Conditions: Raynaud Phenomenon
Keywords: Raynaud Phenomenon AbobotulinumtoxinA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: yes

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.

Arms:
arm 1: Injection of 300 units of abobotulinum toxin A in 10 ml of non-bacteriostatic normal saline to chosen hand. arm 2: Injection of 10 ml of non-bacteriostatic normal saline to chosen hand.

Interventions: intervention 1: AbobotulinumtoxinA intervention 2: Saline solution
Intervention descriptions: intervention 1: AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution intervention 2: Non-bacteriostatic saline solution

Protocol document:
Prot_SAP_000.pdf: 
The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud’s Phenomenon, a 
Double-Blind Randomized Placebo-Controlled Trial 
 
 
NCT03639766 
 
 
Date: September 26th, 2018 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 1 of 20 
Revised: December 7, 2017 
 
PROTOCOL TITLE: 
 
The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud’s Phenomenon, a 
Double-Blind Randomized Placebo-Controlled Trial 
 
PRINCIPAL INVESTIGATOR: 
 
David Weinstein, M.D. 
UCF College of Medicine, UCF Health 
(407) 266 – 3627 
david.weinstein@ucf.edu 
 
Co-Principal Investigator:  
Naveed Sami M.D. 
UCF Health 
Naveed.Sami@ucf.edu 
 
Co-Principal Investigator:  
Amelia Winter, B.A. 
UCF College of Medicine 
arwinter@knights.ucf.edu 
 
Co-Principal Investigator: 
Adam Foley, B.S. 
UCF College of Medicine 
adamfoley7@knights.ucf.edu 
 
Co-Principal Investigator:  
Sun Kim, B.A. 
UCF College of Medicine 
sunkim@knights.ucf.edu  
 
Co-Principal Investigator: 
Samantha Prabakaran, B.S. 
UCF College of Medicine 
sprabakaran@knights.ucf.edu 
 
Sub-Investigator 
Rachel Diem-Trang Truong, B.A. 
UCF College of Medicine 
racheltr@knights.ucf.edu  
 
 
Sub-Investigator 
Kyle Sommerfield, B.S. 
UCF College of Medicine 
ksommerf@knights.ucf.edu 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 2 of 20 
Revised: December 7, 2017 
 
 
 
VERSION NUMBER: 2 
 
 
DATE: 
9/26/2018 
 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 3 of 20 
Revised: December 7, 2017 
 
Table of Contents 
1.0 
Objectives* .............................................................................................................. 4 
2.0 
Background* ............................................................................................................ 4 
3.0 
Inclusion and Exclusion Criteria* ............................................................................ 5 
4.0 
Study-Wide Number of Subjects* ........................................................................... 6 
5.0 
Study-Wide Recruitment Methods* ........................................................................ 6 
6.0 
Multi-Site Research* ............................................................................................... 6 
7.0 
Study Timelines* ..................................................................................................... 6 
8.0 
Study Endpoints* ..................................................................................................... 6 
9.0 
Procedures Involved* ............................................................................................... 7 
10.0 Data and Specimen Banking* ................................................................................ 12 
11.0 Data Management* and Con=dentiality ................................................................ 12 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 14 
13.0 Withdrawal of Subjects* ........................................................................................ 14 
14.0 Risks to Subjects* .................................................................................................. 14 
15.0 Potential Bene=ts to Subjects* .............................................................................. 15 
16.0 Vulnerable Populations* ........................................................................................ 15 
17.0 Community-Based Participatory Research* .......................................................... 15 
18.0 Sharing of Results with Subjects* ......................................................................... 15 
19.0 Setting .................................................................................................................... 15 
20.0 Resources Available ............................................................................................... 15 
21.0 Prior Approvals ...................................................................................................... 16 
22.0 Recruitment Methods ............................................................................................. 16 
23.0 Local Number of Subjects ..................................................................................... 17 
24.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 17 
25.0 Compensation for Research-Related Injury ........................................................... 17 
26.0 Economic Burden to Subjects ................................................................................ 17 
27.0 Consent Process ..................................................................................................... 17 
28.0 Process to Document Consent in Writing .............................................................. 18 
29.0 Drugs or Devices .................................................................................................... 18 
 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 4 of 20 
Revised: December 7, 2017 
 
1.0 
Objectives* 
1.1 This study aims to investigate the effect of abobotulinum toxin A on 
the symptoms of Raynaud’s phenomenon. By studying the effect of 
abobotulinum toxin A on Raynaud’s symptoms among a more 
diverse population we hope to provide insight into the patients most 
likely to benefit from abobotulinum toxin A.   
1.2 Our hypothesis is that hands that receive injections of abobotulinum 
toxin A will experience greater relief from symptoms compared to 
hands which do not 
2.0 
Background* 
2.1 Raynaud’s phenomenon affects up to 20% of the population, and is 
commonly associated with many autoimmune and inflammatory 
diseases.1 It affects over 90% of scleroderma patients, but also 
affects over 10% of patients with systemic lupus, dermatomyositis, 
rheumatoid arthritis, and primary Sjӧgren’s syndrome.2 Additionally, 
Raynaud’s phenomenon associated with an immunological disease is 
commonly has severe progression and can lead to amputation of the 
affected digits.2 Symptoms of Raynaud’s phenomenon are a result of 
worsened circulation to the extremities, particularly in the hands. A 
decrease in circulation leads to ischemia of the tissues, causing pain 
and functional limitations as well as ulcers and gangrene.3 This can 
prove extremely debilitating to patients, reducing quality of life. 
Treatment options include medications which seek to increase 
vasodilation, most commonly calcium channel blockers.4 If patients 
fail to improve under pharmacological interventions, surgery is often 
required to alleviate symptoms or remove ischemic and gangrenous 
tissue.5 However, studies have shown that botulinum toxin (BoNT) 
reduces symptoms in certain patient populations with Raynaud’s 
phenomenon.6-9  
2.2 BoNT works as a vasodilator by blocking the release of 
neurotransmitters and thereby decreasing the muscular sympathetic 
response.10 Therefore, the muscle relaxes and in the case of vascular 
muscle, allows for vasodilation of the blood vessel. Although 
approved by the FDA to treat muscle spasms, the specific use of 
BoNT for the treatment of Raynaud’s phenomenon is not 
recognized.11 Despite its off-label use, multiple studies support the 
benefits of using BoNT as a treatment for Raynaud’s phenomenon.12 
2.3 A 2014 study by Neumeister and colleagues shows BoNT improves 
blood flow in the hand as well as reduces pain and improves 
function.7 However, studies have focused on specific patient 
populations, such as that of scleroderma or systemic sclerosis.6,13 
Additionally, studies have lacked a coordinated methodology with 
some lacking double-blind experimentation, a control group, or 
appropriate treatment dosage. Our prospective double-blind 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 5 of 20 
Revised: December 7, 2017 
 
