Change in Skin Elasticity After Combined Radiofrequency and Electromagnetic Treatment
Phase: NA
Conditions: Skin Abnormalities
Sponsor: Venus Concept

CHANGE IN SKIN ELASTICITY AFTER 
COMBINED RADIO FREQUENCY AND 
ELECTROMAGNETIC TREATMENT 
Protocol Identifying Number:  CS0316 
Principal Investigator: Monica Chau Kieu, DO 
Sponsor: Venus Concept 
Version Number:  v2.0 
15 November 2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sponsor Contact 
• 
Joseph L. Reiz 
Director of Clinical Research 
Telephone 888-907-0115 x 563  
E-mail:  jreiz@venusconcept.com 
Address: Venus Concept Ltd. 255 
Consumers Rd. Suite 110, Toronto, Ontario. 
M2J 1R4, Canada  
 
__________________________________________________________________ 
 
Signature of Sponsor Representative                     Date:  (DD/MMM/YYYY) 
 

2 
Table of Contents 
LIST OF ABBREVIATIONS ............................................................................................................................................... 5 
STATEMENT OF COMPLIANCE ...................................................................................................................................... 6 
PROTOCOL SUMMARY .................................................................................................................................................. 7 
SCHEMATIC OF STUDY DESIGN ..................................................................................................................................... 8 
1 
KEY ROLES ........................................................................................................................................................ 9 
2  
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ................................................ 9 
2.1 
Background Information ....................................................................................................................... 9 
2.2 
Rationale ............................................................................................................................................. 10 
2.3 
Potential Risks and Benefits ................................................................................................................ 10 
2.3.1 
Known Potential Risks ...................................................................................................... 10 
2.3.2 
Known Potential Benefits ................................................................................................ 10 
3 
OBJECTIVES AND PURPOSE ............................................................................................................................ 10 
4 
STUDY DESIGN AND ENDPOINTS .................................................................................................................... 11 
4.1 
Description of the Study Design .......................................................................................................... 11 
4.2.1 
Primary Endpoint ............................................................................................................. 11 
4.2.2 
Secondary Endpoints ....................................................................................................... 11 
4.2.3 
Exploratory Endpoints ..................................................................................................... 11 
5 
STUDY ENROLLMENT AND WITHDRAWAL ..................................................................................................... 11 
5.1 
Participant Inclusion Criteria ............................................................................................................... 11 
5.2 
Participant Exclusion Criteria .............................................................................................................. 12 
5.3 
Strategies for Recruitment and Retention .......................................................................................... 13 
5.4 
Participant Withdrawal or termination ............................................................................................... 13 
5.4.1 
Reasons for Withdrawal or Termination ......................................................................... 13 
5.4.2 
Handling of Participant Withdrawals or termination ...................................................... 14 
5.5 
Premature Termination or Suspension of Study ................................................................................. 14 
6 
STUDY AGENT ................................................................................................................................................. 14 
6.1 
Study Agent(s) and Control Description .............................................................................................. 14 
6.1.1 
Acquisition ....................................................................................................................... 14 
6.1.2 
Device Specific Considerations ........................................................................................ 14 
6.2 
Study agent Accountability Procedures .............................................................................................. 15 
7 
STUDY PROCEDURES AND SCHEDULE ............................................................................................................ 15 
7.1 
Study Procedures/Evaluations ............................................................................................................ 15 
7.1.1 
Study specific procedures ................................................................................................ 15 
7.2 
Laboratory Procedures/Evaluations .................................................................................................... 15 
7.2.1 
Clinical Laboratory Evaluations ........................................................................................ 15 
7.2.2 
Other Assays or Procedures ............................................................................................. 15 
7.3 
Study Schedule .................................................................................................................................... 15 
7.3.1 
Screening 16 
7.3.2 
Enrollment/Baseline ........................................................................................................ 16 
7.3.3 
Follow-up 18 
7.3.4 
Final Study Visit ................................................................................................................ 20 
7.3.5 
Early Termination Visit ..................................................................................................... 20 
7.3.6 
unscheduled visit ............................................................................................................. 20 
7.3.7 
Schedule of Events Table ................................................................................................. 21 
7.4 
Justification for Sensitive Procedures ................................................................................................. 21 

3 
7.5 
Concomitant Medications, Treatments, and Procedures ................................................................... 21 
7.5.1 
Precautionary Medications, Treatments, and Procedures .............................................. 22 
7.6 
Prohibited Medications, Treatments, and Procedures ....................................................................... 22 
7.7 
Prophylactic Medications, Treatments, and Procedures .................................................................... 22 
7.8 
Rescue Medications, Treatments, and Procedures ............................................................................. 22 
7.9 
Participant Access to Study Agent At Study Closure ........................................................................... 22 
8 
ASSESSMENT OF SAFETY ................................................................................................................................ 23 
8.1 
Specification of Safety Parameters ..................................................................................................... 23 
8.1.1 
Definition of Adverse Events (AE) .................................................................................... 23 
8.1.2 
Definition of Serious Adverse Events (SAE) ..................................................................... 23 
8.1.3 
Definition of Unanticipated Problems (UP) ..................................................................... 23 
8.2 
Classification of an Adverse Event ....................................................................................................... 23 
8.2.1 
Severity of Event .............................................................................................................. 23 
8.2.2 
Relationship to Study Agent ............................................................................................ 24 
8.2.3 
Expectedness ................................................................................................................... 24 
8.3 
Time Period and Frequency for Event Assessment and Follow-Up ..................................................... 24 
8.4 
Reporting Procedures .......................................................................................................................... 25 
8.4.1 
Adverse Event Reporting ................................................................................................. 25 
8.4.2 
Serious Adverse Event Reporting..................................................................................... 25 
8.4.3 
Unanticipated Problem Reporting ................................................................................... 26 
8.4.4 
Reporting of Pregnancy ................................................................................................... 26 
8.5 
Study Halting Rules .............................................................................................................................. 26 
8.6 
Safety Oversight .................................................................................................................................. 26 
9 
CLINICAL MONITORING .................................................................................................................................. 26 
10 
STATISTICAL CONSIDERATIONS ...................................................................................................................... 27 
10.1 
Statistical and Analytical Plans ............................................................................................................ 27 
10.2 
Statistical Hypotheses ......................................................................................................................... 27 
10.3 
Analysis Datasets ................................................................................................................................. 27 
10.4 
Description of Statistical Methods ...................................................................................................... 27 
10.4.1 
General Approach ............................................................................................................ 27 
10.4.2 
Analysis of the Primary Efficacy Endpoint(s) ................................................................... 28 
10.4.3 
Analysis of the Secondary Endpoint(s) ............................................................................ 28 
10.4.4 
Safety Analyses ................................................................................................................ 28 
10.4.5 
Adherence and Retention Analyses ................................................................................. 28 
10.4.6  
Baseline Descriptive Statistics ......................................................................................... 28 
10.4.7 
Planned Interim Analyses ................................................................................................ 29 
10.4.7.1 
Safety Review .................................................................................. 29 
10.4.7.2 
Efficacy Review ............................................................................... 29 
         10.4.8                            Additional Sub-Group Analyses ....................................................................................... 29 
10.4.9 
Multiple Comparison/Multiplicity ................................................................................... 29 
10.4.10 
Tabulation of Individual Response Data .......................................................................... 29 
10.4.11 
Exploratory Analyses ....................................................................................................... 29 
10.5 
Sample Size .......................................................................................................................................... 29 
10.6 
Measures to Minimize Bias ................................................................................................................. 29 
10.6.1 
Enrollment/ Randomization/ Masking Procedures ......................................................... 29 
10.6.2 
Evaluation of Success of Blinding ..................................................................................... 30 
10.6.3 
Breaking the Study Blind/Participant Code ..................................................................... 30 

4 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS .......................................................... 30 
12 
QUALITY ASSURANCE AND QUALITY CONTROL ............................................................................................. 31 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS .................................................................................................. 31 
13.1 
Ethical Standard .................................................................................................................................. 31 
13.2 
Institutional Review Board .................................................................................................................. 31 
13.3 
Informed Consent Process .................................................................................................................. 32 
13.3.1 
Consent/assent and Other Informational Documents Provided to Participants ............. 32 
13.3.2 
Consent Procedures and Documentation ........................................................................ 32 
13.4 
Participant and data Confidentiality.................................................................................................... 32 
13.4.1 
Research Use of Stored Human Samples, Specimens or Data ......................................... 33 
13.5 
Future Use of Stored Specimens ......................................................................................................... 33 
14 
DATA HANDLING AND RECORD KEEPING ....................................................................................................... 33 
14.1 
Data Collection and Management Responsibilities ............................................................................. 33 
14.2 
Study Records Retention ..................................................................................................................... 34 
14.3 
Protocol Deviations ............................................................................................................................. 34 
14.4 
Publication and Data Sharing Policy .................................................................................................... 34 
15 
STUDY ADMINISTRATION ............................................................................................................................... 35 
15.1 
Study Leadership ................................................................................................................................. 35 
16 
CONFLICT OF INTEREST POLICY ...................................................................................................................... 35 
17  
LITERATURE REFERENCES ............................................................................................................................... 35 
APPENDIX .................................................................................................................................................................... 37 
 

