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Study of CABTREO for Acne Vulgaris in Children

This study is looking at how safe and effective a topical lotion called CABTREO (a combination of clindamycin phosphate, BPO, and adapalene) is for children aged 9 to 11 years, 11 months who have acne vulgaris (common acne). Researchers will also study how the body processes CABTREO. The study aims to see if CABTREO reduces inflammatory and non-inflammatory acne lesions and to track any side effects. To join, you must be between 9 and 11 years, 11 months old and have moderate to severe acne on your face and body. The study is currently unclear on its recruitment status and plans to enroll 100 participants.

Study design
This is an open-label study, meaning both you and the study team will know you are receiving CABTREO. It will involve approximately 100 participants.
What's involved
You would apply CABTREO lotion to your skin each morning for 12 weeks. There will be study visits at baseline, and on Days 14, 28, 56, and 84, with additional visits for a subset of participants on Days 15 and 29.
Compensation
Not stated in the trial record.
Follow-up
All side effects will be tracked from when they start until the end of the 12-week study visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07524946

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

Recruiting
PHASE4Ages 9–11InterventionalTreatment
Bausch Health Americas, Inc.
~100 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.

At a glance

Recruiting sites
14 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events
Measured over All AEs will be followed from onset of the adverse event through the end of Study Week 12 visit
+3 more outcomes measured

Conditions

Acne Vulgaris

Explore related trials

Acne

Where it's being run

15 sites across 11 states
Arkansas2
California2
Florida2
New York2
Kentucky1
Michigan1
Nevada1
North Carolina1

Who to contact

Emily N Hughes, MACPR
[email protected]
731-415-3174
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Topical astringents and abrasives (including comedo removal strips) on the face -1 week
Nonallowed moisturizers or sunscreens on the face -1 week
Antibiotics on the face -2 weeks
Other topical anti-acne drugs on the face -2 weeks
Soaps containing antimicrobials on the face -2 weeks
Anti-inflammatory agents and corticosteroids on the face -4 weeks
Retinoids, including retinol, on the face -4 weeks
Facial procedures, including chemical peel, microdermabrasion, light (eg, PDT, LED) and laser therapy, and acne surgery -4 weeks 16. Participants who have not undergone the specified washout period(s) for the following systemic medications or participants who require the concurrent use of any of the following systemic medications:
Corticosteroids (including intramuscular injections) (inhaled corticosteroids allowed) -4 weeks
Antibiotics -4 weeks
Other systemic acne treatments -4 weeks
Systemic retinoids -6 months 17. Participants who intend to use a tanning booth or sunbathe during the study 18. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function 19. Participants who have any underlying disease the investigator deems uncontrolled, and that poses a concern for the participant's safety while participating in the study

What this trial measures

  • Incidence of Treatment-Emergent Adverse EventsAll AEs will be followed from onset of the adverse event through the end of Study Week 12 visit

    Starting after signing the informed consent/assent document, and continuing through the end of the study, participants will be assessed for the occurrence of new AEs and changes in ongoing AEs. The descriptions of all AEs will include the dates of onset and resolution (if resolved), maximum severity, seriousness, action taken regarding the study drug, corrective treatment, outcome, and the investigator's assessment of causality. Worsening of disease will not be considered an AE unless it results in discontinuation of the participant from the study or requires medical intervention prohibited by the protocol. All AEs will be followed to resolution or until stable, as determined by the investigator.

  • Change in Inflammatory LesionsBaseline through Week 12

    Changes from Baseline to each study visit in inflammatory lesion counts

  • Change in Non-inflammatory LesionsBaseline through Week 12

    Changes from Baseline to each study visit in non-inflammatory lesion counts

  • EGSS ResultsBaseline through Week 12

    Collection of EGSS results from Baseline visit through end of study Week 12