Recruiting Raynaud’s Patients for Botox® Study – Study Closed

The recruitment for this research  is now completed – the study is closed.  Thanks to all who responded.

We’ve been contacted by a researcher at Mount Sinai Hospital in New York City to help recruit Raynaud’s patients for a clinical trial using Botox® to relieve symptoms from Raynaud’s phenomenon.

If you’re in the NY Metro area, over the age of 18, have either primary or secondary Raynaud’s and are not currently using any medications or other therapies to control your symptoms, you may qualify.

Contact Dr. Elie Lowenstein at elielowenstein@gmail.com.  Below is more information on the study.

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Study for patients with Raynaud’s Disease/Phenomenon 

Title: Botulinum toxin: A potential therapy for patients with Raynaud’s phenomenon: A Double Blinded, Randomized Controlled Trial

 

Principal Investigator and site: Dr Elie Lowenstein, Mount Sinai Hospital/Icahn School of Medicine at Mount Sinai, New York, NY

 

Raynaud’s phenomenon (RP) is a common disorder that affects 3−5% of the general population and more than 90% of patients with scleroderma. Raynaud’s phenomenon results in significant morbidity for many of these patients.  Vasospasm of the digital arteries, triggered by cold or stress, leads to episodic asphyxia of the digits. Aside from the color changes of the involved skin, the vascular compromise often results in significant pain, dysesthesia, ulceration, infarction, and eventual amputation of digits.  Prevention of attacks by avoidance of triggers (cold, certain medications, and smoking) plays a primary role in treatment.  Medications used for RP primarily consist of vasodilators, such as calcium channel blockers, nitrates, prostacyclins, and phosphodiesterase inhibitors.   

The purpose of this study is to assess the efficacy of Botulinum toxin as an investigational drug  for digital (finger and hand) symptoms from Raynaud’s phenomenon. The study will look for improvement in subject’s Raynaud’s Condition Scores (RCS) (a scale that lets us know how bad your Raynaud’s is in your opinion), frequency and duration of daily Raynaud’s attacks, and the Dermatology Quality of Life Index (DLQI) ( a measure of how skin disease affects your life).  Some patients develop ulcers on their fingers because of their Raynaud’s.  Digital ulcers quality and count will also be monitored for improvement throughout the study.

Botulinum toxin is approved for the treatment of glabellar frown lines and hyperhidrosis (excessive sweating).  It is known to paralyze different parts of the nervous system. We believe this effect will help to open up the blood vessels in the hands that are constricted in patients with Raynaud’s.   Botulinum toxin is not approved for the treatment of Raynaud’s.

Recently, botulinum toxin has begun to be studied as a possible non-invasive therapeutic option.  Botulinum toxin’s known effect on inhibiting both autonomic and somatic neurotransmission lends itself to inhibit the inappropriate sympathetically mediated vasoconstriction at play in RP, thereby improving oxygen delivery.  Promising results have been reported in case reports and series in the surgical literature. To date, there are no placebo controlled trials in the dermatologic literature looking at this approach. 

You may qualify to take part in this research study if you over the age of 18 and have Raynaud’s phenomenon due to any cause and have not been well controlled on any current or previous therapies.

For more information about this study, please contact Dr. Elie Lowenstein at elielowenstein@gmail.com