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

Conditions

• Acne Vulgaris

Eligibility Criteria

Sex

ALL

Age

9 Years - 11 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Apr 13, 2026

Start date

Apr 1, 2026

Status verified

Jul 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: All enrolled participants will receive CABTREO in this open-label study.
  CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: All AEs will be followed from onset of the adverse event through the end of Study Week 12 visit ]

Central Contacts

• Emily N Hughes, MACPR
  731-415-3174
  [email protected]
• Alison Magnotti-Nagel, CCRA
  908-541-8664
  [email protected]

Locations (15)

Find similar trials in Bryant, AR

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