Patient Self-Administered Intralesional Injections of Triamcinolone for Acne Vulgaris
Phase: NA
Conditions: Acne Vulgaris
Sponsor: ACOM Labs

 
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STUDY PROTOCOL 
 
 
 
 
ATM-2301 
 
Patient Self-Administered Intralesional Injections of 
Triamcinolone for Acne Vulgaris 
 
 
 
Proof of Concept Study 
 
Version 1.0 
31-Jan-2023 
 
 
 
Study Sponsor 
ACOM Labs Inc. 
1 Letterman Dr., Suite C3500 
San Francisco, California, USA 94129 
 
 
Clinical Research Organization 
ethica CRO Inc. 
3551 St. Charles Blvd, Suite 501 
Kirkland, Quebec, Canada H9H 3C4 
 
 
 
 
 
 
 
 
 
Confidentiality Statement 
The information contained in this document is provided in confidence. It is 
understood that this information will not be disclosed to others without prior 

 
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agreement with the Sponsor, except to other study personnel and to the extent 
necessary to obtain informed consent from participating subject. 
 

 
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PROTOCOL APPROVAL SIGNATURE PAGE 
 
The following individuals approve this version of Protocol ATM-2301. All changes to this version 
of the protocol must have a prior written approval and require an amendment or administrative 
letter. 
 
 
 
Approved by Sponsor – ACOM Labs Inc. 
 
___________________________  ______________________________  
Printed Name 
Title 
 
 
 
___________________________  ______________________________   
Signature 
Date 
 
 
 
 
 
 
 
 
 
 

 
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INVESTIGATOR SIGNATURE PAGE 
 
I agree to: 
● Implement and conduct this study diligently and in strict compliance with the protocol, good 
clinical practices and all applicable laws and regulations. 
● Maintain all information supplied by ACOM Labs, Inc. in confidence and, when this 
information is submitted to an Institutional Review Board (IRB) or another group, it will be 
submitted with a designation that the material is confidential. 
 
 
 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
 
 
 
 
 
Principal Investigator (Printed Name) 
 
Signature 
 
Date 
 
 
 
 

 
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SYNOPSIS 
Version 
Version 1.0 (31-Jan-2023) 
Study Device 
Injection Assistance Device 
Study Number 
ATM-2301 
Phase 
Proof of Concept 
Control Product 
Not Applicable 
Indication 
Inflammatory Acne Lesions 
Study Sites 
~3 sites (US) 
Title 
Patient Self-Administered Intralesional Injections of Triamcinolone for Acne Vulgaris 
Sponsor 
ACOM Labs, Inc. 
Study 
Duration  
14 days per subject 
Sample Size 
~150 subjects 
Study Design 
This is an open-label, prospective, single-arm study. Approximately 150 subjects will be enrolled 
at approximately 3 study sites. 
All subjects will receive standard-of-care intralesional injection with triamcinolone using an 
Injection Assistance Device (i.e., for self-administered intralesional injections) at Visit 1 (Day 1). 
Subjects will then submit photos via secure photographic app for asynchronous follow up on Day 
2 (24-hours post-injection), Day 3 (48-hours post-injection), Day 4 (72-hours post-injection), Day 
7, and Day 14. 
Efficacy assessments (target lesion assessments) will be conducted remotely by the Investigator 
at time of each photo submission. Subjects will conduct lesion pain assessments and satisfaction 
assessments at the time of each remote check-in. Participants will be invited to also have 
additional photography captured by the study team at the study site or at a location as per 
participants’ convenience. 
Study 
Objectives 
The objective of this proof-of-concept study is to investigate the immediate safety of self-
administered intralesional injections of triamcinolone using an Injection Assistance Device. 
Inclusion 
Criteria 
1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of 
childbearing potential must have a negative UPT at Baseline. 
2. Diagnosed with facial acne vulgaris. 
3. At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is 
clinically indicated for standard-of-care intralesional injection(s) of triamcinolone.  
4. Owner of smartphone with capacity for front-facing photography and app download from 
Apple App Store or Google Play. 
5. Able to follow study instructions and likely to comply with virtual follow-up requirements. 
6. In good general health as determined by medical history at the time of screening (Investigator 
discretion). 
7. Sign the IRB-approved ICF (including HIPAA authorization) prior to any study-related 
procedures being performed. 
Exclusion 
Criteria 
1. Female subjects who are pregnant or breast-feeding. 
2. Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone 
injection. 
3. Active cutaneous viral infection in any treatment area at Baseline. 
4. Have concomitant skin disease or infection (other than acne) or presence of skin 
comorbidities in the areas of skin where study device will be used. 
5. History of poor cooperation or unreliability (Investigator discretion). 
6. Subjects who are investigational site staff members or family members of such employees. 
7. Exposure to any other investigational device within 30 days prior to Visit 1. 

