Evaluating IDP-118 Lotion for Children with Plaque Psoriasis

A Phase 4, Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

This study is testing a new lotion for children aged 4 to 16 with moderate to severe plaque psoriasis to see if it's safe and how it affects their body.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 4 Years to 17 Years
• Sex: All
• Sponsor: Bausch Health Americas, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 9 sites (Doral, Florida and 8 other locations)
• Trial ID: NCT03988439 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and pharmacokinetics of IDP-118 lotion in children aged 4 to 16 years with moderate to severe plaque psoriasis. It focuses on assessing systemic exposure and the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression from the topical treatment. Participants must have a specific area of plaque psoriasis suitable for treatment and will be monitored for their adrenal health throughout the study.

Who should consider this trial

Good fit: Ideal candidates are children aged 4 to 16 years with moderate to severe plaque psoriasis affecting at least 10% of their body surface area.

Not a fit: Patients with psoriasis in areas that are excluded from treatment, such as the face, scalp, axillae, and intertriginous areas, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer topical option for managing plaque psoriasis in pediatric patients.

How similar studies have performed: Other studies have shown promise in using topical treatments for psoriasis, but the specific approach with IDP-118 lotion is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Doral, Florida and 8 other locations

• Bausch Site 7 — Doral, Florida, United States (Recruiting)
• Bausch Site 8 — Miami, Florida, United States (Recruiting)
• Bausch Site 3 — Louisville, Kentucky, United States (Recruiting)
• Bausch Site 6 — Saint Joseph, Missouri, United States (Recruiting)
• Bausch Site 1 — Henderson, Nevada, United States (Terminated)
• Bausch Site 11 — Mayfield Heights, Ohio, United States (Recruiting)
• Bausch Site 5 — San Antonio, Texas, United States (Terminated)
• Bausch Site 4 — Murray, Utah, United States (Recruiting)
• Bausch Site 2 — Panama City, Panama (Recruiting)

Study contacts

• Study coordinator: Alison Magnotti-Nagel

Conditions Psoriasis; Plaque psoriasis