NCT07524946

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 9 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS). Participants must also have at least 30 facial acne inflammatory lesions, at least 35 facial acne noninflammatory lesions, and no more than 2 facial nodules; participants should also have acne lesions on at least 1 region of the trunk (chest, back, and/or shoulder).

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.	The study drug will be applied topically to the treatment areas at home, each the morning, for a period of 12 weeks, with the exception of study visit days (baseline \[Day 1\], and Days 14, 15 \[PK substudy only\], 28, 29 \[PK substudy only\], 56, and 84) where study drug will be applied by the participants after the study visit is completed at the study center. The study drug will be applied as a thin coating that is gently rubbed into the skin.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Regulatory

• FDA-regulated drug study