A Phase 4, Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-122 Lotion in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

NCT03987763 Phase 4 RECRUITING

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.

Details

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 4
Status	RECRUITING
Enrolment	45
Start date	2019-10-22
Completion	2026-06

Conditions

• Psoriasis

Interventions

• IDP-122 Lotion

Primary outcomes

• Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes — 0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose
  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.

Countries

United States, Dominican Republic, Panama