Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction
Phase: NA
Conditions: Wrinkle Reduction
Sponsor: Cutera Inc.

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
                                            Page 1 of 34                                                       Version 2.0, 10 Aug 2017 
 
TITLE PAGE 
 
 
Protocol Number: 
C-17-TS14 
Protocol Title: 
Open-label, Prospective, Multicenter Pivotal Study of the 
Cutera truSculpt™ Radiofrequency Device for Wrinkle 
Reduction 
 
Sponsor: 
 
 
 
 
 
 
 
Principal  
Investigators:  
Cutera, Inc. 
3240 Bayshore Boulevard 
Brisbane, CA 94005 
Telephone: 1-415-657-5538 
Fax:  1-415-715-3722 
Contact: Matthew Hammond 
Email: mhammond@cutera.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version, Date: 
Version 2.0, August 10th, 2017 
 
 
 
Statement of Compliance  
The study will be conducted in accordance with the design and specific provisions of this IRB approved protocol, in 
accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent 
with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).  
 
NOTE:  The confidential information in the following document is provided to you as an Investigator, potential 
Investigator, or consultant for review by you, your staff, and applicable Institutional Review Board. By accepting this 
document, you agree that the information contained herein will not be disclosed to others, without written 
authorization from Cutera, Inc. except to the extent necessary to obtain informed consent from those persons to 
whom the device will be administered. 
 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
                                            Page 2 of 34                                                       Version 2.0, 10 Aug 2017 
Protocol Signature Page – Principal Investigator 
 
PROTOCOL C-17-TS14 
 
 
Study Title:  Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ 
Radiofrequency Device for Wrinkle Reduction 
 
 
Protocol Version 2.0, Dated August 10th, 2017 
 
I have received and read the protocol dated August 10th, 2017 and agree to adhere to the requirements. I 
am aware that my adherence to the above protocol is mandatory and that any changes in the protocol or 
informed consent form must first be approved by Cutera, Inc. and the Institutional Review Board, except 
those changes necessary to eliminate apparent immediate hazards to subjects.  I will provide copies of this 
protocol and all pertinent information to the study personnel under my supervision. I will discuss this 
material with them and ensure they are fully informed regarding their role in the study. I will ensure that 
the study is conducted in compliance with the protocol, Good Clinical Practice (GCP), and all applicable 
regulatory requirements, and with the reviewing Institutional Review Board (IRB) requirements. I agree to 
commence this study only after documented IRB approval is obtained. 
 
 
 
 
Principal 
Investigator 
 
 
 
 
 
