Rapid Local Anesthesia by Lidocaine Administered Using STAR Particles
Phase: NA
Conditions: Anesthesia, Local
Sponsor: Emory University

 
 
 
 
 
 
 
 
Rapid local anesthesia by lidocaine administered using STAR particles 
NCT06034340 
 
Date: April 27, 2023 
STUDY00002928 

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 1 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
PROTOCOL TITLE:   Rapid local anesthesia by lidocaine administered using STAR particles 
PRINCIPAL INVESTIGATORS: 
 
Professor of Pediatrics 
Department of Pediatrics 
Division of Endocrinology 
Emory University School of Medicine 
 
 
 
 
VERSION: 4.0 
FUNDING SOURCE: 1998 Society (CHOA) 
 

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 2 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
 
REVISION HISTORY 
Revision # 
Version 
Date 
Summary of Changes 
1.1 
15SEP2021 
Addition of additional information on the formulation of 
STAR particle gel and the safety of LET gel in combination 
with the STAR particle gel. 
2.0 
17NOV2022 
 Only 1 visit, only 15 participants, each get $100 for the visit, 
and phone f/u 1 day, 1 week, and 30 days after visit for skin 
changes. Also only 1 objective. 
3.0 
09DEC2022 
Change in age of participants from 10-15 years old to 10-
21 years old. The first 2 patients will be between the ages 
of 18-21 years old. 
4.0 
27APR2023 
Addition of secondary objective to measure TEWL 
(transepidermal water loss) before and after application of 
STAR particles. Increase from 15 to 25 total participants. 
 
 
 
 
 
 

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 3 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
Table of Contents 
 
1. 
Study Summary ...................................................................................................................... 4 
2. 
Objectives .............................................................................................................................. 5 
3. 
Background ............................................................................................................................ 5 
4. 
Study Endpoints ..................................................................................................................... 6 
5. 
Study Intervention/Investigational Agent .............................................................................. 6 
6. 
Procedures Involved .............................................................................................................. 7 
7. 
Data Specimen Banking ......................................................................................................... 8 
8. 
Sharing of Results with Participants ....................................................................................... 8 
9. 
Study Timelines ...................................................................................................................... 8 
10. 
Inclusion and Exclusion Criteria .......................................................................................... 8 
11. 
Vulnerable Populations ...................................................................................................... 9 
12. 
Local Number of Participants ............................................................................................. 9 
13. 
Recruitment Methods ........................................................................................................ 9 
14. 
Withdrawal of Participants ................................................................................................. 9 
15. 
Risk to Participants ........................................................................................................... 10 
16. 
Potential Benefits to Participants ..................................................................................... 11 
17. 
Compensation to Participants .......................................................................................... 11 
18. 
Data Management and Confidentiality ............................................................................ 11 
19. 
Provisions to Monitor the Data to Ensure the Safety of Participants ............................... 11 
20. 
Provisions to Protect the Privacy Interest of Participants ................................................ 12 
21. 
Economic Burden to Participants ..................................................................................... 13 
22. 
Informed Consent ............................................................................................................ 13 
23. 
Setting .............................................................................................................................. 13 
24. 
Resources Available .......................................................................................................... 13 
25. 
Multi-Site Research When Emory is the Lead Site ............................................................ 14 
26. 
References ....................................................................................................................... 14 
 
 
 
 
 

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 4 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
 
1. Study Summary 
Project Title 
Rapid local anesthesia by lidocaine administered using 
STAR particles 
Project Design 
Feasibility: First-in-humans clinical trial 
Primary Objective 
To determine if the combination of STAR particles with 
topical lidocaine formulations will expedite lidocaine 
delivery into skin and associated local anesthesia in 
comparison to a commonly used FDA-approved topical 
lidocaine (LET gel) in children. 
Secondary Objective(s) 
1. To evaluate 10% STAR-particle concentration and  
500 m length for lidocaine delivery into skin and 
associated local anesthesia in children. 
2. To evaluate the TEWL on the skin before and after 
application of STAR particles  
Research 
Intervention(s)/Interactions 
STAR particles 
STAR particles are millimeter-scale particles with micron-
scale projections made of biocompatible materials that 
painlessly disrupt the stratum corneum. As STAR particles 
are rubbed on skin, their microscopic projections create 
micron-scale pores in the stratum corneum to increase skin 
permeability to topical compounds independent of 
physicochemical properties. After the arms of the STAR 
particle puncture the skin, the elastic forces of the skin 
push the particles out. 
Study Population 
Children, adolescents and young adults (10 to 21 years of 
age) 
Sample Size 
25 
Study Duration for 
individual participants 
One visit with each visit lasting 2-4 hours and follow-up by 
phone 1 week and 4 weeks after the study visit.  
Study Specific 
Abbreviations/ Definitions  
VAPS – Visual analog pain scale; TSP – Time to achieve 
anesthesia for STAR particles; TLET – Time to achieve 
anesthesia for application of topical lidocaine (LET gel); 
ASRs – Acute skin reactions; PLGA – polylactic-co-glycolic 
acid; PLA – polylactic acid; GCMI – Global Center for 
Medical Innovation; TEWL -  trans epidermal water loss 
Funding Source (if any) 
1998 Society (CHOA) 
Study Site 
Emory Childrens Center & Children’s Healthcare of Atlanta 
 
