The Clinical Efficacy And Safety Of SkinStylus Microneedling System for Ventral Torso Hypertrophic Scars: Clinical Results With 30 Patients
Phase: NA
Conditions: Cicatrix, Hypertrophic
Sponsor: Esthetic Education LLC

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
04 August 2017 
 
 
 
 
 
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SkinStylus Microneedling System 
 
Protocol for Clinical Study  
 
Treatment of Ventral Torso Hypertrophic Scars  
 
 
Trial Sponsor: 
Esthetic Education LLC 
7950 E. Acoma Drive 
Suite 100 
Scottsdale, AZ 85260 
 
Principle Investigator: 
Dr. Toni Stockton, MD 
 
 
 
 
Trial number – 2017-002 
 
04 August 2017 
 
 
 

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
04 August 2017 
 
 
 
 
 
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Protocol Synopsis for EE 2017-02 
 
Title of Study: 
The Clinical Efficacy And Safety Of SkinStylus Microneedling 
System for Ventral Torso Hypertrophic Scars: Clinical Results 
With 30 Patients 
Principal 
Investigator: 
Dr. Toni Stockton, M.D. F.A.A.D 
Study Design: 
Blinded, bias minimized comparison of pre and post treatment 
photographs 
Target Population: General population over the age of 22 
Duration of Study: Approximately 6 months 
Treatment 
SkinStylus® Microneedling 
Study Objective: 
This is a study to evaluate the efficacy of SkinStylus 
Microneedling for ventral torso hypertrophic scars  
 

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
04 August 2017 
 
 
 
 
 
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PROTOCOL APPROVAL PAGE 
 
We the undersigned have reviewed this protocol and agree that it contains all relevant 
information and appropriate safeguards for human participants as required by the UK 
MHRA, GCP, ICH and USFDA requirements. 
 
We further agree that the protocol will be executed exactly as written and approved by 
the Institutional Review Board (IRB) and/or Ethics Committee.  Any change required or 
proposed shall be reviewed by the IRB/Ethics Committee prior to its implementation. 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
04 August 2017 
 
 
 
 
 
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Investigator Signature Sheet 
 
I have read the attached protocol and agree that it contains all the necessary details for 
performing the study. 
I will provide copies of this protocol and of the preclinical information on the 
investigational product, which was furnished to me by the sponsor, to all members of the 
study team responsible to me who participate in the study.  I will discuss this material 
with them to assure that they are fully informed regarding the study device and the 
conduct of the study. 
Once this protocol has been approved by the Institutional Review Board (IRB), I will not 
modify it without obtaining the prior approval of the sponsor and of the IRB.  I will submit 
the protocol modifications and/or any informed consent form modifications to the 
sponsor and the IRB, and approval will be obtained before any modifications are 
implemented. 
I understand the protocol and will work according to it, the Code of Federal Regulations, 
the principles of Good Clinical Practice (current ICH guidelines), and the Declaration of 
Helsinki (1964) including all amendments up to and including the Scotland revision (2000). 
 
 
 
 
  

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
04 August 2017 
 
 
 
 
 
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General Information 
 
Study Title - The Clinical Efficacy And Safety Of SkinStylus Microneedling System for 
Treatment of Ventral Torso Hypertrophic Scars: Clinical Results With The SkinStylus® 
System for 30 Patients. 
A. Background 
 
