Raynaud Disease
Conditions
Keywords
Raynaud's, scleroderma, nitroglycerin, MQX-503, treatment
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.
Interventions
DRUG0.9% nitroglycerin in TAM cream
0.5 g of Vascana (0.9% nitroglycerin in proprietary vehicle cream) is applied topically BID for one day before certain planned cold exposures, once just before same planned cold exposures, and, if needed, right after the start of symptoms during same planned cold exposures
DRUGvehicle cream
0.5g of vehicle cream is topically administered BID for one day before certain planned cold exposures, once just before certain planned cold exposures, and, if needed, right after the start of symptoms during certain planned cold exposures
Sponsors
MediQuest Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling) | 2 weeks |
| Changes from baseline in overall disease severity measures | 2 weeks |
| Changes in the time to return to baseline skin temperature | 2 weeks |
| Changes in the maximum reduction in skin temperature | 2 weeks |
Countries
United States
Outcome results
None listed