 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
Printed Name 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
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Table of Contents 
Protocol Summary .......................................................................................................................................... 5 
1 
PURPOSE ................................................................................................................................................ 6 
2 
BACKGROUND INFORMATION ............................................................................................................... 6 
3 
STUDY OBJECTIVES ................................................................................................................................. 7 
4 
STUDY DESIGN ........................................................................................................................................ 7 
4.1       STUDY ENDPOINTS .............................................................................................................................. 8 
4.1.1 
Efficacy Endpoints .................................................................................................................... 8 
4.2 
Study Duration ................................................................................................................................. 8 
4.3 
Study Assessments .......................................................................................................................... 8 
4.3.1 
Effectiveness Assessment ........................................................................................................ 8 
4.3.2 
Safety Assessments ................................................................................................................ 10 
4.4 
Photographs .................................................................................................................................. 10 
4.5 
Study Discontinuation ................................................................................................................... 10 
4.6 
Investigator Selection .................................................................................................................... 10 
5 
STUDY POPULATION ............................................................................................................................. 10 
5.1 
Study Subject Recruitment and Selection ..................................................................................... 10 
5.1.1 
Inclusion Criteria .................................................................................................................... 11 
5.1.2 
Exclusion Criteria .................................................................................................................... 11 
5.2 
Subject Numbering ........................................................................................................................ 12 
5.3 
Subject Discontinuation Criteria.................................................................................................... 12 
6 
STUDY PROCEDURES ............................................................................................................................ 12 
6.1 
Exploratory Analysis Tools ............................................................................................................. 13 
6.2 
Screening and Enrollment Visit Procedures .................................................................................. 13 
6.3 
1st RF Treatment Visit ................................................................................................................... 13 
6.4 
2nd RF Treatment Visit ................................................................................................................... 14 
6.5 
4-week and 12-week Follow-Up Visits .......................................................................................... 15 
7 
ADVERSE EVENTS ................................................................................................................................. 16 
7.1 
Definitions ..................................................................................................................................... 16 
7.1.1 
Adverse Events and Expected Adverse Device Events (ADE)................................................. 16 
7.1.2 
Serious Adverse Event (SAE) .................................................................................................. 16 
7.1.3 
Anticipated Serious Adverse Device Effect (ASADE) .............................................................. 16 
7.1.4 
Unanticipated Serious Adverse Device Effect (USADE/UADE) .............................................. 18 
7.2 
Recording Adverse Events and Expected Adverse Device Events (ADEs) ..................................... 18 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
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7.3 
Follow-up of AEs and ADEs ............................................................................................................ 18 
8 
POTENTIAL RISKS / BENEFITS ............................................................................................................... 18 
8.1 
Potential Risks and Expected Adverse Device Effects (ADEs) ....................................................... 18 
8.2 
Potential Benefits .......................................................................................................................... 20 
8.3 
Risk Management .......................................................................................................................... 20 
9 
DATA ANALYSIS PLAN ........................................................................................................................... 20 
9.1 
Sample Size .................................................................................................................................... 20 
9.2 
Analysis Sets .................................................................................................................................. 20 
9.3 
Analysis of Efficacy Endpoints ....................................................................................................... 20 
9.3.1 
Primary Endpoint Analysis ..................................................................................................... 20 
9.3.2 
Secondary Endpoint Analyses ................................................................................................ 20 
9.4 
Safety Analyses .............................................................................................................................. 21 
10 SUBJECT PAYMENT ............................................................................................................................... 21 
11 STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES ............................................................. 21 
11.1 
Training and Monitoring ............................................................................................................ 21 
11.2 
Informed Consent ...................................................................................................................... 21 
11.3 
Protocol Compliance .................................................................................................................. 22 
11.3.1 
Protocol Amendments ............................................................................................................... 22 
11.3.2 
Protocol Deviations .................................................................................................................... 22 
11.4 
Study Personnel ......................................................................................................................... 22 
11.5 
Disclosure of Financial Interest .................................................................................................. 22 
11.6 
Data Collection, Record Keeping and Storage ........................................................................... 23 
11.7 
Subject Confidentiality ............................................................................................................... 23 
11.8 
Publication Policy ....................................................................................................................... 24 
REFERENCES ............................................................................................................................................. 25 
Appendix 1: Study Schedule ........................................................................................................................ 27 
Appendix 2: Before and After Treatment Instructions ................................................................................ 28 
Appendix 3: Pain Rating Scale .................................................................................................................... 29 
Appendix 4: Fitzpatrick Skin Type Classification ....................................................................................... 30 
Appendix 5: Fitzpatrick Wrinkle Classification System .............................................................................. 31 
Appendix 6: Merz Aesthetics Scale (MAS) ................................................................................................. 32 
Appendix 7: Subject Questionnaire ............................................................................................................. 33 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
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1 
PURPOSE 
The purpose of this investigation is to evaluate the safety and efficacy of the truSculpt radiofrequency (RF) 
device for wrinkle reduction and improvement of skin quality. 
2 
 BACKGROUND INFORMATION 
 
Non-invasive treatment options to improve one’s appearance are in high demand by patients wanting to 
avoid surgical intervention. Due to this demand, patients have a variety of options for non-invasive 
wrinkle-reduction treatment, from laser and light-based treatments to devices that utilize ultrasound and 
radiofrequency. By delivering energy into the skin in the form of light, ultrasound or radio waves, thereby 
causing heat generation in the sub layers, these treatment modalities can be used to improve wrinkles 
and skin laxity [1-24].  
 
