Usability of STAR Particles in Healthy Volunteers: A Pilot Study
Phase: NA
Conditions: Healthy
Sponsor: Emory University

 
 
 
 
 
 
 
 
Usability of STAR particles in healthy volunteers: A pilot study 
NCT06004973 
 
Date: 22April, 2024 
STUDY00005486 

Protocol Title: Usability of STAR particles in healthy volunteers: A pilot study
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PROTOCOL TITLE:   Usability of STAR particles in healthy volunteers: A pilot study
PRINCIPAL INVESTIGATORS:
Department of Pediatrics
Division of Endocrinology
Emory University School of Medicine
VERSION: 4.1
FUNDING SOURCE: Aldena

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REVISION HISTORY
Revision #
Version 
Date
Summary of Changes
2
03NOV2023
Visit schedule changed from 2 visits to 1 visit.
3
17JAN2024
Change in payment to $80 for in-person visit and total 
compensation.
4.1
10APR2024
Corrections on page 8. Figure labeled Visit 2 in error. 
Corrected to visit 1. Changes to application site to include 
face. Assessing and photographing of these sites. Change 
from aloe gel to gel formulation of 0.7%w/w Xanthan Gum 
+ 2.5%w/w Hydroxypropyl methylcellulose + 
Cyclomethicone and Dimethicone.

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Table of Contents
1.
Study Summary .......................................................................................................................5
2.
Objectives................................................................................................................................5
3.
Background .............................................................................................................................5
4.
Study Endpoints ......................................................................................................................5
5.
Study Intervention/Investigational Agent...............................................................................6
6.
Procedures Involved................................................................................................................6
7.
Data Specimen Banking...........................................................................................................7
8.
Sharing of Results with Participants........................................................................................7
9.
Study Timelines .......................................................................................................................8
10.
Inclusion and Exclusion Criteria...........................................................................................8
11.
Vulnerable Populations .......................................................................................................8
12.
Local Number of Participants ..............................................................................................9
13.
Recruitment Methods..........................................................................................................9
14.
Withdrawal of Participants................................................................................................10
15.
Risk to Participants ............................................................................................................10
16.
Potential Benefits to Participants......................................................................................10
17.
Compensation to Participants ...........................................................................................10
18.
Data Management and Confidentiality .............................................................................10
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 ......................................................................................12
22.
Informed Consent..............................................................................................................13
23.
Setting................................................................................................................................15
24.
Resources Available...........................................................................................................16
25.
Multi-Site Research When Emory is the Lead Site.............................................................16
26.
References.........................................................................................................................17

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1. Study Summary
Project Title
Usability of STAR particles in healthy volunteers: A pilot 
study
Project Design
Non-randomized, controlled, non-blinded, single-arm pilot 
(feasibility) study, with an adaptative design at mid trial.
Primary Objective
To identify the most efficacious pressure of administration 
and the minimum number of rubbing cycles necessary to 
perforate the stratum corneum.
Secondary Objective(s)
To evaluate sensation and pain during and after STAR 
particle application.
Exploratory Objective(s)
To assess the dispersion and disposal of the STAR particles.
To evaluate the user’s feedback on product use.
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. Participants will receive the 8 
interventions (different application pressures) plus the 
control (Site and treatment will not be randomly assigned 
on the arm) by the investigator.
Study Population
Adults (18 to 39 years of age)
Sample Size
20
Study Duration for 
individual participants
1 visit to screen for medical history, examine skin, obtain 
informed consent, and application of the STAR particles to 
the participant’s forearm.
Study Specific 
Abbreviations/ Definitions 
GV – Gentian Violet; kPa - kilopascal; microneedle (MN); 
TEWL – trans epidermal water loss; VAPS – visual analog 
pain scale 
Funding Source (if any)
Aldena Therapeutics (United Kingdom)
Study Site
Emory Children’s Center 

