Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo
ConditionAcne Vulgaris
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.
DrugThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: All enrolled participants will receive CABTREO in this open-label study.Other 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
All AEs will be followed from onset of the adverse event through the end of Study Week 12 visit2
Change in Inflammatory Lesions
Changes from Baseline to each study visit in inflammatory lesion counts
Time frame
Baseline through Week 123
Change in Non-inflammatory Lesions
Changes from Baseline to each study visit in non-inflammatory lesion counts
Time frame
Baseline through Week 124
EGSS Results
Collection of EGSS results from Baseline visit through end of study Week 12
Time frame
Baseline through Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bausch Health Americas, Inc.
Lead sponsor
MedTrials Incorporated
Collaborator
Source ClinicalTrials.gov