Psoriasis Clinical Trial
A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
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.
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 Î¼g/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.
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There are 7 Locations for this study
Fountain Valley California, 92708, United States
Thousand Oaks California, 91320, United States
Doral Florida, 33166, United States
Miami Florida, 33125, United States
Miami Florida, 33155, United States
Spartanburg South Carolina, 29303, United States
Spokane Washington, 99216, United States
Panama City , , Panama
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