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

Recruiting now · Phase 4

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT03987763

Run by

Bausch Health Americas, Inc.

People needed

45

Starts

2019-10-22

Expected to finish

2026-06-01

Last updated by the study team

2025-08-27

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is 6 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 07 — Doral, Florida, United States (enrolling)
• Bausch Site 3 — Miami, Florida, United States (enrolling)
• Bausch Site 12 — Santo Domingo, Dominican Republic (enrolling)
• Bausch Site 2 — Thousand Oaks, California, United States (enrolling)
• Bausch Site 11 — Fountain Valley, California, United States
• Bausch Site 4 — Panama City, Panama
• Bausch Site 06 — Miami, Florida, United States
• Bausch Site 05 — Spartanburg, South Carolina, United States
• Bausch Site 1 — Spokane, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.