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LIST OF ABBREVIATIONS 
 
 
AE 
ANOVA 
CFR 
CIOMS 
CRF 
FDA 
GAIS 
GCP 
ICH 
ICH E6 
 
ICMJE 
IDE 
IRB 
MedDRA 
PEMF 
PI 
QC 
RF 
SAE 
SAP 
SOC 
UP 
VAS 
 
Adverse Event 
Analysis of Variance 
Code of Federal Regulations 
Council for International Organizations of Medical Science 
Case Report Form 
Food and Drug Administration 
Global Aesthetic Improvement Scale 
Good Clinical Practice 
International Conference on Harmonisation 
International Conference on Harmonisation Guidance for Industry, Good Clinical  
Practice: Consolidated Guidance 
International Committee of Medical Journal Editors 
Investigational Device Exemption 
Institutional Review Board 
Medical Dictionary for Regulatory Activities 
Pulsed Electromagnetic Field 
Principal Investigator 
Quality Control 
Radio Frequency 
Serious Adverse Event 
Statistical Analysis Plan 
System Organ Class 
Unanticipated Problem 
Visual Analog Scale 
 
 
 
 

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STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with Good Clinical Practice (GCP) as required by the following 
(use applicable regulations depending on study location and sponsor requirements; examples follow):  
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812) or equivalent local 
regulatory regulations or guidelines 
• 
ICH E6  
• 
ISO 14155:2011 
All key personnel (all individuals responsible for the design and conduct of this trial) have  
completed Human Subjects Protection Training. 
I agree to ensure that all staff members involved in the conduct of this study are informed about their 
obligations in meeting the above commitments.  
Principal Investigator:  Monica Chau Kieu 
 
Signed: _____________________________________ Date: ______________  
 
 
 
 
 

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PROTOCOL SUMMARY 
Title: 
Change in skin elasticity after combined radio frequency and 
electromagnetic treatment 
Summary: 
This study is an open-label, baseline-controlled, single-center study to 
measure the change in skin elasticity after combined radio frequency (RF) 
and pulsed electromagnetic field (PEMF) treatment.  Forty-five adult 
females will undergo weekly treatments over a period of 8 weeks.  Skin 
elasticity will be measured by a Cutometer® prior to beginning treatment, 
week 7 and 3 months after completion of treatment.  Photographs will be 
taken prior to treatment, at week 4, week 7 and 3 months after completion 
of treatment.  Patient discomfort/pain and satisfaction questionnaires will 
be completed before, during and after treatment.  
Objectives: 
The objective is to determine the quantitative change in elasticity of facial 
skin in subjects who have undergone treatment with combined RF and 
PEMF.  
Endpoint 
Primary endpoint:  
• 
Quantitatively and objectively measure the change in facial skin 
elasticity following combined radio frequency and electromagnetic 
treatment.  
Secondary endpoints:  
• 
Improvement in facial skin laxity at 7 and 20 weeks post-intervention 
compared to baseline as assessed by blinded evaluators by 
photographic assessment utilizing the Fitzpatrick Wrinkle and Elastosis 
Scale (FWES) scale.  
• 
Improvement in subject appearance at 7 and 20 weeks post-
intervention compared to baseline as assessed by the subject utilizing 
the Global Aesthetic Improvement Scale (GAIS) 
• 
Improvement in subject satisfaction with facial skin laxity at 4, 7 and 20 
weeks post-intervention compared to baseline as measured by the 5-
point Likert Subject Satisfaction questionnaire. 
Population: 
The study will enroll approximately 45 healthy adult females desiring 
improvement in facial skin elasticity and tightness. 
Phase: 
Post-approval 
Number of Sites 
enrolling participants: 
One site 
Description of Study 
Agent: 
Venus Versa is an FDA approved aesthetic device.  The Diamondpolar 
applicator combining multi-polar RF and PEMF energies will be used in this 
study.  It is approved for non-invasive skin tightening of the face in skin 
types I - IV.  
Study Duration: 
8 months 

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Participant Duration: 
5 months 
 
 
SCHEMATIC OF STUDY DESIGN 
 
Prior to 
Enrollment 
Obtain informed consent. Screen potential subjects by inclusion and exclusion 
Enrollment criteria; obtain history, document. 
 
 
Visit 1 
Week 0 
Perform Baseline Assessments 
Physical exam, demographics, medical history,  
AEs, concomitant medication, photographs, Cutometer® 
Administer initial study treatment 
100 mm pain VAS, immediate response 
 
 
Visit 2 
Week 1 
AEs, concomitant medication 
Administer study treatment 
100 mm pain VAS, immediate response 
 
 
Visit 3 
Week 2 
AEs, concomitant medication 
Administer study treatment 
100 mm pain VAS, immediate response 
 
 
Visit 4 
Week 3 
AEs, concomitant medication 
Administer study treatment 
100 mm pain VAS, immediate response 
 
 
Visit 5 
Week 4 
AEs, concomitant medication, photographs, subject satisfaction, 
Administer study treatment 
100 mm pain VAS, immediate response 
 
 
Visit 6 
Week 5 
AEs, concomitant medication 
Administer study treatment 
100 mm pain VAS, immediate response 
 
 
Visit 7 
Week 6 
AEs, concomitant medication 
Administer study treatment 
100 mm pain VAS, immediate response 
 
 
Visit 8 
Week 7 
AEs, concomitant medication, photographs, subject GAIS, subject satisfaction, 
Cutometer® 
Administer study treatment 
100 mm pain VAS, immediate response 
 
 
Visit 9 
Week 20 
Final Assessments 
AEs, concomitant medication, photographs, subject GAIS, subject satisfaction, 
Cutometer® 
 

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1 
KEY ROLES 
 
Monica Chau Kieu, DO - Principal investigator 
Michigan State University, University of Toronto 
500 Sheppard Ave East, Ste 302   
Toronto, ON M2N 6H7  
(416) 229-1050   
Email: monicakieu@hotmail.com 
 
David A.F. Ellis, MD – Sub-investigator  
University of Toronto 
500 Sheppard Ave East, Ste 302   
Toronto, ON M2N 6H7  
(416) 229-1050  
Email: ellis2106@gmail.com  
 
Joseph L. Reiz, Director of Clinical Research 
Venus Concept 
255 Consumers Road, Suite 110 
Toronto, Ontario, M2J 1R4 
(888) 907-0115 ext. 563 
Email: jreiz@venusconcept.com 
 
2  
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE  
 
2.1 
BACKGROUND INFORMATION  
The Venus Versa is a multi-application device used in aesthetic and cosmetic procedures, approved by 
the FDA for over 20 indications.  It is comprised of a console and ten detachable applicators.  The system 
can deliver three types of energies using the associated applicators - radiofrequency (RF), pulsed 
electromagnetic field (PEMF) and intense pulse light (IPL).  The Diamondpolar applicator used in this 
study [combining multi-polar radiofrequency (RF) and pulsed electromagnetic field (PEMF) energies] is 
approved for non-invasive skin tightening of the face in Fitzpatrick skin types I - IV. 
The Cutometer® is a non-invasive measurement device that measures the viscoelastic properties of 
human skin using the suction method.   Negative pressure is created in the device and the skin is drawn 
into the aperture of the probe.  Inside the probe, the penetration depth is determined by a non-contact 
optical measuring system.  This optical measuring system consists of a light source and a light receptor, 
as well as two prisms facing each other, which project the light from transmitter to receptor.  The light 
intensity varies due to the penetration depth of the skin.  The resistance of the skin to be suctioned by 
the negative pressure (firmness) and its ability to return into its original position (elasticity) are 
displayed as curves at the end of each measurement. 
Ryu et al determined that skin aging of women could be expressed numerically by measuring the skin 
elasticity using a Cutometer®.1 A distinct trend in aesthetic medicine is the patient’s demand for 

