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

MediQuest Therapeutics

Status and phase: Unknown; Phase 3

Conditions: Raynaud Disease

Treatments: Drug: 0.9% nitroglycerin in TAM cream; Drug: vehicle cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT00934427

09-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Vascana

Active Comparator group

Treatment:

Drug: 0.9% nitroglycerin in TAM cream

Vehicle

Placebo Comparator group

Treatment:

Drug: vehicle cream