 
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Study 
Treatment 
Delivery System and Injection Assistance Device: The Delivery System consists of an Injection 
Assistance Device used with a sterile, single use 32G intradermal safety needle and 1 mL luer 
lock syringe containing triamcinolone. The Injection Assistance Device is the durable component 
of the delivery system and is a non-sterile, single patient use, reusable device intended for use by 
patients to deliver an intradermal injection of 0.1 mL of an FDA-approved drug contained in a 
commercially-available sterile,  single use, 1 mL plastic luer syringe  
Triamcinolone for Injection: A commercial supply of triamcinolone for injection will be used 
for injection. The site will store triamcinolone as per the conditions described in the package 
insert. A 1.0mL luer syringe will be loaded with an appropriate volume and concentration of 
triamcinolone. A total of 0.1 mL of triamcinolone 1.0% will be injected into each target lesion. 
The syringe will then be installed into the Injection Assistance Device. 
At least one (1), and up to three (3) inflammatory target lesions will be selected for intralesional 
injections of triamcinolone using the Injection Assistance Device. 
Blinding 
Not applicable  
Investigator 
Assessments 
● 
Global Severity Score (GSS): A 5-point scale assessing ranging from 0 (Clear) to 4 (Severe). 
Note: only Baseline assessments will be conducted. 
● 
Target Lesion Erythema: A 5-point scale ranging from 0 (No Erythema) to 4 (Very Severe 
Erythema). 
● 
Target Lesion Severity: A 5-point scale ranging from 0 (None) to 4 (Very Severe). 
● 
Target Lesion Improvement: A 7-point scale ranging from 1 (Clear; 100%) to 7 (Worse). 
● 
Target Lesion Videography: A video will be taken of each injected lesion starting from just 
prior to needle penetration and up to 10 seconds after removed of needle from lesion. 
● 
Target Lesion Photography: Photographs will be taken by study team at Baseline both pre- 
and post-injection. Participants can elect to have additional photography captured by the trial 
team at clinic or location of participants’ convenience at each study time point, or to use the 
photography app that can be used outside of the clinic. 
Subject 
Assessments 
● 
Target lesion time course: At Baseline, subjects will report approximate length of time (in 
days) since lesion emerged on face. 
● 
Target Lesion Pain: Target lesion pain will be self-assessed by the subject using a Visual 
Analog Scale.  
● 
Target Lesion Injection Pain: Target lesion injection pain will be self-assessed by the 
subject using a Visual Analog Scale immediately after the injection of the first target lesion 
and at 5 minutes post-injection. 
● 
Subject Satisfaction: A 5-point scale ranging from 1 (Very satisfied) to 4 (Very dissatisfied). 
● 
Target lesion Photography: Participants will take photos of each injected inflammatory 
lesion at each study time point with the photography app. At Baseline, photographs will be 
taken by participants both pre- and post-injection. Participants can elect to have additional 
photography captured by the trial team at clinic or location of participants’ convenience. For 
tracking of lesion number and size, participants will place next to each lesion a numbered 
adhesive sticker prior to each photography session.  
Safety 
Endpoints 
Adverse Events 
Sample Size 
Approximately 150 subjects will be enrolled. This is a POC study and a formal sample size 
justification is not provided for this study. It is the opinion of the Sponsor that a total of 150 
subjects will be sufficient to achieve the objective of the study. 
Statistical 
Methods 
For categorical parameters, the number and percentage of subjects/observations in each category 
will be presented. The denominator will be based on the number of subjects/observations 
appropriate for the purpose of analysis. For continuous parameters, descriptive statistics will 

 
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include n (number of subjects or observations), mean, standard deviation, median, and range. 
Two-sided 95% CIs will be provided for all study outcomes. 
The modified Intent-to-Treat (mITT) Population (defined as all subjects who were enrolled and 
received at least one application with the study device) will be used for analyses of safety and 
effectiveness endpoints. A Per-Protocol (PP) Population will neither be defined nor analyzed. 
 
 
 
SCHEDULE OF EVENTS AND PROCEDURES 
Visit Number 
V1 
V2 
V3 
V4 
V5 
V6 
Day/Week/Month 
Day 1 
24hr 
Post-Inj. 
48hr 
Post-Inj. 
72hr 
Post-Inj. 
Day 7 
±1 day 
Day 14 
±2 days 
Assessment and Procedures 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
Inc/Excl Criteria 
X 
 
 
 
 
 
Demographics, Med Hx 
X 
 
 
 
 
 
Intralesional Injection(s) 
X 
 
 
 
 
 
Investigator Assessments 
 
 
 
 
 
 
Global Severity Score 
X 
 
 
 
 
 
Target Lesion Assessments 
X 
X 
X 
X 
X 
X 
Target Lesion Photography 
X 
pre-/post- inj. 
X 
opt-in  
X 
opt-in  
X 
opt-in  
X 
opt-in  
X 
opt-in  
Lesion Injection Videography 
X 
 
 
 
 
 
Subject Assessments 
 
 
 
 
 
 
Target Lesion Pain 
X 
pre-inj. 
X 
X 
X 
X 
X 
Intralesional Injection Pain 
X 
post- inj. 
 
 
 
 
 
Target Lesion Photography 
X 
pre-/post- inj. 
X 
X 
X 
X 
X 
Subject Satisfaction 
 
X 
X 
X 
X 
X 
Safety Assessments 
 
 
 
 
 
 
UPT (as applicable) 
X 
 
 
 
 
 
Concomitant Medications 
X 
 
 
 
 
 
Adverse Events 
X 
X 
X 
X 
X 
X 
  
 

 
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TABLE OF CONTENTS 
 
PROTOCOL APPROVAL SIGNATURE PAGE 
3INVESTIGATOR SIGNATURE PAGE
 
4SYNOPSIS
 
51
 
INTRODUCTION
 
9 
2 
STUDY OBJECTIVE 
9 
3 
COMPLIANCE STATEMENT 
9 
3.1 
Variations to the Protocol 
9 
3.2 
Investigational Sites 
9 
4 
OVERVIEW OF STUDY DESIGN 
9 
5 
STUDY POPULATION 
10 
5.1 
Inclusion Criteria 
10 
5.2 
Exclusion Criteria 
10 
5.3 
Subject Withdrawal 
11 
6 
SUBJECT NUMBERING, RANDOMIZATION AND BLINDING 
11 
7 
CONCOMITANT AND PROHIBITED MEDICATION/PROCEDURES 
11 
7.1 
Concomitant Medications and Procedures 
11 
8 
INVESTIGATIONAL PRODUCT MANAGEMENT 
12 
8.1 
Delivery System 
12 
8.2 
Injection Assistance Device 
12 
8.3 
Triamcinolone for Injection 
12 
8.4 
Assembly of Delivery System and Injection delivery 
13 
9 
DATA COLLECTION 
13 
9.1 
Electronic Data Capture 
13 
9.2 
Photography 
13 
10 STUDY EVALUATIONS 
14 
10.1 
Visit Procedures 
14 
10.1.1 Visit 1 (Baseline; Day 1) 
14 
10.1.2 Remote Follow-Up Visits 2 to 6 (24hr, 48hr, 72hr, 7 days±1 day, 14 days±2 days) 
14 
10.2 
Investigator Assessments 
15 
10.2.1 Global Severity Score (GSS) 
15 
10.2.2 Target Lesion Assessments 
15 
10.2.2.1 
Target Lesion Erythema 
15 
10.2.2.2 
Target Lesion Severity 
15 
10.2.2.3 
Target Lesion Improvement 
16 
10.3 
Subject Assessments 
16 
10.3.1 Target Lesion Pain 
16 
10.3.2 Target Lesion Injection Pain 
16 
10.3.2.1 
Target Lesion Improvement 
16 
10.3.3 Subject Satisfaction 
16 
10.3.3.1 
Target Lesion Videography 
17 
10.3.3.2 
Target Lesion Photography 
17 
10.4 
Safety 
17 
10.4.1 Adverse Events 
17 
10.4.1.1 
Definition of Adverse Event 
17 
10.4.1.2 
Documenting Adverse Experiences 
17 
10.4.1.3 
Serious Adverse Events 
18 
10.4.1.4 
Assessment of Severity 
18 

