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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03987763
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : August 12, 2020
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: IDP-122 Lotion Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 22, 2019
Estimated Primary Completion Date : July 8, 2021
Estimated Study Completion Date : July 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: IDP-122 Lotion
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

Primary Outcome Measures :
  1. Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes [ Time Frame: 0 (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.

Secondary Outcome Measures :
  1. Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression [ Time Frame: Week 8 ]
    An HPA axis suppression is defined as a 30 minute poststimulation cortisol level of ≤18 micrograms/deciliter (μg/dL) at the end of the study.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03987763

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Contact: Clinical Trial Manager 1-510-259-5284

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United States, California
Bausch Site 2 Not yet recruiting
Thousand Oaks, California, United States, 91320
United States, Florida
Bausch Site 3 Not yet recruiting
Miami, Florida, United States, 33125
United States, Washington
Bausch Site 1 Recruiting
Spokane, Washington, United States, 99216
Bausch Site 4 Not yet recruiting
Panama City, Panama
Sponsors and Collaborators
Bausch Health Americas, Inc.
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Study Director: Anya Loncaric Bausch Health Americas, Inc.
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Responsible Party: Bausch Health Americas, Inc. Identifier: NCT03987763    
Other Study ID Numbers: V01-122A-401
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bausch Health Americas, Inc.:
Plaque psoriasis
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases