Actively Recruiting
A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
Led by Bausch Health Americas, Inc. · Updated on 2025-08-27
45
Participants Needed
9
Research Sites
344 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, excluding face, scalp, axillae, and intertriginous areas.
- Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline, excluding face, scalp, axillae, and intertriginous areas.
- 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 greater than 18 bcg/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 will not qualify if you...
- 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 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Bausch Site 11
Fountain Valley, California, United States, 92708
Terminated
2
Bausch Site 2
Thousand Oaks, California, United States, 91320
Actively Recruiting
3
Bausch Site 07
Doral, Florida, United States, 33166
Actively Recruiting
4
Bausch Site 3
Miami, Florida, United States, 33125
Actively Recruiting
5
Bausch Site 06
Miami, Florida, United States, 33155
Terminated
6
Bausch Site 05
Spartanburg, South Carolina, United States, 29303
Terminated
7
Bausch Site 1
Spokane, Washington, United States, 99216
Terminated
8
Bausch Site 12
Santo Domingo, Dominican Republic
Actively Recruiting
9
Bausch Site 4
Panama City, Panama
Terminated
Research Team
A
Alison Magnotti-Nagel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here