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efficient, noninvasive treatments with no downtime. These treatments are expected to be as safe and 
painless as possible.  A technique based on a combination of RF and PEMF has shown to be effective in 
the treatment of facial wrinkles and is virtually pain free.2  These previous studies focused on the 
photographic appearance of the skin pre- and post-treatment as judged by blinded raters.  To date, 
there are no studies which use objective parameters to determine treatment efficacy.  This study will 
determine if the Cutometer® can provide objective evidence of treatment efficacy. 
2.2 
RATIONALE  
The combination RF and PEMF technology has already been proven to be safe and effective in the 
improvement of skin laxity.  However, to date, there is no study that quantitatively analyzes the degree 
of improvement.   
The objective of this clinical study is to evaluate the use of the Cutometer® in providing objective 
evidence of improvement in facial skin elasticity after treatment with combined RF and PEMF 
technology in adult females seeking treatment for the aesthetic appearance of facial wrinkles. 
2.3 
POTENTIAL RISKS AND BENEFITS  
 
2.3.1 KNOWN POTENTIAL RISKS  
The potential risks for adverse effects of the treatment procedure include but are not limited to 
temporary swelling, redness, pain and burns at treatment site.  The following long range risks were also 
identified as low probability adverse events:  scarring, skin breakdown and hyper or hypopigmentation. 
Previous studies have shown the immediate risks outlined above are transient and generally well-
tolerated by patients.  The long-range risks outlined above are theoretical, as there have been no 
reports of these incidences.   
2.3.2 KNOWN POTENTIAL BENEFITS  
If the subject agrees to be in this study, she will be contributing to the understanding of the 
Cutometer®’s ability to quantify the device’s impact on the degree of skin rejuvenation, skin tightening 
and improved appearance of facial rhytids.  In addition, the subject may benefit from improvement in 
skin laxity in the treated areas. 
3 
OBJECTIVES AND PURPOSE 
Primary objective:  
Quantitatively and objectively measure the change in facial skin elasticity following combined radio 
frequency and electromagnetic treatment.  
Secondary objectives:  
Improvement in skin laxity at 20 weeks post-intervention compared to baseline as assessed by blinded 
evaluators by photographic assessment utilizing the Fitzpatrick Wrinkle and Elastosis Scale (FWES) scale.  

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Improvement in subject appearance at 7 and 20 weeks post-intervention compared to baseline as 
assessed by the subject utilizing the Global Aesthetic Improvement Scale (GAIS). 
Improvement in subject satisfaction with skin laxity at 4, 7 and 20 weeks post-intervention compared to 
baseline as measured by the 5-point Likert Subject Satisfaction questionnaire.  
4 
STUDY DESIGN AND ENDPOINTS 
 
4.1 DESCRIPTION OF THE STUDY DESIGN 
This is an open-label, baseline-controlled, single-center study to objectively measure the change in 
skin elasticity after combined radio frequency and electromagnetic treatment  
4.2.1 PRIMARY ENDPOINT 
As skin ages, collagen can become disorganized, causing changes in both the mechanical property of the 
skin and skin appearance.  The change in gross elasticity (R2 or Ua/Uf which is a ratio of maximum 
recovery (Ua) and skin distensibility (Uf)) as measured by a Cutometer® has been found to be one of the 
most suitable parameters to represent the influence of aging on skin mechanical properties.i This is 
expressed as a percentage, the closer the value is to 1 (100%), the more elastic the skin. Thus, the 
primary endpoint will be the change in gross elasticity after treatment with combined RF and PEMF.  The 
gross elasticity of facial skin will be measured prior to the start of the treatment regimen (baseline), and 
20 weeks after completion of the treatment regimen.  
4.2.2 SECONDARY ENDPOINTS 
Secondary endpoint #1: Change in photographic appearance of rhytids, as determined by blinded Facial 
Plastic & Reconstructive surgeons using the Fitzpatrick Wrinkle and Elastosis Scale (FWES) from baseline 
to week 20. Photographs from weeks 4 and 7 will only be used to track treatment progress, and will not 
be used by the raters to determine treatment efficacy. 
Secondary endpoint #2:  To assess clinical efficacy subjectively, the subjects will complete the Global 
Aesthetic Improvement Scale (GAIS), which is a 7-grade instrument. 
Secondary endpoint #3:  To assess satisfaction with the treatment, subjects will complete a 5-point 
Likert Subject Satisfaction scale. 
The secondary endpoints serve to augment the findings of the primary endpoint.  They help to provide a 
more complete understanding of treatment efficacy by including evaluations by trained physicians as 
well as the subjects themselves. 
4.2.3 EXPLORATORY ENDPOINTS 
None 
5 
STUDY ENROLLMENT AND WITHDRAWAL 
 
5.1 
PARTICIPANT INCLUSION CRITERIA 

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In order to be eligible to participate in this study, an individual must meet all of the following criteria:  
1. 
Healthy adult female subject at least 18 years of age and older with Fitzpatrick skin types I-
IV who are willing to participate. 
2. 
Women requesting treatment for skin laxity of the face. 
3. 
Able to read, understand and voluntarily provide written Informed Consent. 
4. 
Able and willing to comply with the treatment/follow-up schedule and requirements. 
5. 
Ability to tolerate the RF/PEMF procedure, and willing to adhere to the treatment regimen. 
5.2 
PARTICIPANT EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this study:  
1. 
Having any active electrical implant anywhere in the body, such as a pacemaker or an 
internal defibrillator. 
2. 
Having a permanent implant in the treated area. 
3. 
Prior use of retinoids in treated area within 2 weeks of initial treatment or during the course 
of the study. 
4. 
Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the 
course of the study. 
5. 
Patient on systemic corticosteroid therapy 6 months prior to and during the course of the 
study. 
6. 
Prior use of collagen, fat injections and /or other methods of skin augmentation 
(enhancement with injected or implanted material) in treated area within 4-6 weeks of 
initial treatment or during the course of the study.  Treatment may not be performed at all 
over permanent dermal implants. 
7. 
Prior ablative resurfacing procedure in treated area with laser or other devices within 12 
months of initial treatment or during the course of the study. 
8. 
Any other surgery in treated area within 12 months of initial treatment or during the course 
of the study. 
9. 
History of keloid formation or poor wound healing in a previously injured skin area. 
10. 
History of epidermal or dermal disorders (particularly if involving collagen or micro 
vascularity). 
11. 
Open laceration or abrasion of any sort on the area to be treated. 
12. 
History of immunosuppression/immune deficiency disorders (including HIV infection or 
AIDS) or use of immunosuppressive medications. 

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13. 
Having any form of active cancer at the time of enrollment and during the course of the 
study. 
14. 
Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the 
opinion of the Investigator would interfere with the treatment, or healing process. 
15. 
Participation in a study of another device or drug within 1 month prior to study enrollment 
or during this study, and as per the Investigator’s careful discretion, as long as not 
contradictory to any of the above criteria. 
16. 
Tattoos in the treatment area. 
17. 
Mentally incompetent, prisoner or evidence of active substance or alcohol abuse. 
5.3 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Approximately 45 subjects will be recruited through the site investigator’s outpatient clinic.  Potential 
subjects will be identified through the existing database of over 20,000 patients and a recruitment email 
with a brief description of the study will be sent.  In addition, an ethics-approved flyer will be posted in 
the patient waiting area of the clinic.  It is also anticipated that a substantial number of participants will 
be recruited through word of mouth. 
To enhance participant retention, email and phone calls will be employed to remind patients of 
treatment and follow up appointments. 
No financial incentives will be offered, however the potential for improved aesthetic appearance is a 
compelling non-financial incentive. 
5.4 
PARTICIPANT WITHDRAWAL OR TERMINATION 
 
5.4.1 REASONS FOR WITHDRAWAL OR TERMINATION 
Subjects are free to withdraw from participation in the study without prejudice at any time upon 
request. In the event that a subject drops out of the study or is withdrawn from the study, the 
Exit/Termination CRF form should be completed. On the withdrawal page, the Investigator should 
record the date of the withdrawal, the person who initiated withdrawal and the reason for withdrawal. 
Reasonable effort will be made to contact any subject lost to follow up during the course of the study in 
order to complete assessments and retrieve any outstanding data and study medication/supplies. The 
records of subjects who terminate prior to completing the study will be retained and the reason for 
termination will be documented.  
An investigator may terminate participation in the study if:  
• Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation occurs 
such that continued participation in the study would not be in the best interest of the participant.  
• The subject meets an exclusion criterion (either newly developed or not previously recognized) that 
precludes further study participation.  

