Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome

A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial Assessing the Therapeutic Efficacy of Botulinum Toxin In Treating Scleroderma-Associated Raynaud's Syndrome

This is a randomized, double-blinded, clinical trial assessing the therapeutic efficacy of Botulinum toxin A (Onabotulinumtoxin A) in treating scleroderma-associated Raynaud's syndrome. Each patient will undergo injection with a treatment dose of Botulinum toxin A in one randomly-selected hand, and the contralateral hand will be injected with sterile saline (placebo) to serve as a control.

Study participants at the first study visit will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging to assess blood flow. After this initial assessment, the patients will undergo peri-arterial injection of Botulinum toxin A in one hand, and of sterile saline solution (placebo) in the other, in a randomized, blinded manner.

Patient will report the severity of their Raynaud's symptoms weekly over the four month study period. At one month post-injection, the patient will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. At four months post-injection, the patient will again complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. In addition, patient will be given the option of one week post-injection visit, at which point the same assessment will be performed.

At the conclusion of the study, unblinding will occur.

Inclusion Criteria:

• Aged 18 years and older
• Diagnosed with scleroderma.
• Symptoms of Raynaud's syndrome affecting both hands (not necessarily to equal extents)
• Ability to return/be available for follow-up evaluations
• Able and willing to give informed consent
• Able to speak and read in the English language.

Exclusion Criteria:

• A history of Myasthenia gravis.
• Reported allergy or hypersensitivity to any Botulinum toxin preparation.
• Active infection in either hand.
• Patients who have ever received Botulinum toxin vaccine.
• Pregnant or lactating women.
• Females unable or unwilling to maintain abstinence or use contraception for 28 days following the injections.
• Patients who have previously undergone any vascular surgery on the upper extremity, including surgical sympathectomies.
• Current use of any aminoglycoside antibiotic