Ultrasound and radiofrequency (RF) devices are increasingly utilized for non-invasive tissue tightening due 
to the ability of these technologies to penetrate the dermis at greater depths, as compared to light-based 
devices [25-27]. When collagen is heated sufficiently, intramolecular bonds sensitive to heat are broken 
and the collagen fibril transforms form a highly-organized structure to a random, gel-like state. Immediate 
collagen contraction occurs as a result of unwinding of the triple helix structure and the residual tension 
of the heat-resistant intermolecular bonds [30]. The effect of collagen denaturation from tissue heating is 
dependent on a number of factors, including maximum temperature reached, exposure time, 
concentration and orientation of the collagen fibers, and the hydration level of the tissue [30]. Many 
studies have examined histology of post-treatment skin biopsy samples, which demonstrated increased 
collagen deposition in the weeks to months following device treatments that cause thermal-induced 
wound healing. In addition, histology samples have demonstrated collagen fibers aligned in a horizontal 
orientation parallel to the plane of the epidermis. Some studies have demonstrated dermal and epidermal 
thickening [31]. Uniform volumetric heating of the epidermal, dermal and sub-dermal layers of the skin 
results in a primary effect of immediate collagen contraction and a secondary effect of fibroblast 
proliferation and the production of new collagen and elastic over time as a result of inflammation and the 
wound healing response. [22, 27-29].  
 
RF, which is the most studied device in the non-ablative category, uses electrical current rather than light 
energy.  Unlike light energy, radio waves can penetrate deeper depending on the frequency of operation. 
RF can be used with all Fitzpatrick skin types without jeopardizing epidermal integrity [33].   
 
RF devices generate heat in the form of thermal energy as a result of electrical current delivered to the 
tissue. There is a natural resistance to the movement of electrons within the RF field when electrical 
current is applied [25]. This resistance will dictate the amount of thermal energy generated within the 
tissue according to Ohm’s Law, which states the amount of energy generated is dependent on the 
electrical current, the tissue impedance and the time of application.  Ohm’s Law is expressed as an 
equation, where I is the amount of current (in Amps), Z is the tissue impedance (in Ohms) and t is the time 
current is applied (in seconds) [25, 30, 32]:   
Energy (Joules) = I2x Z x t 
 
RF may be delivered in three different ways: 1) Monopolar when energy is applied as current between a 
single electrode tip and a grounding plate.  2) Bipolar when energy is applied between two points on the 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
                                            Page 10 of 34                                                       Version 2.0, 10 Aug 2017 
4.3.1.5 Treatment-related Discomfort 
Subjects will be asked after each procedure (2 total treatments) to rate the average amount of discomfort 
experienced during RF treatment using the Pain Rating Scale found in Appendix 3. 
4.3.2 
Safety Assessments 
4.3.2.1 Incidence and Severity of Adverse Events:   
Following the first RF treatment, adverse device effects (ADEs) will be assessed post-treatment and at 
each subsequent subject visit using the following scale: 
 
1= mild: requires minimal or no treatment and does not interfere with the Subject’s daily activities. 
2= moderate: may cause some interference with functioning.  
3= severe: interrupts Subject’s usual daily activity and may require treatment. 
4.4 
Photographs 
Standardized digital photographs will be taken of each subject’s face and submental region. Photographs 
will be taken at baseline, prior to all RF treatments, and at each follow-up visit. Photographs will be 
obtained from at least three angles: 1) with the subject facing forward, 2) 45° to the right, and 3) 45° to 
the left. Photographs will be taken in the same windowless room equipped with adequate lighting. The 
room lighting, camera positioning and subject positioning should be consistent for all study visit 
photographs. Digital camera settings should remain the same for all photographs and the highest 
resolution settings should be utilized.  
4.5 
Study Discontinuation 
The study sponsor has the right to terminate this study at any time.  Reasons for terminating the study 
may include, but are not limited to, unsatisfactory subject enrollment or the incidence or severity of 
adverse events in this study, or other studies with the study device, indicates a potential health hazard to 
subjects. 
4.6 
Investigator Selection 
Investigators will be invited to participate in the study based on their medical specialty, experience 
conducting clinical research studies and experience in the use of energy based devices for aesthetic 
indications. The site’s access to potential study subjects and ability to cooperate with study requirements 
will also be considered.  
5 
STUDY POPULATION 
5.1 
Study Subject Recruitment and Selection 
Up to 40 male or female subjects, ages 25 to 65, with Fitzpatrick Skin Type I-VI who desire RF treatment 
for wrinkle reduction. Subjects will be recruited to participate from those patients who present 
themselves to the site requesting treatment, or from those patients who respond to advertisement. Only 
subjects who meet all Inclusion and Exclusion Criteria and provide written informed consent will be 
enrolled into the study.  
 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
                                            Page 11 of 34                                                       Version 2.0, 10 Aug 2017 
Each subject will be evaluated by the Investigator to assess his/her suitability for entry into the study 
according to the following inclusion and exclusion criteria.  
5.1.1 
Inclusion Criteria 
To be included in the study, subjects must meet all of the following Inclusion Criteria: 
 