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2. Objectives
A. Primary
1. To identify the most efficacious pressure of administration and minimum number of 
rubbing cycles necessary for STAR particles to penetrate the stratum corneum.
B. Secondary
1. To evaluate the sensation and pain during and after STAR particle application.
C. Exploratory
1. To assess the dispersion and disposal of the STAR particles.
2. To evaluate the user’s feedback on product use.
3. Background
The objectives of this protocol are motivated by the potential future applications of STAR 
particles to enhance cutaneous bioavailability of topical therapies for treatment of 
dermatoses.
Many medical indications are treated through the topical application of a therapeutic 
compound that has been formulated into a gel, cream, ointment, or lotion (e.g., eczema, 
psoriasis, actinic keratosis, cutaneous warts, etc.) [1,2]. This is especially true in dermatology 
in which the skin is often the primary site of action. Topicals (i.e., drugs applied to the skin’s 
surface) allow patients to easily self-apply these therapies without the need for painful or 
difficult-to-use medical technologies (e.g., hypodermic needles) or the risks associated with 
systemic exposure to a drug (e.g., oral, intravenous, or intramuscular administration).
Despite the advantages associated with topical delivery, the skin significantly hinders the 
transport of most exogenous compounds. The skin derives this functional barrier primarily 
from its outermost layer, the stratum corneum. The stratum corneum is approximately 10-
20 µm in thickness and is composed of denucleated, terminally differentiated skin 
keratinocytes which form a tightly packed lipophilic shield to the outside world [3]. To 
overcome the skin barrier, several techniques have been employed. Various chemical, 
biochemical, and physical methods have been studied to increase skin permeability [4-7]. 
However, chemical, and biochemical methods do not appear to be broadly useful for the 
delivery of large molecule therapeutics (e.g., peptides, proteins, genetic material) across the 
skin. While physical methods have greater promise for the delivery of macromolecules, they 
typically involve the use of sophisticated devices that are relatively large, expensive, and/or 
require training. Microneedles (MNs), in contrast, can be prepared as a low-cost patch that is 
simple for patients to apply for the delivery of a larger range of therapeutics [8-10]. One 
microneedle (MN) technique that has been investigated for enhanced topical drug delivery is 
called “poke-and-patch.” This method most commonly employs solid, non-dissolving 
microneedles (MNs), which are attached to a flat or cylindrical substrate, allowing for 

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penetration into the skin. The MNs are then removed from the skin, thereby revealing 
microscopic puncture sites. Subsequently, a topical formulation can be applied to the MN-
treated site, and the pharmaceutical agent can passively diffuse through the created 
microchannels. Although this technique has shown promise to increase transport into and 
across the skin, there are several drawbacks to its widespread clinical adoption. These 
drawbacks include: (1) training users to properly apply MNs, (2) MN device sterility between 
treatments, (3) MN device cost, (4) complexity of a two-step application process, and (5) the 
small surface area of MN patches (e.g., <10 cm2) in relation to many relevant dermatoses.
4. Study Endpoints
A. Primary
1) For each primary objective, the primary endpoint is the identification of the most 
efficacious conditions measured by the number of perforations per cm2 using GV 
staining and TEWL measurement before and after application of STAR particles [(T0 
(before), T20 (after), T30, GV)].
B. Secondary
1) Evaluate the sensation and pain during and after application of STAR particle 
administration using questionnaires after each application.
2) Assess general safety objectives including standard adverse event (AE) reporting 
from enrollment until 5 days after the last visit.
C. Exploratory
1) Perform a visual inspection of the residual STAR particles to assess potential adverse 
events after removal.
2) To evaluate the user’s feedback using a specific questionnaire. 
5. Study Intervention/Investigational Agent 
This is a non-randomized, controlled, non-blinded, single-arm pilot study trial, with an adaptive 
design at mid-trial. After 10 participants complete the study, an interim analysis will be 
performed and recruitment will either continue with no change to the protocol or, changes may 
occur in regard to the STAR particle application area, position, pressure, or rubbing cycle in an 
adaptive design manner. 
The trial will be performed in a climatized room and participants will have time to adapt and cool 
down to decrease risk of modulation TEWL reading.
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 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. The STAR particles will be mixed with a gel formulation of the 
following composition: 0.7%w/w Xanthan Gum + 2.5%w/w Hydroxypropyl methylcellulose + 
Cyclomethicone and Dimethicone. STAR particles will be produced by Aldena Therapeutics under 
GMP conditions.

