Open-label, Prospective, Multicenter Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment
Phase: NA
Conditions: Scarring, Skin Aging
Sponsor: Cutera Inc.

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 1 of 31                                                                    Version 2.0; 12SEP2017 
 
 
 
 
TITLE PAGE 
 
 
Protocol Number: 
C-17-EV11 
Protocol Title: 
Open-label, Prospective, Multicenter Study to Evaluate 
the Cutera Excel V™ Laser and a Micro-Lens Array 
Attachment 
Sponsor: 
 
 
 
 
 
 
 
Cutera, Inc. 
3240 Bayshore Boulevard 
Brisbane, CA 94005 
Telephone: 1-305-490-8452 
Fax:  1-415-715-3722 
Contact:  Michaela Bell 
Email:  mbell@cutera.com 
Version, Date: 
Version 2.0- Dated: September 12, 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-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 2 of 31                                                                    Version 2.0; 12SEP2017 
Protocol Signature Sheet – Principal Investigator 
 
 
PROTOCOL C-17-EV11 
 
 
Study Title:   Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens 
Array Attachment 
 
Protocol Version 2.0, Date: 12SEP2017   
 
I have received and read the protocol dated September 12, 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 
 
Date 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 3 of 31                                                                    Version 2.0; 12SEP2017 
TABLE OF CONTENTS 
1. BACKGROUND INFORMATION ........................................................................................................................................... 6 
2. STUDY DEVICE .................................................................................................................................................................... 6 
3. STUDY OBJECTIVES ............................................................................................................................................................. 7 
a. 
To evaluate the safety of the Cutera excel V laser and the Micro-Lens Array attachment. .......................................... 7 
b. 
To evaluate the efficacy of the Cutera excel V laser and the Micro-Lens Array attachment in the improvement of skin 
quality…………………………………………………………………………………………….............................................................................................7 
4. STUDY DESIGN ................................................................................................................................................................... 7 
4.1 
Study Endpoints ....................................................................................................................................................... 7 
4.1.1 Primary Safety Endpoint ............................................................................................................................................. 7 
4.1.2 Secondary Efficacy Endpoints ..................................................................................................................................... 7 
         4.1.3 Exploratory Analysis………………………………………………………………………………………………………………………………………………7 
4.2 Study Duration ................................................................................................................................................................. 7 
4.3 Study Effectiveness Assessments ...................................................................................................................................... 8 
4.3.1 Investigator Assessments ........................................................................................................................................... 8 
4.3.3 Subject Satisfaction Assessment ................................................................................................................................ 9 
4.4   Study Safety Assessments ............................................................................................................................................... 9 
4.4.1 Incidence and Severity of Adverse Events: ................................................................................................................. 9 
4.4.2 Treatment-related Discomfort ................................................................................................................................. 10 
4.4.3 Phone Follow-up ....................................................................................................................................................... 10 
4.5 Photographs .................................................................................................................................................................. 10 
4.6 Study Discontinuation .................................................................................................................................................... 10 
4.7 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 ........................................................................................................................................................ 13 
6.1 Screening / Enrollment ................................................................................................................................................... 13 
6.2 Laser Treatment 1 to 6 – Visit Window and Pre-Treatment Procedures .......................................................................... 13 
6.3 Laser Treatment Procedures ........................................................................................................................................... 14 
6.4 Phone and Follow-Up Visits ............................................................................................................................................ 15 
7. ADVERSE EVENTS and EXPECTED ADVERSE DEVICE EFFECTS ............................................................................................ 16 
7.1 Definitions ...................................................................................................................................................................... 16 
7.1.1 
Adverse Event ....................................................................................................................................................... 16 
7.1.2 
Serious Adverse Event .......................................................................................................................................... 16 
7.2 Recording AEs, EADEs, ADEs and SADEs ......................................................................................................................... 19 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 4 of 31                                                                    Version 2.0; 12SEP2017 
7.3 Follow-up of subjects after AEs/ADEs and SAEs/SADEs: ................................................................................................. 19 
8. POTENTIAL RISKS / BENIFITS ............................................................................................................................................ 19 
8.1 Potential Risks ................................................................................................................................................................ 19 
