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Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms

Information source: MediQuest Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Raynaud Disease

Intervention: 0.9% nitroglycerin in TAM cream (Drug); vehicle cream (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: MediQuest Therapeutics

Official(s) and/or principal investigator(s):
Jeff Gregory, MD, Study Director, Affiliation: MediQuest Therapeutics


The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.

Clinical Details

Official title: A Study of a Topical Formulation of Nitroglycerin, Vascana® (MQX-503), and Matching Vehicle in the Treatment and Prevention of Symptoms Associated With Raynaud's Phenomenon

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling)

Secondary outcome:

Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling)

Changes from baseline in duration of Raynaud's attacks

Changes from baseline in number of Raynaud's attacks

Changes from baseline in the Raynaud's Condition Score

Changes in the maximum reduction in skin temperature

Changes from baseline in overall disease severity measures

Changes in the time to return to baseline skin temperature

Detailed description: Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


Inclusion Criteria:

- clinical diagnosis of Raynaud's phenomenon as determined by a history of cold

sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers

- a history of at least two Raynaud's events during a typical winter day

- must be willing to apply creams to fingers

- must be willing to undergo cold temperature exposure

- must be willing and able to stop certain medications

- must be willing to use effective contraception, if applicable

Exclusion Criteria:

- had a Raynaud's attack that required hospital or clinic intervention

- has allergies to nitroglycerin or topical medication ingredients

- has a history of migraine or chronic pain

- has an unstable medical problem that could interfere with the study

- had a heart attack or uncontrolled heart problems, hypertension, or hypotension in

the past 3 months

- used any investigational drug in the past 4 weeks

- has significantly abnormal laboratory tests

- had certain major surgeries in the past 6 months

- has skin lesions on certain parts of the fingers

- women who are pregnant or nursing

Locations and Contacts

Stanford University, Redwood City, California 94063, United States

University of Connecticut, Farmington, Connecticut 06030, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

University of Michigan, Ann Arbor, Michigan 48106, United States

Michigan State University, Grand Rapids, Michigan 49546, United States

University of Minnesota, Minneapolis, Minnesota 55455, United States

University of Medicine and Dentistry in New Jersey, New Brunswick, New Jersey 08903, United States

Carolina Arthritis, Wilmington, North Carolina 28401, United States

Cleveland Clinic, Cleveland, Ohio 44195, United States

University of Toledo, Toledo, Ohio 43614, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: June 2009
Last updated: July 19, 2010

Page last updated: August 23, 2015

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