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This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate psoriasis vulgaris (PV). Patients will be treated twice daily for 8 weeks on specific lesions of PV and safety and symptoms of PV will be assessed throughout the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo only | Placebo Comparator | Subjects will apply placebo cream to both target lesions |
|
| Active plus placebo | Active Comparator | Subjects will apply CT 327 to one target lesion and placebo to the other target lesion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | 1.0 g (w/w) placebo cream applied to both target lesions twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements from baseline on m-Psoriasis Area Severity Index Scale (m-PASI - modified to exclude area assessment): Proportion of subjects with a reduction in score of > 50% at Week 8 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of an 8-week treatment of CT 327 vs Placebo in terms of improvements from baseline on: Proportion of subjects with a reduction in m-PASI-score of > 75% a Week 8 | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metrolina Medical Research | Charlotte | North Carolina | 28209 | United States | ||
| New Hanover Medical Research |
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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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| CT 327 |
| Drug |
1.0 g CT 327 cream will be applied to one target lesion twice daily and 1.0 g placebo cream will be applied to the remaining target lesion twice daily |
|
| Wilmington |
| North Carolina |
| 28401 |
| United States |
| Piedmont Medical Research, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Premier Medical Group, P.C. | Clarksville | Tennessee | 37040 | United States |
| East Tennessee Medical Research | Johnson City | Tennessee | 37604 | United States |
| University Hospital | Basel | CH-4031 | Switzerland |
| Inselspital | Bern | 3010 | Switzerland |
| Kantonsspital | Sankt Gallen | CH-9007 | Switzerland |
| University Hospital | Zurich | CH-8091 | Switzerland |
| Synexus Midlands | Birmingham | Midlands | B15 2SQ | United Kingdom |
| Synexus Scotland | Clydebank | Strathclyde | G81 2DR | United Kingdom |
| Synexus Wales | Cardiff | CF14 5GJ | United Kingdom |