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A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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

NCT03987763•Bausch Health Americas, Inc.

View on ClinicalTrials.gov

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

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

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.

Locations (9)

Bausch Site 11

Fountain Valley, California, United States

Bausch Site 2

Thousand Oaks, California, United States

Bausch Site 07

Doral, Florida, United States

Bausch Site 3

Miami, Florida, United States

Bausch Site 06

Miami, Florida, United States

Bausch Site 05

Spartanburg, South Carolina, United States

Bausch Site 1

Spokane, Washington, United States

Bausch Site 12

Santo Domingo, Dominican Republic

Bausch Site 4

Panama City, Panama

Key Dates

Start Date

October 22, 2019

Primary Completion Date

May 1, 2026

Completion Date

June 1, 2026

Last Updated

August 27, 2025

Enrollment

ESTIMATED participants

Conditions

Psoriasis

Interventions

IDP-122 Lotion

DRUG

Contacts

Alison Magnotti-Nagel

CONTACT

9085418664 alison.magnotti-nagel@bauschhealth.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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