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

Exclusion Criteria

• •Current use of nitrate medications or medications known to interact with nitroglycerin
• •Patients who currently use medications, like calcium channel blockers, that might interfere with study medication
• •Patients with a known allergy to nitroglycerin or common topical ingredients
• •Patients with a history of migraine headaches
• •Patients with a history of unstable medical problems
• •Patients with cognitive or language difficulties that would impair completion of assessment instruments
• •Patients with lab screening values more than 20% outside normal range
• •Patients with non-epithelialized skin lesions, in the area where the gel is to be applied, at the time of screening
• •Pregnant or nursing women
• •Women of child-bearing potential who are unwilling to comply with the contraceptive requirements