【Final Report】 Whitening DEF-HSLIT004 (4) -18077

CLINICAL EFFICACY TEST REPORT
A CLINICAL STUDY OF SKIN

LIGHTENING EFFECT FOR
‘SMW SERIES’
DEF-HSLIT004(4)-18077
March 14, 2019
FOR
Arysta Health and Nutrition Science Corp.
38F, St.Luke’s Tower, 8-1, Akashi-cho, Chuo-ku, Tokyo 104-6591, Japan
Project for NatureLab. Co., Ltd.
Ebisu Prime Square Tower 11F, 1-1-39 Hiroo, Shibuya-ku, Tokyo 150-0012, Japan
BY
DERMAPRO Ltd.
30 Bangbaejoongang-ro, Seocho-gu, Seoul 06684, Republic of Korea
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Table of Contents
REPORT SUMMARY ----------------------------------------------------------------------------6
1. STUDY SPONSOR---------------------------------------------------------------------------8
2. INVESTIGATIVE PERSONNEL ---------------------------------------------------------8
3. CLINICAL RESEARCH STANDARD ---------------------------------------------------8
4. STUDY SCHEDULE ------------------------------------------------------------------------8
5. SUBJECTS ------------------------------------------------------------------------------------8
5.1. Principle of recruitment ----------------------------------------------------------------8
5.2. Inclusion criteria ------------------------------------------------------------------------8
5.3. Exclusion criteria -----------------------------------------------------------------------9
5.4. Prohibition and restriction -------------------------------------------------------------9
5.5. Subject withdrawal --------------------------------------------------------------------10
6. TEST PRODUCT ---------------------------------------------------------------------------10
6.1. Product information -------------------------------------------------------------------10
6.2. Application method -------------------------------------------------------------------10
7. PROCEDURE -------------------------------------------------------------------------------10
7.1. Environmental condition -------------------------------------------------------------10
7.2. Assessment of skin color -------------------------------------------------------------11
7.3. Measurement of melanin index ----------------------------------------------------11
7.4. Measurement of skin lightness and color ------------------------------------------12
7.5. Measurement of reflectance index of melanin -------------------------------------12
7.6. Photography ----------------------------------------------------------------------------13
7.7. Assessment of self-questionnaires --------------------------------------------------13
7.8. Safety evaluation ----------------------------------------------------------------------13
7.9. Statistical analysis ---------------------------------------------------------------------14
8. RESULTS ------------------------------------------------------------------------------------15
8.1. Information of subjects ---------------------------------------------------------------15
8.2. Analysis of skin color -----------------------------------------------------------------16
8.3. Analysis of melanin index ------------------------------------------------------------17
8.4. Analysis of skin lightness -------------------------------------------------------------18
8.5. Analysis of skin color -----------------------------------------------------------------19
8.6. Analysis of reflectance index of melanin -------------------------------------------22
8.7. Assessment of self-questionnaires --------------------------------------------------24
8.7.1. Self-questionnaires for efficacy ---------------------------------------------------24
8.7.2. Self-questionnaires for usability --------------------------------------------------26
9. SAFETY EVALUATION -----------------------------------------------------------------26
10. RESULT SUMMARY ---------------------------------------------------------------------27
11. REFERENCE --------------------------------------------------------------------------------29
_______________________________________________________________________________________________
DM-QW-702 DERMAPRO Ltd.

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APPENDIXES
APPENDIX I / DATA TABLE
APPENDIX II / STATISTICAL DATA
APPENDIX III / IMAGE DATA
APPENDIX IV / RESEARCH MEMBERS AND FACILITIES
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REPORT SUMMARY
Title A clinical of skin lightening effect for ‘SMW series’
Test Center DERMAPRO Ltd. Test Period Oct. 22, 2018 ~ Dec. 20, 2018
Objective To evaluate the skin lightning effect of the test products on human skin
Report Date March 14, 2019
Authentication DERMAPRO Ltd. was validated by receiving a “QUALITY MANAGEMENT

of Test Center SYSTEM CERTIFICATE” (KS Q ISO 9001:2015 / ISO 9001:2015;Certificate
No.5855) from the KTR Certification Center for providing contract research and
consulting services on human skin safety and efficacy.
Method Twenty four female subjects (average age: 51.29±4.78 yrs) who have hyper-
pigmented region on face were participated in this study (test site: SMW Spot
LS, SMW lotion, SMW cream; control site: SMW Spot LS, SM lotion). Visual
assessment, melanin index, L* value, ITA° value and reflectance index on
hyper-pigmented region were evaluated at baseline, 2, 4 and 8 weeks after
treatment. Also self-questionnaires concerning efficacy of the test and control
products was filled out by subjects at 2, 4 and 8 weeks. And self-questionnaires
concerning usability of the test products was filled out by subjects at 8 weeks.
All obtained data was statistically analyzed by SPSS® software.
Result 1. Analysis of skin color grade

As compared to baseline, skin color of test and control sites was significantly
improvement at 4 and 8 weeks after treatment (p<0.05), the improvement rate
was 0.95%~2.86%.
In comparisons between both sites, there was no significant difference.
2. Analysis of melanin index
As compared to baseline, melanin index of test and control sites was
significantly decreased at 2, 4 and 8 weeks (p<0.05), the decrement was
2.10%~5.47%.
3. Analysis of skin lightness
As compared to baseline, L* value of test site was significantly increased at 2,
4 and 8 weeks, and that of control site was significantly increased at 4 and 8
weeks after treatment (p<0.05), the increment was 0.64%~2.16%.
In comparisons between both sites, L* value of test site was significantly
increased than control site at 8 weeks (p<0.05).
4. Analysis of skin color
As compared to baseline, ITA° value of test and control sites was significantly
increased at 4 and 8 weeks after treatment (p<0.05), the increment was
6.84%~11.12%.
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5. Analysis of reflectance index of melanin

As compared to baseline, reflectance index of melanin showed a tendency to
decrease in both sites at 2, 4 and 8 weeks after treatment.
6. Assessment of self-questionnaires
Regarding the result of self-questionnaires for efficacy, approximately
96%~100% of subjects in test group, 79%~96% subjects in control group
were positively answered about all items at 8 weeks after treatment.
Regarding the result of self-questionnaires for usability, approximately
54%~96% of subjects positively answered about all items for all test products.
7. Safety evaluation
Skin adverse reaction was not observed on twenty four subjects during the
course of the study.
Conclusion The test and control sites showed significant improvement effect in all skin
lightness test items at 4 and 8 weeks after treatment. And melanin index of two
sites and skin lightness (L* value) of test site were significantly improved since
2 weeks, that of control site was significantly improved since 4 weeks. Above
all, skin lightness (L* value) of test site was significant improved than control
site at 8 weeks. Therefore, it can be considered to have skin lightning
improvement effect on human skin.
Appendix Data table, Statistical data, Image data, Research members and facilities
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1. STUDY SPONSOR
Monitor: Chie Ino

Sponsor: Arysta Health and Nutrition Science Corp.
2. INVESTIGATIVE PERSONNEL
Investigator: Min kyung Jeong

Principal investigator: Min Kyung Shin, M.D., Ph.D.
3. CLINICAL RESEARCH STANDARD
This study was conducted according to applicable Good Clinical Practices (GCP) and
the Standard Operating Procedures (SOPs) of the Dermapro Ltd.
4. STUDY SCHEDULE
Start Date: October 22, 2018

Finish Date: December 20, 2018
5. SUBJECT
5.1. Principle of recruitment

The investigator primarily selected subjects satisfying the inclusion and exclusion
criteria. The investigator fully explained the purpose and procedures of the study,
schedule, compensation, and anticipated adverse reactions or side effects. After fully
understanding such explanations on the research, subjects voluntarily decided whether
or not to participate as a research subject and filled out an informed consent form.
The study inclusion and exclusion criteria are as follows:
5.2. Inclusion criteria

1) Subjects who have hyper-pigmented region on face aged from 20 to 60.
2) Subjects who signed the informed consent; the purpose and the protocol of the
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study are explained to subjects.

3) Subjects should be cooperative and available for follow-up during the study period.
5.3. Exclusion criteria

1) Subjects who are pregnancy or nursing condition or planning to become pregnant
2) Subjects who have treated immuno-suppressants within one month
3) Subjects who had participated in a previous study without an appropriate
intervening period (three months) between studies
4) Subjects who have sensitivity or hypersensitivity skin
5) Subjects who have damaged skin, in or around the test site, which includes sunburn,
tattoos, scars or other disfiguration of the test site
6) Subjects who have used of similar treatment during the previous three months
7) Subjects who have an experience on examination site (skin decortications, botox,
anti-wrinkle and other skin treatment)
8) Subjects who have chronic disease (diabetes, asthma, high blood-pressure)
9) Subjects who have atopic dermatitis
10) Subjects who have any difficulty which may interfere with the aim of the study as
the judgment of the investigator
11) Subjects who have taken any oral or topical drug for the intension of smoothing
wrinkle during recent 6 months
12) Subjects who use of anti-wrinkle treatment during the previous two weeks
5.4. Prohibition and restriction

1) Subjects do not use of anti-inflammatory drugs or antihistaminic or systemic
steroids, by a general route, is forbidden throughout the duration of the study.
2) No other test instruments should be applied to the application areas during the
entire study.
3) During this testing period, subjects do not use other than the application of the test
article, the use of any cosmetic products, beauty tools, and any skin care procedures.
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5.5. Subject withdrawal

After admission to the study, the subject may withdrawal at any time for any reason, but
must report such reason fairly and accurately.
Subjects failing to complete the study will be identified, and whenever possible, a
reason will be given. Subjects who drop out of the study will not be replaced.
1) Subjects who do not follow the conditions of the Study Information Sheet or they
no longer wish to participate in the study
2) Subjects who suffer from any side effect occurred by test material during the study
3) Subjects who suffer from any illness or accident or develop any condition during
the study which could affect the outcome of the study
4) Subjects could be dropped off from the study by investigator when they affect the
outcome of the study.
6. TEST PRODUCT
6.1. Product information

i) Test site: SMW Spot LS, SMW Lotion, SMW Cream
ii) Control site: SMW Spot LS, SM Lotion
6.2. Application method

According to sponsor’s recommendations, the test products were applied twice a day in
the morning and evening after washing face. Subject divided two sites according to
block randomization. The SMW Spot LS was applied on whole face after cleansing.
Then SM Lotion will be applied on half face, and SMW Lotion and SMW Cream are
applied on another half face, in order.
7. PROCEDURE
7.1. Environmental condition

This study was performed under a given relative temperature and humidity, which was
controlled and maintained identically for each volunteer. The ambient temperature was
maintained at 20~24℃ and the relative humidity in the range of 45%~55%.
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7.2. Assessment of skin color

The skin color grade was assessed by 2 researchers according to detailed criteria (0:
Bright & Clear ~ 9: Dark & Dull) on 0.5 scale at baseline, 2, 4 and 8 weeks after
treatment (Fig. 1).
Bright & Clear
0 1 2 3 4
5 6 7 8 9
Dark & Dull
Figure.1 Criteria for visual assessment of hyper-pigmented region
7.3. Measurement of melanin index

The melanin index was evaluated by Mexameter® MX 18 (C+K, Germany). The
measurement is based on absorption/reflection. The probe of the Mexameter® MX 18
emits 3 specific light wavelengths. A receiver measures the light reflected by the skin.
The positions of emitter and receiver guarantee that only diffuse and scattered light is
measured. As the quantity of emitted light is defined, the quantity of light absorbed by
the skin can be calculated. The melanin is measured by specific wavelengths chosen to
correspond to different absorption rates by the pigments. For the erythema measurement
specific wavelengths are also used, corresponding to the spectral absorption peak of
hemoglobin and to avoid other color influences (e. g. bilirubin). The results for both
parameters are shown within 1 second as index numbers (0-999).
In this study, the melanin index on hyper-pigmented region was measured 3 times every
occasion and the average was used for the analysis at baseline, 2, 4 and 8 weeks after
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treatment.
7.4. Measurement of skin lightness and color

The skin lightness (L* value) and color (ITA° value) were measured by
Spectrophotometer® CM-2500d (Minolta, Japan). Light from xenon lamps diffuses on
the inner surface of the integrating sphere and illuminates the specimen uniformly. The
light reflected by the specimen surface at an angle of 8 degrees to the normal of the
surface is received by the specimen-measuring optical system. The diffused light in the
integrating sphere is received by the illumination-monitoring optical system and guided
to the sensor. The light reflected by the specimen surface and the diffused light are
divided into each wavelength component by the specimen-measuring optical system and
illumination-monitoring optical sensor, respectively, and then signal proportional to the
light intensity of each component are output to the analog processing circuit.
In this study, skin lightness (L* value) and color (ITA° value) on hyper-pigmented
region were measured 3 times every occasion and the average was used for the analysis
at baseline, 2, 4 and 8 weeks after treatment.
Individual Typology Angle (ITA°) value is defined that:
[Arc Tangent ((L* - 50)/ b*)] 180 / 3.14159

L*: Luminance parameters (from dark to light)
a*: Chrominance parameters (green-to-red)
b*: Chrominance parameters (blue-to-yellow)
7.5. Measurement of reflectance index of melanin

The melanin image on hyper-pigmented region was taken by reflectance confocal
microscopy (RCM, Vivascope® 1500, Lucid, USA). This provides an in vivo, non-
invasive view into the epidermis and the dermis all the way down to the upper stratum
reticular. A near-infrared laser (830 nm) is directed onto the individual skin sections
where it is reflected. Melanin and keratin act as natural contrast agents due to their
relatively high refractive index. The device generates black and white images of skin in
an optimal quality.
The RCM image for 5 subjects was analyzed as reflectance index (RI) on hyper-
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pigmented region by Image-pro® plus (MediaCybernetics, USA) at baseline, 2, 4 and 8

weeks after treatment (Fig. 2). The reflectance index (RI) indicates the quantity of skin
pigment melanin. And the decrement of reflectance index (RI) means the improvement
of melanin on hyper-pigmented region.
Figure 2. Analyzed image of reflectance index of melanin by Image-pro® plus
7.6. Photography
Facial images (front, left, right) were taken using VISIA® CR (Canfield, USA) and
hyper-pigmented region image was taken using ANTERA 3D® CS (Miravex Lemited,
Ireland) at baseline, 2, 4 and 8 weeks after treatment.
7.7. Assessment of self-questionnaires

Questionnaire survey was conducted on the efficacy of the test products at 2, 4 and 8
weeks after treatment of test products. The assessment for efficacy rated each criterion
on a scale of one to five (1, strongly disagree; ~ 5, strongly agree) and positive feedback
(rating scale 4, 5) was analyzed. Also, questionnaire was conducted for the usability as 5
scales (1, not good at all/strongly disagree; ~5, very good/strongly agree) and positive
feedback (rating scale 4, 5) was analyzed at 8 weeks after treatment of test products.
7.8. Safety evaluation

