Intralesional Injections of Triamcinolone for Acne Vulgaris
Phase: NA
Conditions: Acne Vulgaris
Sponsor: ACOM Labs

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STUDY PROTOCOL 
 
 
 
 
ATM-2201 
 
Intralesional Injections of Triamcinolone for Acne Vulgaris 
 
 
 
Proof of Concept Study 
 
Version 2.0 
28-Oct-2022 
 
 
 
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 
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-2201. 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 
 
 
 
 
 
 
Approved by Clinical Research Organization - ethica CRO 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 2.0 (28-Oct-2022) 
Study Device 
Intradermal needle adapter 
Study Number 
ATM-2201 
Phase 
Proof of Concept 
Control Product 
Not Applicable 
Indication 
Inflammatory Acne Lesions 
Study Sites 
1 site (US) 
Title 
Intralesional Injections of Triamcinolone for Acne Vulgaris 
Sponsor 
ACOM Labs, Inc. 
Study Duration  14 days per subject 
Sample Size 
~20 subjects 
Study Design 
This is an open-label, prospective, single-arm study. Approximately 20 subjects will be enrolled 
at 1 study site. 
All subjects will receive standard-of-care intralesional injection with triamcinolone using an 
intradermal needle adapter at Visit 1 (Day 1). Subjects will then attend in-clinic visits at Visit 2 
(24-hours post-injection), Visit 3 (48-hours post-injection), Visit 4 (72-hours post-injection), 
Visit 5 (Day 7), and Visit 6 (Day 14). 
Efficacy assessments (target lesion assessments, photography) and safety assessments will be 
conducted by the Investigator at each study visit. Subjects will conduct lesion pain assessments 
at each study visit as well as satisfaction assessments at each post-treatment visit. 
Study 
Objectives 
The objective of this proof-of-concept study is to investigate the safety of using an intradermal 
needle adapter for performing intralesional injections. 
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 and for 
which the research participant has already agreed to have standard-of-care intralesional 
injection(s) of triamcinolone. 
4. Able to follow study instructions and likely to complete all required visits. 
5. In good general health as determined by medical history at the time of screening (Investigator 
discretion). 
6. 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. Planning to move out of the area prior to study completion. 
7. Subjects who are investigational site staff members or family members of such employees. 
8. Exposure to any other investigational /device within 30 days prior to Visit 1. 
Study 
Treatment 
Intradermal Needle Adapter: The intradermal needle adapter is an accessory that slips on the 
end of a standard 32G 0.5” needle and reduces the effective length of the needle to 1mm. The 
adapter is made of biocompatible 304 Stainless Steel. It is packaged in single use bags and will 

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be autoclaved or prepared in the standard manner for typical stainless steel instruments used by 
the Investigator. 
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 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 will be at the discretion of the Investigator as per his clinical judgement. An 
intradermal needle adapter will then be installed on the needle. 
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. 
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 at each study visit of each injected 
inflammatory lesion. At Baseline, photographs will be taken both pre- and post-injection. 
Subject 
Assessments 
• 
Target Lesion Pain: Target lesion pain will be self-assessed by the subject using a Visual 
Analog Scale  
• 
Intralesional Injection Pain: Target lesion injection pain will be self-assessed by the subject 
using a Visual Analog Scale. 
• 
Subject Satisfaction: A 5-point scale ranging from 1 (Very satisfied) to 4 (Very dissatisfied). 
Safety 
Endpoints 
Adverse Events 
Sample Size 
Approximately 20 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 20 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 
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. 
 
 

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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 
 
 
 
 
 
Concomitant Medications 
X 
X 
X 
X 
X 
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 
X 
X 
X 
X 
Lesion Injection Videography 
X 
 
 
 
 
 
Subject Assessments 
 
 
 
 
 
 
Target Lesion Pain 
X 
pre-inj. 
X 
X 
X 
X 
X 
Intralesional Injection Pain 
X 
post- inj. 
 
