12-Week Phase 4 Study of CABTREO Topical Gel for Children Ages 9 to 11 with Moderate to Severe Acne Vulgaris

What this Trial Is About

Researchers are evaluating the safety, how the body absorbs and processes, and the treatment effects of CABTREO lotion when applied to the skin in children aged 9 to 11 years, 11 months who have moderate to severe acne vulgaris. The study is open-label and phase 4, focusing on pediatric participants with specific acne severity and lesion counts on the face and at least one trunk area. The purpose is to understand how well CABTREO works and how safe it is in this age group. Participants will apply CABTREO, a combination gel containing clindamycin phosphate 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15%, to affected areas once each morning for 12 weeks. On study visit days, participants will apply the gel at the study center after assessments. The study includes a main group and a smaller pharmacokinetics PK sub-study group to examine drug levels in the blood. The treatment is a topical gel gently rubbed into the skin. Participants will first complete a screening period of up to 5 weeks to confirm eligibility. During the 12-week treatment, they will attend visits at baseline and Days 14, 15 PK sub-study only, 28, 29 PK sub-study only, 56, and 84. Researchers will monitor safety by tracking any adverse events and measure changes in inflammatory and non-inflammatory acne lesions, as well as global acne severity scores. Participants must follow study instructions and attend visits with their parent or guardian if under age of consent.

Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo