Overview

A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis

Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
Summary
This study is to evaluate the safety, the systemic exposure, and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-118 lotion in pediatric participants with moderate to severe plaque psoriasis.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bausch Health Americas, Inc.
Criteria
Inclusion Criteria:

- Is 4 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.