This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.
This study is an open-label study, consisting of a 12-week primary treatment phase and an optional 40-week long-term extension phase in which all eligible subjects will receive tapinarof cream, 1% once daily. At the end of the 12-week primary treatment phase subjects will have the option to continue for 40 additional weeks of treatment. Subjects who choose not to participate in the optional 40-week long-term extension phase will complete a follow-up visit approximately one week after the end of the primary treatment phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
applied topically once daily
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, United States
First OC Dermatology
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence, frequency, and duration of treatment emergent AEs and SAEs
Time frame: Screening up to Week 53
Number of subjects with clinically significant laboratory test abnormalities
Time frame: Screening up to Week 53
Number of subjects with clinically significant vital signs abnormalities
Time frame: Screening up to Week 53
Investigator-Assessed Local Tolerability Scale (LTS) Scores
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.
Time frame: Baseline up to Week 52
Subject (or Caregiver)-Assessed Local Tolerability Scale (LTS)
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.
Time frame: Baseline up to Week 52
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Detectable Time-Point (AUC0-t) of tapinarof cream, 1%.
Area under the plasma concentration-time curve from time zero to the last quantifiable time point.
Time frame: Week 4 and Week 12
Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.
Maximum observed plasma concentration (Cmax).
Time frame: Week 4 and Week 12
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Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.
Time to maximum observed plasma concentration obtained directly from the observed concentration.
Time frame: Week 4 and Week 12