline, 2, 4, and 8 weeks
Non-inflammatory Lesions
The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks
Time frame: Baseline, 2, 4, and 8 weeks
Subject Questionnaire
Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Time frame: Baseline, 2, 4, and 8 weeks
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