Lab Study of MQX-503 in Treatment of Raynaud's

Study Overview
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Brief Summary
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The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures. Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours. Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response.

Official Title
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Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon

Conditions
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Raynaud Disease, Raynaud Disease Secondary to Scleroderma, Raynaud Secondary to Other Autoimmune Disease

Intervention / Treatment
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* Drug: topical organogel with nitroglycerin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of Raynaud's phenomenon outpoatients agree to apply gel as per protocol willing to discontinue current vasodilator therapy agree to stop other investigational medication for Raynaud's negative pregnancy test is fertile females able to give written informed consent and comply with study requirements Exclusion Criteria: current use of ay nitrate medication or medications that interact with nitroglycerin patients with a known allergy to nitroglycerin or topical gel ingredients patients with a history of migraine headaches patients with unstable medical problems patients with cognitive or language difficulties patients with screening lab values more than 20% outside of normal patients with open lesions at site of application women of child-bearing potential who are unwilling to comply with contraceptive requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: topical organogel with nitroglycerin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differntial time for blood flow to return to baseline following cold exposure. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential time for skin temperature to return to baseline following cold exposure. |  |  | 
| Quantitative reduction or prevention in symptoms following cold exposure. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raynaud's, sclerderma, systemic sclerosis, autoimmune disease