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6. Procedures Involved
After signing the informed consent form, eligible healthy adult participants will be enrolled in the 
study. The study will require one clinic visit. The visit will serve as a screening visit in order to 
explain the study, review inclusion/exclusion criteria, assess the participant’s skin, and perform 
the STAR particle application. The study visit and will last approximately two hours. 
A. Study visit
1) Review study
2) Assess participant skin
3) Obtain Consent
4) Apply STAR particles
B. STAR particle application
A 1.5 gram dose of STAR particles (10% concentration in gel) will be applied to the eight 
application sites (forearm and hand) and 100 mg of the gel without STAR particles will be 
applied to the control site on one of the forearms. Two rubbing cycles (30 and 60 cycles 
at a minimum of 1 cycle/second) and three pressures (40, 60, and 80 kPa) will be 
evaluated. The parameters of each STAR particle application at each site (1-9) are labelled 
in Figure 1. The investigator will apply the STAR particles with two fingers (index and 
middle fingers of the dominant hand) and the pressure point of one finger is 1 cm2. 
Pressures have been established with the following amount of STAR particles applied to 
the skin with one finger:  40 kPa (320 grams); 60 kPa (480 grams); and 80 kPa (640 grams). 
With two fingers, the investigator will apply with a pressure of 40 kPa when scale reads 
640 grams; 60 kPa = 960 grams; and 80 kPa = 1280 grams. This will be practiced enough 
before the study so the investigator will know how much pressure generated on the skin 
based on previous practice with associating pressure according to scale weight.  
C. Participants 1-10
Enrolled healthy adults will receive eight applications (three on each forearm and two to 
one hand) of STAR particles and one control application on the volar side of one of the 
forearms for a total of nine applications to the forearms. In addition, two applications of 
STAR particles will be applied to one of the hands – one application to the palmar surface 
and one to the dorsum of the hand (Figure 1). 
Application of STAR particles to volar side of each forearm (Figure 1)
1. Wash participant’s arms and hands with disinfecting soap before any application.
2. Allowed skin to dry for at least 10 minutes.
3. Investigator to delimit the 9 areas on participant’s forearms and hand with a marker.
4. Measure TEWL T0 on all 9 sites - measure from areas 1 to 9 and then from 9 to 1, giving 
2 measurements for each time point according to Figure 1.
5. Apply STARs (80KPa for 60 cycles) on the dorsum of the closed hand.

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6. Apply STARs (80KPa for 60 cycles) to the palmar surface of the same hand.
7. Apply STARs (pressure and # of cycles) to the six areas on the forearms per Figure 1.
8. Extra care will be taken to wash arms and hand with warm water to remove the STAR 
particles and gel and allowed to dry at least 5 min before the next TEWL (T20) is taken.
9. Measure TEWL T20 on all 9 sites - measure from areas 1 to 9 and then from 9 to 1, 
giving 2 measurements for each time point according to Figure 1.
10. Participant completes Tolerability Questionnaire 
11. Participant completes Removal & Disposal Questionnaire and User’s Feedback 
Questionnaire.
12. Pictures (3) will be taken to assess erythema: both forearms and the hand
13. Measure TEWL T30 on all 9 sites - measure from areas 1 to 9 and then from 9 to 1, 
giving 2 measurements for each time point according to Figure 1.
14. Apply GV staining for 10 minutes on the 2 arms resting with volar arm upward and 
right hand on a gauze containing GV stain. 
15. Wash and wipe off the GV stain thoroughly with ethanol 70%. 
16. Take 3 photos of each site to visualize the puncture after GV staining.
17. Using 2 fingers (index and middle), the participant will apply pressure to a kitchen 
scale in an effort to mimic application of low, medium, and high pressures.
18. The investigator records the weight (from the scale) when the pressure is constant.
19. Participant is discharged.
1
Figure 1: STAR particle application sites for V1 (participants #1-10)
D. Participants 11-20