 
 
 
 
Subject Satisfaction 
 
X 
X 
X 
X 
X 
Safety Assessments 
 
 
 
 
 
 
UPT (as applicable) 
X 
 
 
 
 
 
Adverse Events 
X 
X 
X 
X 
X 
X 
  
 

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TABLE OF CONTENTS 
 
PROTOCOL APPROVAL SIGNATURE PAGE ....................................................................................... 2 
INVESTIGATOR SIGNATURE PAGE ...................................................................................................... 3 
SYNOPSIS ...................................................................................................................................................... 4 
1 
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 ............................................................................................................ 10 
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 .............................................................................. 11 
8.1 
Intradermal Needle Adapter .................................................................................................................. 11 
8.2 
Triamcinolone for Injection ................................................................................................................... 12 
9 
STUDY EVALUATIONS ............................................................................................................................ 12 
9.1 
Visit Procedures ..................................................................................................................................... 12 
9.1.1 
Visit 1 (Baseline; Day 1) ...................................................................................................................................... 12 
9.1.2 
Visits 2 to 6 (24hr , 48hr, 72hr, 7 days, 14 days) ................................................................................................. 13 
9.2 
Investigator Assessments ....................................................................................................................... 13 
9.2.1 
Global Severity Score (GSS) ................................................................................................................................ 13 
9.2.2 
Target Lesion Assessments .................................................................................................................................. 13 
9.2.2.1 
Target Lesion Erythema ......................................................................................................................... 13 
9.2.2.2 
Target Lesion Severity ............................................................................................................................ 14 
9.2.2.3 
Target Lesion Improvement ................................................................................................................... 14 
9.2.2.4 
Target Lesion Videography .................................................................................................................... 14 
9.2.2.5 
Target Lesion Photography ..................................................................................................................... 14 
9.3 
Subject Assessments .............................................................................................................................. 14 
9.3.1 
Target Lesion Pain ............................................................................................................................................... 14 
9.3.2 
Intralesional Injection Pain .................................................................................................................................. 14 
9.3.3 
Subject Satisfaction .............................................................................................................................................. 15 
9.4 
Safety ..................................................................................................................................................... 15 
9.4.1 
Adverse Events .................................................................................................................................................... 15 
9.4.1.1 
Definition of Adverse Event ................................................................................................................... 15 
9.4.1.2 
Documenting Adverse Experiences ........................................................................................................ 15 
9.4.1.3 
Serious Adverse Events .......................................................................................................................... 16 
9.4.1.4 
Assessment of Severity ........................................................................................................................... 16 
9.4.1.5 
Assessment of Causality ......................................................................................................................... 16 
9.4.1.6 
Reporting of Serious Adverse Events ..................................................................................................... 17 
9.4.1.7 
Pregnancy ............................................................................................................................................... 17 
10 STATISTICS ................................................................................................................................................ 17 
10.1 
Sample Size Determination ................................................................................................................... 18 
10.2 
Assessment of Safety ............................................................................................................................. 18 
10.2.1 Adverse Events .................................................................................................................................................... 18 
10.2.2 Concomitant Medications .................................................................................... Error! Bookmark not defined. 
10.3 
Analysis Populations ............................................................................................................................. 18 
10.3.1 Intent-to-Treat (ITT) Population .......................................................................................................................... 18 
10.3.2 Per-Protocol (PP) Population ............................................................................................................................... 18 
10.3.3 Subject Disposition .............................................................................................................................................. 18 

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10.3.4 Protocol Deviations and Violations ..................................................................................................................... 18 
10.3.5 Multicenter Issues ................................................................................................................................................ 18 
10.3.6 Missing Data Imputations .................................................................................................................................... 18 
10.3.7 Statistical Hypothesis Testing and Control of Multiplicity ................................................................................. 18 
10.4 
Interim Analyses .................................................................................................................................... 19 
11 QUALITY CONTROL AND QUALITY ASSURANCE .......................................................................... 19 
11.1 
Study Monitoring ................................................................................................................................... 19 
11.2 
Audits and Inspections ........................................................................................................................... 19 
11.3 
Protocol Deviations ............................................................................................................................... 19 
12 ETHICS AND ADMINISTRATIVE ISSUES ............................................................................................ 20 
12.1 
Ethical Conduct of the Study ................................................................................................................. 20 
12.2 
Ethics Review ........................................................................................................................................ 20 
12.3 
Written Informed Consent ..................................................................................................................... 20 
12.4 
Subject Data Protections ........................................................................................................................ 20 
12.5 
Data Monitoring Committee .................................................................................................................. 21 
12.6 
Investigator Obligation .......................................................................................................................... 21 
12.7 
Changes to the Protocol ......................................................................................................................... 21 
12.8 
Confidentiality Regarding Study Subjects ............................................................................................ 21 
12.9 
Reporting and Publication of Results .................................................................................................... 21 
12.10 Financing and Insurance ........................................................................................................................ 21 
13 APPENDICES .............................................................................................................................................. 22 
APPENDIX A: PROTOCOL VERSION HISTORY ............................................................................... 22 
APPENDIX B: ADJUSTMENT OF VISITS AND ASSESSMENTS DUE TO COVID-19 .................. 23 
 