 
 
 

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 5 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
 
 
2. Objectives 
A. Primary 
1. To determine if the application of STAR particles (10% concentration and 500 m 
length) applied prior to a topical lidocaine formulation (LET gel) will expedite lidocaine 
delivery into skin and associated local anesthesia in comparison to a commonly used 
FDA-approved application of topical lidocaine (LET gel) in children. 
 
3. Background 
Administration of more than 20 billion injections each year around the world, and placement 
of over 200 million intravenous catheters occurs annually in the United States. Pain caused 
by these and other procedures using hypodermic needles leads to fear of needles with 
negative consequences throughout the healthcare system. This fear often starts with 
children, of whom over 60% report a moderate to severe fear of needles. Other than their 
disease, hospitalized children claim that needles are their primary source of pain. There is 
evidence that many children acquire a fear of needles, which often continues and amplifies 
with age leading, for example, to refused blood sampling and vaccine administration in up to 
40% of adults – all due to fear of needles.  
 
Local anesthesia alleviates pain and fear associated with injections. The ideal local anesthetic 
for the clinical setting should be effective; have rapid onset; be fast and easy to load and 
administer with minimal user training; be portable; cause minimal pain; and be cost effective.  
Several methods of inducing local anesthesia exist, but each of them comes with limitations. 
Injectable lidocaine further increases fear and anxiety, and is painful. In contrast, topical 
anesthetics provide a painless and simple means of administering local anesthesia, but they 
unfortunately rely upon slow diffusion into the skin, leading to onset times of 20 to 60 
minutes. This delayed onset is the main barrier for widespread clinical use of topical 
anesthetics for venous access procedures.  
 
Lidocaine delivery into skin is blocked by the skin’s stratum corneum barrier. To address this 
limitation, collaborators at Georgia Tech developed STAR particles, which are millimeter-scale 
particles with micron-scale projections made of biocompatible materials that painlessly 
disrupt the stratum corneum. These particles are made of titanium dioxide, a widely-used 
and safe ceramic material found in sunscreens, cosmetics, and paint. The STAR particles have 
no more risk for causing an adverse or serious adverse event than those of regularly used 
over-the-counter skin products. STAR particles are designed to incorporate invisibly into 
topical formulations applied to skin similarly to conventional topical skin products.  The 
composition of the gel that will be used to formulate the STAR particles will be aloe gel. We 
are not aware of any risks posed by aloe gel, with the exception of the extreme rare cause of 
allergic or anaphylactic reaction. This aloe gel does not pose any obvious risks and is 

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 6 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
contained in numerous products such as skin lotions and hair products. As STAR particles are 
rubbed on skin, their microscopic projections create micron-scale pores in the stratum 
corneum to increase skin permeability to topical compounds independent of physicochemical 
properties. STAR particles are designed small enough to be painless and hard to see, but large 
enough to enable delivery of molecules like lidocaine into skin. A STAR particle micro-
projection length of a few hundred microns with a tapered geometry provides mechanical 
strength with a sharp tip (<10 µm radius) to facilitate insertion into skin without pain. The 
star-shaped geometry is designed to inhibit complete insertion of the particle into skin so 
STAR particles do not remain embedded in the skin. After the arms of the STAR particle 
puncture the skin, the elastic forces of the skin push the particles out. From our previous 
publication, the only adverse effect from the use of STAR particles was local erythema (Tadros 
AR et al. STAR particles for enhanced topical drug and vaccine delivery. Nature Medicine. 
2020, 26: 341–347.). 
The use of LET gel (Edge pharma, London) is indicated for topical anesthesia  
in children for open wounds. We know from our previous study and publication that the STAR 
particles make miniscule punctures in the skin allowing a drug applied after can only enter 
the skin through these tiny pores that quickly seal. Using the STAR particles will be less 
invasive than any open wound a child could present with who would normally be receiving 
LET gel prior to suture closure or instrumentation of the wound. There would be no way that 
when LET gel delivered at the appropriate dose could ever enter the skin and overdose a 
patient than delivering it through any open wound that the LET gel is already approved for. 
We realize that it is not uncommon for the FDA to test drugs or devices in adults (to assess 
safety and efficacy) prior to children, however, there would be no endpoint to determine if 
the STAR particles with LET gel is efficacious in adults, as few adults will be as interested or 
concerned with pain or local anesthesia. 
4. Study Endpoints 
A. Primary 
1) Determine the TSP of the STAR particle (10% concentration and 500 m length) in 
children and compare to the TLET and determine which application results in a more 
rapid time for local anesthesia.  
B. Secondary 
1) Determine the TEWL (trans epidermal water loss) measurement before and after 
application of the STAR particles and compare to the TEWL measurement before and 
after application of the aloe gel.   
 
5. Study Intervention/Investigational Agent  
This is a single-center study to compare the time to local anesthesia following application of  STAR 
particles applied prior to skin application of topical lidocaine (LET gel) to application of topical 
lidocaine (LET gel) alone at one location in 25 healthy children, adolescents and young adults.  

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 7 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
The investigational agent will be STAR particles made of titanium dioxide, a widely-used and safe 
ceramic material found in sunscreens, cosmetics, and paint. The particles will vary in 
concentration and length in order to find the optimal concentration and length. The star-shaped 
geometry is designed to inhibit complete insertion of the particle into skin so STAR particles do 
not remain embedded in the skin. After the arms of the STAR particle puncture the skin, the 
elastic forces of the skin push the particles out. 
 
6. Procedures Involved 
After signing the informed consent form, eligible participants will be enrolled in the study. At the 
visit, the TEWL will be measured using a wireless, portable Vapometer (Delfin Technologies, 
Finland) on the volar surface of the forearm where the the STAR particles will be applied. The 
STAR particle (in aloe gel) will be delivered to the skin immediately prior to the LET gel so that 
the time to achieve anesthesia for the topical lidocaine (LET gel) after STAR particle application 
(TSP) can be compared to the time to achieve anesthesia for application of topical lidocaine (LET 
gel) alone (TLET). The STAR particle will always be applied to the participant’s right arm but the 
order of applying STAR particle will be randomized by a computer-generated random sequence. 
After application of the STAR particles, and prior to applying the LET gel, TEWL will again be 
measured using the wireless, portable Vapometer (Delfin Technologies, Finland). 
 
The same procedure of measuring the TEWL will be followed on the forearm not receiving the 
STAR particle application (Aloe gel).   
 
A. LET Gel after STAR Particle Application (Right Arm): 
Topical lidocaine (0.5 grams of Lidocaine in LET gel) will be applied immediately after applying 
a STAR particle preparation to the volar surface of the mid-forearm at two locations (right 
antecubidal fossa and right wrist). Immediately after application of the STAR particles, the 
topical lidocaine (LET gel) will be applied. Immediately after the topical lidocaine (LET gel) is 
applied, pain will be assessed by the investigator every minute using the Pin-Prick Pain test. 
The time that the subject reports no pain (complete local anesthesia) will be recorded as the 
time to achieve anesthesia for the topical lidocaine after STAR particle application (TSP) at 
both sites.  
 
B. LET GEL Application without STAR Particle Application (Left Arm): 
Topical lidocaine (0.5 grams of Lidocaine in LET gel) will be applied immediately after applying 
aloe gel (CONTROL) to the volar surface of the mid-forearm at two locations (right antecubidal 
fossa and right wrist). Immediately after application of the aloe gel, the topical lidocaine (LET 
gel) will be applied. Immediately after the topical lidocaine (LET gel) is applied, pain will be 
assessed by the investigator every minute using the Pin-Prick Pain test. The time that the 
subject reports no pain (complete local anesthesia) will be recorded as the time to achieve 
anesthesia for the topical lidocaine without STAR particle application (TLET) at both sites.  
 