The safety of the products was assessed a clinical observation by the researcher. The
assessment considered the elements reported by the subjects (subjective and objective
signs) as well as those noted by the researcher (clinical signs). The frequency, the
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duration and the intensity of the sign and a possible or probable relationship with the
test products was investigated. Subjective signs included itching, prickling, tickling,
burning, stinging, stiffness and tightness, etc. Objective signs included redness, edema,
desquamation and papule, etc.
7.9. Statistical analysis

Statistical analysis was conducted using the SPSS® software program (IBM, USA).
On visual assessment, the average was used for the analysis if there is statistical
significance in Intraclass Correlation Coefficient (ICC) value between 2 researchers
over 0.8. To determine whether variables followed a normal distribution or not, we used
the Shapiro-Wilks test or Kurtosis & Skewness for normality test. Statistical analysis of
variables for parametric was conducted using the RM ANOVA. If value was non-
parametric, all of them were initially compared by the Wilcoxon signed rank test and
Bonfferoni correction. Statistical analysis for comparison between sites was conducted
by the RM ANOVA or ANCOVA using variation value from baseline. A statistically
significant difference was set at p<0.05.
Change from baseline (%) was defined that;
(Baseline – After treatment) / Baseline * 100
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8. RESULT
8.1. Information of subjects

For conducting this study, 24 female subjects aged from 45 to 59 years (average age
51.29±4.78 yrs) were recruited and completed all the study. The skin characteristics of
the study subjects are summarized in Table 1 (Appendix I).
Table 1. Information of subjects (n=24)

Item Classification Frequency (N) Percentage (%)
Dry 10 41.67
Normal 10 41.67
Skin type Oily 1 4.17
Dry and oily 3 12.50
Problematic 0 0.00
III type 20 83.33

Fitzpatrick
Skin type
IV type 4 16.67
Sufficient 0 0.00
Hydration Normal 15 62.50
Deficient 9 37.50
Glossy 2 8.33
Sebum Normal 17 70.83
Deficient 5 20.83
Smooth 3 12.50
Surface Normal 19 79.17
Rough 2 8.33
Thin 5 20.83
Thickness Normal 17 70.83
Thick 2 8.33
Less than 1 hr 6 25.00

Duration of UV
1-3 hrs 17 70.83
exposure
More than 3 hrs 1 4.17
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Less than 5 hrs 1 4.17
Sleeping hours 5-8 hrs 14 58.33
More than 8 hrs 9 37.50
No 24 100.00
Smoking Less than 10 pieces 0 0.00
More than 10 pieces 0 0.00
Yes 2 8.33
Irritability
No 22 91.67
Yes 1 4.17
Stinging
No 23 95.83
Yes 0 0.00
Adverse reaction
No 24 100.00
8.2. Analysis of skin color grade

As compared to baseline, skin color of test and control sites was significantly
improvement at 4 and 8 weeks after treatment (p<0.05), the improvement rate was
0.95%~2.86%. In comparisons between both sites, there was no significant difference
(Table 2, 3, Fig. 3).
Table 2. Statistical analysis of skin color by visual assessment

Change from
Site Week N Mean1 SD p-value2
baseline (%)
Baseline 24 4.20 1.17 - -
2 weeks 24 4.18 1.16 0.162 0.48▼

Test site
4 weeks 24 4.16 1.17 0.043* 0.95▼
8 weeks 24 4.08 1.11 0.005* 2.86▼
Baseline 24 4.29 1.22 - -
2 weeks 24 4.26 1.22 0.083 0.70▼

Control site
4 weeks 24 4.24 1.23 0.022* 1.17▼
8 weeks 24 4.21 1.19 0.029* 1.86▼

1 Decrement of the mean value represents improvement of skin color (▼).
2 Significantly different at *p<0.05 compared with baseline
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Table 3. Statistical analysis of skin color grade between test and control sites (p-value)
Site 2 weeks 4 weeks 8 weeks
Test vs. Control 0.664 0.714 0.377
7
Test Control
6
* * *
*
5
Grade (0~7)
0
Baseline 2 weeks 4 weeks 8 weeks
Figure 3. Changes of skin color grade following 8 consecutive weeks

application of the test products (Mean±SD, *p<0.05 after vs. baseline)
8.3. Analysis of melanin index

As compared to baseline, melanin index of test and control sites was significantly
decreased at 2, 4 and 8 weeks (p<0.05), the decrement was 2.10%~5.47%.
In comparisons between both sites, there was no significant difference (Table 4, 5, Fig.
4).
Table 4. Statistical analysis of melanin index by absorption and reflection

Change from
baseline (%)
Baseline 24 193.35 18.72 - -
2 weeks 24 189.14 18.84 0.000* 2.18▼

Test
4 weeks 24 186.26 18.61 0.000* 3.67▼
8 weeks 24 182.77 17.39 0.000* 5.47▼
Baseline 24 196.99 36.64 - -
Control 2 weeks 24 192.86 33.72 0.002* 2.10▼
4 weeks 24 189.83 32.38 0.000* 3.63▼
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8 weeks 24 187.35 31.19 0.000* 4.89▼

1 Decrement of the mean value represents decrement of skin melanin (▼).
Table 5. Statistical analysis of melanin index between test and control sites (p-value)
Test vs. Control 0.946 0.963 0.674
300
Test Control
250 * *
* * * *
Melanin index (A.U)
200
150
100
50
0
Figure 4. Changes of melanin index following 8 consecutive weeks application of the test
products (Mean±SD, *p<0.05 after vs. baseline)
8.4. Analysis of skin lightness

As compared to baseline, L* value of test site was significantly increased at 2, 4 and 8
weeks, and that of control site was significantly increased at 4 and 8 weeks after
treatment (p<0.05). The increment was 0.64%~2.16%.
In comparisons between both sites, L* value of test site was significantly increased than
control site at 8 weeks (p<0.05, Table 6, 7, Fig. 5).
Table 6. Statistical analysis of skin lightness (L* value) by spectral reflectance of light
Change from
baseline (%)
Baseline 24 60.98 1.82 - -
2 weeks 24 61.37 1.71 0.008* 0.64▲

Test
4 weeks 24 61.94 1.60 0.000* 1.57▲
8 weeks 24 62.30 1.63 0.000* 2.16▲
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Baseline 24 60.17 2.24 - -
2 weeks 24 60.29 2.21 0.482 0.20▲

Control
4 weeks 24 60.89 2.20 0.000* 1.20▲
8 weeks 24 61.20 1.91 0.000* 1.71▲

1 Increment of the mean value represents improvement of skin lightness (▲).
Table 7. Statistical analysis of skin lightness (L* value) by spectral reflectance of light (p-value)
Test vs. Control 0.119 0.074 0.048*

*Significantly different at *p<0.05 compared with control site
80.0
Test Control †
70.0 * *
* * *
60.0
L* value (A.U)
50.0
40.0
30.0
20.0
10.0
0.0
Figure 5. Changes of L* value following 8 consecutive weeks application of the test products
(Mean±SD, *p<0.05 after vs. baseline, †p<0.05 test vs. control site)
8.5. Analysis of skin color

As compared to baseline, ITA° value of test and control sites was significantly increased
at 4 and 8 weeks after treatment (p<0.05), the increment was 6.84%~11.12%.
In comparisons between both sites, there was no significant difference (Table 8, 9, Fig.
6, 7).
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Table 8. Statistical analysis of skin color (ITA° value) by spectral reflectance of light
Change from
baseline (%)
Baseline 24 28.23 3.86 - -
2 weeks 24 28.74 3.45 0.068 1.81▲

Test
4 weeks 24 30.45 2.89 0.000* 7.86▲
8 weeks 24 31.37 2.81 0.000* 11.12▲
Baseline 24 26.62 5.68 - -
2 weeks 24 26.81 5.65 0.472 0.71▲

Control
4 weeks 24 28.44 5.45 0.000* 6.84▲
8 weeks 24 29.36 4.99 0.000* 10.29▲

1 Increment of the mean value represents improvement of ITA° value (▲).
Table 9. Statistical analysis of skin color (ITA° value) by spectral reflectance of light (p-value)
Test vs. Control 0.058 0.205 0.265
50
Test Control
45
40 *
* *
*
35
ITA° value (A.U)
30
25
20
15
10
5
0
Figure 6. Changes of ITA° value following 8 consecutive weeks application of the test products
(Mean±SD, *p<0.05 after vs. baseline)
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Measuring
site
#06 Baseline 2 weeks 4 weeks 8 weeks
Cross-
polarized
Melanin
image
Measuring
site
Cross-
polarized
Melanin
image
Figure 7. Changes of skin lightness and color following 8 consecutive weeks application of test
products (Ref. Subject No.06; upper, test site; bottom, control site)
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8.6. Analysis of reflectance index of melanin

As compared to baseline, reflectance index of melanin showed a tendency to decrease in
both sites at 2, 4 and 8 weeks after treatment (Table 10, Fig. 8, 9).
Table 10. Analysis of reflectance index of melanin by reflectance confocal microscopy

Change from
Site Week N Mean1 SD
baseline (%)
Baseline 5 96123.80 14699.41 -
2 weeks 5 95898.80 13982.14 0.23▼

Test
4 weeks 5 95558.40 6832.57 5.79▼
8 weeks 5 89036.60 8583.69 7.37▼
Baseline 5 80420.00 23375.93 -
2 weeks 5 79888.80 21643.54 0.66▼

Control
4 weeks 5 77539.80 18750.02 3.58▼
8 weeks 5 78311.80 19929.53 2.62▼

1 Decrement of mean value represents decrease of melanin (▼).
120,000
Test Control
Reflectance index of melanin (pixel)
100,000
80,000
60,000
40,000
20,000
0
Figure 8. Changes of reflectance index of melanin following 8 consecutive weeks application of

the products (Mean±SD, n=5)
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Measuring site
Mode Baseline 2 weeks 4 weeks 8 weeks
Standard
optical
image
Test RCM
site image
Analyzed
RCM
image
Measuring site
Standard
optical
image
Control RCM
site image
Analyzed
RCM
image
Figure 9. Changes of reflectance index of melanin by RCM following consecutive 8 weeks

application of the test products (Ref. subject No. 20, 22)
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8.7. Assessment of self-questionnaires

8.7.1. Self-questionnaires for efficacy
Regarding the result of self-questionnaires for efficacy, approximately 96%~100% of
subjects in test group, 79%~96% subjects in control group were positively answered
about all items at 8 weeks after treatment (Table 11, Fig. 10).
Table 11. Results of positive answers in self-assessment for efficacy (n=24)

2 weeks 4 weeks 8 weeks
Site Item
N1 %² N1 %² N1 %²
Reduction of skin
14 58.33 21 87.50 24 100.00
hyperpigmentation
Decrease of skin hyper-
14 58.33 19 79.17 22 91.67
pigmented area
Improvement of skin
Test 15 62.50 21 87.50 24 100.00
tone
Improvement of skin
17 70.83 24 100.00 23 95.83
color
Improvement of skin
19 79.17 22 91.67 23 95.83
translucency
Reduction of skin
10 41.67 15 62.50 20 83.33
hyperpigmentation
Decrease of skin hyper-
9 37.50 11 45.83 19 79.17
pigmented area
Improvement of skin
Control 13 54.17 16 66.67 23 95.83
tone
Improvement of skin
18 75.00 18 75.00 20 83.33
color
Improvement of skin
16 66.67 19 79.17 21 87.50
translucency
1N (Frequency) = Number of positive answers (4, Agree; ~ 5, Strongly agree)
2% (Percentage) = Number of positive answers / Total number of subjects (24) × 100
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Reduction of skin 2 weeks

hyperpigmentation 4 weeks
(%) 100
8 weeks
80
60
Improvement of skin 40 Decrease of skin
translucency 20 hyper-pigmented area
0
Improvement of skin Improvement of skin

color tone
Test site
2 weeks
Reduction of skin
hyperpigmentation 4 weeks
(%) 100 8 weeks
80
60
Decrease of skin
Improvement of 40
hyper-pigmented
skin translucency 20 area
0
Improvement of Improvement of
skin color skin tone
Control site
Figure 10. Comparative sensorial profile of test products for efficacy (Positive answers, %)
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8.7.2. Self-questionnaires for usability

Regarding the result of self-questionnaires for usability, approximately 54%~96% of
subjects positively answered about all items for all test products (Table 12, Fig. 11).
Table 12. Result of positive answers in self-questionnaires for usability (n=24)

SMW Spot LS SMW Lotion SM Lotion SMW Cream
Item
N1 %² N1 %² N1 %² N1 %²
Color 21 87.50 23 95.83 18 75.00 23 95.83
Scent 18 75.00 15 62.50 13 54.17 15 62.50
Spreadability 19 79.17 23 95.83 20 83.33 22 91.63
Absorption 19 79.17 20 83.33 18 75.00 20 83.33
Satisfaction 21 87.50 23 95.83 20 83.33 23 95.83

1N (Frequency) = Number of positive answers (4, Good; 5, Very good)
2% (Percentage) = Number of positive answers / Total number of subjects (24) × 100
Color
(%) 100
80
60
40
Satisfaction Scent SMW Spot LS
20
SMW Lotion
0
SM Lotion
SMW Cream
Absorption Spreadability
Figure 11. Comparative sensorial profile of test products for usability (Positive answers, %)
9. SAFTETY EVALUATION
During this study, skin adverse reaction was not observed on twenty four subjects
during the course of the study.
_______________________________________________________________________________________________

Page 27 of 29
10. RESULT SUMMARY
1) Analysis of skin color 4) Analysis of skin color

As compared to baseline, skin color of As compared to baseline, ITA° value of
test and control sites was significantly test and control sites was significantly
improvement at 4 and 8 weeks after increased at 4 and 8 weeks after
treatment (p<0.05), the improvement treatment (p<0.05), the increment was
rate was 0.95%~2.86%. In comparisons 6.84%~11.12%.
between both sites, there was no In comparisons between both sites,
significant difference. there was no significant difference.
2) Analysis of melanin index 5) Analysis of reflectance index of

As compared to baseline, melanin melanin
index of test and control sites was As compared to baseline, reflectance
significantly decreased at 2, 4 and 8 index of melanin showed a tendency to
weeks (p<0.05), the decrement was decrease in both sites at 2, 4 and 8
2.10%~5.47%. In comparisons between weeks after treatment.
both sites, there was no significant
difference. 6) Analysis of self-questionnaires
Regarding the result of self-
3) Analysis of skin lightness questionnaires for efficacy,
As compared to baseline, L* value of approximately 96%~100% of subjects
test site was significantly increased at 2, in test group, 79%~96% subjects in
4 and 8 weeks, and that of control site control group were positively answered
was significantly increased at 4 and 8 about all items at 8 weeks after
weeks after treatment (p<0.05). The treatment.
decrement was 0.64%~2.16%. Regarding the result of self-
In comparisons between both sites, L* questionnaires for usability, approxima-
value of test site was significantly tely 54%~96% of subjects positively
increased than control site at 8 weeks. answered about all items for all test
products.
_______________________________________________________________________________________________

Page 28 of 29
7) Safety evaluation subjects during the course of the study.

