A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of the Renuvion Dermal System for Dermal Resurfacing
Phase: NA
Conditions: Wrinkle, Rhytides
Sponsor: Apyx Medical

 
  
  
 
 
A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of the Renuvion 
Dermal System for Dermal Resurfacing 
 
Clinical Study Protocol 
 
 
 
Study Protocol No:  VP-1909 
 
Revision No.:         
5 
 
Version Date:            May 11, 2020 
 
Sponsor: 
 
Apyx Medical Corporation 
                                                                             
5115 Ulmerton Road 
                                                                             
Clearwater, FL  33760-4004 USA 
                                                                             
Phone: (800) 537-2790 
                                                                             
Fax: (800) 323-1640 
 
 
 
 
 
 
 
 
 
Confidentiality Statement: 
This protocol, its contents, and the information relating to it are the proprietary property of Apyx 
Medical Corporation. All information is to be kept confidential.

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Table of Contents 
 
1 STUDY SYNOPSIS ....................................................................................................5 
2 STUDY ADMINISTRATIVE STRUCTURE .............................................................6 
3 INTRODUCTION .......................................................................................................7 
3.1 Study Background .............................................................................................................. 7 
3.2 Study Rationale ................................................................................................................... 8 
3.3 Study Device Description ................................................................................................... 8 
4 STUDY DESIGN.......................................................................................................11 
4.1 Study Objective ................................................................................................................ 11 
4.2 Study Design ..................................................................................................................... 11 
4.3 Study Endpoints ................................................................................................................ 11 
4.3.1 
Primary Effectiveness Endpoint ................................................................................... 11 
4.3.2 
Primary Safety Endpoint .............................................................................................. 11 
4.3.3 
Secondary Safety Endpoint .......................................................................................... 12 
4.3.4 
Additional Endpoints .................................................................................................... 12 
5 INVESTIGATORS SELECTION AND STUDY POPULATION ...........................13 
5.1 Investigator Selection ....................................................................................................... 13 
5.2 Study Population ............................................................................................................... 13 
5.2.1 
Inclusion Criteria .......................................................................................................... 13 
5.2.2 
Exclusion Criteria ......................................................................................................... 14 
6 STUDY PROCEDURES ...........................................................................................15 
6.1 Informed Consent ............................................................................................................. 15 
6.2 Pre-Procedure ................................................................................................................... 15 
6.3 Study Procedure ................................................................................................................ 16 
6.4 Follow-up Procedures ....................................................................................................... 17 
6.5 Data Collection ................................................................................................................. 21 
6.6 Confidentiality of Data ..................................................................................................... 21 
7 EVALUATION TOOLS ............................................................................................21 
7.1 Fitzpatrick Skin Type Scale (FST) ................................................................................... 21 
7.2 Fitzpatrick Wrinkle and Elastosis Scale (FWS) ............................................................... 21 
7.3 Modified Global Aesthetic Improvement Scale (GAIS) .................................................. 23 
7.4 Re-epithelization and Down Time .................................................................................... 23 
7.5 Visual Analog Scale (VAS) .............................................................................................. 24 
7.6 Subject Diary .................................................................................................................... 24 
7.7 Blinded Identification of 90-Day Images ......................................................................... 24 
8 ADVERSE EVENTS ASSESSMENT REPORTING ...............................................25 
8.1 Adverse Events Evaluation ............................................................................................... 25 
8.2 Adverse Event (AE) and Expected Treatment Effect (ETE) Definition ........................... 25 
8.3 Serious Adverse Event (SAE) Definition ......................................................................... 26 
8.4 Unanticipated Adverse Device Effect (UADEs) Definition ............................................. 26 
8.5 Reporting Requirements ................................................................................................... 26 
8.6 Severity of Adverse Events .............................................................................................. 27 
8.7 Relationship to the Study Device and/or Procedure ......................................................... 27 
8.8 Stopping Guidelines / Stopping Rules: Safety .................................................................. 27 
9 RISK AND BENEFITS .............................................................................................28 
9.1 Benefits ............................................................................................................................. 28 
9.2 Risks ................................................................................................................................. 28 
9.3 Mitigation of Risks ........................................................................................................... 42 

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10 STUDY MANAGEMENT/COMPLIANCE/ QUALITY ASSURANCE .............43 
10.1 Protocol Deviation Reporting ........................................................................................... 43 
10.2 Discontinuation of Study Subjects .................................................................................... 43 
10.3 Supply of Study Materials ................................................................................................ 43 
10.4 Device Malfunction/Observations .................................................................................... 43 
10.5 Monitoring ........................................................................................................................ 43 
10.6 End of Study ..................................................................................................................... 44 
10.6.1 Premature Termination/Suspension of the Study or a Study Site ................................ 44 
10.7 Audits / Inspections .......................................................................................................... 44 
11 STATISTICAL METHODOLOGY ......................................................................45 
11.1 Determination of Sample Size .......................................................................................... 45 
11.2 Performance Goal Rationale ............................................................................................. 45 
11.3 Analysis Sets ..................................................................................................................... 46 
11.3 Other Data Issues .............................................................................................................. 46 
11.3.1 Discontinuations and Missing Data .............................................................................. 46 
11.4 Safety Endpoints ............................................................................................................... 46 
11.4.1 
Primary Safety Endpoint ............................................................................. 47 
11.4.2 
Secondary Safety Endpoint ......................................................................... 47 
11.5 Effectiveness Endpoints.................................................................................................... 47 
11.5.1 
Primary Effectiveness Endpoint ................................................................. 47 
11.6 Additional Endpoints ........................................................................................................ 47 
11.7 Statistical Analysis of Safety Endpoints ........................................................................... 47 
11.8 Statistical Analysis of the Effectiveness Endpoint ........................................................... 48 
11.9 Statistical Analysis of Additional Endpoints .................................................................... 48 
11.10 
Subgroup Analysis ....................................................................................................... 48 
12 DATA HANDLING AND RECORDKEEPING ..................................................49 
12.1 Investigator Records ......................................................................................................... 49 
12.2 Investigator Reports .......................................................................................................... 49 
12.3 Data Management Responsibilities .................................................................................. 50 
12.4 Data Capture Methods ...................................................................................................... 51 
13 PUBLICATION POLICY .....................................................................................51 
14 REFERENCES ......................................................................................................52 
15 APPENDICES .......................................................................................................54 
 
 
 
 
List of Tables 
Table 1: Study Required Procedures............................................................................. 20 
Table 2: Fitzpatrick Skin Scale Evaluation ................................................................... 21 
Table 3: Fitzpatrick Wrinkle and Elastosis Scale ......................................................... 20 
Table 4a: Modified Global Aesthetic Improvement Scale Evaluation (GAIS): Investigator
 
20 
Table 4b: Modified Global Aesthetic Improvement Scale Evaluation (GAIS): Subject21 
Table 5: Required Investigator Reports ........................................................................ 50 
 
      List of Appendices 
 
Appendix A:  Sample Visual Analog Scale (VAS) 
 
Appendix B:  Sample Modified Global Aesthetic Improvement Scale (GAIS): Investigator 
 
Appendix C:  Sample Modified Global Aesthetic Improvement Scale (GAIS): Subject 
 
Appendix D:  Sample Subject Satisfaction Survey 
 
Appendix E:  Sample Study Subject Daily Diary 

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Appendix F:  Renuvion Dermal System Instructions for Use (IFU) 
 
Appendix G:  Facial Zones 
LIST OF ABBREVIATIONS 
 
AE 
Adverse Event 
CRF 
Case Report Form 
CRO 
Clinical Research Organization  
DCF 
Data Clarification Form 
DRM 
Data Review Meeting  
ESU 
Electrosurgical Generator Unit 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
FSS 
Fitzpatrick Skin Scale 
FWS 
Fitzpatrick Wrinkle and Elastosis Scale 
GAIS 
Global Aesthetic Improvement Scale 
GCP 
Good Clinical Practice 
ICH  
International Conference for Harmonization of Technical Requirements 
of Pharmaceuticals for Human Use  
IFU 
Instructions for Use 
IPR 
Independent Photographic Reviewer 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
NSAID 
Non-steroidal Anti-Inflammatory Drug 
PP 
Per Protocol 
PSR 
Plasma Skin Resurfacing 
PPS 
Per Protocol Set 
RF 
Radiofrequency 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
UADE 
Unanticipated Adverse Device Effect 
VAS 
Visual Analog Scale 
 
 
 
 
 

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1 
STUDY SYNOPSIS 
Study Title 
A Prospective, Multicenter, Single-Arm Clinical Study Evaluating the Use of the 
Renuvion® Dermal System for Dermal Resurfacing 
Study Device 
Renuvion® Dermal System 
Study 
Population 
The study population will consist of males and females, 30 years of age or older, 
requesting a procedure for the purpose of improving facial appearance by reducing 
facial wrinkles and rhytides. Those subjects who meet eligibility criteria and agree 
to provide written informed consent will be invited to participate.  
Study 
Objective 
The study objective is to demonstrate the safety and effectiveness of the Renuvion® 
Dermal System for use in dermal skin resurfacing. 
Study Design 
 
This is a multi-center, single arm, evaluator-blind prospective study of up to 55 
study subjects who are seeking a procedure to reduce the appearance of wrinkles and 
rhytides from up to 5 investigational centers in the United States. Each study subject 
will receive one procedure with the Renuvion® Dermal System at enrollment. 
Follow-up will occur immediately following the procedure, at 1 day, at 6 (+2) days, 
at 10 (-1/+4) days, 30 (+7) days, 90 (+10) days, and 180 (+14) days after study 
treatment. 
Study 
Endpoints 
 
Primary Effectiveness Endpoint is the proportion of subjects with at least one-
point improvement from baseline in the Fitzpatrick Wrinkle and Elastosis Scale 
(FWS) at 90 days as determined by 2 out of 3 blinded Independent Photographic 
Reviewers. 
Primary Safety Endpoint is the evaluation of adverse events up to the 3-month 
visit after treatment. 
Secondary Safety Endpoint is the evaluation of the change in pain and discomfort 
after treatment (baseline, within 60 minutes following the procedure) as reported by 
the subject on a visual analog scale (VAS)experienced in the period up to the 10-day 
follow-up visit. Any pain or discomfort will be recorded daily by each participant in 
a diary using an 11-point Visual Analogue Scale (VAS). 
Additional  
Endpoints 
1. Whether or not (yes/no) at least 2 out of 3 blinded Independent Photographic 
Reviewers (IPRs) correctly identify the 90-day image of a subject from the pair of 
baseline and 90-day images. 
2. Magnitude of improvement measured by the mean change in FWS from baseline 
to 90-day visit as determined by Investigators. 
3. Subject modified GAIS at 90-day FUV (follow-up visit). 
4. Investigator modified GAIS at 90-day FUV. 
5. Subject satisfaction with procedure recorded at the 90-day visit. 
6. Achievement of re-epithelialization by facial zone and across all facial zones at 
the 10-day, 30-day and 90-day follow-up visits as reported by the investigator. 
7. Mean duration until study subject feels comfortable going in public after treatment 
as reported by the study subject.  
Planned 
Study 
Duration 
Study enrollment is expected to occur over 3-6 months. Imaging and study 
assessments will continue through 3 months post-procedure, with long term subject 
follow-up and data collection through 6 months post-procedure. Moreover, study 
subjects will be followed until each adverse event is resolved to ensure their safety. 
Total study duration is expected to be approximately 9-12 months. It is expected that 
the 510(k) application for the device will be submitted based on 3-month post-

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procedure results. However, this clinical trial will continue until every enrolled 
subject has reached 6 months following their procedure.  At that time, the trial will be 
considered complete, the final results will be analyzed, and a final report will be 
prepared. 
2 
STUDY ADMINISTRATIVE STRUCTURE 
 
Study Sponsor:                    Apyx Medical Corporation 
5115 Ulmerton Road 
Clearwater, FL  33760-4004  
Phone: (800)537-2790 
Fax: (800)323-1640 
 
 
Proprietary Notice: 
This document contains mainly unpublished data and is the sole 
property of the Sponsor. Therefore, it is provided to you in strict 
confidence as an investigator, potential investigator, or consultant. 
The information may be reviewed by you, your staff, and your 
institutional review board. It is understood that this information 
will not be disclosed to others without written authorization from 
the study Sponsor except to the extent necessary to obtain 
informed consent from those persons to whom the investigational 
device may be implanted. 
 
Ethics Statement: 
The study will be completed in accordance with applicable 
regulations and standards to provide public assurance that the 
rights, safety, and well-being of study subjects are protected, 
consistent with the principles that have their origin in the 
Declaration of Helsinki. 
 