The physician will also evaluate local tolerability by assessing the topical lidocaine (LET gel) alone 
and topical lidocaine (LET gel) post-STAR particle application site for acute skin reactions (ASRs), 
AEs, and SAEs on the day of application, 1 hour [±5 minutes] after the application, 24-hours after 

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 8 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
application, one week after application, and 30 days after application. Specifically, the participant 
(and parent) will report if the participant’s skin has erythema, edema, blistering, tenderness, 
bleeding, bruising, or any type of skin change. ASRs will be scored quantitatively with qualitative 
remarks as needed. ASRs, AEs, and SAEs of interest will be recorded. 
 
7. Data Specimen Banking 
This study will not be banking any specimens or data. 
 
8. Sharing of Results with Participants 
There are no expected incidental findings for the study. Results will not be returned to the 
participant. 
 
 
9. Study Timelines 
• Each subject will participate in the study for the one visit with phone follow-up one day 
to 30 days after the study visit.  
• The duration anticipated enrolling all study participants is 2-3 months. 
• The estimated date for the investigators to complete this study (complete primary 
analyses) is 12 months. 
 
Study Procedures and Assessments 
Procedures and Assessments 
Study Visit 
Follow-Up  
(24-hrs – 30 days) 
Informed consent 
X 
 
Medical history 
X 
 
Inclusion and exclusion criteria 
X 
 
STAR  & Lidocaine application by clinician 
X 
 
topical lidocaine (LET gel)  application by 
clinician 
X 
 
TEWL measurement before and after application 
X 
 
Application site pain by VAS  
X  
 
Application site pain by report  
X 
 
ASRs, SAEs & AEs of interest 
X 
X 
 
10. Inclusion and Exclusion Criteria 
Inclusion criteria:  

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 9 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
a. Children, adolescents and young adults, 10 - 21 years of age. The first 2 patients will be 
between the ages of 18-21 years old. 
b. In good general health as determined by a medical history 
c. Willing to provide informed assent with parental consent and follow study requirements 
 
Exclusion criteria:  
a. Is chronically using pain medication 
b.   Has a plan to move to another location in the next 12 months or foresees any other 
reason that participation in the study would be disrupted during the next 12 months 
c. Has skin disorders or skin allergies 
d.   Has any previous allergy or adverse reaction to STAR particle ingredients (Titanium 
Dioxide) 
e. Has abnormal (e.g., tattooed) skin at proposed the site(s) of STAR particle application 
f. Has known neurological conditions that might affect sensory function or perception of 
pain 
g. Has any condition (social or medical), which in the opinion of the investigator would 
make study participation unsafe, would interfere with adherence to the clinical study 
requirements, or would complicate data interpretation 
 
11. Vulnerable Populations 
The research does not contain vulnerable populations. 
12. Local Number of Participants 
25 children, adolescents and young adults 10-21-years of age. 
 
13. Recruitment Methods 
Participants will be recruited from Emory/CHOA pediatric Endocrine outpatient clinics. 
Participants will be recruited throughout the course of the study. Participants will be approached 
in clinic by the study PI or clinic provider about their interest in participating in this study. There 
will be no recruitment materials. Eligibility will be reviewed through questioning the participants, 
their parents, and review of the patients medical chart. 
 
14. Withdrawal of Participants 
The participant may be withdrawn from the research without their consent if they are not able 
to follow the protocol.  
 
Given the minimal risk associated with STAR particles and previous history of STAR particles used 
in humans, there does not appear to be any obvious anticipated circumstances under which 
participants will be withdrawn from the research without their consent. 
 
If participants withdraw from the research, data collected will be retained and utilized as an 
intention-to-treat (ITT) analysis. 

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 10 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
 
15. Risk to Participants 
The risks to this study are minimal. We will be applying STAR particles that should puncture the 
skin, allowing the lidocaine to have more rapid entry and then, due to the elastic forces of the 
skin, will push the particles out. From the time the STAR particles are applied to the skin, the 
possible risks would be expected to be local skin reactions at the site of STAR particle application 
including  erythema, edema, tenderness, bleeding, and/or bruising.  
 