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. Additionally, we hope that if we have positive 
findings that this data could be used to justify insurance coverage of 
BoNT in Raynaud’s phenomenon. With BoNT costing hundreds to 
thousands of dollars per treatment, it can prove a financial burden for 
patients relying on BoNT for relief from symptoms and prevention 
of amputation.14 Preliminary findings from this study could be used 
to justify further studies for a new indication for Raynaud’s 
phenomenon thus improving patients’ chances for coverage and ease 
of access.  
3.0 
Inclusion and Exclusion Criteria* 
3.1 For this study, patients at UCF Health will be screened in person for 
eligibility using the following inclusion criteria listed in 3.2. 
Screening will be performed by Dr. Weinstein or Dr. Sami. (See 
attached “Eligibility Screening”) 
3.2 Screening Criteria  
• Inclusion Criteria: 
o Male or female adult between 18 and 80 years of 
age 
o Must have health insurance 
o Must have a current diagnosis of Raynaud’s 
phenomenon 
• Exclusion Criteria:  
o Allergy to abobotulinum toxin A or its components 
o Diagnosis of myasthenia gravis 
o Previously received abobotulinum toxin vaccine 
o Previously undergone upper extremity vascular 
surgery (including surgical sympathectomy) 
o Currently receiving aminoglycoside antibiotics 
o Received abobotulinum toxin A treatment in either 
hand in the past 6 months 
o Pregnant women 
o Women currently breastfeeding 
o Current tobacco smoker (use in the past 12 months) 
o Unable to read and speak English 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 6 of 20 
Revised: December 7, 2017 
 
o Adults unable to consent 
o Individuals who are not yet adults (infants, children, 
teenagers)Prisoners 
4.0 
Study-Wide Number of Subjects* 
4.1 We plan on enrolling 20 subjects with the aim to accrue 16 subjects 
who successful screen for eligibility for the study.  This number was 
derived from a power analysis performed with Bee Nash. 
5.0 
Study-Wide Recruitment Methods* 
5.1 
Not applicable. This is not a multicenter research study and 
research will only be conducted at UCF Health clinics in Lake Nona. 
Local recruitment methods are described in section 19.0 Setting.  
6.0 
Multi-Site Research* 
6.1 
Not applicable. This is not a multi-site research project. Research 
will only be conducted at the UCF Health clinic in Lake Nona. 
7.0 
Study Timelines* 
7.1 Subjects are expected to participate in this study for a total of twelve 
months. During these twelve months, subjects will be required to 
come to UCF Health Clinic at 9975 Tavistock Lakes Blvd., Orlando, 
FL 32827 for a total of five appointments: 
• Baseline appointment: 1 hour 
• 48-hours follow-up phone call: 5 minutes 
• 1-month follow-up appointment: 15 minutes 
• 3-month follow-up appointment: 15 minutes 
• 6-month follow-up appointment: 15 minutes 
• 12-month follow-up appointment: 15 minutes 
• For the first 3 months subjects will be asked to complete a weekly 
survey either online or on paper to bring in. 
• For the final 9 months subjects will be asked to complete a 
monthly survey either online or on paper to bring in. 
• Ten months is the anticipated length of time to recruit participants. 
• The study is expected to be completed by October 2019. 
8.0 
Study Endpoints* 
8.1 Primary endpoints: Participation in the study will end 12 months 
after the baseline visit or if the patient elects to be removed from the 
study, whichever comes first. 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 7 of 20 
Revised: December 7, 2017 
 
8.2 Primary and secondary safety endpoints: adverse reaction to the 
abobotulinum toxin A solution. If a participant develops a reaction, 
he or she will be given the option to withdraw but will not be 
required to withdraw, unless life threatening. 
9.0 
Procedures Involved* 
9.1 Our study is a double-blind randomized placebo-controlled trial.  
• Treatment arm: Injection of 300 units of abobotulinum toxin A in 
10 ml of non-bacteriostatic normal saline to chosen hand. 
• Control arm: Injection of 10 ml of non-bacteriostatic normal saline 
to chosen hand. 
• Randomization will be determined by coin flip as follows: 
o Heads: Right hand – treatment arm; Left hand – 
control arm. 
o Tails: Right hand – control arm; Left hand – 
treatment arm. 
9.2 Timeline 
• Subject visits 
o The abobotulinum toxin A solution and saline 
solution will be prepared the same day as the 
subject’s baseline visit 
o Baseline Visit 
a. Minute 00-20: 
i. Screening and consent process in 
screening room 
b. Minute 20-40:  
i. Assessment of baseline Raynaud’s 
symptoms via Baseline Case Report 
(attached) and photographs will be 
taken of both hands 
ii. Administration of abobotulinum 
toxin A solution and normal saline 
solution 
c. Minute 40-60: 
i. Review post-procedure instructions 
and how to complete Brief Follow-
up Case Reports. Observe subject for 
any adverse reaction. 
o 48-hour follow-up phone call: 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 8 of 20 
Revised: December 7, 2017 
 