During this study, skin adverse reaction
was not observed on twenty four
_______________________________________________________________________________________________

Page 29 of 29
11. REFERENCE
1) Korner A, Pawelek J. Mammalian In vivo reflectance confocal micro-
tyrosinase catalyzes three reactions in scopy detects pigmentary changes in
the biosynthesis of melanin. Science, melasma at a cellular level resolution.
1982, 217(4565):1163-1165. Exp Dermatol. 2010;19(8):e228-233.
2) Andersen PH, Bjerring P. Non 8) Ardigo M, Cameli N, Berardesca E,et
invasive computerized analysis of skin al. Characterization and evaluation of
chromophores in vivo by reflectance pigment distribution and response to
spectroscopy. Photoder matol. therapy in melasma using in vivo
Photoim munol. Photomed., 1990, reflectance confocal microscopy: a
7:249-257. preliminary study. J Eur Acad
3) Leyden JJ. Clinical features of ageing Dermatol Venereol. 2010;1296-1303.
skin. Br J Dermatol. 1990 Apr;122 9) Tsilika K, Levy JL, Kang HY, Duteil L,
Suppl 35:1-3. Khemis A, Hughes R, Passeron T,
4) Smalls Pierard GE. EEMCO guidance Ortonne JP, Bahadoran P. A Pilot
for the assessment of skin color. J. Eur. Study Using Reflectance Confocal
Acad. Dermatol. Venereol., 1998, Microscopy (RCM) in the Assess ment
10:1-11. of a Novel Formulation for the
5) Alaluf S, Atkins D, Barrett K, Blount Treatment of Melasma. J Drugs
M, Carter N, Heath A. The impact of Dermatol. 2011 Nov;10(11):1260-4.
epidermal melanin on objective
measurements of human skin colour.
Pigment. Cell Res., 2002, 15:119-126.
6) Kawada A, Kameyama H, Asai M,
Shiraishi H, Aragane Y, Tezuka T,
Iwakiri K. A new approach to the
evaluation of whitening effect of a
cosmetic using computer analysis of
video-captured image. J. Dermatol.
Sci., 2002, 29:18
7) Kang HY, Bahadoran P, Suzuki I, et al.
_______________________________________________________________________________________________

APPENDIXES
APPENDIX I
DATA TABLE
Page 1 of 11
Appendix I. Data table

I-I. Information of subjects
Subject identification Fitzpatrick Duration of UV Sleeping Adverse

Age Sex Skin type1 Hydration3 Sebum4 Surface5 Thickness6 Smoking9 Irritability10 Stinging11 Test site13
code Classification2 exposure7 hours8 effects12
DEF-18077-01 58 F 1 3 3 2 2 3 2 2 1 2 2 2 A
DEF-18077-02 46 F 4 3 2 1 2 2 2 3 1 1 1 2 B
DEF-18077-03 52 F 1 4 3 3 2 2 2 1 1 2 2 2 B
DEF-18077-04 45 F 4 3 3 2 2 1 1 3 1 2 2 2 A
DEF-18077-05 48 F 2 3 2 2 2 2 2 2 1 2 2 2 A
DEF-18077-06 47 F 1 4 2 3 1 2 2 2 1 2 2 2 B
DEF-18077-07 54 F 2 3 2 2 2 1 2 2 1 2 2 2 A
DEF-18077-08 53 F 2 3 2 2 2 2 1 3 1 2 2 2 B
DEF-18077-09 57 F 2 3 2 2 2 2 2 2 1 2 2 2 A
DEF-18077-10 50 F 2 3 2 2 2 2 1 2 1 2 2 2 A
DEF-18077-11 45 F 2 4 2 2 2 2 2 2 1 2 2 2 B
DEF-18077-12 45 F 4 3 2 2 1 2 2 2 1 2 2 2 B
DEF-18077-13 57 F 1 3 3 2 2 2 1 2 1 2 2 2 A
DEF-18077-14 53 F 1 3 3 3 2 2 2 3 1 2 2 2 B
DEF-18077-15 46 F 2 3 2 2 2 1 2 2 1 2 2 2 B
DEF-18077-16 52 F 1 3 3 3 3 2 1 2 1 2 2 2 A
DEF-18077-17 54 F 2 3 2 2 2 1 2 3 1 1 2 2 A
DEF-18077-18 50 F 2 3 2 2 2 2 2 2 1 2 2 2 B
DEF-18077-19 59 F 1 3 3 2 2 3 2 3 1 2 2 2 A
DEF-18077-20 55 F 3 4 2 1 3 2 2 3 1 2 2 2 B
DEF-18077-21 45 F 2 3 2 2 1 1 2 2 1 2 2 2 B
DEF-18077-22 48 F 1 3 3 3 2 2 2 3 1 2 2 2 B
DEF-18077-23 59 F 1 3 2 2 2 2 1 2 1 2 2 2 A
DEF-18077-24 53 F 1 3 3 2 2 2 3 3 1 2 2 2 B
1)Skin type: 1,Dry; 2,Normal; 3,Oily; 4,Normal to oily; 5,Problematic 2)Fitzpatrick skin type: 3, III type; 4, IV type 3)Hydration: 1,Sufficient; 2,Normal; 3,Dry 4)Sebum: 1,Glossy; 2,Normal; 3,Deficient 5)Surface: 1,Smooth; 2,Normal; 3,Rough 6)Thickness: 1,Thin;
2,Normal; 3,Thick 7)Time of UV exposure a day: 1,Less than 1hr; 2,1~3hrs; 3,More than 3hrs 8)Time of sleeping a day: 1,Less than 5hrs; 2,5~8hrs; 3,More than 8hrs 9) Smoking: 1, No; 2, Less than 10 pieces; 3, More than pieces 10 10)Is your skin easy to irritate: 1,Yes; 2,No
11)Do you feel stinging within 30 min after using cosmetics?: 1,Yes; 2,No 12)Have you ever experienced side effects of cosmetics within 12 months?: 1,Yes; 2,No 13)Application site of test product: A group, Left; B group, Right side of the face
Page 2 of 11
I-II. Analysis of svisual assessment
Visual assessment I Visual assessment II Mean

Subject
identification Test (A) Control (B) Test (A) Control (B) Test (A) Control (B)
code
Baseline 2 weeks 4 weeks 8 weeks Baseline 2 weeks 4 weeks 8 weeks Baseline 2 weeks 4 weeks 8 weeks Baseline 2 weeks 4 weeks 8 weeks Baseline 2 weeks 4 weeks 8 weeks Baseline 2 weeks 4 weeks 8 weeks
DEF-18077-01 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 2.50 3.00 3.00 3.00 3.00 3.00 3.00 3.00 2.75 3.00 3.00 3.00 3.00
DEF-18077-02 5.00 5.00 5.00 4.50 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 4.75 5.00 5.00 5.00 5.00
DEF-18077-03 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00
DEF-18077-04 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00
DEF-18077-05 3.00 3.00 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.50 2.75 2.75 2.50 2.50 2.50 2.50 2.50 2.50
DEF-18077-06 3.50 3.50 3.50 3.50 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 3.50 3.50 3.50 3.75 3.75 3.75 3.75 4.00 3.75 3.75 3.75
DEF-18077-07 3.00 3.00 3.00 3.00 4.00 4.00 4.00 4.00 3.50 3.50 3.50 3.50 4.00 4.00 4.00 4.00 3.25 3.25 3.25 3.25 4.00 4.00 4.00 4.00
DEF-18077-08 6.00 6.00 6.00 5.00 6.00 6.00 6.00 5.00 6.00 6.00 6.00 5.50 6.00 6.00 6.00 5.50 6.00 6.00 6.00 5.25 6.00 6.00 6.00 5.25
DEF-18077-09 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00
DEF-18077-10 3.50 3.50 3.50 3.50 3.50 3.50 3.50 3.50 3.00 3.00 3.00 3.00 3.50 3.00 3.00 3.00 3.25 3.25 3.25 3.25 3.50 3.25 3.25 3.25
DEF-18077-11 3.00 3.00 3.00 3.00 3.50 3.50 3.50 3.50 3.00 3.00 3.00 3.00 3.50 3.50 3.50 3.50 3.00 3.00 3.00 3.00 3.50 3.50 3.50 3.50
DEF-18077-12 3.50 3.50 3.50 3.50 4.00 4.00 4.00 4.00 4.00 3.50 3.50 3.50 4.00 4.00 4.00 4.00 3.75 3.50 3.50 3.50 4.00 4.00 4.00 4.00
DEF-18077-13 4.50 4.50 4.50 4.50 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.50 5.50 5.50 5.50 4.75 4.75 4.75 4.75 5.25 5.25 5.25 5.25
DEF-18077-14 7.00 7.00 7.00 6.50 7.50 7.50 7.50 7.50 7.00 7.00 7.00 7.00 7.50 7.50 7.50 7.50 7.00 7.00 7.00 6.75 7.50 7.50 7.50 7.50
DEF-18077-15 4.00 4.00 4.00 4.00 3.50 3.50 3.50 3.50 4.00 4.00 4.00 3.50 3.50 3.50 3.50 3.50 4.00 4.00 4.00 3.75 3.50 3.50 3.50 3.50
DEF-18077-16 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 2.50 2.50 3.00 3.00 3.00 3.00 3.00 3.00 2.75 2.75
DEF-18077-17 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 4.00 3.50 3.50 3.50 3.50 4.00 4.00 4.00 4.00 3.75 3.75 3.75 3.75
DEF-18077-18 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00
DEF-18077-19 4.50 4.50 4.50 4.50 4.50 4.50 4.50 4.50 4.50 4.50 4.50 4.50 4.00 4.00 4.00 4.00 4.50 4.50 4.50 4.50 4.25 4.25 4.25 4.25
DEF-18077-20 6.00 6.00 6.00 6.00 5.00 5.00 5.00 5.00 6.00 6.00 6.00 6.00 6.00 5.50 5.50 5.50 6.00 6.00 6.00 6.00 5.50 5.25 5.25 5.25
DEF-18077-21 4.50 4.50 4.50 4.50 4.50 4.50 4.50 4.50 5.00 5.00 4.50 4.50 5.00 5.00 4.50 4.50 4.75 4.75 4.50 4.50 4.75 4.75 4.50 4.50
DEF-18077-22 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 4.50 4.50 4.50 5.00 5.00 5.00 5.00 5.00 4.75 4.75 4.75 5.00 5.00 5.00 5.00
DEF-18077-23 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.50 5.50 5.50 5.50 5.00 5.00 5.00 5.00 5.25 5.25 5.25 5.25
DEF-18077-24 5.00 5.00 5.00 5.00 6.00 6.00 6.00 6.00 5.00 5.00 5.00 5.00 5.50 5.50 5.50 5.50 5.00 5.00 5.00 5.00 5.75 5.75 5.75 5.75
Mean - - - - - - - - - - - - - - - - 4.20 4.18 4.16 4.08 4.29 4.26 4.24 4.21

p- value1 - - - - - - - - - - - - - - - - - 0.162 0.043* 0.005* - 0.083 0.022* 0.029*
1
Significantly different at *p <0.05 compared with baseline
Page 3 of 11
I-III. Analysis of melanin index on hyper-pigmented region
Subject identification Test (A) Control (B)

code Baseline 2 weeks 4 weeks 8 weeks Baseline 2 weeks 4 weeks 8 weeks
DEF-18077-01 202.67 200.67 200.67 199.67 170.33 167.00 167.33 167.67
DEF-18077-02 201.33 201.67 191.33 186.67 197.33 201.67 198.00 194.33
DEF-18077-03 201.33 200.67 197.00 194.33 211.33 211.00 208.00 201.67
DEF-18077-04 172.67 172.00 170.33 169.67 140.67 140.00 138.00 137.33
DEF-18077-05 185.33 184.33 185.00 177.33 145.67 143.00 143.00 144.67
DEF-18077-06 205.00 198.00 189.67 190.00 247.00 227.00 223.33 218.33
DEF-18077-07 210.00 210.33 214.00 204.67 225.67 217.67 214.67 209.00
DEF-18077-08 183.33 182.33 182.33 168.33 209.67 209.33 205.67 203.33
DEF-18077-09 209.67 202.67 201.67 202.67 207.00 205.33 202.67 210.67
DEF-18077-10 184.67 178.67 180.33 175.33 173.33 171.00 168.67 167.67
DEF-18077-11 190.67 184.33 181.67 167.67 151.67 150.67 142.33 133.33
DEF-18077-12 237.67 235.00 230.00 225.67 288.00 275.00 260.67 256.33
DEF-18077-13 193.33 193.67 189.33 185.67 236.33 233.33 233.00 232.67
DEF-18077-14 230.00 225.67 223.33 215.33 202.33 201.67 199.67 188.67
DEF-18077-15 169.00 165.00 165.67 168.67 178.67 177.00 178.00 179.00
DEF-18077-16 179.33 172.00 171.67 170.67 162.33 162.33 162.67 162.67
DEF-18077-17 189.00 182.00 171.67 169.67 187.00 176.00 172.67 171.67
DEF-18077-18 185.00 174.33 167.00 166.00 171.67 171.33 161.67 162.67
DEF-18077-19 181.00 178.33 168.33 167.67 224.67 218.67 219.67 219.33
DEF-18077-20 211.00 194.00 191.00 190.67 255.00 243.00 234.33 215.67
DEF-18077-21 158.00 152.33 154.00 157.33 194.00 181.00 182.00 170.33
DEF-18077-22 197.33 189.33 188.00 185.00 202.00 203.33 200.67 205.00
DEF-18077-23 193.67 193.33 189.00 180.67 189.00 188.00 188.00 190.00
DEF-18077-24 169.33 168.67 167.33 167.00 157.00 154.33 151.33 154.33
Mean 193.35 189.14 186.26 182.77 196.99 192.86 189.83 187.35

p -value - 0.000* 0.000* 0.000* - 0.002* 0.000* 0.000*
1
Page 4 of 11
I-IV. Analysis of L* value on hyper-pigmented region
Test (A) Control (B)

