IDP-122 Lotion for Psoriasis

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Bausch Health Americas, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for children aged 6 to nearly 17 with moderate to severe plaque psoriasis covering at least 10% of their body, excluding face, scalp, and certain other areas. Participants must avoid excessive UV light exposure and girls able to have children must use birth control. Those with adrenal diseases or allergies to the lotion's ingredients can't join.

Inclusion Criteria

Your body produces enough cortisol, a hormone that helps with stress and metabolism, after a special test.

I have moderate to severe psoriasis, not including my face, scalp, underarms, or skin folds.

I have psoriasis covering 10% of my body, not including my face, scalp, underarms, or skin folds.

+4 more

Exclusion Criteria

I haven't used non-steroid psoriasis creams in the last 14 days or steroid creams in the last 28 days.

Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.

Is considered by the Investigator, for any other reason, to be an unsuitable candidate for the study.

+4 more

Participant Groups

The study tests IDP-122 Lotion's safety in kids with psoriasis, focusing on how much drug gets into the bloodstream and if it affects adrenal gland function (which controls stress response).

1Treatment groups

Experimental Treatment

Group I: IDP-122 LotionExperimental Treatment1 Intervention

Two cohorts of pediatric participants (1 cohort of participants age 12 to 16 years 11 months and 1 cohort of participants age 6 to 11 years 11 months) will apply IDP-122 Lotion to Investigator identified lesions affecting a minimum of 10% body surface area (BSA) once daily for 8 weeks.