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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
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
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
Stanford University
Redwood City, California, United States
University of Connecticut
Farmington, Connecticut, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling)
Time frame: 2 weeks
Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling)
Time frame: 2 weeks
Changes from baseline in duration of Raynaud's attacks
Time frame: 2 weeks
Changes from baseline in number of Raynaud's attacks
Time frame: 2 weeks
Changes from baseline in the Raynaud's Condition Score
Time frame: 2 weeks
Changes in the maximum reduction in skin temperature
Time frame: 2 weeks
Changes from baseline in overall disease severity measures
Time frame: 2 weeks
Changes in the time to return to baseline skin temperature
Time frame: 2 weeks
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University of Michigan
Ann Arbor, Michigan, United States
Michigan State University
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Medicine and Dentistry in New Jersey
New Brunswick, New Jersey, United States
Carolina Arthritis
Wilmington, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Toledo
Toledo, Ohio, United States
...and 1 more locations