Subject identification code
Baseline 2 weeks 4 weeks 8 weeks Baseline 2 weeks 4 weeks 8 weeks
DEF-18077-01 60.18 60.25 60.86 60.80 60.83 61.05 61.43 61.34
DEF-18077-02 59.67 59.89 60.73 61.42 60.69 60.79 61.74 62.59
DEF-18077-03 60.54 61.34 61.69 61.31 56.76 57.59 57.84 58.21
DEF-18077-04 60.56 60.80 62.28 62.84 62.62 62.71 62.93 62.92
DEF-18077-05 57.55 58.73 59.64 60.59 57.87 58.78 58.86 59.47
DEF-18077-06 60.17 61.19 61.36 61.53 55.91 56.78 56.85 58.26
DEF-18077-07 63.20 63.59 63.46 65.00 61.89 62.18 62.57 62.82
DEF-18077-08 62.85 63.51 63.81 64.58 61.76 62.10 62.71 63.57
DEF-18077-09 62.10 62.49 62.41 63.25 61.54 61.72 61.74 61.24
DEF-18077-10 59.46 60.18 60.18 61.15 59.86 60.30 60.36 60.88
DEF-18077-11 60.80 62.25 62.15 62.55 60.30 60.75 61.16 61.32
DEF-18077-12 59.32 59.83 61.41 61.43 56.35 56.40 57.17 58.14
DEF-18077-13 61.85 60.74 61.49 61.31 58.39 57.38 57.84 58.44
DEF-18077-14 59.16 59.43 60.37 60.88 59.06 59.22 60.01 60.51
DEF-18077-15 62.31 62.53 63.11 62.29 62.68 62.55 62.89 62.69
DEF-18077-16 64.80 64.91 64.79 65.65 64.85 64.77 65.43 65.17
DEF-18077-17 59.36 61.28 61.71 61.38 61.13 62.53 62.66 63.65
DEF-18077-18 57.68 57.75 57.86 58.52 58.72 58.78 59.28 59.45
DEF-18077-19 61.79 62.12 62.88 63.05 58.36 58.56 59.40 59.60
DEF-18077-20 61.17 61.84 62.76 63.61 59.18 60.12 61.57 61.79
DEF-18077-21 63.88 64.12 64.76 64.48 62.81 62.82 62.51 62.63
DEF-18077-22 62.02 62.19 63.48 63.44 61.77 61.71 61.83 61.80
DEF-18077-23 60.81 60.59 61.30 61.84 59.32 59.22 60.87 60.90
DEF-18077-24 62.37 61.35 61.99 62.33 61.34 58.16 61.63 61.51
Mean 60.98 61.37 61.94 62.30 60.17 60.29 60.89 61.20

p -value - 0.008* 0.000* 0.000* - 0.482 0.000* 0.000*
1
Page 5 of 11
I-V. Analysis of ITA° value
Test (A) Control (B)

Subject identification code
Baseline 2 weeks 4 weeks 8 weeks Baseline 2 weeks 4 weeks 8 weeks
DEF-18077-01 29.95 30.60 32.78 32.49 35.97 36.28 37.50 38.49
DEF-18077-02 29.62 29.54 31.39 32.54 31.65 31.49 32.86 34.24
DEF-18077-03 30.32 30.95 32.19 31.56 21.43 22.71 24.13 24.52
DEF-18077-04 28.19 28.58 31.61 33.30 36.21 35.72 36.82 36.75
DEF-18077-05 20.88 23.20 25.82 28.26 23.60 25.12 25.80 27.77
DEF-18077-06 27.79 32.24 32.35 33.27 16.26 19.20 19.21 24.05
DEF-18077-07 31.36 31.41 32.97 35.06 28.81 27.54 29.74 29.48
DEF-18077-08 29.98 30.65 32.24 33.79 27.35 28.28 30.53 31.88
DEF-18077-09 30.85 30.63 31.62 33.14 29.37 29.78 31.23 29.96
DEF-18077-10 24.51 26.07 27.14 29.55 27.10 28.32 29.22 30.81
DEF-18077-11 28.91 30.91 30.74 31.67 28.20 28.99 28.22 32.07
DEF-18077-12 22.09 22.61 26.38 26.52 16.27 15.79 17.63 19.67
DEF-18077-13 34.24 33.27 33.53 32.24 20.46 18.19 19.68 20.43
DEF-18077-14 21.61 22.06 24.15 25.54 22.31 22.61 24.84 26.89
DEF-18077-15 30.91 30.91 32.35 30.62 29.17 29.55 28.71 27.88
DEF-18077-16 35.29 33.78 34.39 36.05 36.85 36.73 37.60 37.19
DEF-18077-17 25.89 27.52 29.03 31.02 29.74 32.13 34.14 34.96
DEF-18077-18 21.58 22.85 25.09 25.40 24.14 24.43 27.11 27.76
DEF-18077-19 29.21 29.51 31.06 32.00 21.01 20.56 22.81 23.22
DEF-18077-20 27.80 28.58 30.63 34.76 22.99 24.37 27.79 29.70
DEF-18077-21 31.68 32.09 33.52 32.95 30.25 30.11 30.86 29.88
DEF-18077-22 28.70 28.67 31.61 30.83 29.92 28.54 31.42 31.25
DEF-18077-23 26.17 24.85 27.66 29.16 22.44 21.07 25.01 24.95
DEF-18077-24 29.89 28.29 30.43 31.06 27.38 25.88 29.72 30.84
Mean 28.23 28.74 30.45 31.37 26.62 26.81 28.44 29.36

p -value - 0.068 0.000* 0.000* - 0.472 0.000* 0.000*
1
Page 6 of 11
I-VI. Analysis of reflectance index of melanin on hyper-pigmented region
Subject identification Test (A) Control (B)

code Baseline 2 weeks 4 weeks 8 weeks Baseline 2 weeks 4 weeks 8 weeks
DEF-18077-12 97783.00 87994.00 97506.00 89185.00 86432.00 85495.00 85256.00 88788.00
DEF-18077-19 72081.00 80338.00 80475.00 74196.00 104252.00 101902.00 91365.00 89392.00
DEF-18077-20 110658.00 104924.00 88392.00 94699.00 99361.00 97274.00 95783.00 98343.00
DEF-18077-22 95497.00 91043.00 96213.00 92651.00 51973.00 52760.00 53688.00 50802.00
DEF-18077-23 104600.00 115195.00 90206.00 94452.00 60082.00 62013.00 61607.00 64234.00
Mean 96123.80 95898.80 90558.40 89036.60 80420.00 79888.80 77539.80 78311.80

Change from
- 0.23▼ 5.79▼ 7.37▼ - 0.66▼ 3.58▼ 2.62▼
baseline (%)
Page 7 of 11
I-VII. Assessment of questionnaires for efficacy by subjects

I-VII-I. After 2 weeks
Test Control
Subject identification
Decrease of skin Decrease of skin
code Reduction of skin Improvement of skin Improvement of skin Improvement of skin Reduction of skin Improvement of skin Improvement of skin Improvement of skin
hyper-pigmented hyper-pigmented
hyperpigmentation tone color translucency hyperpigmentationn tone color translucency
area area
DEF-18077-01 4 4 4 4 4 3 3 3 4 3
DEF-18077-02 5 5 4 3 4 4 4 4 4 4
DEF-18077-03 3 3 4 4 5 3 3 4 4 5
DEF-18077-04 4 4 4 4 3 4 4 4 4 3
DEF-18077-05 4 4 4 4 4 4 4 4 4 4
DEF-18077-06 4 4 3 4 4 3 4 3 4 4
DEF-18077-07 3 3 4 4 4 3 3 4 4 4
DEF-18077-08 4 3 3 4 4 4 3 3 4 4
DEF-18077-09 3 3 3 3 4 3 3 3 3 3
DEF-18077-10 3 3 3 4 3 3 3 3 3 3
DEF-18077-11 3 3 3 3 4 3 3 3 4 4
DEF-18077-12 3 3 4 4 4 3 3 4 4 4
DEF-18077-13 4 4 5 5 4 4 3 4 5 4
DEF-18077-14 3 3 3 3 3 3 3 3 4 3
DEF-18077-15 4 3 3 3 4 5 3 3 3 5
DEF-18077-16 3 4 3 4 4 3 4 3 4 4
DEF-18077-17 4 4 5 5 5 4 4 5 5 5
DEF-18077-18 4 4 4 4 4 4 4 4 4 3
DEF-18077-19 4 4 4 4 3 4 4 4 4 4
DEF-18077-20 4 4 5 4 5 3 3 4 3 3
DEF-18077-21 4 4 4 4 5 4 4 4 4 4
DEF-18077-22 4 4 4 3 4 3 3 3 3 4
DEF-18077-23 3 4 4 4 4 3 3 4 4 4
DEF-18077-24 3 3 3 3 3 3 3 3 3 3
Positive answer (N) 14 14 15 17 19 10 9 13 18 16

Percentage (%) 58.33 58.33 62.50 70.83 79.17 41.67 37.50 54.17 75.00 66.67
Page 8 of 11
I-VII-II. After 4 weeks

Test Control
area area
DEF-18077-01 4 4 4 4 4 3 3 3 3 3
DEF-18077-02 4 4 4 4 4 4 4 5 4 4
DEF-18077-03 4 4 4 4 4 3 3 3 4 4
DEF-18077-04 5 5 4 4 3 4 4 4 4 3
DEF-18077-05 4 4 4 4 4 4 5 4 5 4
DEF-18077-06 4 4 4 4 4 4 4 4 4 4
DEF-18077-07 3 3 4 4 4 3 3 3 3 3
DEF-18077-08 4 4 4 4 4 4 3 4 4 4
DEF-18077-09 3 3 3 4 4 3 3 3 4 4
DEF-18077-10 3 3 4 4 4 4 3 2 3 4
DEF-18077-11 4 3 4 4 4 3 3 3 3 4
DEF-18077-12 4 4 4 4 4 3 3 4 3 4
DEF-18077-13 4 4 5 4 5 4 4 4 5 4
DEF-18077-14 4 4 3 4 3 4 4 4 4 4
DEF-18077-15 4 3 3 4 4 4 3 3 4 4
DEF-18077-16 5 5 4 5 4 4 4 4 4 4
DEF-18077-17 4 4 5 5 5 4 4 5 5 5
DEF-18077-18 4 4 4 4 4 4 4 4 4 4
DEF-18077-19 4 4 4 4 4 3 3 4 4 4
DEF-18077-20 4 4 4 5 4 3 2 3 2 3
DEF-18077-21 4 4 4 4 5 4 4 4 4 4
DEF-18077-22 5 4 4 4 5 4 3 4 4 4
DEF-18077-23 4 4 4 4 4 3 3 4 4 3
DEF-18077-24 4 4 4 4 4 4 4 4 4 4

Percentage (%) 87.50 79.17 87.50 100.00 91.67 62.50 45.83 66.67 75.00 79.17
Page 9 of 11
I-VII-III. After 8 weeks

Test Control
area area
DEF-18077-01 5 5 5 5 5 4 4 4 4 4
DEF-18077-02 4 4 4 3 4 4 4 4 3 3
DEF-18077-03 4 4 5 4 5 4 3 5 4 5
DEF-18077-04 4 4 4 4 3 4 4 4 3 3
DEF-18077-05 4 4 4 4 4 4 5 5 4 5
DEF-18077-06 4 4 4 4 4 4 4 4 4 4
DEF-18077-07 4 4 4 4 4 4 4 4 4 4
DEF-18077-08 4 5 4 4 4 4 5 4 4 4
DEF-18077-09 4 4 4 4 4 3 3 4 3 4
DEF-18077-10 4 3 5 4 5 4 3 4 4 4
DEF-18077-11 4 3 4 4 4 3 3 4 4 4
DEF-18077-12 4 4 4 4 4 4 4 4 4 4
DEF-18077-13 5 4 4 5 5 4 4 4 5 4
DEF-18077-14 4 4 4 5 4 4 4 4 4 4
DEF-18077-15 4 4 4 4 4 4 4 4 4 4
DEF-18077-16 5 5 5 5 5 4 4 4 5 5
DEF-18077-17 4 4 4 4 5 4 4 4 4 5
DEF-18077-18 4 4 4 4 4 4 4 4 4 4
DEF-18077-19 4 4 4 5 4 5 4 5 5 5
DEF-18077-20 5 4 5 5 5 3 3 4 3 4
DEF-18077-21 4 4 4 4 4 4 4 4 4 5
DEF-18077-22 5 4 4 4 5 4 4 4 4 4
DEF-18077-23 4 4 4 4 4 3 4 3 4 3
DEF-18077-24 4 4 4 4 4 4 4 4 4 4
Percentage (%) 100.00 91.67 100.00 95.83 95.83 83.33 79.17 95.83 83.33 87.50
Page 10 of 11
I-VIII. Assessment of questionnaires for usability by subjects
SMW Spot LS SMW Lotion SM Lotion SMW Cream

Subject
identification code
Color Scent Spreadability Absorption Satisfaction Color Scent Spreadability Absorption Satisfaction Color Scent Spreadability Absorption Satisfaction Color Scent Spreadability Absorption Satisfaction
DEF-18077-01 4 4 4 5 4 5 4 5 5 5 4 4 4 5 4 5 4 5 5 5
DEF-18077-02 4 3 4 4 4 4 3 3 3 3 4 3 4 4 4 4 3 3 3 3
DEF-18077-03 4 4 3 3 4 4 3 4 3 4 3 3 3 3 3 2 3 3 3 4
DEF-18077-04 3 3 3 3 3 4 3 4 5 4 4 3 4 4 4 4 3 4 4 4
DEF-18077-05 4 4 4 5 5 4 4 5 5 4 4 5 5 5 5 4 5 5 5 5
DEF-18077-06 4 3 4 5 5 4 3 4 4 5 4 3 4 4 5 4 3 4 4 5
DEF-18077-07 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
DEF-18077-08 4 4 5 5 5 4 4 5 5 5 5 4 5 5 5 4 3 4 5 5
DEF-18077-09 4 4 5 5 5 4 3 4 4 4 3 3 4 4 4 4 3 4 3 4
DEF-18077-10 3 3 2 4 3 4 3 4 3 4 4 3 4 3 4 4 3 4 4 4
DEF-18077-11 4 4 3 3 4 3 3 4 4 4 3 3 4 4 4 4 4 4 3 4
DEF-18077-12 4 4 4 4 4 4 4 4 3 4 4 4 3 3 3 4 4 4 4 4
DEF-18077-13 4 4 5 4 4 4 4 5 5 4 5 4 4 5 4 4 4 5 4 4
DEF-18077-14 4 4 4 4 4 4 3 4 4 4 3 3 3 3 3 4 5 5 5 5
DEF-18077-15 3 3 3 3 3 4 4 4 4 4 3 3 3 3 3 4 4 4 4 4
DEF-18077-16 5 4 5 5 5 4 4 5 4 5 4 4 4 5 4 5 5 5 5 5
DEF-18077-17 4 4 4 4 4 4 4 4 4 5 4 4 4 4 5 4 3 4 4 4
DEF-18077-18 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 4
DEF-18077-19 4 4 4 3 4 4 4 4 4 4 5 4 4 4 4 5 5 5 5 5
DEF-18077-20 4 4 5 5 5 4 4 4 4 5 4 4 4 4 5 5 4 5 5 5
DEF-18077-21 4 4 4 5 5 4 5 5 4 4 4 5 5 4 5 4 5 5 5 5
DEF-18077-22 4 4 4 4 5 4 4 5 5 5 4 4 4 4 5 5 5 5 5 5
DEF-18077-23 4 4 4 5 5 4 4 5 4 5 3 3 5 3 4 4 4 5 5 5
DEF-18077-24 4 3 4 4 4 4 3 4 4 4 4 3 4 4 4 4 3 4 4 4
Positive answer (N) 21 18 19 19 21 23 15 23 20 23 18 13 20 18 20 23 15 22 20 23

