Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon
The Purpose of this study is to determine the response to two different strengths of a topical gel containing nitroglycerin in patients with Raynaud's disease.
Raynaud's Disease Secondary to Scleroderma
Raynaud's Disease Secondary to Autoimmune Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Phase II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon|
- Measure the time required for blood flow to return to baseline after cold exposure
- Measure the time required for skin temperature to return to baseline after cold exposure
- Prevention or reduction of symptoms following cold exposure.
|Study Start Date:||July 2006|
|Study Completion Date:||July 2006|
The Purpose of this clinical study is to determine, in a controlled fashion, the response to two dosage strengths of a topical gel formulation of Nitroglycerin, MQX-503, in the determination of changes in finger blood flow and skin temperature in the fingers of patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma. The dosage strength response in the treatment of the symptoms (pain, tingling, numbness) will also be monitored.
|United States, Washington|
|Rainier Clinical Research|
|Renton, Washington, United States, 98055|
|Principal Investigator:||Leslie Klaff, MD||Rainier Clinical Research|