RecruitingPsoriasis
A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
Eligible age
6–17 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Bausch Health Americas, Inc.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
California
Fountain Valley · Thousand Oaks
Florida
Doral · Miami
South Carolina
Spartanburg
Washington
Spokane
Source: ClinicalTrials.gov · NCT03987763 · last updated 2025-08-27