Percentage (%) 87.50 75.00 79.17 79.17 87.50 95.83 62.50 95.83 83.33 95.83 75.00 54.17 83.33 75.00 83.33 95.83 62.50 91.67 83.33 95.83
Page 11 of 11
I-XI. Usage of the test product
SMW Spot LS SMW Lotion SM Lotion SM Cream

Subject
identification code 2 weeks 4 weeks 8 weeks 2 weeks 4 weeks 8 weeks 2 weeks 4 weeks 8 weeks 2 weeks 4 weeks 8 weeks
DEF-18077-01 12.47 11.81 28.12 19.57 11.74 30.66 19.81 27.41 42.06 14.98 14.87 25.04
DEF-18077-02 12.66 14.80 21.12 33.97 26.50 47.84 32.07 29.99 53.61 19.94 18.10 25.64
DEF-18077-03 10.79 11.52 34.30 20.69 14.29 42.93 11.87 14.34 23.01 8.21 7.09 17.72
DEF-18077-04 13.71 12.54 19.26 19.66 15.31 33.91 15.67 11.84 32.52 9.44 7.28 14.90
DEF-18077-05 8.48 7.94 20.68 13.82 14.70 46.61 13.53 9.95 41.22 4.48 5.35 11.84
DEF-18077-06 18.70 21.17 22.28 42.45 44.00 55.66 42.67 41.51 66.35 11.94 15.95 20.38
DEF-18077-07 8.37 9.78 22.31 19.26 23.53 42.91 28.50 23.38 49.09 10.06 10.51 18.81
DEF-18077-08 12.51 13.29 25.53 30.66 23.40 53.47 9.72 11.80 49.50 8.93 9.80 17.59
DEF-18077-09 8.07 11.17 21.09 12.41 10.04 20.14 13.70 10.81 24.67 6.64 7.12 18.58
DEF-18077-10 12.96 13.10 29.62 21.22 20.31 39.62 17.05 24.44 33.72 10.99 10.37 16.80
DEF-18077-11 13.55 11.21 22.75 12.41 12.50 35.85 12.28 10.58 24.39 16.33 16.62 29.28
DEF-18077-12 10.39 16.22 24.56 37.12 38.00 75.22 42.64 38.10 68.89 15.99 13.57 27.13
DEF-18077-13 13.54 11.69 22.93 19.05 19.22 53.11 15.98 17.00 49.15 16.28 10.58 31.24
DEF-18077-14 7.43 11.38 22.40 12.00 10.89 44.97 9.87 6.83 50.40 4.51 4.15 5.22
DEF-18077-15 14.93 9.97 22.97 17.29 17.12 45.86 18.47 23.30 44.76 15.38 12.07 30.05
DEF-18077-16 5.80 7.22 15.97 35.86 28.98 65.65 17.28 18.52 47.75 7.36 10.50 18.77
DEF-18077-17 6.88 7.98 19.74 17.77 26.40 39.94 16.62 28.90 40.03 7.40 9.02 17.83
DEF-18077-18 15.21 11.07 33.59 25.68 23.23 40.18 18.31 12.27 34.43 14.12 16.61 30.74
DEF-18077-19 19.79 10.18 23.00 34.25 33.19 76.24 34.65 43.81 58.84 13.62 17.74 29.92
DEF-18077-20 13.72 10.74 22.83 20.44 19.63 45.74 20.21 23.46 45.74 12.24 10.57 27.34
DEF-18077-21 17.18 11.51 38.36 14.81 13.28 33.22 15.59 11.23 33.33 10.26 9.34 23.17
DEF-18077-22 10.37 8.81 24.78 27.29 24.57 40.29 17.17 21.37 44.87 6.65 9.35 16.33
DEF-18077-23 7.67 15.99 24.63 14.39 18.88 33.31 17.49 17.56 35.50 7.69 9.00 21.71
DEF-18077-24 12.81 11.69 17.48 20.72 22.91 36.08 14.08 20.25 38.26 10.69 9.70 16.50
Mean 12.00 11.78 24.18 22.62 21.36 44.98 19.80 20.78 43.00 11.01 11.05 21.36
APPENDIX II
STATISTICAL DATA
Page 1 of 47
Appendix II. Statistical analysis
II-I. Visual assessment
II-I-I. Reliability
i) Test group
Scale: ALL VARIABLES
Case Processing Summary

N %
Cases Valid 24 100.0
a
Excluded 0 .0
Total 24 100.0
a. Listwise deletion based on all variables in the

procedure.
Reliability Statistics
Cronbach's
Alpha N of Items
.987 2
Intraclass Correlation Coefficient
Intraclass 95% Confidence Interval F Test with True Value 0

b
Correlation Lower Bound Upper Bound Value df1 df2
a
Single Measures .974 .941 .989 75.465 23 23
c
Average Measures .987 .969 .994 75.465 23 23

F Test with True Value 0b
Sig
Single Measures .000
Average Measures .000
Two-way mixed effects model where people effects are random and measures effects are fixed.
a. The estimator is the same, whether the interaction effect is present or not.
b. Type C intraclass correlation coefficients using a consistency definition. The between-measure variance is
excluded from the denominator variance.
c. This estimate is computed assuming the interaction effect is absent, because it is not estimable otherwise.
ii) Control group
Reliability
Page 2 of 47
Scale: ALL VARIABLES
Case Processing Summary

N %
Cases Valid 24 100.0
a
Excluded 0 .0
Total 24 100.0
a. Listwise deletion based on all variables in the

procedure.
Reliability Statistics
Cronbach's
Alpha N of Items
.982 2
Intraclass 95% Confidence Interval F Test with True Value 0

b
Correlation Lower Bound Upper Bound Value df1 df2
a
Single Measures .965 .921 .985 55.864 23 23
c
Average Measures .982 .959 .992 55.864 23 23

F Test with True Value 0b
Sig
Single Measures .000
Average Measures .000
Two-way mixed effects model where people effects are random and measures effects are fixed.
a. The estimator is the same, whether the interaction effect is present or not.
b. Type C intraclass correlation coefficients using a consistency definition. The between-measure variance is
excluded from the denominator variance.
c. This estimate is computed assuming the interaction effect is absent, because it is not estimable otherwise.
II-I-II. Explore
Tests of Normality
Kolmogorov-Smirnova Shapiro-Wilk
Statistic df Sig. Statistic df Sig.
a_0w .167 24 .082 .904 24 .026
*
b_0w .136 24 .200 .937 24 .142
Page 3 of 47
*. This is a lower bound of the true significance.

a. Lilliefors Significance Correction
Descriptives
Descriptive Statistics
N Mean Std. Deviation Skewness
Statistic Statistic Std. Error Statistic Statistic Std. Error
a_0w 24 4.1979 .23792 1.16558 .641 .472
a_2w 24 4.1771 .23769 1.16442 .684 .472
a_4w 24 4.1563 .23974 1.17449 .667 .472
a_8w 24 4.0833 .22706 1.11235 .579 .472
b_0w 24 4.2917 .24940 1.22178 .716 .472
b_2w 24 4.2604 .24976 1.22359 .754 .472
b_4w 24 4.2396 .25157 1.23244 .754 .472
b_8w 24 4.2083 .24389 1.19480 .790 .472
Valid N (listwise) 24
Kurtosis
Statistic Std. Error
a_0w -.270 .918
a_2w -.206 .918
a_4w -.152 .918
a_8w -.259 .918
b_0w .344 .918
b_2w .397 .918
b_4w .411 .918
b_8w .775 .918
Valid N (listwise)
II-I-III. Comparisons between time points
i) Test group
General Linear Model
Within-Subjects Factors
Measure: MEASURE_1
Dependent
week Variable
1 a_0w
Page 4 of 47
2 a_2w
3 a_4w
4 a_8w
Multivariate Testsa
Effect Value F Hypothesis df Error df Sig.
b
week Pillai's Trace .324 3.351 3.000 21.000 .038
b
Wilks' Lambda .676 3.351 3.000 21.000 .038
b
Hotelling's Trace .479 3.351 3.000 21.000 .038
b
Roy's Largest Root .479 3.351 3.000 21.000 .038
a. Design: Intercept
Within Subjects Design: week
b. Exact statistic
Mauchly's Test of Sphericitya

Measure: MEASURE_1
Epsilonb
Approx. Greenhouse-Gei
Within Subjects Effect Mauchly's W Chi-Square df Sig. sser
week .212 33.703 5 .000 .526

Measure: MEASURE_1
Epsilon
Within Subjects Effect Huynh-Feldt Lower-bound
week .558 .333
Tests the null hypothesis that the error covariance matrix of the orthonormalized transformed dependent
variables is proportional to an identity matrix.a
b. May be used to adjust the degrees of freedom for the averaged tests of significance. Corrected tests are
displayed in the Tests of Within-Subjects Effects table.
Tests of Within-Subjects Effects

Measure: MEASURE_1
Type III Sum of
Source Squares df Mean Square F
week Sphericity Assumed .179 3 .060 6.344
Greenhouse-Geisser .179 1.578 .113 6.344
Page 5 of 47
Huynh-Feldt .179 1.674 .107 6.344

Lower-bound .179 1.000 .179 6.344
Error(week) Sphericity Assumed .649 69 .009
Greenhouse-Geisser .649 36.291 .018
Huynh-Feldt .649 38.510 .017
Lower-bound .649 23.000 .028

Measure: MEASURE_1
Source Sig.
week Sphericity Assumed .001
Greenhouse-Geisser .007
Huynh-Feldt .006
Lower-bound .019
Error(week) Sphericity Assumed
Greenhouse-Geisser
Huynh-Feldt
Lower-bound
Tests of Within-Subjects Contrasts

Measure: MEASURE_1
Type III Sum of
Source week Squares df Mean Square F Sig.
week Level 2 vs. Level 1 .010 1 .010 2.091 .162
Level 3 vs. Level 1 .042 1 .042 4.600 .043
Level 4 vs. Level 1 .315 1 .315 9.697 .005
Error(week) Level 2 vs. Level 1 .115 23 .005
Level 3 vs. Level 1 .208 23 .009
Level 4 vs. Level 1 .747 23 .032
Tests of Between-Subjects Effects

Measure: MEASURE_1
Transformed Variable: Average
Type III Sum of
Source Squares df Mean Square F Sig.
Intercept 414.067 1 414.067 312.329 .000
Error 30.492 23 1.326
ii) Control group

Page 6 of 47
Measure: MEASURE_1
Dependent
week Variable
1 b_0w
2 b_2w
3 b_4w
4 b_8w
Multivariate Testsa
week Pillai's Trace .250 2.333b 3.000 21.000 .103
b
Wilks' Lambda .750 2.333 3.000 21.000 .103
Hotelling's Trace .333 2.333b 3.000 21.000 .103
b
b. Exact statistic

Measure: MEASURE_1
Epsilonb
week .311 25.398 5 .000 .591

Measure: MEASURE_1
Epsilon
week .636 .333
Page 7 of 47

Measure: MEASURE_1
Type III Sum of
Huynh-Feldt .089 1.909 .046 3.400
Lower-bound .089 1.000 .089 3.400
Huynh-Feldt .599 43.900 .014
Lower-bound .599 23.000 .026

Measure: MEASURE_1
Source Sig.
Huynh-Feldt .044
Lower-bound .078
Greenhouse-Geisser
Huynh-Feldt
Lower-bound

Measure: MEASURE_1
Type III Sum of
week Level 2 vs. Level 1 .023 1 .023 3.286 .083
Level 3 vs. Level 1 .065 1 .065 6.053 .022
Level 4 vs. Level 1 .167 1 .167 5.412 .029
Error(week) Level 2 vs. Level 1 .164 23 .007
Level 3 vs. Level 1 .247 23 .011
Level 4 vs. Level 1 .708 23 .031

Measure: MEASURE_1
Page 8 of 47

Type III Sum of
Intercept 433.500 1 433.500 293.385 .000
Error 33.984 23 1.478
II-I-IV. Homogeneity
T-Test
Paired Samples Statistics

Mean N Std. Deviation Std. Error Mean
Pair 1 a_0w 4.1979 24 1.16558 .23792
b_0w 4.2917 24 1.22178 .24940
Paired Samples Correlations

N Correlation Sig.
Pair 1 a_0w & b_0w 24 .961 .000
Paired Samples Test

Paired Differences
95% Confidence Interval of the
Difference
Mean Std. Deviation Std. Error Mean Lower Upper
Pair 1 a_0w - b_0w -.09375 .33632 .06865 -.23577 .04827
Paired Samples Test
t df Sig. (2-tailed)
Pair 1 a_0w - b_0w -1.366 23 .185
II-I-V. Comparisons between groups
Measure: MEASURE_1
Dependent
group week Variable
1 1 a_0w
2 a_2w
Page 9 of 47
3 a_4w
4 a_8w
2 1 b_0w
2 b_2w
3 b_4w
4 b_8w
Mean Std. Deviation N
a_0w 4.1979 1.16558 24
a_2w 4.1771 1.16442 24
a_4w 4.1563 1.17449 24
a_8w 4.0833 1.11235 24
b_0w 4.2917 1.22178 24
b_2w 4.2604 1.22359 24
b_4w 4.2396 1.23244 24
b_8w 4.2083 1.19480 24
Multivariate Testsa
b
group Pillai's Trace .073 1.802 1.000 23.000 .193
Wilks' Lambda .927 1.802b 1.000 23.000 .193
b
Roy's Largest Root .078 1.802b 1.000 23.000 .193
b
b
Wilks' Lambda .576 5.145 3.000 21.000 .008
Hotelling's Trace .735 5.145b 3.000 21.000 .008
b
b
group * week Pillai's Trace .175 1.485 3.000 21.000 .247
Wilks' Lambda .825 1.485b 3.000 21.000 .247
b
Within Subjects Design: group + week + group * week
b. Exact statistic

Measure: MEASURE_1
Page 10 of 47
Epsilonb
group 1.000 .000 0 . 1.000
week .147 41.580 5 .000 .479
group * week .389 20.494 5 .001 .641

