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Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily for 12 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTA018 cream | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success). |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy outcomes include time to success (PSGA), change in overall PSGA score, and Area Adjusted Psoriasis Area and Severity Index (AAPASI)changes from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Melnick, MD | OPKO Renal | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Tucson | Arizona | 85710 | United States | ||
| Dermatology Research of Arkansas PLLC |
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| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Radiant Research, Kansas City | Overland Park | Kansas | 66215 | United States |
| Mass General/ Brigham & Women's | Boston | Massachusetts | 02215 | United States |
| Department of Dermatology, Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| UMDNJ-Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| New York University Medical Center | New York | New York | 10016 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Buffalo Medical Group PC | Williamsville | New York | 14221 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Radiant Research | Cincinnati | Ohio | 45249 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Paddington Testing Co. | Philadelphia | Pennsylvania | 19103 | United States |
| Radiant Research Inc. | Anderson | South Carolina | 29621 | United States |
| Palmetto Clinical Trial Services LLC | Greenville | South Carolina | 29607 | United States |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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