 
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10.4.1.5 
Assessment of Causality 
19 
10.4.1.6 
Reporting of Serious Adverse Events 
19 
10.4.1.7 
Pregnancy 
19 
11 STATISTICS 
20 
11.1 
Sample Size Determination 
20 
11.2 
Assessment of Safety 
20 
11.2.1 Adverse Events 
20 
11.3 
Analysis Populations 
20 
11.3.1 Intent-to-Treat (ITT) Population 
20 
11.3.2 Per-Protocol (PP) Population 
20 
11.3.3 Subject Disposition 
20 
11.3.4 Protocol Deviations and Violations 
20 
11.3.5 Missing Data Imputations 
20 
11.3.6 Statistical Hypothesis Testing and Control of Multiplicity 
20 
11.3.7 Interim Analyses 
21 
12 QUALITY CONTROL AND QUALITY ASSURANCE 
21 
12.1 
Study Monitoring 
21 
12.2 
Audits and Inspections 
21 
12.3 
Protocol Deviations 
21 
13 ETHICS AND ADMINISTRATIVE ISSUES 
22 
13.1 
Ethical Conduct of the Study 
22 
13.2 
Ethics Review 
22 
13.3 
Written Informed Consent 
22 
13.4 
Subject Data Protections 
22 
13.5 
Data Monitoring Committee 
23 
13.6 
Investigator Obligation 
23 
13.7 
Changes to the Protocol 
23 
13.8 
Confidentiality Regarding Study Subjects 
23 
13.9 
Reporting and Publication of Results 
23 
13.10 Financing and Insurance 
23 
14 APPENDICES 
24 
APPENDIX A: PROTOCOL VERSION HISTORY 
26APPENDIX B: INSTRUCTIONS FOR USE OF 
PHOTOGRAPHY APP 
27APPENDIX C: INSTRUCTIONS FOR SELF-
INJECTION 
28 

 
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11 INTRODUCTION 
Intralesional injections are a commonplace, low risk therapy for acne lesions. They are typically 
dosed with triamcinolone acetonide at concentrations of 0.5 mg/mL to 2.5 mg/mL (i.e., 0.5% to 
2.5%) in volumes of 0.05 mL to 0.15 mL. 
This proof-of-concept study will investigate the safety of self-administered intralesional 
triamcinolone injections in patients with acne vulgaris using an Injection Assistance Device. 
As intralesional triamcinolone injections are standard-of-care, the purpose of this proof-of-concept 
study is to test the safety of the Injection Assistance Device, not the safety and efficacy of 
triamcinolone per-se. 
12 STUDY OBJECTIVE 
The objective of this proof-of-concept study is to investigate the safety of self-administered 
intralesional injections of triamcinolone using an Injection Assistance Device. 
13 COMPLIANCE STATEMENT 
The study will be conducted in accordance with the Clinical Investigation Plan, International 
Conference on Harmonization (ICH) and Good Clinical Practice (GCP), the Declaration of 
Helsinki, International Organization for Standardization (ISO) 14155, and the United States (US) 
Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 
50, 21 CFR Part 56, and 21 CFR Part 312). In addition, the study will be conducted in compliance 
with all applicable laws and regulatory requirements relevant to the use of new medical devices in 
the United States. 
The sites’ Principal Investigator (PI) is responsible for ensuring the privacy, safety and welfare of 
the subjects during and after the study and must ensure that site personnel are appropriately trained. 
The PI at each site has the overall responsibility for the conduct and administration of the study at 
their site, and for contact with study site management, and local authorities.  
13.1 
Variations to the Protocol 
No changes from the final approved (signed) protocol will be initiated without the prior approval 
by the IRB except 1) when necessary to eliminate immediate hazards to the subjects or when the 
change involves only logistics or administration, or 2) minor administrative or typographical 
corrections. The sites’ PIs and the Sponsor must sign any protocol amendments. 
13.2 
Investigational Sites 
One (1) to three (3) U.S. investigational site will participate in this study. All sites must obtain 
written approval from a 21 CFR 56 compliant IRB prior to recruitment and enrollment of any 
subject into the study. Any changes to the study procedures must be made with the mutual 
agreement of the PI and the Sponsor, documented in an amendment to the protocol, and approved 
by the reviewing IRB.  

 
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14 OVERVIEW OF STUDY DESIGN 
This is an open-label, prospective, single-arm study. Approximately 150 subjects will be enrolled 
at 1 study site. A full description of the inclusion and exclusion criteria can be found in Section 5. 
All subjects will self-administer treatment with the study device (i.e., intralesional injection with 
triamcinolone) at Visit 1 (Day 1). Subjects will submit photos via app pre- and post-injection at 
Visit 1 (Day 1) and for remote follow-up at Day 2 (24-hours post-injection), Day 3 (48-hours post-
injection), Day 4 (72-hours post-injection), Day 7, and Day 14. 
15 STUDY POPULATION 
Potential study participants may be identified and recruited into the study through various 
methods, such as: 
● Database of individuals who have agreed to be contacted for future studies; 
● In-person recruitment; 
● Physician to physician referrals; 
● Internet advertisement; 
● Print advertisement. 
Note that scripts and advertisement fliers will be submitted to the IRB as necessary. 
15.1 
Inclusion Criteria 
1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of 
childbearing potential must have a negative UPT at Baseline. 
A female is considered of childbearing potential unless she is: 
− 
postmenopausal for at least 12 months prior to study device administration; 
− 
without a uterus and/or both ovaries; or 
− 
has been surgically sterile for at least 6 months prior to study device administration.  
2. Diagnosed with facial acne vulgaris. 
3. At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is 
clinically indicated for standard-of-care intralesional injection(s) of triamcinolone. 
4. Owner of smartphone with capacity for front-facing photography and app download from 
Apple App Store or Google Play. 
5. Able to follow study instructions and likely to complete all required visits. 
6. In good general health as determined by medical history at the time of screening 
(Investigator discretion). 
7. Sign the IRB-approved ICF (including HIPAA authorization) prior to any study-related 
procedures being performed. 
15.2 
Exclusion Criteria 
1. Female subjects who are pregnant or breast-feeding. 

 
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2. Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone 
injection. 
3. Active cutaneous viral infection in any treatment area at Baseline. 
4. Have concomitant skin disease or infection (other than acne) or presence of skin 
comorbidities in the areas of skin where study device will be used. 
5. History of poor cooperation or unreliability (Investigator discretion). 
6. Subjects who are investigational site staff members or family members of such employees. 
7. Exposure to any other investigational device within 30 days prior to Visit 1. 
15.3 
Subject Withdrawal 
Subjects are free to withdraw from participating in this study at any time and for whatever reason, 
specified or unspecified, and without prejudice. All premature discontinuations and their reasons 
must be carefully documented by the PI in the source documents, CRF, and (if applicable), on the 
AE form.  
16 SUBJECT NUMBERING, RANDOMIZATION AND BLINDING 
This is an open-label, non-randomized, single-group study. All subjects who are enrolled will 
receive treatment with the study device. Randomization and blinding are not applicable. 
All enrolled subjects will receive a 3-digit subject number, starting at 001. Subject numbers will 
be assigned in ascending order. The subject number will be used to identify the subject throughout 
the study. Subjects withdrawn from the study will retain their subject number; new subjects will 
be allocated a new subject number. Screen Failures will not be entered in the eCRF. 
17 CONCOMITANT AND PROHIBITED MEDICATION/PROCEDURES 
17.1 
Concomitant Medications and Procedures 
All treatment/procedures received by the subject throughout the treatment period, including the 
name of the treatment/procedure, must be recorded in the CRF with end dates, if applicable. Every 
attempt should be made to keep concomitant therapy dosing constant during the study. Any change 
to concomitant therapy should be noted in source documents and the CRF. 
There are no prohibited medications defined for the study. Any necessary therapies that are deemed 
appropriate by the Investigator are permitted. Subjects currently taking medications to treat acne 
should be instructed to maintain their current dosing throughout the study. 
 
 

 
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18 INVESTIGATIONAL PRODUCT MANAGEMENT 
18.1 
Delivery System 
The Delivery System consists of an Injection Assistance Device used in conjunction with a sterile, 
single use 32G intradermal safety needle and 1 mL luer lock syringe containing triamcinolone. A 
schematic of the Delivery System is provided below in  Figure 1. 
 
Figure 1. Delivery System 
18.2 
Injection Assistance Device 
A commercial supply of triamcinolone 10% for injection will be provided to the site and diluted 
with saline to the appropriate concentration. The site will store triamcinolone as per the conditions 
described in the package insert. 
A standard 32G 0.5” needle will be fixed to a 1.0 mL luer syringe and the syringe will be loaded 
with an appropriate volume and concentration of triamcinolone. A total of 0.05 mL to 0.15 mL of 
triamcinolone 0.5% to 2.5% will be injected into each target lesion. The choice of volume and 
concentration for each individual lesion will be at the discretion of the Investigator as per his 
clinical judgement. The needle will then be installed into the Injection Assistance Device. 
At least one (1), and up to three (3) inflammatory target lesions will be selected for intralesional 
injections of triamcinolone using the intradermal needle adapter. 
The Injection Assistance Device is the durable component of the delivery system. It is a non-
sterile, single patient use, reusable device intended for use by patients to deliver an intradermal 
injection of 0.1 mL of an FDA-approved drug contained in a commercially available sterile, single 
use, 1mL plastic luer lock syringe. 
18.3 
Triamcinolone for Injection 
A commercial supply of triamcinolone 10% for injection will be provided to sites and diluted with 
Saline to the appropriate concentration. Sites will store triamcinolone as per the conditions 
described in the package insert. 

 
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A 1.0 mL luer lock syringe will be loaded with an appropriate volume and concentration of 
triamcinolone by the study team. An intradermal safety needle will be affixed to the loaded syringe. 
A total of 0.1 mL of triamcinolone 1.0% will be injected into each target lesion. 
18.4 
Assembly of Delivery System and Injection delivery 
The subject will load assembled, filled needle-syringe into the Injection Assistance Device and 
close the access door of the device. The subject then delivers the injection by depressing the tip of 
the Injection  Assistance Device on the skin, at a 90-degree angle to the skin, then pressing the 
button to activate the device. The Injection  Assistance Device then delivers a fixed volume (0.1 
mL) into the  dermis. The user then lifts the device from the injection site and  the needle safety 
shield is engaged. 
At least one (1), and up to three (3) inflammatory target lesions will be selected for intralesional 
injections of triamcinolone using the Injection Assistance Device. 
19 DATA COLLECTION 
19.1 
Electronic Data Capture 
Treatment and follow-up of subjects will be recorded with an app specifically designed for facial 
dermatologic photography (i.e., the “Appiell app”). This app enables subjects to take consistent, 
serial photographs of the lesion(s) treated at Visit 1.  
Subjects will download the app at time of study enrollment and use the app to take photos and 
complete surveys throughout the study. 
Participants will be trained regarding app use at Visit 1. Functionality of the app will be maintained 
by the Appiell engineering team, and any issue with app technical functionality will be reported 
promptly to the study team. 
19.2 
Photography 
Target lesion photography (pre- and post-injection) will be performed at Visit 1 by the study 
coordinator at the sites using high-quality digital cameras. The same cameras will be used to take 
a video recording of the injection process. Stickers will be placed next to each lesion to identify 
lesions in all photos. Addition stickers will be placed on the face that indicate size and dimension. 
Subjects will download the Appiell app to their smartphones at Visit 1 and, after training by the 
study coordinator, will take photographs (pre- and post-injection) of their target lesions. 
The subject will be asked to sign a separate photography release form to specify whether he/she 
allows other uses of the photographs (e.g., publications, promotion). The subject’s decision will 
be then tracked in a separate photography release log kept at the site. 
9.3 Sponsor Follow-up 
Subjects will be asked to sign a separate Sponsor contact release form to specify whether he/she 
allows the Sponsor to access contact information (name, phone number, email) for follow-up after 
completion of the study. Subject may select as many or as few of the following permissions as 
desired: 1) follow-up about study experience, including use of injection assistance device 2) user 
interviews about personal experience with acne 3) invitations to participate in future acne research 