 

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3 
INTRODUCTION 
3.1 
Study Background 
Physiological skin aging is multi factorial and results from both intrinsic and extrinsic factors.  
Genetics is one example of an intrinsic factor; others include hormone and metabolic processes 
that can cause the skin to age.  Exposure to chronic light, radiation, pollution, chemicals and 
toxins, are examples of extrinsic factors. Since skin health and beauty is contemplated as one of 
the representations of overall “well-being” and “health”, several anti-aging therapies have been 
developed during the recent years. The goal of these therapies is to achieve a healthy, smooth, 
blemish-free, translucent and resilient skin. [1] 
Skin resurfacing or peel procedures have become an established non-surgical method for reducing 
certain skin imperfections such as wrinkles, rhytides, dark spots, scars, or blemishes.  Traditional 
fully ablative and fractional lasers are the most commonly used devices for skin resurfacing. 
The skin is composed of three layers:  the epidermis, the dermis, and the hypodermis.  The dermis 
contains well-organized and oriented collagen fibers that contribute to the firmness and 
smoothness of the skin.  As people age, these collagen fibers reduce in number and become less 
organized, resulting in sagging and/or wrinkled skin. When esthetic procedures are scheduled for 
older adults, the rate of the epidermal turnover associated with a slower wound healing and less 
effective desquamation (shading of outer layers of the skin), needs to be taken into 
consideration.[1]  
In most skin resurfacing procedures, an energy source (heat, radiofrequency energy, etc.) is used 
to selectively damage the skin and prompt a healing response that stimulates the growth of new 
collagen fibers in the dermis that are well-organized.  The healing response and new collagen 
formation results in skin that is smoother and firmer.   
There are numerous traditional fully ablative and fractional lasers on the market today used for 
skin resurfacing.  Traditional and fractional lasers differ in their method of treatment.  Traditional 
lasers have a single beam that burns or damages all of the epidermis within the treatment area of 
the beam. Fractional lasers divide the beam into multiple smaller beams and treat only a “fraction” 
of the epidermis to affect changes in the deeper epidermis or dermis. This results in multiple small 
cores of laser damage surrounded by areas of healthy tissue.  When compared to traditional lasers, 
fractional lasers deliver a more superficial treatment resulting in less risk for complications and 
reduced time for healing. However, this also means more treatments may be required to achieve 
the desired results especially in areas of deep lines or wrinkles.  Healing times vary by amount of 
treatment, but fractional laser recovery time is typically one week compared to three to four weeks 
for traditional lasers. 
In the wake of the demonstrated safety and effectiveness of laser skin resurfacing, multiple 
additional treatment modalities have been developed for this application including the use of 
radiofrequency (RF) energy. The fractionated radiofrequency results in epidermal and 
subepidermal ablation under the conductive pins that reproduces similar effects as a fractional 
CO2 laser with dermal heating, seen in the non-ablative lasers and devices.[2] The combination of 
epidermal ablation and dermal heating with radiofrequency, called sublative resurfacing in some 
studies, is suitable for skin types I–IV, for the treatment of skin laxity, wrinkles, enlarged pores, 
pigmented lesions, acne, telangiectasias, and scarring from trauma or acne. Subject recovery and 

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down time periods are significantly lower when compared with ablative laser healing times, with 
minimal adverse effects.[3] 
3.2 
Study Rationale 
An emerging method utilizing the state of matter known as plasma to create a thermal effect on 
the skin through the use of positively ionized gasses is plasma skin resurfacing (PSR).[4] As this 
plasma comes in contact with the resurfacing target, the positive ions capture back electrons while 
energy is released. With PSR, an inert gaseous source is used to form a plasma that releases 
thermal energy that eliminates oxygen from the targeted skin surface. [5,6] PSR is not dependent 
on a chromophore for its use and does not vaporize tissue as ablative lasers do. This resurfacing 
modality has been hypothesized to function by forming a layer of desiccated epidermis creating 
a natural barrier that facilitates accelerated healing with generation of new epidermis. PSR also 
penetrates to the upper dermis resulting in thermal denaturation of surrounding collagen, thereby 
increasing fibroblast activity, which has been shown to continue up to a year after the plasma 
treatments.[7] Plasma resurfacing has been safely used in Fitzpatrick skin types I–IV. It has been 
approved for the treatment of many skin conditions including photoaging, acne scars, rhytides, 
dyschromias, skin laxity, as well as the treatment of actinic keratosis and seborrheic keratosis. In 
contrast to the ablative laser, plasma resurfacing treatments have a very low incidence of side 
effects such as permanent hypopigmentation, scarring, or prolonged erythema.[8] 
As an alternative treatment modality for skin resurfacing, Apyx Medical Corporation has 
developed the Renuvion® Dermal System that delivers RF energy in a controlled fashion with 
similar depth of thermal effect as predicate devices currently on the market for dermal resurfacing 
and wrinkle reduction procedures. [9,10,11] A potential benefit of this single-treatment low-risk 
technology is reducing wrinkle appearance and enhancing well-being by improving satisfaction 
and perception of having a more youthful appearance. 
3.3 
Study Device Description  
The Renuvion® Dermal System consists of an electrosurgical generator unit (ESU, Figure 1), a 
handpiece with detachable standoffs (Figure 2), and a supply of helium gas.  RF energy is 
delivered to the handpiece by the ESU and used to energize an electrode.  When helium gas is 
passed over the energized electrode, a helium plasma is generated which allows for conduction 
of the RF energy from the electrode to the subject in the form of a precise helium plasma beam.  
 
 
 
 
 
 
 
  

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Figure 1: Electrosurgical generator unit 
Figure 2: Handpieces with Standoffs 

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Apyx Medical Corporation’s Renuvion® helium-based plasma technology has received FDA 
clearance (K112233, K151325, K152570, and K170188) for the cutting, coagulation, and ablation 
of soft tissue.   
Pre-clinical studies comparing Renuvion (formerly known as J-Plasma®) to other energy sources 
such as CO2 laser and RF energy demonstrated less or comparable lateral and depth of thermal 
spread for Renuvion® in porcine peritoneum, bladder, and small intestine.[12]   
Additionally, a pre-clinical study comparing Renuvion to the NeoGen PSR System (K132754) 
when ablating/resurfacing the skin in a naive swine model was conducted.  A single animal was 
utilized in the study to evaluate both devices at an acute time point.  At the treatment settings used 
in this study, the maximum depth of thermal effect measured for tissue treated using the 
Renuvion® System were statistically equivalent to or lower than the maximum depth of thermal 
effect for tissue treated using the NeoGen PSR System.  These results support the safety of 
Renuvion® for this application and equivalent tissue effects for the two technologies. 
These pre-clinical study results demonstrate safety and effectiveness of the Renuvion® Dermal 
System in the ablation of soft tissue within its current FDA cleared indications in an animal model, 
therefore making the Renuvion® Dermal System a viable technology for dermal skin resurfacing. 
 
 
 

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4 
STUDY DESIGN  
4.1 
Study Objective 
The study objective is to demonstrate the safety and effectiveness of the Renuvion® Dermal 
System for use in dermal skin resurfacing.  
4.2 
Study Design 
This is a multi-center, single arm, evaluator-blind prospective study of up to 55 study subjects 
who are seeking a procedure to reduce the appearance of wrinkles and rhytides at up to 5 
investigational centers in the United States. The maximum enrollment per site is 20 subjects. 
 
Study subjects that meet study eligibility criteria and have provided informed consent will be 
enrolled in the study. During the procedure, the investigators will use the Renuvion® Dermal 
System on applicable facial zones to reduce wrinkles and rhytides.   
Study subjects will be followed immediately following the procedure, at 1 day, at 6 (+2) days, at 
10 (-1/+4) days, 30 (+7) days, 90 (+14) days, and 180 (+30) days after study treatment for study 
assessments.  
Study enrollment is expected to occur over 3-6 months. Imaging and study assessments will 
continue through 6 months post-procedure. Total study duration is expected to be approximately 
9-12 months.  It is expected that the 510(k) application for the device will be submitted based on 
90-day post-procedure results. However, this clinical trial will continue until every enrolled 
subject has reached 180 days following their procedure and all adverse events are resolved.  At 
that time, the trial will be considered complete, the final results will be determined, and a final 
report will be prepared. 
4.3 
Study Endpoints 
The following endpoints will be assessed in this study.  
4.3.1 
Primary Effectiveness Endpoint 
The primary effectiveness endpoint is the proportion of subjects with at least one-point 
improvement from baseline in the Fitzpatrick Wrinkle and Elastosis Scale (FWS) at 90 days as 
determined by 2 out of 3 blinded Independent Photographic Reviewers. Three experienced, 
blinded Independent Photographic Reviewers (IPRS) will perform an analysis/review of the 
pre-treatment and post-treatment sets of images of each subject in a blinded and randomized 
order.  
 
 
4.3.2 
Primary Safety Endpoint 
The primary safety endpoint is the evaluation of adverse events up to the 90-day visit after 
treatment. 

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4.3.3 
Secondary Safety Endpoint 
The secondary safety endpoint is the evaluation of the change in pain and discomfort after 
treatment (baseline, within 60 minutes following the procedure) experienced in the period 
up to the 10 (-1/+4) day follow-up visit. Pain or discomfort will be recorded daily by each 
participant in a diary using an 11-point Visual Analogue Scale (VAS). 
4.3.4 
Additional Endpoints 
Other endpoints to be evaluated include: 
 
1. Whether or not (Yes/No) at least 2 out of 3 blinded Independent Photographic 
Reviewers (IPRs) correctly identify the 90-day image of a subject from the pair of 
baseline and 90-day images.  
2. Magnitude of improvement measured by the mean change in FWS from baseline to 
90-day visit as determined by Investigators. 
3. Subject modified GAIS at 90-day FUV. 
4. Investigator modified GAIS at 90-day FUV. 
5. Subject satisfaction with procedure recorded at the 90-day visit. 
6. Achievement of re-epithelialization by facial zone and across all facial zones at the 
10 day, 30 days and 90 days follow-up visits as reported by the investigator. 
7. Mean duration until study subject feels comfortable going in public after treatment 
as reported by the study subject.  
 
 
 

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5 
INVESTIGATORS SELECTION AND STUDY POPULATION 
5.1 
Investigator Selection  
Participating Investigators will be qualified based on professionals experienced in treatment of 
wrinkles, such as dermatologists or plastic surgeons.  Investigators will be selected based on 
interest and availability for participation in the study; ability to provide qualified subjects; 
adequate support staff; experience conducting clinical research; and willingness to comply with 
the protocol, IRB requirements, regulatory requirements (including the signed investigator 
agreement and statements disclosing any financial relationship investigators might have with 
Apyx Medical Corporation), and FDA regulations. 
5.2 
Study Population   
All subjects requesting a procedure for the purpose of improving facial appearance by reducing 
facial wrinkles and rhytides from each participating investigator’s subject population will be 
considered as candidates for the study.  Those subjects who meet eligibility criteria and agree to 
provide written informed consent will be invited to participate.  
Subjects will be considered enrolled into the study when they have signed an approved informed 
consent form. Enrolled subjects who meet all study criteria and have undergone a procedure with 
the Renuvion Dermal System will be part of the full analysis set.  
5.2.1 
Inclusion Criteria 
     Potential subjects must meet all of the following inclusion criteria: 
 
1. Male or female subjects ≥30 years of age.  
2. Subject is seeking improvement of facial appearance by reducing facial wrinkles and 
rhytides. 
3. Subject with a facial wrinkle score rating of at least 4 on the FWS. 
4. Subject with a Fitzpatrick Skin Scale score ≤III. 
5. Subjects who are willing and able to take protocol allowed medications prescribed at 
investigator discretion which may include Keflex or Z-pack as an antibiotic, Acyclovir 
or Valtrex as an antiviral, Diflucan as an antifungal, Ativan or Valium for anxiety 
during treatment, Norco or Ultram for pain control during or post-procedure, 
Gabapentin, Tylenol with Codeine or NSAIDS for post-procedure pain control, and/or 
Antihistamines for itching during healing. 
6. Subjects who are willing to have polycarbonate eye shields placed for study treatment. 
7. Subject is willing and able to provide written informed consent. 
8. Subject is willing and able to comply with protocol requirements, including obtaining 
study-required images/photos and assessments, post-care instructions, and returning 
for follow-up visits. 
9. Subject is willing to maintain baseline skin care regimen during study participation 
with the exception when protocol specified ointments, moisturizers, and cleansers are 
required during healing stage (through approximately the 30-day follow-up). 
Sunblock is required throughout the study starting on approximately day 10.   

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10. Subject is willing to release rights to study Sponsor for the use of the photos, including 
in potential publication. 
11. Subject is willing to abstain from other facial cosmetic procedures through the 6-
month follow-up visit; examples include, but are not limited to, laser or chemical re-
surfacing, dermabrasion, neuromodulator and/or filler injections, aesthetic facial 
surgery, etc. 
5.2.2 
Exclusion Criteria 
     Subjects will be excluded from the study if they meet any of the following criteria: 
1. Subject with a Fitzpatrick Skin Scale score ≥IV. 
2. Subject is pregnant or lactating. 
3. Active HSV-1 or diabetes mellitus. 
4. Active cut, wound, or infection on the skin of the face. 
5. Subject has used, within 30 days prior to screening or plans to use during study 
participation, Accutane, Retinol, or any medication that can cause dermal 
hypersensitivity. 
6. Subject has used, within 10 days prior to study treatment, aspirin or NSAIDs. 
7. Subject has a history of autoimmune disease (excluding Hashimoto’s thyroiditis). 
8. Subject with a known bleeding disorder or who is on blood thinning medication that 
may be at risk for bleeding.  
9. Subject has a known adverse reaction to lidocaine and/or epinephrine. 
10. Subjects with active skin disease of the facial area or known connective tissue disease. 
11. Subjects with known susceptibility to keloid formation or hypertrophic scarring. 
12. Subjects with present cancerous or pre-cancerous lesions in the area to be treated. 
13. Subject who, for any reason, suspects that they will not be able to complete the 
prescribed follow-up assessment(s). 
14. Subject has had concurrent therapy that, in the investigator’s opinion, would interfere 
with the evaluation of the safety and effectiveness of the study treatment method. 
15. Subject is not willing to release rights to study Sponsor for the use of the photos, 
including in potential publication. 
16. Subject is enrolled in another investigational (drug or device) clinical trial that can 
interfere with this study’s assessments.  
17. Subject has undergone a facelift procedure within 12 months prior to the screening 
visit. 
18. Subject has received IPL, microneedling, or chemical peels within 3 months prior to 
the screening visit. 
19. Subject has received microneedling with RF or any facial treatment with an energy-
based device within 6 months prior to the screening visit. 
20. Subject has received facial injections with BOTOX® or other toxins within 6 months 
prior to the screening visit. 
21. Subject has received hyaluronic acid or calcium hydroxylapatite fillers within 4 
months prior to the screening visit. 
22. Subject who is a family member or employee of the investigator or sponsor. 
23. Participation in any other investigational study within 30 days prior to consent. 
24. Subject who, in the opinion of the investigator, is not an appropriate candidate for the 
study. 
 

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6 
STUDY PROCEDURES 
6.1 
Informed Consent  
The Investigator must ensure that written informed consent to participate in the study and written 
authorization for use and disclosure of protected health information is obtained before including 
any individual as a subject in the study, and before conducting any study-related assessments. 
The Investigator must provide the prospective subject with enough opportunity to consider 
whether or not to participate and minimize the possibility of coercion or undue influence.  
 
To participate in the study, a subject must sign and date an IRB-approved consent document.  The 
original, signed documents will be kept with the subjects’ files and copies will be provided to the 
subjects. The informed consent process must be followed, and the subject’s participation in the 
study, must be documented in the subject’s medical record/chart. 
6.2 
Pre-Procedure 
The subjects will have verification of eligibility criteria, a brief general examination including 
medical history, and wrinkles/rhytides assessment completed within 30 days prior to undergoing 
the study procedure. In response to the ongoing coronavirus disease (COVID-19) pandemic, 
preoperative testing can be completed at the Investigator’s discretion.  Pre-operative testing 
should be performed as close to the scheduled study procedure as feasible, but in time to get 
results. Up to two urine pregnancy tests must be obtained prior to study procedure for females 
with child-bearing potential (one at pre-procedure screening and one on the day of the procedure 
prior to the procedure. Screening and procedure will not be performed on the same day).  
Additionally, photographs of the area to be treated with the study device will be taken using the 
Canfield Scientific Visia-CR system (see also Section 12.3 Data Management Responsibilities 
and Section 12.4 Data Capture Methods) for each subject to document the appearance of their 
facial wrinkles and rhytides. The same standardized photography views will be used throughout 
the study as documented in the Canfield User Manual document developed for the study. Subjects 
will specifically be instructed to lightly rest their chin on the chinrest rather than resting heavily 
and distorting the chin appearance. 
All screening images will be reviewed by the Sponsor prior to study treatment to ensure 
enrollment criteria are met and study baseline images are high quality. 
The study subjects may be given medication for the prophylactic treatment of bacterial and viral 
infections including herpes simplex based on investigator’s discretion; allowed medications 
include: 
• Antibiotics: Keflex 500mg BID (first dose just prior, within 90 minutes, to procedure) x 
7 days. Alternative, Z-pack. 
• Antivirals: Acyclovir 400mg BID (start 1 day prior and continue for 10 days). Alternative, 
Valtrex 1 gram every day for 10 days (start 1 day prior). 
• Antifungals: Diflucan 150mg (1 day prior). 
 

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Medications subject is taking upon entry into the study should also be documented in the Case 
Report Forms (CRF). Documentation should include medications and supplements that study 
subjects take on an elective basis in addition to prescribed medications. Medication used for 
analgesia and/or anesthesia should be recorded as concomitant medication as well. To ensure the 
capture of the foregoing information on pre-existing conditions, sites should also be attentive to 
the need to document without limitation and whenever discovered: (1) all chronic, episodic or ‘as 
needed’ medications used before study enrollment; (2) prior episodic or ‘as needed’ therapeutic 
interventions, procedures or hospitalizations; and, (3) recent or planned surgical procedures.  
6.3 
Study Procedure 
On the day of the procedure and prior to the study procedure, female subjects with child-bearing 
potential must complete a urine pregnancy test (result must be obtained prior to the procedure).  
Additionally, subjects must complete a VAS pain assessment pre-procedure and immediately 
following the procedure (within 60 minutes after the procedure).   
Prior to study treatment, the following medications may be administered at investigator’s 
discretion: 
• Ativan 2mg or Valium 10-20mg. 
• Norco 5-10mg or Ultram 200mg. 
 
A responsible driver (friend or family member) is required if these medications are prescribed. 
The skin in the treatment area will be prepped by wiping the area with 70% isopropyl alcohol, 
then cleaned with 0.012% Hypochlorous Acid, then the entire area will be wiped clean with sterile 
saline.  
Facial Nerve Blocks will be done prior to infiltration of tumescent anesthesia to the ophthalmic 
nerve (v1), the maxillary nerve (V2), and the mandibular nerve (V3) using 1%-2% lidocaine with 
epinephrine (1:100,000). 
Regional blocks and local tumescent anesthesia (an anesthetic) will be used during the study 
procedure.  The local anesthetic is commonly referred to as Klein’s Solution. Per standard of care, 
this Klein’s Solution is prepared at the time of use and contains USP injection grade saline 
solution, USP injection grade Lidocaine for pain, and injection grade Epinephrine for 
vasoconstriction. A 0.2% concentration (double Klein solution) will be utilized in this study. The 
Tumescent solution is made by adding the following to 500 cc of normal saline: 
1. 50cc of 2% Lidocaine = to 1000mg 
2. 0.5cc of 1 mg/ml Epinephrine (1:1000) 
 
Tumescent local and regional anesthesia will be injected percutaneously infused with a 22 Gauge 
spinal needle.  The total volume of tumescent used should be between 250 – 500cc for the entire 
treatment area at investigator’s discretion and will be documented in the CRFs.  
 
Polycarbonate plastic eye shields will be used as per product IFU during study treatment. 
Numbing eye drops may be used to place eye shields at investigator’s discretion. 
 

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During the study procedure, the face of each subject will be treated by the study investigator using 
the Renuvion Dermal System according to the Instructions for Use (IFU; see Appendix F) and 
procedures described in this section. The face will be divided into 6 zones: Zone 1 (perioral), 
Zone 2 (periorbital), Zone 3 (forehead), Zone 4 (nose), Zone 5 (cheeks), and Zone 6 
(jawline/mandibular border) – see Appendix G: Facial Zones.   
 
The plasma beam will be used to ablate the tissue in each Zone using a consistent movement of 
the beam. Zones 1, 3, 4, and 5 (perioral, forehead, nose, and cheeks, respectively) will be treated 
with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing 
the appropriate standoff with one pass done horizontally and the other pass done perpendicular.  
Zone 2 (periorbital) will be treated with one (1) or two (2) passes, 20% power, and 4 liters/minute 
helium flow utilizing the appropriate standoff with up to 2 passes done horizontally or only in one 
direction. Zone 6 (jawline/mandibular border) will be treated with one (1) or two (2) passes, based 
on the investigator’s discretion, at 20% - 40% power and 4 liters/minute helium flow using the 
appropriate standoff and a treatment pattern in a variable motion to achieve blending.  Special 
care must be taken to not pass over any treated area more than twice.  Areas that are treated with 
1 pass (optional for Zone 2 and/or Zone 6) are not wiped after the pass. For areas that will be 
treated with a 2nd pass, the eschar will be wiped away entirely prior to start of the 2nd pass.  Pat 
skin dry prior to performing 2nd pass.  Do not wipe eschar away in areas that are treated with only 
1 pass. Do not wipe eschar away following 2nd pass.   
6.4 
Follow-up Procedures 
At investigator’s discretion, subjects may be given the following medications post-procedure 
PRN or and as needed: 
• Gabapentin 300mg TID x 6 days. 
• Tylenol with Codeine (T3) x 15 tablets. 
• Norco 5-10mg x 15 tablets. 
• NSAIDS and Antihistamines (e.g. Benadryl, Zyrtec) 
 
Following the procedure, the research staff and the subject will care for the treated areas using  
the Post-Procedure Care Guidelines listed below: 
 
Post-Procedure Care Guidelines 
You will likely experience the following treatment effects from your procedure with the Renuvion 
Dermal System: 
• Pain immediately after the procedure, decreasing substantially by 10 days post-procedure; 
and  
• Swelling, crusting, and itching persisting approximately 7-14 days. 
• Pin-point bleeding during the healing process resolving by 14 days. 
• Temporary post-inflammatory hyperpigmentation (redness or darkening of the skin) 
resolving by 90 days, 
 
Please following these Post-Procedure Instructions: 
 
 Stage 1 (days 1-3) 

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o Tepid to cool showers multiple times/day 
o Vinegar water soaks multiple times/day (wear gloves when doing 
vinegar soaks) 
 To make a vinegar water soak, fill a clean bowl with 
cold tap water and a few ice cubes and 1 tablespoon of 
white vinegar for every cup of water. 
 Using clean 4x4 gauze pads, wet them with the water 
solution and apply over the face, replacing them with 
new wet gauzes before they dry; alternatively, cold 
water may be repeatedly dripped over the gauze. 
 Continue soak for approximately 30 minutes. 
 The soak should not sting. Make sure the water stays 
chilled and replace when warm. 
o After showering or applying vinegar soaks, apply Aquaphor or 
alternative Crisco. Wear gloves to apply Aquaphor or Crisco. 
 
 Stage 2 (days 4-14) 
o Tepid to cool showers multiple times/day 
o Vinegar soaks as needed 
o Alcohol free cleansers (Neutrogena Fresh Foaming Facial Cleanser 
& Makeup Remover) and alcohol-free ointments (Aquaphor or 
Crisco) allowed 
  
 Stage 3 (days 15 and beyond) 
o Sunblock (Neutrogena Sheer Zinc Oxide Dry-Touch Face Sunscreen 
with Broad Spectrum SPF 50) 
o No hydroquinone 
o No retinol 
o Use light moisturizer (Neutrogena Oil Free Moisture Daily 
Hydrating Facial Moisturizer & Neck Cream) 
 
   
Following the study procedure, subjects will be asked to complete VAS pain assessment and 
return to the study site at 1 day, 6 days (4-8 days), 10 days (9-14 days), 30 days (23-37 days), 90 
days (80-100 days), and 180 days (166-194 days) for post-procedure assessments and to complete 
study questionnaires.  At the 1-day, 6-day, and 10-day follow-up visits, study staff may soak and 
debride the treatment area as needed. 
Photographs of the treated areas will be taken at each study follow-up visit using the Canfield 
Scientific Visia-CR system (see also Section 12.3 Data Management Responsibilities and Section 
12.4 Data Capture Methods) for each. Subjects may also text selfie pictures to study staff as 
needed for questions related to the healing process; these images will not be maintained by study 
sponsor.   
Study subjects will be asked to report complications experienced post-procedure and complete 
daily VAS 0-11 scale pain assessments utilizing the Subject Diary (see Appendix E: Subject 
Diary), and date when study subject felt comfortable, willing and able to go in public following 
the procedure.  
Table 1 illustrates study procedures that will occur at each visit.  

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Table 1: Study Required Procedures 
Table 1:  Study Required Procedures  
 
 
Baseline/ 
Pre-
Procedure 
Screening1 
Procedu
re 
1 
Day 
6, 10 Days 30 
Days 
90 
Days 
180 
Day
s 
1 
day 
6+2 days 
and 10+4/-
1 days 
30±7 
days 
90±1
0 
days 
180±
14 
days 
Informed Consent 
√ 
 
 
 
 
 
 
Assess Inclusion/Exclusion Criteria 
√ 
 
 
 
 
 
 
Urine Pregnancy Test2 
√ 
√ 
 
 
 
 
 
Medical History 
√ 
 
 
 
 
 
 
General Physical Exam 
√ 
 
 
 
 
 
 
Review Medications 
√ 
 
√ 
√ 
√ 
√ 
√ 
Photographic Images3 
√9 
 
√ 
√ 
√ 
√9 
√ 
Fitzpatrick Skin Type Scale (FST) 
√ 
 
 
 
 
 
 
Fitzpatrick Wrinkle and Elastosis 
Scale (FWS) 4 
√ 
 
 
 
√ 
√ 
√ 
Visual Analog Scale (11-point 
VAS) 5 
 
√ 
√ 
√ 
√ 
√ 
√ 
Study Procedure 
 
√ 
 
 
 
 
 
Debride Treatment Area (PRN) 
 
 
√ 
√ 
 
 
 
Subject Diary (11-point VAS)6 
 
√ 
√ 
√ 
 
 
 
Adverse Event Assessment  
 
√ 
√ 
√ 
√ 
√ 
√ 
Re-epithelization and Down Time7 
 
 
√ 
√ 
√ 
√ 
 
Modified Global Aesthetic 
Improvement Scale (GAIS) 8  
 
 
 
 
√ 
√ 
√ 
Subject Satisfaction Survey 
 
 
 
 
 
√ 
 
 
1 Pre-procedure Screening assessments to take place within 30 days prior to undergoing the 
procedure. 
2 Up to two urine pregnancy tests must be obtained prior to study procedure for females with child-
bearing potential (one at pre-procedure screening and one on the day of the procedure prior to the 
procedure if screening and procedure are not performed on the same day). 
3Digital photographs of the subject’s face will be taken and labeled according to Photography 
Instructions. 
4To be completed by Investigator. 
5 To be completed by the study subject on a day of the procedure (prior to the procedure and 
immediately following the procedure, e.g. within 60 minutes) and at specified follow-up visits.  
6 To be completed by the study subject daily starting from the day of procedure (after procedure, at 
home) until the 10-day follow-up visit.  
7 To be completed by Investigator to capture achievement of epidermal recovery status at follow-up 
visits; and date when study subject felt comfortable, willing and able to go in public following study 
procedure (assessed at the 10-day follow-up visit).  
8 To be completed by Investigator at all follow-up visits and study subject at the 30, 90, and 180-day 
follow-up visits. 
9 Images taken on this visit as primary endpoint for effectiveness.  

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6.5 
Data Collection 
Subject demographic information, procedural data, adverse events, device observations, and 
study required assessments will be documented on the CRFs.  Study subjects will complete Visual 
Analog Scale and Modified Global Aesthetic Improvement Scale (GAIS): Subject Form at 
follow-up visits. 
6.6 
Confidentiality of Data 
The Principal Investigator will oversee the conduct of the study and all data will be kept 
confidential. Confidentiality will be maintained by using subject identification numbers instead 
of names. Informed consent forms, data collection sheets and records, linking a subject’s name 
with their ID number will be maintained in a locked cabinet or locked office. Information to be 
stored on the computer will be identified by subject ID and will be password protected.  
 
Data disclosed outside the study team will be de-identified or will only include general group 
demographic information. Protected Health Information and/or identifiable study data will not be 
shared with anyone outside the study team or Health System, with the exception of the study 
sponsor, and federal regulators/ institutional officials for the purposes of auditing. 
7 
EVALUATION TOOLS 
The following evaluation tools will be used in this study: 
7.1 
Fitzpatrick Skin Type Scale (FST) 
Assessment of subject’s skin color will be determined prior to study procedure by the Investigator 
using the FST.  The scale delineates skin color into the categories as shown in Table 2.  
 
Table 2: Fitzpatrick Skin Type Scale (FST) 
Table 2: Fitzpatrick Skin Type Scale Evaluation 
Skin Type 
Description 
Type I 
White skin that never tans and always burns easily 
Type II 
White skin that tans slightly and always burns easily 
Type III 
Light brown skin that tans gradually and can burn moderately 
Type IV 
Moderately brown skin that tans well and burns slightly 
Type V 
Dark brown skin that tans profusely and burns rarely  
Type VI 
Black skin with deep pigmentation that never burns   
7.2 
Fitzpatrick Wrinkle and Elastosis Scale (FWS) 
Assessment of each subject’s wrinkles at baseline and 30, 90, and 180-day follow-up visits will 
be performed by the Investigator. As well,  assessment of each subject’s baseline and the 90-day 
follow-up visit images viewed simultaneously will be performed by three board-certified 
dermatologists or plastic surgeons sourced and managed by Canfield Scientific and the Sponsor, 
called Independent Photographic Reviewers (IPRs), using the Fitzpatrick Wrinkle and Elastosis 
Scale (FWS) categories as shown in Table 3 (see also Section 12.3 Data Management 
Responsibilities and Section 12.4 Data Capture Methods). The FWS is a clinically validated 

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assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, 
where the lower score is considered better. Three Independent Photographic Reviewers will be 
blinded to the study subject’s visit (baseline and follow-up visit) and will perform photographic 
assessments of each subject’s wrinkle depth in the treated zones (identified only as “Zones to 
Evaluate” to the IPRs) using FWS and ignoring nasolabial folds and marionette lines (effects of 
gravity), and artifacts from the chin rest.  The IPRs will assign a single FWS score per subject for 
both the right and left photo. Each photograph will have a unique identification number but sets 
of images will not be arranged in any specific order (i.e., randomized order). 
 
Independent Photographic Review Evaluation Process for FWS: 
1. Each blinded assessor will be provided with identical photos to be assessed.  The pre-
treatment and follow-up photos will be consistent in lighting, subject positioning and 
focus.  Each photo’s visit interval, i.e., pre-treatment and follow-up, will NOT be marked. 
The images placement (right or left) will be randomly ordered for pre-treatment and 
follow-up images. Images for each subject will be grouped together into one set with all 
pre-treatment and follow-up images in the same location (right/left) for the subject set. 
2. Each blinded assessor will conduct their assessment independently with no input from 
another blinded assessor. 
3. Each blinded assessor reviews the Left photo and assigns a FWS score. 
4. Each blinded assessor reviews the Right photo and assigns a FWS score. 
5. Enough time should be allowed to do this for each image, so the assessments are not 
rushed. 
6. The change between FWS scores will be calculated during data analysis after assessments 
are complete. 
7. Success will be determined by at least 1-point improvement in FWS by at least two out 
of three blinded, independent reviewers.  
 
Table 3: Fitzpatrick Wrinkle and Elastosis Scale 
Table 3: Fitzpatrick Wrinkle and Elastosis Scale 
Class 
Description 
Score 
Description 
I 
Fine wrinkles 
1-3 
Mild: Fine texture changes with 
subtly accentuated skin lines. 
II 
Fine to moderate depth 
wrinkles, 
Moderate number of lines 
4-6 
Moderate: Distinct papular elastosis 
(individual papules with yellow 
translucency under direct lighting) 
and dyschromia. 
III 
Fine to deep wrinkles, 
numerous lines, with or without 
redundant skin folds 
7-9 
Severe: Multipapular and confluent 
elastosis (thickened, yellow and 
pallid) approaching or consistent with 
cutis rhomboidalis. 

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7.3 
Modified Global Aesthetic Improvement Scale (GAIS) 
The Global Aesthetic Improvement Scale (GAIS) is a subjective rating of improvement in 
treatment results compared to pre-treatment.  A modification of the GAIS to include “much 
worse” and “very much worse” as rating options will be used in this study.  The Investigator will 
grade the overall improvement of treatment area as indicated in Table 4a by comparing the 
subject’s appearance at follow-up visits against a photograph taken prior to procedure.  Likewise, 
the subject will also rate their improvement compared to pre-treatment as shown in Table 4b.   
 
The modified GAIS results will be collected at the 30, 90, and 180-day follow-up visits.   
 
Table 4: Modified Global Aesthetic Improvement Scale Evaluation 
Table 4a: Modified Global Aesthetic Improvement Scale Evaluation (GAIS): 
Investigator 
Rating 
Description  
Very much 
improved 
Optimal cosmetic result from this procedure in this subject 
Much improved 
Marked improvement in appearance from the initial condition, but 
not completely optimal for this subject 
Improved 
Obvious improvement in appearance from the initial condition 
No change 
The appearance is essentially the same as the original condition 
Worse  
The appearance is worse than the original condition 
Much worse 
The appearance is much worse than the original condition 
Very much worse 
The appearance is very much worse than the original condition 
 
 
Table 4b: Modified Global Aesthetic Improvement Scale Evaluation (GAIS): 
Subject 
Rating 
Very much improved 
□ Optimal cosmetic result. 
Much improved 
□ Marked improvement in appearance from the initial 
condition, but not completely optimal. 
Improved 
□ Obvious improvement in appearance from initial condition. 
No change 
□ The appearance is essentially the same as the original 
condition 
Worse  
□ The appearance is worse than the original condition. 
Much worse 
□ The appearance is much worse than the original condition. 
Very much worse 
□ The appearance is very much worse than the original 
condition. 
 
7.4 
Re-epithelization and Down Time 
The study investigators and/or Independent Photographic Reviewers (as applicable) will be 
required to obtain and document re-epithelization and down time defined as per below:  

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1. Achievement of Re-epithelization - determine percentage epidermal recovery per 
treatment zone at the 1, 6, 10, 30, and 90-day follow-up visits. 
2. Down Time - date when study subject felt comfortable, willing and able to go in public 
following study procedure (assessed at the 1, 6, 10, and 30-day follow-up visit). 
7.5 
Visual Analog Scale (VAS) 
The study subjects will be asked to complete an 11-point Visual Analog Scale (VAS) for the 
following assessments: 
1. Level of pain and discomfort associated with study procedure – to be completed by the 
subjects on the day of the procedure (prior to the procedure and immediately following 
the procedure), daily between the date of the procedure (reported at home) and the 10 day 
follow-up visit, and at all follow-up visits. 
2. Subject satisfaction with treatment – at the 3 visits. Additionally, the subjects will be asked 
if they would recommend the treatment to friends and acquaintances (yes, perhaps, or no) 
and improvements noted (if any). 
 
Scoring for the VAS will consist of making a mark on a 10-cm line demarcated at 1-cm intervals. 
Each end of the line will be awarded a score of 0 or 10 according to the extreme points of reference 
pertaining to an individual measure. 
 
7.6 
Subject Diary 
Study subjects will be asked to complete a daily diary (see Appendix E: Subject Diary) starting 
from the procedure date (after study procedure, at home) until the 10 day follow-up visit to 
complete daily 11-point VAS pain assessments and document any complications they have 
experienced.  
 
7.7 
Blinded Identification of 90-Day Images 
Assessment of each subject’s baseline and 90-day follow-up images viewed simultaneously will 
be performed by the Independent Photographic Reviewers (IPR) who will be blinded to the study 
subject’s visit (baseline and 3-month follow-up visit).  Each IPR will view each subject’s 
randomized baseline and 90-day follow-up images and assess which set of images represent the 
subject’s post-treatment images. Each photograph will have a unique identification number, but 
the sets of images will not be arranged in any specific order (i.e., randomized order). 
 
Independent Photographic Review Evaluation Process for Masked Assessment: 
1. Each blinded assessor will be provided with identical photos to be assessed.  The pre-
treatment and follow-up photos will be consistent in lighting, subject positioning and 
focus.  Each photo’s visit interval, i.e., pre-treatment and follow-up, will NOT be marked. 
The images placement (right or left) will be randomly ordered for pre-treatment and 
follow-up images. Images for each subject will be grouped together into one set with all 
pre-treatment and follow-up images in the same location (right/left) for the subject set. 

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2. Each blinded assessor will conduct their assessment independently with no input from 
another blinded assessor. 
3. Each blinded assessor compares the Left and Right photo for improvement. Assessors 
should look through each view and assess change.  Enough time should be allowed to do 
this for each subject, so the assessments are not rushed. 
4. The following definition will be used: 
• Change: An improvement that is: 
o Striking, substantial and immediately noticeable, or 
o Readily apparent but modest in nature, or  
o Slight and subtle in nature; may require close examination. 
5. The assessor chooses which photo they believe to be the Post treatment photo (i.e., Left 
photo or Right photo) once all images in the subject set have been reviewed. 
6. Post-Analysis Coding of Masked Assessment: 
• If the assessor incorrectly chooses the Post treatment photo, this will be coded as 
an “Incorrect post selection”. 
• If the assessor correctly chooses the Post treatment photo, this will be coded as a 
“Correct post selection”. 
7. Success will be determined by correct identification of post treatment follow-up visit 
photographs by at least two out of three blinded, independent reviewers.  
 
8 
ADVERSE EVENTS ASSESSMENT REPORTING 
8.1 
Adverse Events Evaluation  
Safety evaluations for this study include an interview with the study subject at each follow-up 
visit by the Investigator or Research Coordinator to elicit information about any medical 
occurrence that meets the definition of Adverse Event. This information will be documented in 
CRF without regard for cause or relation to device and/or procedure.  
 
