Open-label, Prospective, Multicenter Study to Evaluate the Cutera Enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the Treatment of Moderate to Severe Acne Scars
Phase: NA
Conditions: Scarring, Acne
Sponsor: Cutera Inc.

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 1 of 37                                                                    Version 2.0; 03JAN201 
 
 
 
 
TITLE PAGE 
 
 
Protocol Number: 
C-17-ML03 
Protocol Title: 
Open-label, Prospective, Multicenter Study to Evaluate 
the Cutera enlighten™ Laser and a Micro-Lens Array 
Handpiece Attachment for the Treatment of Moderate 
and Severe Acne Scars 
 
Sponsor: 
 
 
 
 
 
 
 
Cutera, Inc. 
3240 Bayshore Boulevard 
Brisbane, CA 94005 
Telephone: 1-415-657-5538 
Fax:  1-415-715-3722 
Contact:  Michaela Bell 
Email:  mbell@cutera.com 
Principal Investigator: 
 
 
 
 
 
 
 
 
 
 
 
Version, Date: 
Version 2.0- Dated: January 3, 2018   
 
 
 
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-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 2 of 37                                                                    Version 2.0; 03JAN201 
 
 
 
Protocol Signature Sheet – Principal Investigator 
 
 
PROTOCOL C-17-ML03 
 
 
Study Title:   Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a 
Micro-Lens Array Handpiece Attachment for the Treatment of Moderate and Severe Acne Scars  
 