Device under investigation – The SkinStylus® Microneedling System is a handheld 
device that creates channels as well as microinjuries into the skin, by virtue of a 1A DC 
motor that rapidly reciprocates an array of 32 gauge microneedles that are no longer than 
2.5mm. The device consists of a power source, a motor body with depth adjustment, a 
removable nosecone interface, and a disposable, single use cartridge containing an array 
of microneedles.  
The power source consists of two separate systems. One option is a rechargeable lithium-
ion battery that delivers no more than 5 volts DC and 1 amp of current to power the 
motor. The other option consists of an AC wall adaptor that converts 110v AC into 5v 
DC. A power cord connects the wall adaptor to the device via a USB connector and a 
standard 1/8” headphone plug on the device side.  
The motor body is comprised of anodized aluminum with a dial mechanism that controls 
the depth of penetration of the microneedles from 0 mm to a maximum of 2.5mm. 
The removable nosecone interface provides the SkinStylus® the unique ability to have an 
interface between the motor and the cartridge that can be autoclave sterilized.  
The SkinStylus® cartridge is designed in three configurations, an 11 needle array with all 
needles @2.5mm, 36 needle array with all needles @2.5mm and a 36 needle array with 
18 needles @2.5mm and 18 needles @1.0mm alternating in row.. The needle array is 
housed in a specially designed (patented) cartridge housing that prevents liquids from 
entering the motor body via the inside lumen of the cartridge. This has been an issue with 
other microneedling systems.  
 
Research Supporting Safety 
 

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
04 August 2017 
 
 
 
 
 
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The SkinStylus® will be used to improve the appearance of ventral torso hypertrophic 
scars, such as abdominoplasty and breast augmentation scars.  
 
Microneedling hypertrophic scars has an impeccable safety record as evidenced by the 30 
articles attached at the end of this letter as a Resource List. Most notably in 2017, 
researcher Hou, et al, performed a comprehensive overview of the available literature 
regarding the efficacy and safety of microneedling performed for dermatologic conditions 
in human subjects. Hou’s group stated the following with respect to adverse events 
associated with all of the studies analyzed,  
 
“Microneedling is associated with a low rate of AE. Histologic examination taken 24 
hours after therapy demonstrates an intact epidermis and no change in melanocyte 
number, resulting in limited downtime and minimal risk of dyspigmentation.5 Adverse 
effects are rare and temporary, with transient post-procedure erythema being most 
common.6”  
 
This study protocol was based, in part, on a microneedling study performed by Schwarz 
M, and Laaff H. titled, “A prospective controlled assessment of microneedling with the 
Dermaroller device.” and published in Plastic Reconstructive Surgery 2011; 127:146e–
148e. This study was reviewed by Hou et. Al and there were no adverse events reported 
in this study.  
 
Indications for Use/Intended Use 
 
The purpose of the trial is to provide objective evidence the SkinStylus may be used 
safely and effectively for the treatment of ventral torso hypertrophic scars.   
 
 
Inclusion Criteria 
 
1) Participants must be at least 23 years old 
2) Each participant shall have at least one suitable ventral torso hypertropic scar of 
sufficient length that it may be easily visualized in two halfs. 
3) The scar(s) present along a flat surface suitable for application of the SkinStylus® 
device and consistent medical photography. 
 
Trial Summary 
 
Each participant shall have at least one suitable ventral torso hypertropic scar of 
sufficient length that it may be easily visualized in two halfs.  At the conclusion of the 
trial all participants shall be provided with a cross over treatment on the non-treated 

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
04 August 2017 
 
 
 
 
 
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portion of the scar identical to that which was provided within the trial for the purpose 
of “evening” the ventral torso hypertrophic scar. This is entirely voluntary and 
participants may decline the treatment if they wish. 
 
Efficacy (primary) Endpoint  
 
The Visual analogue Scale (VAS) scar scoring system was defined and validated by 
Duncan et al. in 2006. This scale consists of a 10-cm line representing scar quality, with 0 
representing normal skin and 10 indicating a poor scar. The assessor places a mark along 
the line to represent the appearance of the scar. This mark is then translated into a score 
by measuring its position on the 10-cm line to one decimal place.  
 
 
 
 
The improvement in the appearance of the scar will be evaluated using a paired t-test 
for the mean difference. The paired t-test will be used to compare the treated side and 
untreated (control) side of the scar to determine if there is a statistically significant 
improvement in the average difference of Visual Analogue Scale (VAS) measurements 
(difference determined by VAS measurements pre- and post-treatment). Efficacy will be 
determined by at least 2 out of 3 blinded physician evaluators, comparing baseline 
photographs to photographs taken approximately 90 days after the last treatment.  
 
