Study of IDP-122 Lotion for Children and Teens Aged 6 to 16 with Moderate to Severe Plaque Psoriasis Evaluating Safety, Absorption, and Hormone Effects

What this Trial Is About

Researchers are evaluating the safety, how the body absorbs, and the effect on hormone regulation of a topical lotion called IDP-122 containing halobetasol propionate in children aged 6 to 16 years with moderate to severe plaque psoriasis. The study aims to understand how this lotion affects young patients, especially regarding its impact on the hypothalamic-pituitary-adrenal HPA axis, which controls stress hormone levels. Two groups of pediatric participants, one aged 12 to 16 years 11 months and the other aged 6 to 11 years 11 months, will apply IDP-122 Lotion once daily to psoriasis lesions covering at least 10% of their body surface area. This treatment will continue daily for 8 weeks, with the lotion applied to specific sites identified by the investigator. Participants will undergo blood tests to measure the maximum concentration of the drug in their plasma at various times after dosing. Researchers will also monitor for signs of HPA axis suppression at Week 8. The study involves regular assessments to track safety and systemic exposure, with a total participation period that includes these 8 weeks of treatment and monitoring.

A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis