A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma® for Dermal Resurfacing
Phase: NA
Conditions: Facial Wrinkles, Rhytides
Sponsor: Apyx Medical

 
  
  
 
 
A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of 
J-Plasma® for Dermal Resurfacing 
 
Clinical Study Protocol 
 
 
 
Study Protocol No:  VP-1558 
 
Revision No.:         
2 
 
Version Date:            November 5, 2018 
 
Sponsor: 
 
Bovie 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 Bovie 
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.......................................................................................................10 
4.1 Study Objective ................................................................................................................ 10 
4.2 Study Design..................................................................................................................... 10 
4.3 Study Endpoints ................................................................................................................ 10 
4.3.1 Primary Efficacy Endpoint ........................................................................................... 10 
4.3.2 Primary Safety Variable ............................................................................................... 10 
4.3.3 Secondary Efficacy Endpoint ....................................................................................... 10 
4.3.4 Secondary Safety Variable ........................................................................................... 11 
4.3.5 Additional Endpoints .................................................................................................... 11 
4.3.6 Subgroup Analysis ....................................................................................................... 11 
5 INVESTIGATORS SELECTION AND STUDY POPULATION ...........................12 
5.1 Investigator Selection ....................................................................................................... 12 
5.2 Study Population ............................................................................................................... 12 
5.2.1 Inclusion Criteria .......................................................................................................... 12 
5.2.2 Exclusion Criteria ......................................................................................................... 13 
6 STUDY PROCEDURES ...........................................................................................14 
6.1 Informed Consent ............................................................................................................. 14 
6.2 Pre-Procedure ................................................................................................................... 14 
6.3 Study Procedure ................................................................................................................ 14 
6.4 Follow-up Procedures ....................................................................................................... 15 
6.5 Data Collection ................................................................................................................. 16 
6.6 Confidentiality of Data ..................................................................................................... 17 
7 EVALUATION TOOLS ............................................................................................17 
7.1 Fitzpatrick Skin Scale (FSS) ............................................................................................. 17 
7.2 Fitzpatrick Wrinkle and Elastosis Scale (FWS) ............................................................... 17 
7.3 Modified Global Aesthetic Improvement Scale (GAIS) .................................................. 18 
7.4 Re-epithelization and Down Time .................................................................................... 19 
7.5 Visual Analog Scale (VAS) .............................................................................................. 19 
7.6 Subject Diary .................................................................................................................... 19 
7.7 Blinded Identification of 3-Month Images ....................................................................... 20 
8 ADVERSE EVENTS ASSESSMENT REPORTING ...............................................21 
8.1 Adverse Events Evaluation ............................................................................................... 21 
8.2 Adverse Event (AE) Definition ........................................................................................ 21 
8.3 Serious Adverse Event (SAE) Definition ......................................................................... 21 
8.4 Unanticipated Adverse Device Effect (UADEs) Definition ............................................. 22 
8.5 Reporting Requirements ................................................................................................... 22 
8.6 Severity of Adverse Events .............................................................................................. 22 
8.7 Relationship to the Study Device and/or Procedure ......................................................... 22 
9 RISK AND BENEFITS .............................................................................................23 
9.1 Benefits ............................................................................................................................. 23 
9.2 Risks ................................................................................................................................. 23 

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9.3 Mitigation of Risks ........................................................................................................... 24 
10 STUDY MANAGEMENT/COMPLIANCE/ QUALITY ASSURANCE.............25 
10.1 Protocol Deviation Reporting ........................................................................................... 25 
10.2 Discontinuation of Study Subjects.................................................................................... 25 
10.3 Supply of Study Materials ................................................................................................ 25 
10.4 Device Malfunction/Observations .................................................................................... 25 
10.5 Monitoring ........................................................................................................................ 25 
10.6 End of Study ..................................................................................................................... 26 
10.6.1 
Premature Termination or Suspension of the Study or a Study Site ................... 26 
10.7 Audits / Inspections .......................................................................................................... 26 
11 STATISTICAL METHODOLOGY ......................................................................27 
11.1 Determination of Sample Size .......................................................................................... 27 
11.2 Analysis Sets..................................................................................................................... 27 
11.2.1 
Full Analysis Set (FAS) ....................................................................................... 27 
11.2.2 
Per Protocol Set (PPS) ......................................................................................... 27 
11.3 Endpoints for Analysis ..................................................................................................... 28 
11.3.1 
Primary Efficacy Endpoint ......................................................................... 28 
11.3.2 
Secondary Efficacy Endpoint ..................................................................... 28 
11.4 Statistical Analysis for Safety Variables .......................................................................... 28 
11.4.1 
Primary Safety Variable .............................................................................. 28 
11.4.2 
Secondary Safety Variables ........................................................................ 28 
11.5 Additional Endpoints ........................................................................................................ 28 
11.6 Statistical Analysis for Efficacy and Additional Endpoints ............................................. 29 
11.7 Subgroup Analysis ............................................................................................................ 30 
11.8 Other Statistical/Analytical Issues .................................................................................... 30 
11.8.1 
Discontinuations and Missing Data ............................................................ 30 
12 DATA HANDLING AND RECORDKEEPING ..................................................32 
12.1 Investigator Records ......................................................................................................... 32 
12.2 Investigator Reports .......................................................................................................... 32 
12.3 Data Management Responsibilities .................................................................................. 33 
12.4 Data Capture Methods ...................................................................................................... 34 
13 PUBLICATION POLICY .....................................................................................34 
14 REFERENCES ......................................................................................................35 
 
