Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study of a Topical Formulation of Nitroglycerin, Vascana® (MQX-503), and Matching Vehicle in the Treatment and Prevention of Symptoms Associated With Raynaud's Phenomenon

Conditions
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Raynaud Disease

Intervention / Treatment
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* Drug: 0.9% nitroglycerin in TAM cream
* Drug: vehicle cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vascana<br> | Drug: 0.9% nitroglycerin in TAM cream<br>* 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<br>* Other names: Vascana;|
| Placebo Comparator: Vehicle<br> | Drug: vehicle cream<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raynaud's, scleroderma, nitroglycerin, MQX-503, treatment