Raynaud Phenomenon
Conditions
Keywords
Raynaud Phenomenon, AbobotulinumtoxinA
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.
Interventions
AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution
OTHERSaline solution
Non-bacteriostatic saline solution
Sponsors
University of Central Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a double-blind placebo-controlled trial.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
The study had to be close early due to lack of support and time resulting in a lower number of participants than hoped for.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants received an injection of Abobotulinum Toxin A into one hand. They received an injection of saline in the other hand.
The Abobotulinum Toxin A injection solution consisted of 300 units in 10 ml of non-bacteriostatic normal saline.
The saline injection consisted of 10 ml of non-bacteriostatic normal saline. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 2 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Abobotulinum Toxin A | Raynaud's Condition Score | 12 Months | 1.4 score on a scale |
| Abobotulinum Toxin A | Raynaud's Condition Score | Baseline | 1.3 score on a scale |
| Abobotulinum Toxin A | Raynaud's Condition Score | 3 Months | 3 score on a scale |
| Abobotulinum Toxin A | Raynaud's Condition Score | 9 Months | 1 score on a scale |
| Saline Solution | Raynaud's Condition Score | 9 Months | 1 score on a scale |
| Saline Solution | Raynaud's Condition Score | 12 Months | 0.6 score on a scale |
| Saline Solution | Raynaud's Condition Score | 3 Months | 0.67 score on a scale |
| Saline Solution | Raynaud's Condition Score | Baseline | 1.3 score on a scale |