APPENDICES………………………….……………………………………………………33 
 
 
 
List of Tables 
 
Table 1: Study Required Procedures ......................................................................................... 16 
Table 2: Fitzpatrick Skin Scale Evaluation ............................................................................... 17 
Table 3: Fitzpatrick Wrinkle and Elastosis Scale ...................................................................... 18 
Table 4a: Modified Global Aesthetic Improvement Scale Evaluation (GAIS): Investigator .... 18 
Table 4b: Modified Global Aesthetic Improvement Scale Evaluation (GAIS): Subject ........... 18 
Table 5: Required Investigator Reports ..................................................................................... 32 
 
List of Appendices 
 
Appendix A:  Sample Case Report Forms 
 
Appendix B:  Sample Informed Consent Form 
 
Appendix C:  Subject Diary 
 
 

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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 
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 J-
Plasma® for Dermal Resurfacing 
Study Device 
J-Plasma® 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 efficacy of the J-Plasma® 
system for use in dermal skin resurfacing. 
Study Design 
 
This is a multi-center, single arm, evaluator-blind prospective study of 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 J-Plasma® at enrollment. Follow-up will 
occur immediately following the procedure, at 10 days, 1, 3, and 6 months after 
enrollment. 
Study 
Endpoints 
 
Primary Efficacy Endpoint is the comparison of the proportion of subjects (i.e. 
percentage of treatment responders) with a ≥ 1-score improvement on the FWS at 
the 3-month visit, as compared to baseline as determined by at least 2 out of 3 
blinded Independent Photographic Reviewers.  The study design assumes a 75% 
success rate of subjects with treated wrinkles with a ≥ 1-score change on the FWS; 
therefore, greater than 75% of subjects must be rated with a ≥ 1-score 
improvement 3 months after treatment and must be statistically significantly 
greater than 75%. 
 
Primary Safety Variable is the evaluation of adverse events up to the 3-month 
visit after treatment. 
 
Secondary Efficacy Endpoint:  
Subjects with a ≥ 1-score improvement on the FWS and at least a self-reported 
“improved” rating on the modified GAIS at the 3-month visit will be considered to 
have an aesthetic pleasing outcome. The modified GAIS is a measure of aesthetic 
improvement relative to the baseline, pre-treatment condition. 
 
Secondary Safety Variable is the evaluation of the pain and discomfort after 
treatment as reported by the subject on a visual analog scale (VAS). 
Additional  
Endpoints 
• 
FWS ≥ 1-score improvement and ≥ 75% agreement with at least an 
“improved” rating by the subject on the modified GAIS.  
• 
Magnitude of improvement measured by the mean change in FWS from 
baseline to 3 months visit. 
• 
Subject satisfaction with procedure recorded at the 3-month visit. 
• 
Achievement of re-epithelialization by facial zone and across all facial zones 
at the 10 day, 1-month and 3-month follow-up visits as reported by the 
investigator. 
• 
Mean duration until study subject feels comfortable going in public after 
treatment as reported by the study subject.  
• 
Daily 10-point Visual Analog Scale (VAS) pain assessment following 
treatment through the 10 day follow-up visit by diary day with a change from 
the VAS pain score at baseline. 

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• 
The proportion of subjects (i.e. percentage of treatment responders) with 
correctly identified 3-month images, in comparison to baseline, as determined 
by at least 2 out of 3 blinded Independent Photographic Reviewers.  
 
Planned Study 
Period 
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. 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-
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 determined, and a final report will 
be prepared. 
2 
STUDY ADMINISTRATIVE STRUCTURE 
 
Study Sponsor:                    Bovie Medical Corporation 
5115 Ulmerton Road 
Clearwater, FL  33760-4004  
Phone:  (800)537-2790 
Fax:  (800)323-1640 
Clinical Research  
Organization (CRO):   
NAMSA 
400 Hwy 169 South, STE 500 
Minneapolis, MN 55426 
 
 
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 representation 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 efficacy 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 

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pores, pigmented lesions, acne, telangiectasias, and scarring from trauma or acne. Subject 
recovery and 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, Bovie Medical Corporation has 
developed the J-Plasma® 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 J-Plasma® system consists of an electrosurgical generator unit (ESU, Figure 1), a handpiece 
(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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Bovie Medical Corporation’s J-Plasma® 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 J-Plasma® to other energy sources such as CO2 laser and RF 
energy demonstrated less or comparable lateral and depth of thermal spread for J-Plasma® in 
porcine peritoneum, bladder, and small intestine[12].   
Additionally, a pre-clinical study comparing J-Plasma® to the Rhytec Portrait PSR for ablation 
of porcine dermis was conducted to evaluate performance the J-Plasma®.  Four animals were 
utilized in the study to evaluate both devices at acute and chronic time points.  At the acute time 
point, J-Plasma using 1 pass at both 20% and 40% power was very similar to the results 
observed with the Rhytec system at PSR2 and PSR3 settings.  At the chronic time point, dermal 
changes with the J-Plasma® appeared to extend deeper into the dermis than that observed with 
the Rhytec treated tissue, which may be beneficial and possibly demonstrate superior 
performance.  These results support the safety of J-Plasma® for this application and equivalent 
tissue effects for the two technologies.   
These pre-clinical study results demonstrate safety and efficacy of the J-Plasma® system in the 
ablation of soft tissue within its current FDA cleared indications in an animal model, therefore 
making the J-Plasma® system a viable technology for dermal skin resurfacing. 
 
 
 
Figure 1: Electrosurgical generator unit 
Figure 2: Handpiece  

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4 
STUDY DESIGN  
4.1 
Study Objective 
The study objective is to demonstrate the safety and efficacy of the J-Plasma® system for use in 
dermal skin resurfacing.  
4.2 
Study Design 
This is a multi-center, single arm, evaluator-blind prospective study of 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. 
 
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 J-Plasma® on applicable 
facial zones to reduce wrinkles and rhytides.   
Study subjects will be followed immediately following the procedure, at 10 days, 1, 3, and 6 
months post-procedure 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 3 month post-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 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 Efficacy Endpoint 
The primary efficacy endpoint is the comparison of the proportion of subjects (i.e. 
percentage of treatment responders) with a ≥ 1-score improvement on the FWS at the 3-
month visit, as compared to baseline as determined by at least 2 out of 3 blinded 
Independent Photographic Reviewers.  The study design assumes a 75% success rate of 
subjects with treated wrinkles with a ≥ 1-score change on the FWS; therefore, greater 
than 75% of subjects must be rated with a ≥ 1-score improvement 3 months after 
treatment and must be statistically significantly greater than 75%. 
4.3.2 
Primary Safety Variable 
The primary safety variable is the evaluation of adverse events up to the 3-month visit 
after treatment. 
4.3.3 
Secondary Efficacy Endpoint 
Subjects with a ≥ 1-score improvement on the FWS and at least a self-reported 
“improved” rating on the modified GAIS at the 3-month visit will be considered to have 

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an aesthetic pleasing outcome. The modified GAIS is a measure of aesthetic 
improvement relative to the baseline, pre-treatment condition.   
 
4.3.4 
Secondary Safety Variable 
The secondary safety variable is the evaluation of the pain and discomfort after 
treatment as reported by the subject on a visual analog scale (VAS). 
4.3.5 
Additional Endpoints 
Other endpoints to be evaluated include: 
 
1. FWS ≥ 1-score improvement and ≥ 75% agreement with at least an “improved” 
rating by the subject on the modified GAIS. The modified GAIS is a measure of 
aesthetic improvement relative to the baseline, pre-treatment condition. 
2. Magnitude of improvement measured by the mean change in FWS from baseline to 
3 months visit. 
3. Subject satisfaction with procedure recorded at the 3-month visit. 
4. Achievement of re-epithelialization by facial zone and across all facial zones at the 
10 day, 1-month and 3-month follow-up visits as reported by the investigator. 
5. Mean duration until study subject feels comfortable going in public after treatment 
as reported by the study subject. 
6. Daily 10-point Visual Analog Scale (VAS) pain assessment following treatment 
through the 10 day follow-up visit by diary day with a change from the VAS pain 
score at baseline. 
7. The proportion of subjects (i.e. percentage of treatment responders) with correct 
identification of 3-month images, in comparison to baseline, as determined by at 
least 2 out of 3 blinded Independent Photographic Reviewers.  
 
