A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis

Completed · Phase 4

Conditions studied: Psoriasis

In brief

This study is to evaluate the safety, the systemic exposure, and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-118 lotion in pediatric participants with moderate to severe plaque psoriasis.

Key facts

Study ID

NCT03988439

Run by

Bausch Health Americas, Inc.

People needed

16

Starts

2021-03-24

Expected to finish

2026-02-06

Last updated by the study team

2026-04-09

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is 4 to 16 years 11 months of age at time of informed consent/assent obtained.
• Verbal and written informed consent/assent obtained from the participant and/or parent or legal guardian.
• Has a clinical diagnosis of psoriasis at Screening and Baseline with an Investigator's Global Assessment (IGA) score of 3 or 4. The face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.
• Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline. The face, scalp, axillae, and intertriginous areas are to be excluded in this calculation.
• Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of 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.
• Females of childbearing potential and females who are pre-menses (9 years and older) must be willing to practice effective contraception for the duration of the study.

You may not qualify if…

• Has a history of adrenal disease.
• Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.
• Is pregnant, nursing an infant, or planning a pregnancy during the study period.
• Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to baseline or is concurrently participating in another clinical study with an investigational drug or device.
• Received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the Baseline visit and/or treatment containing corticosteroids within 28 days prior to the screening HPA axis stimulation test.
• 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.

Where it is running

• Bausch Site 7 — Doral, Florida, United States
• Bausch Site 11 — Miami, Florida, United States
• Bausch Site 3 — Louisville, Kentucky, United States
• Bausch Site 6 — Saint Joseph, Missouri, United States
• Bausch Site 1 — Henderson, Nevada, United States
• Bausch Site 5 — San Antonio, Texas, United States
• Bausch Site 4 — Murray, Utah, United States
• Bausch Site 12 — Santo Domingo, Dominican Republic
• Bausch Site 2 — Panama City, Panama

Full record on ClinicalTrials.gov

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