Protocol Version 2.0, Date: 03JAN2018   
 
I have received and read the protocol dated August 4, 2017and 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-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 3 of 37                                                                    Version 2.0; 03JAN201 
TABLE OF CONTENTS 
1. PURPOSE ............................................................................................................................................................................ 6 
2. BACKGROUND INFORMATION ........................................................................................................................................... 6 
3. STUDY DEVICE .................................................................................................................................................................... 7 
4. STUDY OBJECTIVES ............................................................................................................................................................. 8 
a. 
To evaluate the safety of the Cutera enlighten laser with a Micro-Lens Array handpiece attachment in the 
improvement of acne scars. .................................................................................................................................................... 8 
b. 
To evaluate the efficacy of the Cutera enlighten laser with a Micro-Lens Array handpiece attachment in the 
improvement of acne scars. .................................................................................................................................................... 8 
5. STUDY DESIGN ................................................................................................................................................................... 8 
5.1 
Study Endpoints ....................................................................................................................................................... 9 
5.1.1 
Primary Efficacy Endpoint ....................................................................................................................................... 9 
5.1.2 
Secondary Efficacy Endpoints ................................................................................................................................. 9 
5.1.3 
Safety Endpoints ..................................................................................................................................................... 9 
5.2 Study Duration ................................................................................................................................................................. 9 
5.3 Study Effectiveness Assessments ...................................................................................................................................... 9 
5.3.1 
Blinded Evaluators and Investigator’s Global Assessment of Improvement .......................................................... 9 
5.3.2 
Investigator Assessments ...................................................................................................................................... 10 
5.3.3     Subject Satisfaction Assessment ........................................................................................................................... 11 
5.4   Study Safety Assessments ............................................................................................................................................. 12 
5.4.1 Incidence and Severity of Adverse Events: ............................................................................................................... 12 
5.4.2 Treatment-related Discomfort ................................................................................................................................. 12 
5.4.3 Phone Follow-up ....................................................................................................................................................... 12 
5.5 Photographs .................................................................................................................................................................. 12 
5.6 Study Discontinuation .................................................................................................................................................... 12 
5.7 Investigator Selection..................................................................................................................................................... 12 
6. STUDY POPULATION ........................................................................................................................................................ 13 
6.1 Study Subject Recruitment and Selection ....................................................................................................................... 13 
6.1.1 Inclusion Criteria ....................................................................................................................................................... 13 
6.1.2 Exclusion Criteria ...................................................................................................................................................... 13 
6.2 Subject Numbering ......................................................................................................................................................... 14 
6.3 Subject Discontinuation Criteria ..................................................................................................................................... 15 
7. STUDY PROCEDURES ........................................................................................................................................................ 15 
7.1 Screening / Enrollment ................................................................................................................................................... 15 
7.2 Laser Treatment 1 to 6 – Visit Window and Pre-Treatment Procedures .......................................................................... 16 
7.3 Laser Treatment Procedures ........................................................................................................................................... 16 
7.4 Phone and Follow-Up Visits ............................................................................................................................................ 18 
8. ADVERSE EVENTS and ADVERSE DEVICE EFFECTS ............................................................................................................. 19 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 4 of 37                                                                    Version 2.0; 03JAN201 
8.1 Definitions ...................................................................................................................................................................... 19 
8.1.1 
Adverse Event ....................................................................................................................................................... 19 
8.1.2 
Serious Adverse Event .......................................................................................................................................... 19 
8.2 Recording AEs, ADEs and SADEs ..................................................................................................................................... 22 
8.3 Follow-up of subjects after AEs/ADEs and SAEs/SADEs: ................................................................................................. 22 
9. POTENTIAL RISKS / BENIFITS ............................................................................................................................................ 22 
9.1 Potential Risks ................................................................................................................................................................ 22 
9.2 Potential Benefits ........................................................................................................................................................... 23 
10. RISK MANAGEMENT ....................................................................................................................................................... 23 
11. DATA ANALYSIS PLAN .................................................................................................................................................... 24 
11.1 Sample Size .................................................................................................................................................................. 24 
11.2 Statistical Analysis Methods ......................................................................................................................................... 24 
12. SUBJECT PAYMENT ......................................................................................................................................................... 24 
13. STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES ......................................................................................... 24 
13.1 Training and Monitoring .............................................................................................................................................. 24 
13.2 Informed Consent ......................................................................................................................................................... 24 
13.3 Protocol Compliance .................................................................................................................................................... 25 
13.4 Protocol Amendments ............................................................................................................................................... 25 
13.5 Protocol Deviations ................................................................................................................................................... 25 
13.6 Study Personnel............................................................................................................................................................ 25 
13.7 Disclosure of Financial Interest ..................................................................................................................................... 26 
13.8 Data Collection, Record Keeping and Storage .............................................................................................................. 26 
14. SUBJECT CONFIDENTIALITY ............................................................................................................................................ 26 
15. PUBLICATION POLICY ..................................................................................................................................................... 27 
Appendix 1: Study Schedule ................................................................................................................................................. 29 
Appendix 2: Pain Rating Scale .............................................................................................................................................. 30 
Appendix 3:  Follow-Up Subject Questionnaire (page 1 of 2) ................................................................................................ 31 
Appendix 3:  Follow-Up Subject Questionnaire (page 2 of 2) ................................................................................................ 32 
Appendix 4:  Baseline Subject Questionnaire (page 1 of 1) ................................................................................................... 33 
Appendix 5:  1 Week Follow-Up Questionnaire .................................................................................................................... 34 
Appendix 7:  Before and After Laser Treatment Instructions ............................................................................................... 36 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 5 of 37                                                                    Version 2.0; 03JAN201 
Protocol Summary 
Title 
 
Open-label, Prospective, Multicenter Pivotal Study to Evaluate the Cutera 
enlighten Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Acne Scars 
Objective 
 
a. To evaluate the safety of the Cutera enlighten laser with a Micro-Lens Array 
handpiece attachment in the improvement of acne scars. 
b. To evaluate the efficacy of the Cutera enlighten laser with a Micro-Lens Array 
handpiece attachment in the improvement of acne scars. 
Study Design 
Open-label, Prospective, Multicenter Pivotal Study to Evaluate the Cutera 
enlighten multi-wavelength 532 nm and 1064 nm 
picosecond duration 
laser with a Micro-Lens Array handpiece attachment for the Improvement of 
Moderate and Severe Acne Scars.  
Enrollment 
 Approximately 15 subjects will be treated 
 
 
 
Primary Endpoint 
 
• 
 
 
 an improvement of one point in 
the ASAS. 
Safety Endpoint 
• 
Safety of the Cutera enlighten laser with a Micro-Lens Array handpiece 
attachment assessed by the frequency and severity of device related 
adverse events 
Secondary Endpoints 
• 
 
 
 
 
 
 
 
 
 
 
Exploratory Analysis 
• 
 
 
 