4.3.6 
Subgroup Analysis 
Subgroup analyses will include stratifying the primary endpoint, (percent treatment 
responders on FWS), on age, gender, race/ethnicity, and Fitzpatrick Skin Scale (FSS).  
Additionally, the degree of improvement on FWS (e.g. 2, 3 or 4-score improvement) 
will be reported. 
 
 

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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 
Bovie 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, meet all study criteria, and have undergone a procedure with the J-
Plasma system.  
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 2 on the FWS as determined by 
the investigator. 
4. Subject with a Fitzpatrick Skin Scale score ≤III. 
5. Subject is willing and able to provide written informed consent. 
6. Subject is willing and able to comply with protocol requirements, including 
obtaining study-required images/photos and assessments, and returning for follow-
up visits. 
7. Subject is willing to release rights to study Sponsor for the use of the photos, 
including in potential publication. 
8. 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. 

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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 >III. 
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 the past 30 days, Accutane or any medication that can cause 
dermal hypersensitivity. 
6. Subject has a history of autoimmune disease. 
7. Subject with a bleeding disorder or who is on blood thinning medication that may be 
at risk for bleeding.  
8. Subject has a known adverse reaction to anesthetics. 
9. Subjects with active skin disease of the facial area or known connective tissue 
disease. 
10. Subjects with known susceptibility to keloid formation or hypertrophic scarring. 
11. Subjects with present cancerous or pre-cancerous lesions in the area to be treated. 
12. Subject who, for any reason, suspects that they will not be able to complete the 
prescribed follow-up assessment(s); 
13. Subject has had concurrent therapy that, in the investigator’s opinion, would 
interfere with the evaluation of the safety and efficacy of the study treatment 
method. 
14. Subject is not willing to release rights to study Sponsor for the use of the photos, 
including in potential publication. 
15. Subject is enrolled in another investigational (drug or device) clinical trial that can 
interfere with this study’s assessments.  
16. Subject has undergone a facelift procedure or received facial injections within the 
past year. 
 
 

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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 sufficient 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 21 days prior to undergoing 
the study procedure. 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 pre-procedure screening and procedure are not 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 2.3 system (see also Section 12.3 Data Management 
Responsibilities and Section 12.3 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. 
The study subjects may be given medication for the prophylactic treatment of bacterial and viral 
infections including herpes simplex based on investigator’s discretion.  
 
Medications subject is taking upon entry into the study should also be documented in the Case 
Report Forms (CRF). Documentation should include medications 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).  

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Additionally, subjects must complete a VAS pain assessment pre-procedure and immediately 
following the procedure.   
During the study procedure, the face of each subject will be treated by the study investigator 
using J-Plasma® according to the IFU and procedures described in this section. The face will be 
divided into 5 zones: Zone 1 (perioral), Zone 2 (periorbital), Zone 3 (forehead), Zone 4 (nose), 
and Zone 5 (cheeks).  Tumescent (an anesthetic) will be injected under the subject’s skin.  The 
volume of tumescent used in each Zone will be based on the investigator’s discretion and will 
be documented in the CRFs. The plasma beam will be used to ablate the tissue in each Zone 
using slow, but steady movement of the beam. All Zones will be treated with only a single pass 
of the plasma beam. Special care must be taken to not pass over any treated area more than 
once.  Zone 1 (perioral) and Zone 2 (periorbital) will be treated with a maximum of 20% power 
and 4 liters/minute helium flow.  Zones 3, 4, and 5 (forehead, nose, and cheeks, respectively) 
will be treated with a maximum of 40% power and 4 liters/minute of helium flow.  The ablated 
tissue will not be wiped away.   
6.4 
Follow-up Procedures 
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 
Days 0-10: 
• Keep skin moist at all times, use of a cool mist vaporizer on face as much as possible 
is recommended 
• Keep skin covered with a generous layer of petroleum jelly (i.e., Vaseline Petroleum 
Jelly) at all times 
• Perform cool water soaks every 1-2 hours as tolerated on days 0-2, then every 2-4 
hours on days 3-10 
 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 
• After soak is over, pat dry with a clean, soft towel and reapply petroleum jelly 
Days 11 and beyond: 
• Apply light moisturizer and sun protection as directed by the investigator 
 