In addition, study subjects will be instructed to report all of complications experienced post study 
procedure to the site personnel as soon as they occur/are observed.                                                                       
 
It is the Investigator’s responsibility to determine seriousness, severity, and relatedness of the 
Adverse Event to the device and procedure using the definitions below. 
8.2 
Adverse Event (AE) and Expected Treatment Effect (ETE) Definition 
An adverse event (AE) is any untoward or unfavorable medical occurrence in a human subject, 
including any abnormal sign (for example, abnormal physical exam or laboratory finding), 
symptom, or disease temporally associated with the subject’s participation in the research, 
whether or not considered related to the subject’s participation in the research. An expected 
treatment effect (ETE) is any typical treatment side-effect of the Renuvion Dermal System 

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lasting up to a typical maximum duration. All ETEs and AEs will be collected during the conduct 
of this trial.  
 
A preexisting condition (one that is present at the start of the study) will be recorded as an AE 
only if the frequency, intensity, or the character of the condition worsens during the study period.  
 
Neither the condition, hospitalization, prolonged hospitalization, nor surgery are reported as an 
AE in the following circumstances: hospitalization or prolonged hospitalization for diagnostic or 
elective surgical procedures for a preexisting condition. Surgery should not be reported as an 
outcome of an AE if the purpose of the surgery was elective or diagnostic and the outcome was 
uneventful. 
8.3 
Serious Adverse Event (SAE) Definition  
Serious Adverse Event (SAE) is an adverse event that: 
• Led to a death or  
• Led to a serious deterioration in the health of a subject that: 
o Resulted in a life-threatening illness or injury, 
o Resulted in a permanent impairment of a body structure or body function, 
o Required in-patient hospitalization or prolongation of existing hospitalization, 
o Resulted in medical or surgical intervention to prevent impairment to body structure or 
a body function 
o Led to fetal distress, fetal death or a congenital abnormality or birth defect, or   
o Other serious (important) medical events that may jeopardize the subject and may 
require medical or surgical intervention to prevent on of the other outcomes. 
 
All SAEs that occur during the study period, whether considered to be related to the 
investigational product or not, must be reported to the Sponsor within 24 hours of knowledge of 
the event. IRB reporting requirements may also apply for SAEs. 
8.4 
Unanticipated Adverse Device Effect (UADEs) Definition 
An unanticipated adverse device effect (UADEs) is defined as any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, a device, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, or any other unanticipated serious problem associated with 
a device that relates to the rights, safety, or welfare of subjects.   
In addition, any UADEs will be reported to the Sponsor and the reviewing IRB as soon as 
possible, but no later than within 24 hours of knowledge of the event.   
All adverse events, anticipated or unanticipated, will be monitored until they are adequately 
resolved or explained.    
8.5 
Reporting Requirements 
All adverse events (AEs) observed by study subjects, investigators or other study staff from first 
exposure to the study product through last study follow-up visit will be recorded. If a device-
related AE, SAE, or unanticipated serious device related effect is ongoing at the final study visit, 

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the subject will be followed until resolution, until the condition stabilizes, until the event is 
otherwise explained, or the subject is lost to follow-up. The investigator should make every effort 
to ensure that follow-up includes any supplemental investigations as may be indicated to 
elucidate, as completely as practical, the nature and/or causality of the AE or SAE. This may 
include unscheduled follow up visits for AE assessment. 
Study subjects will be instructed to report all AEs to the clinical study staff.  AE information will 
be collected throughout the study and recorded on CRFs.  
8.6 
Severity of Adverse Events 
The severity of adverse events will be categorized using the following criteria: 
• Mild: easily tolerated by the subject, causing minimal discomfort and not interfering with 
everyday activities. These events generally do not require treatment.  
• Moderate: sufficiently discomforting to interfere with normal everyday activities.  These 
vents are usually relieved by simple therapeutic measures.  
• Severe:  prevents normal, everyday activities.  These events may require systemic drug 
therapy or other medical treatment. 
8.7 
Relationship to the Study Device and/or Procedure 
The relationship to the study device and/or procedure will be determined by the investigator 
utilizing the following categories: 
 
• Not Related: An event for which an alternative explanation is conclusively identified – 
e.g., concomitant drug(s), concomitant disease(s), and/or the relationship in time suggests 
that a causal relationship is highly unlikely. 
 
• Related: The adverse event follows a reasonable temporal sequence related to treatment 
by the device, follows a known or suspected response pattern and a plausible alternative 
etiology cannot be identified. 
 
• Undetermined: The relation of the adverse event has some temporal relationship to the 
device and/or device procedure, is not clearly due to another condition and the 
involvement of the study device is unknown.  
8.8 
Stopping Guidelines / Stopping Rules: Safety 
The Sponsor and/or investigator may recommend termination or modification of 
the study if there is an occurrence of any device- or treatment-related Serious 
Adverse Event, using the clinical protocol definitions of Serious Adverse Event in 
Section 8.3 of this protocol. In addition, termination or modification may be 
recommended for any other perceived safety concern based on clinical judgment, 
including but not limited to a severe burn (anticipated or unanticipated), a higher 
than anticipated rate for any component of the safety measures, device failures 
resulting in Adverse Events, or unexpected SAEs. 
 

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9 
RISK AND BENEFITS 
9.1 
Benefits  
A possible benefit of using the Renuvion Dermal System is the potential for improvement in 
wrinkle severity.  Additional potential benefits of improving the appearance of wrinkles could 
include enhanced well-being, with improved satisfaction with the appearance of less facial 
wrinkles or the perception of a having a more youthful appearance. 
9.2 
Risks  
The following are expected treatment effects (ETE) with the Renuvion Dermal System: 
• Pain & tenderness immediately after the procedure, decreasing substantially by 10 days 
post-procedure; and  
• Erythema, swelling, induration (crusting) and/or urticaria (itching) persisting 
approximately 7-14 days. 
• Pin-point bleeding during reepithelialization resolving by 14 days. 
• Temporary post-inflammatory hyperpigmentation resolving by 90 days, 
Potential risks with the Renuvion Dermal System are similar to those that are encountered for 
many routine facial soft tissue reductions.  These include but are not limited to:  
• pain, 
• tenderness, 
• itching, 
• bleeding,  
• bruising/hematoma/seroma,  
• allergic reaction,  
• hypersensitivity to the treatment (resulting in erythema, swelling, induration and/or 
urticaria),  
• temporary or permanent post-inflammatory hyperpigmentation, 
• telangiectasias, 
• skin overheating/burn, 
• hypertrophic scarring 
• discoloration/permanent hypopigmentation,  
• vessel laceration or occlusion,  
• abscess (infection) at treatment site which may result in induration and/or scar formation, 
and 
• prolonged wound healing.   
Subjects using drugs that reduce coagulation (aspirin or NSAIDs) may experience increased 
bruising or bleeding at the treatment site. 
 
Side effects of nerve blocks and tumescent local anesthesia containing lidocaine or epinephrine 
include: 
• Nausea 
• Vomiting  
• Mild sleepiness 

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• Confusion 
• Convulsions 
• Respiratory depression and/or respiratory arrest 
• Cardiovascular stimulation or depression 
• Cardiac arrest 
• Lightheadedness or dizziness 
• Nervousness 
• Apprehension 
• Euphoria 
• Tinnitus 
• Blurred or double vision 
• Sensations of heat, cold or numbness 
• Twitching 
• Tremors 
• Unconsciousness 
• Anaphylactic response (hypotension, difficulty breathing, tightness in chest, and/or 
shortness of breath) 
 
Side effects and subject instructions for medications that are at investigator discretion 
include: 
• Keflex 
If any of these effects persist or worsen, tell your doctor or pharmacist 
promptly: 
• 
Diarrhea 
• 
Nausea 
• 
Vomiting 
• 
Upset stomach 
This medication may rarely cause a severe intestinal condition due to 
resistant bacteria. This condition may occur during treatment or weeks to 
months after treatment has stopped. Do not use anti-diarrhea or opioid 
medications if you have any of the following symptoms because these 
products may make them worse. Tell your doctor right away if you 
develop: 
• 
Persistent diarrhea 
• 
Abdominal or stomach pain/cramping 
• 
Blood/mucus in your stool 
A very serious allergic reaction to this drug is rare. However, get medical 
help right away if you notice any symptoms of a serious allergic reaction, 
including: 
• 
Rash 

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• 
Itching/swelling 
• 
Severe dizziness 
• 
Trouble breathing 
Other things to note: 
• 
Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast 
infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal 
discharge, or other new symptoms. 
• Z-pak 
If any of these effects persist or worsen, tell your doctor or pharmacist 
promptly: 
• 
Stomach upset 
• 
Diarrhea/loose stools 
• 
Nausea 
• 
Vomiting 
• 
Abdominal pain 
Tell your doctor right away if any of these unlikely but serious side 
effects occur: 
• 
Hearing changes 
• 
Eye problems 
• 
Difficulty speaking/swallowing 
• 
Muscle weakness 
• 
Signs of liver problems 
Get medical help right away if any of these rare but serious side effects 
occur: 
• 
Fast/irregular heartbeat 
• 
Severe dizziness 
• 
Fainting 
This medication may rarely cause a severe intestinal condition due to 
resistant bacteria. This condition may occur during treatment or weeks to 
months after treatment has stopped. Do not use anti-diarrhea or opioid 
medications if you have any of the following symptoms because these 
products may make them worse. Tell your doctor right away if you 
develop: 

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• 
Persistent diarrhea 
• 
Abdominal or stomach pain/cramping 
• 
Blood/mucus in your stool 
A very serious allergic reaction to this drug is rare. However, get medical 
help right away if you notice any symptoms of a serious allergic reaction, 
including: 
• 
Fever that doesn't go away 
• 
New or worsening lymph node swelling 
• 
Rash 
• 
Itching/swelling 
• 
Severe dizziness 
• 
Trouble breathing 
Other things to note: 
• 
Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast 
infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal 
discharge, or other new symptoms. 
• 
An allergic reaction to this medication may return even if you stop the drug. If you have an 
allergic reaction, continue to watch for any of the above symptoms for several days after your 
last dose. 
• Acyclovir 
If any of these effects persist or worsen, tell your doctor or pharmacist 
promptly: 
• 
Nausea 
• 
Diarrhea 
• 
Headache 
• 
Vomiting 
Tell your doctor right away if any of these unlikely but serious side 
effects occur: 
• 
Dizziness 
• 
Drowsiness 
• 
Signs of kidney problems 
• 
Mental/mood changes 

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• 
Shaky/unsteady movement 
• 
Trouble speaking 
This medication may rarely cause a life-threatening disorder that affects 
the blood cells, kidneys, and other parts of the body. This disorder is 
more likely to occur if you have conditions related to a weakened 
immune system. Seek immediate medical attention if any of these rare 
but serious side effects occur: 
• 
Extreme tiredness 
• 
Slow/fast/irregular heartbeat 
• 
Easy bruising/bleeding 
• 
New fever 
• 
Bloody/dark urine 
• 
Severe stomach/abdominal pain 
• 
Yellowing eyes/skin 
• 
Sudden vision changes 
• 
Loss of consciousness 
• 
Seizures 
A very serious allergic reaction to this drug is rare. However, seek 
immediate medical attention if you notice any symptoms of a serious 
allergic reaction, including: 
• 
Rash 
• 
Itching/swelling 
• 
Severe dizziness 
• 
Trouble breathing 
• Valtrex 
If any of these effects persist or worsen, tell your doctor or pharmacist 
promptly: 
• 
Nausea 
• 
Stomach pain 
• 
Headache 
• 
Dizziness 

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Tell your doctor right away if you have any serious side effects, 
including: 
• 
Mental/mood changes 
• 
Trouble speaking 
• 
Shaky/unsteady movements 
• 
Signs of kidney problems 
This medication may rarely cause a life-threatening disorder that affects 
the blood cells, kidneys, and other parts of the body. This disorder is 
more likely to occur if you have conditions related to a weakened 
immune system. Get medical help right away if you have any serious 
side effects, including: 
• 
Extreme tiredness 
• 
Slow/fast/irregular heartbeat 
• 
Easy bruising/bleeding 
• 
New fever 
• 
Bloody/dark urine 
• 
Severe stomach/abdominal pain 
• 
Yellowing eyes/skin 
• 
Sudden vision changes 
• 
Loss of consciousness 
• 
Seizures 
A very serious allergic reaction to this drug is rare. However, get 
medical help right away if you notice any symptoms of a serious 
allergic reaction, including: 
• 
Rash 
• 
Itching/swelling 
• 
Severe dizziness 
• 
Trouble breathing 
• Diflucan 
If any of these effects persist or worsen, tell your doctor or pharmacist 
promptly: 
• 
Nausea 

