Evaluating a lotion for treating plaque psoriasis in children

A Phase 4, Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-122 Lotion in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

This study is testing a new lotion for children with moderate to severe plaque psoriasis to see if it’s safe and effective for treating their skin condition.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: Bausch Health Americas, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 9 sites (Fountain Valley, California and 8 other locations)
• Trial ID: NCT03987763 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and pharmacokinetics of IDP-122 lotion in pediatric participants aged 6 to 16 years with moderate to severe plaque psoriasis. The focus is on assessing the systemic exposure of halobetasol propionate and the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression. Participants must have a clinical diagnosis of psoriasis and an appropriate area of plaque psoriasis for topical treatment. The study aims to ensure that the treatment is safe and effective for this young population.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 16 years with moderate to severe plaque psoriasis affecting at least 10% of their body surface area.

Not a fit: Patients with psoriasis localized to the face, scalp, axillae, or intertriginous areas may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new topical treatment option for children suffering from plaque psoriasis.

How similar studies have performed: Other studies have shown success with topical treatments for psoriasis, indicating that this approach is promising.

Eligibility criteria

Inclusion Criteria:

* 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.

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

Fountain Valley, California and 8 other locations

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

Study contacts

• Study coordinator: Alison Magnotti-Nagel

Conditions Psoriasis; Plaque psoriasis