8.2 Potential Benefits ........................................................................................................................................................... 20 
9. RISK MANAGEMENT......................................................................................................................................................... 20 
10. DATA ANALYSIS PLAN .................................................................................................................................................... 21 
10.1 Sample Size .................................................................................................................................................................. 21 
10.2 Statistical Analysis Methods ......................................................................................................................................... 21 
11. SUBJECT PAYMENT ......................................................................................................................................................... 21 
12. STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES ......................................................................................... 21 
12.1 Training and Monitoring .............................................................................................................................................. 21 
12.2 Informed Consent ......................................................................................................................................................... 21 
12.3 Protocol Compliance .................................................................................................................................................... 22 
12.4 Protocol Amendments ............................................................................................................................................... 22 
12.5 Protocol Deviations ................................................................................................................................................... 22 
12.6 Study Personnel............................................................................................................................................................ 22 
12.7 Disclosure of Financial Interest ..................................................................................................................................... 23 
12.8 Data Collection, Record Keeping and Storage .............................................................................................................. 23 
13. SUBJECT CONFIDENTIALITY ............................................................................................................................................ 23 
14. PUBLICATION POLICY ..................................................................................................................................................... 24 
Appendix 1: Study Schedule ................................................................................................................................................. 26 
Appendix 2: Pain Rating Scale .............................................................................................................................................. 27 
Appendix 3:  Follow-Up Subject Questionnaire (page 1 of 2) ................................................................................................ 28 
Appendix 3:  Follow-Up Subject Questionnaire (page 2 of 2) ................................................................................................ 29 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 6 of 31                                                                    Version 2.0; 12SEP2017 
1. BACKGROUND INFORMATION 
Non-invasive treatment options are in high demand by patients wanting to improve their appearance 
without surgical intervention. As a result, patients now have a variety of options for non-invasive skin 
rejuvenation, from laser and light-based treatments to devices that utilize ultrasound and radiofrequency, 
however this was not always the case. Initial skin rejuvenation procedures utilized ablative lasers, such as 
the carbon dioxide (CO2) and erbium:yttrium-aluminum-garnet (Er:YAG), and resulted in substantial 
improvement in skin appearance, texture, rhytides and laxity[1-3]. However, since ablative treatments 
destroy the epidermal layer of the skin in order to penetrate and heat the deeper dermal layers, ample 
post-procedure recovery time is required and patients may experience side effects lasting for a few weeks. 
Furthermore, hypo- or hyperpigmentation, prolonged wound healing and even scarring can occur 
following ablative procedures [4-6]. Treatment methods with less risk of side effects and post-treatment 
down time are in high demand. As such, the choices are vast and varied, ranging from fractional non-
ablative laser devices to those that use radiofrequency [7-15]. Fractional lasers inflict microscopic zones 
of thermal damage in the dermal layers of the skin without destruction of the epidermis, thereby reducing 
recovery time significantly as compared to ablative procedures[16]. Treatment with non-fractional, non-
ablative laser devices requires little to no post-procedure recovery time. Nonablative lasers of various 
wavelengths are effective for skin rejuvenation based on the principle of selective photothermolysis, 
whereby laser light is absorbed by hemoglobin in blood vessels and melanin in pigment-producing skin 
cells [17, 18]. Absorption of laser light by these molecular chromophores results in the production of heat, 
leading to destruction of unwanted blood vessels and pigment cells. Heat production within the dermis 
by the laser light also results in immediate collagen contraction and heat-induced wound healing that, 
over time, causes a cascade of cellular events leading to new collagen production and improved skin 
appearance [8, 10, 19-23]. 
 
 
 
 
 
 
 
 
 
 
 
 
  
2. 
 
 
 
 
 
 
 
, 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 9 of 31                                                                    Version 2.0; 12SEP2017 
 
 
 
 
4.4   Study Safety Assessments 
 
4.4.1 Incidence and Severity of Adverse Events: 
Following the first laser treatment, adverse effects (AEs) will be assessed post-treatment and at each 
subsequent 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. 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 10 of 31                                                                    Version 2.0; 12SEP2017 
4.4.2 Treatment-related Discomfort 
After each laser treatment, subjects will be asked to rate the average amount of discomfort 
experienced during treatment and immediately after laser treatment. 
4.4.3 
 
 
 
   
  4.5 Photographs 
Standardized digital photographs will be taken of each subject’s treatment area at baseline, prior to              
and post all laser treatments and at each follow-up visit. Treatment area will be cleansed and any 
jewelry and make-up will be removed from the area being photographed. For facial photographs, hair 
will be pulled away from the face with a headband. 
 
