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Active, not recruiting Phase 4

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

NCT03987763 · tracked via the Priya Life Science USA tracker
Phase
Phase 4
Started
2019-10-22
Last updated
2026-10-02

Condition(s) studied

Psoriasis

Investigational drug(s) / intervention(s)

IDP-122 Lotion

IDP-122 Lotion: Topical

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes — 0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose
    On Days 28-29, blood samples will be collected from each participant for the determination of plasma concentrations and PK parameters of IDP-122 Lotion analytes.

Trial sites (9)

FacilityCityRegionStatus
Bausch Site 11 Fountain Valley California
Bausch Site 2 Thousand Oaks California
Bausch Site 07 Doral Florida
Bausch Site 3 Miami Florida
Bausch Site 06 Miami Florida
Bausch Site 05 Spartanburg South Carolina
Bausch Site 1 Spokane Washington
Bausch Site 12 Santo Domingo Dominican Republic
Bausch Site 4 Panama City Panama
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03987763 on ClinicalTrials.gov ↗ ← All trials in the USA