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Enrolled healthy adults will receive eight applications (one on the forearm and one on the 
side of the face of STAR particles and one control application on the other forearm and 
on the other side of the face).
Application of STAR particles to volar side of each forearm 
20. Wash participant’s arms and face with disinfecting soap before any application.
21. Allowed skin to dry for at least 10 minutes.
22. Investigator to delimit the 9 areas on participant’s forearms and face with a marker.
23. Measure TEWL T0 on all 4 sites - measure from areas 1 to 4 and then from 4 to 1, giving 
2 measurements for each time point.
24. Apply STARs (80KPa for 60 cycles) on the forearm.
25. Apply STARs (80KPa for 60 cycles) to the side of the face.
26. Apply gel without STARs on the other forearm and on the other side of the face.
27. The study team will take photos of the application sites.
28. After approximately 5 minutes, the gel (with or without STAR particles) will be 
removed with a dry tissue or gauze. 
29. The study team will take photos of the areas of application.
30. After the gel is removed in all areas, the investigator will examine the participant to 
check if there are any remaining STAR particles on the participant and/or the 
surrounding environment. 
31. Participant completes Tolerability Questionnaire 
32. Participant completes Removal & Disposal Questionnaire and User’s Feedback 
Questionnaire.
33. Pictures (3) will be taken to assess erythema: both forearms and the face
34. Measure TEWL T30 on all 4 sites - measure from areas 1 to 4 and then from 4 to 1, 
giving 2 measurements for each time point.
35. Apply GV staining for 10 minutes on the 2 arms resting with volar arm upward and 
right hand on a gauze containing GV stain. 
36. Wash and wipe off the GV stain thoroughly with ethanol 70%. 
37. Take 3 photos of each site to visualize the puncture after GV staining.
38. Using 2 fingers (index and middle), the participant will apply pressure to a kitchen 
scale in an effort to mimic application of low, medium, and high pressures.
39. The investigator records the weight (from the scale) when the pressure is constant.
40. Participant is discharged.
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 1 visit. 

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
The duration anticipated enrolling all study participants is 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
Visit
1-30 days post Visit
Informed consent
X
Medical history
X
Inclusion and exclusion criteria
X
Anthropometric Information
X
Physical examination of Skin
X
Label treating zones (9)
X
TEWL (T0) 
X
STAR particle application
X
TEWL (T20)
X
Complete Questionnaires
X
VAPS & Disposal 
X
Photograph (Erythema)
X
TEWL (T30)
X
GV Staining
X
Picture of GV Staining
X
Test Pressure (on Scale)
X
AE Reporting
X
X
10. Inclusion and Exclusion Criteria
1) Inclusion criteria: 
a. Adult, 18 – 39 years of age
b. In good general health as determined by a medical history
c.
Willing and able to provide informed consent and follow all study requirements
d. Not pregnant and does not desire to become pregnant in subsequent two months. 
a. Verbally confirmed with participant during consent process.

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2) Exclusion criteria: 
a.   Has a known allergy or sensitivity to .7%w/w Xanthan Gum + 2.5%w/w Hydroxypropyl 
methylcellulose + Cyclomethicone and Dimethicone or alumina
b.   Has any skin disorders or skin allergies
c.   Has any medical condition that may affect skin or skin sensation
d.   Has abnormal (e.g., tattooed) skin at forearms or face
e.   Has known neurological condition affecting sensory function or perception of pain 
f.    Has inflammatory bowel disease
g.   Has applied skin ointment or cream to forearms in the previous 24 hours
h.   Has a major congenital or chromosomal abnormality known to affect skin 
i.    Has taken pain medication in the last 24 hours
j.    Is currently participating in another interventional clinical trial
k.   Has previously participated in a STAR particle interventional clinical trial
l.    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
20 healthy adults, 18-39 years of age.
13. Recruitment Methods
Participants will be recruited from students, faculty, and ancillary staff at Emory University and 
the Georgia Institute of Technology. Participants will be recruited through word-of-mouth and 
recruitment flyer. Eligibility will be reviewed through questioning the participants and 
examination of their skin.
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.
15. Risk to Participants

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The risks to this study are minimal. We will be applying STAR particles that should puncture the 
skin, and 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).  
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. 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 a total of $100 for completion of the study. Participants will receive 
$80 at the completion of the in-person study visit. Participants who drive to the visit will be 
reimbursed for parking in the designated ECC parking area. Participants will also receive $20 30-
days after the in-person study visit assuming they are able to report to the study team if they 
developed adverse reactions at the application sites 24-hours and 30-days after the in-person 
study visit.
18. Data Management and Confidentiality
Data will be stored either electronically in OneDrive 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 

