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

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Bausch Health Americas, Inc.
Study ID
NCT03987763
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • IDP-122 Lotion — DRUG
    Topical

Study Details

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.

Key Dates

Start date
Oct 22, 2019
Status verified
Aug 2025
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IDP-122 Lotion
    Two cohorts of pediatric participants (1 cohort of participants age 12 to 16 years 11 months and 1 cohort of participants age 6 to 11 years 11 months) will apply IDP-122 Lotion to Investigator identified lesions affecting a minimum of 10% body surface area (BSA) once daily for 8 weeks.

Primary Outcome Measure

Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes [ Time Frame: 0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Bausch Site 11Fountain ValleyCalifornia92708-
Bausch Site 2Thousand OaksCalifornia91320-
Bausch Site 07DoralFlorida33166-
Bausch Site 06MiamiFlorida33155-
Bausch Site 3MiamiFlorida33125-
Bausch Site 05SpartanburgSouth Carolina29303-
Bausch Site 1SpokaneWashington99216-

Find similar trials in Fountain Valley, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Bausch· Fountain Valley, CABausch· Thousand Oaks, CABausch· Doral, FLBausch· Miami, FLBausch· Spartanburg, SCBausch· Spokane, WA

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