A Phase 4, Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-122 Lotion in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
Bausch Health Americas, Inc.
Summary
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.
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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, scal…
Interventions
- DrugIDP-122 Lotion
Topical
Locations (9)
- Bausch Site 11Fountain Valley, California
- Bausch Site 2Thousand Oaks, California
- Bausch Site 07Doral, Florida
- Bausch Site 3Miami, Florida
- Bausch Site 06Miami, Florida
- Bausch Site 05Spartanburg, South Carolina