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

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.

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Key information

Conditions

Raynaud Disease Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Embolism and Thrombosis Immune System Diseases Livedoid Vasculopathy Peripheral Vascular Diseases Raynaud Disease Secondary to Scleroderma Raynaud Secondary to Other Autoimmune Disease Scleroderma, Systemic Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical organogel with nitroglycerin

Drug

Primary outcomes

Differntial time for blood flow to return to baseline following cold exposure.

Secondary outcomes

Differential time for skin temperature to return to baseline following cold exposure.
Quantitative reduction or prevention in symptoms following cold exposure.

Sponsors and collaborators

Lead sponsor

MediQuest Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Study completion: 2005
First posted: Nov 15, 2005
Registry last updated: May 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed