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This study is to evaluate the safety, the systemic exposure, and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-118 lotion in pediatric participants with moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-118 Lotion | Experimental | Two cohorts of pediatric participants (1 cohort of participants age 12 to 16 years 11 months and 1 cohort of participants age 4 to 11 years 11 months) will apply IDP-118 Lotion to Investigator identified lesions affecting a minimum of 10% body surface area (BSA) once daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-118 Lotion | Drug | Topical |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: : Maximum Observed Drug (Halobetasol Propionate, Tazarotene, or Tazarotenic Acid) Concentration in Plasma (Cmax) of IDP-118 Lotion Analytes | On Days 28-29, blood samples will be collected from each participant for the determination of plasma concentrations and PK parameters of IDP-118 lotion analytes. | 0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression at Week 8 | An HPA axis suppression is defined as a 30 minute poststimulation cortisol level of ≤18 micrograms/deciliter (μg/dL) at the end of the study. | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Magnotti-Nagel | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch Site 7 | Doral | Florida | 33166 | United States | ||
| Bausch Site 11 |
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| Miami |
| Florida |
| 33173 |
| United States |
| Bausch Site 3 | Louisville | Kentucky | 40217 | United States |
| Bausch Site 6 | Saint Joseph | Missouri | 64506 | United States |
| Bausch Site 1 | Henderson | Nevada | 89052 | United States |
| Bausch Site 5 | San Antonio | Texas | 78213 | United States |
| Bausch Site 4 | Murray | Utah | 84123 | United States |
| Bausch Site 12 | Santo Domingo | Dominican Republic |
| Bausch Site 2 | Panama City | Panama |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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