A 12-Week, Phase 4, Open-Label Study To Assess Safety, Pharmacokinetics, and Treatment Effect of CABTREO (Clindamycin Phosphate 1.2%, Adapalene 0.15%, and Benzoyl Peroxide 3.1%) Topical Gel In Pediatric Participants Ages 9 to 11 Years, 11 Month With Acne Vulgaris
Bausch Health Americas, Inc.
Summary
This study is to evaluate the safety, pharmacokinetics, and treatment effect for topically applied CABTREO lotion in pediatric participants ages 9 to 11 years, 11 months with Acne Vulgaris.
Description
This is an open-label study designed to assess the safety, plasma PK, and treatment effect of topically applied CABTREO. This study includes both a main study and a PK sub-study. All participants will undergo a screening period of up to 5 weeks (up to 35 days) and a treatment period of up to 12 weeks (approximately 84 days). A subset of participants in the main study will be included in the PK sub-study. To be eligible for this study, participants must be between 9 years and 11 years, 11 months of age, inclusive, and have a clinical diagnosis of moderate to severe acne, defined as a score of 3…