Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome
Scleroderma, Raynaud's Syndrome
About this trial
This is an interventional treatment trial for Scleroderma focused on measuring Scleroderma, Systemic, Raynaud Disease, Botulinum Toxins, Type A
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
Sites / Locations
- Johns Hopkins Bayview Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Onabotulinumtoxin A
Placebo
One hand of each patient will be randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL). Injections are performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.
One hand of each patient will be randomly selected for injection of sterile saline solution (placebo). Injections are performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).