Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera Excel V™ Laser With Green Genesis and a Micro-Lens Array Attachment as Compared to the Standard-of-care With an Excel V™ Laser
Phase: NA
Conditions: Wrinkle, Rosacea, Scarring
Sponsor: Cutera Inc.

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 1 of 36                                                                    Version 1.0; 06Nov17 
 
 
 
TITLE PAGE 
 
 
Protocol Number: 
C-17-EV12 
Protocol Title: 
Open-label, Prospective, Single-Center Feasibility Study to 
Evaluate the Cutera excel V™ Laser with Green Genesis and 
a Micro-Lens Array Attachment as compared to the 
standard-of-care with an excel V™ Laser  
 
Sponsor: 
 
 
 
 
 
 
 
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 1.0, Dated: November 6th, 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-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 2 of 36                                                                    Version 1.0; 06Nov17 
 
 
Protocol Signature Sheet – Principal Investigator 
 
 
PROTOCOL C-17-EV12 
 
Study Title:   
Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser 
with Green Genesis and a Micro-Lens Array Attachment as compared to the standard-of-care with an excel 
V™ Laser  
 
Protocol Version 1.0, Date: November 6th, 2017 
 
I have received and read the protocol dated November 6th, 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-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 3 of 36                                                                    Version 1.0; 06Nov17 
TABLE OF CONTENTS 
1. BACKGROUND INFORMATION ................................................................................................ Error! Bookmark not defined. 
2. STUDY DEVICE .................................................................................................................................................................... 6 
3. STUDY OBJECTIVES ............................................................................................................................................................. 7 
4. Study Design and Endpoints ............................................................................................................................................... 7 
4.1. 
Primary Endpoint .................................................................................................................................................... 7 
4.1.2 
Secondary Endpoints .............................................................................................................................................. 8 
4.1.3    Exploratory Analysis ................................................................................................................................................. 8 
4.2 Study Duration ................................................................................................................................................................. 8 
4.3 Study Effectiveness Assessments ...................................................................................................................................... 8 
4.3.1 
Investigator Assessments ........................................................................................................................................ 8 
4.3.2 Subject Satisfaction Assessment .............................................................................................................................. 10 
4.4   Study Safety Assessments ............................................................................................................................................. 10 
4.4.1 Incidence and Severity of Adverse Events: ............................................................................................................... 10 
4.4.2 Treatment-related Discomfort ................................................................................................................................. 10 
4.4.3 Phone Follow-up ....................................................................................................................................................... 10 
4.5 Photographs ................................................................................................................................................................... 10 
4.6 Study Discontinuation .................................................................................................................................................... 11 
4.7 Investigator Selection ..................................................................................................................................................... 11 
5. STUDY POPULATION ........................................................................................................................................................ 11 
5.1 Study Subject Recruitment and Selection ....................................................................................................................... 11 
5.1.1 Inclusion Criteria ....................................................................................................................................................... 11 
5.1.2 Exclusion Criteria ...................................................................................................................................................... 12 
5.2 Subject Numbering ......................................................................................................................................................... 13 
5.3 Subject Discontinuation Criteria ..................................................................................................................................... 13 
6. STUDY PROCEDURES ........................................................................................................................................................ 13 
6.1 Screening / Enrollment ................................................................................................................................................... 13 
6.2 Laser Treatment Visits 1 to 5 – Visit Window and Pre-Treatment Procedures ................................................................ 15 
6.3 Laser Treatment Procedures ........................................................................................................................................... 16 
6.4 Phone and Follow-Up Visits ............................................................................................................................................ 16 
6.5 Evening Laser Treatment Visits (up to 2) ........................................................................................................................ 17 
7. ADVERSE EVENTS and ADVERSE DEVICE EFFECTS ............................................................................................................. 18 
7.1 Definitions ...................................................................................................................................................................... 18 
7.1.1 
Adverse Event ....................................................................................................................................................... 18 
7.1.2 
Serious Adverse Event .......................................................................................................................................... 18 
7.1.2.1  Anticipated Serious Adverse Device Events …………………………………………………………………………………………………….19 
7.1.2.2  Unanticipated Serious Adverse Device Events …………………………………………………………………………………………………19 
7.2 Recording AEs, EADEs, ADEs and SADEs ......................................................................................................................... 21 
7.3 Follow-up of subjects after AEs/ADEs and SAEs/SADEs: ................................................................................................. 21 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 4 of 36                                                                    Version 1.0; 06Nov17 
8. POTENTIAL RISKS / BENIFITS ............................................................................................................................................ 21 
8.1 Potential Risks ................................................................................................................................................................ 21 
8.2 Potential Benefits ........................................................................................................................................................... 22 
9. RISK MANAGEMENT......................................................................................................................................................... 22 
10. DATA ANALYSIS PLAN .................................................................................................................................................... 23 
10.1 Sample Size .................................................................................................................................................................. 23 
10.2 Statistical Analysis Methods ......................................................................................................................................... 23 
11. SUBJECT PAYMENT ......................................................................................................................................................... 23 
12. STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES ......................................................................................... 23 
12.1 Training and Monitoring .............................................................................................................................................. 23 
12.2 Informed Consent ......................................................................................................................................................... 23 
12.3 Protocol Compliance..................................................................................................................................................... 24 
12.4 Protocol Amendments .................................................................................................................................................. 24 
12.5 Protocol Deviations ...................................................................................................................................................... 24 
12.6 Study Personnel ............................................................................................................................................................ 24 
12.7 Disclosure of Financial Interest ..................................................................................................................................... 24 
12.8 Data Collection, Record Keeping and Storage............................................................................................................... 25 
13. SUBJECT CONFIDENTIALITY ............................................................................................................................................ 25 
14. PUBLICATION POLICY ..................................................................................................................................................... 26 
Appendix 1: Study Schedule ................................................................................................................................................. 29 
Appendix 2: Pain Rating Scale .............................................................................................................................................. 30 
Appendix 3:  Follow-Up Subject Questionnaire  ................................................................................................................... 32 
Appendix 4: Fitzpatrick Skin Type Classification  .................................................................................................................. 33 
Appendix 5: Befor and After Treatment Instructions …………………………………………………………………………………………………………34 
Apendix 6: Subject Spilt-Face Treatment Paramerters ………………………………………………………………………………………………………35 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 5 of 36                                                                    Version 1.0; 06Nov17 
Protocol Summary 
Title 
 
Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ 
Laser with Green Genesis and a Micro-Lens Array Attachment as compared to the standard-
of-care with an excel V™ Laser  
Objective 
 
a. To evaluate the safety and efficacy of the Cutera excel V laser and the Micro-Lens 
Array attachment to the Genesis V hand piece.  
b. To evaluate the safety and efficacy of the Cutera excel V laser Green Genesis V hand 
piece to the CoolView hand piece. 
 
Study Design 
Open-label, Prospective, Split-Face Study to Evaluate the Cutera excel V laser with Green 
Genesis (532 nm in a low fluence, high repetition rate mode) and the Micro-Lens Array 
attachment used with excel V laser at 1064 nm and/or 532 nm for the improvement of skin 
quality.  
Enrollment 
 Approximately 30 subjects will be treated 
 
 
 
Primary 
Endpoint 
 
• 
Safety of the Cutera excel V laser with Green Genesis assessed by frequency and 
severity of number of device adverse events as reported up to the 12 week follow-
up visit. 
• 
Safety of the Cutera excel V laser with Micro-Lens Array attachment assessed by 
frequency and severity of number of device adverse events as reported up to the 
12 week follow-up visit. 
• 
Efficacy of the Cutera excel V laser with the Micro-Lens Array to treat
 
 
 
• 
Efficacy of the Cutera excel V laser with Green Genesis t
 
 
 
 
Secondary 
Endpoints 
•
 
  
Exploratory 
Analysis 
• 
 
• 
The improvement of ≥1 point on the Global Aesthetic Improvement Scale (GAIS) 
 
 
Subject 
Population 
Female or male subjects, age 18 to 65 years, Fitzpatrick skin types I-VI 
Estimated 
Planned 
Schedule 
First subject enrolled:  November 2017 
Last subject last visit:   July 2019 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 6 of 36                                                                    Version 1.0; 06Nov17 
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. Conventional treatment of dyschromia pigmentation disorders and rosacea have primarily 
been treated by external application of topical agents such as hydroquinone and azelaic acid, respectively [1,2]. 
Dyschromia and diffuse redness can also be treated by lasers of various wavelengths for correcting skin tone 
heterogeneity based on the principle of selective photothermolysis, whereby the laser wavelength is matched 
to the light absorption spectra of the target chromophore such as hemoglobin in blood vessels or melanin in 
pigment-producing skin cells [3, 4]. Absorption of laser light by these molecular chromophores results in the 
production of heat, leading to the ablative destruction of unwanted blood vessels and pigment cells. 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 laser treatments [5-7]. 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 [8-15]. 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. In addition, the micro-thermal 
damage zones and heating within the dermis 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 [17-18]. 
 
 
 
 
 
 
 
 
 
  
 
2. STUDY DEVICE 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 8 of 36                                                                    Version 1.0; 06Nov17 
4.1.2. 
 
