A Single-Center Open-Label Study of 1064 nm for Nonablative Skin Rejuvenation
Phase: NA
Conditions: Skin Pigment, Photoaging
Sponsor: Cutera Inc.

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
Page 1 of 38                                                       
Version 1.0, 22 FEB 2016 
 
TITLE PAGE 
 
 
 
Protocol Number: 
C-16-EV10 
Protocol Title: 
A Single-Center Open-Label Study of 1064 nm Nd:YAG for 
Nonablative Skin Rejuvenation 
 
Sponsor: 
 
Cutera, Inc. 
3240 Bayshore Boulevard 
Brisbane, CA 94005 
Telephone: 1-415-657-5722 
Fax:  1-415-715-3722 
Contact:  Gayle Weiss 
Email:  gweiss@cutera.com 
 
 
Principal Investigator: 
 
 
 
 
Version, Date: 
Version 1.0  Dated  February 22, 2016 
 
 
 
 
 
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-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
Page 2 of 38                                                       
Version 1.0, 22 FEB 2016 
 
Protocol Signature Page – Principal Investigator 
 
 
PROTOCOL C-16-EV10 
 
 
Study Title:   A Single-Center Open-Label Study of 1064 nm
 Laser for Nonablative Skin 
Rejuvenation 
 
 
Protocol Version 1.0, Dated February 22, 2016 
 
I have received and read the protocol dated February 22, 2016 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-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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Table of Contents 
Protocol Summary .......................................................................................................................................... 6 
1 
PURPOSE ................................................................................................................................................ 7 
2 
BACKGROUND INFORMATION ............................................................................................................... 7 
2.1 
Photo-Rejuvenation ............................................................................................................................ 7 
2.2 
Study Device ........................................................................................................................................ 7 
3 
STUDY OBJECTIVES ................................................................................................................................. 8 
4 
STUDY DESIGN ........................................................................................................................................ 8 
4.1 
Study Endpoints .................................................................................................................................. 9 
4.1.1 
Efficacy endpoints ........................................................................................................................... 9 
4.1.1.1 
Primary Efficacy Endpoint ............................................................................................................ 9 
4.1.1.2 
Secondary Efficacy Endpoints ...................................................................................................... 9 
4.1.2 
Safety Endpoint ............................................................................................................................... 9 
4.2 
Study Duration .................................................................................................................................... 9 
4.3 
Study Effectiveness Assessments ........................................................................................................ 9 
4.3.1 
Blinded Assessments ....................................................................................................................... 9 
4.3.1.1 
Blinded Reviewer’s Global Assessment of Improvement ............................................................. 9 
4.3.1.2 
Blinded Reviewer’s Assessment of Photoaging ......................................................................... 10 
4.3.2 
Investigator Assessments .............................................................................................................. 10 
4.3.2.1 
Investigator’s Global Assessment of Improvement ................................................................... 10 
4.3.3 
Subject Assessments ..................................................................................................................... 10 
4.4 
Exploratory Assessments ........................................................................................................... 11 
4.4.1 
Fitzpatrick Wrinkle Classification .................................................................................................. 11 
4.4.2 
Skin Texture Assessment ............................................................................................................... 11 
4.5 
Study Safety Assessments.......................................................................................................... 11 
4.5.1 
Incidence and Severity of Adverse Events: ................................................................................... 11 
4.5.2 
Treatment-related Discomfort ...................................................................................................... 11 
4.6 
Photographs .................................................................................................................................. 11 
4.7 
Study Discontinuation ................................................................................................................... 12 
4.8 
Investigator Selection .................................................................................................................... 12 
5 
STUDY POPULATION ............................................................................................................................. 12 
5.1 
Study Subject Recruitment and Selection ..................................................................................... 12 
5.1.1 
Inclusion Criteria .................................................................................................................... 12 
5.1.2 
Exclusion Criteria .................................................................................................................... 13 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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5.2 
Subject Numbering ........................................................................................................................ 14 
5.3 
Subject Discontinuation Criteria.................................................................................................... 14 
6 
STUDY PROCEDURES ............................................................................................................................ 14 
6.1 
Screening / Enrollment ...................................................................................................................... 14 
6.2 
Laser Treatment # 1 ........................................................................................................................... 15 
6.2.1 
Pre-Treatment Procedures ............................................................................................................. 15 
6.2.2 
Global 1064nm Nd:YAG Laser Genesis Treatment  - Treatment #1 - #6 ..................................... 15 