 

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1 
INTRODUCTION 
Intralesional injection of corticosteroids is standard of care therapy for stubborn 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 using an intradermal needle adapter for 
delivery of intralesional triamcinolone injections in patients with acne vulgaris. The intradermal 
needle adapter is an accessory that slips on the end of a standard 32G 0.5” needle and reduces the 
effective length of the needle to 1mm. The adapter (currently a prototype) is made of biocompatible 
304 Stainless Steel and is being developed to allow patients to safely self-inject triamcinolone, 
rather than depending on injections performed by a physician. 
As intralesional triamcinolone injections are standard-of-care, the purpose of this proof-of-concept 
study is to test the safety of the intradermal needle adapter, not the safety and efficacy of 
triamcinolone per-se. 
2 
STUDY OBJECTIVE 
The objective of this proof-of-concept study is to investigate the safety of using an intradermal 
needle adapter for performing intralesional injections. 
3 
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.  
3.1 
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. 
3.2 
Investigational Sites 
One (1) U.S. investigational site will participate in this study. The site 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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4 
OVERVIEW OF STUDY DESIGN 
This is an open-label, prospective, single-arm study. Approximately 20 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 receive standard-of-care intralesional injection with triamcinolone using an 
intradermal needle adapter at Visit 1 (Day 1). Subjects will then attend in-clinic visits at Visit 2 
(24-hours post-injection), Visit 3 (48-hours post-injection), Visit 4 (72-hours post-injection), Visit 
5 (Day 7), and Visit 6 (Day 14). 
5 
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. 
5.1 
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 indicated for standard-of-care intralesional injection(s) of 
triamcinolone and for which the research participant has already agreed to have standard-
of-care intralesional injection(s) of triamcinolone. 
4. Able to follow study instructions and likely to complete all required visits. 
5. In good general health as determined by medical history at the time of screening 
(Investigator discretion). 
6. Sign the IRB-approved ICF (including HIPAA authorization) prior to any study-related 
procedures being performed. 
5.2 
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. 

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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. Planning to move out of the area prior to study completion. 
7. Subjects who are investigational site staff members or family members of such employees. 
8. Exposure to any other investigational /device within 30 days prior to Visit 1. 
5.3 
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.  
6 
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. 
7 
CONCOMITANT AND PROHIBITED MEDICATION/PROCEDURES 
7.1 
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. 
8 
INVESTIGATIONAL PRODUCT MANAGEMENT 
8.1 
Intradermal Needle Adapter 
The intradermal needle adapter is an accessory that slips on the end of a standard 32G 0.5” needle 
and reduces the effective length of the needle to 1mm (Figure 1). The adapter is made of 
biocompatible 304 Stainless Steel. It is packaged in single use bags and will be autoclaved or 
prepared in the standard manner for typical stainless steel instruments used by the Investigator. 

