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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Raynaud Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vascana

Group Type ACTIVE_COMPARATOR

0.9% nitroglycerin in TAM cream

Intervention Type DRUG

0.5 g of Vascana (0.9% nitroglycerin in proprietary vehicle cream) is applied topically BID for one day before certain planned cold exposures, once just before same planned cold exposures, and, if needed, right after the start of symptoms during same planned cold exposures

Vehicle

Group Type PLACEBO_COMPARATOR

vehicle cream

Intervention Type DRUG

0.5g of vehicle cream is topically administered BID for one day before certain planned cold exposures, once just before certain planned cold exposures, and, if needed, right after the start of symptoms during certain planned cold exposures

Interventions

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0.9% nitroglycerin in TAM cream

0.5 g of Vascana (0.9% nitroglycerin in proprietary vehicle cream) is applied topically BID for one day before certain planned cold exposures, once just before same planned cold exposures, and, if needed, right after the start of symptoms during same planned cold exposures

Intervention Type DRUG

vehicle cream

0.5g of vehicle cream is topically administered BID for one day before certain planned cold exposures, once just before certain planned cold exposures, and, if needed, right after the start of symptoms during certain planned cold exposures

Intervention Type DRUG

Other Intervention Names

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Vascana

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No