6.2.3 
Post-Treatment Procedures ............................................................................................................ 16 
6.3 
Follow-Up Visits ............................................................................................................................... 16 
6.4 
Biopsy Samples .............................................................................................................................. 17 
6.5 
Biopsy Procedure (if performed) ...................................................................................................... 17 
6.6 
Biopsy Suture Removal Visit (as applicable) .................................................................................... 17 
7 
ADVERSE DEVICE EFFECTS .................................................................................................................... 18 
7.1 
Definitions ......................................................................................................................................... 18 
7.1.1 
Adverse Device Effect ................................................................................................................... 18 
7.1.2 
Serious Adverse Device Effect ...................................................................................................... 18 
7.1.2.1 
Anticipated Serious Adverse Device Effect (ASADE) ................................................................ 18 
7.1.2.2 
Unanticipated Serious Adverse Device Effect (USADE/UADE) ............................................... 18 
7.2 
Recording ADEs and SADEs ............................................................................................................ 21 
7.3 
Follow-up of Subjects after ADEs and SADEs: ............................................................................... 21 
8 
POTENTIAL RISKS / BENEFITS ............................................................................................................... 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 Demographics and Subject Characteristics at Baseline .................................................................... 23 
10.3 Statistical Analysis Methods ............................................................................................................. 23 
10.3.1 
Analysis Sets ................................................................................................................................. 23 
10.3.2 
Analysis of Primary Endpoint ....................................................................................................... 23 
10.3.3 
Analyses of Secondary Endpoints ................................................................................................. 23 
10.3.4 
Safety Analyses ............................................................................................................................. 23 
11 SUBJECT PAYMENT ............................................................................................................................... 24 
12 STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES ............................................................. 24 
12.1 Training and Monitoring ................................................................................................................... 24 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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12.2 Informed Consent .............................................................................................................................. 24 
12.3 Protocol Compliance ......................................................................................................................... 25 
12.3.1 
Protocol Amendments .................................................................................................................... 25 
12.3.2 
Protocol Deviations ....................................................................................................................... 25 
12.4 Study Personnel ................................................................................................................................. 25 
12.5 Disclosure of Financial Interest ........................................................................................................ 25 
12.6 Data Collection, Record Keeping and Storage ................................................................................. 26 
13 SUBJECT CONFIDENTIALITY .................................................................................................................. 27 
14 PUBLICATION POLICY............................................................................................................................ 27 
REFERENCES ............................................................................................................................................. 29 
Appendix 1: Study Schedule ........................................................................................................................ 31 
Appendix 2: Pain Rating Scale .................................................................................................................... 32 
Appendix 3: Fitzpatrick Wrinkle Classification System .............................................................................. 33 
Appendix 4: Fitzpatrick Skin Type Classification ....................................................................................... 34 
Appendix 5:  Before and After Treatment Instructions ............................................................................... 35 
Appendix 6:  Before and After Biopsy Instructions .................................................................................... 36 
Appendix 7:  Subject Questionnaire ............................................................................................................ 37 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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Protocol Summary 
 
Title 
A Single-Center Open-Label Study of 1064 nm 
 Laser for 
Nonablative Skin Rejuvenation 
Objective 
 
To evaluate the efficacy and safety of the Cutera excel V Laser 
Genesis/ 1064 nm 
 laser for skin rejuvenation. 
Study Design 
A single-center prospective, open-label uncontrolled study. 
Enrollment 
15 subjects 
Primary Endpoint 
• Degree of improvement at 12 weeks post-final treatment as 
assessed by independent blinded reviewers (Physician’s Global 
Assessment). 
Secondary Endpoints 
 
 
 
 
 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subject Population 
Female or male subjects, age 35 to 55 years, Fitzpatrick skin types I-IV 
Planned Schedule 
First subject enrolled:  March 15, 2016 
Last subject last visit:   January 15, 2017 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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post-final treatment photographs will be randomized such that the baseline photograph will be randomly 
assigned to the left or right side of the page. The order of subject photograph pairs will also be 
randomized. The reviewers will be blinded to the treatment parameters used, the subject data, the 
temporal order of photographs (before and after), and follow-up time point. 
 
