NCT03987763PHASE4Recruiting
A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
Bausch Health Americas, Inc.
Start Date
10/22/2019
Completion Date
6/1/2026
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
Age Range: 6 years to 17 years
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.
Interventions
DRUG
IDP-122 Lotion
Conditions
Psoriasis
Locations
Bausch Site 11
Fountain Valley, California 92708
United States
Bausch Site 2
Thousand Oaks, California 91320
United States
Bausch Site 07
Doral, Florida 33166
United States
Bausch Site 3
Miami, Florida 33125
United States
Bausch Site 06
Miami, Florida 33155
United States
Bausch Site 05
Spartanburg, South Carolina 29303
United States
Bausch Site 1
Spokane, Washington 99216
United States
Bausch Site 12
Santo Domingo,
Dominican Republic
Bausch Site 4
Panama City,
Panama