 
Subject Population 
Female or male subjects, age 18 to 65 years, Fitzpatrick skin types I-VI 
Planned Schedule 
First subject enrolled:  August 2017 
Last subject last visit:   September 2018 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 6 of 37                                                                    Version 2.0; 03JAN201 
1. PURPOSE 
The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten 
multi-wavelength 532 nm and 1064 nm 
 picosecond pulse duration laser and an investigational 
micro-lens array (MLA) handpiece attachment for improvement of acne scars. 
2. BACKGROUND INFORMATION 
Affecting nearly 40 to 50 million people annually, acne is the most common skin condition in the United 
States.1 Acne lesions typically begin to appear in puberty and persist throughout adolescence. 
Approximately 85% of people between the ages of 12 and 24 have experienced acne.2 This wide spread 
skin condition predominantly affects teens and young adults, but can occur in older adults as well. 
Countless treatment modalities exist for acne sufferers, however even with effective treatment moderate 
and severe lesions can result in scarring. Post-acne scarring is estimated to occur in 95% of patients and is 
a common cosmetic concern for many patients.3 Furthermore, in some patient groups acne scarring is 
especially devastating and may be a risk factor for suicide.4 
 
Scar formation occurs as a result of damage to the layers and substructures of the skin. Following injury 
to the skin from the acne infection and more severe lesions, a multi-stage healing process begins, which 
includes inflammation, proliferation and maturation. Unsightly scars result from an abnormal healing 
process. While the exact cause of abnormal skin healing is unknown, it is thought that excessive collagen 
and fibrotic tissue forms and a lack of elastic fibers contributes to tough, stiff, nodular scar tissue.5-6 
Certain factors increase the likelihood of an abnormal skin healing process, such as patient age or 
racial/ethnic background, depth of injury and extent of infection.7-8  
 
Acne scars are atrophic scars, with subtypes classified based on scar appearance and skin depth. Ice pick 
scars are narrow in width at the surface (<2mm) and typically taper in width as the scar extends vertically 
deep into the dermis. Box car scars are round or oval indentations in the skin surface, with well-defined 
edges, that may be shallow or deep. Rolling scars are atrophic scars that occur as a result of abnormal 
fibrous anchoring of the dermis to the subcutis and create a rolling or rippling appearance of the skin 
surface.9 
 
Treatment modalities for acne scarring include ablative laser skin resurfacing, dermabrasion, chemical 
peels, or a combination of modalities.10 These traditional, highly effective treatment options are 
accompanied by undesirable side effects such as significant pain and post-procedure downtime. There is 
a demand for effective, noninvasive treatment methods for patients suffering from acne scars such as 
non-ablative laser and light-based therapy to devices that utilize radiofrequency waves.11-13 Treatment 
with non-ablative, non-invasive devices cause heat production and heat-induced wound healing within 
the dermis that over time causes a cascade of cellular events leading to new collagen production.14-15 
Dermal collagen remodeling leads to an improved texture and appearance of the skin, which should also 
improve the appearance of facial acne scars.  
 
Histology of fractionated laser delivery has demonstrated the formation of vacuoles, or areas of laser 
induced optical breakdown (LIOB).16 LIOB occurs when the intensity of the pulse is sufficiently high to 
generate plasma.  Plasma is caused by electrons being stripped from the target material.  The resulting 
electrons continue to absorb the laser heat, creating a vapor plume which forms a cavitation bubble that 
is observed as an LIOB in histological preparations.   

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 7 of 37                                                                    Version 2.0; 03JAN201 
 
In 2012, Habbema et al., demonstrated that highly focused, fractionated 1064 nm picosecond pulses could 
create subsurface LIOBs in the upper dermis and 30 days post treatment, they showed new collagen in 
the areas of the LIOBs, a natural wound healing process as a response to this type of injury.17   
 
Subsequently, picosecond lasers utilizing 755nm wavelength and a fractionated delivery system have been 
shown to improve the appearance of facial acne scars.18 Histological samples taken from the acne scar 
patients demonstrated improvements in the dermal elastic fibers, collagen and mucin.  No severe side 
effects were observed and the patients tolerated the procedures without complications.  The LIOBs 
observed in the facial acne study were located in the epidermis due to the higher absorption 
characteristics of 755nm in melanin as compared to 1064 nm used in Habbema’s study.   
 
