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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Psoriasis
Intervention / Treatment

-

Contacts and Locations

Fountain Valley

Bausch Site 11, Fountain Valley, California, United States, 92708

Thousand Oaks

Bausch Site 2, Thousand Oaks, California, United States, 91320

Doral

Bausch Site 07, Doral, Florida, United States, 33166

Miami

Bausch Site 3, Miami, Florida, United States, 33125

Miami

Bausch Site 06, Miami, Florida, United States, 33155

Spartanburg

Bausch Site 05, Spartanburg, South Carolina, United States, 29303

Spokane

Bausch Site 1, Spokane, Washington, United States, 99216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bausch Health Americas, Inc.,

Varsha Bhatt, STUDY_DIRECTOR, Bausch Health Americas, Inc.

Study Record Dates

2024-06