Subject Feedback (patient perception) Endpoint - Patient satisfaction will be 
determined by evaluating scores on a subject satisfaction survey to be completed 
approximately 90 days after the last treatment.  Subjects will indicate on the survey 
whether they saw improvement in the areas treated.  Baseline and 90 day post-
treatment photographs will be made available for viewing by the patient for their 
assessment. Subjects will have access to a full length mirror in a room lit by natural light. 
T-tests will be used to determine if on average patients had a good experience and saw 
improvement in the appearance of the scar while being treated by evaluating ratings 
from the Self-Assessed Scar Improvement Scale and the Subject Global Aesthetic 
Improvement Scale. For the Self Assessed Scar Improvement Scale, ratings of 1 and 

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
04 August 2017 
 
 
 
 
 
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greater (1=1%-25% improvement, 2=26%-50% improvement, 3=51%-75% improvement, 
and 4=76%-100% improvement) indicate that patients were satisfied with the 
treatment. For the Subject Global Aesthetic Improvement Score, ratings of 3 and lower 
(1=very much improved, 2=much improved, 3=improved) indicate that patients were 
satisfied with the treatment. 
 
The Subject Satisfaction Survey is a 6-point scale (1-6) describing an overall assessment 
as follows: 
 
Rating 
Description 
6 
Very satisified 
5 
Satisfied 
4 
Somewhat satisfied 
3 
Somewhat dissatified 
2 
Dissatified 
1 
Very dissatified 
Safety Endpoint  
 
For the purposes of determining a safety endpoint, the following conditions are not 
considered adverse incidents, have been known to occur with similar microneedling 
procedures, and are expected to occur as part of a normal and necessary healing process 
after each treatment: 
a) Erythema – superficial reddening of the skin in the area treated  
b) Edema – mild swelling in the area treated  
c) Crusting – a scab  
d) Mild to moderate pain during treatment that resolves within 2 hours after 
treatment 
e) Hypo/hyperpigmentation, the skin in the treatment area becomes temporarily 
lighter or darker than the surrounding skin but resolves with 90 days of treatment  
f) Mild Pruritis – mild itching around the treatment area  
g) Mild to moderate petechiae – pinpoint bleeding that resolves (stops) within 1 hour 
of treatment 
For the purposes of determining a safety enpoint, the following six conditions have been 
known to occur with similar microneedling procedures and are considered adverse 
incidents regardless if they result in the need for medical intervention or not: 
1) Moderate to severe pruritis– severe itching not resolving within 24 hours 
2) Moderate to severe pain that continues more than 2 hours after the end of 
the treatment. 
3) The presence of active infection in the treatment area after treatment 

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
04 August 2017 
 
 
 
 
 
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4) Fever developing after treatment 
5) Hypo/hyperpigmentation, the skin in the treatment area becomes lighter or 
darker than the surrounding skin and does not resolve with 90 days of 
treatment 
6) Moderate to severe petechiae – pinpoint bleeding that does not resolve 
within 1 hour of treatment 
 
Safety endpoint analysis 
Subjects will be photographed approximately 180 days after the last treatment and 
asked about the incidence and/or persistence of any of the above six listed conditions 
considered to be adverse incidents. 
 
Patient Population 
The patient cohort shall be comprised of not less than 35 qualified persons (using the 
inclusion criteria).  Any more than 5 dropouts shall be replaced so that a total of at least 
30 participants complete the trial.   
 
Regulatory Compliance  
The trial will be conducted in compliance with this protocol, GCP, and the applicable 
regulatory requirements of the United States. 
 
The trial shall be under the supervision of a duly accredited Institutional Review Board 
or equivalent ethics oversight committee.  The SkinStylus® and this trial is considered a 
Non-Significant Risk (NSR) as the device is being used entirely within its foreign agency 
cleared performance specification.   
 