 
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trials and 4) information about Sponsor’s products, including the injection assistance device. The 
subject’s decision will be then tracked in a separate Sponsor-contact release log kept at the site. 
110 STUDY EVALUATIONS 
110.1 Visit Procedures 
110.1.1 Visit 1 (Baseline; Day 1) 
● Written informed consent (incl. HIPAA and California Bill of Rights) 
● Inclusion / exclusion criteria 
● UPT (if female subject of childbearing potential) 
● Medical history and demographics 
● Concomitant medications/treatments 
● Investigator Assessments 
- 
Global Severity Score (GSS) 
- 
Target Lesion Assessments: lesion erythema, lesion severity 
- 
Target Lesion Photography (pre- and post-injection) 
- 
Target Lesion Injection Videography 
● Subject Assessments 
- 
Target lesion time course (pre-injection) 
- 
Target lesion pain (pre-injection) 
- 
Intralesional injection pain (post-injection) 
- 
Target Lesion Photography (pre- and post-injection) 
● Intralesional injection(s) 
● AE Assessment 
110.1.2 Remote Follow-Up Visits 2 to 6 (24hr, 48hr, 72hr, 7 days±1 day, 14 days±2 days) 
● Investigator Assessments of Submitted Photographs 
- 
Target Lesion Assessments: lesion erythema, lesion severity, improvement 
- 
Target Lesion Photography (if opt-in) 
● Subject Assessments 
- 
Target lesion photography 
- 
Target lesion pain 
- 
Target lesion improvement  
- 
Subject Satisfaction 
● Concomitant medications/treatments 
● AE Assessment 

 
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110.2 Investigator Assessments 
110.2.1 Global Severity Score (GSS) 
The Investigator will use the GSS scale to determine subjects’ Baseline acne severity (Table 1).  
Table 1: Global Severity Score 
Score 
Grade 
Description 
0 
Clear 
Normal, clear skin with no evidence of acne vulgaris 
1 
Almost Clear Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be 
resolving and may be hyperpigmented, though not pink-red 
2 
Mild 
Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules 
only; no nodulocystic lesions) 
3 
Moderate 
Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to 
many comedones and papules/pustules, and there may or may not be one nodulocystic lesion 
4 
Severe 
Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or 
may not be up to 2 nodulocystic lesions 
110.2.2 Target Lesion Assessments 
Up to 3 inflammatory lesions on the face will be chosen for intralesional injections of 
triamcinolone using the Injection Assistance Device as per Section 8. Days since lesion eruption 
will be also be reported by the participant for each lesion. 
Each injected lesion will be individually assessed as per the following methods. 
110.2.2.1 Target Lesion Erythema 
The Investigator will use the following scale to determine the severity of erythema for each target 
lesion (Table 2).  
Table 2: Target Lesion Erythema 
Grade 
Description 
0 
No Erythema 
1 
Mild Erythema 
2 
Moderate Erythema 
3 
Severe Erythema 
4 
Very Severe Erythema 
 
110.2.2.2 Target Lesion Severity 
The Investigator will determine the severity of each target lesion as per the scale in Table 3.  
Table 3: Target Lesion Severity 
Grade 
Description 
0 
None 
1 
Mild 
2 
Moderate 
3 
Severe 
4 
Very Severe 
 

 
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110.2.2.3 Target Lesion Improvement  
The Investigator will determine the improvement seen with each target lesion as per the scale in 
Table 4.  Lesion improvement will not be assessed at Baseline. 
Table 4: Target Lesion Improvement 
Grade 
Description 
1 
Clear (100%) 
2 
Almost clear (90% to <100%) 
3 
Marked improvement (75% to <90%) 
4 
Moderate improvement (50% to <75%) 
5 
Fair improvement (25% to <50%) 
6 
No change 
7 
Worse 
 
110.3 Subject Assessments 
110.3.1 Target Lesion Pain 
For each inflammatory lesion injected, lesion pain will be assessed by the subject using a 10 cm 
Visual Analog Scale (VAS)  Scale. Lesion pain at Baseline will be recorded prior to injection(s). 
The occurrence of inflammatory lesion pain is expected and will not be considered an AE. 
110.3.2 Target Lesion Injection Pain 
Injection pain will be assessed at each study timepoint by the subject using the VAS. Lesion pain 
at Baseline will be recorded prior to injection(s). Injection Site Pain during injection will be 
assessed immediately after the injection of the first target lesion and at 5 minutes post-injection. 
The occurrence of injection site pain is expected and will not be considered an AE. 
110.3.2.1 Target Lesion Improvement  
The subject will assess subjective improvement seen with each target lesion compared to Baseline 
as per the scale in Table 4.  Lesion improvement will not be assessed at Baseline. 
Table 4: Target Lesion Improvement 
Grade 
Description 
1 
Clear (100%) 
2 
Almost clear (90% to <100%) 
3 
Marked improvement (75% to <90%) 
4 
Moderate improvement (50% to <75%) 
5 
Fair improvement (25% to <50%) 
6 
No change 
7 
Worse 
●  
110.3.3 Subject Satisfaction 
Subject Satisfaction will be assessed by the subject using the following subjective 5-grade scale 
as detailed in Table 5. Subject will be instructed: “Rate your level of satisfaction with the effect of 
study treatment on inflammatory acne lesions by using the following scale”: 

 
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Table 5.  Subject Satisfaction Scale 
Grade 
Description 
1 
Very satisfied 
2 
Satisfied 
3 
Neither satisfied nor dissatisfied 
4 
Dissatisfied 
5 
Very dissatisfied 
 
110.3.3.1 Target Lesion Videography  
A video will be taken of the entire injection process, including preparation, application of device 
to skin, needle penetration, and up to 30 seconds after removed of needle from lesion. 
110.3.3.2 Target Lesion Photography 
Photographs will be taken at each study time point of each injected inflammatory lesion. At 
Baseline, photographs will be taken both pre- and post-injection. At Baseline, photographs will be 
taken by the study team and by subject. At other timepoints, photographs will be taken by subject 
with the option to participate in further photography by the study team. Prior to each photographic 
session, numbered stickers will be placed on the face next to each lesion selected for treatment.  
110.4 Safety  
110.4.1 Adverse Events 
All observed or volunteered AEs regardless of suspected causal relationship to the study device 
will be recorded in the CRF. Subjects will be questioned for the occurrence of any new or 
worsening signs or symptoms at each visit. 
110.4.1.1 Definition of Adverse Event 
An AE is any untoward medical occurrence in a patient or clinical investigation subject 
administered a study device and which does not necessarily have a causal relationship with the 
study device. AEs include any unfavorable and unintended illness, sign, symptom, clinically 
significant laboratory test abnormality, or disease temporally associated with the use of a study 
device that has appeared or worsened during the course of the clinical trial, regardless of causal 
relationship to the study device under study. 
The collection of non-serious AEs and serious adverse events (SAEs) will begin following the 
subject's exposure to study device. 
110.4.1.2 Documenting Adverse Experiences 
The PI is responsible for documenting all Treatment-Related AEs (TRAEs) and SAEs that occur 
at the study visits. AEs should be documented as a single medical diagnosis. When this is not 
possible, AEs should be documented in terms of signs/symptoms observed by the PI or reported 
by the subject at each study visit. Each AE that appears to be independent of any prior event will 
be reported separately. 
All TRAEs occurring after the subject first exposure to study device through the last study visit 
must be reported. AEs that are not related to study treatment will not be recorded. All SAEs will 

 
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be recorded.  
At the first study visit, the subject will be assessed for the occurrence of TRAEs. The following 
data will be collected on all TRAEs and recorded on the appropriate eCRF: 
● Event name (diagnosis preferred, if unknown, record the signs/symptoms) 
● Onset date and end date 
● Maximum intensity (severity) 
● Seriousness 
● Action taken regarding study device 
● Corrective treatment, if given 
● Outcome 
● Investigator assessment of causality 
110.4.1.3 Serious Adverse Events 
All AEs will be assessed as either serious or non-serious. 
An SAE is defined as any untoward medical occurrence that at any dose: 
● Results in death 
● Is immediately life threatening, (the term "life threatening" in the definition of "serious" 
refers to an event in which the subject is at risk of death at the time of the event; it does not 
refer to an event which hypothetically might have caused death if it were more severe) 
● Requires inpatient hospitalization or prolongation of existing hospitalization 
(hospitalization for elective surgery for a Baseline condition is not considered an AE) 
● Results in persistent or significant disability/incapacity (permanent or substantial 
disruption of a person’s ability to conduct normal life functions) 
● Is a congenital anomaly/birth defect 
● Is a medically important event that may not be immediately life threatening or result in 
death or hospitalization but may jeopardize the subject and may require medical or surgical 
intervention to prevent one of the above listed outcomes. Examples of such events include, 
but are not limited to, allergic bronchospasm requiring intensive treatment in an emergency 
room or at home; blood dyscrasias or convulsions that do not result in inpatient 
hospitalization. 
Note: A spontaneous abortion will be considered an SAE and must be reported per Reporting of 
SAEs under Section 10.4.1.6. 
110.4.1.4 Assessment of Severity 
The severity assigned to an AE should be determined by the maximum severity of the AE. The 
categories described below should be used to estimate the severity of AEs: 
● Mild: Transient or mild discomfort; no limitation in activity; no medical 
intervention/therapy required 
● Moderate: Mild to moderate limitation in activity; some assistance may be needed; no or 
minimal medical intervention/therapy required 
● Severe: Marked limitation in activity; some assistance usually required; medical 
intervention/therapy required; hospitalization or prolongation of current hospitalization 

 
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possible; may be incapacitating or life threatening 
110.4.1.5 Assessment of Causality 
The PI should assess the relationship of the AE to the study device as either “Related” or “Not 
Related”. The following should be considered when assessing AE causality: 
● Related: There is at least a reasonable possibility that the AE/SAE is related to the study 
device. Reasonable possibility means that there is evidence to suggest a causal relationship 
between the study device and the AE. 
● Not Related: There is little or no reasonable possibility that the AE/SAE is related to the 
study device. This assessment implies that the AE/SAE has little or no temporal 
relationship to the study device and/or a more likely or certain alternative etiology exists. 
110.4.1.6 Reporting of Serious Adverse Events 
Adverse events classified as “serious” require expeditious handling and reporting to ethica CRO 
within 24 hours of investigational center notification. 
All SAEs, whether related or unrelated to study device, must be immediately reported to the ethica 
CRO Clinical Project Manager (or designate) within 24 hours of the PI’s awareness of the event. 
All SAEs must be reported via confirmed facsimile or email transmission and must be submitted 
on a written SAE report form signed by the PI within 24 hours of the PI’s awareness of the event. 
PIs should not wait to receive additional information to fully document the event before notifying 
ethica CRO of an SAE. If only limited information is initially available, follow-up reports are 
required. Additional relevant information such as hospital records and autopsy reports should be 
provided to the Sponsor as soon as they are available. 
The PI should take all appropriate measures to ensure the safety of the subjects, notably he/she 
should follow a subject with an SAE until the event has resolved or the condition has stabilized. 
This may imply that follow-up will continue after the subject has left the study, and that additional 
investigations may be requested by the Sponsor. When an SAE persists at the end of the study, the 
PI will conduct follow-up contacts with the subject until the PI/Sponsor agree the event is 
satisfactorily resolved and/or stabilized. 
110.4.1.7 Pregnancy 
During the study, all female subjects of childbearing potential should be instructed to contact the 
PI immediately if they suspect they might be pregnant (e.g., missed or late menstrual period). 
If a subject or PI suspects that the subject may be pregnant prior to study enrolment, the study 
device must be withheld until the results of laboratory pregnancy testing are available. If pregnancy 
is confirmed, the subject must not receive study device and must not be enrolled in the study. 
If pregnancy is suspected while the subject is receiving study device, the study device must 
immediately be withheld until the result of pregnancy testing is known. If pregnancy is confirmed, 
the study device will be permanently discontinued, and the subject will be followed until the 
pregnancy comes to term. 
All confirmed pregnancies must be reported via confirmed facsimile or email transmission and 
must be submitted on an Unanticipated Problems Reporting Form within 24 hours of the PI’s 

