IDP-118 Lotion for Psoriasis

Palo Alto (17 mi)

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 trial tests a special lotion called IDP-118 for children with moderate to severe plaque psoriasis. It aims to ensure the lotion is safe, see how much gets into the body, and check if it affects stress-related hormones. The goal is to find a safe and effective treatment for these children. IDP-118 is a combination of halobetasol propionate and tazarotene, which has shown effectiveness in treating moderate-to-severe plaque psoriasis in adults.

Eligibility Criteria

This trial is for children aged 4 to nearly 17 with moderate to severe plaque psoriasis, covering at least 10% of their body excluding face, scalp, and certain areas. They must have normal adrenal function and agree to avoid sun/UV exposure. Girls able to have children must use birth control during the study.

Inclusion Criteria

I am between 4 and 16 years old.

Verbal and written informed consent/assent obtained from the participant and/or parent or legal guardian.

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

I have psoriasis covering 10% of my body, excluding my face, scalp, and certain areas.

I can stay out of the sun and away from UV lights during the study.

Is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is >18 μg/dL at the Screening visit.

I am willing to use birth control during the study.

Treatment Details

The trial tests IDP-118 Lotion's safety and effects on the body when applied topically in kids with plaque psoriasis. It also checks if it affects adrenal gland hormones by measuring cortisol levels after a stimulation test.

1Treatment groups

Experimental Treatment

Group I: IDP-118 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 4 to 11 years 11 months) will apply IDP-118 Lotion to Investigator identified lesions affecting a minimum of 10% body surface area (BSA) once daily for 8 weeks.