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Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Reference Listed Drug" [RLD]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, moderate to severe, plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 188-0551 Spray | Experimental | Investigational Topical Spray Product |
|
| Reference Listed Drug (RLD) | Active Comparator | FDA Approved Topical Cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 188-0551 Spray | Drug | Applied topically twice daily for two weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects to exhibit adrenal suppression as measured by a cortrosyn stimulation test | A subject is considered to have adrenal suppression evidence if post stimulation lab draw result is ≤ 18 µg/dL (497 nmol/L). | Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TI Site #13 | Scottsdale | Arizona | 85258 | United States | ||
| TI Site #12 |
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| RLD |
| Drug |
Applied topically twice daily for two weeks |
|
| Thousand Oaks |
| California |
| 91320 |
| United States |
| TI Site #11 | Miami | Florida | 33147 | United States |
| TI Site #31 | Batumi | Georgia |
| TI Site #32 | Tbilisi | Georgia |
| TI Site #23 | Lviv | Ukraine |
| TI Site #22 | Rivne | Ukraine |
| TI Site #21 | Zaporizhzhya | Ukraine |