 
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awareness of the pregnancy using the same reporting as procedure for an SAE under Section 
10.4.1.6. 
111 STATISTICS 
There is no inferential statistical testing conducted for this study.  Descriptive data summaries will 
be prepared for all outcome variables.  
For categorical parameters, the number and percentage of subjects/observations in each category 
will be presented. The denominator will be based on the number of subjects/observations 
appropriate for the purpose of analysis. For continuous parameters, descriptive statistics will 
include n (number of subjects or observations), mean, standard deviation, median, and range. Two-
sided 95% CIs will be provided for all study outcomes. 
111.1 Sample Size Determination 
Approximately 150 subjects will be enrolled. This is a POC study and a formal sample size 
justification is not provided for this study. It is the opinion of the Sponsor that a total of 150 
subjects will be sufficient to achieve the objective of the study. 
111.2 Assessment of Safety 
111.2.1 Adverse Events 
All TRAEs occurring during the study will be recorded and classified on the basis of MedDRA 
terminology. Descriptions of TRAEs will include the date of onset, the date the TRAE ended, the 
severity of the TRAE, the action taken regarding study medication usage, the action taken to treat 
the TRAE, and the outcome. All reported TRAEs will be summarized by the number of subjects 
reporting AEs, system organ class, severity, and seriousness. 
111.3 Analysis Populations 
111.3.1 Intent-to-Treat (ITT) Population 
The modified Intent-to-Treat (mITT) Population is defined as all subjects who were enrolled and 
received at least one application with the study device. The mITT Population will be used for 
analyses of safety and effectiveness endpoints. 
111.3.2 Per-Protocol (PP) Population 
A Per-Protocol (PP) Population will neither be defined nor analyzed. 
111.3.3 Subject Disposition 
A tabulation of subject disposition will be provided which will include the numbers of subjects 
who enter, complete, and discontinue the study. The reasons for discontinuation will be included. 
111.3.4 Protocol Deviations and Violations 
All protocol deviations and violations will be reported to the Sponsor and recorded throughout the 
study. A tabulation of protocol deviations will be included in the final study report. 
111.3.5 Missing Data Imputations 
Data will be analyzed as observed; no imputations will be made for missing data. 

 
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111.3.6 Statistical Hypothesis Testing and Control of Multiplicity 
Not Applicable. 
111.3.7 Interim Analyses 
An interim analysis will be conducted after approximately 125 injections (projected to be 50 to 65 
participants). As this is a proof-of-concept study, no statistical or sample size adjustments are 
applicable. 
112 QUALITY CONTROL AND QUALITY ASSURANCE 
112.1 Study Monitoring 
An initiation webinar will be conducted with the PI and study coordinator(s) by Sponsor and/or its 
designee. During this meeting, an extensive review and discussion of the protocol, all study 
procedures, source documents, and CRFs will be conducted. Evaluation scales will be reviewed 
extensively. 
The Clinical Project Manager(s) and Clinical Trial Associate(s) will be trained prior to study 
initiation. 
The conduct of the study will be closely monitored by the Sponsor (or designate) following GCP 
guidelines. The reports of these verifications will also be archived with the study report. In 
addition, inspections or on-site audits may be carried out by local and/or federal authorities. The 
PIs will allow the Sponsor's representatives and any regulatory agency to examine all study 
records, corresponding subject medical records, clinical dispensing records and storage area, and 
any other documents considered source documentation. The PIs agree to assist the representative, 
if required. 
112.2 Audits and Inspections 
The study will be conducted under the Sponsorship of the Sponsor in conformation with all 
appropriate local and federal regulations, as well as ICH guidelines. 
112.3 Protocol Deviations 
The PIs must read the protocol thoroughly and must follow the instructions exactly. 
A deviation from the protocol is an unintended and/or unanticipated departure from the procedures 
and/or processes approved by the Sponsor and the IRB and agreed to by the PI. Deviations usually 
have an impact on individual subjects or a small group of subjects and do not involve 
inclusion/exclusion or tolerability and cosmetic endpoint criteria. 
A protocol violation occurs when there is non-adherence to the protocol that results in a significant, 
additional risk to the subject, when the subject or PI has failed to adhere to significant protocol 
requirements (inclusion/exclusion criteria) and the subject was enrolled without prior Sponsor 
approval, or when there is non-adherence to ICH GCP guidelines. 
The issue of noncompliance may be either on the part of the subject, the PI, or the study site staff. 
As a result of deviations, corrective actions are to be developed by the site and implemented 
promptly. 

 
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All protocol deviations and violations must be addressed in study subject source documents. A 
completed copy of the ethica CRO Inc. Protocol Deviation Form must be maintained in the 
regulatory file, as well as in the subject’s source document. Protocol deviations must be sent to the 
IRB per its guidelines. 
113 ETHICS AND ADMINISTRATIVE ISSUES 
113.1 Ethical Conduct of the Study 
This study will be conducted in accordance with the ethical principles originating from the 
Declaration of Helsinki, ICH guidelines, GCP, and in compliance with local regulatory 
requirements. The PI agrees, when signing the protocol, to adhere to the instructions and 
procedures described in it and thereby to adhere to the principles of GCP. 
113.2 Ethics Review 
The study protocol, informed consent form and other information to subjects, and all appropriate 
amendments will be reviewed and approved by an Institutional Review Board (IRB). A signed and 
dated notification of the IRB approval will be provided to the Sponsor and PI prior to study 
initiation. The name and occupation of the chairman and members of the IRB will be supplied to 
the Sponsor to the extent allowable by the IRB. The PI will provide required progress reports and 
report all SAEs to the IRB as required by the IRB. 
113.3 Written Informed Consent 
This study will be conducted in compliance with 21 CFR Part 50 for informed consent. The 
subject’s willingness to participate in the study will be documented in writing on a consent form, 
which will be signed by the subject with the date and time of that signature indicated. 
The study coordinator will obtain written informed consent from each subject before any 
procedures or assessments are done and after the aims, methods, anticipated benefits, potential 
hazards, compensation and/or honoraria, and insurance arrangements in force are explained. It will 
also be explained to the subject that they are free to refuse entry into the study and free to withdraw 
from the study at any time without prejudice to future treatment. The Investigator will be available 
to respond as needed to questions raised by the participant. 
Written and/or oral information about the study in a language understandable by the subject will 
be given to all subjects. The subjects will be given the opportunity to discuss the procedure, risks, 
benefits, alternative therapies and the study requirements with the Investigator (or qualified 
designee) and have any and all questions answered to the subject’s satisfaction. 
The site will keep the original consent forms and copies will be given to the subjects. 
113.4 Subject Data Protections 
Subject data will be protected by ensuring that no captured data contain subject names, addresses, 
telephone numbers, email addresses, or other personally identifying information will be included 
in the study datasets. Subjects’ email addresses and phone numbers will entered into the Appiell 
app and will be used for communication purposes and app functionality; however, email addresses 
and phone numbers will not be included in the study datasets and will be purged from the system 
at study completion. 

