Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome
Condition: Scleroderma; Raynaud's Syndrome
MeSH terms: Raynaud Disease; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Syndrome
Intervention: Onabotulinumtoxin A; sterile saline solution
Intervention MeSH terms: Botulinum Toxins; abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Scleroderma, Systemic; Raynaud Disease; Botulinum Toxins, Type A

Summary:

      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.
    

Eligibility criteria:

        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