Multi-Center, Clinical Evaluation of the Cutera Secret RF Device
Phase: NA
Conditions: Skin Quality
Sponsor: Cutera Inc.

Cutera, Inc. 
Protocol # C-18-SRF01 
“Multi-Center Clinical Evaluation of the Secret RF Device” 
 
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TITLE PAGE 
 
 
 
 
Protocol Number: 
C-18-SRF01 
Protocol Title: 
Multi-Center, Clinical Evaluation of the Secret RF Device 
Sponsor: 
 
Cutera, Inc. 
3240 Bayshore Boulevard 
Brisbane, CA 94005 
Telephone: 305-490-8452 
Fax: 415-715-3518 
Contact: Michaela Bell 
Email: mbell@cutera.com 
 
 
Version, Date: 
Version 2, Dated March 29, 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-18-SRF01 
“Multi-Center Clinical Evaluation of the Secret RF Device” 
 
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Protocol Signature Page – Principal Investigator 
 
 
PROTOCOL C-18-SRF01 
 
 
Study Title:   Multi-Center, Clinical Evaluation of the Secret RF Device 
 
 
Protocol Version 2.0, Dated March 29, 2018 
 
I have received and read the protocol dated March 29, 2018 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-18-SRF01 
“Multi-Center Clinical Evaluation of the Secret RF Device” 
 
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Table of Contents 
 
1 
PURPOSE 
5 
2 
BACKGROUND INFORMATION 
5 
3 
STUDY OBJECTIVES 
5 
4 
STUDY DESIGN 
5 
4.1.1 
Efficacy Endpoint 
5 
4.1.2               Safety Endpoint                                                                                                                                      5 
4.1.3               Exploratory Analyses                                                                                                                             5 
4.2 
Study Duration 
5 
4.3 Study Assessments 
6 
4.3.1 
Efficacy Assessments 
6 
4.3.2 
Safety Assessments 
7 
4.4 
Study Discontinuation 
7 
4.5 
Investigator Selection 
8 
5 
STUDY POPULATION 
8 
5.1 
Study Subject Recruitment and Selection 
8 
5.1.1 
Inclusion Criteria 
8 
5.1.2 
Exclusion Criteria 
8 
5.2 
Subject Numbering 
9 
6 
STUDY PROCEDURES 
10 
6.1 
Screening and Enrollment Visit Procedures 
10 
6.2 
Pre-Treatment Procedures and Treatment Visits 
10 
7 
ADVERSE EVENTS AND ADVERSE DEVICE EVENTS 
11 
7.1 
Definitions 
11 
7.1.1 
Adverse Event (AE) 
11 
7.1.2 
Serious Adverse Event (SAE) 
11 
7.1.3 
Anticipated Serious Adverse Device Effect (ASADE) 
12 
7.1.4 
Unanticipated Serious Adverse Device Effect (USADE) 
12 
7.2 
Recording AEs/ADEs and SAEs/SADEs 
12 
7.3                   Follow-up AEs                                                                                                                                       12 
8 
POTENTIAL RISKS / BENEFITS 
13 
8.1 
Potential Risks 
13 

Cutera, Inc. 
Protocol # C-18-SRF01 
“Multi-Center Clinical Evaluation of the Secret RF Device” 
 
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8.2 
Potential Benefits 
14 
9 
DATA ANALYSIS PLAN 
14 
9.1 
Sample Size 
14 
9.2 
Analysis Sets 
14 
9.3 
Analysis of Efficacy/Exploratory Endpoints 
14 
9.4 
Safety Analyses 
14 
10 
STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES 
15 
10.1 
Training and Monitoring 
15 
10.2 
Informed Consent 
15 
10.3 
Protocol Compliance 
15 
10.3.1 
Protocol Amendments 
15 
10.3.2 
Protocol Deviations 
16 
10.4 
Data Collection, Record Keeping and Storage 
16 
10.5 
Subject Confidentiality 
16 
10.6 
Publication Policy 
17 
REFERENCES                                                                                                                                                                18 
Appendix 1: Study Schedule 
19 
Appendix 2: Pain Scale                                                                                                                                                20 
Appendix 3: Before and After Treatment Instructions                                                                                         23 
Appendix 4: Subject Questionnaire                                                                                                                         24 
 