   
Following the study procedure, subjects will be asked to complete VAS pain assessment and 
return to the study site at 10 days (9-14 days), 1 month (23-37 days), 3 months (80-100 days), 
and 6 months (166-194 days) for post-procedure assessments and to complete questionnaires or 
answer questions asked by study staff.  Additionally, photographs of the treated areas will be 
taken using the Canfield Scientific Visia-CR 2.3 system (see also Section 12.3 Data 
Management Responsibilities and Section 12.3 Data Capture Methods) for each subject to 
document the appearance of their facial wrinkles and rhytides.  Study subjects will also be asked 

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to report complications experienced post-procedure and complete daily VAS 0-10 scale pain 
assessments utilizing the Subject Diary (see Appendix C: 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.  
 
Table 1:  Study Required Procedures  
 
 
Baseline/ 
Pre-
Procedure 
Screening1 
Procedure 
10 Days 
1 mo 
3 mo 
6 mo 
10+4/-1 
days 
30±7 
days 
90±10 
days 
180±14 
days 
Informed Consent 
√ 
 
 
 
 
 
Assess Inclusion/Exclusion Criteria 
√ 
 
 
 
 
 
Urine Pregnancy Test2 
√ 
√ 
 
 
 
 
Medical History 
√ 
 
 
 
 
 
General Physical Exam 
√ 
 
 
 
 
 
Review Medications 
√ 
 
√ 
√ 
√ 
√ 
Photographic Images3 
√ 
 
√ 
√ 
√ 
√ 
Fitzpatrick Skin Scale (FSS) 
√ 
 
 
 
 
 
Fitzpatrick Wrinkle and Elastosis 
Scale (FWS) 4 
√ 
 
√ 
√ 
√ 
√ 
Visual Analog Scale (10-point 
VAS) 5 
 
√ 
√ 
√ 
√ 
√ 
Study Procedure 
 
√ 
 
 
 
 
Subject Diary (10-point VAS)6 
 
√ 
√ 
 
 
 
Adverse Event Assessment  
 
√ 
√ 
√ 
√ 
√ 
Re-epithelization and Down Time7 
 
 
√ 
√ 
√ 
 
Modified Global Aesthetic 
Improvement Scale (GAIS) 8  
 
 
√ 
√ 
√ 
√ 
1 Pre-procedure Screening assessments to take place within 21 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 and Independent Photographic Reviewers (IPRs). 
5 To be completed by the study subject on a day of the procedure (prior to the procedure and immediately following 
the procedure) and at all 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 and/or Independent Photographic Reviewer (as applicable) 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 and study subject at all study follow-up visits. 
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. 

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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 Scale (FSS) 
Assessment of subject’s skin color will be determined prior to study procedure by the 
Investigator using the FSS.  The scale delineates skin color into the categories as shown in 
Table 2.  
 
Table 2: Fitzpatrick Skin 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 subject wrinkles at baseline and follow-up visits will be performed by the 
Investigator and assessment of subject wrinkles at baseline and follow-up visits (excluding the 
10 day follow-up visit) will be performed by three board-certified dermatologists or plastic 
surgeons sourced and managed by Canfield Scientific, 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 12.3 Data 
Capture Methods). The FWS is a clinically validated 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 all applicable follow-up visits) 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 at each time point. 

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Each photograph will have a unique identification number, but they will not be arranged in any 
specific order. 
 
A subject will be considered a success if at least 2 out of the 3 IPRs agree that the subject has 
reached at least one degree of wrinkle score reduction per FWS when comparing the score 
obtained at the 3 month follow-up visit to the baseline wrinkle score.  
 
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. 
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 all follow-up visits.   
 
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 
 
 

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Table 4b: Modified Global 
Aesthetic Improvement Scale 
Evaluation (GAIS): Subject 
Rating 
Very much 
improved 
□ 
Much improved 
□ 
Improved 
□ 
No change 
□ 
Worse  
□ 
Much worse 
□ 
Very much worse 
□ 
 
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:  
1. Achievement of Re-epithelization - determine percentage epidermal recovery per 
treatment zone at all 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 10 day follow-up visit). 
7.5 
Visual Analog Scale (VAS) 
The study subjects will be asked to complete a 10-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 all follow-up visits. Additionally, the subjects 
will be asked if they would recommend the treatment to friends and acquaintances (yes, 
perhaps, or no) 
 
Scoring 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 C: Subject Diary) starting 
from the procedure date (after study procedure, at home) until the 10 day follow-up visit to 
complete daily 10-point VAS pain assessments and document any complications they have 
experienced.  
 