Fractionated delivery of picosecond lasers on humans has been demonstrated to be safe.  A similar device 
to MLA, utilizing 755nm wavelength and a fractionated delivery system, has obtained FDA 510K clearance 
(K143105) and has been shown to improve the appearance of facial acne scars.18  
 
Recently, a holographic diffractive beam-splitter technology delivering fractionated picosecond 532 nm 
and 1064 nm wavelengths has also been described and is available commercially outside of the US 
(Syneron Candela), but to date, no FDA clearance exists for this device.  The company reports the device 
is able to focus the LIOBs in the epidermis with the 532 nm wavelength and in the upper papillary dermis 
with the 1064 nm wavelength safely.19 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
   
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 9 of 37                                                                    Version 2.0; 03JAN201 
5.1 
Study Endpoints 
5.1.1 Primary Efficacy Endpoint 
The primary endpoint is 
 
 an improvement 
of one point in the ASAS.  
5.1.2 
 
 
 
 
 
 
 
 
 
 
 
5.1.3 Safety Endpoints 
• Safety of the Cutera enlighten laser with Micro-Lens Array handpiece attachment as assessed 
by the frequency and severity of device related adverse events. 
   5.1.4   
 
 
              
 
 
 
 
 
 
5.2 Study Duration 
Subjects enrolled in this trial will participate for approximately 13 months, 
 
 
 
  
 
The screening and first laser treatment may be combined into one visit provided that the subject has 
signed the IRB-approved Informed Consent Form prior to the commencement of any study-related 
procedures and has met all criteria to be enrolled in the study.   
5.3 Study Effectiveness Assessments 
5.3.1 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 11 of 37                                                                    Version 2.0; 03JAN201 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 12 of 37                                                                    Version 2.0; 03JAN201 
 
5.4   Study Safety Assessments 
 
5.4.1 Incidence and Severity of Adverse Events: 
Following the first laser treatment, adverse effects (AEs) will be assessed post-treatment and at each 
subsequent visit using the following scale: 
1= mild: requires minimal or no treatment and does not interfere with the subject’s daily activities. 
2= moderate: may cause some interference with functioning.  
3= severe: interrupts subject’s usual daily activity and may require treatment. 
5.4.2 Treatment-related Discomfort 
After each laser treatment, subjects will be asked to rate the average amount of discomfort 
experienced during treatment and immediately after laser treatment using the Pain Rating Scale (VAS 
Scale) Appendix 2.   
 
 
 
 
 
  5.5 Photographs 
Standardized digital photographs will be taken of each subject’s treatment area at baseline, prior to              
and post all laser treatments and at each follow-up visit. Treatment area will be cleansed and any 
jewelry and make-up will be removed from the area being photographed. For facial photographs, hair 
will be pulled away from the face with a headband. 
 
Facial photographs will be obtained from at least 3 angles: with the subject facing forward, 45° to the 
right and 45° to the left. Photographs will be taken in the same windowless room equipped with 
adequate lighting. The room lighting, camera positioning and subject positioning should be consistent 
for all study visit photographs. Digital camera settings should remain the same for all photographs and 
the highest resolution settings should be utilized. 
5.6 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. 
5.7 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.  

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 13 of 37                                                                    Version 2.0; 03JAN201 
 
6. STUDY POPULATION 
6.1 Study Subject Recruitment and Selection 
Approximately 15 male or female subjects, ages 18 to 65, with Fitzpatrick Skin Type I-VI who desire laser 
treatment for moderate to severe facial 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 to assess his/her suitability for entry into the study 
according to the following inclusion and exclusion criteria.  
6.1.1 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 (Appendix 6). 
4.  
Subject desires treatment for acne scars and wishes to undergo laser treatments for 
improvement. 
5.  
Subject has bilateral moderate to severe signs of facial acne scarring. 
6.  
Must be willing to have Cutera enlighten laser with the Micro-Lens Array handpiece 
attachment treatments and able to adhere to the treatments, follow-up visit schedule, 
and post-treatment care instructions. 
7.  
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. 
8.  
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. 
9.  
Agree to not undergo any other procedure(s) or treatment(s) for acne scars during the 
study and has no intention of having such procedures performed during the course of 
the study. 
10.  
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.,  
6.1.2 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 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  procedures, facial fillers, i.e. (Bellafill) and those used for 
general aesthetic correction, facial peel, lightening creams, or facial surgery. 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 14 of 37                                                                    Version 2.0; 03JAN201 
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. 
6.2 Subject Numbering  
If a subject completes the Informed Consent Form, meets the study eligibility criteria and is willing to 
participate, the subject will be assigned a study subject identification number. This number is comprised 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 15 of 37                                                                    Version 2.0; 03JAN201 
of a site number (which is provided by the sponsor) and a sequential subject number and the subject 
initials (first and last names). 
6.3 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. 
  