Facial photographs will be obtained from at least 3 angles: with the subject facing forward, 45° to the 
right and 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. 
4.6 Study Discontinuation 
Cutera, Inc. (the sponsor) has the right to terminate this study at any time.  Reasons for terminating the 
study may include, but are not limited to, the following: incidence or severity of adverse events in this or 
other studies indicates a potential health hazard to subjects; subject enrollment is unsatisfactory; number 
of protocol deviations is unacceptable; data recording is inaccurate or incomplete; or questionable study 
site compliance with ICH-E6, Good Clinical Practice23. 
4.7 Investigator Selection 
The Investigator(s) will be invited to participate in the study based on his or her medical specialty, 
experience conducting clinical research studies and experience in the use of light-based devices for 
aesthetic indications. Access to potential study subjects and the Investigator’s sincere interest in this study 
along with expressed willingness to cooperate with the study process and requirements was also 
considered.  
5. STUDY POPULATION 
5.1 Study Subject Recruitment and Selection 
Approximately 60 male or female subjects, ages 18 to 65, with Fitzpatrick Skin Type I-VI who desire laser 
treatment for rhytides, lentigines, pigmentation, pore size, acne scars, erythema, telangiectasia and skin 
texture.   Subjects will be recruited to participate from the local population. Subjects may also be recruited 
from the Investigator’s existing patient database or from patients who present themselves to the study 
site requesting treatment. Only subjects who meet all eligibility criteria and who provide written informed 
consent will be enrolled into the study. 
 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 11 of 31                                                                    Version 2.0; 12SEP2017 
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.  
Subject must be able to read, understand and sign the Informed Consent Form. 
2.  
Female or Male, 18 to 65 years of age (inclusive). 
3.  
Fitzpatrick Skin Type I – VI. 
4.  
Must be willing to have Cutera excel V laser treatments and able to adhere to the 
treatments, follow-up visit schedule, and post-treatment care instructions. 
5.  
Willing to have very limited sun exposure and use sunscreen on the treatment area 
every day for the duration of the study, including the follow-up period. 
6.  
Willing to have digital photographs taken of the treatment area and agree to use of 
photographs for presentation (educational and/or marketing), publications, and any 
additional marketing purposes. 
7.  
Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the face 
during the study and has no intention of having such procedures performed during the 
course of the study. 
8.  
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.,  
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 another drug, or device administered to the 
treatment area, within 3 months prior to enrollment or during the study. 
2. 
Any type of prior cosmetic treatment to the target area within 6 months of study 
participation, such as laser procedures, facial fillers, toxins and those used for general 
aesthetic correction. 
3. 
Use of prescription topicals in the treatment area within one month prior to 
treatment or use of topical agents one week prior to treatment that may cause facial 
sensitivity. 
4. 
Suffering from significant skin conditions in the treated areas or inflammatory skin 
conditions, including but not limited to, open lacerations or abrasions, hidradenitis, 
rash, infection , or dermatitis of the treatment area prior to treatment (duration of 
resolution as per the Investigator’s discretion). 
5. 
Pregnant and/or breastfeeding, or planning to become pregnant. 
6. 
Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune 
deficiency disorders (including HIV infection or AIDS) or using immunosuppressive 
medication. 
7. 
Hypersensitivity to light exposure.  
8. 
Any use of medication that is known to increase sensitivity to light according to the 
Investigator’s discretion. 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 12 of 31                                                                    Version 2.0; 12SEP2017 
9. 
History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone 
to bruising.  
10. 
Has a history of squamous cell carcinoma or melanoma in the treatment area. 
11. 
History of epidermal or dermal disorders (particularly if involving collagen or 
microvascularity), including collagen vascular disease or vasculitic disorders. 
12. 
A history or active skin condition that in the opinion of the Investigator may 
interfere/confound with the treatment.  
13. 
History of connective tissue disease, such as systemic lupus erythematosus or 
scleroderma.  
14. 
History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes 
zoster (shingles) in the treatment area, unless treatment is conducted following a 
prophylactic regimen. 
15. 
History of pigmentary disorders, particularly tendency for hyper- or hypo-
pigmentation, or any that are considered not acceptable by the study investigator. 
16. 
Has used oral isotretinoin (Accutane or therapeutic vitamin A supplements of ≥ 
10,000 units per day) within 12 months of initial treatment or plans on using during 
the course of the study (note: skin must regain its normal degree of moisture prior to 
treatment, e.g. lack of noticeable skin flaking and peeling).  
17. 
Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely to 
refrain from tanning during the study.  
19.  
Excessive facial hair in the area to be treated (beards, sideburns, and/or moustache,) 
that would interfere with diagnosis, assessment, and treatment. 
20. 
As per the Investigator’s discretion, any physical or mental condition which might make 
it unsafe for the subject to participate in this study, including excessive alcohol or drug 
abuses, or a condition that would compromise the subject’s ability to comply with the 
study requirements. 
5.2 Subject Numbering  
If a subject completes the Informed Consent Form, meets the study eligibility criteria and is willing to 
participate, the subject will be assigned a study subject identification number. This number is comprised 
of a site number (which is provided by the sponsor) and a sequential subject number and the subject 
initials (first and last names). 
5.3 Subject Discontinuation Criteria 
If possible, every subject should remain in the study until completion of the required follow-up period. 
However, participation in this study is completely voluntary and a subject can choose to withdraw from 
the study at any time.  Decision to withdraw will not affect or prejudice the subject’s continued medical 
care in any way. In those instances, the investigator will attempt to obtain a final clinical assessment and 
an adverse device effect evaluation for the subject prior to this withdrawal. A subject will be considered 
lost to follow-up only after three unsuccessful, documented attempts to contact the subject have been 
made.   
 