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5.4.2 HANDLING OF PARTICIPANT WITHDRAWALS OR TERMINATION 
Every effort will be made to continue follow-up of withdrawn or terminated subjects or subjects who 
discontinue the intervention but remain in the study for follow-up, especially for safety and efficacy 
study endpoints.  Every effort will be made to undertake protocol-specified safety follow-up procedures 
to capture AEs, serious adverse events (SAEs), and unanticipated problems (UPs). Subjects that 
withdraw will be replaced until a maximum of 60 subjects are randomized with 45 subjects expected to 
complete the study. Subjects that withdraw or are terminated from the study will still be requested to 
complete the week 20 follow-up procedure in order to evaluate for possible AEs or unanticipated 
problems (UPs). 
5.5 
PREMATURE TERMINATION OR SUSPENSION OF STUDY 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to the principal investigator (PI) and Venus Concept. If 
the study is prematurely terminated or suspended, the PI will promptly inform the ethics board and will 
provide the reason(s) for the termination or suspension.  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
Study may resume once concerns about safety, protocol compliance, data quality are addressed and 
satisfy the sponsor, ethics board and/or regulatory authorities. 
6 
STUDY AGENT 
 
6.1 
STUDY AGENT(S) AND CONTROL DESCRIPTION 
 
6.1.1 ACQUISITION 
The investigational device will be shipped to the investigative site directly from the sponsor.  An 
activation code will be required to activate the device. This code will not be provided to the investigative 
site until all regulatory and institutional review board (IRB) approvals are in place and the site has 
received training for both the device and the study. 
6.1.2 DEVICE SPECIFIC CONSIDERATIONS 
The Venus Versa (MP)2 by Venus Concept Ltd. is a non-invasive dermatological treatment system based 
on  patented and proprietary (MP)2 technology which combines Multi Polar Radiofrequency (RF) and 
Pulsed Magnetic Fields. The RF energy penetrates the skin and results in RF-generated tissue heating 
that has known effect on skin laxity. The magnetic field that is simultaneously induced increases 
fibroblast collagen production through a non-thermal mechanism and contributes to the clinical effect 

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of skin laxity improvement.  The Diamondpolar applicator used for this study includes electrodes that 
deliver the Multi Polar Radiofrequency (RF) and Pulsed Magnetic Fields energy.  
6.2 
STUDY AGENT ACCOUNTABILITY PROCEDURES 
The device will be shipped to the site by the sponsor. The device will require an activation code in order 
to function.  The activation code will only be provided once all the ethics and regulatory approvals for 
the site are in place. The treatments will be administered by a trained technician according to the 
protocol under direct supervision of the PI.  When not in use, the device will be turned off and kept in a 
locked room. At the end of the study, the device will be returned to the sponsor. 
7 
STUDY PROCEDURES AND SCHEDULE 
 
7.1 
STUDY PROCEDURES/EVALUATIONS 
7.1.1 STUDY SPECIFIC PROCEDURES  
• Medical history:  obtained through interview.  History will include age, other medical conditions, and 
previous invasive or non-invasive cosmetic procedure to the face or neck in the last 6 months. 
• Medication history:  current medications will be obtained through interview and will include 
prescription, over the counter, and herbal medications taken 4 weeks prior to study enrollment.  
• Physical examination:  completed by PI.  Focused head and neck skin assessment that will include 
Fitzpatrick skin type and evidence of scars, infection, or inflammation of the face or neck. 
• Imaging assessment:  standard photos of the treated area will be taken by the PI using a Nikon D3100 
using a 105 mm lens with fixed 2 Nikon flashes using diffuse bounce flash technique that reduces 
shadows and accentuates the subject’s contours.   
• Cutometer assessment at baseline, week 7 and at week 20. 
• Rater assessment:  The FWES will be used to rate the level of skin aging.  
• Patient-reported outcomes:  subjects will be asked to complete the GAIS questionnaire at weeks 7 and 
20, and a 5-point Likert subject satisfaction scale at weeks 4, 7 and 20. 
7.2 
LABORATORY PROCEDURES/EVALUATIONS 
 
7.2.1 CLINICAL LABORATORY EVALUATIONS  
Not applicable 
7.2.2 OTHER ASSAYS OR PROCEDURES 
Not applicable  
7.3 
STUDY SCHEDULE 

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7.3.1 SCREENING 
If the subject meets the preliminary study criteria the study doctor, and/or his/her designee, will obtain 
an informed consent from the subject, clearly indicating her understanding of the requirements and 
possible risks involved with study participation and other applicable treatment options.  
During the first visit, the study investigator, and/or his/her designee, will screen the subject for eligibility 
to participate in the clinical study using the inclusion/exclusion criteria.  During screening the study 
doctor will review the subject's medical/surgical history, and examine the subject's targeted area to 
ensure that it meets the study criteria. The subject will complete screening and the treatment will be 
scheduled.  
Enrollment/baseline visit can be conducted on the same day as screening or up to 30 days after 
screening.   
7.3.2 ENROLLMENT/BASELINE 
Enrollment/Baseline Visit (Visit 1, Week 0)  
Once a subject has been confirmed that they continue to meet inclusion/exclusion criteria, each subject 
will receive a unique identifying number that will be composed of a two-digit site number and a three-
digit subject number in sequence.  This unique identifier will be used throughout the entire study and 
will be entered in the subject's CRF for each treatment. 
Baseline Cutometer® measurements of the area to be treated will be obtained. 
Subjects will be asked to refrain from using skin products or medications containing ingredients listed in 
the exclusion criteria, and may have to undergo washout periods for any such substances or medications 
prior to receiving treatment as part of this study.  The Investigator should review the subject’s skin care 
regimen and suggest appropriate alternatives for the course of the study, as needed. 
All subjects will have photographs taken of the area to be treated. All subjects will be asked to remove 
all jewelry and piercings and wash the area to be photographed with provided cleanser to remove all 
makeup and skincare products.  Subject will then wait 10 minutes for any washing related erythema to 
subside prior to initiation of photography session. All stray hairs will then be pulled away from the face. 
If seated photos, the stool height will be adjusted to ensure the subject’s head, neck and spine are 
aligned and the subject is sitting up straight. Subject will then be positioned so they are centered in the 
frame using chin and forehead rests as applicable for seated three-point photo capture and if standing, 
feet are aligned with standardized photo foot marking on the floor standing straight with back flat 
against the draped back drop (blue, green or white) wall. All photography is to take place within the 
same room with standardized lighting, no natural light, for the duration of the study. 
Standardized photographs will be taken using a high quality digital SLR camera to obtain three photos 
(frontal 90°, right 45° and left 45°).  These photographs will be used as an assessment tool.  They may 
also be used for publication and/or presentation of the study findings and generalized characterization 
of the disease state.  Moreover, they may use the photographs for marketing or other commercial 
purposes. 

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The photos will be taken in a private room or area. The investigative site will ensure that digital 
photography equipment with standardized illumination and background is available for use during this 
study. Digital photos will be stored on dedicated media.  A copy of all study photographs will be 
transferred to Venus Concept at the end the study or as part of interim analysis.  Only the subject code 
will appear on the records being transferred to the sponsor to ensure anonymity of the subjects. 
Study visits that include photography:  Baseline, week 4, week 7, week 20.  
Standard conditions: The photos should be taken in standardized conditions, including distance, angle, 
background, and illumination in order to achieve high-quality before & after sets. Do not use direct 
illumination. 
Subject posture: The subject will be placed in the same position each time. As each photograph is taken, 
it should be viewed to ensure that it is in focus and is similar to its baseline counterpart in all technical 
aspects, including lighting, distance and angle.   
Order of photos: the first photograph in each session should be of an identification card that will include 
subject code and visit details. 
File names: The digital files should follow a consistent standard naming scheme, for example: 01-
001TS_Tx1_face. 
Treatment Procedure (also see user manual) 
During each treatment session, subjects will be treated with the Venus Versa system using the 
Diamondpolar applicator as per standard treatment parameters.   
Prior to the treatment, glycerin in gel formulation should be applied thoroughly to the treatment area. 
In the initial treatment it is important to adjust the treatment required energy level to best suit the 
patient's tolerance to the treatment. Tolerance will increase as the patient becomes more familiar with 
the treatments. 
The aim of the procedure is to heat the surface of the skin on the treatment area and raise the 
temperature up to at least 39°C and maintain it for a minimum of 5 minutes. Always aim for the highest 
temperature that the subject can tolerate. The treatment should be monitored with an external infrared 
(IR) thermometer. 
During the procedure, the applicator's electrodes will press against the patient's skin, making sure that 
all electrodes are in contact with the skin as much as possible. 
The applicator strokes are long and continuous, and performed in form of "8" figures, circles, ellipses or 
waves. The applicator will always be in motion, while in contact with the skin surface. 
If the measured skin surface temperature (as measured by the IR thermometer) is less than 39⁰C, 
treatment is not optimal and the desired results will not be accomplished. The achieved skin 
temperature depends on the applicator movement speed and energy level. The lower the energy, the 
slower the movement will be and vice-versa. 

