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

University of Central Florida

Status and phase: Terminated; Phase 4

Conditions: Raynaud Phenomenon

Treatments: Drug: AbobotulinumtoxinA; Other: Saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03639766

BIO-18-14092

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3 participants in 2 patient groups, including a placebo group

Abobotulinum toxin A

Experimental group

Description:

Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand.

Treatment:

Drug: AbobotulinumtoxinA

Saline solution

Placebo Comparator group

Description:

Injection of 10 ml of non-bacteriostatic normal saline to chosen hand.

Treatment:

Other: Saline solution