Raynaud's Disease Clinical Trial
Official title:
Phase II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
The purpose of this clinical study is to determine the response to two different dosage strengths of a topical nitroglycerin gel in patients with Raynaud's Phenomenon. Patient fingers will be monitored for changes in blood flow and skin temperature. Symptoms of pain, tingling and numbness will also be monitored.
It is the intention of this protocol to study, in a controlled manner, the response of
fingers of patients with Raynaud's phenomenon to two dosage strengths of a fast acting
topical formulation of Nitroglycerin, MQX-503. Patients may have moderate to severe primary
Raynaud's phenomenon or Raynaud's phenomenon secondary to autoimmune diseases such as
scleroderma.
Quantitative changes in blood flow in the fingers of the non-dominant hand will be measured
after the clinical induction of constriction of blood vessels by exposure to local cold
temperatures. Secondarily, the quantitative reduction in skin temperature recovery time and
symptoms of pain, tingling and numbness associated with Raynaud's phenomenon will be
evaluated using a patient hand symptom analog assessment score. The frequency and severity
of adverse events associated with MQX-503 will be assessed.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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