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In the event that the patient experiences discomfort or pain during the treatment, either the energy 
percentage will be decreased, more glycerin in gel should be applied or wider and quicker movements 
should be performed.  Treatment may also be halted. 
Subject discomfort evaluation 
The subject will record their assessment of discomfort/pain on a 100 mm VAS CRF page immediately 
after each treatment which will be considered to be a source document. 
Skin safety – immediate response after procedure 
Local (dermal) tolerability examination (only on the face) will be performed immediately following 
treatment at the time-points given in the Study Visit Table and will include assessments of pain during 
treatment, hemorrhage, burn, erythema, edema or other reactions.  All tolerability assessments must be 
completed by the same person throughout the study whenever possible.  Local tolerability on the face 
will be rated as none, mild, moderate, or severe.  
Subjects should remain in the research setting at least 30 minutes after treatment in order to ensure 
their well-being. 
Subjects will be discharged from the clinic and will be instructed to return for the Visit 2, Week 1 
assessment and treatment. 
7.3.3 FOLLOW-UP  
Visit 2, Week 1 
Subjects will return to the clinic one week (±3 days) after the first treatment. Adverse events and any 
changes to concomitant medications will be recorded.  
Subjects will receive treatment of the face as described above in section 7.3.2. Following treatment, the 
investigator will examine the treated area and report the immediate response.  
The assessment of discomfort/pain will be based on the subject’s completion of the 100 mm VAS 
immediately after treatment.  
Subjects will be discharged from the clinic and will be instructed to return for the Visit 3, Week 2 
assessment and treatment. 
Visit 3, Week 2 
Subjects will return to the clinic one week (±3 days) after the last treatment. Adverse events and any 
changes to concomitant medications will be recorded.  
Subjects will receive treatment of the face as described above in section 7.3.2. Following treatment, the 
investigator will examine the treated area and report the immediate response.  
The assessment of discomfort/pain will be based on the subject’s completion of the 100 mm VAS 
immediately after treatment.  

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Subjects will be discharged from the clinic and will be instructed to return for the Visit 4, Week 3 
assessment and treatment. 
Visit 4, Week 3 
Subjects will return to the clinic one week (±3 days) after the last treatment. Adverse events and any 
changes to concomitant medications will be recorded.  
Subjects will receive treatment of the face as described above in section 7.3.2. Following treatment, the 
investigator will examine the treated area and report immediate response.  
The assessment of discomfort/pain will be based on the subject’s completion of the 100 mm VAS 
immediately after treatment.  
Subjects will be discharged from the clinic and will be instructed to return for the Visit 5, Week 4 
assessment and treatment. 
Visit 5, Week 4 
Subjects will return to the clinic one week (±3 days) after the last treatment. Adverse events and any 
changes to concomitant medications will be recorded.  Photographs will be taken as described above in 
section 7.3.2.  Subjects will complete a 5-point Likert satisfaction scale.  
Subjects will receive treatment of the face as described above in section 7.3.2. Following treatment, the 
investigator will examine the treated area and report immediate response.  
The assessment of discomfort/pain will be based on the subject’s completion of the 100 mm VAS 
immediately after treatment.  
Subjects will be discharged from the clinic and will be instructed to return for the Visit 6, Week 5 
assessment and treatment. 
Visit 6, Week 5 
Subjects will return to the clinic one week (±3 days) after the last treatment. Adverse events and any 
changes to concomitant medications will be recorded.  
Subjects will receive treatment of the face as described above in section 7.3.2. Following treatment, the 
investigator will examine the treated area and report immediate response.  
The assessment of discomfort/pain will be based on the subject’s completion of the 100 mm VAS 
immediately after treatment.  
Subjects will be discharged from the clinic and will be instructed to return for the Visit 7, Week 6 
assessment and treatment. 
Visit 7, Week 6 
Subjects will return to the clinic one week (±3 days) after the last treatment. Adverse events and any 
changes to concomitant medications will be recorded.  

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Subjects will receive treatment of the face as described above in section 7.3.2. Following treatment, the 
investigator will examine the treated area and report immediate response.  
The assessment of discomfort/pain will be based on the subject’s completion of the 100 mm VAS 
immediately after treatment.  
Subjects will be discharged from the clinic and will be instructed to return for the Visit 8, Week 7 
assessment and treatment. 
Visit 8, Week 7 
Subjects will return to the clinic one week (±3 days) after the last treatment. Adverse events and any 
changes to concomitant medications will be recorded.  Photographs will be taken as described above in 
section 7.3.2.  Cutometer® measurements of the treated area will be obtained. 
Subjects will receive treatment of the face as described above in section 7.3.2. Following treatment, the 
investigator will examine the treated area and report immediate response.  
The assessment of discomfort/pain will be based on the subject’s completion of the 100 mm VAS 
immediately after treatment.  
Subjects will complete the GAIS scale and the 5-point Likert satisfaction scale. 
Subjects will be discharged from the clinic and will be instructed to return for the final study visit, Visit 9, 
Week 20 assessment. 
7.3.4 FINAL STUDY VISIT 
Visit 9, Week 20 
Subjects will return to the clinic twelve weeks (±2 weeks) after the last treatment for the final visit. 
Adverse events and any changes to concomitant medications will be recorded.  Photographs will be 
taken as described above in section 7.3.2. The subject will complete the GAIS scale and the 5-point Likert 
satisfaction scale.  Cutometer® measurements of the treated area will be taken. 
The termination form will be completed and subjects will be discharged from the clinic and terminated 
from the study. The PI will record all reportable events with start dates occurring any time after 
informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of 
study participation. 
7.3.5 EARLY TERMINATION VISIT 
Subjects who terminate the study early for whatever reason, will be asked to return to the clinic, if they 
are willing, to complete the final visit (Visit 9).  Adverse events and the reason for early termination will 
be recorded. 
7.3.6 UNSCHEDULED VISIT 
Participants will be encouraged to contact the PI at any time during the course of the study if they 
believe they are experiencing an AE or undesirable outcome.  If necessary, an unscheduled visit will be 
made to examine the participant and provide further care as needed.  If an unscheduled visit occurs, the 

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reason for the unscheduled visit will be documented. If the unscheduled visit is the result of an adverse 
event, the event will be recorded on the adverse event CRF. 
7.3.7 SCHEDULE OF EVENTS TABLE 
 
Procedures 
Screening 
(Visit 1, Week 0) 
Baseline 
(Visit 1, Week 0) 
Follow-up 
(Visit 2, Week 1) 
Follow-up 
(Visit 3, Week 2) 
Follow-up 
(Visit 4, Week 3) 
Follow-up 
(Visit 5, Week 4) 
Follow-up 
(Visit 6, Week 5) 
Follow-up 
(Visit 7, Week 6) 
Follow-up 
(Visit 8, Week 7) 
Final Study Visit 
(Visit 9, Week 
20) 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
Eligibility assessment 
X 
X 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
 
Physical exam 
X 
 
 
 
 
 
 
 
 
 
Photographic imaging 
 
X 
 
 
 
X 
 
 
X 
X 
Cutometer® readings 
 
X 
 
 
 
 
 
 
X 
X 
Administer treatment 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Immediate response 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Subject pain VAS 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Subject GAIS 
 
 
 
 
 
 
 
 
X 
X 
Subject satisfaction  
 
 
 
 
 
X 
 
 
X 
X 
Adverse events 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant 
medications 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
7.4 
JUSTIFICATION FOR SENSITIVE PROCEDURES 
Not applicable 
7.5 
CONCOMITANT MEDICATIONS, TREATMENTS, AND PROCEDURES  
 
All concomitant prescription medications taken during study participation will be recorded on the case 
report forms (CRFs).  For this protocol, a prescription medication is defined as a medication that can be 

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prescribed only by a properly authorized/licensed clinician.  Medications to be reported in the CRF are 
concomitant prescription medications, over-the-counter medications and non-prescription medications.  
7.5.1 PRECAUTIONARY MEDICATIONS, TREATMENTS, AND PROCEDURES 
Not applicable 
7.6 
PROHIBITED MEDICATIONS, TREATMENTS, AND PROCEDURES  
Treatment with any invasive or non-invasive cosmetic procedure to the face and neck (other than the 
investigative treatment) during the study period will not be permitted. 
7.7 
PROPHYLACTIC MEDICATIONS, TREATMENTS, AND PROCEDURES  
Medical grade glycerin will be applied to the treated area. 
7.8 
RESCUE MEDICATIONS, TREATMENTS, AND PROCEDURES  
In the event that the subject experiences pain, the principal investigator may prescribe any analgesic 
deemed appropriate to the level of pain. If a subject experiences any first, second or third degree burn 
or pain beyond narcotics, then the following procedure will be implemented: 
• 
Immediate triage and treatment of the patient shall be determined by the treating physician and 
based upon severity and type of burn identified.  
• 
Event will be reported to the study Director within 24 hours of occurrence. If the event meets the 
criteria of a SAE, then it must be reported on the SAE form. 
• 
Copy of the patient chart and treatment parameters are to be forwarded to the study Director 
within 24 hours.   
• 
Study Director will be responsible for issuing a written report to the company and the IRB Chairman 
no later than 7 days from the incident.  
• 
Long term follow-up and care shall continue at the discretion of the treating physician.  
All patients experiencing a complication of the device will be followed a minimum of 2 years following 
the initial injury.  Longer care and observation will be at the discretion of the treating physician.   
All minor complications such as appearance or altered sensation, except for pain, can be reported within 
30 days of patient complaint.  Both chart and treatment parameters are to be provided to the study 
Director and shared with the company and IRB chairman. 
7.9 
PARTICIPANT ACCESS TO STUDY AGENT AT STUDY CLOSURE  
At study closure, participants will be given a list of providers in the area who can continue treatments to 
the same area or other body areas if desired.  However, subjects will be notified that additional 
treatments will incur a cost not covered by the study. 