A systemic reaction would be unlikely to occur, but due to the potential that the application and 
retention of STAR particles in the skin could facilitate bacterial entry into the skin, in addition to 
the local reactions listed above, systemic reactions including: fever, cough, nausea, vomiting, 
diarrhea, fatigue, and headaches could also occur. Based on previous human research with STAR 
particles, local and systemic reactions are unlikely to occur (1). Acute skin reactions (ASRs) will 
be scored quantitatively with qualitative remarks as needed. The application of the STAR particles 
is expected to have a minimal risk to the subject. It is possible subjects could describe the 
placement of the STAR particles as uncomfortable or painful, but based on previous human 
studies (1) this seems less likely. We will take precautions to prevent infections, such as using 
sterilized or low bioburden materials and wiping the skin with an alcohol swab before the study. 
 
We hypothesize that the STAR particles will not remain in the skin. Our previous research on STAR 
particles suggests that the risk for application of STAR particles  to be minimal (1).  The only AE 
discovered in studying patients receiving a STAR particle application has been transient local 
erythema and otherwise, has been very well tolerated in healthy human participants. The article 
published in Nature Medicine can be referenced (Tadros AR et al. STAR particles for enhanced 
topical drug and vaccine delivery. Nature Medicine. 2020, 26: 341–347.) The composition of the 
gel that will be used to formulate the STAR particles will be aloe gel. We are not aware of any 
risks posed by aloe gel, with the exception of the extreme rare cause of allergic or anaphylactic 
reaction. This aloe gel does not pose any obvious risks and is contained in numerous products 
such as skin lotions and hair products.These particles are made of titanium dioxide, a widely-used 
and safe ceramic material found in sunscreens, cosmetics, and paint. STAR particles are designed 
to incorporate invisibly into topical formulations applied to skin similarly to conventional topical 
skin products.  
The local anesthetic we are evaluating (LET gel) is approved in children for open wounds. We 
know from our previous study and publication that the STAR particles make miniscule punctures 
in the skin allowing a drug applied after can only enter the skin through these tiny pores that 
quickly seal. Using the STAR particles will be less invasive than any open wound a child could 
present with who would normally be receiving LET gel prior to suture closure or instrumentation 
of the wound. There would be no way that when LET gel delivered at the appropriate dose could 
ever enter the skin and overdose a patient than delivering it through any open wound that the 
LET gel is already approved for. 

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 11 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
The LET gel delivered will be minimal, applied over a small surface area and below the limit of 
what would cause an adverse event even if that amount of LET gel was injected locally. The  dose 
of the application will be 100-500 mg of LET gel to the skin which is far below toxic doses. The 
LET gel is FDA-approved for children 2-years and older and is used in individuals who need a local 
anesthetic and have an open wound. There have been no reports of adverse reactions or events 
associated with LET gel, however, an allergic reaction or even anaphylaxis, are always potential 
possibilities. 
Based on previous clinical studies and FDA approvals of other drugs/devices using these 
materials,  we therefore expect non-significant risk. 
 
16. Potential Benefits to Participants 
There is no direct benefit to the participant, however, there are potential future benefits to 
society from the understanding gained by the study. 
17. Compensation to Participants 
Study participants will receive $100 for completion of the study visit. Participants who drive to 
the visit will be reimbursed for parking in the designated ECC parking area. 
 
18. Data Management and Confidentiality 
Data will be stored either electronically in HIPAA compliant locations or in locked offices 
and cabinets. The data will be stored locally until we are allowed by the sponsor or Emory 
to destroy them. Only staff directly involved in completing study procedures will have 
access to the data. Staff listed on the delegation of authority log will be responsible for 
receipt and transmission of data. The coordinator or PI/Sub-I will be responsible for 
transporting the data locally.  
 
If a participant declines to participate or is ineligible to participate for any or all portions 
of the study, the participant will not be assigned a study ID number and the study staff 
will refrain from collecting any data on the participant.  
 
19. Provisions to Monitor the Data to Ensure the Safety of Participants 
As this study is one with minimal risk, a DSMB will not be needed.  
Subject safety: 
• Specific subject safety parameters: subjects will report any safety-related issues or 
concerns to the PI (phone/email when not at a visit)  or in person to the PI when at the 
visit. 
• Subjects will report observations when at the clinic for the initial visit, and will record 
observations to be made available to the research team when either contacting the 
research team or the research team contacting them. 
• The PIs will be responsible for safety monitoring 

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 12 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
• If the subject has skin irritation, pain, itching, or infection, a topical medication could be 
applied to address the symptoms.  
• The minimal risk associated with STAR particles makes it unlikely that a subject would 
develop any significant local or systemic consequence and therefore, other than subject 
choice or PI choice, there is not expected to be any condition that should stop the study.  
• Deviations, AEs, and SAEs will be reported to the IRB by the PI. 
 