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7.7 
Blinded Identification of 3-Month Images 
Assessment of each subject’s baseline and 3-month follow-up images viewed simultaneously 
will be performed by the Independent Photographic Reviewers 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 3-month 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. 
 
A subject will be considered a success if at least 2 out of the 3 IPRs correctly identify the 3-
month images. 
 
 

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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) 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.  
 
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, or 
o Led to fetal distress, fetal death or a congenital abnormality or birth defect.   
 
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. 

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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, 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. 
 

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• 
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.  
 
9 
RISK AND BENEFITS 
9.1 
Benefits  
A possible benefit of using J-Plasma 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  
Potential risks with J-Plasma 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),  
• post-inflammatory hyperpigmentation, 
• telangiectasias, 
• skin overheating/burn, 
• hypertrophic scarring 
• calcification,  
• discoloration/permanent hypopigmentation,  
• loss of correction,  
• vessel laceration or occlusion,  
• abscess 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. 
Additionally, other wrinkle reduction products have shown rare occurrences of the following 
symptoms:  
• systemic events such as flu-like symptoms (such as fever, headache, myalgia, neuralgia, 
nausea, malaise or dizziness),  
• pruritis,  
• shedding, 
• flaking, 

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• scaling, 
• peeling, 
• rash,  
• transient visual disturbances (blurred vision),  
• tingling,  
• numbness,  
• transient polyarthralgia, 
• infection,   
• anaphylactic response (hypotension, difficulty breathing, tightness in chest, and/or 
shortness of breath). 
 
Side effects of Tumescent anesthesia containing lidocaine or epinephrine include: 
• Nausea 
• Vomiting  
• Mild sleepiness 
 
9.3 
Mitigation of Risks  
These risks are 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 the anticipated acceptable risk, the risk-benefit assessment of the use of J-Plasma for use 
in dermal skin resurfacing appears to offer a substantial clinical benefit at a reasonable risk. 
 
 

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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.  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 or 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. 
 
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. 
11.1 
Determination of Sample Size 
The objective of this study is to demonstrate that study participants positively respond to the J-
Plasma® therapy, thus the primary endpoint will be assessed via the percentage of study 
participants that demonstrated an improvement in the FWS from baseline to the 3-month visit.  
An improvement is clinically important when there is ≥ 1-score change.  The planned sample 
size to provide sufficient power for a statistical comparison of the proportion of treatment 
responders (P) versus a reasonable cutoff (P0) was based on a power calculation utilizing the 
(one proportion) binomial exact test based on the following assumptions.  
• 
H0: P ≤ P0 versus Ha: P > P0 
• 
Type I error rate:  α = 0.05 (one-sided) 
• 
Population proportion under the null hypothesis: P0 = 0.75 
• 
Population proportion under the alternative hypothesis: P = 0.90 
• 
Total N: 50 study participants 
 
Based on the above assumptions, the study power is estimated to be approximately 88%. To 
account for possible missing data (up to 10% attrition), a total of 55 subjects will be enrolled.  
Other tests (i.e., a test of the mean improvement of FWS) would be expected to provide more 
power. 
 
One study investigating the effects of radiofrequency energy on the improvement of appearance 
of wrinkles and rhytides (De Novo, NewaTM) utilized a FWS cutoff as 75%, supporting this 
value in the present sample size computation.[13] 
11.2 
Analysis Sets 
The full analysis set (FAS) will be used for analysis of this study. 
11.2.1 
Full Analysis Set (FAS) 
All subjects enrolled in the study who have a FWS value at baseline will be included in 
the FAS.  Subjects with missing FWS data at the 3-month visit will be imputed as no 
change and included in the FAS population. 
11.2.2 
Per Protocol Set (PPS) 
The PPS is the subset of subjects in the FAS without major protocol deviations. Major 
protocol deviations will be decided and finalized at a data review meeting (DRM) that 
will be conducted prior to database lock. The efficacy analyses will be repeated on the 
PP population if there is at least a 10% difference in the number of subjects in the PPS 
and intent-to-treat (ITT) populations. 