The trial shall be monitored at planned and at unannounced intervals by a Registered 
Nurse who has appropriate training in the conduct of medical research.  The RN Monitor 
shall ensure the trial is conducted according to the requirements of the approved 
protocol.  In addition to examining the Case Report Forms (CRF) for each participant the 
RN Monitor shall review the digital photographs taken and will report to the PI any 
instance where an injury may have occurred. 
 
The PI and all sub-PI’s shall be appropriately trained in the Protection of Human Subjects 
as provided by the National Institute of Health or equivalent body.  
 
C. 
Trial Design  
1. The SkinStylus has been designated as a non-significant risk and therefore will be 
granted an Investigational Device Exemption (IDE).  There are no meaningful 

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
04 August 2017 
 
 
 
 
 
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changes to the SkinStylus® instructions for use and specifically no new risks will be 
introduced. 
2. There are three endpoints under investigation.  The primary endpoint is a 
statistically significantly improvement using the VAS scale on page 7. The secondary 
endpoint is patient feedback by the Subject Satisfaction Survey on page 7.  The third 
endpoint is safety related and is the absence of adverse incidents as previously 
defined. 
3. The trial shall be blinded and bias minimized in that three (3) physicians who are 
either dermatologists or plastic surgeons (and not affiliated with the trial or Esthetic 
Education LLC) shall review the baseline and treatment photographs and score them 
using the VAS scale (see page 7). 
4. Inclusion Criteria - patients age 23 years or older as described on page 6.  The 
subjects shall all be volunteers.  Subjects shall not be hand picked or otherwise 
manipulated or shown favor. There will be some effort expended to ensure 
reasonable representations of both sexes and of all Fitzpatrick Skin Types as shown 
below: 
 
 
 
 
 
 
 
Type 
Score 
Description 
I 
0-6 
Skin always burns; never tans.  (Pale peach, blond, or 
red hair, blue eyes, freckles 
II 
7-13 
Skin usually burns, tans minimally (peach; fair; blond or 
red hair; blue, green, or hazel eyes) 
III 
14-20 
Skin sometimes mild burn, tans uniformly (light brown; 
fair with any hair or eye color) 
IV 
21-27 
Skin burns minimally, always tans well (moderate 
brown) 
V 
28-34 
Skin very rarely burns, tans very easily (dark brown) 
VI 
35-36 
Skin never burns, always tans (deeply pigmented dark 
brown to darkest brown) 
 
 
5. Exclusion Criteria – patients with any of the following shall be excluded from the 
study.   
a. Women who are or think they may be pregnant 

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
04 August 2017 
 
 
 
 
 
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b. Participants currently taking Coumadin/Warfarin® or heparin 
c. Any type of bleeding disorder 
d. Any history of keloid formation  
e. Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity 
f. Patients with mental disorders 
g. Patients with metal implants around the proposed treatment areas 
h. Patients with any undefined wasting disease (Cachexia for example) 
i. Presence of an active infection in the treatment area other than mild acne 
j. Presence of tumors or those who are being treated by chemotherapy or 
radiation therapy 
k. Presence of severe cardiovascular and cerebrovascular disease 
l. Presence of renal failure 
6. Withdrawal from the study - the patient will be withdrawn from the study upon 
his/her request or if the PI determines the patient has become part of the excluded 
population.  For example, during the trial a female participant discovers she has 
unexpectedly become pregnant. 
7. The PI or his designee will discuss the study with each potential participant 
reviewing the SkinStylus® and its operation, the treatment protocol, the need of 
completion of the trial as written, the inclusion and exclusion criteria; the warnings 
and contraindications and the taking of photographs prior to obtaining informed 
consent.  Any potential participant not meeting all the selection requirements shall 
not be accepted into the trial and therefore no informed consent from them shall be 
required. 
8. Adverse Incidents – adverse incidents are defined above.  The PI shall be 
immediately informed whenever an adverse incident, as defined above, is detected 
or even suspected to have occurred. The circumstances relating to adverse 
incidents, their resolution and the participant’s condition and treatment shall be 
recorded on the CRF. 
9. Photographs  
a. General – a digital photography system shall be used to take photographs.  
The system set up and the patient positioning shall be standardized across 
the population for both baseline and post treatment digital pictures.  To the 
greatest extent possible the photographic equipment shall be fixed in a single 
location and not be moved or taken down during the trial.  If the 
photography equipment must be moved, the exact location and orientation 
shall be recorded to permit the photography equipment to be reinstalled in a 
standardized orientation for baseline and treatment photographs.  For each 
photograph taken the SkinStylus® settings, number and duration of 
treatments to the location shall be recorded in the CRF.   

