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IDP-122 Lotion for Pediatric Plaque Psoriasis

This study is testing a topical lotion called IDP-122 in children and teenagers with moderate to severe plaque psoriasis. Researchers want to understand how safe IDP-122 lotion is and how much of its active ingredient, halobetasol propionate (HP), gets into the body. They also want to see if it affects the hypothalamic-pituitary-adrenal (HPA) axis, which is a system in your body that controls stress and other functions. You may be able to join if you are between 6 and 17 years old and have a diagnosis of psoriasis with an IGA score of 3 or 4. The study aims to measure the maximum amount of the drug in the blood at different times after application. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 45 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures drug concentration in the blood at 0, 1, 2, 4, 8, 12, and 24 hours postdose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03987763

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

Recruiting
PHASE4Ages 6–17InterventionalTreatment
Bausch Health Americas, Inc.
~45 participants
Updated 2025-08-27 on ClinicalTrials.gov
What's tested:IDP-122 Lotion

At a glance

Recruiting sites
4 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes
Measured over 0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose

Conditions

Psoriasis

Explore related trials

Chronic small plaque psoriasis

Where it's being run

9 sites across 6 states
Florida3
California2
South Carolina1
Washington1
Dominican Republic1
Panama1

Study leadership

  • Alison Magnotti-Nagel · STUDY_DIRECTOR · Bausch Health Americas, Inc.

Who to contact

Alison Magnotti-Nagel
[email protected]
9085418664
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes0 (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.