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

NCT07524946 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: V01-126A-401
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acne Vulgaris

Keywords

Pediatric; Open-Label; Cabtreo; Acne Vulgaris; Topical

Outcome Measures

Primary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events

  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.

  All AEs will be followed from onset of the adverse event through the end of Study Week 12 visit

• Change in Inflammatory Lesions

  Changes from Baseline to each study visit in inflammatory lesion counts

  Baseline through Week 12

• Change in Non-inflammatory Lesions

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

  Baseline through Week 12

• EGSS Results

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

  Baseline through Week 12

Study Arms (1)

All enrolled participants will receive CABTREO in this open-label study.

OTHER

CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.

Drug: CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.

Interventions

CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%. DRUG

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.

Also known as: IDP-126

All enrolled participants will receive CABTREO in this open-label study.

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Effective contraception is defined as being stabilized on an oral contraceptive for at least 3 months; using an intrauterine device/system, condom with spermicide, diaphragm with spermicide, implant, NuvaRing®, injection, transdermal patch; bilateral tubal ligation; vasectomized partner; or practicing abstinence. Females on birth control pills must have taken the same type of pill for at least 3 months prior to entering the study and must not change types during the study. Those who have used birth control pills in the past must have discontinued use at least 3 months prior to the start of the study. Those who use birth control for acne control only should be excluded.
• Premenses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline, and must have a negative serum pregnancy test at screening.
• Participants must be willing to comply with study instructions and return to the study center for required visits; participants under the age of consent must be accompanied by the parent/legal guardian at the time of providing assent/consent
• If a cleanser, moisturizer or sunscreen is needed during the study, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products; the participant must agree to use noncomedogenic products (including makeup and shaving products) Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study

You may not qualify if:

• 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
• If female, participant has a history of hirsutism, polycystic ovarian disease, or clinically significant menstrual irregularities
• History of regional enteritis, ulcerative colitis, inflammatory bowel disease, pseudomembranous colitis, chronic or recurrent diarrhea, or antibiotic-associated colitis
• Treatment of any type of cancer within the 6 months prior to screening, with the exception of complete surgical excision of skin cancer outside the treatment area
• Participant uses medications and/or vitamins during the study that are reported to exacerbate acne (azathioprine, haloperidol, Vitamin D, Vitamin B12, halogens such as iodides or bromides, lithium, systemic or topical mid- to super-high potency corticosteroids on the treatment area, phenytoin, and phenobarbital); multivitamins, including Vitamin A, at recommended daily doses, and Vitamin D at stable doses, are acceptable
• History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of clindamycin phosphate, BPO, or adapalene
• Concomitant use of potentially irritating over the counter products that contain ingredients such as BPO, alpha-hydroxy acid, salicylic acid, retinol, or glycolic acids
• Participants who have not undergone the specified washout period(s) for the following topical preparations or physical treatments used on the face or participants who require the concurrent use of any of the following topical agents in the treatment area:

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• MedTrials Incorporated: collaborator

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Central Study Contacts

Emily N Clinical Trial Manager, MACPR

CONTACT

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

Alison Magnotti-Nagel, CCRA

CONTACT

908-541-8664; Alison.Magnotti-Nagel@bauschhealth.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04