Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

Exclusion Criteria

• •BMI less than 18.5;
• •Clinically significant medical abnormality or history or presence of significant neurological, hepatic, renal, endocrine, gastrointestinal, cardiovascular, pulmonary, psychiatric and/or metabolic condition as determined by the Investigator);
• •Clinical diagnosis of Systemic Sclerosis in association with other rheumatologic diseases including Mixed Connective Tissue Disease;
• •Clinically significant abnormal laboratory test results at screening as determined by the Investigator;
• •Raynaud's Phenomenon thought to be of non-systemic sclerosis etiology;
• •Peripheral or central vasculopathy other than Systemic Sclerosis;
• •History of Scleroderma renal crisis or currently being treated for hypertension, however, subjects with controlled hypertension will not be excluded;
• •Active digital ulcers or rash on hand intended for study medication;
• •History in the past (5) five years of autonomic neuropathy or postural hypotension;
• •Upper extremity sympathectomy at any level in the 12 months prior to study;
• •Tobacco smoking within six months of screening or unwillingness to avoid smoking throughout the study (e.g., cigarette, pipe, cigar, e-cigarettes) and the use of nicotine-containing products;
• •Systolic Blood pressure less than 85mm/Hg;
• •Prostanoid use by any route of administration within the previous six months;
• •Current use of systemic or topical nitrates, endothelin receptor antagonists (e.g., bosentan) or any long-acting PDE-5 Inhibitors (e.g. tadalafil);
• •Use of topical corticosteroid to the hand or fingers within 10 days of screening;
• •Current use of ergot preparations, methysergide, B-adrenergic antagonists, contraceptives containing female steroid hormones, cyclosporine, clonidine, nicotine and cocaine;
• •Pregnant or lactating female;
• •Has known exaggerated pharmacological sensitivity or hypersensitivity to any drug similar to Alprostadil or its excipients;
• •Has known hypersensitivity to nitrile;
• •Involvement in any investigational drug or device study within 30 days prior to screening;
• •History of non-compliance with treatment or clinic visit attendance.