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Figure 1. Intradermal Needle Adapter 
8.2 
Triamcinolone for Injection 
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 intradermal needle adapter will then be installed on the needle. 
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. 
9 
STUDY EVALUATIONS 
9.1 
Visit Procedures 
9.1.1 
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 pain (pre-injection) 
- 
Intralesional injection pain (post-injection) 
• Intralesional injection(s) 
• AE Assessment 

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9.1.2 
Visits 2 to 6 (24hr, 48hr, 72hr, 7 days±1 day, 14 days±2 days) 
• Investigator Assessments 
- 
Target Lesion Assessments: lesion erythema, lesion severity, improvement 
- 
Target Lesion Photography 
• Subject Assessments 
- 
Target lesion pain 
- 
Subject Satisfaction 
• Concomitant medications/treatments 
• AE Assessment 
 
9.2 
Investigator Assessments 
9.2.1 
Global Severity Score (GSS) 
The Investigator will use the following 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 
 
9.2.2 
Target Lesion Assessments 
Up to 3 inflammatory lesions on the face will be chosen for intralesional injections of 
triamcinolone using the study device as per Section 8 (i.e., target lesions). 
Each injected lesion will be individually assessed as per the following methods. 
9.2.2.1 
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 
 

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9.2.2.2 
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 
 
9.2.2.3 
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 
 
9.2.2.4 
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. 
9.2.2.5 
Target Lesion Photography 
Photographs will be taken at each study visit of each injected inflammatory lesion. At Baseline, 
photographs will be taken both pre- and post-injection. 
9.3 
Subject Assessments 
9.3.1 
Target Lesion Pain 
For each inflammatory lesion to be injected, lesion pain will be self-assessed by the subject using 
a 10 cm Visual Analog Scale (VAS) Pain 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. 
9.3.2 
Intralesional Injection Pain 
Injection pain will be self-assessed at each study visit by the subject using the Visual Analog Scale 
(VAS). Lesion pain at Baseline will be recorded prior to injection(s). Injection Site Pain during 
injection will be assessed for all injected lesions immediately after the final lesion has been 
injected. Ten (10) minutes after these assessments, injection pain will be assessed again for all 
injected lesions.  The occurrence of injection site pain is expected and will not be considered an 
AE. 

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9.3.3 
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”: 
Table 5.  Subject Satisfaction Scale 
Grade 
Description 
1 
Very satisfied 
2 
Satisfied 
3 
Neither satisfied nor dissatisfied 
4 
Dissatisfied 
5 
Very dissatisfied 
9.4 
Safety  
9.4.1 
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. 
9.4.1.1 
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 signature of the informed consent form. 
9.4.1.2 
Documenting Adverse Experiences 
The PI is responsible to document all AEs that occur during the study. 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 AEs occurring after the subject signs the informed consent form through the last study visit 
must be reported, regardless of AE causality. All AEs, whether in response to a query, observed 
by the study site personnel, or reported spontaneously by the subject, will be recorded.  
At each visit during the study, the subject will be assessed for the occurrence of new and ongoing 
AEs. The following data will be collected on all AEs and recorded on the appropriate CRF: 
• 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 

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• Outcome 
• Investigator assessment of causality 
9.4.1.3 
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 9.4.1.6. 
9.4.1.4 
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 
possible; may be incapacitating or life threatening 
9.4.1.5 
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. 

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• 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. 
9.4.1.6 
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. 
9.4.1.7 
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 
awareness of the pregnancy using the same reporting as procedure for an SAE under Section 
9.4.1.6. 
10 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 

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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. 
10.1 
Sample Size Determination 
Approximately 20 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 20 subjects 
will be sufficient to achieve the objective of the study. 
10.2 
Assessment of Safety 
10.2.1 
Adverse Events 
All AEs occurring during the study will be recorded and classified on the basis of MedDRA 
terminology. Descriptions of AEs will include the date of onset, the date the AE ended, the severity 
of the AE, the relationship to study medication, the action taken regarding study medication usage, 
the action taken to treat the AE, and the outcome. All reported treatment-emergent AEs (TEAEs) 
and treatment-related events (TRAEs) will be summarized by the number of Subjects reporting 
AEs, system organ class, severity, seriousness, and relationship to study medication. 
AEs will be summarized by treatment group and severity, and by treatment group and relationship 
to study device. Each subject will be counted only once within a system organ class or a preferred 
term by using the AEs with the greatest relationship within each category. 
10.3 
Analysis Populations 
10.3.1 
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. 
10.3.2 
Per-Protocol (PP) Population 
A Per-Protocol (PP) Population will neither be defined nor analyzed. 
10.3.3 
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. 
10.3.4 
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. 
10.3.5 
Multicenter Issues 
Not applicable 
10.3.6 
Missing Data Imputations 
Data will be analyzed as observed; no imputations will be made for missing data. 
10.3.7 
Statistical Hypothesis Testing and Control of Multiplicity 
Not Applicable. 