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• 
Diarrhea 
• 
Stomach pain 
• 
Headache 
• 
Dizziness 
Get medical help right away if any of these rare but serious side effects 
occur: 
• 
Fast/irregular heartbeat 
• 
Severe dizziness 
• 
Fainting 
This drug may rarely cause serious liver disease. Get medical help right 
away if you develop any signs of liver disease, including: 
• 
Severe stomach/abdominal pain 
• 
Persistent nausea/vomiting 
• 
Yellowing eyes/skin 
• 
Dark urine 
• 
Unusual tiredness 
A very serious allergic reaction to this drug is rare. However, get medical 
help right away if you notice any symptoms of a serious allergic reaction, 
including: 
• 
Rash 
• 
Itching/swelling 
• 
Severe dizziness 
• 
Trouble breathing 
Other things to note: 
• 
If your doctor has directed you to use this product, remember that he or she has judged 
that the benefit to you is greater than the risk of side effects. Many people using the 
product do not have serious side effects. 
• Ativan 
If any of these effects persist or worsen, tell your doctor or pharmacist 
promptly: 
• 
Drowsiness 
• 
Dizziness 

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• 
Loss of coordination 
• 
Headache 
• 
Nausea 
• 
Blurred vision 
• 
Change in sexual interest/ability 
• 
Constipation 
• 
Heartburn 
• 
Change in appetite 
Tell your doctor right away if you have any unlikely but serious side 
effects, including: 
• 
Mental/mood changes 
• 
Slurred speech or difficulty talking 
• 
Vision changes 
• 
Unusual weakness 
• 
Trouble walking 
• 
Memory problems 
• 
Signs of infection 
Get medical help right away if you have any rare but very serious side 
effects, including: 
• 
Yellowing eyes or skin 
• 
Seizures 
• 
Slow/shallow breathing 
A very serious allergic reaction to this drug is rare. However, get medical 
help right away if you notice any symptoms of a serious allergic reaction, 
including: 
• 
Rash 
• 
Itching/swelling 
• 
Severe dizziness 
• 
Trouble breathing 
• Valium 

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If any of these effects persist or worsen, tell your doctor or pharmacist 
promptly: 
• 
Drowsiness 
• 
Dizziness 
• 
Tiredness 
• 
Blurred vision 
• 
Unsteadiness 
Tell your doctor right away if you have any serious side effects, 
including: 
• 
Mental/mood changes 
• 
Trouble speaking 
• 
Trouble walking 
• 
Muscle weakness 
• 
Shaking 
• 
Trouble urinating 
• 
Yellowing eyes/skin 
• 
Signs of infection 
Get medical help right away if you have any very serious side effects, 
including: 
• 
Slow/shallow breathing 
A very serious allergic reaction to this drug is rare. However, get medical 
help right away if you notice any symptoms of a serious allergic reaction, 
including: 
• 
Rash 
• 
Itching/swelling 
• 
Severe dizziness 
• 
Trouble breathing 
• Norco 
Tell your doctor right away if you have any serious side effects, 
including: 
• 
Mental/mood changes 
• 
Stomach/abdominal pain 

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• 
Difficulty urinating 
• 
Signs of your adrenal glands not working well 
Get medical help right away if you have any very serious side effects, 
including: 
• 
Fainting 
• 
Seizure 
• 
Slow/shallow breathing 
• 
Severe drowsiness/difficulty waking up 
A very serious allergic reaction to this drug is rare. However, get medical 
help right away if you notice any symptoms of a serious allergic reaction, 
including: 
• 
Rash 
• 
Itching/swelling 
• 
Severe dizziness 
• 
Trouble breathing 
Other things to note: 
• 
Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. 
Some of these side effects may decrease after you have been using this medication for a 
while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. 
• 
To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may 
also need to take a laxative. Ask your pharmacist which type of laxative is right for you. 
• 
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a 
sitting or lying position. 
• Ultram 
Tell your doctor right away if you have any serious side effects, 
including: 
• 
Mental/mood changes 
• 
Severe stomach/abdominal pain 
• 
Difficulty urinating 
• 
Signs of your adrenal glands not working well 
Get medical help right away if you have any very serious side effects, 
including: 
• 
Fast/irregular heartbeat 

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• 
Severe dizziness 
• 
Fainting 
• 
Seizure 
This medication may increase serotonin and rarely cause a very serious 
condition called serotonin syndrome/toxicity. The risk increases if you 
are also taking other drugs that increase serotonin, so tell your doctor or 
pharmacist of all the drugs you take. Get medical help right away if you 
develop some of the following symptoms: 
• 
Fast heartbeat 
• 
Hallucinations 
• 
Loss of coordination 
• 
Severe dizziness 
• 
Severe nausea/vomiting/diarrhea 
• 
Twitching muscles 
• 
Unexplained fever 
• 
Unusual agitation/restlessness 
Tramadol is changed into a strong opioid drug in your body. In some 
people, this change happens faster and more completely than usual, 
which increases the risk of very serious side effects. Get medical help 
right away if you notice any of the following: 
• 
Slow/shallow breathing 
• 
Severe drowsiness/difficulty waking up 
• 
Confusion 
A very serious allergic reaction to this drug is rare. However, get medical 
help right away if you notice any of the following symptoms: 
• 
Rash 
• 
Itching/swelling 
• 
Severe dizziness 
• 
Trouble breathing 
Other things to note: 
• 
Nausea, vomiting, constipation, sweating, trouble sleeping, dry mouth, fatigue, 
lightheadedness, dizziness, drowsiness, or headache may occur. Some of these side 

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effects may decrease after you have been using this medication for a while. If any of 
these effects persist or worsen, tell your doctor or pharmacist promptly. 
• 
To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may 
also need to take a laxative. Ask your pharmacist which type of laxative is right for you. 
• 
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a 
sitting or lying position. 
• Gabapentin 
If any of these effects persist or worsen, tell your doctor or pharmacist 
promptly: 
• 
Drowsiness 
• 
Loss of coordination 
• 
Dizziness 
Tell your doctor right away if you have any serious side effects, 
including: 
• 
Swelling of the hands/ankles/feet 
Get medical help right away if you have any very serious side effects, 
including: 
• 
Slow/shallow breathing 
A very serious allergic reaction to this drug is rare. However, get medical 
help right away if you notice any symptoms of a serious allergic reaction, 
including: 
• 
Fever 
• 
Swollen lymph nodes 
• 
Rash 
• 
Itching/swelling 
• 
Severe dizziness 
• 
Trouble breathing 
Other things to note: 
• 
A small number of people who take anticonvulsants for any condition may experience 
depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor 
right away if you or your family/caregiver notice any unusual/sudden changes in your 
mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, 
thoughts about harming yourself. 
• Tylenol with Codeine 

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Common side effects of Tylenol with Codeine include:  
• nausea,  
• vomiting,  
• upset stomach, 
• constipation,  
• headache,  
• lightheadedness, 
• dizziness, 
• drowsiness,  
• blurred vision, or  
• dry mouth 
• Inform your doctor if you experience unlikely but serious side effects of 
Tylenol with Codeine including mental/mood changes, severe 
stomach/abdominal pain, or difficulty urinating. 
• NSAIDS 
The most common side effects are: 
• 
vomiting,  
• 
nausea,  
• 
constipation,  
• 
diarrhea,  
• 
reduced appetite,  
• 
headache,  
• 
dizziness,  
• 
rash, and  
• 
drowsiness.  
NSAIDs also may cause swelling of the arms and legs due to the retention of 
fluid from their renal effects.  
The most serious side effects are ulcers, bleeding, kidney failure, and, rarely, 
liver failure.  

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Individuals allergic to NSAIDs may experience shortness of breath after taking 
an NSAID and may experience a similar reaction when other NSAIDs are 
taken.  
People with asthma are at higher risk for experiencing serious allergic 
reactions to NSAIDs.  
NSAIDs (except aspirin) may increase the risk of heart attacks, stroke, and 
related conditions, which can be fatal. This risk may increase with duration of 
use and in patients who have underlying risk factors for disease of the heart 
and blood vessels.  
NSAIDs, particularly non-selective NSAIDs, cause an increased risk of 
serious, even fatal, stomach and intestinal adverse reactions such as bleeding, 
ulcers, and perforation of the stomach or intestines. These events can occur at 
any time during treatment and without warning symptoms. Elderly patients are 
at greater risk for these types of reaction.  
• Antihistamines 
• 
Less common or rare 
• 
Abdominal or stomach pain  
• 
burning  
• 
chills  
• 
clay-colored stools or dark urine  
• 
cough  
• 
diarrhea  
• 
difficulty swallowing  
• 
dizziness  
• 
fast or irregular heartbeat  
• 
fever  
• 
headache  
• 
hives  
• 
itching  
• 
prickly sensations  
• 
puffiness or swelling of the eyelids or around the eyes, face, lips or tongue  
• 
redness of skin  

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• 
seizures  
• 
shortness of breath  
• 
skin rash  
• 
swelling  
• 
tightness in chest  
• 
tingling  
• 
unusual tiredness or weakness  
• 
wheezing  
Check with your doctor as soon as possible if any of the following side effects occur: 
• 
Less common or rare 
• 
Sore throat  
• 
unusual bleeding or bruising  
• 
unusual tiredness or weakness  
• 
Symptoms of overdose 
• 
Clumsiness or unsteadiness  
• 
convulsions (seizures)  
• 
drowsiness (severe)  
• 
dryness of mouth, nose, or throat (severe)  
• 
feeling faint  
• 
flushing or redness of face  
• 
hallucinations (seeing, hearing, or feeling things that are not there)  
• 
shortness of breath or troubled breathing  
• 
trouble in sleeping  
9.3 
Mitigation of Risks  
These risks have been mitigated by utilizing qualified clinical Investigators who have training 
and are experienced in wrinkle reduction procedures and following study treatment procedures.  
In addition, risks are mitigated by including only those subjects that meet the study eligibility 
criteria. This study also includes evaluation of study subject satisfaction with this procedure. 
Given that the anticipated risks have been mitigated to an acceptable level, the benefits of using 
the Renuvion Dermal System for use in dermal skin resurfacing outweigh the reasonable risks. 

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10 
STUDY MANAGEMENT/COMPLIANCE/ QUALITY ASSURANCE 
10.1 
Protocol Deviation Reporting 
A protocol deviation is an event in which the investigator or site personnel did not conduct the 
study in accordance with the protocol or the Clinical Trial Agreement.  Prior approval by the 
Sponsor is expected in situations where the Investigator anticipates, contemplates, or makes a 
conscious decision to deviate.  Prior approval is not required when a deviation is necessary to 
protect the life or physical well-being of a subject in an emergency.  Prior approval is not expected 
in situations where unforeseen circumstances are beyond the Investigator’s control (e.g. 
inadvertent errors, product failure, or inability to perform required procedures due to subject’s 
illness).   
All protocol deviations are to be reported to the Sponsor, along with the justification for the 
deviation, on the Protocol Deviation CRF.  Protocol deviations should be reported as soon as 
possible upon center notification of the deviation.   
10.2 
Discontinuation of Study Subjects 
A subject may discontinue from the study at any time without any penalty or loss of benefits to 
which the subject is otherwise entitled. An Investigator may also discontinue a subject from the 
study without the subject’s consent, if the Investigator feels it is in the best medical interest of the 
subject.  The date and the reason for study withdrawal will be indicated on the Study Exit CRF.  
Every effort should be made to contact subjects lost to follow-up, and all such efforts should be 
documented in the subject’s file. 
10.3 
Supply of Study Materials 
Each clinical site will be provided with the investigational devices. A Device Accountability Log 
will be used to track the receipt, use and return of study devices at each study site. All 
investigational devices will be returned to study Sponsor after enrollment of all subjects. Study 
Sponsor will provide appropriate packaging and shipping instructions to the study sites. 
10.4 
Device Malfunction/Observations 
All malfunctions of, or defects of the delivery system will be recorded on the Device 
Malfunction/Observation Case Report Form and reported to the Sponsor by the investigational 
sites.  This will include situations where the delivery system did not perform as intended; user 
errors; study device/component being physically defective, including out of the box failure.   
10.5 
Monitoring 
It is the responsibility of the study Sponsor to ensure that proper monitoring of this clinical 
investigation is conducted.  Appropriately trained personnel appointed by the Sponsor will 
conduct monitoring activities, as needed, and ensure that the investigation is conducted in 
accordance with the study protocol, the Clinical Trial Agreement, applicable laws and regulations, 
including ICH GCP, and overseeing IRBs. 