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11.3 
Endpoints for Analysis 
11.3.1 Primary Efficacy Endpoint 
The primary efficacy endpoint is the comparison of the proportion of subjects (i.e. 
percentage of treatment responders) with a ≥ 1-score improvement on the FWS at the 3-
month visit, as compared to baseline as determined by at least 2 out of 3 blinded 
Independent Photographic Reviewers.  The study design assumes a 75% success rate of 
subjects with treated wrinkles with a ≥ 1-score change on the FWS; therefore, greater 
than 75% of subjects must be rated with a ≥ 1-score improvement 3 months after 
treatment and must be statistically significantly greater than 75%. 
11.3.2  Secondary Efficacy Endpoint 
Subjects with a ≥ 1-score improvement on the FWS and at least a self-reported 
“improved” rating on the modified GAIS at the 3-month visit will be considered to have 
an aesthetic pleasing outcome. The modified GAIS is a measure of aesthetic 
improvement relative to the baseline, pre-treatment condition. 
11.4 
Statistical Analysis for Safety Variables 
11.4.1 Primary Safety Variable 
The primary safety variable is the evaluation of adverse events up to the 3-month visit 
after treatment. Adverse events reported at each scheduled study visit, as well as adverse 
events self-reported in the Subject Diary (see Appendix C: Subject Diary), will be 
summarized. A descriptive analysis including type, onset after treatment, duration, 
severity, and relationship to study device and/or procedure will be provided. With the 
same descriptive methodology, the duration of adverse events will be summarized with a 
delineation from 0-7 days, 8-14 days, 15-28 days, and more than 28 days. 
11.4.2 Secondary Safety Variables 
The secondary safety variable is the evaluation of the pain and discomfort after 
treatment as reported by the subject on a 10-point visual analog scale (VAS). Results of 
the VAS on a scale of 0 (no pain) to 10 (most severe pain) and the change from baseline 
will be summarized descriptively utilizing mean, standard deviation, minimum, 
maximum, median, and the 95% confidence interval of the mean and mean change from 
baseline.   
11.5 
Additional Endpoints 
Other endpoints to be evaluated include: 
 
1. 
FWS ≥ 1-score improvement and ≥ 75% agreement with at least an “improved” rating by 
the subject on the modified GAIS. The modified GAIS is a measure of aesthetic 
improvement relative to the baseline, pre-treatment condition. 
2. 
Magnitude of improvement measured by the mean change in FWS from baseline to 3-
month visit. 
3. 
Subject satisfaction with procedure recorded at the 3-month visit. 

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4. 
Achievement of re-epithelialization by facial zone (and across facial zones) at the 10-day, 
1-month and 3-month follow-up visits as reported by the study investigator and/or 
Independent Photographic Reviewers (as applicable).  
5. 
Mean duration until subject feels comfortable going in public after treatment as reported 
the study subject. 
6. Daily 10-point Visual Analog Scale (VAS) pain assessments following treatment through 
the 10 day follow-up visit by diary day with a change from the VAS pain score at baseline. 
7.   The proportion of subjects (i.e. percentage of treatment responders) with correct 
identification of 3-month images, in comparison to baseline, as determined by at least 2 out 
of 3 blinded Independent Photographic Reviewers.  
11.6 
Statistical Analysis for Efficacy and Additional Endpoints 
 
Endpoint 
Variable 
Statistical analyses 
Primary efficacy 
endpoint  
 
Percentage of subjects 
with a ≥ 1-score 
improvement on the 
FWS from baseline to 
3-month visit 
The percentage of subjects with a ≥ 1-score improvement 
will be summarized as counts and percentages.  This 
percentage will be compared to the cutoff of 75% using a 
binomial exact test (one-sided). Descriptive upper 95% 
confidence limit will be provided for the difference 
between treatment and cutoff rate and the associated p-
value will also be provided.  
Secondary 
efficacy 
endpoint 
 
Investigator – 
Modified GAIS 
 
 
An “improvement” on the modified GAIS by the treating 
investigator at the 3-month visit will be classified as 
“improved,” “much improved,” or “very much improved.” 
All other ratings on the modified GAIS will be classified 
as “no improvement.” Cross-tabulation of improvement 
status of modified GAIS versus 1-score FWS response 
will then be summarized as counts and percentages. 
Primary safety 
variable 
Adverse event rate 
Adverse event rates (total and categorized by duration) 
will be summarized as counts and percentages.  
Stratification on type, onset after treatment, duration, 
severity, and relationship to study device and/or 
procedure will also be provided. 
Secondary 
safety variable 
Study Subject - 
Pain/Discomfort VAS 
after treatment 
Evaluation of pain and discomfort after treatment (and the 
change from baseline) as reported by the subject on a 10-
point visual analog scale (VAS). Results of the VAS on a 
scale of 0 to 10 will be summarized descriptively utilizing 
mean, standard deviation, minimum, maximum, median, 
and the 95% confidence interval of the mean and mean 
change from baseline.   
Additional 
endpoint #1 
 