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8 
ASSESSMENT OF SAFETY 
 
8.1 
SPECIFICATION OF SAFETY PARAMETERS 
In addition to spontaneous reports of adverse events, subjects will complete a 100 mm pain VAS and the 
principal investigator will examine the treated area and report immediate response. 
8.1.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
8.1.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or 
sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient 
hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or 
substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth 
defect. Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. Examples of such medical events include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do 
not result in inpatient hospitalization, or the development of drug dependency or drug abuse.  
8.1.3 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
This definition could include an unanticipated adverse device effect, 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 application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of 
subjects (21 CFR 812.3(s)). 
8.2 
CLASSIFICATION OF AN ADVERSE EVENT 
 
8.2.1 SEVERITY OF EVENT 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning.  
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or 
other treatment. Severe events are usually potentially life-threatening or incapacitating.  
 

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8.2.2 RELATIONSHIP TO STUDY AGENT 
The clinician’s assessment of an AE's relationship to study agent (drug, biologic, device) is part of the 
documentation process, but it is not a factor in determining what is or is not reported in the study. If 
there is any doubt as to whether a clinical observation is an AE, the event should be reported. All AEs 
must have their relationship to study agent assessed. In a clinical trial, the study product must always be 
suspect. To help assess, the following guidelines are used.  
Related – The AE is known to occur with the study agent, there is a reasonable possibility that the study 
agent caused the AE, or there is a temporal relationship between the study agent and event. Reasonable 
possibility means that there is evidence to suggest a causal relationship between the study agent and 
the AE.  
Not Related – There is not a reasonable possibility that the administration of the study agent caused the 
event, there is no temporal relationship between the study agent and event onset, or an alternate 
etiology has been established.  
 
8.2.3 EXPECTEDNESS  
Expected adverse reactions are AEs that are common and known to occur for the study agent being 
studied. Expected adverse events in this study include pain, tenderness, purpura, persistent erythema, 
edema, burn, blistering, crusting, hyperpigmentation, hypopigmentation, scarring and potential for 
damage to hair follicles within the treatment area and subsequent loss of hair within the treatment 
area. 
 An AE or suspected adverse reaction is considered "unexpected" if it is not known to occur for the study 
agent being studied and at the specificity or severity that has been observed. 
The sub-investigator (SI) will be responsible for determining whether an AE is expected or unexpected. 
An AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent 
with the risk information previously described for the study agent.  
8.3 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and 
interviews of a study participant presenting for medical care, or upon review by a study monitor. 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate CRF.  Information to be collected includes event description, time of onset, clinician’s 
assessment of severity, relationship to study product (assessed only by those with the training and 
authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while 
on study must be documented appropriately regardless of relationship. All AEs will be followed to 
adequate resolution.  
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any 
time during the study, it will be recorded as an AE.  UPs will be recorded in the data collection system 
throughout the study.  

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Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode.  
The PI will record all reportable events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.  At 
each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events 
will be followed for outcome information until resolution or stabilization.  
 
8.4 
REPORTING PROCEDURES 
 
8.4.1 ADVERSE EVENT REPORTING  
All AEs will be recorded on the appropriate CRF and will include information about the start and stop 
dates, severity and relatedness. There should be an attempt to report a “diagnosis” rather than the 
individual signs, symptoms and abnormal laboratory values associated with the diagnosis. However, a 
diagnosis should be reported only if, in the Investigator’s judgment, it is relatively certain (i.e., definite 
or possible). Otherwise individual signs, symptoms and abnormal laboratory values should be reported 
as distinct adverse events. 
8.4.2 SERIOUS ADVERSE EVENT REPORTING  
All serious AE, whether or not deemed expected or device related, must be reported to the sponsor’s 
clinical research department immediately or within 24 hours by telephone (see contact details below). 
Name: Joseph Reiz, Director of Clinical Research 
Phone: 888-907-0115 ext. 563 
Email: jreiz@venusconcept.com 
Address: 255 Consumers Road, #110, Toronto, Ontario, Canada, M2J 1R4 
A written report prepared by the Principal Investigator using the Serious Adverse Event or Serious 
Adverse Device Effect Report must follow within seven working days to the clinical monitor and should 
include a full description of the event and sequence. 
The study investigator shall complete an Unanticipated Adverse Device Effect Form and submit to the 
study sponsor and to the reviewing IRB as soon as possible, but in no event later than 10 working days 
after the investigator first learns of the effect. The study sponsor contact information is provided in 
Section 1, Key Roles. The study sponsor is responsible for conducting an evaluation of an unanticipated 
adverse device effect and shall report the results of such evaluation to FDA, any other country 
regulatory authority and to all reviewing IRBs and participating investigators within 10 working days 
after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit such additional 
reports concerning the effect as the applicable regulatory authority requests. 
 
 

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8.4.3 UNANTICIPATED PROBLEM REPORTING  
Incidents or events that meet the criteria for UPs require the creation and completion of an UP report 
form.  It is the site investigator’s responsibility to report UPs to their IRB and to the study sponsor. The 
UP report will include the following information: 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
• 
A detailed description of the event, incident, experience, or outcome; 
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP; 
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated 
adverse device effect occurring during an investigation as soon as possible, but in no event later than 10 
working days after the investigator first learns of the effect (21 CFR 812.150(a)(1)), A sponsor who 
conducts an evaluation of an unanticipated adverse device effect under 812.46(b) shall report the 
results of such evaluation to the applicable regulatory authority and to all reviewing IRB's and 
participating investigators within 10 working days after the sponsor first receives notice of the effect. 
Thereafter the sponsor shall submit such additional reports concerning the effect as the applicable 
regulatory authority requests. 
 
8.4.4 REPORTING OF PREGNANCY  
Not applicable  
8.5 
STUDY HALTING RULES  
The study may be halted at any time by the sponsor, the IRB, Health Canada or the FDA due to safety 
concerns. Examples of findings that might trigger a safety review are the number of SAEs overall, the 
number of occurrences of a particular type of SAE, severe AEs/reactions, or increased frequency of 
events. If the study is halted, the sponsor will immediately notify all investigational sites, the IRB(s) and 
the applicable regulatory authority. 
 
8.6 
SAFETY OVERSIGHT 
Independent oversight is an important component to ensure human subjects' protection. Safety 
oversight will be under the direction of the sponsor and a medical monitor. 
9 
CLINICAL MONITORING 
Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects are  
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of 

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the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with 
applicable regulatory requirement(s).  
• 
Monitoring for this study will be performed by the sponsor or designate. 
• 
On-site monitoring will occur within 4 weeks of first enrolled subject and will occur at a 
frequency described in the Monitoring Plan. 
• 
Variables to be monitored will be described in the Monitoring Plan. 
• 
The Study Director or designate will be provided copies of monitoring reports within 15 business 
days of visit.  
• 
The sub-investigator will provide on-site monitoring weekly during the study period to ensure 
patient safety and verify accurate data collection.  
• 
The clinical site will perform internal quality management of study conduct, data collection, 
documentation and completion. An individualized quality management plan will be developed 
to describe a site’s quality management. 
10 
STATISTICAL CONSIDERATIONS  
 
