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

Phase 4

Terminated

• Conditions: Raynaud Phenomenon
• Interventions: Drug: AbobotulinumtoxinA; Other: Saline solution

• Registration Number: NCT03639766
• Lead Sponsor: University of Central Florida

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 Timeline

• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Study Start: 2018-08-31
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Results First Submitted: 2021-05-15
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-09
• Results First Posted: 2021-06-30
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abobotulinum toxin A	AbobotulinumtoxinA	Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand.
Saline solution	Saline solution	Injection of 10 ml of non-bacteriostatic normal saline to chosen hand.

Primary Outcome Measures

Name	Time	Method
Raynaud's Condition Score	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.

Trial Locations

Locations (1)

UCF Health Lake Nona Office; 🇺🇸 Orlando, Florida, United States