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
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b. Baseline – prior to SkinStylus® treatment a digital picture of each treatment 
location shall be taken and a description of the hypertrophic scar shall be 
recorded in the CRF.  The description should include skin assessment using 
the Fitzpatrick scale (see table on page 16).   
c. 90 days following the final treatment a digital photograph using an identical 
technique to that used in baseline photograph shall be taken and used for 
evaluation  
d. When taking baseline and post treatment digital pictures if the treatment 
location is in close proximity to the patient’s face, the patient: 
o Shall not wear any makeup or skin care products in or around the 
treatment areas.  Make-up includes any type of lipstick, mascara, 
eyeliner, foundation or any other article which alters the nature 
appearance of the skin in and around the treatment areas. 
o Patients shall not wear any jewelry in or around the treatment areas.  
This includes earrings; piercings; necklaces or other article which may 
obscure the digital photograph. 
o Patients shall not wear glasses. 
o The patient’s hair shall be approximated identically in both baseline 
and post treatment photographs.  The hair should be held up and 
away from the treatment areas using hairpins.  Hairbands should be 
avoided.  Preferably, the patient ‘s hair shall be covered using a white 
hair cover as is used in clean rooms   
o Patients shall be encouraged to make no facial expression to avoid 
altering the natural appearance of the treatment area.   
o The patient’s eyes should be closed for each photograph.   
e. When taking baseline and post treatment digital pictures if the treatment 
location is not in close proximity to the patient’s face, the patient: 
o Shall not wear any makeup or skin care products in or around the 
treatment areas.  Make-up includes any type of cosmetic, temporary 
tattoo or any other article which alters the nature appearance of the 
skin in and around the treatment areas. 
o Patients shall not wear any jewelry in or around the treatment areas.  
This includes piercings; necklaces or belts or other article which may 
obscure the digital photograph. 

Esthetic Education, LLC Scottsdale, AZ 
SkinStylus  
Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
04 August 2017 
 
 
 
 
 
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o The photograph shall be taken with the patient standing in a 
completely relaxed fashion. 
o The patient’s hair shall be approximated identically in both baseline 
and post treatment photographs.  The hair should be held up and 
away from the treatment areas using hairpins.  Hairbands should be 
avoided.  Preferably, the patient ‘s hair shall be covered using a white 
hair cover as is used in clean rooms. 
NOTE:  Any personal identifying features shall be obscured electronically in order to 
avoid any twisting or other unintentional distortions within the photograph.      
10. Dermal Spectroscope readings. 
a. General – a specialized dermal spectroscope may be used to measure the 
color of the skin in the treatment area. This device painlessly scans the skin 
and provides a melanin and redness reading in the form of an integer.  
b. For each set of data captured by the dermal spectroscope, the SkinStylus® 
settings, number and duration of treatments to the location shall be 
recorded in the CRF.  
c. Baseline – prior to SkinStylus® treatment, data readings from the dermal 
spectroscope of each treatment location may be taken and a description of 
the atrophic scar treatment areas shall be recorded in the CRF.   
11. Records 
a. The CRF shall be considered the principal record of the study.   
b. The CRF shall contain all records of treatment as well as the photographs 
taken. 
c. The CRF shall be the only record used for source data. 
d. In consideration of HIPAA requirements, the CRF shall identify patients only 
by code using the first three letters of the device name and a numerical 
designation.  For example – O17-1; O17-2, etc. 
e. The Study Coordinator (Kristin Groop) shall maintain a key which can be used 
to identify a particular patient, if necessary. The Registered Nurse Monitor 
(Terri Masaheri RN) shall have access to the key upon request.  
 