In addition, a subject can be discontinued for any of the following reasons: the Principal Investigator 
decides that continuing in the study would not be in the subject’s best interest, a subject is noncompliant 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 13 of 31                                                                    Version 2.0; 12SEP2017 
with the protocol, a subject has a serious reaction to the treatment, a subject develops any of the exclusion 
criteria during the study period or the study is stopped by the study sponsor. 
  
6. STUDY PROCEDURES  
A summary of all study required procedures and assessments can be found in Appendix 1. 
 
 
 
   
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
  
 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 15 of 31                                                                    Version 2.0; 12SEP2017 
  
 
 
  
 
 
 
   
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 16 of 31                                                                    Version 2.0; 12SEP2017 
7. ADVERSE EVENTS and ADVERSE DEVICE EFFECTS  
7.1 Definitions 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 17 of 31                                                                    Version 2.0; 12SEP2017 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 18 of 31                                                                    Version 2.0; 12SEP2017 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 20 of 31                                                                    Version 2.0; 12SEP2017 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
8.2 Potential Benefits 
The subjects may or may not benefit from the treatment with the study device. Potential benefit of laser 
treatment is improved in the appearance of the skin. There is no guarantee of success.  
9. RISK MANAGEMENT 
The investigator participating in this study was chosen based on extensive and safe experience with the 
use of lasers in dermatology applications. This is the most critical element in managing subject risk. In 
addition, study investigators will be trained on the use of the Cutera excel V laser system by a 
representative of Cutera. 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 22 of 31                                                                    Version 2.0; 12SEP2017 
 
 
 
  
 
 
 
 
 
  
 
 
  
 
 
 
 
  
 
 
 
 
  
12.3 Protocol Compliance 
The principal investigator must comply with all terms of the protocol. 
12.4 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. 
12.5 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. 
12.6 Study Personnel 
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.). 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 23 of 31                                                                    Version 2.0; 12SEP2017 
12.7 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. 
12.8 
 
 
 
 
   
 
 
 
 
 
  
 
 
 
 
 
  
13. 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:   
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 24 of 31                                                                    Version 2.0; 12SEP2017 
 
 
 
 
 
  
14. 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-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 25 of 31                                                                    Version 2.0; 12SEP2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 26 of 31                                                                    Version 2.0; 12SEP2017 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 27 of 31                                                                    Version 2.0; 12SEP2017 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 28 of 31                                                                    Version 2.0; 12SEP2017 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 29 of 31                                                                    Version 2.0; 12SEP2017 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
 Page 30 of 31                                                                    Version 2.0; 12SEP2017 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV11 
“Open-label, Prospective, Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment” 
Confidential and Proprietary 
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