10.1 
STATISTICAL AND ANALYTICAL PLANS 
An initial statistical analysis plan has been developed and will be finalized once all data collection is 
complete. 
10.2 
STATISTICAL HYPOTHESES 
Statistical null hypothesis for primary endpoint:  there will be no statistical change in gross elasticity as 
measured by the Cutometer® after treatment with combined RF/PEMF compared to before treatment. 
Statistical null hypothesis for secondary endpoint #1:  there will be no statistical change in the FWES as 
rated by blinded clinicians after treatment with combined RF/PEMF compared to before treatment. 
Statistical null hypothesis for secondary endpoint #2:  there will be no statistical change in the GAIS as 
rated by the subjects after treatment with combined RF/PEMF compared to before treatment. 
Statistical null hypothesis for secondary endpoint #3:  there will be no statistical change in the subject 
satisfaction score after treatment with combined RF/PEMF compared to before treatment.  
10.3 
ANALYSIS DATASETS 
There will be one analysis dataset, which will only include subjects who completed the entire treatment 
and follow up protocol. 
10.4 
DESCRIPTION OF STATISTICAL METHODS 
 
10.4.1 GENERAL APPROACH 

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After data set compilation and cleaning, a series of descriptive statistics will first be generated to 
examine the data set for distributional/potential missing data patterns and sample characteristics. The 
study team will conduct a series of pooled time series analyses with generalized estimating equations 
regression (GEE) models.3  These types of non-parametric (i.e., not based on normal distribution 
assumptions) predictive modeling procedures are capable of using both robust and standard estimating 
functions to more fully evaluate the influence RF/PEMF treatments and other factors/covariates on 
serial face gross elasticity measurements.  These types of procedures will also enable the study team to 
examine the potential effects of both within group (e.g., face gross elasticity measurements for Patient X 
at three measurement points) and between group (e.g., face gross elasticity measurement changes of 
younger women versus older women) model variables. A P-value of <0.05 will be considered statistically 
significant. 
 
10.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
Gross elasticity as measured by the Cutometer® is a ratio expressed as a percentage.  Baseline and post-
treatment measurements will be taken and analyzed using analysis of variance (ANOVA). 
Results will be reported as baseline means with standard deviation, post-treatment means with 
standard deviation, and individual change for each subject.  
Subjects with missing data, non-adherence, or lost to follow-up will not be included in the final analysis 
dataset. 
10.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
Secondary endpoint #1: The FWES is based on an ordinal scale (from 1-9) and will be measured as a 
single endpoint. 
Secondary endpoint #2:  The GAIS is a 7-point (-3 to 3) ordinal scale and will be a repeated measure.  
Secondary endpoint #3: The subject satisfaction score is a 5-point Likert scale and will be a repeated 
measure. 
10.4.4 SAFETY ANALYSES 
There are no formal safety endpoints in this study, however all AEs and relevant information related to 
the incidents (start date, stop date, severity, relationship, outcome, and duration) will be recorded and 
reported.  Adverse events leading to premature discontinuation from the study and serious treatment 
emergent AEs will be presented in a table.  
10.4.5 ADHERENCE AND RETENTION ANALYSES 
Not applicable.  
10.4.6  BASELINE DESCRIPTIVE STATISTICS 
Baseline characteristics including age, Fitzpatrick skin type, and initial Cutometer® readings will be 
reported using descriptive statistics.  

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10.4.7 PLANNED INTERIM ANALYSES  
 
10.4.7.1 
SAFETY REVIEW 
Not applicable. 
10.4.7.2 
EFFICACY REVIEW 
Not applicable. 
10.4.8 ADDITIONAL SUB-GROUP ANALYSES 
For all endpoints, additional sub-group analysis may be performed based on age group and Fitzpatrick 
skin type. 
10.4.9 MULTIPLE COMPARISON/MULTIPLICITY 
Not applicable 
10.4.10 
TABULATION OF INDIVIDUAL RESPONSE DATA 
Individual participant data will be listed by time point. 
10.4.11 
EXPLORATORY ANALYSES 
Not applicable. 
10.5 
SAMPLE SIZE 
 
The PI has used G*Power 3.10.10 software4 to generate a priori minimal sample size calculations for the 
primary study endpoint: changes in gross elasticity (GE) repeated measure face measurement in a 
sample of consented eligible women at three time points: a) prior to RF/PEMF, b) at time of RF/PEMF 
completion, and c) three months after treatment completion.  
These calculations indicate that a minimal sample size of approximately 45 patients would easily afford 
at least a 0.804784 1 minus β level of statistical power to detect statistically significant RF/PEMF sample 
subgroup measurement differences observing a coefficient Alpha of 0.05 two-tailed level of significance. 
This sample size is based on both a conservative 0.3 (i.e., Medium) Effect Size for RF/PEMF treatment 
and pre-post procedure Cutometer® face gross elasticity measurement differences reported in Krueger, 
et. al (2011).5  
10.6 
MEASURES TO MINIMIZE BIAS 
 
10.6.1 ENROLLMENT/ RANDOMIZATION/ MASKING PROCEDURES 
At screening, once a subject has signed the informed consent, and inclusion/exclusion criteria has been 
met, a subject number will be assigned. The subject number will consist of a two-digit code 
corresponding to the site and a two-digit subject code in numerical sequence. (Example: 10-05 
corresponds to site #10, subject #5.) 

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Due to the nature of the treatment, it is not possible to blind subjects.  
Photographic imaging provided to the raters will not contain any participant identifying information or 
dates.  The physician raters will be blinded to which stage of treatment (if any) completed by the subject 
in the photograph.  
10.6.2 EVALUATION OF SUCCESS OF BLINDING  
Not applicable. 
10.6.3 BREAKING THE STUDY BLIND/PARTICIPANT CODE 
There are no instances in which the blind will need to be broken for the physician raters.  
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS 
Each participating site will maintain appropriate medical and research records for this trial, in 
compliance with ICH E6, ISO 14155:2011 and regulatory and institutional requirements for the 
protection of confidentiality of participants.  
Source data are all information, original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial. Examples of these original 
documents and data records include, but are not limited to, hospital records, clinical and office charts, 
laboratory notes, memoranda, participants' memory aids or evaluation checklists, pharmacy dispensing 
records, recorded audio tapes of counseling sessions, recorded data from automated instruments, 
copies or transcriptions certified after verification as being accurate and complete, microfiches, 
photographic negatives, microfilm or magnetic media, x-rays, and participant files and records kept at 
the pharmacy, at the laboratories, and medico-technical departments involved in the clinical trial. It is 
acceptable to use CRFs as source documents. For this protocol, responses to subject questionnaires and 
scales will be collected on two-part no carbon required (NCR) paper CRF pages.   One copy will be 
collected by the sponsor with the remaining copy left at the investigation site.  
It is not acceptable for the CRF to be the only record of a subject’s participation in the study. This is to 
ensure that anyone who would access the patient medical record has adequate knowledge that the 
patient is participating in a clinical trial. 
Source documents for this study will include: 
• Digital photographs - will be kept in a password-protected file on the secure server at the investigation 
site.  Only the PI and SI will have access to the digital files.  Participants will sign a photograph waiver 
at the beginning of the study which will describe in detail how these photos may be used, such as web-
based marketing purposes or academic publications. 
• CRFs - will be in paper format.  There will be one CRF for each participant in the study, which will be 
kept in a locked drawer at the investigation site.  At the completion of the study, the CRFs will be 
scanned to pdf format and stored in a password-protected file on the secure server at the 
investigation site.  After the paper forms are scanned and digitized, they will be shredded and properly 
disposed as sensitive medical records.  

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• Recorded data from Cutometer® - all data is electronically recorded and saved in a software program 
on the PI’s password-protected desktop computer at the investigation site.   
• Subject questionnaires - will be in paper format, then scanned to pdf format and stored in a password-
protected file on the secure server at the investigation site.  After the paper forms are scanned and 
digitized, they will be shredded and properly disposed as sensitive medical records. 
• Rater data collection sheets - will be in paper format, then scanned to pdf format and stored in a 
password-protected file on the secure server at the investigation site.  After the paper forms are 
scanned and digitized, they will be shredded and properly disposed as sensitive medical records. 
12 
QUALITY ASSURANCE AND QUALITY CONTROL 
Quality control (QC) procedures will be implemented beginning with the data entry system and data QC 
checks that will be run on the database will be generated.  Any missing data or data anomalies will be 
communicated to the site(s) for clarification/resolution.  
Following written SOPs, the monitors will verify that the clinical trial is conducted and data are 
generated, documented (recorded), and reported in compliance with the protocol, GCP, and the 
applicable regulatory requirements.  
The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and 
regulatory authorities.  
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS  
 
13.1 
ETHICAL STANDARD  
 
The investigator will ensure that this study is conducted in full conformity with Regulations for the 
Protection of Human Subjects of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 
and/or the ICH E6, ISO 14155:2011, the Declaration of Helsinki, Council for International Organizations 
of Medical Science (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human 
Subjects (2002), or another country’s ethical policy statement, whichever provides the most protection 
to human subjects. 
 
