A Study of a Novel Multi-Wavelength Laser for Tattoo Removal
Phase: NA
Conditions: Tattoo Removal
Sponsor: Cutera Inc.



Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
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Protocol Signature Page – Principal Investigator 
 
 
PROTOCOL C-16-EN14 
 
 
Study Title:   A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal 
 
 
Protocol Version 1.0, Dated August 08, 2016 
 
I have received and read the protocol dated August 08, 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 Independent Review Board 
(IRB)/Ethics Committee (EC), 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 IRB/EC 
requirements. I agree to commence this study only after documented IRB/EC approval is obtained. 
 
 
 
 
Principal 
Investigator 
 
 
 
 
 
 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
Printed Name 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
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Table of Contents 
Protocol Summary ..........................................................................................................................................6 
1 
PURPOSE ................................................................................................................................................7 
2 
BACKGROUND INFORMATION ...............................................................................................................7 
2.1 
Tattoo Removal ...................................................................................................................................7 
3 
STUDY OBJECTIVES .................................................................................................................................9 
4 
STUDY DESIGN ........................................................................................................................................9 
4.1 
Study Endpoints ................................................................................................................................10 
4.1.1 
Efficacy endpoints .........................................................................................................................10 
4.1.1.1 
Primary Efficacy Endpoint ..........................................................................................................10 
4.1.1.2 
Secondary Efficacy Endpoints ....................................................................................................10 
4.1.2 
Exploratory Efficacy Endpoint .......................................................................................................10 
4.1.3 
Safety Endpoint .............................................................................................................................10 
4.2 
Study Duration ..................................................................................................................................10 
4.3 
Blinding and Randomization of Photographs ...................................................................................11 
4.3.1 
Blinding ..........................................................................................................................................11 
4.3.2 
Randomization of Photographs .....................................................................................................11 
4.4 
Study Effectiveness Assessments ......................................................................................................11 
4.4.1 
Investigator Assessments ..............................................................................................................11 
4.4.2 
Subject Assessments .....................................................................................................................11 
4.4.3 
Exploratory Blinded Assessment ...................................................................................................12 
4.5 
Study Safety Assessments..........................................................................................................12 
4.6 
Photographs ..................................................................................................................................13 
4.7 
Study Discontinuation ...................................................................................................................13 
4.8 
Investigator Selection ....................................................................................................................13 
5 
STUDY POPULATION .............................................................................................................................13 
5.1 
Study Subject Recruitment and Selection .....................................................................................13 
5.1.1 
Inclusion Criteria ....................................................................................................................13 
5.1.2 
Exclusion Criteria ....................................................................................................................14 
5.2 
Subject Numbering ........................................................................................................................15 
5.3 
Subject Discontinuation Criteria....................................................................................................15 
6 
STUDY PROCEDURES ............................................................................................................................15 
6.1 
Screening / Enrollment Procedures ..................................................................................................15 
6.2 
Laser Treatment Visits – Pre-Treatment Procedures ........................................................................16 

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Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
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6.3 
Laser Treatment Procedures – All Visits ...........................................................................................16 
6.4 
Follow-Up Visits .................................................................................................................................17 
6.5 
Biopsy Procedure ...........................................................................................................................17 
6.6 
Biopsy Suture Removal Visit (as applicable) ..................................................................................18 
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) ...................................................................19 
7.1.2.2 
Unanticipated Serious Adverse Device Effect (USADE/UADE) ...................................................19 
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 ..............................................................................................................................23 
9 
RISK MANAGEMENT .............................................................................................................................23 
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 ..............................................................................................................................24 
11 SUBJECT PAYMENT ...............................................................................................................................24 
12 STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES .............................................................24 
12.1 Training and Monitoring ....................................................................................................................24 
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 .........................................................................................................26 
12.6 Data Collection, Record Keeping and Storage ...................................................................................26 

Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
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13 SUBJECT CONFIDENTIALITY ..................................................................................................................27 
14 PUBLICATION POLICY............................................................................................................................28 
REFERENCES .................................................................................................................................................29 
Appendix 1: Study Schedule .........................................................................................................................31 
Appendix 2: Pain Rating Scale ......................................................................................................................32 
Appendix 3: Fitzpatrick Skin Type Classification ..........................................................................................33 
Appendix 4:  Before and After Treatment Instructions ...............................................................................34 
Appendix 5:  Follow-Up Subject Questionnaire ...........................................................................................35 
Appendix 6: Before and After Biopsy Instructions .......................................................................................37 
 
 
 

Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
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Protocol Summary 
 
Title 
A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo 
Removal 
Objective 
 
To evaluate the safety and efficacy of an investigational version of the 
Cutera enlightenTM laser that offers multiple wavelengths for tattoo 
removal. 
Study Design 
A single-center prospective, open-label, uncontrolled pilot study. 
Enrollment 
A maximum of 10 subjects 
Primary Endpoint 
• Degree of tattoo clearing at 6 weeks post-final treatment as 
assessed by the Investigator (Physician’s Global Assessment 
of Improvement). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subject Population 
Female or male subjects, age 18 to 65 years, Fitzpatrick skin types I-VI 
Planned Schedule 
First subject enrolled:  September 2016 
Last subject last visit:  December 2018 
 
 

Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
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because of decreased melanin absorption. Still, lower fluences are recommended for treatment of 
darker skin patients with Nd:YAG lasers.  Scarring is rarely observed following treatments with QS lasers 
as water is no longer the target chromophore. 
 