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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. 
DSMP Requirement
How this Requirement is Met 
Frequency
Responsible Party(ies)
Site Monitoring at pre-
determined intervals: 
The Principal Investigator 
has a responsibility to 
ensure that the study is 
following all aspects of 
the protocol. 
There should be a standard 
operating procedure to review data 
(whether a sample or 100%) at pre-
determined intervals to ensure that 
there is adequate documentation of 
critical elements such as eligibility 
criteria. Monitoring is required at the 
following timepoints (but may be 
done more frequently):

study initiation  

at least every six months 
while participants are 
receiving intervention and 

annually while participants 
are in follow-up
Based on risk,  
a review is 
required 
annually when 
participants 
have been 
enrolled.
Delegate a responsible 
party for each 
requirement below. 
Self-assessment is 
acceptable.*
Self-assessment: a 
process for self-
assessment of 
protocol compliance 
and data integrity 
which can be part of 
an overall DSMP. See 
Emory’s self-
assessment tool on  
this page. 
Real-time review of 
participant data during 
initial data collection.
Will review the collected data on 
each participant after collecting the 
data.
Expectation is 
that this 
happens every 
time you 
obtain 
information.
Everyone on the study 
team responsible for 
primary data 
collection.
100% review of consent 
forms
After each participant is enrolled so 
that every time a participant is 
enrolled, his/her CONSENT FORMS 
will be reviewed for completeness. IN 
addition, forms will also be re-
reviewed when all participants have 
completed the study. 
After each 
participant is 
enrolled and 
after all 
participants 
have 
completed the 
study.
The Research Study 
Coordinator & the PI.

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Review of credentials, 
training records, the 
delegation of 
responsibility logs (if 
applicable)
Before enrolling the first participant 
all credentials of all research study 
members will be reviewed.
Prior to the 
enrollment of 
the first 
participant.
The Research Study 
Coordinator & the PI.
Comparison of case 
report forms (CRF) to 
source documentation 
for accuracy and 
completion
After each enrolled participant 
completes the one-day study, CRFs 
will be compared to source 
documentation for accuracy and 
completion. In addition, these 
comparisons will also be made when 
all participants have completed the 
study.
After each 
participant is 
enrolled and 
after all 
participants 
have 
completed the 
study.
The Research Study 
Coordinator & the PI.
Review of 
documentation of all 
adverse events
For any participant who develops an 
adverse event during the study or 
after the completion of the study, we 
will evaluate and compare to other 
participants. If a similar adverse 
event occurs for more than 2 
participants, we will review the 
adverse events and not continue with 
the study until we can ensure the 
study is safe. Adverse events will be 
assessed at the time of the study, 
with reports from the participants, 
and with follow-up contact between 
the study team and the participants.
On the day 
each 
participant is 
studied as well 
as weekly 
follow-up 
contact for 
one month.
The Research Study 
Coordinator & the PI.
Monitoring of critical 
data points (eligibility, 
study endpoints, etc.)
Prior to enrolling participants 
(eligibility criteria) and after each 
enrolled participant completes the 
one-day study, we will monitor the 
critical data points. 
After each 
participant is 
enrolled .
The Research Study 
Coordinator & the PI.
For FDA regulated 
studies, the following 
requirements apply:
How this Requirement is Met
Timing, 
frequency, 
and intensity 
of monitoring
Responsible Party(ies)
Monitoring methods 
(may include centralized, 
on-site, and self-
assessment)
N/A
N/A
N/A
Subject safety:

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
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.
o
Most common risk = redness to skin where STAR particles lasting less than 2 
hours
o
Less Common Risks = mild irritation or small marks at the site where STAR 
particles applied
o
RARE risk = skin infection or foreign body growth (100 applications in > 20 
participants – This has never occurred)

Subjects will report observations:
o
During the procedure and 2 hours after the procedure is performed
o
Via follow-up contact from participant to investigating team ANYTIME after 
completing the study
o
Via follow-up call from investigating team 7 days after the study

Individual responsible for safety monitoring
o
The PI will be responsible for safety monitoring.

Subject stopping rules – under what conditions will a subject be removed from study 
participation and who will make the decision?
o
The study is a one-day study – if the participant has enough discomfort during 
the study (application of the STARS) the participant can inform the PI that he/she 
wants to discontinue OR, if the PI determines that the participant is in significant 
pain, the PI will stop the study
o
If the subject has skin irritation, pain, itching, or infection, a topical medication 
could be applied to address the symptoms. 
o
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. 

Study stopping rules - under what conditions will the study be modified or stopped and 
who will make the decision?
o
If 2 participants have to stop the study to discomfort, the study will be stopped 
and modifications will be made before resuming the study.
o
Reporting mechanisms (i.e. Deviations, adverse events, UPs)Deviations, AEs, and 
SAEs will be reported to the IRB by the PI according to Emory IRB reporting 
guidelines.

