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
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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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
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
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).
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.
①
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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
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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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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 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
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
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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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
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.
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
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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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. 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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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 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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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
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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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
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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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
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
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
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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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
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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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
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
27
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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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
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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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
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.
[Attachment 1] Testing Results (Detailed Information)
[Attachment 2] Clinical Trial Images
[Attachment 3] Testing Product Components
Attachment
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30
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
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. 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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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) 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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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) 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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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) 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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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) 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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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) 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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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) 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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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
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
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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
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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
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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
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Testee 19
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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
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Testee 22
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Testee 23
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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
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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
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Testee 10
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Testee 11
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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
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Testee 13
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Testee 14
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Testee 15
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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
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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
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Testee 23
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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
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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
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Testee 5
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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
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Testee 9
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Testee 10
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Testee 11
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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
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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
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Testee 19
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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
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Testee 22
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Testee 23
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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
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Testee 5
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Testee 6
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Testee 7
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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
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Testee 11
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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
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Testee 14
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Testee 15
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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
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Testee 17
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Testee 18
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Testee 19
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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
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Testee 22
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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
[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
203 (Company Research Facility II), 194-41,
Osongsaengmyeong 1-ro, Osong-eup,
Heungdeok-gu, Cheongju-si,
Chungcheongbuk-do, Korea