Efficacy and Safety of Vascana® in Subjects With Secondary Raynaud's Phenomenon

Inclusion criteria

• ✓. Provide written consent prior to any study-specific evaluation
• ✓. Males and females aged 18 years to 75 years, inclusive
• ✓. A clinical diagnosis of secondary Raynaud's Phenomenon (defined as Raynaud's Phenomenon (RP) significant enough to cause a patient to modify daily behavior) as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers, or by such an event observed by the study physician and a diagnosis of a disease state known to be associated with RP. Secondary RP may be due to scleroderma, systemic lupus erythematosus, mixed connective tissue disease, or other connective tissue diseases
• ✓. Agree to apply the study drug to their fingers as specified in the protocol
• ✓. Agree to the controlled cold exposures as described in the protocol
• ✓. Willing to discontinue current vasodilator therapies used specifically for the treatment of Raynaud's
• ✓. Agree not to use any other investigational medications or approved or unapproved therapies to treat RP and its symptoms while participating in this study. Such medications include, but are not limited to: other dosages forms of nitroglycerin, eg, isosorbide dinitrate, fenoldopam mesylate, milrinone lactate, nifedipine, diltiazem, felodipine, nimodipine, nisoldipine, fluoxetine, pregabalin, and verapamil. Use of phosphodiesterase 5 inhibitors (eg, sildenafil, tadalafil, vardenafil) is excluded unless being used intermittently for male erectile dysfunction and not taken within 48 hours of scheduled study drug dosing
• ✓. Negative urine pregnancy test for women of child-bearing potential prior to the first study treatment and who agree to use effective contraception throughout the study

Exclusion criteria