The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon

Study Overview
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Brief Summary
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This study aims to investigate the effect of abobotulinum toxin A on the symptoms of Raynaud's phenomenon.

Detailed Description
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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.

Official Title
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The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial

Conditions
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Raynaud Phenomenon

Intervention / Treatment
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* Drug: AbobotulinumtoxinA
* Other: Saline solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a two-arm parallel assignment involves two groups of participants. One group/hand receives the abobotulinum toxin A, and the other group/hand receives a saline solution (control).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abobotulinum toxin A<br>Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand. | Drug: AbobotulinumtoxinA<br>* AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution<br>|
| Placebo Comparator: Saline solution<br>Injection of 10 ml of non-bacteriostatic normal saline to chosen hand. | Other: Saline solution<br>* Non-bacteriostatic saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raynaud's Condition Score | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raynaud Phenomenon, AbobotulinumtoxinA