Measure: MEASURE_1
Epsilon
group 1.000 1.000
week .502 .333
group * week .698 .333

Measure: MEASURE_1
Type III Sum of
group Sphericity Assumed .446 1 .446 1.802
Huynh-Feldt .446 1.000 .446 1.802
Lower-bound .446 1.000 .446 1.802
Error(group) Sphericity Assumed 5.687 23 .247
Greenhouse-Geisser 5.687 23.000 .247
Huynh-Feldt 5.687 23.000 .247
Lower-bound 5.687 23.000 .247
Huynh-Feldt .254 1.507 .168 5.900
Lower-bound .254 1.000 .254 5.900
Huynh-Feldt .989 34.666 .029
Page 11 of 47
Lower-bound .989 23.000 .043

group * week Sphericity Assumed .014 3 .005 1.241
Huynh-Feldt .014 2.095 .007 1.241
Lower-bound .014 1.000 .014 1.241
Error(group*week) Sphericity Assumed .259 69 .004
Huynh-Feldt .259 48.182 .005
Lower-bound .259 23.000 .011

Measure: MEASURE_1
Source Sig.
group Sphericity Assumed .193
Huynh-Feldt .193
Lower-bound .193
Error(group) Sphericity Assumed
Greenhouse-Geisser
Huynh-Feldt
Lower-bound
Huynh-Feldt .011
Lower-bound .023
Greenhouse-Geisser
Huynh-Feldt
Lower-bound
group * week Sphericity Assumed .302
Huynh-Feldt .299
Lower-bound .277
Error(group*week) Sphericity Assumed
Greenhouse-Geisser
Huynh-Feldt
Lower-bound

Measure: MEASURE_1
Page 12 of 47
Type III Sum of

Source group week Squares df
group Level 2 vs. Level 1 .223 1
Error(group) Level 2 vs. Level 1 2.844 23
week Level 2 vs. Level 1 .016 1
Level 3 vs. Level 1 .053 1
Error(week) Level 2 vs. Level 1 .062 23
group * week Level 2 vs. Level 1 Level 2 vs. Level 1 .003 1
Error(group*week) Level 2 vs. Level 1 Level 2 vs. Level 1 .310 23

Measure: MEASURE_1
Source group week Mean Square F Sig.
group Level 2 vs. Level 1 .223 1.802 .193
Error(group) Level 2 vs. Level 1 .124
week Level 2 vs. Level 1 .016 6.053 .022
Level 3 vs. Level 1 .053 10.180 .004
Level 4 vs. Level 1 .235 9.621 .005
Error(week) Level 2 vs. Level 1 .003
Level 3 vs. Level 1 .005
group * week Level 2 vs. Level 1 Level 2 vs. Level 1 .003 .193 .664
Level 3 vs. Level 1 .003 .138 .714
Level 4 vs. Level 1 .023 .812 .377
Error(group*week) Level 2 vs. Level 1 Level 2 vs. Level 1 .013

Measure: MEASURE_1
Type III Sum of
Page 13 of 47
Intercept 423.728 1 423.728 309.120 .000

Error 31.527 23 1.371
Parameter Estimates
95%
Confidence
Interval
Dependent Variable Parameter B Std. Error t Sig. Lower Bound
a_0w Intercept 4.198 .238 17.644 .000 3.706
a_2w Intercept 4.177 .238 17.574 .000 3.685
a_4w Intercept 4.156 .240 17.336 .000 3.660
a_8w Intercept 4.083 .227 17.984 .000 3.614
b_0w Intercept 4.292 .249 17.208 .000 3.776
b_2w Intercept 4.260 .250 17.058 .000 3.744
b_4w Intercept 4.240 .252 16.852 .000 3.719
b_8w Intercept 4.208 .244 17.255 .000 3.704
Parameter Estimates
95% Confidence Interval
Dependent Variable Parameter Upper Bound
a_0w Intercept 4.690
b_0w Intercept 4.808
Estimated Marginal Means
Grand Mean
Measure: MEASURE_1
Mean Std. Error Lower Bound Upper Bound
4.202 .239 3.707 4.696
II-II. Analysis of melanin index
II-II-I. Explore
Page 14 of 47
Tests of Normality
*
a_0w .090 24 .200 .974 24 .774
b_0w .098 24 .200* .970 24 .677

Descriptives
a_0w 24 193.3471 3.82133 18.72060 .473 .472
a_2w 24 189.1388 3.84635 18.84318 .525 .472
a_4w 24 186.2638 3.79867 18.60961 .673 .472
a_8w 24 182.7650 3.55040 17.39334 .853 .472
b_0w 24 196.9863 7.48012 36.64498 .595 .472
b_2w 24 192.8608 6.88332 33.72122 .437 .472
b_4w 24 189.8342 6.61034 32.38392 .198 .472
b_8w 24 187.3475 6.36578 31.18581 .142 .472
Kurtosis
a_0w .454 .918
a_2w .645 .918
a_4w .351 .918
a_8w .166 .918
b_0w .213 .918
b_2w -.019 .918
b_4w -.545 .918
b_8w -.410 .918
Valid N (listwise)
II-II-II. Comparisons between time points
i) Test group

Page 15 of 47
Measure: MEASURE_1
Dependent
week Variable
1 a_0w
2 a_2w
3 a_4w
4 a_8w
a_0w 193.3471 18.72060 24
a_2w 189.1388 18.84318 24
a_4w 186.2638 18.60961 24
a_8w 182.7650 17.39334 24
Multivariate Testsa
b
Wilks' Lambda .253 20.670b 3.000 21.000 .000
b
Hotelling's Trace 2.953 20.670 3.000 21.000 .000
Roy's Largest Root 2.953 20.670b 3.000 21.000 .000
b. Exact statistic

Measure: MEASURE_1
Epsilonb
week .510 14.618 5 .012 .744

Measure: MEASURE_1
Epsilon
week .828 .333
Page 16 of 47

Measure: MEASURE_1
Type III Sum of
week Sphericity Assumed 1445.974 3 481.991 34.864
Greenhouse-Geisser 1445.974 2.233 647.529 34.864
Huynh-Feldt 1445.974 2.484 582.019 34.864
Lower-bound 1445.974 1.000 1445.974 34.864
Error(week) Sphericity Assumed 953.919 69 13.825
Greenhouse-Geisser 953.919 51.361 18.573
Huynh-Feldt 953.919 57.141 16.694
Lower-bound 953.919 23.000 41.475

Measure: MEASURE_1
Source Sig.
Huynh-Feldt .000
Lower-bound .000
Greenhouse-Geisser
Huynh-Feldt
Lower-bound

Measure: MEASURE_1
Type III Sum of
week Level 2 vs. Level 1 425.042 1 425.042 23.980 .000
Level 3 vs. Level 1 1204.167 1 1204.167 32.861 .000
Level 4 vs. Level 1 2687.532 1 2687.532 65.233 .000
Error(week) Level 2 vs. Level 1 407.663 23 17.724
Page 17 of 47
Level 3 vs. Level 1 842.809 23 36.644

Level 4 vs. Level 1 947.571 23 41.199

Measure: MEASURE_1
Type III Sum of
Intercept 847161.253 1 847161.253 2581.043 .000
Error 7549.162 23 328.224
Parameter Estimates
95%
Confidence
Interval
a_0w Intercept 193.347 3.821 50.597 .000 185.442
a_2w Intercept 189.139 3.846 49.174 .000 181.182
a_4w Intercept 186.264 3.799 49.034 .000 178.406
a_8w Intercept 182.765 3.550 51.477 .000 175.420
Parameter Estimates
Grand Mean
Measure: MEASURE_1
187.879 3.698 180.229 195.529
ii) Control group

Page 18 of 47
Measure: MEASURE_1
Dependent
week Variable
1 b_0w
2 b_2w
3 b_4w
4 b_8w
b_0w 196.9863 36.64498 24
b_2w 192.8608 33.72122 24
b_4w 189.8342 32.38392 24
b_8w 187.3475 31.18581 24
Multivariate Testsa
b
Wilks' Lambda .508 6.786b 3.000 21.000 .002
b
b. Exact statistic

Measure: MEASURE_1
Epsilonb
week .135 43.570 5 .000 .470

Measure: MEASURE_1
Epsilon
week .491 .333
Page 19 of 47

Measure: MEASURE_1
Type III Sum of
Huynh-Feldt 1240.908 1.474 841.915 14.778
Lower-bound 1240.908 1.000 1240.908 14.778
Huynh-Feldt 1931.284 33.900 56.970
Lower-bound 1931.284 23.000 83.969

Measure: MEASURE_1
Source Sig.
Huynh-Feldt .000
Lower-bound .001
Greenhouse-Geisser
Huynh-Feldt
Lower-bound

Measure: MEASURE_1
Type III Sum of
Level 3 vs. Level 1 1227.655 1 1227.655 21.162 .000
Level 4 vs. Level 1 2229.732 1 2229.732 16.620 .000
Page 20 of 47
Level 3 vs. Level 1 1334.283 23 58.012

Level 4 vs. Level 1 3085.704 23 134.161

Measure: MEASURE_1
Type III Sum of
Intercept 882499.655 1 882499.655 799.134 .000
Error 25399.357 23 1104.320
Parameter Estimates
95%
Confidence
Interval
b_0w Intercept 196.986 7.480 26.335 .000 181.512
b_2w Intercept 192.861 6.883 28.019 .000 178.622
b_4w Intercept 189.834 6.610 28.718 .000 176.160
b_8w Intercept 187.348 6.366 29.430 .000 174.179
Parameter Estimates
Grand Mean
Measure: MEASURE_1
191.757 6.783 177.725 205.790
II-II-III. Homogeneity
T-Test
Page 21 of 47

Pair 1 a_0w 193.3471 24 18.72060 3.82133
b_0w 196.9863 24 36.64498 7.48012

N Correlation Sig.
Pair 1 a_0w & b_0w 24 .637 .001
Paired Samples Test

Paired Differences
Difference
Pair 1 a_0w - b_0w -3.63917 28.62628 5.84331 -15.72698 8.44865
Paired Samples Test
Pair 1 a_0w - b_0w -.623 23 .540
II-II-IV. Comparisons between groups
Measure: MEASURE_1
Dependent
group week Variable
1 1 a_0w
2 a_2w
3 a_4w
4 a_8w
2 1 b_0w
2 b_2w
3 b_4w
4 b_8w
Page 22 of 47

a_0w 193.3471 18.72060 24
a_2w 189.1388 18.84318 24
a_4w 186.2638 18.60961 24
a_8w 182.7650 17.39334 24
b_0w 196.9863 36.64498 24
b_2w 192.8608 33.72122 24
b_4w 189.8342 32.38392 24
b_8w 187.3475 31.18581 24
Multivariate Testsa
b
group Pillai's Trace .022 .524 1.000 23.000 .476
Wilks' Lambda .978 .524b 1.000 23.000 .476
b
Hotelling's Trace .023 .524 1.000 23.000 .476
Roy's Largest Root .023 .524b 1.000 23.000 .476
b
b
Wilks' Lambda .351 12.966 3.000 21.000 .000
b
b
group * week Pillai's Trace .023 .166 3.000 21.000 .918
b
Wilks' Lambda .977 .166 3.000 21.000 .918
Hotelling's Trace .024 .166b 3.000 21.000 .918
b
Roy's Largest Root .024 .166 3.000 21.000 .918
b. Exact statistic

Measure: MEASURE_1
Epsilonb
group 1.000 .000 0 . 1.000
week .210 33.899 5 .000 .533
group * week .377 21.212 5 .001 .611

Measure: MEASURE_1
Page 23 of 47
Epsilon
group 1.000 1.000
week .566 .333

Measure: MEASURE_1
Type III Sum of
group Sphericity Assumed 722.068 1 722.068 .524
Greenhouse-Geisser 722.068 1.000 722.068 .524
Huynh-Feldt 722.068 1.000 722.068 .524
Lower-bound 722.068 1.000 722.068 .524
Error(group) Sphericity Assumed 31700.632 23 1378.288
Huynh-Feldt 31700.632 23.000 1378.288
Lower-bound 31700.632 23.000 1378.288
Huynh-Feldt 2678.815 1.699 1576.484 32.666
Lower-bound 2678.815 1.000 2678.815 32.666
Huynh-Feldt 1886.126 39.082 48.260
Lower-bound 1886.126 23.000 82.005
group * week Sphericity Assumed 8.067 3 2.689 .186
Greenhouse-Geisser 8.067 1.832 4.405 .186
Huynh-Feldt 8.067 1.982 4.070 .186
Lower-bound 8.067 1.000 8.067 .186
Error(group*week) Sphericity Assumed 999.078 69 14.479
Huynh-Feldt 999.078 45.586 21.916
Page 24 of 47
Lower-bound 999.078 23.000 43.438

Measure: MEASURE_1
Source Sig.
Huynh-Feldt .476
Lower-bound .476
Greenhouse-Geisser
Huynh-Feldt
Lower-bound
Huynh-Feldt .000
Lower-bound .000
Greenhouse-Geisser
Huynh-Feldt
Lower-bound
Huynh-Feldt .829
Lower-bound .671
Greenhouse-Geisser
Huynh-Feldt
Lower-bound

Measure: MEASURE_1
Type III Sum of
group Level 2 vs. Level 1 361.034 1
week Level 2 vs. Level 1 416.708 1
Level 3 vs. Level 1 1215.883 1
Error(week) Level 2 vs. Level 1 379.629 23
Page 25 of 47

Level 4 vs. Level 1 1342.437 23
group * week Level 2 vs. Level 1 Level 2 vs. Level 1 .165 1
Error(group*week) Level 2 vs. Level 1 Level 2 vs. Level 1 824.262 23
Level 3 vs. Level 1 1199.898 23
Level 4 vs. Level 1 2696.802 23

Measure: MEASURE_1
group Level 2 vs. Level 1 361.034 .524 .476
Error(group) Level 2 vs. Level 1 689.144
week Level 2 vs. Level 1 416.708 25.246 .000
Level 3 vs. Level 1 1215.883 35.463 .000
Level 4 vs. Level 1 2453.293 42.032 .000
Error(week) Level 2 vs. Level 1 16.506
Level 3 vs. Level 1 34.286
group * week Level 2 vs. Level 1 Level 2 vs. Level 1 .165 .005 .946
Level 3 vs. Level 1 .113 .002 .963
Level 4 vs. Level 1 21.357 .182 .674
Error(group*week) Level 2 vs. Level 1 Level 2 vs. Level 1 35.837

