Actively Recruiting
A Phase 4, Open-Label, Multicenter Study Evaluating Absorption, Pharmacokinetics, and HPA Axis Suppression of Topical IDP-122 Lotion in Pediatric Moderate to Severe Plaque Psoriasis
Led by Bausch Health Americas, Inc. · Updated on 2025-08-27
45
Participants Needed
9
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, how the body absorbs, and the effect on hormone regulation of a topical lotion called IDP-122 containing halobetasol propionate in children aged 6 to 16 years with moderate to severe plaque psoriasis. The study aims to understand how this lotion affects young patients, especially regarding its impact on the hypothalamic-pituitary-adrenal (HPA) axis, which controls stress hormone levels. Two groups of pediatric participants, one aged 12 to 16 years 11 months and the other aged 6 to 11 years 11 months, will apply IDP-122 Lotion once daily to psoriasis lesions covering at least 10% of their body surface area. This treatment will continue daily for 8 weeks, with the lotion applied to specific sites identified by the investigator. Participants will undergo blood tests to measure the maximum concentration of the drug in their plasma at various times after dosing. Researchers will also monitor for signs of HPA axis suppression at Week 8. The study involves regular assessments to track safety and systemic exposure, with a total participation period that includes these 8 weeks of treatment and monitoring.
CONDITIONS
Brief 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...
- Age between 6 and 16 years 11 months at consent/assent
- Verbal and written informed consent/assent from participant and/or guardian
- Clinical diagnosis of psoriasis with Investigator's Global Assessment (IGA) score of 3 or 4 excluding face, scalp, axillae, and intertriginous areas
- Plaque psoriasis area suitable for topical treatment covering at least 10% body surface area excluding face, scalp, axillae, and intertriginous areas
- Willing and able to avoid prolonged ultraviolet radiation exposure during study
- Good adrenal health confirmed by serum cortisol >18 mcg/dL after cosyntropin stimulation
- Females of childbearing potential and pre-menses females aged 9 or older willing to use effective contraception during study
You will not qualify if you...
- History of adrenal disease
- Concurrent skin conditions interfering with treatment evaluation
- Pregnant, nursing, or planning pregnancy during the study
- Use of investigational drugs/devices within 60 days or concurrent participation in another investigational study
- Use of non-corticosteroid topical antipsoriatic drugs within 14 days or corticosteroids within 28 days before baseline
- History of hypersensitivity or allergy to study drug components
- Considered unsuitable candidate by Investigator for any other reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants apply IDP-122 Lotion to affected skin lesions once daily.
Daily application with periodic visits for assessments
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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