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 range9 Years – 11 Years

SexALL

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
✕. 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

What they're measuring

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

Change in Inflammatory Lesions

Timeframe: Baseline through Week 12

Change in Non-inflammatory Lesions

Timeframe: Baseline through Week 12

EGSS Results

Timeframe: Baseline through Week 12

Trial details

NCT IDNCT07524946

SponsorBausch Health Americas, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Emily N Clinical Trial Manager, MACPR

731-415-3174 Emily.Hughes@BauschHealth.com

View on ClinicalTrials.gov More Acne Vulgaris trials

Who can participate

Age range9 Years – 11 Years

SexALL

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
✕. 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

What they're measuring

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

Change in Inflammatory Lesions

Timeframe: Baseline through Week 12

Change in Non-inflammatory Lesions

Timeframe: Baseline through Week 12

EGSS Results

Timeframe: Baseline through Week 12