Measure: MEASURE_1
Type III Sum of
Intercept 864740.196 1 864740.196 1589.637 .000
Error 12511.681 23 543.986
Parameter Estimates
95%
Confidence
Interval
Page 26 of 47
a_0w Intercept 193.347 3.821 50.597 .000 185.442

a_2w Intercept 189.139 3.846 49.174 .000 181.182
a_4w Intercept 186.264 3.799 49.034 .000 178.406
a_8w Intercept 182.765 3.550 51.477 .000 175.420
b_0w Intercept 196.986 7.480 26.335 .000 181.512
b_2w Intercept 192.861 6.883 28.019 .000 178.622
b_4w Intercept 189.834 6.610 28.718 .000 176.160
b_8w Intercept 187.348 6.366 29.430 .000 174.179
Parameter Estimates
Grand Mean
Measure: MEASURE_1
189.818 4.761 179.969 199.667
II-III. Analysis of L* value
II-III-I. Explore
Tests of Normality
*
A_0W .088 24 .200 .984 24 .955
*
B_0W .092 24 .200 .978 24 .862

Page 27 of 47
Descriptives
A_0W 24 60.9833 .37109 1.81796 .059 .472
A_2W 24 61.3708 .34807 1.70516 .061 .472
A_4W 24 61.9367 .32703 1.60211 -.348 .472
A_8W 24 62.3013 .33309 1.63179 .143 .472
B_0W 24 60.1663 .45712 2.23944 -.131 .472
B_2W 24 60.2904 .45048 2.20691 -.038 .472
B_4W 24 60.8867 .43222 2.11744 -.281 .472
B_8W 24 61.2042 .38974 1.90934 -.059 .472
Kurtosis
A_0W -.218 .918
A_2W -.006 .918
A_4W .677 .918
A_8W .246 .918
B_0W -.370 .918
B_2W -.794 .918
B_4W -.189 .918
B_8W -.587 .918
Valid N (listwise)
II-III-II. Comparisons between time points
i) Test group

Measure: MEASURE_1
Dependent
week Variable
1 A_0W
2 A_2W
3 A_4W
4 A_8W
Page 28 of 47
Multivariate Testsa
b
Wilks' Lambda .230 23.421 3.000 21.000 .000
Hotelling's Trace 3.346 23.421b 3.000 21.000 .000
b
Roy's Largest Root 3.346 23.421 3.000 21.000 .000
b. Exact statistic
Measure: MEASURE_1
Epsilonb
week .672 8.643 5 .125 .783

Measure: MEASURE_1
Epsilon
week .877 .333
Measure: MEASURE_1
Type III Sum of
Huynh-Feldt 24.688 2.632 9.380 37.849
Lower-bound 24.688 1.000 24.688 37.849
Error(week) Sphericity Assumed 15.002 69 .217
Huynh-Feldt 15.002 60.537 .248
Lower-bound 15.002 23.000 .652
Page 29 of 47

Measure: MEASURE_1
Source Sig.
Huynh-Feldt .000
Lower-bound .000
Greenhouse-Geisser
Huynh-Feldt
Lower-bound

Measure: MEASURE_1
Type III Sum of
Level 3 vs. Level 1 21.812 1 21.812 40.365 .000
Level 4 vs. Level 1 41.686 1 41.686 58.789 .000
Error(week) Level 2 vs. Level 1 9.991 23 .434
Level 3 vs. Level 1 12.429 23 .540
Level 4 vs. Level 1 16.309 23 .709

Measure: MEASURE_1
Type III Sum of
Intercept 91211.483 1 91211.483 33813.966 .000
Error 62.041 23 2.697
ii) Control group
Measure: MEASURE_1
Dependent
week Variable
1 B_0W
Page 30 of 47
2 B_2W
3 B_4W
4 B_8W
Multivariate Testsa
b
b
Wilks' Lambda .340 13.607 3.000 21.000 .000
b
b
b. Exact statistic

Measure: MEASURE_1
Epsilonb
week .432 18.236 5 .003 .768

Measure: MEASURE_1
Epsilon
week .859 .333

Measure: MEASURE_1
Type III Sum of
Page 31 of 47
Huynh-Feldt 17.418 2.577 6.759 20.809

Lower-bound 17.418 1.000 17.418 20.809
Error(week) Sphericity Assumed 19.252 69 .279
Huynh-Feldt 19.252 59.268 .325
Lower-bound 19.252 23.000 .837

Measure: MEASURE_1
Source Sig.
Huynh-Feldt .000
Lower-bound .000
Greenhouse-Geisser
Huynh-Feldt
Lower-bound

Measure: MEASURE_1
Type III Sum of
week Level 2 vs. Level 1 .370 1 .370 .510 .482
Level 3 vs. Level 1 12.456 1 12.456 32.506 .000
Level 4 vs. Level 1 25.855 1 25.855 33.397 .000
Error(week) Level 2 vs. Level 1 16.683 23 .725
Level 3 vs. Level 1 8.813 23 .383
Level 4 vs. Level 1 17.806 23 .774

Measure: MEASURE_1
Type III Sum of
Intercept 88243.935 1 88243.935 20548.543 .000
Error 98.772 23 4.294
Page 32 of 47
II-III-III. Homogeneity
T-Test

Pair 1 A_0W 60.9833 24 1.81796 .37109
B_0W 60.1662 24 2.23944 .45712
N Correlation Sig.
Pair 1 A_0W & B_0W 24 .642 .001
Paired Samples Test

Paired Differences
Difference
Pair 1 A_0W - B_0W .81708 1.75969 .35919 .07403 1.56013
Paired Samples Test
Pair 1 A_0W - B_0W 2.275 23 .033
II-III-IV. Comparisons between groups
Univariate Analysis of Variance

Between-Subjects Factors
N
VAR00009 1.00 24
2.00 24

Dependent Variable: A_2W
Type III Sum of
a
Corrected Model 168.230 2 84.115 153.416 .000
Intercept 2.168 1 2.168 3.954 .053
A_0W 154.222 1 154.222 281.284 .000
VAR00009 1.386 1 1.386 2.528 .119
Page 33 of 47
Error 24.673 45 .548

Total 177810.420 48
Corrected Total 192.903 47
a. R Squared = .872 (Adjusted R Squared = .866)

Custom Hypothesis Tests
Contrast Results (K Matrix)

Dependent
Variable
VAR00009 Simple Contrasta A_2W
Level 2 vs. Level 1 Contrast Estimate -.347
Hypothesized Value 0
Difference (Estimate - Hypothesized) -.347
Std. Error .218
Sig. .119
95% Confidence Interval for Lower Bound -.786
Difference Upper Bound .093
a. Reference category = 1
Test Results
Source Sum of Squares df Mean Square F Sig.
Contrast 1.386 1 1.386 2.528 .119
Error 24.673 45 .548
N
VAR00009 1.00 24
2.00 24

Type III Sum of
a
Corrected Model 157.470 2 78.735 197.745 .000
Intercept 4.054 1 4.054 10.181 .003
A_0W 144.240 1 144.240 362.262 .000
VAR00009 1.336 1 1.336 3.356 .074
Page 34 of 47
Error 17.917 45 .398

Total 181202.242 48

Dependent
Variable
VAR00009 Simple Contrasta A_4W
Std. Error .186
Sig. .074
Difference Upper Bound .034
Test Results
Contrast 1.336 1 1.336 3.356 .074
Error 17.917 45 .398
N
VAR00009 1.00 24
2.00 24

Type III Sum of
a
Corrected Model 133.862 2 66.931 117.319 .000
Intercept 10.066 1 10.066 17.645 .000
A_0W 119.419 1 119.419 209.322 .000
Page 35 of 47
VAR00009 2.349 1 2.349 4.118 .048

Error 25.673 45 .571
Total 183202.590 48

Dependent
Variable
a
VAR00009 Simple Contrast A_8W
Std. Error .223
Sig. .048
Difference Upper Bound -.003
Test Results
Contrast 2.349 1 2.349 4.118 .048
Error 25.673 45 .571
II-IV. Analysis of ITA value
II-IV-I. Explore
Tests of Normality
A_0W .163 24 .097 .936 24 .133
*
B_0W .117 24 .200 .961 24 .466

Page 36 of 47
Descriptives
A_0W 24 28.2258 .78728 3.85688 -.476 .472
A_2W 24 28.7404 .70496 3.45360 -.703 .472
A_4W 24 30.4450 .59019 2.89134 -.883 .472
A_8W 24 31.3658 .57393 2.81168 -.719 .472
B_0W 24 26.6200 1.15873 5.67660 .013 .472
B_2W 24 26.8079 1.15240 5.64560 -.035 .472
B_4W 24 28.4408 1.11164 5.44591 -.188 .472
B_8W 24 29.3600 1.01845 4.98939 -.093 .472
Kurtosis
A_0W -.215 .918
A_2W -.525 .918
A_4W -.323 .918
A_8W .161 .918
B_0W -.428 .918
B_2W -.517 .918
B_4W -.299 .918
B_8W -.362 .918
Valid N (listwise)
II-IV-II. Comparisons between time points
i) Test group
Measure: MEASURE_1
Dependent
week Variable
1 A_0W
2 A_2W
3 A_4W
4 A_8W
Page 37 of 47
Multivariate Testsa
b
Wilks' Lambda .195 28.823 3.000 21.000 .000
b
b. Exact statistic

Measure: MEASURE_1
Epsilonb
week .389 20.500 5 .001 .623

Measure: MEASURE_1
Epsilon
week .676 .333

Measure: MEASURE_1
Type III Sum of
Huynh-Feldt 154.173 2.029 75.980 43.175
Lower-bound 154.173 1.000 154.173 43.175
Page 38 of 47

Huynh-Feldt 82.130 46.670 1.760
Lower-bound 82.130 23.000 3.571

Measure: MEASURE_1
Source Sig.
Huynh-Feldt .000
Lower-bound .000
Greenhouse-Geisser
Huynh-Feldt
Lower-bound

Measure: MEASURE_1
Type III Sum of
Level 3 vs. Level 1 118.193 1 118.193 56.495 .000
Level 4 vs. Level 1 236.630 1 236.630 49.349 .000
Level 3 vs. Level 1 48.118 23 2.092
Level 4 vs. Level 1 110.287 23 4.795

Measure: MEASURE_1
Type III Sum of
Intercept 21161.993 1 21161.993 2143.130 .000
Error 227.110 23 9.874
ii) Control group
Page 39 of 47
Measure: MEASURE_1
Dependent
week Variable
1 B_0W
2 B_2W
3 B_4W
4 B_8W
Multivariate Testsa
b
Wilks' Lambda .262 19.739b 3.000 21.000 .000
b
b. Exact statistic

Measure: MEASURE_1
Epsilonb
week .412 19.258 5 .002 .631

Measure: MEASURE_1
Epsilon
week .685 .333

Measure: MEASURE_1
Page 40 of 47
Type III Sum of

Huynh-Feldt 125.297 2.056 60.940 33.394
Lower-bound 125.297 1.000 125.297 33.394
Huynh-Feldt 86.297 47.289 1.825
Lower-bound 86.297 23.000 3.752

Measure: MEASURE_1
Source Sig.
Huynh-Feldt .000
Lower-bound .000
Greenhouse-Geisser
Huynh-Feldt
Lower-bound

Measure: MEASURE_1
Type III Sum of
week Level 2 vs. Level 1 .848 1 .848 .535 .472
Level 3 vs. Level 1 79.570 1 79.570 42.396 .000
Level 4 vs. Level 1 180.182 1 180.182 35.848 .000
Level 3 vs. Level 1 43.167 23 1.877
Level 4 vs. Level 1 115.603 23 5.026

Measure: MEASURE_1
Type III Sum of
Page 41 of 47
Intercept 18557.752 1 18557.752 646.069 .000

Error 660.654 23 28.724
II-IV-III. Homogeneity
T-Test

Pair 1 A_0W 28.2258 24 3.85688 .78728
B_0W 26.6200 24 5.67660 1.15873

N Correlation Sig.
Pair 1 A_0W & B_0W 24 .430 .036
Paired Samples Test

Paired Differences
Difference
Pair 1 A_0W - B_0W 1.60583 5.31690 1.08531 -.63930 3.85096
Paired Samples Test
Pair 1 A_0W - B_0W 1.480 23 .153
II-IV-IV. Comparisons between groups
Measure: MEASURE_1
Dependent
group week Variable
1 1 A_0W
2 A_2W
3 A_4W
4 A_8W
Page 42 of 47
2 1 B_0W
2 B_2W
3 B_4W
4 B_8W
A_0W 28.2258 3.85688 24
A_2W 28.7404 3.45360 24
A_4W 30.4450 2.89134 24
A_8W 31.3658 2.81168 24
B_0W 26.6200 5.67660 24
B_2W 26.8079 5.64560 24
B_4W 28.4408 5.44591 24
B_8W 29.3600 4.98939 24
Multivariate Testsa
b
group Pillai's Trace .125 3.293 1.000 23.000 .083
Wilks' Lambda .875 3.293b 1.000 23.000 .083
b
b
b
Wilks' Lambda .182 31.446 3.000 21.000 .000
b
b
group * week Pillai's Trace .186 1.600 3.000 21.000 .219
Wilks' Lambda .814 1.600b 3.000 21.000 .219
b
b. Exact statistic

Measure: MEASURE_1
Within Subjects Effect Mauchly's W Approx. df Sig. Epsilonb
Page 43 of 47
Chi-Square Greenhouse-Gei
sser
group 1.000 .000 0 . 1.000
week .244 30.597 5 .000 .558
group * week .302 25.980 5 .000 .689

Measure: MEASURE_1
Epsilon
group 1.000 1.000
week .597 .333

Measure: MEASURE_1
Type III Sum of
group Sphericity Assumed 170.932 1 170.932 3.293
Huynh-Feldt 170.932 1.000 170.932 3.293
Lower-bound 170.932 1.000 170.932 3.293
Error(group) Sphericity Assumed 1193.923 23 51.910
Huynh-Feldt 1193.923 23.000 51.910
Lower-bound 1193.923 23.000 51.910
Huynh-Feldt 278.162 1.790 155.370 49.067
Lower-bound 278.162 1.000 278.162 49.067
Huynh-Feldt 130.388 41.177 3.167
Lower-bound 130.388 23.000 5.669
Page 44 of 47
group * week Sphericity Assumed 1.308 3 .436 .791

Greenhouse-Geisser 1.308 2.067 .633 .791
Huynh-Feldt 1.308 2.274 .575 .791
Lower-bound 1.308 1.000 1.308 .791
Error(group*week) Sphericity Assumed 38.039 69 .551
Huynh-Feldt 38.039 52.298 .727
Lower-bound 38.039 23.000 1.654

Measure: MEASURE_1
Source Sig.
Huynh-Feldt .083
Lower-bound .083
Greenhouse-Geisser
Huynh-Feldt
Lower-bound
Huynh-Feldt .000
Lower-bound .000
Greenhouse-Geisser
Huynh-Feldt
Lower-bound
Huynh-Feldt .473
Lower-bound .383
Greenhouse-Geisser
Huynh-Feldt
Lower-bound