13.2 
INSTITUTIONAL REVIEW BOARD  
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form must 
be obtained before any participant is enrolled. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form 
will be IRB approved; a determination will be made regarding whether previously consented participants 
need to be re-consented.  
 

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13.3 
INFORMED CONSENT PROCESS  
 
13.3.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
Informed consent is required for all subjects in a study. In obtaining and documenting informed consent, 
the investigator should comply with applicable regulatory requirements and should adhere to 45 CFR 
Part 46, 21 CFR Part 50, 21 CFR Part 56), another country’s ethical policy statement and/or ICH GCP. 
Prior to the   beginning of a trial, the investigator should have the IRB's written approval for the protocol 
and the written informed consent forms(s) and any other written information to be provided to the 
participants. Consent forms describing in detail the study agent, study procedures, and risks are given to 
the participant and written documentation of informed consent is required prior to starting 
intervention/administering study product. 
The following consent materials are submitted with this protocol: 
• Consent to participate in study 
• Photograph consent  
13.3.2 CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Extensive discussion of risks and 
possible benefits of participation will be provided to the participants and their families. Consent forms 
will be IRB-approved and the participant will be asked to read and review the document. The 
investigator will explain the research study to the participant and answer any questions that may arise. 
All participants will receive a verbal explanation in terms suited to their comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research participants. Participants will 
have the opportunity to carefully review the written consent form and ask questions prior to signing. 
The participants should have the opportunity to discuss the study with their surrogates or think about it 
prior to agreeing to participate. The participant will sign the informed consent document prior to any 
procedures being done specifically for the study. The participants may withdraw consent at any time 
throughout the course of the trial. A copy of the informed consent document will be given to the 
participants for their records. The rights and welfare of the participants will be protected by 
emphasizing to them that the quality of their medical care will not be adversely affected if they decline 
to participate in this study.  
13.4 
PARTICIPANT AND DATA CONFIDENTIALITY  
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological samples and 
genetic tests in addition to the clinical information relating to participants. Therefore, the study 
protocol, documentation, data, and all other information generated will be held in strict confidence. No 
information concerning the study or the data will be released to any unauthorized third party without 
prior written approval of the sponsor.  

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The study monitor, other authorized representatives of the sponsor, representatives of the IRB or 
company supplying study device may inspect all documents and records required to be maintained by 
the investigator, including but not limited to, medical records (office, clinic, or hospital) and pharmacy 
records for the participants in this study. The clinical study site will permit access to such records.  
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by local IRB and regulations.  
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored at the statistician coordinating center. This will not include the 
participant’s contact or identifying information. Rather, individual participants and their research data 
will be identified by a unique study identification number. The study data entry and study management 
systems used by the clinical site and research staff will be secured and password protected. At the end 
of the study, all study databases will be de-identified and archived at the Art of Facial Surgery. 
13.4.1 RESEARCH USE OF STORED HUMAN SAMPLES, SPECIMENS OR DATA 
Storage:  Access to data and photographs will be limited using password protection. Data will be stored 
using codes assigned by the investigators. Data will be kept in password- protected computers. Only 
investigators will have access to the photographs and data.  
13.5 
FUTURE USE OF STORED SPECIMENS  
Data collected for this study will be analyzed and stored at the Art of Facial Surgery. After the study is 
completed, the de-identified, archived data will be stored at this site. 
When the study is completed, access to study data will be provided only through written consent by the 
PI or SI through the Art of Facial Surgery.  
Patient photographs will be stored on the password protected server at the investigation site, and will 
only be used as expressly permitted on the Photograph Consent. Steps will be taken to ensure 
anonymity of the subject in the photograph.  
 
14 
DATA HANDLING AND RECORD KEEPING  
 
14.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
PI. The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of 
the data reported.  
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data. Black ink is required to ensure clarity of reproduced copies. When making changes or 
corrections, cross out the original entry with a single line, and initial and date the change. DO NOT 
ERASE, OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL.  

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Copies of the paper CRF will be provided for use as source documents and maintained for recording data 
for each participant enrolled in the study. Data reported in the paper CRF derived from source 
documents should be consistent with the source documents or the discrepancies should be explained 
and captured in a progress note and maintained in the participant’s official electronic study record.  
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) and clinical 
laboratory data from paper CRFs will be collected by the study sponsor and will be entered into a 21 CFR 
Part 11-compliant data capture system. The data system includes password protection and internal 
quality checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, or 
inaccurate. Clinical data will be entered directly onto paper CRFs from the source documents. 
14.2 
STUDY RECORDS RETENTION  
Study documents should be retained for a minimum of 5 years which is the projected time life of the 
device. These documents will be retained for a longer period, however, if required by local regulations. 
No records will be destroyed without the written consent of the sponsor. It is the responsibility of the 
sponsor to inform the investigator when these documents no longer need to be retained.  
14.3 
PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or MOP requirements. 
The noncompliance may be either on the part of the participant, the investigator, or the study site staff. 
As a result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 These practices are consistent with ICH E6:  
 
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
 
• 
5.1 Quality Assurance and Quality Control, section 5.1.1 
 
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
It is the responsibility of the site to use continuous vigilance to identify and report deviations within 10 
working days of identification of the protocol deviation, or within 10 working days of the scheduled 
protocol-required activity. All deviations must be addressed in study source documents, reported to the 
PI.  Protocol deviations must be sent to the local IRB per their guidelines. The site PI/study staff is 
responsible for knowing and adhering to their IRB requirements. Further details about the handling of 
protocol deviations will be included in the Monitoring Plan.  
14.4 
PUBLICATION AND DATA SHARING POLICY 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted a 
clinical trials registration policy as a condition for publication. The ICMJE defines a clinical trial as any 
research project that prospectively assigns human subjects to intervention or concurrent comparison or 
control groups to study the cause-and-effect relationship between a medical intervention and a health 
outcome. Medical interventions include drugs, surgical procedures, devices, behavioral treatments, 
process-of-care changes, and the like. Health outcomes include any biomedical or health-related 
measures obtained in patients or participants, including pharmacokinetic measures and adverse events. 
The ICMJE policy, and the Section 801 of the Food and Drug Administration Amendments Act of 2007, 

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requires that all clinical trials be registered in a public trials registry such as ClinicalTrials.gov, which is 
sponsored by the National Library of Medicine. Other biomedical journals are considering adopting 
similar policies. For interventional clinical trials, it is the grantee’s responsibility to register the trial in an 
acceptable registry, so the research results may be considered for publication in ICMJE member 
journals. The ICMJE does not review specific studies to determine whether registration is necessary; 
instead, the committee recommends that researchers who have questions about the need to register 
err on the side of registration or consult the editorial office of the journal in which they wish to publish.  
FDA Administration Amendments Act mandates that a "responsible party" (i.e., the sponsor or 
designated principal investigator) register and report results of certain "applicable clinical trials:  
• Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations, of a 
product subject to FDA regulation;  
• Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation (other 
than small feasibility studies) and pediatric post market surveillance studies.  
At the end of the study, the PI will make results of the research available to the research community and 
public at large.  
15 
STUDY ADMINISTRATION 
 
15.1 
STUDY LEADERSHIP 
The Study Team will govern the conduct of the study. The Study Team will be composed of the PI, SI and 
representatives of the sponsor, Venus Concept. The Study Team will meet in person at least annually.  
16 
CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence, such as by the medical device 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the trial. The study leadership has established policies 
and procedures for all study group members to disclose all conflicts of interest and will establish a 
mechanism for the management of all reported dualities of interest.  
17  
LITERATURE REFERENCES  
 
1. Ryu, HS, Joo, YH, et al.  Influence of age and regional differences on skin elasticity as measured 
by the Cutometer.  Skin Research and Technology 2008; 14: 354–358 
 
2. Kreuger, N, Levy, H, Sadick, N. Safety and Efficacy of a New Device Combining 
Radiofrequency and Low-Frequency Pulsed Electromagnetic Fields for the Treatment of Facial 
Rhytides.  Jour Drugs in Derm.  Vol 11 Issue 11 Nov 2012 
 
3. Hardin J, Hilbe J. Generalized Estimating Equations. 2003. London: Chapman and Hall/CRC. 

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4. Faul F, Erdfelder E, Buchner A Lang AG. Statistical power analyses using G*Power 3.1: Tests for 
correlation and regression analyses. Behav Res Methods. 2009, 41(4): 1149-1160. 
 
5. Kreuger, N, Luebberding, S, et al.  Age-related changes in skin mechanical properties: a 
quantitative evaluation of 120 female subjects.  Skin Research and Technology 2011; 17:141-148 
 
 
 

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APPENDIX 
 
Version 
Date 
Significant Revisions