Data Integrity: 
• Specific data elements to be reviewed include: pain (if any) associated with STAR particle 
formulation insertion, local skin findings at initial placement, and local skin findings during 
the study.  
• Monitoring of data will occur every month after every 5 subjects are enrolled so that data 
will be monitored 4-5 times during the study depending on how quickly enrollment is 
complete.  
• The PIs will be responsible for data monitoring 
 
Additional considerations for FDA regulated trials  
• All study activities except production of the STAR particles will be done on-site 
• The study team will self-monitor the study 
• The study team will use Emory University’s self-monitoring tool found on the CTAC 
website 
• The first subject enrolled will trigger a self-monitoring event 
• No Identification of deviations or failures that would be critical to study integrity 
 
20. Provisions to Protect the Privacy Interest of Participants 
Whenever possible, a study number, rather than the participants name will be used on study 
records. The participants name and other identifying information will not appear when study 
results are presented or published. All study documents will be kept in a locked office or secure 
server.  
The sponsor representatives and regulatory authorities (e.g., IRB, OHRP) may inspect all 
documents and records required to be maintained by the investigator. The study team will permit 
access to such records. 
Subjects will be made aware that all research activities are completely voluntary and will not 
impact the care they receive. They will also be informed that they are allowed to withdraw from 
the study at any time. 
The quantitative data from this study will be uploaded to the DDL or another repository within 
30 days of the primary manuscript publication. A description of the data repository will be 
included in the informed consent. 

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 13 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
21. Economic Burden to Participants 
There will be no costs for the participant associated with the research study.  
22. Informed Consent  
• 
Participants will be consented by the Principal Investigator in a private space in the 
CHOA Endocrine clinic or the ECC. 
• 
There is no standard waiting period before the participant is approached for consent 
after being told about the study.  
• 
The participant will be reminded throughout the study visit that participation is 
completely voluntary and that they are allowed to withdraw at any point during the 
visit or after the visit.  
• 
The study will be explained thoroughly to the participant and the participant will be 
allowed to ask questions. The study team will give ample time to the potential 
participants to ask questions and decide whether they would like to participate. The 
participants will be reminded that the study is completely voluntary and that not 
participating will not affect their care for their medical condition. The staff 
performing the informed consent process will also ask the participant questions to 
verify understanding of the information relayed. 
  
Non-English-Speaking Participants:  
We will not enroll any non-english speaking participants since we are not able to get certified 
translations of the study questionnaire.  
This study will need a partial HIPAA waiver for recruitment purposes ONLY (i.e. identifying 
potentially eligible subjects). As subjects are contacted, HIPAA authorization will be 
obtained. 
23. Setting 
The research will be conducted at the Emory Childrens Center (ECC) on the Emory University 
campus. All procedures will be performed by the study investigators when subjects are present 
for visits. Subjects will be in contact (email/phone) with the PI to report any unexpected issues 
relating to STAR particle placement or skin, if it occurs when not at the ECC for a visit.  
 
All research procedures will be performed at the Emory Childrens Center on the Emory University 
campus.  
24. Resources Available 
We are performing this study as a feasibility study and believe we have enough resources 
(Emory/CHOA outpatient Endocrine clinic) to recruit the number of subjects we seek to study. 
 
Eric I. Felner, MD, MS will devote 15% time to this study. 
 

Protocol Title: Rapid local anesthesia by lidocaine administered using STAR particles 
 
 
Page 14 of 14 
  
Version: 4.0 27APR2023 
IRB Form BIO 03152021 
The PI (medical physician) and the research study team will be monitoring the subjects and 
subjects will be able to contact the study team for any potential consequences that could come 
about from the research. 
 
The PI will review the protocol and procedures with the research study team. 
25. Multi-Site Research When Emory is the Lead Site 
N/A 
26. References 
1. Tadros, AR, Romanyuk A, Miller JC, Santiago A, Noel RK, O’Farrell L, Kwong GA, Prausnitz 
MR (2020). STAR particles for enhanced topical drug and vaccine delivery. Nature 
Medicine, 26: 341 – 347.