 
 
 

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Protocol # C-18-SRF01 
“Multi-Center Clinical Evaluation of the Secret RF Device” 
 
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1 
PURPOSE 
The purpose of this study is to evaluate the efficacy and safety of the Secret RF device.  
2 
 BACKGROUND INFORMATION 
“The use of radiofrequency (RF) microneedling systems in aesthetic medicine has grown substantially. 
The technology has been widely used for wrinkles, cutaneous ptosis, the treatment of acne scars, skin 
tightening and stretch marks, among other treatment possibilities”1.   
 
Fractional Intradermal Radiofrequency (FIRF) delivers superfine needles into the middle layer of the skin 
and activates radiofrequency energy to tighten and remodel collagen. FIRF uses non-laser radiofrequency 
technology delivered to the dermis without damaging the top layer of the skin. Micro-needle penetration 
depth can be adjusted from 0.5 to 3.5mm to tailor the treatment to various thickness of the skin and skin 
irregularities. The advantage is effective treatment with minimal recovery time. 
 
 
3 
STUDY OBJECTIVES 
The objectives of this study are to evaluate the efficacy and safety of the Secret RF device. 
4 
STUDY DESIGN 
This is a multi-center, study in approximately 50 subjects, age 18 and older. .  Subjects may receive 
 
 treatments and will be followed at 4 and 12 weeks post the final treatment. 
 
 
   
 
4.1       Study Endpoints 
4.1.1 
Efficacy Endpoints 
• Efficacy of treatments with Cutera’s Secret RF as assessed by the investigator for the 
treatment of improvement in skin quality. 
• 
   
 
4.1.2 
Safety Endpoints  
• Incidence and severity of adverse device events. 
4.1.3    
 
 
 
4.2 
Study Duration 
Subjects enrolled in this trial will be asked to participate for approximately 8 months, depending on 
treatment(s).   

Cutera, Inc. 
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“Multi-Center Clinical Evaluation of the Secret RF Device” 
 
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4.3 Study Assessments 
4.3.1 
Efficacy Assessments 
At baseline, and starting at the follow up visits, the Investigator will assess the efficacy of the Cutera Secret 
RF treatment using the GAIS, 
  Baseline photos 
of subjects may be used while assessing the GAIS, 
 
   
 
Global Aesthetic Improvement Scale (GAIS): [Only performed after treatment] 
4 = Very Significant Improvement (≥ 75%) 
3 = Significant Improvement (50 – 74%) 
2 = Moderate Improvement (25 – 49%) 
1 = Mild Improvement (6 – 24%) 
0 = No Change (< 5%) 

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Protocol # C-18-SRF01 
“Multi-Center Clinical Evaluation of the Secret RF Device” 
 
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4.5 
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 microneedle RF 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 are also 
considered. 
5 
STUDY POPULATION 
5.1 Study Subject Recruitment and Selection 
Approximately 50 male or female subjects, age 18 and older., with Fitzpatrick Skin Type I-VI who desire 
treatment with Secret RF. 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.  
Subject must be able to read, understand and sign the Informed Consent Form. 
2.  
Female or Male, age 18 and older.  
3.  
Willing to undergo treatments with Secret RF. 
4.  
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. 
5.  
Subject must adhere to the follow-up schedule and study instructions. 
6.  
Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the treatment 
area during the study and has no intention of having such procedures performed during 
the course of the study. 
7.  
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. 
8.  
For female subjects: not pregnant or lactating and is either post-menopausal, surgically 
sterilized, or using a medically acceptable form of birth control prior to enrollment and 
during the entire course of the study. 
5.1.2 Exclusion Criteria 
Subjects will be excluded from the study if they meet any of the following Exclusion Criteria: 
1.  
Participation in a clinical trial of another device or drug within 1 month of study 
participation, or during the study period. 

