Title
Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris
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
Phase
Phase 4Lead Sponsor
GaldermaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
AcneIntervention/Treatment
adapalene benzoyl peroxide ...Study Participants
81This 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.
Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30 (once daily)
Foam Wash (twice daily)
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
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.
| Event Type | Organ System | Event Term | Adapalene/BPO Gel/Foam Wash/Moisturizer |
|---|
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.
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.
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
Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