a. Minute 0-5: 
i. Brief phone call to assess for any adverse 
reactions.  
o 1-month (+/- 8 days) Follow-up  
a. Minute 00-15:  
i. Assessment of Raynaud’s symptoms 
via Follow-up Case Report 
(attached) and photographs will be 
taken of both hands 
o 3-month (+/- 15 days) Follow-up 
a. Minute 00-15:  
i. Assessment of Raynaud’s symptoms 
via Follow-up Case Report 
(attached) 
o 6-month (+/- 15 days) Follow-up 
a. Minute 00-15:  
i. Assessment of Raynaud’s symptoms 
via Follow-up Case Report 
(attached) and photographs will be 
taken of both hands 
o 12-month (+/- 15 days) Follow-up 
a. Minute 00-15:  
i. Assessment of Raynaud’s symptoms 
via Follow-up Case Report 
(attached) and photographs will be 
taken of both hands 
• Subject surveys 
o Months 0-3: 
a. Every week the subjects will be asked to 
complete the Brief Follow-up Case Report 
either online or on a paper version given to 
the subject. 
o Months 4-12 
a. Every month the subjects will be asked to 
complete the Brief Follow-up Case Report 
either online or on a paper version given to 
the subject 
• Solution preparation 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 9 of 20 
Revised: December 7, 2017 
 
o 300 unit vials of abobotulium toxin A will be 
reconstituted with 10 ml of non-bacteriostatic 
normal saline yielding a final concentration of 30 
units per 1 ml. 
o The solutions will be drawn up in 1 cc syringes 
utilizing a 25g needle by Dr. Weinstein. The needle 
with then be replaced with a capped 30g ½ inch 
needle.  
o All solutions will be prepared and drawn up by Dr. 
David Weinstein the day of use after consent has 
been obtained and discarded immediately after use. 
o The syringes will be labeled with a red or blue label 
for randomization by Amelia Winter, Samantha 
Prabakaran, or Dr. Naveed Sami. 
• Screening and consent: 
o Each participant will sit down with the principal 
investigator to discuss the study in depth and review 
the screening criteria. After all risks, benefits, 
alternatives, and questions have been discussed 
consent will be obtained. 
o After the informed consent form is signed, the 
eligibility screening portion of the case report form 
will be filled out by the principal investigator with 
the research subject. If necessary, a pregnancy test 
will be performed. 
• Administration of study solution: 
o 10 sites on each palm will be used (see image 
below): 
a. Two at the base of the thumb 
b. Three in the middle of the palm 
c. Five at the proximal base between each 
finger 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 10 of 20 
Revised: December 7, 2017 
 
 
o The participants’ sites of administration will be 
cleansed with isopropyl alcohol before 
administration. Needles will be introduced at a 90-
degree angle subcutaneously. 1 ml of solution will 
be injected per site. 
o A board-certified dermatologist, Dr. Weinstein, will 
be administering all solutions to minimize risks for 
participants. 
o Subjects will be given the clinic number and asked 
to call if they think they are experiencing any 
adverse effects. 
o Subjects will be evaluated either in person or over 
the phone 1 month and 3 months after treatment. 
• Disposal protocol: 
o After use, needles will be disposed of in red harps 
container according to UCF Health policy. 
o After use, urine samples will be disposed of in the 
toilet according to UCF Health policy. 
 
9.3 
 
• Risk Management: 
o Participants will be directly observed during the 
administration of the botulinum toxin and placebo for any 
adverse events. An anaphylaxis kit is available in clinic 
should any participant experience such an event. The 
principal investigator is certified in basic cardiopulmonary 
life support and an AED is present in the facility. 
Participants will be provided with the phone number of the 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 11 of 20 
Revised: December 7, 2017 
 
PI should any issues related to participation in the study 
arise.  
o Abobotulinum toxin A is the only drug used in this research 
study. It is currently FDA-approved for cervical dystonia, 
moderate to severe glabellar lines, upper limb spasticity, 
and lower limb spasticity. 
o The following are the source documents (see 
attached): 
a. Subject ID Assignment Log 
b. Screening and Enrollment Log 
c. Drug Accountability Log 
d. Eligibility Form 
e. Demographics Form 
f. Medical History Form 
g. Baseline Case Report Form 
h. Follow Up Case Report Form 
i. Brief Follow Up Case Report Form 
j. Adverse Event Form 
9.4 
Data to be collected 
• Age 
• Gender 
• Race 
• Ethnicity 
• Medical History  
o Past Medical and Surgical History 
o Medications 
o Allergies 
o Social History 
a. Tobacco use 
b. Alcohol use 
• Duration of Raynaud’s phenomenon 
• Visual Analog Scale for Pain (VAS Pain) 
• Raynaud’s Condition Score (RCS) 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 12 of 20 
Revised: December 7, 2017 
 
• The Disabilities of the Arm, Shoulder and Hand Score 
(QuickDASH) 
• Number of digital ulcers 
• Number of attacks/episodes per week 
• Photographs of both hands will be taken during every subject visit and will 
be stored directly in the password protected HIPAA compliant network 
drive for clinical research at UCF Health. Though the photos will not 
contain any identifiers, subjects are potentially identifiable from the 
photos and thus they will be stored in the password protected HIPAA 
compliant network drive for clinical research at UCF Health. 
 
10.0 Data and Specimen Banking* 
10.1 
There will be no data or specimen banking for future use. 
 
11.0 Data Management* and Confidentiality 
11.1 The data will be analyzed for significant differences with aid of a 
statistician. A significance level of 0.05 will be used for statistical 
hypothesis testing. The results of the data analysis will be graphed 
for each parameter.  
• Categorical variables, such as sex (male and female), age, and 
comorbidities (e.g., scleroderma) will be reported descriptively, as 
frequencies and percentages. Outcomes in this study are visual 
analog scale for pain (VAS Pain), Raynaud’s Condition Score 
(RCS), and the Disabilities of the Arm, Shoulder and Hand Score 
(QuickDASH), which are continuous variables. In addition, the 
number of digital ulcers and number of attacks/episodes per week, 
which are discrete variables, will measured as outcomes. These 
continuous and discrete variables will be expressed as mean ± 
standard deviation, with standard error of the mean (SEM).   
• To assess between group differences, an Independent samples t-
tests will be conducted separately for the three time periods: 
baseline, 1-month, and 3-month. Additionally, a dependent sample 
t-test will be used to assess within-group differences from 1-month 
to 3-month, separately for the experimental and control groups. It 
is possible to use the baseline measurement as a covariate in an 
analysis of covariance (ANCOVA) and/or in a repeated measures 
ANOVA. Thus, the researchers will also explore these additional 
analyses if the sample size permits. 
• All tests will be two-sided, and p-values < 0.05 will be considered 
statistically significant. Statistical analyses will be conducted using 
SPSS 24.0 (IBM; Chicago, IL).  


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 13 of 20 
Revised: December 7, 2017 
 
11.2 Utilizing the statistical software G*Power it was determined that 16 
patients would be needed to detect a 2-point difference in the RCS 
among the treatment arms. (G*Power) This assumes a standard 
deviation of 1.92, power of 0.8, alpha of 0.05, and effect size (d) of 
1.04. (Merkel)  
11.3 Data will be managed as follows: 
• Data will be stored in the secure HIPAA-compliant database called 
REDCap. 
• Unique identifiers will be created using sequential numbers (i.e. 1, 
2, 4 etc.). 
• No data collection instrument in REDCap will contain identifying 
information 
• The Screening and Enrollment Log, Drug Accountability Log, Eligibility 
Forms, Demographics Forms, Medical History Forms, Baseline Case 
Report Forms, Follow Up Case Report Forms, Brief Follow Up Case 
Report Forms. Adverse Event Forms (see attached documents) will all be 
stored in the regulatory binder in a locked drawer in a locked room at UCF 
Health. Only Dr. David Weinstein will have access to this locked drawer. 
• Photographs will be taken with a UCF Health digital camera. The 
photographs will then be transferred to a folder on a password protected 
HIPAA compliant network drive for clinical reserach at UCF Health. 
After transfer of photographs to clinical research folder they will be 
deleted from the camera. Photographs will be labeled with subject ID 
number and visits number (i.e Subject 01 3-month) 
• A subject ID assignment list (see attached document “Subject ID 
Assignment List”) that links the subject name and contact 
information with their unique identifier will be stored in a separate 
folder in locked drawer in a locked room at UCF Health. Only Dr. 
David Weinstein will have access to this locked drawer. 
• Identifying information such as the “Subject ID Assignment List” 
will only be accessed by the PI and co-PIs for initial entry. It is 
possible the identifiable information may be referenced if 
questionable data are detected during data analysis (e.g.: number 
out of range, missing data). 
• The “Screening and Enrollment Log” and the “Subject ID 
assignment List” will both be disposed of in a HIPAA-compliant 
shred bin at the completion of the study. 
• Informed consents and HIPAA authorizations will be stored in 
locked drawer in a locked room at UCF Health and kept for a 
minimum of six years after the conclusion of the study (per UCF 
data retention policies.) 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 14 of 20 
Revised: December 7, 2017 
 
• Only de-identified data will be used and exported for analysis.  
• De-identified data and photographs will be stored for a minimum 
of five years after the conclusion of the study (per UCF data 
retention policies). 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
12.1 
The plan to periodically evaluate the data collected regarding both harms 
and benefits to determine whether subjects remain safe is as follows: 
• The principal investigator and statistician will review cumulative VAS 
Pain scores, RCS data, QuickDASH, number of digital ulcers, and number 
of attacks/episodes per week data at the halfway point (8 subjects). 
• If any of the change in VAS Pain scores, RCS, QuickDASH, number of 
digital ulcers, or number of attacks/episodes per week for the treatment 
should become statistically significantly worse than the control with a p < 
0.05 then the study will be suspended immediately.  
• Alternatively, if the change in VAS Pain scores, RCS, QuickDASH, 
number of digital ulcers and number of attacks/episodes per week for the 
treatment should become statistically significantly better than the control 
with a p < 0.05 then the study will also be suspended immediately. 
13.0 Withdrawal of Subjects* 
13.1 Subjects will be withdrawn from the research without their consent if 
they become intolerant to the treatment and/or the researchers 
determine that they are too nervous, anxious to continue.  
13.2 Orderly termination will proceed at the end of study period for all 
subjects. This will simply mean no further visits and no further data 
collection will occur.  
13.3 Subjects may voluntarily terminate their participation in the research 
at any time by informing a member of the research team. A subject 
may partially withdraw from the study after the initial treatment and 
control have been administered or even during administration if the 
participant is unable or unwilling to continue or do the follow up 
visits. 
If a subject withdraws or is withdrawn from the study prior to 
completion, further data collection will be stopped. However, partial 
data already collected will be used for analysis. 
14.0 Risks to Subjects* 
14.1 There is no major anticipated risk associated with the study. 
However potential risks to the subject include: 
• Discomfort and pain upon injection and infiltration of 
abobotulinum toxin A or normal saline 
• Temporary muscle weakness that may last 6 weeks 
• Negligible bleeding or bruising 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 15 of 20 
Revised: December 7, 2017 
 
• Minimal risk of infection (<1%)16 
• Allergy to abobotulinum toxin A solution (<1%) 
• Furthermore, true allergy to abobotulinum toxin A is extremely 
rare.17 
15.0 Potential Benefits to Subjects* 
15.1 Potential benefits are not guaranteed to subjects but include: 
• Relief from Raynaud’s phenomenon symptoms 
• Free treatment for their Raynaud’s phenomenon 
16.0 Vulnerable Populations* 
16.1 This study does not involve individual who are vulnerable to 
coercion or undue influence. 
17.0 Community-Based Participatory Research* 
17.1 This is not community-based participatory research. 
18.0 Sharing of Results with Subjects* 
18.1 There are no plans to share results with participants. 
19.0 Setting 
19.1 Research will be conducted at UCF Health:  
• Potential subjects will be identified and recruited at both the UCF Health 
clinic in Lake Nona and the UCF Health clinic on Quadrangle Blvd. 
• Screening, enrollment, initial/baseline study, and follow up study visits 
will take place at the UCF Health clinic in Lake Nona.  
• There will not be a community advisory board. 
20.0 Resources Available 
20.1 
Dr. Weinstein has significant prior experience conducting research, 
knowledge of the regulations and customs at UCF Health, and works regularly 
with patients performing dermatologic surgery. All injections will be administered 
by Dr. Weinstein. Dr. Sami has extensive experience conducting clinical research. 
In addition, the medical students involved in the project will be able to help 
significantly. Through the FIRE project Bee Nash will be able to assist with data 
analysis. 
 
20.2 
Resources available to conduct research: 
 
• The study's small sample size of 20 subjects to be enrolled in order to have 
16 subjects complete the study makes it likely that the required number of 
participants will be recruited in less than 8 months. Drs. Weinstein and 
Sami see at least this number of patients with Raynaud’s phenomenon 
annually. In addition, the rheumatologists at UCF Health see at 3 to 4 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 16 of 20 
Revised: December 7, 2017 
 
times as many patients with Raynaud’s phenomenon. Finally, recruiting 
through the local dermatology society and advertising should supplement 
the numbers needed to complete the study. 
• Research will be conducted during Dr. Weinstein's administrative time or 
on the weekend.  
• The study will be conducted at the UCF Health Clinic, see section 19. 
Setting. 
• While the chances of a research related injury are extremely rare, 
participants will be required to have health insurance in order to 
participate in this study. Treatment for research related injury will be made 
available, however costs associated with this treatment will be billed to the 
participant's insurance company. Costs not covered by participant's 
insurance company will be the subject's responsibility. (see Consent Form 
attached) 
• All individuals assisting in the research study will be provided a copy of 
the IRB-approved protocol and given the opportunity to meet with the 
principal investigator before recruitment begins. The principal 
investigator, Dr. Weinstein, will be responsible for informing all research 
staff of their research-related duties during a personal meeting or via 
phone or email. The contact information of the principal investigator and 
co-principal investigator will be distributed to all research staff and the 
subjects. 
 
21.0 Prior Approvals 
21.1 Approval from the medical director and the HIPAA privacy officer 
of UCF Health will be obtained prior to commencing research. 
22.0 Recruitment Methods 
22.1 
The research team will start recruitment shortly after IRB approval 
and the abobotulinum toxin A has been received. Patients with a diagnosis 
of Raynaud’s phenomenon will be recruited from the UCF Health Clinic 
during a patient’s visit (medical records will not be searched for patients 
with a diagnosis of Raynaud’s phenomenon) and through advertising on 
the UCF Health website and within the UCF Health clinic.  
22.2 
The primary source of subjects will be patients at the UCF Health 
Clinic and people in the greater Orlando area. This represents a large pool 
of potential subjects from which to recruit. 
22.3 
Dr. Weinstein and Dr. Sami will rely on prior labs, pathology 
reports, and physical examination to determine if the participant has a 
diagnosis of Raynaud’s phenomenon. 
22.4 
An e-mail and within clinic advertisement may be used to recruit patients 
(see attached Advertisements). This is a small paragraph describing the study. 
This text may be displayed in the UCF Health clinic, to other providers at UCF 
Health or members of the local dermatology society. In addition, a similar small 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 17 of 20 
Revised: December 7, 2017 
 
paragraph describing the study will be posted on the UCF Health website (see 
attached Advertisements). 
22.5 
Participants will not be compensated for their time. 
23.0 Local Number of Subjects 
23.1 We plan to enroll approximately 20 subjects. 
23.2 We anticipate most subjects that enrolled to be successfully 
screened. There may be a few subjects that will fail screening due to 
failing urine pregnancy testing. Given this, it may be that 18 to 20 
subjects need to be enrolled and screened to obtain 16 eligible 
subjects.  
24.0 Provisions to Protect the Privacy Interests of Subjects 
24.1 Subjects will be in the same general vicinity during study and will be 
recruited from UCF Health Clinic. Therefore, there will be the 
possibility that participants may know and recognize each other.  
24.2 Prior to enrollment subjects will be made aware of this possibility 
and if unacceptable, will be given the option to decline to participate. 
24.3 All investigators will have access to all of the information collected 
on the subjects. The “Subject ID Assignment Log” will be kept in a 
separate folder so that investigators will only have access to 
identifiable information if needed for data entry or if there is a data 
discrepancy. Only de-identified data will be exported and used for 
data analysis. 
25.0 Compensation for Research-Related Injury 
25.1 While the chances of a research related injury are extremely rare, 
participants will be required to have health insurance in order to 
participate in this study. Treatment for research related injury will be 
made available, however costs associated with this treatment will be 
billed to the participant’s insurance company. Costs not covered by 
participant’s insurance company will be the participant’s 
responsibility. 
26.0 Economic Burden to Subjects 
26.1 Subjects have to give his or her time (approximately 2.5 hours) and 
bear any transportation costs (gas, tolls, etc.). If the subject’s health 
insurance does not cover the costs for treatment related injury, the 
subjects will be billed for the treatment. There are no other expected 
costs that subjects will incur as a result of participating in the study.  
 
27.0 Consent Process 
27.1 Consent process: 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 18 of 20 
Revised: December 7, 2017 
 
• The consent process will take place in person at the UCF Health 
clinic in Lake Nona. 
• Subjects will be given the option of picking up the consent and 
HIPAA authorization prior to participation to discuss with their 
primary care physician, significant other, etc., to help minimize the 
possibility of coercion or undue influence. Subjects will be able to 
wait however long they desire after obtaining the study 
information and before signing the consent and HIPAA 
authorization.  However, if the study is completed before the 
subject chooses to sign the consent then they will not be allowed to 
participate. 
• Subjects may voluntarily terminate their participation in the 
research at any time by informing a member of the research team. 
Other than the initial informed consent no other formal process 
will be done to document ongoing consent. 
• The UCF “SOP: Informed Consent Process for Research (HRP-
090)” will be followed. 
• The consent process and HIPAA authorization will be documented 
in writing. The investigator will describe the details of the study 
and answer any questions the subject may have about the study. 
Subjects will be given an informed consent and HIPAA 
authorization for the study and the primary investigator’s contact 
information. Those subjects who express interest in the study will 
be required to sign the Informed Consent form and HIPAA 
authorization to ensure that there is no coercion in the study.  
28.0 Process to Document Consent in Writing 
28.1 The UCF “SOP: Written Documentation of Consent (HRP-091)” 
will be followed. 
28.2 All participants will be required to complete and sign the informed 
written consent document (see attached) to ensure that there is no 
coercion in the study. The informed consent documents will be 
signed both by the participant and by the principal investigator (see 
attached “Informed Consent”).  
 
29.0 Drugs or Devices 
29.1 Abobotulinum toxin A being used will be stored in bag label “For 
Research” in a locked medication refrigerator in a locked room at the 
UCF Health clinic in Lake Nona. This will only be accessible by 
authorized study personal.  The medication will only be used on 
research subjects by authorized study personnel. Logging of the drug 
inventory and administration will be kept on the Drug Accountability 
Log (see attached). 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 19 of 20 
Revised: December 7, 2017 
 
29.2 The abobotulinum toxin A and normal saline solutions are not 
investigational drugs and are readily available FDA-approved 
medications. 
 
1. 
Devulder J, van Suijlekom H, van Dongen R, et al. 25. Ischemic pain in the 
extremities and Raynaud's phenomenon. Pain Pract. 2011;11(5):483-491. doi: 
10.1111/j.1533-2500.2011.00460.x. 
2. 
Block JA, Sequeira W. Raynaud's phenomenon. Lancet. 2001;357(9273):2042-
2048. doi: 10.1016/S0140-6736(00)05118-7. 
3. 
Fregene A, Ditmars D, Siddiqui A. Botulinum toxin type A: a treatment option for 
digital ischemia in patients with Raynaud's phenomenon. J Hand Surg Am. 
2009;34(3):446-452. doi: 10.1016/j.jhsa.2008.11.026. 
4. 
Levien TL. Advances in the treatment of Raynaud's phenomenon. Vasc Health 
Risk Manag. 2010;6:167-177. https://www.ncbi.nlm.nih.gov/pubmed/20448801. 
5. 
Herrick AL. Treatment of Raynaud's phenomenon: new insights and 
developments. Curr Rheumatol Rep. 2003;5(2):168-174. 
https://www.ncbi.nlm.nih.gov/pubmed/12628049. 
6. 
Motegi S, Yamada K, Toki S, et al. Beneficial effect of botulinum toxin A on 
Raynaud's phenomenon in Japanese patients with systemic sclerosis: A 
prospective, case series study. J Dermatol. 2016;43(1):56-62. doi: 10.1111/1346-
8138.13030. 
7. 
Neumeister MW, Webb KN, Romanelli M. Minimally invasive treatment of 
Raynaud phenomenon: the role of botulinum type A. Hand Clin. 2014;30(1):17-
24. doi: 10.1016/j.hcl.2013.09.006. 
8. 
Sycha T, Graninger M, Auff E, Schnider P. Botulinum toxin in the treatment of 
Raynaud's phenomenon: a pilot study. Eur J Clin Invest. 2004;34(4):312-313. doi: 
10.1111/j.1365-2362.2004.01324.x. 
9. 
Uppal L, Dhaliwal K, Butler PE. A prospective study of the use of botulinum 
toxin injections in the treatment of Raynaud's syndrome associated with 
scleroderma. J Hand Surg Eur Vol. 2014;39(8):876-880. doi: 
10.1177/1753193413516242. 
10. 
Mannava S, Plate JF, Stone AV, et al. Recent advances for the management of 
Raynaud phenomenon using botulinum neurotoxin A. J Hand Surg Am. 
2011;36(10):1708-1710. doi: 10.1016/j.jhsa.2011.07.011. 
11. 
Neumeister MW. The role of botulinum toxin in vasospastic disorders of the 
hand. Hand Clin. 2015;31(1):23-37. doi: 10.1016/j.hcl.2014.09.003. 
12. 
Segreto F, Marangi GF, Cerbone V, Persichetti P. The Role of Botulinum Toxin 
A in the Treatment of Raynaud Phenomenon. Ann Plast Surg. 2016;77(3):318-
323. doi: 10.1097/sap.0000000000000715. 
13. 
Bello RJ, Cooney CM, Melamed E, et al. The Therapeutic Efficacy of Botulinum 
Toxin in Treating Scleroderma-Associated Raynaud's Phenomenon: A 
Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Arthritis 
Rheumatol. 2017;69(8):1661-1669. doi: 10.1002/art.40123. 
14. 
Roze S, Kurth H, Hunt B, Valentine W, Marty R. Evaluation of the cost per 
patient per injection of botulinum toxin A in upper limb spasticity: comparison of 


PROTOCOL TITLE: The Effect of Abobotulinum Toxin A on the Symptoms of 
Raynaud’s Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial 
 
 
Page 20 of 20 
Revised: December 7, 2017 
 
two preparations in 19 countries. Med Devices (Auckl). 2012;5:97-101. doi: 
10.2147/MDER.S35563. 
15. 
Cohen J. Statistical power analysis for the behavioral sciences 2nd edn. Erlbaum 
Associates, Hillsdale; 1988. 
16. 
Maragh SL, Brown MD. Prospective evaluation of surgical site infection rate 
among patients with Mohs micrographic surgery without the use of prophylactic 
antibiotics. J Am Acad Dermatol. 2008;59(2):275-278. doi: 
10.1016/j.jaad.2008.03.042. 
17. 
Schussler E, Sobel J, Hsu J, et al. Workgroup report by the joint task force 
involving American Academy of Allergy, Asthma & Immunology (AAAAI); 
Food Allergy, Anaphylaxis, Dermatology and Drug Allergy (FADDA)(Adverse 
Reactions to Foods Committee and Adverse Reactions to Drugs, Biologicals, and 
Latex Committee); and the Centers for Disease Control and Prevention Botulism 
Clinical Treatment Guidelines Workgroup—Allergic reactions to botulinum 
antitoxin: a systematic review. Clin Infect Dis. 2017;66(suppl_1):S65-S72. 
 

ICF_001.pdf: 
The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud’s Phenomenon, a 
Double-Blind Randomized Placebo-Controlled Trial 
 
 
NCT03639766 
 
 
Date: May 21st, 2019 


Permission to Take Part in a Human Research Study 
Page 1 of 7 
 
 
 
 
 
 
The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud’s Phenomenon, 
a Double-Blind Randomized Placebo-Controlled Trial 
 
Informed Consent  
 
 
Principal Investigator:   
 
David Weinstein M.D., Assistant Professor of Dermatology 
 
Co-Investigators:   
 
 
Naveed Sami M.D., Professor of Dermatology 
Adam Foley, B.S., UCF College of Medicine 
Amelia Winter, B.A., UCF College of Medicine 
Sun Kim, B.A., UCF College of Medicine 
Samantha Prabakaran, B.S., UCF College of Medicine 
Sub-Investigators:  
 
 
Rachel Diem-Trang Truong, B.A., UCF College of Medicine 
 
 
 
 
 
Kyle Sommer)eld, B.S., UCF College of Medicine 
 
Investigational Site(s):  
UCF Health Clinic, 9975 Tavistock Lakes Blvd, Orlando, FL 
32827, (407) 266-4900 
 
Why am I being invited to take part in a research study? 
We invite you to take part in a research study because you have a current diagnosis of Raynaud’s 
phenomenon, a disease the is characterized by the spasm of the blood vessels in the fingers, and 
you have health insurance. You must be 18 years of age or older to participate in this study. 


Permission to Take Part in a Human Research Study 
Page 2 of 7 
 
You cannot be in this study if: (1) you are allergic  to abobotulinum toxin A or its components, (2) you 
have a diagnosis of myasthenia gravis; (3) you are unable to read and speak English, (4) you are pregnant or 
breastfeeding, (5) you have previously received botulinum toxin vaccine, (6) you have previously undergone 
upper extremity vascular surgery, (7) you have previously received abobotulinum toxin A treatment in either 
hand in the past 6 months, (8) you are a current smoker or quit in the past 12 months, or (9) you are a 
prisoner.  
What should I know about a research study? 
• Someone will explain this research study to you. 
• Whether or not you take part is up to you. 
• You can choose not to take part. 
• You can agree to take part and later change your mind. 
• Your decision will not be held against you. 
• You can ask all the questions you want before you decide. 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research 
team by phone at (407)266-3627 and ask for Dr. David Weinstein MD, UCF College of Medicine, 
UCF Health, or by e-mail at david.weinstein@ucf.edu . 
This research has been reviewed and approved by an Institutional Review Board (“IRB”). You may 
talk to them at 407-823-2901or irb@ucf.edu if: 
• Your questions, concerns, or complaints are not being answered by the research team. 
• You cannot reach the research team. 
• You want to talk to someone besides the research team. 
• You have questions about your rights as a research subject. 
• You want to get information or provide input about this research. 
Why is this research being done? 
Background and Purpose: Raynaud’s phenomenon is a debilitating disorder where circulation in the 
extremities, like the fingers and toes, is severely reduced. Although botulinum toxin (BoNT) is most 
well-known for its cosmetic uses, studies have shown it provides relief from symptoms for patients 
suffering from Raynaud’s. Studies have shown that BoNT improves blood flow in the hands as well as 
reduces pain and improves function. However, studies have focused on specific patient population and 
lacked coordinated methodology. Abobotulinum toxin A, a type of botulinum toxin, is currently FDA-
approved for cervical dystonia, moderate to severe glabellar lines, upper limb spasticity, and lower 
limb spasticity. But it is not approved to treat the symptoms of Raynaud’s phenomenon. Only a few 
clinical trial studies have been done with several of them supporting the use of this drug to treat this 
medical condition. As there is no drug approved specifically for treating Raynaud’s phenomenon this 
treatment may benefit you.  However, FDA has not determined that the drug is safe and effective for 
the treatment of your condition.   Our double-blind randomized placebo-controlled trial seeks to 
compare a BoNT group with a placebo saline group, studying the effect of abobotulinum toxin A (a 
type of botulinum toxin A) on Raynaud’s symptoms among a more diverse population to provide 
insight into the patients most likely to benefit from BTX.   


Permission to Take Part in a Human Research Study 
Page 3 of 7 
 
How long will the research last? 
We expect that you will be in this research study for 12 months, including one 1-hour appointment and 
four 15-minute follow-up appointments at UCF Health. You will also be asked to complete weekly or 
monthly progress surveys during the study duration.  
How many people will be studied? 
We expect about 20 people here will be in this research study. 
What happens if I say yes, I want to be in this research? 
• You will not be required to discontinue any of your current medications 
• Upon arrival at UCF Health, you will have time to read, ask questions and fill out this consent 
form before participation. 
• After you sign this consent form you will be asked a series of questions regarding your health 
history to determine if you are eligible to participate in this study. 
Note: If you are female, you may need to provide a urine sample for a pregnancy test to 
determine if you are eligible to participate in this research study. The reason for this is because 
one of the drugs you will receive as part of this study is abobotulinum toxin A, and even though 
the dose is very small (300 units), the effects of abobotulinum toxin A on an embryo or fetus 
are not known. The urine pregnancy test must be negative for you to participate in the study. 
• If you continue to be eligible to participate in the study the following will occur: 
• Day 0:   
o You will be asked to fill out a baseline questionnaire, which includes questions that 
assess the symptoms of your Raynaud’s. 
o You will be evaluated by Dr. David Weinstein. 
o Photographs will be taken of your hands. 
• You will receive 20 small injections, 10 on each palm, administered by Dr. David Weinstein. 
1ml will be injected in each location. The abobotulinum toxin A solution will consist of 30 
units abobotulinum toxin A per ml and the normal saline solution will consist of 0.9 % sodium 
chloride. 
o 
 
o You will be asked to wait 20 minutes after injection to be observed for any reactions. 
• 48 hours after injections: 


Permission to Take Part in a Human Research Study 
Page 4 of 7 
 
o You will receive a follow up phone call from Dr. Weinstein 48-hours after the 
injections to make sure you are doing well 
• 1-month follow-up: 
o You will be evaluated, asked to complete a questionnaire in person, and have your 
hands photographed 
• 3-month follow-up: 
o You will be evaluated, asked to complete a questionnaire in person, and have your 
hands photographed 
• 6-month follow-up: 
o You will be evaluated, asked to complete a questionnaire in person, and have your 
hands photographed 
• 12-month follow-up: 
o You will be evaluated, asked to complete a questionnaire in person, and have your 
hands photographed 
• In addition, you will be asked to complete a survey either online or in paper every week for the 
first 3 months and then every month for the final 12 months. 
The treatment you get will in each hand be chosen by chance, like +ipping a coin. Neither you nor the 
study doctor will choose which treatment each hand will receive. Each hand will have an equal chance 
of being given each treatment, though only one hand will receive the treatment with abobotulinum 
toxin A. Neither you nor the study doctor will know which treatment which hand is getting.  
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible to: 
• Receive a one-time set of 20 injections (10 per hand) at your first visit  
• Attend five in-clinic appointments and answer a 48-hour follow-up phone call 
• Answer truthfully questionnaires given to you at your in-clinic appointments 
• Complete paper or online questionnaire weekly during your first 3 months in the study 
and then monthly for the final 9 months 
 
What happens if I do not want to be in this research? 
Participation in research is completely voluntary. You can decide to participate or not to participate. 
Instead of being in this research study, your choices may include: continuing to receive your current 
care for Raynaud’s phenomenon with your rheumatologist or dermatologist. 
The important risks and possible benefits of these alternatives include:  
• No change or possible progression of your Raynaud’s phenomenon. 
What happens if I say yes, but I change my mind later? 
You can leave the research at any time. It will not be held against you. 


