The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Raynaud's Condition Score
Study Overview
Brief Summary
This study aims to investigate the effect of abobotulinum toxin A on the symptoms of Raynaud's phenomenon.
Detailed Description
This prospective double-blind randomized control trial seeks to compare a single formulation of BoNT, aboboutlinum toxin A (Dysport), to a placebo saline group, studying the effect of BoNT on Raynaud's symptoms among a more diverse population to provide insight into the patients most likely to benefit from BoNT.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
This is a double-blind placebo-controlled trial.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female adult between 18 and 80 years of age
- •Must have health insurance
- •Must have a current diagnosis of Raynaud's phenomenon
Exclusion Criteria
- •Allergy to abobotulinum toxin A or its components
- •Diagnosis of myasthenia gravis
- •Previously received abobotulinum toxin vaccine
- •Previously undergone upper extremity vascular surgery (including surgical sympathectomy)
- •Currently receiving aminoglycoside antibiotics
- •Received abobotulinum toxin A treatment in either hand in the past 6 months
- •Pregnant women
- •Women currently breastfeeding
- •Current tobacco smoker (use in the past 12 months)
- •Unable to read and speak English
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Prisoners
Arms & Interventions
Abobotulinum toxin A
Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand.
Intervention: AbobotulinumtoxinA (Drug)
Saline solution
Injection of 10 ml of non-bacteriostatic normal saline to chosen hand.
Intervention: Saline solution (Other)
Outcomes
Primary Outcomes
Raynaud's Condition Score
Time Frame: 12 months
Raynaud's Condition Score is a validated outcome measure used to assess a person's functionality owing to their Raynaud's symptoms. 0 to 10, with 0 being no symptoms and 10 being more severe symptoms of Raynaud's.
Secondary Outcomes
No secondary outcomes reported
Investigators
David Weinstein
Assistant Professor of Dermatology
University of Central Florida