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.
This is an open-label study designed to assess the safety, plasma PK, and treatment effect of topically applied CABTREO. This study includes both a main study and a PK sub-study. All participants will undergo a screening period of up to 5 weeks (up to 35 days) and a treatment period of up to 12 weeks (approximately 84 days). A subset of participants in the main study will be included in the PK sub-study. To be eligible for this study, participants must be between 9 years and 11 years, 11 months of age, inclusive, and have a clinical diagnosis of moderate to severe acne, defined as a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS). Participants must also have at least 30 facial acne inflammatory lesions, at least 35 facial acne noninflammatory lesions, and no more than 2 facial nodules; participants should also have acne lesions on at least 1 region of the trunk (chest, back, and/or shoulder).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Dermatology Trial Associates
Bryant, Arkansas, United States
RECRUITINGNorthwest Arkansas Clinical Trials Center
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 visit
Change in Inflammatory Lesions
Changes from Baseline to each study visit in inflammatory lesion counts
Time frame: Baseline through Week 12
Change in Non-inflammatory Lesions
Changes from Baseline to each study visit in non-inflammatory lesion counts
Time frame: Baseline through Week 12
EGSS Results
Collection of EGSS results from Baseline visit through end of study Week 12
Time frame: Baseline through Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rogers, Arkansas, United States
Center for Dermatology Clinical Research
Freemont, California, United States
RECRUITINGAblon Skin Institute and Research Center
Manhattan Beach, California, United States
RECRUITINGZiaderm Research, LLC
North Miami Beach, Florida, United States
RECRUITINGClinical Research Trials of Florida, Inc
Tampa, Florida, United States
RECRUITINGDS Research of Kentucky, LLC
Louisville, Kentucky, United States
RECRUITINGMichigan Center for Skin Care Research
Clinton Township, Michigan, United States
RECRUITINGJDR Dermatology Research
Las Vegas, Nevada, United States
RECRUITINGDermResearchCenter of New York
Stony Brook, New York, United States
RECRUITING...and 5 more locations