Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms
- Conditions
- Raynaud Disease
- Interventions
- Drug: vehicle cream
- Registration Number
- NCT00934427
- Lead Sponsor
- MediQuest Therapeutics
- Brief Summary
The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.
- Detailed Description
Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- clinical diagnosis of Raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers
- a history of at least two Raynaud's events during a typical winter day
- must be willing to apply creams to fingers
- must be willing to undergo cold temperature exposure
- must be willing and able to stop certain medications
- must be willing to use effective contraception, if applicable
- had a Raynaud's attack that required hospital or clinic intervention
- has allergies to nitroglycerin or topical medication ingredients
- has a history of migraine or chronic pain
- has an unstable medical problem that could interfere with the study
- had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months
- used any investigational drug in the past 4 weeks
- has significantly abnormal laboratory tests
- had certain major surgeries in the past 6 months
- has skin lesions on certain parts of the fingers
- women who are pregnant or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle vehicle cream - Vascana 0.9% nitroglycerin in TAM cream -
- Primary Outcome Measures
Name Time Method Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling) 2 weeks
- Secondary Outcome Measures
Name Time Method Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling) 2 weeks Changes from baseline in duration of Raynaud's attacks 2 weeks Changes from baseline in number of Raynaud's attacks 2 weeks Changes from baseline in the Raynaud's Condition Score 2 weeks Changes in the maximum reduction in skin temperature 2 weeks Changes from baseline in overall disease severity measures 2 weeks Changes in the time to return to baseline skin temperature 2 weeks
Trial Locations
- Locations (11)
University of Connecticut
🇺🇸Farmington, Connecticut, United States
University of Medicine and Dentistry in New Jersey
🇺🇸New Brunswick, New Jersey, United States
Michigan State University
🇺🇸Grand Rapids, Michigan, United States
University of Toledo
🇺🇸Toledo, Ohio, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Carolina Arthritis
🇺🇸Wilmington, North Carolina, United States
Stanford University
🇺🇸Redwood City, California, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States