Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris
Completed · Phase 4
Conditions studied: Acne
In brief
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.
Key facts
- Study ID
- NCT01951417
- Run by
- Galderma R&D
- People needed
- 81
- Starts
- 2013-10-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2022-08-23
Who can join
Age: 9 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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