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The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.
Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vascana | Active Comparator |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% nitroglycerin in TAM cream | Drug | 0.5 g of Vascana (0.9% nitroglycerin in proprietary vehicle cream) is applied topically BID for one day before certain planned cold exposures, once just before same planned cold exposures, and, if needed, right after the start of symptoms during same planned cold exposures |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling) | 2 weeks | |
| Changes from baseline in duration of Raynaud's attacks | 2 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Gregory, MD | MediQuest Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Redwood City | California | 94063 | United States | ||
| University of Connecticut |
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|
|
| vehicle cream | Drug | 0.5g of vehicle cream is topically administered BID for one day before certain planned cold exposures, once just before certain planned cold exposures, and, if needed, right after the start of symptoms during certain planned cold exposures |
|
| Changes from baseline in number of Raynaud's attacks |
| 2 weeks |
| Changes from baseline in the Raynaud's Condition Score | 2 weeks |
| Changes in the maximum reduction in skin temperature | 2 weeks |
| Changes from baseline in overall disease severity measures | 2 weeks |
| Changes in the time to return to baseline skin temperature | 2 weeks |
| Farmington |
| Connecticut |
| 06030 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
| Michigan State University | Grand Rapids | Michigan | 49546 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Medicine and Dentistry in New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Carolina Arthritis | Wilmington | North Carolina | 28401 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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