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

Phase 4

Completed

Interventions: Drug: Adapalene/BPO Gel
Other: Moisturizer SPF 30
Other: Foam Wash

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Adapalene/BPO Gel/Foam Wash/Moisturizer	Adapalene/BPO Gel	Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel/Foam Wash/Moisturizer	Moisturizer SPF 30	Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel/Foam Wash/Moisturizer	Foam Wash	Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

Primary Outcome Measures

Name	Time	Method
Total Lesion Count	Baseline, 2, 4, and 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Non-inflammatory Lesions	Baseline, 2, 4, and 8 weeks	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
Inflammatory Lesions	Baseline, 2, 4, and 8 weeks	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.
Subject Questionnaire	Baseline, 2, 4, and 8 weeks	Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.

Locations (5): 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
Study Protocol, Inc.
🇺🇸Boynton Beach, Florida, United States