This study is to evaluate the safety, the systemic exposure, and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-118 lotion in pediatric participants with moderate to severe plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Topical
Bausch Site 7
Doral, Florida, United States
Bausch Site 11
Miami, Florida, United States
Bausch Site 3
Louisville, Kentucky, United States
Bausch Site 6
Saint Joseph, Missouri, United States
Pharmacokinetics: : Maximum Observed Drug (Halobetasol Propionate, Tazarotene, or Tazarotenic Acid) Concentration in Plasma (Cmax) of IDP-118 Lotion Analytes
On Days 28-29, blood samples will be collected from each participant for the determination of plasma concentrations and PK parameters of IDP-118 lotion analytes.
Time frame: 0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose
Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression at Week 8
An HPA axis suppression is defined as a 30 minute poststimulation cortisol level of ≤18 micrograms/deciliter (μg/dL) at the end of the study.
Time frame: Week 8
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Bausch Site 1
Henderson, Nevada, United States
Bausch Site 5
San Antonio, Texas, United States
Bausch Site 4
Murray, Utah, United States
Bausch Site 12
Santo Domingo, Dominican Republic
Bausch Site 2
Panama City, Panama