Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo (NCT07524946) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo
100 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
9 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female participants, ≥ 9 years of age and ≤ 11 years, 11 months of age at baseline
. Participants must provide verbal and signed, written informed consent; participants less than the age of consent must sign an assent for the study and a parent/legal guardian must sign the informed consent
. Participants must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at baseline
. Participants must have a facial acne inflammatory lesion (papules, pustules, and nodules) count ≥ 30 at baseline
. Participants must have a facial acne noninflammatory lesion (open and closed comedones) count ≥ 35 at baseline
. Participants must have acne lesions in at least 1 truncal region (ie, on the chest, back, and/or shoulder) at baseline
. Participants must have ≤ 2 facial nodules at baseline
. Women of childbearing potential and female participants who are premenses (≥ 9 years of age) must be willing to practice effective contraception for the duration of the study.
Exclusion criteria
. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events
Timeframe: All AEs will be followed from onset of the adverse event through the end of Study Week 12 visit
. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, and/or eczema
. Any underlying disease(s) or other dermatological condition of the face that requires the use of interfering topical or systemic therapy, or makes evaluations and lesion counts inconclusive
. Participants with \> 2 facial nodules at baseline
. Evidence or history of cosmetic-related acne
. Participants with a history of experiencing significant burning or stinging when applying any facial treatment (eg, makeup, soap, masks, washes, sunscreens) to the face
. Female participants who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study
. Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen) for less than 12 weeks immediately preceding study entry; a participant who is treated with estrogens for ≥ 12 consecutive weeks immediately prior to study entry need not be excluded unless the participant expects to change the dose, the drug, or discontinue estrogen use during the study