Phase 4
Completed N=81
Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris
Source: ClinicalTrials.gov NCT01951417 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Total Lesion Count — 76.7; 53.9; 50.0; 43.7 lesions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Lesion Count |
76.7; 53.9; 50.0; 43.7 | — |
| SECONDARY Inflammatory Lesions |
27.3; 17.4; 15.7; 14.4 | — |
| SECONDARY Non-inflammatory Lesions |
49.4; 36.4; 34.1; 29.2 | — |
| SECONDARY Subject Questionnaire |
23; 42; 5; 3; 1; 3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01951417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.