  
 
 
 
 
   
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 16 of 37                                                                    Version 2.0; 03JAN201 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
  
 
 
 
 
   
 
  
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 18 of 37                                                                    Version 2.0; 03JAN201 
 
 
 
 
 
 
 
 
  
 
 
   
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 19 of 37                                                                    Version 2.0; 03JAN201 
8. ADVERSE EVENTS and ADVERSE DEVICE EFFECTS  
8.1 Definitions 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 20 of 37                                                                    Version 2.0; 03JAN201 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 23 of 37                                                                    Version 2.0; 03JAN201 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
9.2 Potential Benefits 
The subjects may or may not benefit from the treatment with the study device. Potential benefit of laser 
treatment for acne scars is improved appearance of treated area. There is no guarantee of success.  
10. 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. 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 24 of 37                                                                    Version 2.0; 03JAN201 
11. DATA ANALYSIS PLAN  
11.1 Sample Size 
The planned sample size of approximately 15 subjects has been deemed sufficient for the histology 
evaluation.   
11.2 Statistical Analysis Methods 
This is a study to evaluate safety and efficacy of the Cutera enlighten laser with the Micro-Lens Array 
handpiece attachment. Outcome measures will be assessed around multiple endpoints.  These measures 
will be: degree of improvement as assessed by the Investigator, blinded evaluators, 
 
 Formal hypothesis testing and statistical analysis are not planned for this study.   
11.3 Safety Analyses 
Safety variables will be analyzed descriptively.  The safety variables for this study are: 
• 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. 
12. 
 
 
13. STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES  
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 25 of 37                                                                    Version 2.0; 03JAN201 
 
 
 
  
 
 
 
 
 
  
 
 
  
 
 
 
 
  
 
 
 
 
  
13.3 Protocol Compliance 
The principal investigator must comply with all terms of the protocol. 
13.4 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. 
13.5 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. 
13.6 Study Personnel 
The investigator must supply the sponsor with a list of the names and curricula vitae that describe the 
professional backgrounds of the clinically responsible study investigators (principal, sub-investigators), 
research nurses, and other possible participants (e.g. medical doctor, nurse, etc.). 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 26 of 37                                                                    Version 2.0; 03JAN201 
13.7 Disclosure of Financial Interest 
Each investigator [principal and sub-investigator(s)] is required to disclose sufficient accurate financial 
information to the sponsor, to allow sponsor to submit complete and accurate certification or disclosure 
statements. 
 
 
 
 
   
 
 
 
 
 
  
 
 
 
 
 
  
14. 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-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 27 of 37                                                                    Version 2.0; 03JAN201 
 
 
 
 
 
  
15. 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-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 28 of 37                                                                    Version 2.0; 03JAN201 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 31 of 37                                                                    Version 2.0; 03JAN201 
 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 32 of 37                                                                    Version 2.0; 03JAN201 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 34 of 37                                                                    Version 2.0; 03JAN201 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 35 of 37                                                                    Version 2.0; 03JAN201 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 36 of 37                                                                    Version 2.0; 03JAN201 
 
 
 
 
  
 
 
 
   
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cutera, Inc. 
Protocol # C-17-ML03 
“Open-label, Prospective, Multicenter Study to Evaluate the Cutera enlighten™ Laser and a Micro-Lens Array Handpiece Attachment for the 
Treatment of Moderate and Severe Acne Scars” 
Confidential and Proprietary 
 Page 37 of 37                                                                    Version 2.0; 03JAN201