100 Participants NeededMy employer runs this trial

CABTREO for Acne

Recruiting at 14 trial locations
EN
EN
Overseen ByEmily N Hughes, MACPR
Age: < 18
Sex: Any
Trial Phase: Phase 4
Sponsor: Bausch Health Americas, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for boys and girls ages 9 to just under 12 who have moderate to severe acne on their face and at least one area of the chest, back, or shoulders. Participants need a certain number of acne spots and must agree to study rules about consent and contraception if applicable.

Inclusion Criteria

I am between 9 and 11 years old.
I am willing to use effective birth control during the study.
3. Participants must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at baseline
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • CABTREO

Trial Overview

The study tests CABTREO lotion, which combines three medicines (clindamycin phosphate, benzoyl peroxide, adapalene), applied to the skin. The goal is to see how safe it is, how it's absorbed by the body, and how well it treats acne in kids aged 9–11.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: All enrolled participants will receive CABTREO in this open-label study.Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bausch Health Americas, Inc.

Lead Sponsor

Trials
265
Recruited
82,000+
Dr. Jonathan Sadeh profile image

Dr. Jonathan Sadeh

Bausch Health Americas, Inc.

Chief Medical Officer

MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School

Thomas J. Appio profile image

Thomas J. Appio

Bausch Health Americas, Inc.

Chief Executive Officer since 2021

Bachelor's degree in Biology from Rutgers University

MedTrials Incorporated

Collaborator

Trials
1
Recruited
530+