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

NCT03987763 | Recruiting Phase 4 FDA Drug

• 1 other identifier: V01-122A-401
• Study Type: interventional
• Target: 45
• Locations: 3 countries
• Sites: 9

Brief 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.

Conditions

Psoriasis

Keywords

Plaque psoriasis

Outcome Measures

Primary Outcomes (1)

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

  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.

  0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose

Secondary Outcomes (1)

• Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

  Week 8

Study Arms (1)

IDP-122 Lotion

EXPERIMENTAL

Two cohorts of pediatric participants (1 cohort of participants age 12 to 16 years 11 months and 1 cohort of participants age 6 to 11 years 11 months) will apply IDP-122 Lotion to Investigator identified lesions affecting a minimum of 10% body surface area (BSA) once daily for 8 weeks.

Drug: IDP-122 Lotion

Interventions

IDP-122 Lotion DRUG

Topical

IDP-122 Lotion

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (9)

Bausch Site 11

Fountain Valley, California, 92708, United States

TERMINATED

Bausch Site 2

Thousand Oaks, California, 91320, United States

RECRUITING

Bausch Site 07

Doral, Florida, 33166, United States

RECRUITING

Bausch Site 3

Miami, Florida, 33125, United States

RECRUITING

Bausch Site 06

Miami, Florida, 33155, United States

TERMINATED

Bausch Site 05

Spartanburg, South Carolina, 29303, United States

TERMINATED

Bausch Site 1

Spokane, Washington, 99216, United States

TERMINATED

Bausch Site 12

Santo Domingo, Dominican Republic

RECRUITING

Bausch Site 4

Panama City, Panama

TERMINATED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alison Magnotti-Nagel

  Bausch Health

  STUDY DIRECTOR

Central Study Contacts

Alison Magnotti-Nagel

CONTACT

9085418664; alison.magnotti-nagel@bauschhealth.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 17, 2019
• Study Start: October 22, 2019
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

PA (1); DO (1); US (7)