Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo
ConditionAcne Vulgaris
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age9-11
SponsorBausch Health Americas, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.
Treatment groups
100 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Bausch Health Americas, Inc.
Lead sponsor
MedTrials Incorporated
Collaborator
Source ClinicalTrials.gov