 
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It is acknowledged that subject initials, demographics (including birthdates), medical histories, and 
prior concomitant medication uses. Other than where necessary to meet regulatory requirements, 
all data collected in this study will be presented in tabulated (i.e., aggregate) form and listings 
containing information that could be used to identify an individual subject will not be included in 
any public disclosures of the study data or the study results. 
As part of the study database, study data will be stored at Equinix and Amazon Web Services 
facilities in Germany and Ireland that are SOC 1, SOC 2, ISO 27001, and FISMA examined and 
certified. Security monitoring includes biometric scanning protocols, continuous surveillance, and 
24x7 production environment management. Data privacy complies with Canadian and US 
standards, as well as the European Union’s General Data Protection Regulation (GDPR).  
The study database utilizes encryption to safeguard data and all data is durably stored with National 
Institute of Standards and Technology (NIST) approved ciphers, transport layer security (TLS) 
technology, and AES 256-bit at-rest encryption.  
113.5 Data Monitoring Committee 
Not applicable. 
113.6 Investigator Obligation 
The PI agrees, when signing the protocol, to adhere to the instructions and procedures described 
in it and thereby to adhere to the principles of Good Clinical Practice (GCP). 
113.7 Changes to the Protocol 
The PIs must read the protocol thoroughly and must follow the instructions exactly. Whenever 
possible, any planned deviations should be agreed to by prior discussion between the Sponsor and 
the PI, with appropriate documentation of Sponsor approval prior to effecting the changes agreed 
upon. Any amendment to the protocol containing major modifications (particularly if it may 
involve an increased risk to the subjects) will be approved by the IRB before it may be 
implemented. No change in the conduct of the study can be instituted without written approval 
from the Sponsor. 
113.8 Confidentiality Regarding Study Subjects 
All the data furnished to the PI and his/her staff and all data obtained through this protocol will be 
regarded as confidential and proprietary in nature and will not be disclosed to any third party 
without written consent from the Sponsor. 
113.9 Reporting and Publication of Results 
ACOM Labs, Inc., as the Sponsor, has a proprietary interest in this study. Authorship and 
manuscript composition will reflect joint between the PI and ACOM Labs, Inc. personnel.  
All information, including but not limited to information regarding the study device or the 
Sponsor’s operations supplied by the Sponsor to the PI and not previously published, along with 
any data generated as a result of this study are considered confidential and remain the sole property 
of the Sponsor. The PI agrees to maintain this information in confidence and will use the 
information only to perform the study. 
The Sponsor or its designee is responsible for publicly registering this study on 
http://www.clinicaltrials.gov/ prior to initiating enrolment. 

 
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113.10 Financing and Insurance 
A separate financial agreement (Clinical Study Agreement) will be made between the Sponsor and 
the PI at each site. ACOM Labs, Inc. will procure and maintain for the duration of the study a 
policy of insurance covering its liabilities in the conduct thereof. The certificate of insurance will 
be provided upon request. 
 

 
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114 APPENDICES 
Appendix A: Protocol Version History 
Appendix B: Instructions for Use of Photography App 
Appendix C: Instructions for Self-Injection 
 
 
APPENDIX A: PROTOCOL VERSION HISTORY 
Version and Date 
Description 
v.1.0; 31-Jan-2023 
Final Protocol 
 
 
 
 
 

 
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APPENDIX B: INSTRUCTIONS FOR USE OF PHOTOGRAPHY APP 
 
Participation in this study requires use of a smartphone app named “Appiell”. Participants will be 
provided instructions and trained on the following: 
  
1. Download Appiell app from App store or Google Play 
2. Create account using the email address you provided to the clinical study team 
3. Complete introductory questionnaire  
4. Complete Baseline visit within app by taking photos 
a. Click “take more photos” button within app 
b. Follow instruction guide within app to prepare for photographs, including setting up study-
provided ring light and placing numbered stickers adjacent to each lesion. 
c. Take 3 full face photographs by fitting face in frame included in app 
d. Take 1-3 close-up “lesion specific” photographs by fitting acne spot selected for injection 
within circle frame on app. 
5. Following injection and for each follow-up timepoint, complete the in-app visit by following the 
instructions in app for photograph collection.  
 
ADDITIONAL INFORMATION 
Authentication: 
● Each time a participant logs in to the Appiell app, he/she requires a One Time Password 
(OTP) that is sent to the participant’s email address. 
Data Security: 
● Source passwords are not contained in the database 
● The platform used an advanced PostgreSQL database that allows full data encryption. 
● The database server only accepts requests from known servers and a known port number 
(i.e., the platform’s mid-tier servers); a standard practice for high security setups and 
extremely difficult to hack. 
 
 
 
 

 
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APPENDIX C: INSTRUCTIONS FOR SELF-INJECTION 
Important Information to Know Before Use: 
1. Do not share any components of the intradermal injection system with others. The entire injection 
system is for single patient use only. 
2. Do not reuse any needle assembly for more than one injection 
3. Do not use any system components that have been dropped or appear damaged. 
4. The Injection Assistance Device will need to be manually “reset” after or prior to each injection. 
Clinical staff will reset the device for you prior to each injection. 
 
1. Clean hands 
 
2. Clean injection site identified by the clinical 
team 
 
Do not inject into the eyes, lips, nostrils, ears, or 
any other body orifices. 
 
3. Administer the Injection 
 
Step 1: Place the device needle end against the 
injection site so the Button is furthest from the site, 
as shown. 
Step 2: Press the Activation Button to initiate the 
dosing sequence, you will hear a click. 
Step 3: Hold and Wait 5 seconds. 
 
THEN 
● 
Remove device from injection site. 
● 
Do not point the intradermal injection system 
towards your eyes at any time. 
 
4. Prepare for additional injections 
● 
Return study device to clinical team for device 
reset and preparation for subsequent injection 
● 
Repeat above process beginning at step 2 for up 
to 3 injections total. 
 
 

 
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