A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon

Inclusion Criteria:

• Outpatients ages 15 - 70.

• Patients with a diagnosis of Raynaud's phenomenon.

• Patients who agree to apply study medication to their fingers.

• Patients who are willing to stop current topical vasodilator therapies.

• Patients who agree not to start or change dosage of current oral vasodilatortherapies.

• Patients who agree not to use any nitrate therapy while participating in this study.

• Negative pregnancy test in fertile women and agreement to use effective contraceptionthroughout the study.

Exclusion Criteria:

• Patients who currently use nitrate medication or medications known to interact withnitroglycerin.

• Patients who have an allergy to nitroglycerin or common topical gel ingredients.

• Patients with a history of severe headaches.

• Patients with an unstable medical problem.

• Patients with cognitive or language difficulties that would impair their ability tocomplete assessment of pain instruments.

• Patients who have had a recent heart attack or other uncontrolled heart condition.

• Patients who have participated in an investigational drug study within four weeks ofvisit one.

• Patients who have clinically significant abnormal lab values.

• Patients who have had recent major abdominal, thoracic or vascular surgery.

• Patients with interfering skin conditions.

• Pregnant or nursing women or women unwilling to comply with contraceptiverequirements.