There are some challenges associated with tattoo removal. If mixtures of pigments and/or multicolors 
are used, a complete clearing of the tattoo may not be achieved with lasers[19].  Different colors are 
usually mixed to achieve various levels of brightness and lightness. Another contributing factor to 
unsuccessful outcome is that most tattoo pigments are not regulated and may include various elements 
and chemical compounds.  When the exact compound of the tattoo pigment is not known, paradoxical 
darkening of the pigment may happen following tattoo removal, which may be difficult to remove [20-
23].  Additionally, white, orange, yellow and brown tattoo inks are particularly difficult to treat[24]. 
 
Although the mechanism of action is not clearly understood, the effects of the lasers on the pigment are 
thought to be: 1) photothermal/photochemical and 2) photoacoustic/photomechanical[25, 26].  
Conversion of absorbed energy into heat (photothermal effect) breaks the chemical bonds inside the 
pigment and causes pigment modification.  At the same time, the ultrashort heating of the particle shell 
may cause heating of the surrounding tissue via rapid thermal expansion resulting in shock waves. These 
shock waves may help destroy the surrounding cellular structures and tattooed compounds 
mechanically (photoacoustic/photomechanical). The resultant fragmented particles are then removed 
by three mechanisms: 1) transepidermal elimination, 2) removal via lymphatics, and 3) rephagocytosis 
by other cells (inflammatory or resident cells) in the dermis. 
 
Histological examinations show that the tattoo pigments are exclusively found intracytoplasmatically in 
lysosomes which is a result of active phagocytosis in dermal cells, such as macrophages and 
fibroblasts[27, 28]. In electron microscopy of black tattoos immediately after treatment with 1064 nm 
Nd:YAG, vacuoles were observed in the dermis [29].  Vacuoles were lined by remnants of pigment-
containing cells, flattened cell nuclei and disrupted lysosomes. Cells without pigment located close to 
the vacuoles were not affected. One week after treatment, a moderate chronic inflammatory infiltrate 
was observed in the dermis and all tattoo particles were phagocytosed and intracellular within 
fibroblasts and macrophages. At one month post-treatment, all residual pigment particles were within 
lysosomes with mild residual inflammatory infiltrate around dermal vessels. 
 
Although nanosecond QS lasers are safe and effective in the treatment of tattoos, treatment sessions 
are often painful and as many as 6 to 10 treatments are necessary to achieve acceptable clearance. It 
could be argued that this is a result of most tattoo particles ranging in size from 40 to 300 nm in vivo and 
their thermal relaxation times being mostly in the picosecond range[30].  For example, the most 
common pigment particle, carbon black in india ink, which is shown to be about 40 nm in diameter, will 
approximately have a thermal relaxation time of 1 nanosecond[31]. In that case, a thermally confined 
disruption of the particle can only be achieved via picosecond pulses.  This suggests that energy delivery 
in the picosecond range be more effective and require lower fluences than the nanosecond range.  
Moreover, the resultant ultra-short pulses with higher peak temperatures should decrease adverse 
effects, such as dyspigmentation as the heat transfer to the surrounding tissue is significantly minimized.   
 
Up to date, various studies of picosecond QS lasers, both in vitro and in vivo, have been conducted to 
test the hypotheses on the potential benefits of picosecond QS lasers[30-34].  In a split-tattoo study, 
Ross et all reported better clearing in 75% (12/16) of tattoos with on picosecond side than the clearing 

Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
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4.1 
Study Endpoints 
4.1.1 
Efficacy endpoints 
4.1.1.1 Primary Efficacy Endpoint 
• Degree of tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator 
(Physician’s Global Assessment of Improvement). 
 
 
 
 
 
 
 
 
 
 
 
 
4.1.3 
Safety Endpoint 
• Incidence and severity of adverse device effects during the study period, including subject pain 
level during laser treatment. 
 
4.2 
Study Duration 
Subjects enrolled in this trial will be asked to participate for up to 15 months, 
 
. 
  1 screening visit, 
 
 laser treatment visits 
, and 1 required follow-up visit at 6 weeks 
 
) post-final treatment. At the Investigator’s discretion, an optional follow-up visit may be 
conducted at 12 weeks 
 post-final treatment. 
 
The screening and first laser treatment may be combined into one visit provided that the informed 
consent process has been completed (see Section 12.2) and the subject has signed the IRB/EC-approved 
Informed Consent Form prior to the commencement of any study-related procedures and device 
treatments. 

Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
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4.3 
Blinding and Randomization of Photographs 
4.3.1 
Blinding 
A panel of independent reviewers may assess subject photographs taken at baseline, 6 weeks and 12 
weeks post-final treatment. The reviewers will be blinded to the type of treatment device, the 
parameters used, the subject data, the temporal order of photographs (before and after), and follow-up 
time point. 
4.3.2 
Randomization of Photographs 
The presentation order of subject photographs will be randomized. First, a unique identification number 
will be assigned to each pair of subject photographs (1 baseline and 1 post-treatment), then the order of 
photograph presentation will be assigned by randomizing the identification numbers. In addition, the 
location of the baseline photograph on the assessment page will be randomized such that each 
photograph pair will be arranged with the baseline photograph located either on the right side or left 
side of the page. Minitab statistical package, version 16.2.2.0 (Minitab Inc., State College, Pennsylvania) 
will be used to do randomizations. The photograph pairs from each subject will be then organized 
according to randomization and will be presented to the blinded reviewers for assessment. 
 
4.4 
Study Effectiveness Assessments 
4.4.1 
Investigator Assessments 
4.4.1.1 Investigator’s Global Assessment of Improvement 
At 6 weeks, 
, the Investigator will be asked to rate the 
degree of tattoo clearing observed in the subject’s treated area using the Physician’s Global Assessment 
of Improvement Scale:  
 
4 = Very Significant or Complete Clearing (
 
3 = Significant Clearing 
 
2 = Moderate Clearing 
 
1 = Mild Clearing (
 
0 = No Clearing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
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0
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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. 

Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
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4.6 
Photographs 
Standardized digital photographs will be taken of each subject’s treatment area at baseline, prior to all 
laser treatments, immediately following laser treatments and at each follow-up visit. Any jewelry will be 
removed from the area being photographed. 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 (including any flash settings) should 
remain the same for all photographs and the highest resolution settings should be utilized. 
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 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 
Up to 10 male or female subjects, ages 18 to 65, with Fitzpatrick Skin Type I-VI who desire laser 
treatment for tattoo removal 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 study 
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, 18 to 65 years of age (inclusive). 
2.  
Fitzpatrick Skin Type I – VI (Appendix 3). 
3.  
Target tattoo contains single or multi-color ink.  
4.  
Subject must be able to read, understand and sign the Informed Consent Form. 
5.  
Must be willing and able to adhere to the treatment and follow-up schedule and post-
treatment care instructions. 
6.  
Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun 
exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 
2 to 4 weeks before the treatment and/or every day for the duration of the study, 

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“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
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including the follow-up period. 
7.  
Willing to have digital photographs taken of the treatment area and agree to use of 
photographs for presentation, educational or marketing purposes. 
8.  
Agree to not undergo any other procedure(s) for tattoo removal during the study (as 
applicable). 
9.  
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 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 a drug or another device in the target area during the 
study. 
2.  Target tattoo contains only black ink. 
3.  History of allergic reaction to pigments following tattooing. 
4.  History of allergy to local anesthetics. 
5.  History of allergy to topical antibiotics. 
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 medications.  
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 
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.  Systemic use of corticosteroid or isotretinoin within 6 months of study participation.  
22.  Anytime in life, having have used gold therapy (gold salts) for disorders such as 
rheumatologic disease or lupus. 
23.  Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning 
during the study.  

Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
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7 ADVERSE DEVICE EFFECTS  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 

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. 
 
 
 

Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
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Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
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Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
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 tattoos is lightening or complete removal of tattoo. 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 enlighten laser system by a 
representative of Cutera. 
10  DATA ANALYSIS PLAN  
10.1 Sample Size 
Up to 10 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 the 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, degree of 
tattoo clearing at 6 weeks post-final treatment as assessed by the Investigator (Physician’s Global 
Assessment), will be summarized descriptively.  
 
 
  
 
 
 
 
 
 
 
 

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10.3.4 Safety Analyses 
Safety variables will be analyzed descriptively. 
 
The safety variables for this study are: 
 
1. 
Subject discomfort (pain) during and after treatment (to be descriptively displayed).  
2. 
Incidence and severity of adverse effects during study duration (to be displayed descriptively 
as counts and frequency distributions).  
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. 
 
  
 
 
 
 
  
12   STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES  
  
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 

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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/EC 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 the IRB/EC according to their policies. 
 
 
 

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“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
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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-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
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13   SUBJECT CONFIDENTIALITY 
 
   
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  

Cutera, Inc. 
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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. 
 
 
 
 
 
 
 
 

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Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
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Cutera, Inc. 
Protocol # C-16-EN14 
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Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
Page 34 of 37                                                       
Version 1.0 08 AUG 2016 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-16-EN14 
“A Single-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal” 
 
Confidential and Proprietary 
Page 37 of 37                                                       
Version 1.0 08 AUG 2016