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

Phase 4TerminatedNCT03639766

University of Central Florida3 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Raynaud Phenomenon

Interventions

AbobotulinumtoxinADRUG

AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution

Saline solutionOTHER

Non-bacteriostatic saline solution

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UCF Health Lake Nona Office

Orlando, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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