1.  
Must be able to understand and provide written informed consent and release of health 
information 
2.  
Male or Female, 25 to 65 years of age (inclusive) 
3.  
Fitzpatrick Skin Type I – VI (Appendix 4) 
4.  
Has visible wrinkles or skin laxity in the treatment area 
5.  
On the Fitzpatrick Classification Wrinkle Classification System subject has a pre-
treatment score of 4-9 (inclusive) (Appendix 5) 
6.  
No use of tobacco products for at least 6 months and willing to refrain from use for the 
duration of the study 
7.  
Subject must agree to not undergo any other cosmetic procedure(s) area, or start 
topical retinol products in the treatment area during the study period 
8.  
Subject must be willing to adhere to the follow-up schedule and study instructions 
9.  
Subject must be willing to adhere to the same diet and/or exercise routine throughout 
the study, and agree to maintain the same weight throughout the study, within 10% of 
baseline weight measurement 
10.  
Willing to have digital photographs taken of the treatment area and agree to use of 
photographs for presentations, educational, and/or marketing purposes 
11.  
For female subjects: not pregnant or lactating and is either post-menopausal, surgically 
sterilized, or using a medically acceptable form of birth control at least 3 months prior to 
enrollment and during the entire course of the study, and no plans to become pregnant 
5.1.2 
Exclusion Criteria 
Subjects will be excluded from the study if they meet any of the following Exclusion Criteria: 
 
1.  
Participation in a clinical trial of a drug or another device in the target area within 3 
months of study participation, or during the study. 
2.  
Any type of prior cosmetic treatment to the target area within 12 months of study 
participation e.g., radiofrequency, cryolipolysis, deoxycholate injection, or light-based 
treatments 
3.  
Prior injection of botulinum toxin, collagen, hyaluronic acid filler, or other dermal filler, 
and medium-depth to deep chemical peels, to the treatment area within 6 months of 
study participation 
4.  
History of systemic steroid use within 3 months; history of topical steroid use in the 
target area within 2 months 
5.  
History of systemic retinoid (isotretinoin) and therapeutic dose of Vitamin A within 6 
months of study participation 
6.  
Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve 
stimulator implant, cochlear implant or any other electronically, magnetically or 
mechanically activated implant 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
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Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
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7 
ADVERSE EVENTS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
                                            Page 17 of 34                                                       Version 2.0, 10 Aug 2017 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
                                            Page 20 of 34                                                       Version 2.0, 10 Aug 2017 
8.2 
Potential Benefits 
The subjects may or may not benefit from the treatment. Potential benefits include improved appearance 
of the wrinkles and sagging skin treated in the face or submental region. There is no guarantee of success.  
8.3 
Risk Management 
The Investigator chosen for this study will have extensive and safe experience with the use of RF systems 
in dermatology applications. This is the most critical element in managing subject risk. In addition, the 
Investigators will be trained on the use of the Cutera RF device and any investigational handpieces. 
9 
DATA ANALYSIS PLAN  
9.1 
Sample Size 
The primary objective is to 
 
 is statistically greater than 50%.  
Under the assumption that the true population response rate is 76%, 35 subjects will provide 80% power 
to reject the primary hypothesis.  To allow for up to a 10% dropout rate, 39 subjects will be enrolled.   The 
planned sample size of up to 35 subjects was determined based on clinical judgment to provide sufficient 
information to evaluate safety and efficacy of RF treatment for wrinkle reduction in the face and/or 
submentum region. 
9.2 
Analysis Sets 
The efficacy analysis set will include all enrolled subjects who complete one RF treatment session using 
the study device. 
 
The safety analysis set will include all subjects enrolled in the study who start the RF treatment session 
using the study device. 
 