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10.4 
Interim Analyses 
No interim analyses are planned. 
11 QUALITY CONTROL AND QUALITY ASSURANCE 
11.1 
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. 
11.2 
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. 
11.3 
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. 
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. 

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12 ETHICS AND ADMINISTRATIVE ISSUES 
12.1 
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. 
12.2 
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. 
12.3 
Written Informed Consent 
This study will be conducted in compliance with 21 CFR Part 50 for informed consent.  
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 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 site will keep the original consent forms and copies will be given to the subjects. 
12.4 
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. It is 
acknowledged that subject initials, demographics (including birthdates), medical histories, and 
prior concomitant medication uses, along with the name and address of the enrolling PI may allow 
for personal identification of study participants. 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 

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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.  
12.5 
Data Monitoring Committee 
Not applicable. 
12.6 
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). 
12.7 
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. 
12.8 
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. 
12.9 
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. 
12.10 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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13 APPENDICES 
Appendix A: Protocol Version History 
Appendix B: Adjustment of Visits and Assessments due to COVID-19 
 
 
APPENDIX A: PROTOCOL VERSION HISTORY 
Version and Date 
Description 
v.1.0; 17-Oct-2022 
Final Protocol 
v.2.0; 28-Oct-2022 
Revisions made in response to 28-Oct-2022 conditional IRB 
approval. 
 
 
 

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APPENDIX B: ADJUSTMENT OF VISITS AND ASSESSMENTS DUE TO COVID-19 
 
1. General Guidance 
Subject safety and preserving the integrity of the data are of the highest priority. Any federal, state, 
and local rules, guidances, or laws shall be followed.  
Study visits and procedures should be followed per-protocol whenever possible. Any specific 
changes in study conduct that deviate from the protocol should be communicated to the Sponsor 
via reporting to the Clinical Project Manager (CPM) and IRB, as applicable. All protocol 
deviations which occur as a result of COVID-19 disruptions (including remote visits), will be 
differentiated from other deviations, and must be documented on the appropriate reporting 
forms/source document, and clearly annotated “protocol deviations due to COVID-19 
illness/restrictions/etc.”. If the subject is unable or unwilling to come to the site due to COVID-
19, the PI needs to ask for the reasons and document them in the source documents. 
The PI is responsible for ensuring subjects’ safety and for monitoring all active subjects per 
protocol. PI must ensure that study subjects are kept informed of changes to the study and 
monitoring plans that could impact them. 
Should a subject develop any symptoms that could be related to COVID-19 or any other acute 
infection disease, the subject will be instructed to: 
• Contact the PI as soon as possible 
• Contact their general physician to be examined and determine the course of action 
according to the standard of care. 
The PI or designee will follow-up with the subject as needed but at least within 72 hours of 
awareness to obtain an update on the subject’s health and to obtain information on whether 
COVID-19 has been diagnosed or not. If the subject has been diagnosed with COVID-19, the event 
will be reported as an AE. 
2. Adjustment of Study Visits 
Telemedicine is understood as a possible solution due to COVID-19 disruption and it is not 
mandatory; if the situation allows it, study visits should be done in person. 
On-site Study Visit: If the local situation allows for conduct of on-site study visits, the PI and 
study personnel must take all necessary steps/precautionary measures at the site to minimize or 
eliminate immediate hazards of viral transmission within and/or outside the clinical site premises.  
Before any research activities occur on-site, both subjects and research staff should be screened 
for symptoms or risk of COVID-19 infection. Subjects should be pre-screened by phone before 
their on-site study visit. 
If the local situation only allows for completion of some study procedures, the PI will prioritize 
the research activities that absolutely require an in-person visit in order to maintain the viability 
and integrity of the research. The PI may consider conducting the other assessments (e.g., medical 
history review, subject questionnaires) using telemedicine to minimize subject time on site and 
risk of exposure at the site. However, all efforts should be made to conduct all assessments at the 
scheduled visits, if possible. 