Description of the plan for notifying the IRB of reportable events; whether the sponsor 
requires reporting above and beyond the Emory IRB reporting requirements, and if so, a 
description of the requirements and plan for meeting them.
o
We will record from participant questionnaires any adverse events and report to 
the sponsor (Aldena). If the adverse events are serious they will be reported to 
the IRB and a plan to modify the application to prevent future SAEs from 
occurring would be implemented.

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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 performed 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.
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 
ECC.

There is no standard waiting period before the participant is approached for consent 
after being told about the study. 

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
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 speaking participants since we are not able to get certified translations of 
the study questionnaire.
23. Setting
The research will be conducted at the Emory Children’s 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 Children’s Center on the Emory 
University campus. 
24. Resources Available
We are performing this study as a feasibility study and believe we have enough resources to 
recruit the number of subjects we seek to study.
 will devote 10% time to this study.
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.
Hay, Roderick J., et al. "The global burden of skin disease in 2010: an analysis of the prevalence 
and impact of skin conditions." Journal of Investigative Dermatology 134.6 (2014): 1527-1534.

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2.
R. Langer. (1998). Drug delivery and targeting. Nature, 392, 5-10
3.
Vinson, L. J., et al. "The nature of the epidermal barrier and some factors influencing skin 
permeability." Toxicology and Applied Pharmacology 7 (1965): 7-19.
4.
D. S. Hsieh. (editor). (1994). Drug Permeation Enhancement. Vol. 62. New York: Marcel Dekker
5. J. Hadgraft, R. H. Guy. (editors). (1989). Transdermal Drug Delivery: Developmental Issues 
and Research Initiatives. New York: Marcel Dekker
6. E. W. Smith, H. I. Maibach (editors). (1995). Percutaneous Penetration Enhancers. Boca 
Raton, FL: CRC Press.
7. B. G. Amsden, M. F. A. Goosen. (1995). Transdermal delivery of peptide and protein drugs: 
An overview. AIChE J. 41, 1972-97
8.
Y.C. Kim, JH Park and MR Prausnitz. (2012). Microneedles for drug and vaccine delivery, 
Advanced Drug Delivery Reviews, 64, 1547–1568.
9. Lee, J.W., J.H. Park, and M.R. Prausnitz, Dissolving microneedles for transdermal drug 
delivery. Biomaterials, 2008. 29(13): p. 2113-2124
10. Kim, Y.C., J.H. Park, and M.R. Prausnitz, Microneedles for drug and vaccine delivery. Adv 
Drug Deliv Rev, 2012. 64(14): p. 1547-68.
11. R. G. Crystal. (1995). Transfer of genes to humans, Science, 270, 404-10
12. J. G. Hardman, L. E. Limbird (editors). (1996). Goodman and Gilman's The Pharmacological Basis 
of Therapeutics. 9th ed. New York: McGraw- Hill
13. G. P. Wormser, S. Bittker, G. Forster, I. K. Hewlett, I. Argani, B. Joshi, J. S. Epstein and 
D. Buchner. (1992). Absence of infectious human immunodeficiency virus type 1 in 
‘natural’ eccrine sweat. J. Infectious Diseases, 165, 155-58
14. J. F. Val-Bernal, C. Sanchez-Quevedo, J. Corral, and A. Campos. (1995). Cutaneous 
Sarcoidosis and Foreign Bodies: An Electron Probe Roentgenographic Microanalytic 
Study, Arch. Pathol. Lab. Med., 119,471-4
15. D. J. Edell, V. Van Toi, V. M. McNeil, and L. D. Clark. (1992). Factors influencing 
biocompatibility of insertable silicon microshafts in cerebral cortex, IEEE Transactions 
on Biomedical Engineering, 39(6), 635-41
16. W. S. Rapson (1985). Skin contact with gold and gold alloys, Contact Dermatitis, 13, 56-65.
17. E. A. Dinces, J. A. Mauriello Jr., J. A. Kwartler and M. Franklin. (1997) Complications of gold weight 
eyelid implants for treatment of fifth and seventh nerve paralysis, Laryngoscope, 107, 1617-22
18. M. Gjuric and S. Schagerl. (1998). Gold prostheses for ossiculoplasty, Am. I Otol., 19, 273-6
19. C. Fleming, A. Forsyth and R. MacKie. (1997). Prevalence of gold contact hypersensitivity 
in the West of Scotland, Contact Dermatitis, 36, 302-304
20. T. Aro, L. Kanerva, R. Hayrinen-Immonen, S. Silvennoinen-Kassinen, Y. T. Konttinen, R. 
Jolanki and T. Estlander. (1993). Long-lasting allergic patch test reaction caused by gold, 
Contact Dermatitis, 28,276-281
21. T. Fischer, S. Fregert, B. Gruvberger and I. Rystedt. (1984). Contact Dermatitis, 10, 23-24.
22. Liden, C., Menne, T. and Burrows, D. (1996). Nickel-containing alloys and platings and 
their ability to cause dermatitis, British Journal of Dermatology, 134(2), 193-8
23. Britton, R.S., Ramm, G.A., Olynyk. J., Singh, R., O'Neill, R., Bacon, B.R., (1994) 
Pathophysiology of iron toxicity, Exp Med Biol, 356, 239-53
24. Drugacz, J., Lekston, Z., Morawiec, H. and Januszewski, K. (1995). Use of TiNICo shape-
memory clamps in the surgical treatment of mandibular fractures, J. Oral Maxillofac. Surg., 
53, 665-71