Missing data will not be imputed for efficacy or safety endpoints. 
9.3 
Analysis of Efficacy Endpoints 
9.3.1 
 
 
 
 
 
 
 
 
9.3.2 
Endpoint Analyses 
 efficacy endpoints will be analyzed descriptively.  
• Principal Investigator’s assessment of improvement at 12 weeks post-final treatment (Physician’s 
Global Assessment) 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
                                            Page 21 of 34                                                       Version 2.0, 10 Aug 2017 
•
 
 
 
 
9.4 
Safety Analyses 
Device-related and procedure-related adverse device effects (ADEs) and subjects who prematurely 
terminate from the study due to an adverse device effect, including the treatment-related pain ratings, 
will be tabulated and analyzed. For a given ADE term, counting will be done by subject, not by event, i.e. 
for a subject reporting the same ADE more than once, the event will be counted only once, at the most 
severe and longest duration.  The number and percentage of subjects experiencing each ADE Term will be 
descriptively summarized. Subject pain ratings during treatment will also be summarized descriptively. 
10 SUBJECT PAYMENT 
.  
11 STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES  
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
.  
 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
                                            Page 22 of 34                                                       Version 2.0, 10 Aug 2017 
 
  
 
 
 
 
  
 
 
 
 
 
11.3 Protocol Compliance 
The principal investigator must comply with all terms of the protocol. 
11.3.1 Protocol Amendments 
Neither the principal investigator nor the sponsor will modify or alter this protocol without first obtaining 
the concurrence of the other party (with the exception of amendments which involves mitigating a 
medical emergency or immediate health risk to the subject). The party initiating an amendment must 
confirm it clearly in writing and it must be signed and dated by the sponsor and the principal investigator. 
IRB approval must be obtained before implementation of an amendment. 
11.3.2  Protocol Deviations 
All protocol deviations must be clearly described on the case report form (i.e., Cutera Protocol Deviation 
Form). Deviations from the protocol may include but are not limited to subject’s failure to attend 
scheduled visit during a visit window, use of out of range treatment parameters and incomplete or 
incorrect study procedures. Any medical emergency or immediate health risk to the subject which results 
in a protocol deviation and must be reported to the sponsor within 5 working days 
 
Significant protocol deviations must be reported to IRB according to their policies. 
11.4 Study Personnel 
Prior to the start of the study, the investigator must supply the sponsor with a list of the names and 
curricula vitae that describe the professional backgrounds of the clinically responsible study investigators 
(principal, sub-investigators), research nurses, and other possible participants (e.g. medical doctor, nurse, 
etc.). 
11.5 Disclosure of Financial Interest 
Each investigator [principal and sub-investigator(s)] is required to disclose sufficient accurate financial 
information to the sponsor, to allow sponsor to submit complete and accurate certification or disclosure 
statements. 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
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11.7 Subject Confidentiality 
This study preserves the confidentiality of all subjects under the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) Privacy Rule. The following safeguards will be in place to protect the 
privacy of the individuals who are the subjects of the health information to be used in the research and 
the confidentiality of that information:   
 
The subjects will be informed by the investigator or the investigator’s designee that their medical records 
will be kept as confidential as possible but may be subject to review by: (1) Cutera, or its representative; 
(2) reviewing IRB; and/or (3) by appropriate regulatory bodies (e.g. the US Food and Drug Administration 
(FDA), Department of Health and Human Services (DHHS) agencies).  
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
                                            Page 24 of 34                                                       Version 2.0, 10 Aug 2017 
 
 
 
 
 
 
 
 
11.8 Publication Policy 
The investigator shall have the right to publish the results of the study. Unless mutually agreed upon in 
writing, prior to submission for publication of any manuscript, poster, presentation, abstract or other 
written or oral material describing the results of the study, the investigator shall allow sponsor to review 
manuscript, poster presentation, abstract or other written or oral material which describes the results of 
the study for the purpose only of determining if any patentable information is disclosed. At the sponsor’s 
request, the investigator shall withhold any publication or presentation to permit sponsor to seek patent 
protection and to remove any confidential information from all publications.  
 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted a trials 
registration policy as a condition for publication. This policy 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. It 
is the responsibility of the sponsor to register this trial in ClinicalTrials.gov. Any clinical trial starting 
enrollment after September 27, 2007 must be registered either on or before the onset of patient 
enrollment. 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
                                            Page 25 of 34                                                       Version 2.0, 10 Aug 2017 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
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Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
 
                                            
                                                       
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-TS14 
“Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction” 
 
Confidential and Proprietary 
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