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Remote Study Visit: If the local situation does not allow for an on-site study visit to be conducted 
or if a subject does not wish to come to the study site due to COVID-19 disruption, a remote study 
visit may be conducted via video conferencing in lieu of an on-site visit. Phone call may also be 
used to perform some assessments if a subject has no video conferencing capabilities. 
The PI or study personnel who will conduct remote visits must be trained on how to conduct real-
time video conferencing visits. Also, procedures should be put in place to maintain the subject’s 
privacy, as would be done for a clinical visit: 
• 
Before the scheduled date of the visit: 
o The site personnel should determine if the subject can accommodate for video 
conferencing (e.g., internet access, PC, smartphone, video conference apps, etc.). 
o The PI or site personnel conducting the remote visit should obtain the subject’s verbal 
consent before proceeding with the visit and document it in the source document. The 
PI or personnel should also explain to the subject how the visit will be conducted. 
o The site personnel should send all required study material to conduct the visit to the 
subject (e.g., UPTs, etc.). 
o A test call may also be completed with the subject prior to the appointment. 
• 
On the day of the scheduled visit:  
o Both the PI/site delegate and the subject should confirm their respective identities with 
one another before engaging in a real-time video conference visit. For example, the 
site personnel will state their name and role and the subject may be identified by using 
two subject identifiers (e.g., name and date of birth) and a photo ID. 
o The date and time of the real-time video interaction, the location of the subject, and 
the location of the PI or site personnel conducting the remote visit should be 
documented in the source document. 
o Remote collection of data by PI or delegate will be conducted as described in Section 
3 below. 
3. Adjustment of Study Assessments  
Informed consent: The following process will be followed for consenting a prospective subject 
remotely: 
• Each subject will be provided with an IRB-approved electronic consent form to aid in the 
consent discussion before the consent process begins.  
• The PI and/or site delegate will participate in the consent process via video conference. All 
parties must introduce themselves and their role in the consenting process.  
• The consent form will be reviewed in detail and the subject will be invited to ask any 
questions and to have them addressed by the study team.   
• If the subject is interested in joining the research study, the subject will be asked to 
electronically sign the consent document. 
• The PI and appropriate witness(es) will also provide electronic signatures as required. 

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• The site should ensure to obtain all electronic signature pages from the subject and to 
document the consent process in the source document. The site should also provide a 
softcopy of the consent form to the subject and a hardcopy (in person or by mail).  
Inclusion/Exclusion Criteria: The list of inclusion/exclusion criteria will be reviewed via video 
conference or phone call with the subject to confirm that they are eligible for the study. Data will 
be documented in the source documents and CRF. 
For potential subjects in a high-risk population for COVID-19 (e.g., 60 years old and older, with 
comorbidities such as diabetes, cardiovascular disease, respiratory system issues, etc.), deferring 
participation should be considered to minimize risks of exposure. 
Investigator Assessments of Efficacy and Safety: Investigator assessments of efficacy and safety 
can be conducted remotely via FaceTime and photos taken by the subject using his/her phone.  
Subject Assessments: Subject assessments of lesion pain cannot be conducted remotely. Subject 
Satisfaction Assessment can be conducted remotely and reviewed via video conference at each 
remote visit and reported in the source documents and CRF. 
Urine Pregnancy Tests: UPTs can be conducted remotely and reviewed via video conference at 
each remote visit and reported in the source documents and CRF. 
Demographics: Demographic information will be collected via video conference or phone call 
from the subject at the remote screening visit and will be documented in the source documents and 
CRF. 
Medical History / Concomitant Medications: Medical history and concomitant medications will 
be reviewed via video conference or phone call at each remote visit and reported in the source 
documents and CRF. 
Adverse Events: AEs will be reviewed remotely via video conference or phone call with the 
subject at each remote study visit. Any AE/SAE (including suspected / confirmed COVID-19 
cases) elicited by a subject during a remote visit / phone call must be immediately captured, and 
all attempts should be done to capture the necessary clinical and medical information. Reporting 
of AEs and SAEs to the Sponsor and IRB should follow the protocol procedure and IRB 
requirements.