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The purpose of this study is to evaluate the blood flow response to topical Glyceryl Trinitrate when applied to the skin of patient's fingers with Raynaud's Phenomenon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. | Placebo Comparator | placebo cream applied to 2 adjacent fingers on non-dominant hand one time |
|
| 2 | Active Comparator | 0.6mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand |
|
| 3 | Active Comparator | 1.2mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time |
|
| 4 | Active Comparator | 1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers on non-dominant hand one time |
|
| 5 | Active Comparator | 2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo cream | Drug | placebo cream applied to 2 adjacent fingers of non-dominant hand one time |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate vascular responses to topical Glyceryl Trinitrate versus placebo in patients with Raynaud's using laser Doppler imaging to measure blood flow | 6 visits no less than 10 hours between visits |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the dose proportionality of the microvascular response to topical Glyceryl Trinitrate | 6 visits no less than 10 hours between visits | |
| Compare the systemic versus topical effect of Glyceryl Trinitrate on vascular response. | 6 visits no less than 10 hours between visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa-Institute for Clinical and Translational Science | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| 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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| Glyceryl Trinitrate |
| Drug |
0.6mg of Glyceryl Trinitrate applied to 2 adjacent fingers on non-dominant hand one time |
|
| Glyceryl Trinitrate | Drug | 1.2mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time |
|
| Glyceryl Trinitrate | Drug | 1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time |
|
| Glyceryl Trinitrate | Drug | 2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time |
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |