clinical trial for using milux (and 1 other beauty device

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Clinical Trial Results Report KISCS-AFA011-GTG Clinical Trial for Using 'MILUX (and 1 other beauty device)' to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles Commissioned by GTG Wellness Co., Ltd. March 7, 2016

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Page 1: Clinical Trial for Using MILUX (and 1 other beauty device

Clinical Trial Results Report

KISCS-AFA011-GTG

Clinical Trial for Using 'MILUX

(and 1 other beauty device)' to

Improve External and Internal Skin

Elasticity, Neck Lift, Skin Tone,

Sebum, Dead Skin Cells, and

Wrinkles

Commissioned by GTG

Wellness Co., Ltd.

March 7, 2016

Page 2: Clinical Trial for Using MILUX (and 1 other beauty device

This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences; its transfer, plagiarization, and disclosure to thir parties is prohibited.

Table of Contents

I. Background ·· ·· ················· 1

Ⅱ. Purpose ·· ·· ···················

Ⅲ. Test Period · ·· ··················

Ⅳ. Testing Institution ·· ···············

V. Commissioning Company ···············

Ⅵ. Test Method ·····················

Ⅶ. Results ························ 13

Ⅷ. Conclusion ······················

IX. Bibliography ····················· 29

Attachments

[Attachment 1] Testing Results (Detailed Information)

[Attachment 2] Clinical Trial Images

[Attachment 3] Testing Product Components

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Page 3: Clinical Trial for Using MILUX (and 1 other beauty device

This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences;its transfer, plagiarization, and disclosure to thir parties is prohibited.

□Title of the clinical study : A clinical study for the effects of 'Milux and Pepbu:w' on the

improvement of epidermal elasticity, dermal elasticity, neck lifting,

skin tone, sebum excretion, flaky skin and facial wrinkles

□Case control No. : KISCS-AFA011-GTG

This study was conducted according to the regulations of designation as the test institution for

drugs, quasi-drugs, cosmetics, and medical devices; the guidelines of the management standards

for clinical drug evaluations; the guidelines of in vivo clinical and in vitro evaluation studies;

the guidelines of the experimental methods for cosmetic display and advertisements; and the

guidelines of the validation of functional cosmetics of the Ministry of Food and Drug Safety, Republic

of Korea; the laws of the bioethics and safety of the Ministry of Health and Welfare, Republic of

Korea; and the standard operation procedure of the Korea Institute for Skin and Clinical Sciences.

All procedures were investigated by the person in charge of reliability assurance.

Title of the clinical

study

A clinical study for the effects of 'Milux and Pepbu:w'

on the improvement of epidermal elasticity, dermal elasticity, neck lifting, skin tone,

sebum excretion, flaky skin and facial wrinkles

Date Step Categories Result Reporting date Note

January 11, 2016 Study plan Reporting plan Approved January 11, 2016

January 21, 2016 ~

February 18, 2016

Performing

clinical trial

Reporting

implementationApproved February 18, 2016

March 02, 2016Inspection of

draft report

Raw data,

Inspecting draft reportApproved March 02, 2016

March 07, 2016Inspection of

final reportInspecting final report Approved March 07, 2016

This report was prepared on the basis of the experiment results and accurately reflects the data.

March 7, 2016

Scientific director In Sook An, Ph.D. (seal)

Reliability Assurance Hyosun Han (seal)

CERTIFICATE FOR RELIABILITY ASSURANCE

Page 4: Clinical Trial for Using MILUX (and 1 other beauty device

This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences;its transfer, plagiarization, and disclosure to thir parties is prohibited.

Title of the clinical study

A clinical study for the effects of 'Milux and Pepbu:w' on the improvement of

epidermal elasticity, dermal elasticity, neck lifting, skin tone, sebum excretion, flaky

skin and facial wrinkles

Clinical trial institution

Korea Institute for Skin and Clinical Sciences203, 194-41, Osongsaengmyeong 1-ro, Osong-eup,Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea

Sponsor GTG Wellness Co., Ltd.

Chief researcher

In Sook An, Ph. D.

Researcher Seung Bin Kwon, Ph. D.

Name of the test materials

Milux (Sample A)

Pepbu:w (Sample B)

Trial periodJanuary 11, 2016 (study initiation) ~ March 7, 2016 (study termination)For the study initiation, the person in charge of the study signed the clinical study proposal; for the study termination, the person in charge of the study signed the final report.

SubjectsTwenty three female subjects over thirty years old who met the inclusion criteria

and were not included in the exclusion criteria were selected for this study.

Methods

Usage of

test materials

Three times a week for four weeks, after washing face, subjects

applied Sample A (Milux) for 15 minutes after applying the same

amount of Sample B (Pepbu:w) on the face and neck.

Evaluations

The evaluations were conducted by Standard Operating

Procedures of KISCS and all of the procedures were investigated

by the person in charge of reliability assurance.

1. Measurements

1) Evaluation of epidermal elasticity improvement using the

Ballistometer

2) Evaluation of dermal elasticity improvement using the Dermal

Torque Meter

3) Evaluation of neck lifting improvement using the ANTERA 3D

4) Evaluation of skin tone improvement using the Spectro-

photometer and the Facial Stage

5) Evaluation of sebum excretion improvement using the

DermaLab USB sebum probe

SUMMARY OF THE CLINICAL STUDY

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This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences;its transfer, plagiarization, and disclosure to thir parties is prohibited.

Methods Evaluations

6) Evaluation of flaky skin improvement using the Video

Microscope and the Image Analyzing Program

7) Evaluation of facial wrinkles improvement using the ANTERA

3D

2. Evaluation of abnormal skin response

3. Survey

Results

1. The evaluation results of epidermal elasticity improvement using the Ballistometer

The CoR value indicating epidermal layer elasticity was increased 5.17% and

7.76% after two and four weeks of the test materials application respectively in

comparison with the pre-application (p<.001).

2. The evaluation results of dermal elasticity improvement using the Dermal Torque

Meter

The Ur/Ue value indicating dermal layer elasticity was increased 6.78% and

10.69% after two and four weeks of the test materials application respectively in

comparison with the pre-application (p<.001).

3. The evaluation results of neck lifting improvement using the ANTERA 3D

The Depressions medium value indicating volume of skin depression was

decreased 8.32% and 12.46% after two and four weeks of the test materials

application respectively in comparison with the pre-application (p<.001).

4. The evaluation results of skin tone improvement using the Spectrophotometer

and the Facial Stage

The L* value indicating skin brightness was increased 0.57%, 1.33% and 2.13%

immediately after and after two and four weeks of the materials application

respectively in the comparison with the pre-application (p<.05).

5. The evaluation results of sebum excretion improvement using the DermaLab

USB sebum probe

The sebum excretion was decreased 27.77% and 52.52% after two and four

weeks of the test materials application respectively in comparison with the pre-

application (p<.001).

Page 6: Clinical Trial for Using MILUX (and 1 other beauty device

This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences;its transfer, plagiarization, and disclosure to thir parties is prohibited.

Results

6. The evaluation results of flaky skin improvement using the Video Microscope

and the Image Analyzing Program

The extent of flakiness was decreased 76.82%, 75.42% and 78.66% immediately

after and after two and four weeks of the test materials application respectively in

comparison with the pre-application (p<.001).

7. The evaluation results of facial wrinkles improvement using the ANTERA 3D

The Wrinkles medium value indicating skin wrinkles was decreased 9.71% and

16.37% after two and four weeks of the test materials application respectively in

comparison with the pre-application (p<.001).

8. Subjects’ abnormal skin responses were not detected during the trial period.

Conclusion

In the study requested by GTG Wellness Co., Ltd., the ‘Milux and Pepbu:w’ were

found to improve epidermal elasticity, dermal elasticity, neck lifting, skin tone,

sebum excretion, flaky skin and facial wrinkles. Also, the test materials were

found to be effective on the dual elasticity by improving epidermal elasticity and

dermal elasticity. And have effect on the anti-aging by improving epidermal

elasticity, dermal elasticity, neck lifting and facial wrinkles.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Ⅰ. Test Background

Scientific developments have contributed to increased life expectancies and a

growing aging population. Due to active modern lives, society is becoming more

concerned with appearance, resulting in an increased importance on research and

methods to delay the aging process. As such, research is being conducted in the

medical technology, welfare, and beauty industries to regulate the aging process.

In particular, the market for anti-wrinkle cosmetics that help aging skin accounts

for a large portion of the cosmetics industry.

The skin is the body’s most outer layer and protects the body from the

environment. As such, it is exposed to a variety of external factors. Not only do

climate factors such as seasonal changes, cosmetics, clothes, and other personal

care goods affect the skin, but also environmental factors and other such diverse

elements. The skin can become easily damaged from a variety of irritants, and

the degree of these damages can result in the degree of skin aging or

pigmentation.

Skin aging results from both internal and external factors. Internal factors

include hereditary elements and time, which are not possible to regulate. On the

other hand, external factors including smoking, excessive drinking, nutrition,

sunlight, and more can be regulated with effort, and therefore slow down the

aging process. In particular, 80% of facial skin aging is attributed to exposure to

ultraviolet rays. Other environmental factors cause wrinkles and reduce

elasticity, resulting in aging. This is a significant issue in cosmetology.

Along with the development of modern society, more and more people are

becoming concerned with their appearance. As such, more effort is being

concentrated on turning rough, aged skin damaged by external factors into

beautiful, moisturized skin. A variety of skin care products have been developed,

such as moisturizers and exfoliation scrubs, and the market for such beauty

industries are continuously growing.

This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences;its transfer, plagiarization, and disclosure to thir parties is prohibited.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

The trend for cosmetic research is concentrated on developing new raw

materials and their utilization, coinciding with society’s need for a youthful and

fresh appearance. However, more scientific research is needed for suppressing

and preventing wrinkles. Developing functional cosmetics based on systematic

clinical trials and scientific analysis is needed to tap into this market’s infinite

potential.

This test was commissioned by GTG Wellness Co., Ltd. to evaluate the

effectiveness of the testing product MILUX (and 1 other beauty device) in

improving external and internal skin elasticity, neck lift, skin tone, sebum, dead

skin cells, and wrinkles.

This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences;its transfer, plagiarization, and disclosure to thir parties is prohibited.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Ⅱ. Purpose

The purpose of this test is to evaluate the effectiveness of MILUX (and 1 other

beauty device) on improving external and internal skin elasticity, neck lift, skin tone,

sebum, dead skin cells, and wrinkles on women over 30.

Ⅲ. Test Period

Jan. 11, 2016 – Mar. 7, 2016

Ⅳ. Testing Institution

Name: Korea Institute for Skin and Clinical Sciences

Address: 203 (Company Research Facility II), 194-41, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, CheongJu-si, Chungcheongbuk-do, Korea

Phone Number: 070-7707-2277

Email: [email protected]

Homepage: www.skinresearch.or.kr

Evaluator: Kwon Seung Bin

Ⅴ. Commissioning Company

Name: GTG Wellness Co., Ltd.

Commissioner: Kim Dong Soo

Phone Number: 02-3462-5400

Email: [email protected]

Address: 606, Bundang Technopark, D-dong, 700, Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea

This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences;its transfer, plagiarization, and disclosure to thir parties is prohibited.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

VI. Test Method

1. Selecting Test Subjects

The subjects for this clinical trial are women over 30 who volunteered to be a part ofthis testing. They were selected in accordance with the items listed under 1), and if any items under 2) did not apply. The person in charge of this clinical trial, as well as those delegated to administer this test, disclosed all relevant information to the subjects. The subjects voluntarily and of free will gave their consent to participate in this test.

1) Test Subject Selection Factors

(1) Subjects who listened to all relevant information regarding the clinical trial from

the person in charge of the test or those delegated to administer the test, and then

voluntarily and of free will gave their consent to participate in this test.

(2) Healthy women over 30 (who do not have acute or chronic diseases, including

skin diseases)

(3) Subjects who are able to be monitored carefully throughout the entire testing

period

2) Subject Exclusion Criteria

The following subjects were excluded after conducting interviews.

(1) Subjects who were pregnant, breast feeding, or had a possibility of becoming

pregnant

(2) Subjects who treated skin diseases with external skin applications that contained

steroids for over 1 month

(3) Subjects who participated in the same test less than 6 months ago

(4) Subjects with sensitive or hypersensitive skin

(5) Subjects with birth marks, acne, red spots, hemotelangiosis, or other such skin

problems on testing area

This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences;its transfer, plagiarization, and disclosure to thir parties is prohibited.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

(6) Subjects who received surgical procedures less than 6 months ago on testing

area

(7) All other subjects who were deemed unfit for by the person in charge of this

clinical trial

3)) Test Subject Elimination Criteria

In case of the following items, the person in charge of this clinical trial stopped

testing for the subject. These test results were excluded when evaluating test

results, but were recorded in the final report.

(1) If the subject developed itching, red spots, or experienced other adverse

effects at testing area

(2) If results were skewed and could not be properly evaluated due to the subject

receiving medical attention, applying other products, excessively exposing testing

area to ultraviolet rays, excessive drinking and smoking, etc.

(3) If the subject could not be monitored during the testing period due to personal

reasons

(4) If the subject violated usage methods or appointments due to no particular

reason

This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences;its transfer, plagiarization, and disclosure to thir parties is prohibited.

2. Testing Area

The testing area for this clinical trial was in accordance with the usage

methods of the testing product. Therefore, the subjects’ face and neck areas

were selected as the testing area.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

3. Testing Product Use

1) Testing Product Information

(1) Testing Product Name

Testing Product A: MILUX

② Testing Product B: Pepbu:w

(2) Testing Product Management Number

① Testing Product A: M-KISCS-AFAP01-GTG

② Testing Product B: M-KISCS-AFAP02-GTG

(3) Commissioning Company: GTG Wellness Co., Ltd.

(4) Testing Product Formation

① Testing Product A: LED galvanic beauty device in the form of a facial mask

② Testing Product B: Colorless, transparent ampoule type

(5) Complete List of Components: Refer to ‘Attachment 3’

2) Usage Method and Capacity of Testing Product

(1) During the 4 week testing period, the subjects evenly applied testing

product B ‘Pepbu:w’ for 3 weeks after washing their face to their face and

neck areas. Then, they used testing product A ‘MILUX’ for 15 minutes.

(2) During the clinical trial, subjects were prohibited from using products and

functional cosmetics other than the ones provided by this institution (such as

eye creams, whitening creams, anti-aging creams, etc.) so that it would not

influence test results. The use of face packs, massages, or other such

procedures were also prohibited.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

4. Evaluation

1) Testing Location

This clinical trial was conducted at the Korea Institute for Skin and Clinical

Sciences. All test subjects used the same face cleanser and then entered into a

steady temperature and humidity room (temperature: 22±1℃, humidity : 45

±5%) after 30 minutes. After the room was stabilized, results were measured.

2) Measurements

(1) Evaluation of External Skin Elasticity Improvements from the Ballistometer

Evaluation of External Skin Elasticity Improvements from the Ballistometer

This clinical trial applied the Ballistometer (Ballistometer BLS780, Dia-Stron

Ltd., UK) to evaluate the testing product’s ability to improve external skin

elasticity. A single tester measured the right cheek of each of the test subjects.

The ballistometer utilizes a 2mm diameter arm located on its probe to calculate

skin elasticity by quantifying its vibration energy when it comes in contact with it.

MApp, the official Ballistometer analysis program, was used to analyze these

results. The value for measuring skin elasticity was the CoR (Coefficient of

Restitution) value (the recovery coefficient), which revealed the ratio of the

impact velocity to the arm’s rebound speed. The average CoR value was

calculated for the first 3 bounces, with the maximum value set at 1.0. These

values were compared with the values before testing product use. An increase in

the measured value signifies improvement in external elasticity. Measurements

were conducted before testing product use, after 2 weeks of use, and after 4

weeks of use.

(2) Evaluation of Internal Skin Elasticity Improvements from the Dermal Torque Meter

This clinical trial applied the Dermal Torque Meter (Dermal Torque Meter

DTM310, Dia-Stron Ltd., UK) to evaluate the testing product’s ability to

improve internal skin elasticity. A single tester measured the internal elasticity of

all test subjects by taping a probe onto the right cheek and applying torque for 10

seconds (at a steady angle and pressure). The Dermal Torque Meter utilizes the

torque meter built in the probe to measure the skin’s angular displacement (by

calculating shear force). The torque motor is connected to a torque disk that is 20

mm in diameter (horizontally) and applies a rotary power directly to the skin.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

In addition, detachable guard rings with ring gaps of 1, 3, and 5 mm are attached

to the probe head to limit the rotary power to the area of the skin being measured.

The larger the ring gap, the deeper the rotary power is delivered. In order to

measure how much the testing product improved internal elasticity, the guard ring

with a 3mm ring gap was attached to deliver a rotary power to the skin. The Ur/

Ue value (which is used to measure skin elasticity) was used during analysis. The

Ur/Ue value has a maximum value of 1.0, and reveals the skin’s resilience

towards changes initiated by the rotary power. MApp, the official analysis

program was used to analyze these values. These values were compared with the

values before testing product use. An increase in the measured value signifies

improvement in internal elasticity. Measurements were conducted before testing

product use, after 2 weeks of use, and after 4 weeks of use.

Image 1. Ballistometer. Image 2. Dermal Torque Meter.

(3) ) Evaluation of Neck Lift Improvements from the ANTERA 3D

This clinical trial applied the ANTERA 3D (Miravex, Ireland) to evaluate the

testing product’s ability to improve neck lifts. A single tester measured the neck

area of all test subjects. To ensure that measurements could be reproduced, the

image taken before testing product use was overlapped to measure the same area.

The images were matched with ANTERA 3D’s official software ANTERA pro

software and then used to analyze the corresponding measurement areas. The

depressions medium value for the skin (which represents the skin’s volume

loss) was the measurement value, which was measured in ㎣. These values were

compared with the values before testing product use. An increase in the measured

value signifies improvement in internal elasticity. Measurements were conducted

before testing product use, after 2 weeks of use, and after 4 weeks of use.

This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences;its transfer, plagiarization, and disclosure to thir parties is prohibited.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Image 3. ANTERA 3D

(4) Evaluation for Skin Tone Improvement from the Spectrophotometer and Cosmetic Full-Face Photography System Facial Stage

This clinical trial applied a spectrophotometer (Spectrophotometer CM-2600D,

Konica Minolta, Japan) and cosmetic full-face photography system facial stage

(Cosmetic Full-Face Photography System Facial Stage DM-3, MORITEX Corp.,

Japan) to evaluate the testing product’s ability to improve skin tone. A single

tester used the spectrophotometer to measure the left cheek of all test subjects

3 times in succession, and then calculated their average for analysis. The

measurement value for the spectrophotometer is composed of 3 factors, L*, a*,

and b*. The L* value measures brightness, the a* value measures redness, and

the b* value measures yellowness. The L* value was used to measure and

analyze the testing product’s ability to improve skin tone. These values were

compared with the values before testing product use. An increase in the

measured value signifies improvement in skin tone. In order to maintain

consistent photographs, a single tester measured the facial areas of all test

subjects with the cosmetic full-face photography system facial stage by using

the same lighting and position. In order to secure the hairline of the test subjects,

a hair band was used to fix the hair. Afterwards, the subjects put on the same top

gown and sat on a chair. After securing their face on the tool bar underneath the

cage, their face was photographed. Measurements were conducted before and

right after testing product use, after 2 weeks of use, and after 4 weeks of use.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Image 4. Spectrophotometer Image 5. Cosmetic Full-Face Photography System Facial Stage

(5) Evaluation for Improvements in Sebum Amounts from the DermaLab USB Sebum Probe

This clinical trial applied the DermaLab USB Sebum Probe (Cortex Technology,

Inc., Denmark) to evaluate the testing product’s ability to improve sebum

amounts. A single tester used a sebum collecting strip to measure the left nostril

of all test subjects at the same pressure for 30 seconds. After the sebum was

adsorbed, the sebum collecting strip was inserted into a tape reader to calculate

the strip’s degree of transparency (due to sebum). The tape reader marked the

saturation degree of the film in percentages (%). These values were compared

with the values before testing product use. A decrease in the measured value

signifies improvement in sebum amounts. Measurements were conducted before

testing product use, after 2 weeks of use, and after 4 weeks of use.

(6) Evaluation for Improvements in Dead Skin Cells from the Video Microscope

This clinical trial applied a video microscope (Skin Diagnosis System SDM,

Bomtech, Korea) and an image analysis program (Image J, National Institute of

Health, USA) to evaluate the testing product’s ability to improve dead skin cells.

For consistent recording, the video microscope was used under the same lighting

and position for all test subjects. A single tester measured the left mouth areas of

all test subjects by magnifying it 250 times. The image was then subject to the

image analysis program, and through the Otsu method, applied thresholding for a

binarized image. The binarized image determined white areas that went above the

threshold as dead skin cells and analyzed results as a ratio of the entire area.

These values were compared with the values before testing product use. A

decrease in the measured value signifies improvement in dead skin cells.

Measurements were conducted before testing product use, after 2 weeks of use,

and after 4 weeks of use.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Image 6. DermaLab USB Sebum Probe Image 7. Video Microscope

(7) Evaluation for Wrinkle Improvements from the ANTERA 3D

This clinical trial applied the ANTERA 3D (Miravex, Ireland) to evaluate the

testing product’s ability to improve wrinkles. A single tester measured the left

nasolabial folds of all test subjects. To ensure that measurements could be

reproduced, the image taken before testing product use was overlapped to

measure the same area. The images were matched with ANTERA 3D’s official

software ANTERA pro software and then used to analyze the corresponding

measurement areas. The measured value was taken from the indentation index

(which is the measuring variable) to analyze the wrinkles medium values (which

represents the skin’s wrinkles). These values were compared with the values

before testing product use. A decrease in the measured value signifies

improvement in wrinkles. Measurements were conducted before testing product

use, after 2 weeks of use, and after 4 weeks of use.

(8) Evaluating Abnormal Reactions

The person in charge of this clinical trial observed any abnormal skin reactions

at the testing area such as erythema, edema, scaling, itching, stinging, burning,

tightness, and prickling. If such abnormal skin reactions occurred, the tester

marked the degree of severity and recorded results. In addition, a survey was

administered to the test subjects to check for any abnormal skin reactions.

(9) Surveys

Surveys were conducted to check for test subjects’ general skin condition and

characteristics, skin condition before and after testing product use, and user

experience with testing product. 1 question was asked for general skin condition

and characteristics, and 8 questions were asked for skin conditions before and

after testing product use in a multiple choice survey. In addition, 5 dichotomous

questions were asked (satisfied/dissatisfied) to check for user experience with

testing product A, B.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

5. Cases of Harmful Side Effects

Evaluation of harmful side effects was conducted on individual case report forms

during each visit by the test subject. Through medical examinations and visual

observations, cases of harmful side effects (such as erythema, edema, scaling,

itching, stinging, burning, tightness, prickling) or other abnormalities were

evaluated. They were recorded based on weak, normal, or severe degrees, and

cases where testing stopped or subjects were eliminated (based on inspections)

were recorded in the individual case report forms. If subjects could no longer

participate in the clinical trial (even if it was not their day to visit), they were

required to write and sign an ‘Early Termination Agreement.’

6. Statistical Analysis Method

This clinical trial used the SPSS 17.0 for Windows Program for statistical

analysis. The average, standard deviation, frequency, and percentage were

calculated for the test subjects’ survey analysis. A paired t-test analysis was

conducted to measure any significant changes for results regarding a variety of

skin improvements.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Ⅶ. Results Report

1. Test Subject Basic Information

The following is information on test subjects who participated in this clinical trial (Table 1).

Table 1. Test Subject Basic Information

Registered Test Subjects 23 people

Final Test Subjects 23 people

Gender Female

Average Age 46, 48 years old

Standard Deviation 5.30

Image 8. represents test subjects who participated in this clinical trial by age (refer to Attachment 1 for more detailed information).

Image 8. Test Subject Age Distribution

This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences;its transfer, plagiarization, and disclosure to thir parties is prohibited.

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

2. Evaluation of External Elasticity Improvements Before and After

Testing Product Use

The following represents evaluation results for external elasticity improvement measured by the Ballistometer before, after 2 weeks, and after 4 weeks of testing product use (Table 2 – 4, Image 9, 10)

The Ballistometer was used to analyze any improvements in external elasticity

for the test subjects’ right cheek. The CoR value used to represent skin

elasticity revealed the following increases when compared with the

measurements taken before testing product use: after 2 weeks by 5.17% and

after 4 weeks by 7.76%. In addition, when the values taken before testing

product use were compared with those taken after 2 weeks and 4 weeks of use,

they were found to be statistically significant (p<.001). Thus, this testing

product conclusively improves external elasticity. Refer to Attachment 1 for

more detailed evaluation of the device.

Table 2. Changes in CoR Values (N=23)

Before Use After 2 Weeks of Use After 4 Weeks of Use

Average 0.59 0.62 0.63

Standard Deviation 0.05 0.05 0.04

Table 3. Improvement Rates (%) of CoR Values

After 2 Weeks of Use After 4 Weeks of Use

Improvement Rate (%) 5.17 7.76

| Measured Value After Use – Measured Value Before Use |× 100

Measured Value Before UseImprovement Rate (%)=

Table 4. Statistical Analysis of CoR Values

After 2 Weeks of Use After 4 Weeks of Use

p-value .000*** .000***

*p <.05 **p <.01 ***p <.001: p-value is measured by paired t-test

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Image 9. Changes in CoR Values Image 10. Improvement Rates (%) of CoR Values

3. Evaluation of Internal Elasticity Improvements Before and After

Testing Product Use

The following represents evaluation results for internal elasticity improvement measured by the Dermal Torque Meter before, after 2 weeks, and after 4 weeks of testing product use (Table 5 – 7, Image 11, 12)

The Dermal Torque Meter was used to analyze any improvements in internal

elasticity for the test subjects’ right cheek. The Ur/Ue value used to represent

skin elasticity revealed the following increases when compared with the

measurements taken before testing product use: after 2 weeks by 6.78% and

after 4 weeks by 10.69%. In addition, when the values taken before testing

product use were compared with those taken after 2 weeks and 4 weeks of use,

they were found to be statistically significant (p<.001). Thus, this testing

product conclusively improves internal elasticity. Refer to Attachment 1 for more

detailed evaluation of the device.

Table 5. Changes in Ur/Ue Values (N=23)

Before Use After 2 Weeks of Use After 4 Weeks of Use

Average 0.42 0.45 0.47

Standard Deviation 0.05 0.05 0.04

Table 6. Improvement Rates (%) of Ur/Ue Values

After 2 Weeks of Use After 4 Weeks of Use

Improvement Rate (%) 6.78 10.69

Improvement Rate (%) =| Measured Value After Use – Measured Value Before Use |

× 100Measured Value Before Use

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Table 7. Statistical Analysis of Ur/Ue Values

After 2 Weeks of Use After 4 Weeks of Use

p-value .000*** .000***

*p <.05 **p <.01 ***p <.001: p-value is measured by paired t-test

Image 11. Changes in Ur/Ue Values Image 12. Improvement Rates (%) of Ur/Ue Values

4. Evaluation of Neck Lift Improvements Before and After Testing

Product Use

The following represents evaluation results for neck lift improvements measured by the ANTERA 3D before, after 2 weeks, and after 4 weeks of testing product use (Table 8 – 10, Image 13, 14).

The ANTERA 3D was used to analyze any neck lift improvements. The

depressions medium value, which represents the skin’s volume loss, revealed

the following decreases when compared with the measurements taken before

testing product use: after 2 weeks by 8.32% and after 4 weeks by 12.46%. In

addition, when the values taken before testing product use were compared with

those taken after 2 weeks and 4 weeks of use, they were found to be statistically

significant (p<.001). Thus, this testing product conclusively improves neck lifts.

Refer to Attachment 1, 2 for more detailed evaluation of the device.

Table 8. Changes in Depressions Medium Values (N=23)

Before Use After 2 Weeks of Use After 4 Weeks of Use

Average 43.12 39.54 37.75

Standard Deviation 15.63 15.68 14.98

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Table 9. Improvement Rates (%) of Depressions Medium Values

After 2 Weeks of Use After 4 Weeks of Use

Improvement Rate (%) 8.32 12.46

Improvement Rate (%) =| Measured Value After Use – Measured Value Before Use |

× 100

Table 10. Statistical Analysis of Depressions Medium Values

After 2 Weeks of Use After 4 Weeks of Use

p-value .000*** .000***

*p <.05 **p <.01 ***p <.001: p-value is measured by paired t-test

Image 13. Changes in Depressions Medium Values

Image 14. Improvement Rates (%) of Depressions Medium Values

Measured Value Before Use

5. Evaluation of Skin Tone Improvements Before and After Testing

Product Use

The following represents evaluation results for skin tone improvements measured bythe spectrophotometer and cosmetic full-face photography system facial stage before, right after, after 2 weeks, and after 4 weeks of testing product use (Table 11 – 14, Image 15, 16).

The spectrophotometer and cosmetic full-face photography system facial stage

was used to analyze any skin tone improvements. The L* value, which represents

the skin’s brightness, revealed the following increases when compared with the

measurements taken before testing product use: right after by 0.57%, after 2

weeks by 1.33% and after 4 weeks by 2.13%. In addition, when the values taken

before testing product use were compared with those taken right after, after 2

weeks and 4 weeks of use, they were found to be statistically significant (p<.05).

Thus, this testing product conclusively improves skin tone. Refer to Attachment

1, 2 for more detailed evaluation of the device.

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Table 11. Changes in L* Values (N=23)

Before Use Right After Use After 2 Weeks After 4 Weeks

Average 63.14 63.51 63.98 64.49

Standard Deviation 2.47 2.71 2.55 2.42

Table 12. Changes in ΔL* Values

ΔL*₁ ΔL*₂ ΔL*₃

Average 0.36 0.84 1.34

Standard Deviation 0.70 0.70 0.75

ΔL*₁=Right After Use – Before Use, ΔL*₂=After 2 Weeks of Use – Before Use,

ΔL*₃=After 4 Weeks of Use – Before Use

Table 13. Improvement Rates (%) of L* Values

Right After Use After 2 Weeks After 4 Weeks

Improvement Rate (%) 0.57 1.33 2.13

Improvement Rate (%) =| Measured Value After Use – Measured Value Before Use |

× 100Measured Value Before Use

Table 14. Statistical Analysis of L* Values

Right After Use After 2 Weeks After 4 Weeks

p-value .022* .000*** .000***

*p <.05 **p <.01 ***p <.001: p-value is measured by paired t-test

Image 15. Changes in L* Values Image 16. Improvement Rates (%) of L* Values

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6. Evaluation of Sebum Amount Improvements Before and After

Testing Product Use

The following represents evaluation results for improvements for sebum measured by the DermaLab USB Sebum Probe before, after 2 weeks, and after 4 weeks of testing product use. (Table 15 – 17, Image 17, 18).

The DermaLab USB Sebum Probe was used to analyze improvements in sebum

amounts on the left nostril. The following decreases were observed when

compared with the measurements taken before testing product use: after 2

weeks by 27.77% and after 4 weeks by 52.52%. In addition, when the values

taken before testing product use were compared with those taken after 2 weeks

and 4 weeks of use, they were found to be statistically significant (p<.001).

Thus, this testing product conclusively improves sebum amounts. Refer to

Attachment 1 for more detailed evaluation of the device.

Table 15. Changes in Sebum Amounts (N=23)

Before Use After 2 Weeks of Use After 4 Weeks of Use

Average 20.15 14.55 9.57

Standard Deviation 7.82 5.36 5.14

%

Table 16. Improvement Rates (%) of Sebum Amounts

After 2 Weeks of Use After 4 Weeks of Use

Improvement Rate (%) 27.77 52.52

| Measured Value After Use – Measured Value Before Use |× 100

Measured Value Before UseImprovement Rate (%)=

Table 17. Statistical Analysis of Sebum Amounts

After 2 Weeks of Use After 4 Weeks of Use

p-value .000*** .000***

*p <.05 **p <.01 ***p <.001: p-value is measured by paired t-test

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Image 17. Changes in Sebum Amounts Image 18. Improvement Rates (%) of Sebum Amounts

7. Evaluation of Improvement in Dead Skin Cells Before and After

Testing Product Use

The following represents evaluation results for improvements in dead skin cellsmeasured by the video microscope and image analysis program before, right after, after 2 weeks, and after 4 weeks of testing product use (Table 18 – 20, Image 19, 20).

The video microscope and image analysis program was used to analyze

improvements in dead skin cells on the left side of the mouth. The following

decreases were observed when compared with the measurements taken before

testing product use: right after by 76.82%, after 2 weeks by 75.42% and after 4

weeks by 78.66%. In addition, when the values taken before testing product use

were compared with those taken right after, after 2 weeks and 4 weeks of use,

they were found to be statistically significant (p<.001). Thus, this testing

product conclusively improves dead skin cells. Refer to Attachment 1, 2 for more

detailed evaluation of the device.

Table 18. Changes in Dead Skin Cells (N=23)

Before Use Right After Use After 2 Weeks After 4 Weeks

Average 13.04 3.02 3.21 2.78

Standard Deviation 4.47 0.84 1.19 0.73

%

Table 19. Improvement Rates (%) of Dead Skin Cells

Right After Use After 2 Weeks After 4 Weeks

Improvement Rate (%) 76.82 75.42 78.66

Improvement Rate (%)= | Measured Value After Use – Measured Value Before Use |

× 100Measured Value Before Use

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Table 20. Statistical Analysis of Degree of Dead Skin Cells

Right After Use After 2 Weeks After 4 Weeks

p-value .000*** .000*** .000***

*p <.05 **p <.01 ***p <.001: p-value is measured by paired t-test

Image 19. Changes in Dead Skin Cells Image 20. Improvement Rates (%) of Dead Skin Cells

8. Evaluation of Wrinkle Improvements Before and After Testing

Product Use

The following represents evaluation results for wrinkle improvements measured by the ANTERA 3D before, after 2 weeks, and after 4 weeks of testing product use(Table 21– 23, Image 21, 22).

The ANTERA 3D was used to analyze any wrinkle improvements on the left

nasolabial fold. The wrinkles medium value, which represents the skin’s

wrinkles, revealed the following decreases when compared with the

measurements taken before testing product use: after 2 weeks by 9.71% and

after 4 weeks by 16.37%. In addition, when the values taken before testing

product use were compared with those taken after 2 weeks and 4 weeks of use,

they were found to be statistically significant (p<.001). Thus, this testing

product conclusively improves wrinkles. Refer to Attachment 1, 2 for more

detailed evaluation of the device.

Table 21. Changes in Wrinkles Medium Values (N=23)

Before Use After 2 Weeks After 4 Weeks

Average 129.19 116.64 108.04

Standard Deviation 24.31 22.22 21.12

Indentation index

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Table 23. Statistical Analysis of Wrinkles Medium Values

After 2 Weeks After 4 Weeks

p-value .000*** .000***

*p <.05 **p <.01 ***p <.001: p-value is measured by paired t-test

Image 21. Changes in Wrinkles Medium Values Image 22. Improvement Rates (%) of Wrinkles Medium Values

Table 22. Improvement Rates (%) of Wrinkles Medium Values

After 2 Weeks After 4 Weeks

Improvement Rate (%) 9.71 16.37

Improvement Rate (%)=| Measured Value After Use – Measured Value Before Use |

× 100Measured Value Before Use

9. Evaluation of Abnormal Skin Reactions

1) Evaluation of Abnormal Skin Reactions by the Tester

No allergic contact dermatitis or irritant contact dermatitis was detected in all

test subjects after use of testing product.

2) Abnormal Skin Reactions Reports from Test Subject Surveys

Separate from the abnormal skin reaction evaluation conducted by the tester,

the following represents any abnormal skin reactions reported by the test

subjects through a survey.

Table 24. Abnormal Skin Reactions Reported by Test Subjects (N=23)

Abnormal Reaction

1. Erythema(Redness)

0 0 5. Stinging (Pain) 0 0

2. Edema(Swelling)

0 0 6. Burning 0 0

3. Scaling(Dead Skin Cells)

0 0 7. Tightness 0 0

4. Itching 0 0 8. Prickling 0 0

0: None, 1: Weak Degree, 2: Normal Degree, 3: Severe Degree

2 Weeks 4 Weeks Abnormal Reaction 2 Weeks 4 Weeks

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10. Subjective Surveys from Test Subjects on Before and AfterTesting Product Use

1) Survey of Test Subjects’General Skin Condition Characteristics

Table 25. General Skin Condition Characteristics (N=23)

Survey Item Frequency (%)

Skin Type

Oily 1 4.3

Normal 2 8.7

Combination 10 43.5

Dry 10 43.5

Sensitive 0 0.0

Total 23 100.0

2) Survey of Test Subjects’Skin Conditions Before Testing Product Use

The following represents test subjects’skin conditions before testing product use based on a multiple choice survey (Table 26).

Table 26. Skin Condition Before Testing Product Use (N=23)

Survey Item Frequency (%)

Overall, my skin is firm and has volume.

Not at all 5 21.7

To a small extent 16 69.6

To some extent 2 8.7

To a moderate extent 0 0.0

To a large extent 0 0.0

Overall, my skin is firm and has strong internal elasticity.

7 30.5

15 65.2

1 4.3

0 0.0

0 0.0

Overall, my skin is dense and has strong elasticity with no sagging.

8 34.8

13 56.5

2 8.7

0 0.0

0 0.0

The following represents test subjects’general skin condition characteristics based

on a multiple choice survey (Table 25).

Not at all

To a small extent

To some extent

To a moderate extent

To a large extent

Not at all

To a small extent

To some extent

To a moderate extent

To a large extent

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Overall, my neck doesn’t sag or have any wrinkles.

5 21.7

14 60.9

4 17.4

0 0.0

0 0.0

Overall, my skin glows.

7 30.4

12 52.2

4 17.4

0 0.0

0 0.0

Overall, I don’t have a lot of sebum on my skin.

4 17.4

12 52.2

7 30.4

0 0.0

0 0.0

Overall, my skin doesn’t produce white dead skin cells.

6 26.1

17 73.9

0 0.0

0 0.0

0 0.0

Overall, I do not have deep nasolabial folds.

6 26.1

14 60.9

3 13.0

0 0.0

0 0.0

Total 23 100.0

3) Survey of Test Subjects’User Experiences After Testing Product Use

The following represents test subjects’ user experiences with the testing product (A, B) based on a dichotomous survey (satisfied/dissatisfied) (Table 26).

Table 27. User Experienced with Testing Product A (N=23)

Survey Item ResponseAfter 2 Weeks After 4 Weeks

Frequency (%)

Operational ConvenienceSatisfied 19 82.6 22 95.7

Dissatisfied 4 17.4 1 4.3

Not at all

To a small extent

To some extent

To a moderate extent

To a large extent

Not at all

To a small extent

To some extent

To a moderate extent

To a large extent

Not at all

To a small extent

To some extent

To a moderate extent

To a large extent

Not at all

To a small extent

To some extent

To a moderate extent

To a large extent

Not at all

To a small extent

To some extent

To a moderate extent

To a large extent

Frequency (%)

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Maintenance, Storage Convenience

Satisfied 16 69.6 18 78.3

Dissatisfied 7 30.4 5 21.7

Thermal Temperature21 91.3 22 95.7

2 8.7 1 4.3

Effectiveness23 100.0 23 100.0

0 0.0 0 0.0

Overall Satisfaction with User Experience

23 100.0 23 100.0

0 0.0 0 0.0

Table 28. User Experienced with Testing Product B (N=23)

Survey Item

Brightening22 95.7 23 100.0

1 4.3 0 0.0

Elasticity19 82.6 23 100.0

4 17.4 0 0.0

Application21 91.3 22 95.7

2 8.7 1 4.3

Absorption21 91.3 22 95.7

2 8.7 1 4.3

Overall Satisfaction with User Experience

22 95.7 23 100.0

1 4.3 0 0.0

4) Survey of Test Subjects’Skin Conditions After Testing Product Use

The following represents test subjects’skin conditions after testing product use based on a multiple choice survey (Table 29).

Table 29. Skin Condition After Testing Product Use (N=23)

Survey Item

My skin’s firmness and volume seems to have improved.

Not at all 0 0.0 0 0.0

To a small extent 0 0.0 0 0.0

To a moderate extent 7 30.4 2 8.7

To some extent 14 60.9 15 65.2

To a large extent 2 8.7 6 26.1

Satisfied

Dissatisfied

Satisfied

Dissatisfied

Satisfied

Dissatisfied

ResponseAfter 2 Weeks After 4 Weeks

Frequency (%) Frequency (%)

Satisfied

Dissatisfied

Satisfied

Dissatisfied

Satisfied

Dissatisfied

Satisfied

Dissatisfied

Satisfied

Dissatisfied

After 2 Weeks After 4 Weeks

Frequency (%) Frequency (%)

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My skin’s firmness and internal elasticity seem

to have improved.

0 0.0 0 0.0

0 0.0 0 0.0

3 13.0 1 4.3

18 78.3 13 56.5

2 8.7 9 39.2

My skin’s density, sagging, and elasticity

seem to have improved.

0 0.0 0 0.0

0 0.0 0 0.0

5 21.7 2 8.7

16 69.6 14 60.9

2 8.7 7 30.4

Any sagging or wrinkles on my neck seem to have improved.

0 0.0 0 0.0

0 0.0 0 0.0

8 34.8 2 8.7

14 60.9 16 69.6

1 4.3 5 21.7

My skin seems to be glowing.

0 0.0 0 0.0

0 0.0 0 0.0

3 13.0 0 0.0

15 65.3 11 47.8

5 21.7 12 52.2

My skin doesn’t have a lot of sebum.

0 0.0 0 0.0

0 0.0 0 0.0

5 21.7 0 0.0

15 65.3 12 52.2

3 13.0 11 47.8

My skin is not producing any white dead skin cells.

0 0.0 0 0.0

1 4.3 0 0.0

2 8.7 1 4.4

18 78.3 11 47.8

2 8.7 11 47.8

My nasolabial folds seem to have improved.

0 0.0 0 0.0

0 0.0 0 0.0

7 30.4 2 8.7

14 60.9 15 65.2

2 8.7 6 26.1

Total 23 100.0 23 100.0

Not at all

To a small extent

To a moderate extent

To some extent

To a large extent

Not at all

To a small extent

To a moderate extent

To some extent

To a large extent

Not at all

To a small extent

To a moderate extent

To some extent

To a large extent

Not at all

To a small extent

To a moderate extent

To some extent

To a large extent

Not at all

To a small extent

To a moderate extent

To some extent

To a large extent

Not at all

To a small extent

To a moderate extent

To some extent

To a large extent

Not at all

To a small extent

To a moderate extent

To some extent

To a large extent

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Ⅷ. Conclusion

The Korea Institute for Skin and Clinical Sciences was commissioned by GTG

Wellness Co., Ltd. to conduct a clinical trial on 23 test subjects (women). The

clinical trial involved using MILUX (and 1 other beauty device) to improve

external and internal skin elasticity, neck lift, skin tone, sebum, dead skin cells,

and wrinkles.

According to the Ballistometer analysis conducted (before and after testing

product use) to measure improvements in external elasticity, MILUX (and 1

other beauty device) showed statistically significant results (p<.001).

Improvement rates in external elasticity are as follows: after 2 weeks of use by

5.17%, and after 4 weeks of use by 7.76%.

According to the Dermal Torque Meter analysis conducted (before and after

testing product use) to measure improvements in internal elasticity, results were

statistically significant (p<.001). Improvement rates in internal elasticity are as

follows: after 2 weeks of use by 6.78%, and after 4 weeks of use by 10.69%.

According to the ANTERA 3D analysis conducted (before and after testing

product use) to measure neck lift improvements, results were statistically

significant (p<.001). Improvement rates in neck lifts are as follows: after 2

weeks of use by 8.32%, and after 4 weeks of use by 12.46%.

According to the Spectrophotometer and Cosmetic Full-Face Photography

System Facial Stage analysis conducted (before and after testing product use) to

measure improvements in skin tone, results were statistically significant

(p<.05). Improvement rates in neck lifts are as follows: right after use by

0.57%, after 2 weeks of use by 1.33%, and after 4 weeks of use by 2.13%.

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According to the DermaLab USB sebum probe analysis conducted (before and

after testing product use) to measure improvements in sebum amounts, results

were statistically significant (p<.001). Improvement rates in sebum amounts are

as follows: after 2 weeks of use by 27.77%, and after 4 weeks of use by 52.52%.

According to the video microscope analysis conducted (before and after

testing product use) to measure improvements in dead skin cells, results were

statistically significant (p<.001). Improvement rates in dead skin cells are as

follows: right after use by 76.82%, after 2 weeks of use by 75.42%, and after 4

weeks of use by 78.66%.

According to the ANTERA 3D analysis conducted (before and after testing

product use) to measure improvements in wrinkles, results were statistically

significant (p<.001). Improvement rates in wrinkles are as follows: after 2

weeks of use by 9.71%, and after 4 weeks of use by 16.37%.

As such, MILUX (and 1 other beauty device) conclusively improves external

and internal elasticity, neck lifts, skin tone, sebum, dead skin cells, and wrinkles.

In addition, as this device improves both external and internal elasticity, as well

as improves neck lifts and wrinkles, it is helpful as an anti-aging product.

This report is the confidential document and property of the Korea Institute for Skin and Clinical Sciences;its transfer, plagiarization, and disclosure to thir parties is prohibited.

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Ⅸ. Bibliography

Kim Han Sik, Bum Hee Joo. Cosmetology. Chung Goo Cultural Publishers, pp90-350, 2007

Suh Eun Kyung. Research on the Effectiveness of Deep Sea Water Cosmetics on Skin Moisture. Konyang University Master’s Thesis, 2009.

Lee Joo Hee. Research on Skin Conditions of Female High School Students based on Lifestyle. Nambu University Master’s Thesis, 2006.

Lee Hye Young, Kim Gwi Jung, Kim Young Soon, Lee Sung Nae, Lee Sung Ok. Dermatology. Koonja Publishers, pp58-61, 2007.

Jun Sae Youl, Hong Ran Hee, Kim Bong In, Jang Jin Mi, Cho So Eun. Beauty, Anatomy, and Physiology. Kwangmoonkag Publishers, 2004.

Jung Jin Ho. Establishing an Evaluation System for Beauty Related Product Functions. Korea Food & Drug Administration, 2003.

Ha Byung Cho, Kim Joo Duk, Yang Hyun Ok, Choi Eun Young, Ko Won Bae. Cosmetic Sciences. Soomoonsa Publishers, p145, 2002.

Han Seung Kyun, Han Young Sook, Choi Tae Boo, Lee Youn Hee, Kim Choon Ja, Kim Joo Yeon. Dermatology for Aestheticians. JD Media Publishers, 2004.

Han Chae Jung, Kwon Hye Young, Kim Sun Ok, Jeon Young Sun, Jang Moon Jung. Skin Care. Hoonmin Publishers, p237, 2010.

Baumann L. Cosmetic Dermatology. JD Media Publishers, pp19-122, 2004.

Kahan V, Andersen ML, Tomimori J, Tufik S. Stress, immunity and skin collagen integrity:Evidence from animal models and clinical conditions. Brain Behav. Immun ., 23: 1089-1095, 2009.

Page 36: Clinical Trial for Using MILUX (and 1 other beauty device

[Attachment 1] Testing Results (Detailed Information)

[Attachment 2] Clinical Trial Images

[Attachment 3] Testing Product Components

Attachment

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

[Attachment 1] Testing Results (Detailed Information)

1. Testee Information

No Name Age Gender

1 BJS 42 Female

2 KYM 51 Female

3 JMN 48 Female

4 KJY 41 Female

5 YJS 39 Female

6 HSK 50 Female

7 POY 49 Female

8 MKH 38 Female

9 KSH 46 Female

10 CYM 48 Female

11 LSN 59 Female

12 OJH 57 Female

13 SKS 44 Female

14 KJA 43 Female

15 CJH 45 Female

16 KHS 42 Female

17 JME 43 Female

18 KKA 45 Female

19 LJY1 42 Female

20 JSY 52 Female

21 PSH 46 Female

22 LJY2 51 Female

23 SIY 48 Female

Average 46.48Female 23

Standard Deviation 5.30

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2. Equipment evaluation

1) Surface elasticity measured value changes

(1) CoR Value

No. Before Use After 2 weeks After 4 weeks

1 0.71 0.73 0.72

2 0.63 0.66 0.68

3 0.58 0.60 0.63

4 0.58 0.62 0.64

5 0.59 0.63 0.65

6 0.55 0.57 0.56

7 0.57 0.61 0.63

8 0.57 0.61 0.62

9 0.58 0.62 0.64

10 0.71 0.71 0.72

11 0.56 0.59 0.63

12 0.52 0.54 0.58

13 0.53 0.56 0.59

14 0.61 0.65 0.66

15 0.56 0.59 0.59

16 0.57 0.62 0.65

17 0.64 0.68 0.71

18 0.58 0.60 0.61

19 0.60 0.60 0.59

20 0.54 0.57 0.58

21 0.59 0.64 0.64

22 0.60 0.64 0.65

23 0.56 0.59 0.61

Average 0.59 0.62 0.63

Standard Deviation 0.05 0.05 0.04

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2) Surface elasticity measured value changes

(1) Ur/Ue Value

No. Before Use After 2 weeks After 4 weeks

1 0.39 0.41 0.43

2 0.38 0.42 0.44

3 0.41 0.45 0.47

4 0.40 0.43 0.43

5 0.45 0.50 0.51

6 0.46 0.50 0.53

7 0.47 0.52 0.48

8 0.49 0.51 0.50

9 0.45 0.48 0.51

10 0.43 0.40 0.45

11 0.42 0.45 0.46

12 0.31 0.34 0.39

13 0.46 0.48 0.51

14 0.39 0.42 0.44

15 0.38 0.40 0.43

16 0.40 0.43 0.46

17 0.32 0.36 0.39

18 0.47 0.50 0.48

19 0.40 0.44 0.47

20 0.49 0.52 0.53

21 0.36 0.39 0.42

22 0.48 0.50 0.53

23 0.52 0.54 0.51

Average 0.42 0.45 0.47

Standard Deviation 0.05 0.05 0.04

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3) Neck lifting measured value changes

(1) Depressions medium value

No. Before Use After 2 weeks After 4 weeks

1 23.37 19.13 16.03

2 56.76 49.76 46.69

3 42.77 29.05 27.25

4 28.99 30.13 29.94

5 35.61 31.22 33.67

6 81.69 79.35 76.82

7 46.24 41.59 39.21

8 39.90 31.86 33.59

9 34.43 30.42 24.63

10 61.27 60.90 57.18

11 28.08 26.55 22.64

12 58.25 53.21 49.68

13 42.58 39.49 37.71

14 40.12 35.92 35.71

15 51.83 50.97 46.91

16 19.92 19.65 19.35

17 37.04 34.64 31.24

18 25.16 24.35 23.61

19 60.80 59.42 61.00

20 38.94 32.95 29.40

21 64.80 57.86 51.90

22 24.17 20.01 25.83

23 49.09 50.88 48.22

Average 43.12 39.54 37.75

Standard Deviation 15.63 15.68 14.98

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4) Skin tone measured value changes

(1) L* value

No. Before Use After Use After 2 weeks After 4 weeks

1 59.11 60.07 59.99 61.25

2 62.65 63.92 63.51 63.94

3 59.64 59.01 60.07 60.94

4 67.21 67.43 67.78 69.45

5 65.10 67.59 66.73 67.04

6 62.91 62.93 64.55 63.07

7 59.82 58.93 60.05 61.20

8 64.10 63.87 64.77 65.21

9 65.94 66.32 66.80 66.90

10 64.08 63.84 63.26 64.15

11 65.31 65.91 65.92 65.92

12 63.62 64.11 64.16 64.74

13 63.60 64.54 64.67 65.21

14 64.29 64.85 66.05 66.21

15 67.03 67.35 67.81 68.11

16 62.16 62.87 63.60 61.90

17 62.87 62.51 62.36 63.79

18 64.23 64.97 66.00 66.55

19 62.31 62.51 63.22 63.83

20 61.93 61.68 61.96 63.65

21 57.04 57.52 58.74 59.78

22 63.84 63.88 65.47 65.77

23 63.53 64.04 64.10 64.63

Average 63.14 63.51 63.98 64.49

Standard Deviation 2.47 2.71 2.55 2.42

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(2) ΔL* value

No. ΔL*₁ ΔL*₂ ΔL*₃

1 0.96 0.88 2.14

2 1.27 0.86 1.29

3 -0.63 0.43 1.30

4 0.22 0.57 2.24

5 2.49 1.63 1.94

6 0.02 1.64 0.16

7 -0.89 0.23 1.38

8 -0.23 0.67 1.11

9 0.38 0.86 0.96

10 -0.24 -0.82 0.07

11 0.60 0.61 0.61

12 0.49 0.54 1.12

13 0.94 1.07 1.61

14 0.56 1.76 1.92

15 0.32 0.78 1.08

16 0.71 1.44 -0.26

17 -0.36 -0.51 0.92

18 0.74 1.77 2.32

19 0.20 0.91 1.52

20 -0.25 0.03 1.72

21 0.48 1.70 2.74

22 0.04 1.63 1.93

23 0.51 0.57 1.10

0.36 0.84 1.34

Standard Deviation 0.70 0.70 0.75

Average

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5) Sebum measured value changes

(1) Amount of sebum

No. Before Use After 2 weeks After 4 weeks

1 22.90 19.20 11.10

2 15.50 9.60 11.80

3 13.80 8.50 9.60

4 27.20 19.50 12.50

5 10.60 8.30 6.40

6 29.60 16.10 15.20

7 24.60 19.40 16.90

8 9.80 11.10 2.70

9 24.50 17.50 13.50

10 31.40 24.40 13.90

11 12.60 9.20 15.40

12 15.80 10.20 5.10

13 22.50 15.40 11.00

14 9.90 9.90 8.90

15 17.30 9.90 17.60

16 12.40 11.10 4.40

17 32.90 20.80 16.60

18 31.60 27.70 4.70

19 12.70 10.00 3.70

20 11.40 13.90 10.20

21 29.00 14.30 2.90

22 23.90 15.90 2.20

23 21.50 12.80 3.70

20.15 14.55 9.57

Standard Deviation 7.82 5.36 5.14

Average

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6) Dead skin cell measured value changes

(1) Amount of Dead skin cell

No. Before Use After Use After 2 weeks After 4 weeks

1 15.08 4.01 4.82 2.69

2 14.59 1.57 1.69 2.92

3 19.42 2.09 2.88 2.97

4 17.06 3.54 3.92 3.05

5 15.01 1.21 3.93 4.12

6 16.08 4.09 5.03 3.61

7 12.95 4.74 1.45 2.85

8 12.01 2.06 2.56 3.25

9 16.63 2.88 2.36 2.38

10 8.00 3.26 2.21 1.92

11 9.70 3.00 4.44 2.64

12 4.89 2.79 1.39 1.79

13 25.91 2.81 4.63 2.83

14 12.16 3.50 3.07 3.54

15 13.89 2.45 2.37 2.01

16 8.35 2.87 3.13 2.79

17 11.80 3.21 4.05 2.31

18 9.75 3.00 3.16 2.90

19 11.63 3.15 5.89 4.10

20 15.34 3.10 2.48 2.40

21 8.37 4.49 2.80 3.64

22 9.10 3.03 2.73 1.31

23 12.17 2.68 2.74 1.98

Average 13.04 3.02 3.21 2.78

Standard Deviation 4.47 0.84 1.19 0.73

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7) Wrinkles measured value changes

(1) Wrinkles medium value

No. Before Use After 2 weeks After 4 weeks

1 100.06 83.29 89.01

2 151.38 127.55 110.63

3 135.39 130.92 98.99

4 88.51 82.06 80.13

5 132.72 102.98 102.67

6 163.43 138.85 129.57

7 105.18 100.05 85.56

8 116.16 114.79 97.33

9 128.79 126.33 107.33

10 94.11 92.10 88.31

11 137.36 119.18 108.73

12 161.47 145.90 129.25

13 126.56 117.59 115.58

14 101.78 90.53 80.69

15 131.82 100.37 99.19

16 98.96 99.49 93.99

17 128.57 109.99 88.43

18 121.19 104.91 108.74

19 140.18 115.73 106.98

20 179.84 163.81 155.07

21 148.46 145.65 144.53

22 121.41 119.24 116.97

23 158.12 151.51 147.34

Average 129.19 116.64 108.04

Standard Deviation 24.31 22.22 21.12

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

[Attachment 2] Clinical Trial Images

1. Neck lifting analysis photograph by ANTERA 3D

Testee 1

Before Use After 4 weeks

Testee 2

Before Use After 4 weeks

Testee 3

Before Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 4

Before Use After 4 weeks

Testee 5

Before Use After 4 weeks

Testee 6

Before Use After 4 weeks

Testee 7

Before Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 8

Before Use After 4 weeks

Testee 9

Before Use After 4 weeks

Testee 10

Before Use After 4 weeks

Testee 11

Before Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 12

Before Use After 4 weeks

Testee 13

Before Use After 4 weeks

Testee 14

Before Use After 4 weeks

Testee 15

Before Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 16

Before Use After 4 weeks

Testee 17

Before Use After 4 weeks

Testee 18

Before Use After 4 weeks

Testee 19

Before Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 20

Before Use After 4 weeks

Testee 21

Before Use After 4 weeks

Testee 22

Before Use After 4 weeks

Testee 23

Before Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

2. Skin tone analysis photograph by Facial stage

Testee 1

Before Use After Use After 4 weeks

Testee 2

Before Use After Use After 4 weeks

Testee 3

Before Use After Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 4

Before Use After Use After 4 weeks

Testee 5

Before Use After Use After 4 weeks

Testee 6

Before Use After Use After 4 weeks

Testee 7

Before Use After Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 8

Before Use After Use After 4 weeks

Testee 9

Before Use After Use After 4 weeks

Testee 10

Before Use After Use After 4 weeks

Testee 11

Before Use After Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 12

Before Use After Use After 4 weeks

Testee 13

Before Use After Use After 4 weeks

Testee 14

Before Use After Use After 4 weeks

Testee 15

Before Use After Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 16

Before Use After Use After 4 weeks

Testee 17

Before Use After Use After 4 weeks

Testee 18

Before Use After Use After 4 weeks

Testee 19

Before Use After Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 20

Before Use After Use After 4 weeks

Testee 21

Before Use After Use After 4 weeks

Testee 22

Before Use After Use After 4 weeks

Testee 23

Before Use After Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

3. Dead skin cell analysis photograph by the video microscope

Testee 1

Before Use After Use After 4 weeks

Testee 2

Before Use After Use After 4 weeks

Testee 3

Before Use After Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 4

Before Use After Use After 4 weeks

Testee 5

Before Use After Use After 4 weeks

Testee 6

Before Use After Use After 4 weeks

Testee 7

Before Use After Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 8

Before Use After Use After 4 weeks

Testee 9

Before Use After Use After 4 weeks

Testee 10

Before Use After Use After 4 weeks

Testee 11

Before Use After Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 12

Before Use After Use After 4 weeks

Testee 13

Before Use After Use After 4 weeks

Testee 14

Before Use After Use After 4 weeks

Testee 15

Before Use After Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 16

Before Use After Use After 4 weeks

Testee 17

Before Use After Use After 4 weeks

Testee 18

Before Use After Use After 4 weeks

Testee 19

Before Use After Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 20

Before Use After Use After 4 weeks

Testee 21

Before Use After Use After 4 weeks

Testee 22

Before Use After Use After 4 weeks

Testee 23

Before Use After Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

4. Wrinkles analysis photograph by ANTERA 3D

Testee 1

Before Use After 4 weeks

Testee 2

Before Use After 4 weeks

Testee 3

Before Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 4

Before Use After 4 weeks

Testee 5

Before Use After 4 weeks

Testee 6

Before Use After 4 weeks

Testee 7

Before Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 8

Before Use After 4 weeks

Testee 9

Before Use After 4 weeks

Testee 10

Before Use After 4 weeks

Testee 11

Before Use After 4 weeks

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Clinical Trial for Using MILUX (and 1 other beauty device) to Improve External and Internal Skin Elasticity, Neck Lift, Skin Tone, Sebum, Dead Skin Cells, and Wrinkles

Testee 12

Before Use After 4 weeks

Testee 13

Before Use After 4 weeks

Testee 14

Before Use After 4 weeks

Testee 15

Before Use After 4 weeks

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Testee 16

Before Use After 4 weeks

Testee 17

Before Use After 4 weeks

Testee 18

Before Use After 4 weeks

Testee 19

Before Use After 4 weeks

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Testee 20

Before Use After 4 weeks

Testee 21

Before Use After 4 weeks

Testee 22

Before Use After 4 weeks

Testee 23

Before Use After 4 weeks

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[Attachment 3] Testing Product Components

Pepbu:w (Testing Product B)

Water, Glycerin, Arbutin, Defined Cell Culture Media 2, Scutellaria Baicalensis Root Extract, Xanthan

Gum, Butylene Glycol, Adenosine

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203 (Company Research Facility II), 194-41,

Osongsaengmyeong 1-ro, Osong-eup,

Heungdeok-gu, Cheongju-si,

Chungcheongbuk-do, Korea