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Prior to study initiation at each investigational site, approval to enroll subjects will be given by 
the Sponsor and/or designee.   
The Sponsor will determine frequency and timing of interim or periodic monitoring visits for each 
site based on enrollment rate, volume, study compliance, and findings from previous visits.  Each 
enrolling site will be visited at least annually.  Remote monitoring will be conducted to manage 
study data between site visits.  During a monitoring visit, the Monitor will evaluate the site’s 
compliance with regulatory and protocol requirements, verify data recorded on CRFs to available 
source documents, etc.  
In addition, the Monitor will check whether all AEs and SAEs have been reported appropriately 
within the time periods required. 
Data Clarification Forms (DCFs) will be created for identified errors on CRFs that have been 
submitted to the Sponsor to ensure errors/omissions are corrected.  New and previous findings 
and recommended corrective and preventative actions, if they exist, will be communicated with 
the study staff during the visit, and will also be addressed in a final letter that will be sent to the 
Investigator after the visit.  
10.6 
End of Study 
The end of study will be defined as completion of all study visits by all enrolled subjects. If a 
device-related AE, SAE, or unanticipated serious device-related effect is ongoing at the final 
study visit, the subject will be followed until resolution, until the condition stabilizes, until the 
event is otherwise explained, or the subject is lost to follow-up.  
Study closure visits may be conducted at all clinical sites in order to review record retention 
requirements, device disposition requirements, etc., with site personnel.  The Sponsor may choose 
to conduct the closure visit via telephone contact if appropriate. 
10.6.1 Premature Termination/Suspension of the Study or a Study Site 
The study or parts of the study may be prematurely terminated or suspended by the 
Sponsor. This discontinuation may be based on a significant number of AEs of a similar 
nature that warrant such action. Furthermore, the study may be prematurely ended if the 
regulatory authority or the IRB make a recommendation to terminate or suspend approval 
for the study, the study site, or the Investigator. 
 
If the study is prematurely terminated or suspended for any reason, the investigator must 
inform the subjects and assure appropriate follow-up treatment. Within the timeframes 
noted in applicable regulations, the Sponsor will promptly inform the investigators, study 
sites, the IRB, and regulatory authorities of the termination or suspension of the study, as 
appropriate 
10.7 
Audits / Inspections 
The Sponsor, their designee, and the reviewing IRB may monitor or audit the study centers. 
Likewise, regulatory authorities may inspect Sponsor or CRO files or any study center to evaluate 
the conduct of the study. The Investigator must allow access to the subject files and inspection of 
their clinical research protocol procedures when requested.   
 

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11 
STATISTICAL METHODOLOGY 
This section describes the statistical analyses foreseen at the time of study planning. For more 
detail please refer to the Statistical analysis plan. 
 
Any deviations from planned analyses, the reasons for such deviation, and all alternative or 
additional statistical analyses that may be performed before database close will be summarized in 
the Clinical Study Report. 
 
Full details of planned statistical analyses will be outlined in a separate Statistical Analysis Plan 
(SAP) for the study. 
11.1 
Determination of Sample Size 
The objective of this study is to demonstrate response to treatment with the Renuvion Dermal 
System. The IPR will assess each subject image and assess using the FWS.  The proportion of 
subjects achieving at least a one-point improvement in 2 out of 3 IPR assessors will be calculated; 
this is the proportion of treatment successes.  
 
The sample sizes were estimated using PASS 20191 with the following inputs: 
• A performance goal (PG) of 50% success; 
• A one-sample, one-sided t-test against the PG; 
• α = 0.05; 
• Power = 90%; 
• Renuvion success proportions (P) of 70%; 
• Test is Fisher’s Exact Test. 
 
Table 5: Numeric Results for Testing One Proportion using the Exact Test 
Table 5: Numeric Results for Testing One Proportion using the Exact Test 
Alternative Hypothesis: One-Sided (H0: P ≤ P0 vs. H1: P > P0) 
Power 
N 
Performance 
Goal (PG) 
Renuvion 
Proportion 
Δ = 
Renuvion 
- PG 
Alpha 
Reject Ho if 
Successes >  
0.90 
50 
0.5 
0.70 
0.20 
0.05 
32 
 
The 50 subjects will be augmented by 10% to 55 subjects to accommodate dropouts and losses to 
follow-up. 
 
11.2 
Performance Goal Rationale 
A performance goal of 50% will be used for testing.  A performance goal of 50% is clinically 
relevant to ensure that there are significant benefits of the procedure to outweigh its risk.  The 
lower bound of the confidence interval of the proportion of subject achieving treatment 
 
1 PASS 2019 Power Analysis and Sample Size Software (2019). NCSS, LLC. Kaysville, Utah, USA, 
ncss.com/software/pass. 

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successes will be compared against this Performance Goal.  This primary effectiveness endpoint 
definition and performance goal have been used in prior clinical studies to support their 510(k) 
clearances (i.e., eTwo Skin Treatment System, cleared under K141507 on December 8, 20142). 
Moreover, the expected Renuvion proportion used to determine the study sample size is within 
the observed results range of the clinical studies conducted to support this indication for other 
FDA cleared devices (e.g., Picosure Workstation, cleared under K140719 on May 23, 20163 and 
the eTwo Skin Treatment System mentioned above). 
11.3 
Analysis Sets 
The full analysis dataset will be used in our main analyses. 
 
Full Analysis Dataset (Intent-to-Treat Sample, ITT) 
Participants enrolled in the study who had baseline photographs taken will be included. 
Those with missing data items at 90-day visit will be imputed using multiple imputation. 
The primary efficacy endpoints will use this data set.  The primary safety endpoint will 
also use this data set, but without multiple imputation.  The reason is that the analysis 
method takes into account missing data (see the Analysis section below). 
 
Modified Analysis Datasets (modified Intent-to-Treat Samples, mITT) 
Participants enrolled in the study who had baseline data and endpoint data will be 
included. No imputation will be done for missing endpoints unless there is evidence that 
the endpoint is missing for cause. The Secondary and Additional endpoints will use these 
datasets.  The reason that there are more than one mITT data set is that the data set is 
dependent upon the endpoint in questions; only those subjects with baseline and endpoint 
data for that endpoint will be included in the analysis. 
 
Per Protocol Dataset (Per-Protocol Sample, PP) 
This will be a subset of the full analysis dataset comprising participants without major 
protocol deviations. Participants with major protocol deviations will be identified at the 
data review meeting that takes place before database lock. If the primary effectiveness 
endpoint is not met, it will be repeated on the PP data set. 
11.3 
Other Data Issues  
11.3.1 Discontinuations and Missing Data 
The primary endpoints will be tested or estimated using the full (ITT) sample, with 
missing endpoints will be multiply imputed. Secondary and Additional endpoints will use 
the mITT data sets. 
11.4 
Safety Endpoints 
An interim safety report of 30-day safety data including analysis of treatment data, adverse 
events, and pain scores will be completed. 
 
2 https://www.accessdata.fda.gov/cdrh_docs/pdf14/K141507.pdf 
3 https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140719.pdf 

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11.4.1 
Primary Safety Endpoint 
The primary safety endpoint is the enumeration of each subject’s adverse events (AE) up to the 
90-day visit after treatment.  Each AE will be categorized by cause, severity, seriousness, and 
relatedness to the procedure, the device, and the therapy.  
11.4.2 
Secondary Safety Endpoint 
The secondary safety endpoint is the evaluation of the change in pain and discomfort after 
treatment (baseline, within 60 minutes following the procedure) experienced in the period up to 
the 10-day follow-up visit.  Pain or discomfort will be recorded daily by each participant in a 
diary using an 11-point Visual Analogue Scale (VAS). 
11.5 
Effectiveness Endpoints 
11.5.1 
Primary Effectiveness Endpoint 
Primary Effectiveness Endpoint 
On each subject, the appearance of facial wrinkles and rhytides at baseline and the 90-day images 
will be assessed by three blinded Independent Photographic Reviewers using the FWS.  Each 
subject will have three change scores; if 2 or more of the 3 change scores are one point or higher, 
the subject will be considered a success (Y or 1) and if 2 or more of the 3 change scores are less 
than one point, the subject will be considered a failure (N or 0). 
11.6 
Additional Endpoints 
Other endpoints to be evaluated include: 
 
1. Whether or not (Yes/No) at least 2 out of 3 blinded Independent Photographic 
Reviewers (IPRs) correctly identify the 90-day image of a subject from the pair of 
baseline and 90-day images.  
2. Magnitude of improvement measured by the mean change in FWS from baseline 
to 90-day visit as determined by the Investigators. 
3. Subject modified GAIS at 90-day FUV. 
4. Investigator modified GAIS at 90-day FUV. 
5. Subject satisfaction with procedure recorded at the 90-day visit. 
6. Achievement of re-epithelialization by facial zone and across all facial zones at the 
10 day, 30-day and 90-day follow-up visits as reported by the investigator. 
7. Mean duration until study subject feels comfortable going in public after treatment 
as reported by the study subject.  
11.7 
Statistical Analysis of Safety Endpoints 
All statistical analyses will be described in detail in an accompanying statistical analysis plan 
(SAP).  
 
Primary Safety Endpoint 
Adverse event rates will be estimated using Kaplan-Meier time-to-event analyses.  The monthly 
event rates and their 95% confidence intervals (CIs) will be reported by their type, severity, and 
relationship to the study procedure, device, and therapy. 

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Secondary Safety Endpoint 
The mean VAS score will be reported at each measurement along with it 95% CI, its SD and its 
minimum and maximum.  The change from baseline will be similarly reported.    
 
11.8 
Statistical Analysis of the Effectiveness Endpoint 
All statistical analyses will be described in detail in an accompanying statistical analysis plan 
(SAP).  
 
For the primary effectiveness endpoint, the proportion of successful patients (P) will be tested 
against the PG. If the lower bound of the 95% confidence interval of the proportion of subject 
achieving treatment successes is greater than the Performance Goal, the effectiveness endpoint 
would be met. The statistical test will be a one-sided Fisher’s Exact Test at α = 0.05.  For the 
effectiveness endpoint to be met, Ho must be rejected. 
 
Ho:  P < 50%      vs.    Ha:  P > 50% 
 
11.9 
Statistical Analysis of Additional Endpoints 
These analyses will be described in the accompanying SAP. 
11.10 Subgroup Analysis 
Subgroup analyses will include modeling (using linear regression analysis) the effect of on age, 
gender, race/ethnicity, and Fitzpatrick Skin Scale (FSS) on the ∆FWS. (Age et al are called 
“independent variables”.) The goal is to determine whether certain types of subjects are more 
likely to have a better response than other types.  If any of the independent variables are 
significant, the effect size and better responders will be reported.  This is examined in greater 
depth in the SAP. 
 
 

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12 
DATA HANDLING AND RECORDKEEPING 
12.1 
Investigator Records 
The Investigator is responsible for the preparation, review, signature, and retention of the records 
listed below: 
• signed Clinical Trial Agreement and Curriculum Vitae  
• all correspondence pertaining to the investigation with other investigators, the reviewing 
IRB, the study Sponsor, the Monitor and FDA, 
• investigational device receipt, use and disposition records, 
• subject case history records relating to use of the device, including Case Report Forms, 
medical records, progress notes, nurses’ notes, etc., 
• all signed informed consent forms, 
• all shipping and disposition records for investigational devices and relevant observations 
relating to the device, and 
• the protocol and documentation of date and reason for any deviation from 
investigational plan. 
Records are subject to FDA inspection and must be retained for a period of at least two years after 
the latter of two dates:   
1. date on which the investigation is terminated or completed, or  
2. date that the records are no longer required for purposes of supporting an 
application to the FDA to market the device. 
12.2 
Investigator Reports 
The Investigator is responsible for the preparation, review, signature, and submission of the 
reports listed in Table 6.  These are also subject to the FDA inspection and the retention 
requirements described above for the Investigator’s Records. 

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Table 6: Required Investigator Reports 
Table 6: Required Investigator Reports  
Report  
Submit to 
Description 
Unanticipated Adverse 
Device Effect (UADE) 
Sponsor and IRB 
The Investigator must submit to the Sponsor 
and reviewing IRB a report of any UADE as 
soon as possible but not less than 10 working 
days after the Investigator first learns of the 
effect. 
Withdrawal of IRB 
Approval 
Sponsor 
The Investigator must report a withdrawal of 
the reviewing IRB approval within 5 
working days. 
Progress Report 
Sponsor, Monitor 
and IRB 
The Investigator must submit this report at 
regular intervals, but not less than once per 
year to the IRB, Sponsor and Monitor.  
Deviation from 
Protocol in Emergency  
Sponsor and IRB 
Deviation from the study protocol that is 
made to protect the life or physical well-
being of a subject in an emergency situation 
must be reported within 5 working days after 
the emergency occurred.  
Deviation from 
Protocol that affect the 
scientific soundness of 
the study plan or the 
rights, safety or welfare 
of human subjects 
Sponsor 
Prior approval by the Sponsor is required 
when a deviation of this nature is anticipated. 
 
 
Failure to obtain 
informed consent 
Sponsor and IRB 
If a study device was used without obtaining 
informed consent, the Investigator must 
notify the Sponsor and IRB within 5 working 
days of the use of the device.    
Final Report 
Sponsor and IRB 
The Investigator must submit this report to 
the Sponsor and IRB within 3 months after 
the termination or completion of the study, or 
after the Investigator’s participation in the 
study is complete.   
 
12.3 
Data Management Responsibilities 
Data collection is the responsibility of the study staff at the site under the supervision of the site 
Principal Investigator.  During the study, the Investigator must maintain complete and accurate 
documentation for the study.   
 

