Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon

Inclusion Criteria: * Outpatients, 18 years to 70 years. * Patients with a clinical diagnosis of Raynaud's phenomenon. * Patients who are willing to discontinue current vasodilator therapies. * Patients who agree not to use any other investigational medications or approved therapies to treat Raynaud's phenomenon and its symptoms while participating in this study. * Negative pregnancy test in fertile women. * Patients who are able to give written informed consent and comply with all study requirements. Exclusion Criteria: * Patients who concurrently use any nitrate medication or medications known to interact with Nitroglycerin. * Patients who concurrently use any medication or device which might interfere with the study medication. * Patients who have a known allergy to Nitroglycerin or common topical gel ingredients. * Patients with a history of headaches. * Patients who have a history of an unstable medical problem. * Patients with cognitive or language difficulties. * Patients who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension. * Patients who participated in a study of any investigational drug within four weeks prior to Visit 1. * Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal. * Patients who have had major surgery within six months of Visit 1. * Patients with interfering skin conditions. * Pregnant or nursing women.