A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
- Conditions
- Psoriasis
- Interventions
- Drug: IDP-122 Lotion
- Registration Number
- NCT03987763
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IDP-122 Lotion 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.
- Primary Outcome Measures
Name Time Method 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 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
Name Time Method Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression 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.
Trial Locations
- Locations (8)
Bausch Site 11
🇺🇸Fountain Valley, California, United States
Bausch Site 05
🇺🇸Spartanburg, South Carolina, United States
Bausch Site 06
🇺🇸Miami, Florida, United States
Bausch Site 07
🇺🇸Doral, Florida, United States
Bausch Site 3
🇺🇸Miami, Florida, United States
Bausch Site 4
🇵🇦Panama City, Panama
Bausch Site 2
🇺🇸Thousand Oaks, California, United States
Bausch Site 1
🇺🇸Spokane, Washington, United States