The reviewers will be asked to first determine the temporal order of each photograph pair, then rate the 
degree of improvement observed in the post-treatment photograph using the Physician’s Global 
Assessment of Improvement Scale: 
 
 
 
 
4 = Very Significant Improvement 
 
 
 
 
3 = Significant Improvement
 
 
 
 
2 = Moderate Improvement 
 
 
 
 
1 = Mild Improvement 
 
 
 
 
0 = No Change 
 
4.3.1.2 
 
 
4.3.2 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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4.3.3.2 
 
 
 
 
  
 
 
 
4.4 
 
 
 
 
 
 
 
 
 
 
4.5 
Study Safety Assessments 
4.5.1 
Incidence and Severity of Adverse Events:   
Following the first laser 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. 
4.5.2 
Treatment-related Discomfort 
Subjects will be asked to rate the average amount of discomfort experienced during laser treatment 
using the Pain Rating Scale found in Appendix 2. 
4.6 
Photographs 
Standardized digital photographs will be taken of each subject’s face at baseline, prior to all laser 
treatments and at both follow-up visits. Any jewelry will be removed from the area being photographed. 
Hair will be pulled away from the face with a headband and subject will have recently cleansed skin. Facial 
photographs will be obtained from 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.  

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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4.7 
Study Discontinuation 
The sponsor (Cutera, Inc.) 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 Practice. 
4.8 
Investigator Selection 
The Investigator will be invited to participate in the study based on his/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 will also be considered.  
5 
STUDY POPULATION 
5.1 
Study Subject Recruitment and Selection 
Twenty male or female subjects, ages 35 to 55, with Fitzpatrick Skin Type I-IV (see Appendix 4 for skin type 
classification) who desire laser treatment for facial wrinkles or photo-rejuvenation will be studied. 
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 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.  
Female or Male, 35 to 55 years of age (inclusive). 
2.  
Fitzpatrick Skin Type I – IV (Appendix 4). 
3.  
Desires non-invasive and non-ablative treatment of skin-aging or photo-rejuvenation of 
the skin. 
4.  
Have signs of moderate skin aging, including presence of mild to moderate rhytides 
around eyes and upper lip, multiple lentigines, diffuse erythema or telangiectasia, and a 
score between 4 and 7 (inclusive) on the Fitzpatrick Wrinkle Classification Scale 
(Appendix 3).   
5.  
Subject must be able to read, understand and sign the Informed Consent Form. 
6.  
Must be willing and able to adhere to the treatment and follow-up schedule and post-
treatment care instructions. 
7.  
Willing to have very limited sun exposure and use an approved sunscreen of SPF 30 or 
higher on the treatment area every day for the duration of the study, including the 
follow-up period. 
8.  
Willing to have digital photographs taken of the treatment area and agree to use of 
photographs for presentation, educational or marketing purposes. 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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9.  
Agree to not undergo any other procedure(s) for skin rejuvenation during the study, 
including but not limited to chemical peel, laser and light based device treatment, and 
home-use device treatment. 
10.  
Agree to not undergo any injection of botulinum toxin, collagen, hyaluronic acid filler or 
other dermal filler during the study. 
11.  
Post-menopausal or 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 or to father a child for the duration 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 device or drug within 6 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 or light-based procedures or surgery. 
3.  
Prior injection to the face of botulinum toxin, collagen, hyaluronic acid filler or other 
dermal filler within 6 months of study participation, as applicable. 
4.  
Systemic use of retinoid, such as isotretinoin, or corticosteroid, as applicable, within 6 
months of study participation.  
5.  
Use of topical medications on the face, such as antibiotics, benzoyl peroxide, retinoids 
(isotretinoin), corticosteroids, hydroquinone, or products containing dihydroxyacetone 
or alpha-hydroxy with concentration > 8%, within 1 month of participation. 
6.  
History of malignant tumors in the target area. 
7.  
Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles. 
8.  
Pregnant and/or breastfeeding.  
9.  
Having an infection, dermatitis or a rash in the treatment area. 
10.  
Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., 
uncontrolled hypertension. 
11.  
Suffering from coagulation disorders, or taking prescription anticoagulation medication 
which might make study participation unsafe according to Investigator’s discretion. 
12.  
History of keloid scarring, hypertrophic scarring or of abnormal wound healing.  
13.  
History of immunosuppression/immune deficiency disorders or currently using 
immunosuppressive medications.  
14.  
History of vitiligo, eczema, or psoriasis. 
15.  
History of connective tissue disease, such as systemic lupus erythematosus or 
scleroderma.  
16.  
History of seizure disorders due to light. 
17.  
Any use of medication that is known to increase sensitivity to light according to 
Investigator’s discretion. 
18.  
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 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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19.  
History of radiation to the treatment area or undergoing systemic chemotherapy for the 
treatment of cancer.  
20.  
History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. 
21.  
Anytime in life, having have used gold therapy (gold salts) for disorders such as 
rheumatologic disease or lupus. 
22.  
Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during 
the study.  
23.  
Current smoker or history of smoking within 6 months of study participation. 
24.  
As per the Investigator’s discretion, any physical or mental condition which might make 
it unsafe for the subject to participate in this study. 
5.2 
Subject Numbering  
If a subject 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 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 
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 
 