Permission to Take Part in a Human Research Study 
Page 5 of 7 
 
You can withdraw from the study at any time during the study by contacting the principal investigator 
or co-investigators. If you decide to leave the research, no further data will be collected from you and 
you are free to leave. However, partial data already collected will be used for analysis. There will be no 
consequences for your choice to leave. If you decide to leave the study, contact the investigator so that 
the investigator can stop recording data from you.  
Is there any way being in this study could be bad for me? 
Risks: This  study  is  considered  more  than  minimal  risk  because  of  the  injection  you 
will  receive, however there are no major anticipated risks associated with the study. Potential 
risks include: 
• Discomfort and minimal pain upon injection and infiltration of abotulinum toxin A/saline 
• Temporary muscle weakness that may last 6 weeks 
• Negligible bleeding or bruising 
• Risk of infection (<1%) 
• Allergy to abobotulinum toxin A solution (<1%) 
There may be uncommon or previously unforeseen risks. You should report any problems to the 
researcher immediately. 
Note: DO NOT take part in this study if you are known to be allergic to abobotulinum toxin A. 
If you do suspect that you are having any adverse reaction, please contact Dr. David 
Weinstein. He can be reached via e-mail at david.weinstein@ucf.edu  or by phone at UCF 
Health at (407)266-4900. If you need emergency care, call 911 or go to your nearest hospital 
or emergency room right away. It is important that you tell the doctors at the hospital or 
emergency room that you are participating in this research study. If possible, take a copy of 
this consent form with you when you go. 
The procedures in this research are known to hurt a pregnancy or fetus in the following ways:  
DYSPORT® produced embryo-fetal toxicity in relation to maternal toxicity when given to pregnant 
rats and rabbits at doses lower than or similar to the maximum recommended human dose (MRHD) of 
1000 Units on a body weight (Units/kg) basis. The research may also hurt a pregnancy or fetus in ways 
that are unknown. These may be a minor inconvenience or may be so severe as to cause death. You 
should not be or become while on this research study. 
You and your insurance company will be charged for the health care services that you would ordinarily 
be responsible to pay. In some cases, insurance will not pay for services ordinarily covered because 
these services were performed in a research study. You should check with your insurance to see what 
services will be covered by your insurance and what you will be responsible to pay. 
Will being in this study help me in any way? 
We cannot promise any benefits to you or others from your taking part in this research. However, 
possible benefits include relief from your Raynaud’s symptoms. This relief may only be temporary and 
only last a few months. 


Permission to Take Part in a Human Research Study 
Page 6 of 7 
 
What happens to the information collected for the research? 
We will limit your personal data collected in this study to people who have a need to review 
this  information.  We  cannot  promise  complete  secrecy.  Organizations  that  may  inspect  and 
copy  your  information  include  the  IRB  and  other  representatives  of  UCF.  There  is  the 
possibility that the Food and Drug Administration (FDA) and/or the Office for Human Research 
Protections (OHRP) may inspect the research records.  
Monitors,  auditors,  IRB,  and  regulatory  authorities  will  be  granted  direct  access  to  the 
participant's  original  medical  records  for  verification  of  clinical  trial  procedures  and  data, 
without violating the confidentiality of the participant, to the extent permitted by applicable 
laws  and  regulations  and  that,  by  signing  the  consent  document,  the  participant  or  the 
participant's legally authorized representative is authorizing such access.   
If the results of the trial are published, the participant’s identity will remain confidential. 
Your name and contact information will be coded. Your unique identifier will be stored in a separate 
folder in locked drawer in a locked room at UCF Health. Data will be stored in locked drawer in a 
locked room at UCF Health and kept for a minimum of six years after the conclusion of the study (per 
UCF data retention policies.) We may publish the results of this research. However, we will keep your 
name and other identifying information confidential. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time. 
Federal law provides additional protections of your medical records and related health information. 
These are described in an attached document. 
Can I be removed from the research without my OK? 
The person in charge of the research study or the sponsor can remove you from the research study 
without your approval. Possible reasons for removal include:  
• failure to follow instructions from staff 
• adverse reaction to one of the solutions 
• The principal investigator ends the research study early 
We will tell you about any new information that may affect your health, welfare, or choice to stay in 
the research. 
What else do I need to know? 
You will not be compensated for your time (approximately 2.5 hours) and will have to bear any 
transportation costs (gas, tolls, etc.). If your health insurance does not cover the costs for treatment 
related injury, you may be billed for the treatment. 
 
If you need medical care because of taking part in this research study, contact the investigator and 
medical care will be made available. Generally, this care will be billed to you, your insurance, or other 
third party. UCF Health has no program to pay for medical care for research-related injury. In the 
event that you suffer a research-related injury, your medical expenses will be your responsibility or 


Permission to Take Part in a Human Research Study 
Page 7 of 7 
 
that of your third-party payer, although you are not precluded from seeking to collect compensation for 
injury related to malpractice, fault, or blame on the part of those involved in the research. 
You will be informed about the results of the study when we have completed data collection and 
published our results in a scientific journal. 
You will be provided with a copy if this signed consent, in case you want to read it again.  
You have to additional sign the UCF Health HIPAA Authorization to start your participation in this 
study.  
 
 
 
Signature Block for Capable Adult 
Your signature documents your permission to take part in this research. 
 
 
 
  
Signature of subject 
 
Date 
 
 
Printed name of subject 
 
  
Signature of person obtaining consent 
 
Date 
 
Printed name of person obtaining consent