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The purpose of this study is to determine the safety, metabolism and potential effect of drug product SFA-002 on mild moderate and severe chronic plaque psoriasis. Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no cure for psoriasis and treatment is directed at controlling patients' symptoms.
Up to ninety volunteers with mild to moderate chronic plaque psoriasis will be recruited for an open label 24 week prospective study of the safety of 2 different dosages for 12 weeks of active therapy and 12 weeks of follow up. Blood will be drawn to determine any clinical effect on each group at the 12 week time mark and residual effects after 24 weeks. Throughout the study the investigators will perform both clinical and laboratory assessments to measure safety and response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug (SFA002) Formula 1 | Experimental |
| |
| Drug (SFA002) Formula 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SFA002 | Drug | Study drug formula without excipient |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) Score | +/- % Change in Psoriasis (PASI) index from baseline measurement at first dose | From enrollment to final visit at 24 weeks treatment and 4 week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IGA score | % Patients achieving 2 point change in IGA Score on 5 point scale and/or score of 2 (almost clear) or 1 Clear. | From enrollment to final visit at 24 weeks treatment and 4 week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VP Development | Contact | 267-625-4873 | info@sfatherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NuLine Clinical Trial Center | Recruiting | Pompano Beach | Florida | 33060 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Open label
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| SFA002 |
| Drug |
Study Drug SFA002 with excipient (Propionate) |
|
| Axis Clincals USA/ Red River Research Patners. LLC | Recruiting | Fargo | North Dakota | 58104 | United States |
|
| Temple University | Recruiting | Philadelphia | Pennsylvania | 19140 | United States |
|