This study is to evaluate the safety, the systemic exposure of halobetasol propionate (HP), and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-122 lotion in pediatric participants with moderate to severe plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Topical
Bausch Site 11
Fountain Valley, California, United States
TERMINATEDBausch Site 2
Thousand Oaks, California, United States
RECRUITINGBausch Site 07
Doral, Florida, United States
Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 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-122 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
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 3
Miami, Florida, United States
RECRUITINGBausch Site 06
Miami, Florida, United States
TERMINATEDBausch Site 05
Spartanburg, South Carolina, United States
TERMINATEDBausch Site 1
Spokane, Washington, United States
TERMINATEDBausch Site 12
Santo Domingo, Dominican Republic
RECRUITINGBausch Site 4
Panama City, Panama
TERMINATED