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

Last updated: July 25, 2023
Sponsor: Bausch Health Americas, Inc.
Overall Status: Active - Recruiting

Phase

4

Condition

Rosacea

Rash

Warts

Treatment

IDP-122 Lotion

Clinical Study ID

NCT03987763
V01-122A-401
  • Ages 6-17
  • All Genders

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 Criteria

Inclusion

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 parentor legal guardian.
  • Has a clinical diagnosis of psoriasis at Screening and Baseline with an Investigator'sGlobal Assessment (IGA) score of 3 or 4. The face, scalp, axillae, and intertriginousareas are to be excluded in this assessment, if psoriasis is present.
  • Has an area of plaque psoriasis appropriate for topical treatment that involves a BSAof at least 10% at Screening and Baseline. The face, scalp, axillae, andintertriginous areas are to be excluded in this calculation.
  • Is willing and able to avoid prolonged exposure of the treatment area to ultravioletradiation (natural and artificial) for the duration of the study.
  • Is in good general adrenal health, as determined by a 30-minute postcosyntropinstimulation 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

Exclusion Criteria:

  • Has a history of adrenal disease.
  • Presents with any concurrent skin condition that could interfere with the evaluationof 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 5drug half-lives (whichever is longer) prior to baseline or is concurrentlyparticipating in another clinical study with an investigational drug or device.
  • Received treatment with a topical antipsoriatic drug product other thancorticosteroids within 14 days prior to the Baseline visit and/or treatment containingcorticosteroids within 28 days prior to the screening HPA axis stimulation test.
  • Has a history of hypersensitivity or allergic reaction to any of the study drugconstituents.
  • Is considered by the Investigator, for any other reason, to be an unsuitable candidatefor the study.

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: IDP-122 Lotion
Phase: 4
Study Start date:
October 22, 2019
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Bausch Site 4

    Panama City,
    Panama

    Site Not Available

  • Bausch Site 11

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Bausch Site 2

    Thousand Oaks, California 91320
    United States

    Active - Recruiting

  • Bausch Site 07

    Doral, Florida 33166
    United States

    Active - Recruiting

  • Bausch Site 06

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Bausch Site 3

    Miami, Florida 33125
    United States

    Active - Recruiting

  • Bausch Site 05

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • Bausch Site 1

    Spokane, Washington 99216
    United States

    Terminated

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