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“Multi-Center Clinical Evaluation of the Secret RF Device” 
 
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2.  
History of clotting disorders and/or current use of blood thinning medications.   
3.  
History of autoimmune disorders or diabetes.   
4.  
Cardiac pacemaker or active implantable metal device in the treatment area.  
5.  
Allergies to metals i.e. gold. 
6.  
Has a history of squamous cell carcinoma or melanoma in the treatment area. 
7.  
Significant uncontrolled concurrent illness that in the opinion of the Investigator would 
make the subject unsuitable for inclusion. 
8.  
History of any disease or condition that could impair wound healing. 
9.  
History of keloid formation or abnormal/delayed wound healing. 
10.  
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. 
11.  
Use of topical agents one week prior to treatment that may cause facial sensitivity. 
12.  
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). 
13.  
As per the Investigator’s discretion, any physical or mental condition which might make 
it unsafe for the subject to participate in this study or a condition that would compromise 
the subject’s ability to comply with the study requirements. 
 
5.2 
Subject Numbering  
If a subject completes the Informed Consent Form, meets the study eligibility criteria and is willing to 
participate, the subject will be assigned a study subject identification number. This number is comprised 
of a site number (which is provided by the sponsor) and a sequential subject number and the subject 
initials (first and last names). 
5.2.1 
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. 
 

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6 
 
 
 
 
 
 
 
 
   
 
 
 
  
 
   
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 

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7.2 
Recording AEs/ADEs and SAEs/SADEs 
All AEs/SAEs or ADEs/SADEs will be: (1) evaluated and must be recorded in the subject’s study case report 
forms (CRFs); (2) monitored and tracked from the time of the first treatment.  
At each contact with the subject, the investigator must seek information on AEs/ADEs/SADEs by specific 
questioning and, as appropriate, by examination. AEs/ADEs/SADEs may be observed by the investigator 
and/or clinical research staff, elicited from the subject and/or family member or volunteered by the 
subject. All observed and volunteered adverse signs and symptoms, anticipated or unanticipated, 
regardless of severity or frequency, will be recorded in the case histories (medical chart and CRFs). 
Included in the description should be the nature of the sign or symptom, the date of onset, date of 
resolution (duration), the severity, anticipated or unanticipated, the relationship to study treatment or 
other therapy, the action taken (if any), and the outcome.  All SAEs/SADEs, anticipated or unanticipated, 
must be reported to Cutera immediately but not later than 5 working days.  The SADE must be recorded 
in: (1) the CRF and (2) a written report must be submitted to Cutera within five (5) working days after the 
investigator first learns of the event and is to include a full description of the event and sequelae, in the 
format detailed by the Cutera Serious Adverse Event Form. 
7.3   Follow-up of Subjects after AEs 
All reported AEs/ADEs/SAEs/SADEs should be followed until resolution or until the subject’s participation 
in the study ends.  Resolutions of AEs/ADEs/SAEs/SADEs are to be documented on the appropriate CRFs.  

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“Multi-Center Clinical Evaluation of the Secret RF Device” 
 
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8.2 
Potential Benefits 
The subjects may or may not benefit from the treatment with the study device. Potential benefit is 
improved appearance of treated area. There is no guarantee of success.  
9 
DATA ANALYSIS PLAN  
9.1 
Sample Size 
This is an efficacy and safety study on an approved device and 40 subjects has been deemed appropriate 
for evaluation of the device.   
9.2 
Analysis Sets 
The analysis sets will include all enrolled subjects who complete treatment. 
9.3 
Analysis of Efficacy/Exploratory Endpoints 
Formal hypothesis testing and statistical analysis are not planned for this study.  
9.4 
Safety Analyses 
Device-related and procedure-related adverse effects (AEs) 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 longest duration. The number and 
percentage of subjects experiencing each AE Term will be descriptively summarized. 

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“Multi-Center Clinical Evaluation of the Secret RF Device” 
 
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10 STUDY MANAGEMENT AND ADMINISTRATIVE PROCEDURES  
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
10.3 Protocol Compliance 
The principal investigator must comply with all terms of the protocol. 
10.3.1 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. 

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10.3.2  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, 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. 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
10.5 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:   
 
 
 
 
  
 
 
 
 
 
 
 

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10.6 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.  
 
 
 
 

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“Multi-Center Clinical Evaluation of the Secret RF Device” 
 
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