Protocol Title: Usability of STAR particles in healthy volunteers: A pilot study
Page 19 of 19
 
Version: 4.1 10APR2024 
IRB Form BIO 03152021
25. Musialek, J., Filip, P. and Nieslanik, J. (1998). Titanium-nickel shape memory clamps in 
small bone surgery, Arch. Orthopedic Trauma Surgery, 117, 341-4
26. L. Fernandez de Corres, Bernaola, G., Munoz, D., Audicana, N. and Urrutia, I. (1988). The 
innumerable sources of nickel. Contact Dermatitis, 19, 386-7
27. Liden, C., Maibach, H. I. And Wahlberg, J. E. (1995) Skin. In ‘Metal Toxicology’, R.
28. I. Gotman. (1997). Characteristics of metals used in implants, J. Endourol., 11, 383-9.
29. C. M. Agrawal, A. Pennick, X. Wang and R. C. Schenck. (1997). Porous-coated titanium 
implant impregnated with a biodegradable protein delivery system, J. Biomed. Mater. 
Res., 36, 516-21.
30. E. Piskin. (1994). Review: Biodegradable polymers as biomaterials, I Biomater. Sci. 
Polymer Edn., 6, 775-95
31. C. M. Agrawal, C. G. Niederauer and K. A. Athanasiou. (1995). Fabrication and 
characterization of PLA-PGA orthopaedic implants, Tissue Engineering, 1, 241-52.
32. J. M. Schakenraad, P. Niewenhues, I. Molenaas, J. Helder, P. J. Dykstra and J. Feijen 
(1989). In vivo and in vitro degradation of glycine/ DL- Lactic acid copolymer ratios, I 
Biomed. Mater. Res., 23, 1271-88
33. S. Kayashima, T. Arai, M. Kikuchi, N. Sato, N. Nagata, O. Takatani, N. Ito, J. Kimura, T. 
Kuriyama and A. Kaneyoshi. (1991). New noninvasive transcutaneous approach to blood 
glucose monitoring: Successful glucose monitoring on Human 75 g OGTT with novel 
sampling chamber, IEEE Transactions of Biomedical Engineering, 38, 752-57
34. BD Ratner, AS Hoffman, FJ Schoen, JE Lemons. (2004) Biomaterials Science, Elsevier, New 
York. 
35. Package Insert NDC: 00409 - 4277 – 01, Hospira, Inc. Lake Forest, Illinois, U.S.A.
36. Package Insert – Hylenex. Baxter Healthcare Corporation Deerfield, IL 60015 USA
37. A.H. Kibbe (ed).  Handbook of Pharmaceutical Excipients, American Pharmaceutical 
Association, Washington DC., 2000. 
38. http://www.who.int/medicines/publications/pharmacopoeia/2012-04-
03MicrobialPurity_QAS11-41_FINAL.pdf
39. Gupta, J., et al., Kinetics of skin resealing after insertion of microneedles in human subjects. 
Journal of controlled release, 2011. 154(2): p. 148-155.
40. Tadros, Andrew R., et al. "STAR particles for enhanced topical drug and vaccine 
delivery." Nature medicine 26.3 (2020): 341-347.
41. Korkmaz, Emrullah, et al. "Emerging skin-targeted drug delivery strategies to engineer 
immunity: A focus on infectious diseases." Expert Opinion on Drug Delivery 18.2 (2021): 
151-167.