12. Sequence of Treatment 
a. The patient shall wash the treatment area to remove dirt, cosmetics and 
other impurities from the treatment area. 
b. The technician administering the treatment shall further clean the treatment 
areas, if necessary. 
c. The hypertrophic scar to be treated shall be divided into two equal segments 
and the technician shall randomly choose one half to be treated. 

Esthetic Education, LLC Scottsdale, AZ 
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Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
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d. The technician shall describe in the CRF, which half of the scar was treated.  
e. Subsequent treatments shall only treat the same half of the scar that was 
initially designated the treatment side.  
f. If the scar is to be locally anesthetized, the entire scar (both halves) are to be 
anesthesized. 
g. A proprietary glide serum, EstheCeuticals® HA-Cu Serum, shall be applied 
prior to treatment and again as necessary. The purpose of the serum is to act 
as a glide and no therapeutic effect is known or anticipated. This serum has 
been used in several hundred microneedling treatments without any 
incidence of adverse events.  
h. The depth settings and clinical endpoints shall be established by the PI. 
i. Each participant shall receive three SkinStylus treatments . 
j. Each participant shall receive one treatment using each of the three different 
array configurations. The order in which each is used shall be randomized at 
intake but a different array configuration must be used in each of the three 
treatments. 
k. The treatments shall be not less than 12 days or more than 14 days apart. 
l. The treatments shall consist of 2 to 3 passes at the targeted area over a 
period of 15-30 minutes. 
m. While the technician may adjust the treatment settings, the treatment 
settings shall remain within the range specified by the PI, usually 2.5mm 
depth.   
n. At the conclusion of treatment the technician completes the CRF as 
stipulated. 
o. 90 days following the final treatment the post treatment photograph shall be 
taken and recorded in the CRF. There may be other photographs taken 
periodically during the trial in addition to the dermal spectroscope readings 
taken.  
p. 180 days following the initial treatment the patients shall be evaluated to 
provided objective evidence of what adverse incidents, as previously defined,  
may have occurred.  
 
D. Determination of Results 
 
A panel of 3 physicians who are either dermatologists or plastic surgeons (and not 
affiliated with the trial or Esthetic Education LLC) shall review the baseline and post 
treatment photographs and score each them using the VAS scar score on page 7.  A 
successful outcome on the primary endpoint (efficacy) shall be determined to a 
statistically significant improvement when comparing the score determined for the 90 
day post final treatment photographs to the score determined at baseline.   

Esthetic Education, LLC Scottsdale, AZ 
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Treatment of  
Ventral Torso Hypertrophic Scars  
 
 
Clinical Protocol 
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A successful outcome on secondary endpoint (patient feedback) shall be determined by 
the evaluation of the Subject Satisfaction Survey on page 7. 
The evaluation of the third endpoint (safety) shall be determined by the relative lack of 
adverse incidents as previously defined above. 
 
E.  Statistical  Analysis for the SkinStylus® Clinical Study 
 
The sample size for this study consisted of 30 subjects with assessable data. Performance 
will be evaluated by the (VAS) visual analogue scale scar score as described above from 
SkinStylus® treated sites and control sites at approximately 90 days after the final 
treatment. 
The VAS scar scoring system was defined and validated by Duncan et al. in 2006. This 
scale consists of a 10-cm line representing scar quality, with 0 representing normal skin 
and 10 indicating a poor scar. The assessor places a mark along the line to represent the 
appearance of the scar. This mark is then translated into a score by measuring its position 
on the 10-cm line to one decimal place.  
Measurements: 
a) Primary Endpoint:  A statistically significant improvement between the 
measurements taken at baseline and two weeks following the end of the 
treatment, on the VAS Scar Scale. The scores are determined based on a panel of 
three independent physicians (dermatologist and/or plastic surgeons). 
b) Second Endpoint:  The patient surveys shall be tabulated and reported.  It is 
anticipated the patients shall have a good experience while being treated by the 
SkinStylus for scar revision. 
c) Third Endpoint: - The tertiary endpoint is the relative absence of adverse 
incidents as previously defined.   
 
