Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms

• Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Changes from baseline in duration of Raynaud's attacks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Changes from baseline in number of Raynaud's attacks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Changes from baseline in the Raynaud's Condition Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Changes in the maximum reduction in skin temperature [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Changes from baseline in overall disease severity measures [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Changes in the time to return to baseline skin temperature [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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.

• Drug: 0.9% nitroglycerin in TAM cream
  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
  Other Name: Vascana
• Drug: vehicle cream
  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

• Active Comparator: Vascana
  Intervention: Drug: 0.9% nitroglycerin in TAM cream
• Placebo Comparator: Vehicle
  Intervention: Drug: vehicle cream

Inclusion Criteria:

• clinical diagnosis of Raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers
• a history of at least two Raynaud's events during a typical winter day
• must be willing to apply creams to fingers
• must be willing to undergo cold temperature exposure
• must be willing and able to stop certain medications
• must be willing to use effective contraception, if applicable

Exclusion Criteria:

• had a Raynaud's attack that required hospital or clinic intervention
• has allergies to nitroglycerin or topical medication ingredients
• has a history of migraine or chronic pain
• has an unstable medical problem that could interfere with the study
• had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months
• used any investigational drug in the past 4 weeks
• has significantly abnormal laboratory tests
• had certain major surgeries in the past 6 months
• has skin lesions on certain parts of the fingers
• women who are pregnant or nursing