Study Subject – 
Modified GAIS 
 
 
An “improvement” on the modified GAIS by the subject 
at the 3-month visit will be classified as “improved,” 
“much improved,” or “very much improved.” All other 
ratings on the modified GAIS will be classified as “no 
improvement.” Cross-tabulation of improvement status of 
modified GAIS versus 1-score FWS response will then be 
summarized as counts and percentages. 
Additional 
endpoint #2 
Mean change in FWS 
from baseline to 3-
Descriptive summary statistics (number of observations, 
mean, standard deviation, minimum, maximum, median, 

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month visit 
95% confidence interval of the mean) will be used for 
summarizing the change in FWS from baseline to the 3-
month visit.  The FWS from baseline to the 3-month visit 
will also be stratified on both the treating-investigator and 
subject modified GAIS. 
Additional 
endpoint #3 
 
Study subject 
satisfaction at 3-month 
visit 
Evaluation of the subject satisfaction as reported by the 
subject on a visual analog scale (VAS). Results of VAS on 
a scale of 0 to 10 will be summarized descriptively 
utilizing mean, standard deviation, minimum, maximum, 
median, and the 95% confidence interval of the mean.  
Cross tabulation of subject satisfaction/improvement 
versus 1-score FWS response will be summarized as 
counts and percentages. 
Additional 
endpoint #4 
 
Achievement of re-
epithelialization by 
facial zone and across 
facial zones after 
treatment 
Descriptive summary statistics (number of observations, 
mean, standard deviation, minimum, maximum, median, 
95% confidence interval of the mean) will be used for 
summarizing the achievement of re-epithelialization by 
facial zone and across facial zones at all   follow-up visits 
through the 3-month visit.   
Additional 
endpoint #5 
 
Mean duration for 
study subject to feel 
comfortable in public 
after treatment 
Descriptive summary statistics (number of observations, 
mean, standard deviation, minimum, maximum, median, 
95% confidence interval of the mean) will be used for 
summarizing the mean duration for study subject to feel 
comfortable after treatment.   
Additional 
endpoint #6 
Study Subject - 
Pain/Discomfort VAS 
after treatment through 
the 10 day follow-up 
visit 
Descriptive summary statistics by diary day (number of 
observations, mean, standard deviation, minimum, 
maximum, median, 95% confidence interval of the mean)   
and the change from the VAS pain score at baseline will 
be provided. 
Additional 
endpoint #7 
Percentage of subjects 
with correct 
identification of 3 
month image 
The percentage of subjects with correct identification of 3-
month images will be summarized as count, percentage, 
and 95% exact binomial confidence interval.  
 
11.7 
Subgroup Analysis 
Subgroup analyses will include stratifying the primary endpoint (percent treatment 
responders on FWS), on age, gender, race/ethnicity, and Fitzpatrick Skin Scale (FSS).  
Additionally, the degree of improvement on FWS (e.g. 2, 3 or 4-score improvement) 
will be reported. 
11.8 
Other Statistical/Analytical Issues 
11.8.1 Discontinuations and Missing Data 
Subjects with missing 3-month FWS data will be imputed as having no change from 
baseline.  No other imputations for missing data will be employed.  Furthermore, no 
estimation of missing data for self-reported pain within the 10 day Subject Diary will be 
imputed. 

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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 5.  These are also subject to the FDA inspection and the retention 
requirements described above for the Investigator’s Records. 
 
Table 5: 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.  

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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.   
 
Electronic Data Capture (EDC) Data management and oversight is the responsibility of North 
American Science Associates, Inc. (NAMSA).  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 

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12.4 
Data Capture Methods 
Electronic Data Capture (EDC) will be utilized in the investigation.  NAMSA is responsible for 
creating the EDC system as well as training all sites and Sponsor on the EDC system, hosting 
the database/servers, and reviewing and correcting the data. 
 
Photographic images will be captured utilizing the Canfield Scientific Visia-CR 2.3 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 
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Appendices