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The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures.
Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours.
Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical organogel with nitroglycerin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Differntial time for blood flow to return to baseline following cold exposure. |
| Measure | Description | Time Frame |
|---|---|---|
| Differential time for skin temperature to return to baseline following cold exposure. | ||
| Quantitative reduction or prevention in symptoms following cold exposure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura K Hummers, MD | Johns Hopkins University | Principal Investigator |
| Carin Dugowson, MD, MPH | University of Washington Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States | ||
| University of Washington Medical College |
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| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| D012595 | Scleroderma, Systemic |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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| Seattle |
| Washington |
| 98195 |
| United States |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003240 | Connective Tissue Diseases |
| D007154 | Immune System Diseases |