 
 
 
 
 
 
 
 
 
  

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
Page 18 of 38                                                       
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7 ADVERSE DEVICE EFFECTS  
7.1 
Definitions  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
Laser for Nonablative Skin Rejuvenation” 
Confidential and Proprietary 
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Version 1.0, 22 FEB 2016 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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8.2 
Potential Benefits 
The subjects may or may not benefit from the treatment with the study device. Potential benefit of laser 
treatment for photo-rejuvenation is improved appearance of skin, diminished appearance of rhytides, 
improvement in telangiectasia and lightening of lentigines. 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 excelV laser system by a 
representative of Cutera. 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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10 DATA ANALYSIS PLAN  
10.1 Sample Size 
Up to 
 subjects will be enrolled in this safety and efficacy study. 
10.2 Demographics and Subject Characteristics at Baseline 
Subject demographics, medical history, concomitant medications will be tabulated and summarized 
descriptively. 
10.3 Statistical Analysis Methods 
10.3.1 Analysis Sets 
The efficacy analysis set will include all subjects who received at least one laser treatment session and 
complete a follow-up visit. The safety analysis set will include all subjects enrolled in the study who had 
at least one laser treatment session. 
 
Missing data will not be imputed for efficacy or safety endpoints. 
10.3.2 Analysis of Primary Endpoint 
Formal statistical analysis is not planned for this study. The primary efficacy endpoint data, blinded 
reviewer degree of improvement at 12 weeks post-final treatment, will be summarized descriptively.  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.3.4 Safety Analyses 
Safety variables will be analyzed descriptively. 
 
The safety variables for this study are: 
 
1. 
Subject discomfort (pain) during treatment (to be descriptively displayed).  
 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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2. 
Incidence and severity of adverse effects during study duration (to be displayed descriptively 
as counts and frequency distributions).  
 
Enrolled subjects who received at least one treatment will be included in the safety analyses. Device-
related and procedure-related adverse effects (AEs) and subjects who prematurely terminate from the 
study due to an adverse device effect, including the treatment-related pain ratings, as reported on case 
report forms will be tabulated and analyzed. For a given AE term, counting will be done by subject, not by 
event, i.e. for a subject reporting the same AE more than once, the event will be counted only once, at the 
most severe and most-related occurrence.  The number and percentage of subjects experiencing each AE 
Term will be descriptively summarized. Statistical hypothesis testing will not be performed for safety data. 
11   
 
 
 
 
   
12   STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES  
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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12.3 Protocol Compliance 
The principal investigator must comply with all terms of the protocol. 
12.3.1 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. 
12.3.2  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. 
12.4 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.). 
12.5 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-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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12.6 Data Collection, Record Keeping and Storage 
The principal investigator is responsible for assuring that all study records including case report forms 
 
  
 
 
 
 
 
 
  
 
 
  
  
  
 
 
  
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
  
 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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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:   
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
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.  
 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
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Version 1.0, 22 FEB 2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
Page 30 of 38                                                       
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Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
Page 31 of 38                                                       
Version 1.0, 22 FEB 2016 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
Page 32 of 38                                                       
Version 1.0, 22 FEB 2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
Page 33 of 38                                                       
Version 1.0, 22 FEB 2016 
 
 
 

Cutera, Inc. 
Protocol # C-16-EV10 
“A Single-Center Open-Label Study of 1064 nm 
 Laser for Nonablative Skin Rejuvenation” 
 
Confidential and Proprietary 
Page 34 of 38                                                       
Version 1.0, 22 FEB 2016