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A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
NCT03987763 · Bausch Health Americas, Inc.
In plain English
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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
About this study
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 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.
Study design
Enrollment target: 45 participants
Allocation: na
Masking: none
Age groups: child
Timeline
Starts: 2019-10-22
Estimated completion: 2026-06
Last updated: 2025-08-27
Interventions
Drug: IDP-122 Lotion
Primary outcomes
- • Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes (0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose)
Sponsor
Bausch Health Americas, Inc. · industry
Contacts & investigators
ContactAlison Magnotti-Nagel · contact · alison.magnotti-nagel@bauschhealth.com · 9085418664
InvestigatorAlison Magnotti-Nagel · study_director, Bausch Health
All locations (9)
Bausch Site 11Terminated
Fountain Valley, California, United States
Bausch Site 2Recruiting
Thousand Oaks, California, United States
Bausch Site 07Recruiting
Doral, Florida, United States
Bausch Site 3Recruiting
Miami, Florida, United States
Bausch Site 06Terminated
Miami, Florida, United States
Bausch Site 05Terminated
Spartanburg, South Carolina, United States
Bausch Site 1Terminated
Spokane, Washington, United States
Bausch Site 12Recruiting
Santo Domingo, Dominican Republic
Bausch Site 4Terminated
Panama City, Panama