Raynaud's Disease
Conditions
Keywords
Raynaud's phenomenon, Raynaud's Disease, Raynaud's disease secondary to scleroderma, Raynaud's phenomenon secondary to autoimmune disease
Brief summary
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.
Detailed description
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.
Interventions
DRUGNitroglycerin
Sponsors
MediQuest Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Raynaud's phenomenon * Patients who are willing to discontinue any current therapies for Raynaud's phenomenon
Exclusion criteria
* The use of any medication containing nitroglycerin or known to interact with nitroglycerin * Patients with a history of migraine or other severe headaches * Open skin lesions or skin conditions in the area where medication is to be applied * Pregnant or nursing women or those wishing to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in blood flow in the fingers of the non-dominant hand after the induction of constriction of blood vessels by exposure to local cold temperatures. | 130 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in skin temperature recovery time and symptoms in the fingers of the non-dominant hand after the induction of constriction of blood vessels by exposure to local cold temperatures. | 130 minutes |
| Frequency and severity of adverse events | 2 weeks |
Countries
United States
Outcome results
None listed