 
 
 
4.1.3    
 
 
 
 
 
• 
The improvement of ≥1 point on the Global Aesthetic Improvement Scale (GAIS) as assessed by up to 
three blinded assessors in at least 75% of subjects. 
4.2 Study Duration 
Subjects enrolled in this trial will participate for approximately 12 months, 
. One 
screening and enrollment visit, 
, spaced 2 weeks 
. Subjects will 
have 
 follow-up visits, 
, and second at 12 weeks  
 following the final laser treatment visit.  
 
 
 
 
 
 
. 
4.3 Study Effectiveness Assessments 
 
4.3.1 Investigator Assessments 
Baseline photos of subjects may be used while assessing the GAIS, 
 
  
 
 at the 12 week follow-up visit the Investigator 
will assess the efficacy of the Cutera excel V laser with GG and the MLA attachment treatment using the Global 
Aesthetic Improvement Scale (GAIS), 
.   
 
Global Aesthetic Improvement Scale (GAIS):  
4 = Very Significant Improvement 
 
3 = Significant Improvement (
 
2 = Moderate Improvement (
 
1 = Mild Improvement 
 
0 = No Change 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidentia
 
 
                                                                    
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 11 of 36                                                                    Version 1.0; 06Nov17 
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 30 male or female subjects, ages 18 to 65, with Fitzpatrick Skin Type I-VI who desire laser 
treatment for the improvement of diffused redness, dyschromia (pigment), fine lines and texture, and acne 
scars.   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. 
 
Each subject will be evaluated by the Investigator/Sub-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 with MLA and/or Green Genesis 
(532 nm) 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.,  

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 12 of 36                                                                    Version 1.0; 06Nov17 
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 3 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. 
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. 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 14 of 36                                                                    Version 1.0; 06Nov17 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 18 of 36                                                                    Version 1.0; 06Nov17 
 
 
7. ADVERSE EVENTS and ADVERSE DEVICE EFFECTS  
7.1 Definitions 
7.1.1 
Adverse Event 
 
   
 
 
7.1.2 
Serious Adverse Event 
 
 
 
• 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 19 of 36                                                                    Version 1.0; 06Nov17 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 22 of 36                                                                    Version 1.0; 06Nov17 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
 
 
 
 
 
 
 
 
  
 
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-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 24 of 36                                                                    Version 1.0; 06Nov17 
 
  
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
.  
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.). 
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 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 25 of 36                                                                    Version 1.0; 06Nov17 
statements. 
12.8 Data Collection, Record Keeping and Storage 
The principal investigator is responsible for assuring that all study records including case report forms (CRFs), 
informed consent forms, device accountability records, source documents (e.g., notes, medical records, 
lab/histology reports etc.) and other study records are complete, accurate and recorded in a timely manner. 
For the study, CRFs will be considered source documents. All study data will be captured on the CRFs. 
 
All data entries on the CRFs will be recorded completely, promptly, and legibly using blue or black indelible ink 
pen and accuracy will be ensured. The corrections on CRFs will be made only by the investigator or the 
documented investigator’s designee. To make a correction to an entry, the data will be crossed through with 
a single line (the original entry should be visible) and then will be initialed and dated by the person making the 
correction.  
 
The study records will be maintained in a secure location throughout the duration of the study.  Upon study 
completion or termination, records will be kept at a secure location until at least 2 years after the last approval 
of a marketing application and until there are no pending or contemplated marketing applications or at least 
2 years have elapsed since the formal discontinuation of clinical development of the investigational product.  
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-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 26 of 36                                                                    Version 1.0; 06Nov17 
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-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 27 of 36                                                                    Version 1.0; 06Nov17 
REFERENCES 
. 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 28 of 36                                                                    Version 1.0; 06Nov17 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 29 of 36                                                                    Version 1.0; 06Nov17 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 30 of 36                                                                    Version 1.0; 06Nov17 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 31 of 36                                                                    Version 1.0; 06Nov17 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 32 of 36                                                                    Version 1.0; 06Nov17 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 33 of 36                                                                    Version 1.0; 06Nov17 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 34 of 36                                                                    Version 1.0; 06Nov17 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 35 of 36                                                                    Version 1.0; 06Nov17 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-EV12 
“Open-label, Prospective, Single-Center Feasibility Study to Evaluate the Cutera excel V™ Laser with Green Genesis and a Micro-Lens Array 
Attachment as compared to the standard-of-care with an excel V™ Laser” 
Confidential and Proprietary 
 Page 36 of 36                                                                    Version 1.0; 06Nov17