Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT03987763

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

Conditions: Psoriasis

Sex: All
Ages: 6 Years – 17 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 45
Sponsor: Bausch Health Americas, Inc.

Location: Bausch Site 11 Fountain Valley California

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03987763). StuddyBuddy aggregates publicly available trial information.