Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon

Exclusion Criteria

• •Concurrent use of any nitrate medication or medications known to interact with Nitroglycerin such as sildenafil, and other treatments for erectile dysfunction
• •Patients who have a known allergy to Nitroglycerin or common topical gel ingredients
• •Patients with a history of migraine, cluster or vascular headaches, or those who suffer from chronic pain
• •Patients with a history of an unstable medical problem or any current condition that would interfere in participation in the study
• •Patients unable to complete pain assessment instructions
• •Patients who in the last three months have had a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension
• •Patients who have participated in another investigational drug study within four weeks of the first study treatment
• •Patients with out of range laboratory screening values
• •Patients who have had major abdominal, thoracic or vascular surgery within six months of the first study treatment
• •Patients with open lesions or skin conditions where gel is to be applied
• •Pregnant or nursing women
• •Women who will not agree to comply with contraceptive requirements
• •Patients with a history of poor compliance, poor cooperation or unreliability