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Data management and oversight is the responsibility of the Sponsor or Sponsor representative.  
Responsibilities include, but are not limited to, the following:   
• Clinical strategy and oversight 
• Clinical study operations 
• File management and study documentation 
• Site initiation visits and study close-out visits 
• Clinical quality assurance 
• Statistical support and programming 
• Data management, including database development and programming and electronic 
data capture (EDC) programming, training, and management 
 
Additionally, management and oversight of photographic imaging is the responsibility of 
Canfield Scientific.  Responsibilities include, but are not limited to, the following:  
• Providing photographic equipment and supplies as well as installation and training at 
each investigational site 
• Project management of photographic imaging throughout the investigation 
• Preparation of the User Manual for use during the study to ensure consistent serial 
photography is achieved  
• Monitoring and quality review of incoming images 
• Digital image management and storage 
• Management of all independent photographic panel review activities, including sourcing 
and contracting independent reviewers, facilitating reviews, and transferring the data per 
an approved Data Transfer Agreement 
 
12.4 
Data Capture Methods 
Data will be recorded on Paper Data Capture forms, then transcribed into an Electronic Data 
Capture (EDC) system and saved in that system as an electronic case report form (eCRF).   
 
Photographic images will be captured utilizing the Canfield Scientific Visia-CR system as 
specified in the Canfield User Manual for the study. 
 
13 
PUBLICATION POLICY 
The publication policy will be in accordance with the Investigator Agreement with each Principal 
Investigator or similar agreement. 
 
 
 

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14 
REFERENCES 
1. Ganceviciene R,  Liakou A,  Theodoridis A, Makrantonaki E,  and Zouboulis C. Skin anti-
aging strategies, Dermatoendocrinol. 2012 Jul 1; 4(3): 308–319.  
 
2. Hruza G, Taub AF, Collier SL, Mulholland SR. Skin rejuvenation and wrinkle reduction using 
a fractional radiofrequency system. J Drugs Dermatol. 2009;8(3):259–265. 
 
3. Mulholland RS, Ahn DH, Kreindel M, Paul M. Fractional Ablative Radio-Frequency 
Resurfacing in Asian and Caucasian Skin: A Novel Method for Deep Radiofrequency 
Fractional Skin Rejuvenation. Journal of Cosmetics, Dermatological Sciences and 
Applications. 2012;2(3):144–150. 
 
4. Loesch M, Somani A, Kingsley MM, Travers J, Spandau D. Skin resurfacing procedures: 
new and emerging options. Clin Cosmet Investig Dermatol. 2014; 7: 231–241. 
5. Alster TS, Konda S. Plasma Skin Resurfacing for Regeneration of Neck, Chest, and Hands: 
Investigation of a Novel Device. Dermatol Surg. 2007;33(11):1315–1321. 
6.    Heinlin J, Isbary G, Stolz W, et al. Plasma applications in medicine with a special focus on 
       dermatology. J Eur Acad Dermatol Venereol. 2011;25(1):1–11.  
 
7.    Lin MG, Yang TL, Chiang CT, et al. Evaluation of dermal thermal damage by multiphoton    
       autofluorescence and second-harmonic-generation microscopy. J Biomed 
Opt.2006;11(6):064006.  
8.   Foster KW, Moy RL, Fincher EF. Advances in plasma skin regeneration. J Cosmet 
      Dermatol. 2008;7(3):169–179.   
 
9. Bovie Medical Corporation Data on File.   
 
10. Chernoff WG, Slatkine M, Zair E, Mead D. Silktouch: a new technology for skin resurfacing 
in aesthetic surgery.  J Clin Laser Med Surg.  1995;13:97-100. 
 
11. Harris DM, Bell T, From L, Schacter D.  Facial skin resurfacing with a very short pulsed CO2 
laser: beam characteristics and initial histological results.  In: Anderson RR, et al, eds.  Lasers 
in Surgery: Advanced Characterization, Therapeutics, and Systems VII (Proceedings of 
Society Photo-Optical Instrumentation Engineers). Bellingham, Wash: SPIE-The 
International Society for Optical Engineering; 1996;267:211-218. 
 
12. Pedroso J, Gutierrez M, Volker W. J-Plasma, monopolar pencil, argon beam and CO2 laser 
electrosurgery: comparative evaluation of thermal spread in a porcine tissue model (White 
Paper). Bovie Medical Corporation. June 2014.  
 
13. EndyMed Medical Ltd., De Novo Classification Request for NewaTM: Submission Number: 
DEN150005. January 16, 2015. 
 

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15 
APPENDICES 
 
 

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Appendix A:  Sample Visual Analog Scale (VAS) 
 
 

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Visual Analog Scale (VAS):  Study subjects will use the visual numeric scale below to 
determine the level of pain/discomfort they are experiencing pre-procedure and post-procedure 
 
 
 
 
 
 
 
 

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Appendix B:  Sample Modified Global Aesthetic Improvement Scale (GAIS) Evaluation - 
Investigator 
 
 

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Modified Global Aesthetic Improvement Scale (GAIS) Evaluation - Investigator 
Rating 
Description  
Very much 
improved 
Optimal cosmetic result from this procedure in this subject 
Much improved 
Marked improvement in appearance from the initial condition, but 
not completely optimal for this subject 
Improved 
Obvious improvement in appearance from the initial condition 
No change 
The appearance is essentially the same as the original condition 
Worse  
The appearance is worse than the original condition 
Much worse 
The appearance is much worse than the original condition 
Very much worse 
The appearance is very much worse than the original condition 
 
 
 
 
 
 
 
 

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Appendix C:  Sample Modified Global Aesthetic Improvement Scale (GAIS) Evaluation - 
Subject 
 
 
 
 

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Subject Global Aesthetic Improvement Scale (GAIS) Evaluation - Subject 
Rating 
Very much improved 
□ Optimal cosmetic result. 
Much improved 
□ Marked improvement in appearance from the initial condition, 
but not completely optimal. 
Improved 
□ Obvious improvement in appearance from initial condition. 
No change 
□ The appearance is essentially the same as the original 
condition 
Worse  
□ The appearance is worse than the original condition. 
Much worse 
□ The appearance is much worse than the original condition. 
Very much worse 
□ The appearance is very much worse than the original 
condition. 
 
 

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Appendix D:  Sample Subject Satisfaction Survey 
 
 

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Subject Satisfaction Survey 
1.  Are you happy with your results of the procedure performed on your face?
 Yes   
 
No 
 
2.  Would you recommend the procedure performed on your face to a friend?
 Yes   
 
No 
 
3.  Would you consider having the procedure that was performed on your face  
     performed again?  
 
 Yes   
 No 
 
4.  Which, if any, changes do you see in the area treated?  
 
           a.  Skin Texture Improvement 
 Yes   
 No 
                       b.  Skin Tone Improvement 
 Yes   
 No 
                       c.  Skin Pigmentation Improvement 
 Yes   
 No 
                       d.  Fine Lines & Wrinkles Improvement 
 Yes   
 No 
                       e.  Skin Pore Size Improvement 
 Yes   
 No 
                       f.   Skin Feels Better  
 Yes   
 No 
                       g.  Skin Feels Tighter 
 Yes   
 No 
                       h.  Skin Appears Tighter 
 Yes   
 No 
                       i.   Skin Looks more Radiant  
 Yes   
 No 
                       j.   Skin Appears Brighter 
 Yes   
 No 
                       k.  Skin Seems more Youthful 
 Yes   
 No 
 
                       l.   Other: _______________________________________ 
 
              
                      
  NONE 
 
5.  Since your treatment have you felt…  
 
  a. An improvement in your social life? 
    
 Completely   
 A great deal    
 Somewhat    
 Not much    
 Not at all    
 It is 
worse  
 
  b. An improvement in your family life? 
    
 Completely   
 A great deal    
 Somewhat    
 Not much    
 Not at all    
 It is 
worse  
 
  c. More secure? 
    
 Completely   
 A great deal    
 Somewhat    
 Not much    
 Not at all    
 It is 
worse  
 
    d. An improvement in how people respect you? 
    
 Completely   
 A great deal    
 Somewhat    
 Not much    
 Not at all    
 It is 
worse  
  
  e. An improvement in your mood? 

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 Completely   
 A great deal    
 Somewhat    
 Not much    
 Not at all    
 It is 
worse  
 
  f. An improvement in your daily quality of life? 
    
 Completely   
 A great deal    
 Somewhat    
 Not much    
 Not at all    
 It is 
worse  
 
  g. An improvement in your self-esteem? 
    
 Completely   
 A great deal    
 Somewhat    
 Not much    
 Not at all    
 It is 
worse  
 
  h. More confident? 
    
 Completely   
 A great deal    
 Somewhat    
 Not much    
 Not at all    
 It is 
worse  
 
  i. An improvement in your sensuality? 
    
 Completely   
 A great deal    
 Somewhat    
 Not much    
 Not at all    
 It is 
worse  
 
  j. An improvement in your vitality? 
    
 Completely   
 A great deal    
 Somewhat    
 Not much    
 Not at all    
 It is 
worse  
 
 
Appendix E:  Sample Study Subject Daily Diary

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Apyx Medical Corporation Renuvion Dermal System Study 
SUBJECT DAILY DIARY 
Site ID 
Subject ID 
Procedure Date (DD/MMM/YYYY) 
 
  
 
 
    
    
/
 
 
/
 
 
 
 
 
Instructions: 
 
Please use this Form to gather any complications on your health condition after study procedure.  
Please complete this Form daily for up to 14 days after Procedure until 1st Study Follow-Up Visit (10 Days Follow-up) with the study team.   
 
Use the scale below to determine the level of pain/discomfort that you are experiencing each day in the area treated.  Record your pain score each 
day where 0 means no pain and 10 means the worst pain you can imagine. 
 
 
 
Use these Definitions to describe the degree of any complications you are experiencing each day: 
 
 
Mild: easily tolerated by the patient, causing minimal discomfort and not interfering with everyday activities.  
 
These events generally do not require treatment. 
 
 
 
 
Moderate: sufficiently discomforting to interfere with normal everyday activities.  These events are usually  
 
relieved by simple therapeutic measures. 
 
 
 
 
Severe: prevents normal, everyday activities.  These events may require systemic drug therapy  
 
or other medical treatment. 
 

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Expected device related adverse events with the Renuvion Dermal System include: 
• Pain immediately after the procedure, decreasing substantially by 10 days post-procedure; and  
• Swelling persisting approximately 7-14 days. 
Be sure to include all anticipated adverse events in your daily report as well as any unanticipated complications. 
 
 
Please return this Form at your next study visit. 
 
 
Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
post study 
procedure? 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 
Day 0 
(within 60 
minutes 
following 
procedure) 
 
No □     Yes □ 
 
No □     Yes □ 
DAY 0 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with  
0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary. 
 
Score: _______ 
 
  
 
Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
post study 
procedure? 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 
Day 1 
 
No □     Yes □ 
 
No □     Yes □ 

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DAY 1 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary. 
 
Score: _______ 
 
 
 
Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
post study 
procedure? 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 
Day 2 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 2 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 
 
 
 
 
 
 
 
Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 

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post study 
procedure? 
Day 3 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 3 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 
 
 
 
 
Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
post study 
procedure? 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 
Day 4 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 4 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 
 
 
 
 
Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 

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post study 
procedure? 
Day 5 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 5 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 
 
 
 
 
Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
post study 
procedure? 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 
Day 6 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 6 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 
 
 
 
 
 

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Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
post study 
procedure? 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 
Day 7 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 7 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 
 
 
 
Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
post study 
procedure? 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 
Day 8 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 8 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 
 
 
 
Date Logged  
(dd/mmm/yy) and 
Any 
Complication 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 

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Subject Initials 
experienced 
post study 
procedure? 
Day 9 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 9 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 
 
 
 
 
 
 
 
Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
post study 
procedure? 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 
Day 10 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 10 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 
 
 

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Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
post study 
procedure? 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 
Day 11 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 11 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 
 
 
 
 
Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
post study 
procedure? 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 
Day 12 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 12 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 
 
 

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Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
post study 
procedure? 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 
Day 13 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 13 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 
 
 
 
 
 
 
Date Logged  
(dd/mmm/yy) and 
Subject Initials 
Any 
Complication 
experienced 
post study 
procedure? 
Description of your complication including  
the degree (mild, moderate, severe*) 
Contacted Study 
Personnel? 
Day 14 
 
No □     Yes □ 
 
 
 
No □     Yes □ 
DAY 14 PAIN SCORE 
Please indicate the number that represents the current level of pain and discomfort associated with the study procedure you are experiencing on this 
day, with 0 representing no pain/discomfort and 10 the worst possible pain/discomfort.  Refer to the pain scale on page 1 of this patient diary 
 
Score: _______ 

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Appendix F:  Renuvion Dermal System Instructions for Use (IFU) 
 
 

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Appendix G:  Facial Zones 

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Zone 1 – Perioral 
 
 
Zone 2 – Periorbital 
 
 
Zone 3 – Forehead 
 
 
Zone 4 – Nose 
 
 
 
 
 
 
Zone 5 – Cheeks 
 
 
 
 
 
 
Zone 6 – Jawline/Mandibular Border