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The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase blood flow to the fingers.
The purpose of this clinical study is to determine, in a controlled fashion, the ability of Topical AmphiMatrix formulation with Nitroglycerin (MQX-503) to improve the patient's health assessment as indicated by patient and physician assessments, decrease the frequency of Raynaud's events, decrease the duration of Raynaud's events, and decrease the symptoms (pain, tingling, numbness) in the fingers of Raynaud's patients. The study will include patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases such as scleroderma.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical AmphiMatrix with nitroglycerin (MQX-503) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Raynaud's Condition Score |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Severity of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Standford Medical School | Stanford | California | 94305 | United States | ||
| University of Connecticut |
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| Farmington |
| Connecticut |
| 06030 |
| United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| The Center for Rheumatology | Albany | New York | 12206 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Lund University Hospital | Lund | 221 185 | Sweden |
| Royal National Hospital for Rheumatic Diseases | Bath | LX1 3EX | United Kingdom |
| Ninewells Hospital and Medical School | Dundee | DD1 9SY | United Kingdom |
| University of Leeds | Leeds | LS7 4SA | United Kingdom |
| Royal Free Hospital | London | NW3 2QH | United Kingdom |
| Hope Hospital | Salford | M6 8HD | United Kingdom |
| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| D045743 | Scleroderma, Diffuse |
| D001327 | Autoimmune Diseases |
| 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 |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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