 
Prior data indicate that the standard deviation of the paired differences in visual analogue 
scale scores is not expected to exceed 1.46.  
Statistical analysis on the scoring will commence using appropriate measures for 
statistical significance using the standard cutoff for significance of P<0.05. The scoring 
will include the analysis of the VAS, the Subject Satisfaction Survey, and any post 
treatment complications. 
 
Criterion Used: 
 

Esthetic Education, LLC Scottsdale, AZ 
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The criterion for significance (alpha) has been set at 0.050.  The test is one-tailed.  
 
Power Findings: 
 
The minimum power for the statistical analysis shall be least 80% power with a sample 
size of 30.  
 
Resources in Support of SkinStylus® Ventral Hypertrophic Torso Scar Study 
 
Hou  A. Hou, B. Cohen, A. Haimovic, N. Elbuluk. “Microneedling: a comprehensive review.” 
Dermatol Surg. 2017;43(3):321–39 
Duncan JA, Bond JS, Mason T, et al. Visual analogue scale scoring and ranking: A suitable and 
sensitive method for assessing scar quality? Plast Reconstr Surg. 2006;118:909–918. 
Gurtner GC, Werner S, Barrandon Y, Longaker MT. Wound repair and regeneration. Nature. 
2008;453:314–321.  
Thomas JR, Somenek M. Scar revision review. Arch Facial Plast Surg. 2012;14:162–174.  
American Society of Plastic Surgeons. [Accessed March 5, 2013];2012 Report of the 2011 
Statistics National Clearinghouse of Plastic Surgery Statistics. Available at: 
http://www.plasticsurgery.org/Documents/news-resources/statistics/2011-
statistics/2011_Stats_Full_Report.pdf. 
Gurtner GC, Dauskardt RH, Wong VW, et al. Improving cutaneous scar formation by controlling 
the mechanical environment: Large animal and phase I studies. Ann Surg. 2011;254:217–225.  
Majid I.  Microneedling therapy in atrophic facial scars: an objective assessment. J Cutan Aesthet 
Surg. 2009;2: 26–30. 
Eilers Jr R. E., et al. "A Combination Approach to Surgical Scars." Dermatologic Surgery 42 (2016): 
S150-S156. 
Birchall JC, Clemo r, Anstey A, et al. Microneedles in clinical practice–an exploratory study into 
the opinions of healthcare professionals and the public. Pharm Res. 2011;28:95–106. 
A. Chambers.” Unified Approach to the Treatment of Hypertrophic and Atrophic Scars.” 
American Journal of Cosmetic Surgery Vol 33, Issue 4, pp. 176 –183, 2016 
G. Fabbrocini, N. Fardella, A. Monfrecola, I. Proietti, and D. Innocenzi,  “Acne  scarring  
treatment  using  skin  needling,” Clinical and Experimental Dermatology, vol. 34, no. 8, pp. 874–
879, 2009. 

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Alam  M, Han S, Pongprutthipan M,  Wareeporn  D, et al. Efﬁcacy  of a needling device for the 
treatment of acne scars: a randomized clinical trial. JAMA Dermatol 2014;150:844–9. 
Doddaballapur S. Microneedling with dermaroller. J Cutan Aesthet  Surg. 2009;2:110–111. 
Aust MC, Fernandes D, Kolokythas P, et al. Percutaneous collagen induction therapy: an 
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