Measure: MEASURE_1
Page 45 of 47
Type III Sum of

group Level 2 vs. Level 1 85.466 1
week Level 2 vs. Level 1 2.961 1
Error(week) Level 2 vs. Level 1 34.450 23
group * week Level 2 vs. Level 1 Level 2 vs. Level 1 2.561 1
Error(group*week) Level 2 vs. Level 1 Level 2 vs. Level 1 14.852 23

Measure: MEASURE_1
group Level 2 vs. Level 1 85.466 3.293 .083
Error(group) Level 2 vs. Level 1 25.955
week Level 2 vs. Level 1 2.961 1.977 .173
Level 3 vs. Level 1 97.930 68.741 .000
Level 4 vs. Level 1 207.446 49.677 .000
Error(week) Level 2 vs. Level 1 1.498
group * week Level 2 vs. Level 1 Level 2 vs. Level 1 2.561 3.966 .058
Level 3 vs. Level 1 3.808 1.701 .205
Level 4 vs. Level 1 3.840 1.307 .265
Error(group*week) Level 2 vs. Level 1 Level 2 vs. Level 1 .646

Measure: MEASURE_1
Type III Sum of
Page 46 of 47
Intercept 19838.506 1 19838.506 1548.612 .000

Error 294.642 23 12.811
Parameter Estimates
95%
Confidence
Interval
A_0W Intercept 28.226 .787 35.852 .000 26.597
A_2W Intercept 28.740 .705 40.769 .000 27.282
A_4W Intercept 30.445 .590 51.585 .000 29.224
A_8W Intercept 31.366 .574 54.651 .000 30.179
B_0W Intercept 26.620 1.159 22.973 .000 24.223
B_2W Intercept 26.808 1.152 23.263 .000 24.424
B_4W Intercept 28.441 1.112 25.585 .000 26.141
B_8W Intercept 29.360 1.018 28.828 .000 27.253
Parameter Estimates
A_0W Intercept 29.854
B_0W Intercept 29.017
Grand Mean
Measure: MEASURE_1
28.751 .731 27.239 30.262
Page 47 of 47
II-V. Analysis of melanin cap
II-V-I. Explore
Tests of Normality
*
A_0W .283 5 .200 .897 5 .391
*
B_0W .208 5 .200 .895 5 .382

Descriptives
A_0W 5 96123.8000 6573.77742 14699.41318 -1.340 .913
A_2W 5 95898.8000 6253.00217 13982.13792 .540 .913
A_4W 5 90558.4000 3055.61841 6832.57048 -.678 .913
A_8W 5 89036.6000 3838.74100 8583.68582 -1.898 .913
B_0W 5 80420.0000 10454.03248 23375.92727 -.355 .913
B_2W 5 79888.8000 9679.28625 21643.54203 -.394 .913
B_4W 5 77539.8000 8385.26303 18750.01815 -.534 .913
B_8W 5 78311.8000 8912.75524 19929.52659 -.688 .913
Kurtosis
A_0W 2.280 2.000
A_2W -1.185 2.000
A_4W -.135 2.000
A_8W 3.643 2.000
B_0W -2.648 2.000
B_2W -2.469 2.000
B_4W -2.549 2.000
B_8W -1.660 2.000
Valid N (listwise)
APPENDIX III
IMAGE DATA
Page 1 of 12
Appendix III. IMAGE DATA

III-I. Skin color image (Cross-polarized mode)
No. Baseline After 2 weeks After 4 weeks After 8 weeks
Test
01
Control
Test
02
Control
Page 2 of 12
Test
03
Control
Test
04
Control
Page 3 of 12
Test
05
Control
Test
06
Control
Page 4 of 12
Test
07
Control
Test
08
Control
Page 5 of 12
Test
09
Control
Test
10
Control
Page 6 of 12
Test
11
Control
Test
12
Control
Page 7 of 12
Test
13
Control
Test
14
Control
Page 8 of 12
Test
15
Control
Test
16
Control
Page 9 of 12
Test
17
Control
Test
18
Control
Page 10 of 12
Test
19
Control
Test
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III-II. Image of hyper-pigmented region

Cross-
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.No. Baseline After 2 weeks After 4 weeks After 8 weeks
Cross-
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III-III. Reflectance index of melanin image

i) Test site
#12 A Baseline 2 weeks 4 weeks 8 weeks
Viva cam
image
RCM image
Analyzed
RCM image
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#19 A Baseline 2 Weeks 4 Weeks 8 Weeks
Viva cam
image
RCM image
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RCM image
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#20 A Baseline 2 Weeks 4 Weeks 8 Weeks
Viva cam
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RCM image
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RCM image
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#22 Baseline 2 Weeks 4 Weeks 8 Weeks
Viva cam
image
RCM image
Analyzed
RCM image
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Viva cam
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RCM image
Analyzed
RCM image
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ii) Control site
Viva cam
image
RCM image
Analyzed
RCM image
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image
RCM image
Analyzed
RCM image
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RCM image
APPENDIX IV
RESEARCH MEMBERS AND FACILITIES

Page 1 of 13
APPENDIX IV.
RESEARCH MEMBERS & FACILITIES
1. COMPANY INFORMATION
Company name DERMAPRO LTD.
Human clinical evaluation of efficacy and safety for cosmetics,
Business fields
cosmeceuticals, toiletries and neutraceuticals
Head office 30, Bangbaejoongang-ro, Seocho-gu, Seoul 06684, Korea
President Jae Sook Koh, Ph.D.
2. EVALUATION FIELDS
Classification Test Item

Human Skin Wrinkle Test (I)
Human Skin Lightening Effect Test (I)
Sun protection of UVB, UVA Test
Efficacy Water Proof SPF Test

Evaluation for Hair Loss Prevention and Growth Effect Test (I)
MFDS (I) Human Skin Wrinkle Test of Food Supplement
Human Skin Lightening Effect Test of Food Supplement
Human Skin Hydration Test of Food Supplement
Acne Skin Improvement Effect Test
Human Skin Wrinkle Test (II)
Human Skin Lightening Effect Test (II)
Sweat Resistance SPF Test
Human Skin Firming & Sagging Test
Efficacy
Damaged Skin Recovery Effect Test (I),(II),(III)
Evaluation (II)
Human Skin Water Holding Capacity Test of 24 Hours
Human Skin Scale Test
Human Skin Radiance & Gloss Test
Damaged Skin Recovery Effect Test (I), (II), (III)
Page 2 of 13
Cleansing Effect Test
Body Human Breast Firming Test

Evaluation Cellulite Reduction Test
Evaluation of Lip Products
Evaluation of Mascara
Make-Up Evaluation
Evaluation of Make-up products
Cleansing Effect Test
Hair Loss Prevention and Growth Effect Test (II)
Hair Dandruff and Itching Improvement Effect Test
Hair & Scale
Evaluation of Hair products
Evaluation
Eyelash Growth Effect Test
Scalp condition Test
Skin Primary Irritation Test
Skin Repeat Insult Patch Test
Skin Sting Test
Skin Photo-irritation Test
Safety Skin Cumulative Irritation Test

Evaluation Eye Tolerance Test
Eye Rim Use Test
Skin Adverse Reaction Test
Skin Usage Test
Skin Photo-Sensitization Test
Antimicrobial
Skin Antimicrobial Efficacy Test
Efficacy Evaluation
Sensory
Sensory Test
Evaluation
Human Skin Wrinkle Test of Food Supplement
Food
Human Skin Lightening Effect Test of Food Supplement
Supplement
Human Skin Hydration Test of Food Supplement
in vitro Skin Lightening Effect Test
Page 3 of 13
Assay Anti-wrinkle Effect Test

Antioxidant Activity Test
Skin Absorption Test
Skin adsorption prevention test of fine dust
in vitro SPF Test
3. PRINCIPAL INVESTIGATOR
Min Kyung Shin, Dermatologist

Graduated with a M.D., Ph.D.in Medical Science from College of Medicine, Kyung Hee
University
4. INVESTIGATORS
1) Min Kyung Jeong

Graduated with a Master’s degree in Medical Science from Yonsei University
2) Hyun Jin Jeong

Graduated with a Master’s degree in Genetic engineering from Kyung Hee University
5. QUALITY ASSURANCE (QA)
1) Young Kyoung Seo

Graduated with a Master’s degree in Physiology from College of Medicine, Chung-Ang
University
Page 4 of 13
6. RESEARCH FACILITIES
No. Device Description

To visualize layers of the skin and
1 DermaScan® C Ver.3 subcutaneous tissue and to make
approximate dimensional measurements
Periscan PIM II® Laser Doppler
2 To measure the circulation of microvessels
Perfusion Imaging system
To measure the melanin and the erythema
3 Mexameter® MX 18
index of the skin
®
Spectrophotometer To measure the Lightness (L*), Green-Red
4
CM-2500d (a*) and Blue-Yellow (b*) of the skin
5 Antera 3D CS To evaluate the color on the skin
To measure the viscoelasticity of the skin
6 Cutometer® MPA 580
for face
7 Dermal Torque Meter DTM310 To measure the viscoelasticity of the skin
8 Torsional Ballistometer BLS780 To measure the viscoelasticity of the skin

To measure the reviscoelasticity of the
9 Reviscometer®
skin
To measure the sebum content variation in
10 Sebumeter® SM 810
the stratum corneum
To measure the water content variation in
11 Corneometer® CM 825
the stratum corneum
12 Moisturemeter® SC
the stratum corneum
13 Moisturemeter® D
the dermis
14 DERMALAB® To measure the water content variation
15 Epsilon® To capture dielectric permittivity image

To Activate the hydrophilic factor and
16 Facial ion Steamer®
replenish water in skin
To measure the pH variation in the stratum
17 Skin-pH-Meter® pH 900
corneum
18 Tewameter® TM 300 To measure the transepidermal water loss
To measure the transepidermal water loss
19 Vapometer®
in the stratum
20 Skin Visiometer® SV 600 To analyze the skin roughness
Page 5 of 13
21 VisioLine® To analyze the skin roughness

To visualize an exact 3D image in vivo
22 VECTRA XT measurement of human face and body
skin surface
23 PRIMOS® premium measurement of human facial skin
surfaces
24 PRIMOS® lite
measurement of human body skin surface
25 PRIMOS® shapescan measurement of human facial skin
surfaces
26 SquameScan® 850A To measure the desquamation of the skin
To estimate the desquamation and the
27 Visioscan® VC 98
sebum
28 UVB Irradiator To induce artificial pigmentation
29 Radiometer VLX-3W To measure the UV A and B irradiance
30 Photometer/Radiometer PMA2100 Detector
31 One port solar simulator LS-1000 To measure the SPF & PA value
Multiport Solar UV Simulator
32 To measure the SPF & PA value
(601-300W)
33 Ultraviolet Meter Model 3D-600 Detector
34 Sauna room system To use for SPF/PA test (sweat resistance)
35 Whirlpool massage system To use for SPF/PA test (water proof)
36 Inbody® 330 To measure the body mass

To measure body (intracellular and
37 Inbody® S10
extracellular water) water state
38 ThemaCam® T360 To measure a temperature on the skin
39 SPOT THERMOMETER® (HT-20) To measure the skin temperature

Image Analyzer
40 To analysis the image
(Image-pro® plus 5.1)
To take a picture of face under wood lamp
41 Facial stage® DM 3
and fluorescent light
Page 6 of 13

42 VISIA®
43 Janus®
44 Folliscope2.8® To evaluate the hair loss
45 Charm View® To examine the skin surface

To take a picture of the human body skin
46 AramoTS®
surface
To analyze an porphyrin and photoaging
47 ECOSKIN®
value in skin surface image
48 Glossmeter® To measure the gloss of the skin
49 Radioscan To measure the skin transparency
50 Translucency meter To measure the translucency on the skin
51 Neurometer® CPT To measure perception and pain thresholds
52 Moire topography To take a picture of the skin
53 F-ray® To take a picture of the skin
54 Vivascope® 1500 To take a picture of the melanin
55 NeoScope JCM-5000® To scan electron microscope

To visualize an cornea image in direct
56 SLIT LAMP® (SL-7F)
Installation test
57 Digital still camera DSC-S75 To take a picture of the skin
58 Digital still camera D300 To take a picture of the skin
61 Digital camera Powershot A520 To take a picture of the hair

To analyze hair length force, tension,
62 Cometech QC-508E
extension and pushing force
Trichogram system
63 To evaluate the hair loss
(Trichoscan professional ver. 2.0)
Page 7 of 13
To measure the tensile load, combing

64 Universal Testing Machine force, frictional force, stiffness and
bending(flexural) force of hair
65 Hair luster system To evaluate the hair luster ring
66 UV irradiation system To detract the hair by UVB

To evaluate the formation and
67 Hair retentivity chamber
maintenance of hair curling
68 Moisture analyzer (XM-60-HR) To measure the moisture content of hair
Environmental control unit
69 To maintain the temperature and humidity
(DKA-3U)
(BCTH-A075SU)
(HT-A3GG3)
Page 8 of 13
7. RESEARCH ACHIEVEMENT
1) 한국인과 몽골인의 주름 패턴분석. Technology 22(4):406-411. Nov. 2016.
서영경⋅김민지⋅김소정⋅백지훈⋅고재 7) Safety and Efficacy Assessment for
숙⋅양성 민⋅김종현⋅임유리⋅최성원. J. Cosmetics in Human skin. Baek JH,
Soc. Cosmet. Sci. Korea. 44(3):259- An SM, Koh JS. Fragnance Jounal of
266. 2018 Korea. Mar. 2016.
8) Itching sensation and neuronalsensitivity
2) 레스베라트릴 트라이아세테이트(RTA)
of the skin. Ham H, An SM, Lee EJ,
를 함유한 크림의 피부 노화 완화 Lee E, Kim HO, Koh JS. Skin
효과. 최고운, 정현진, 석진경, Research and Technology. 22(1):104-
백지훈, 김영미, 부용출. J. Soc. 107. Feb. 2016.
Cosmet. Sci. Korea 44(2):161-170. 9) Impact of chemical peeling combined
2018. with negative pressure on human skin.
3) Using Refectance Confocal Kim SJ, Kang IJ, Shin MK, Jeong KH,
Microscopy to Observe In Vivo Baek JH, Koh JS, Lee SJ.
Melanolysis After Treatment With the International Journal of Cosmetic
picosecond Alexandrite Laser and Q- Science 38(5):440-443. Oct. 2016.
Switched NdYAG Laser in Melasma. 10) How much related to skin wrinkles
Da Jung Jo, In-Hye Kang, Ji Hwoon between facial and body site? Age-
Baek, Min Jae Gwak, Sang Jun Lee, related changes in skin wrinkle on the
and Min Kyung Shin. Lasers in knee assessed by skin bioengineering
Surgery and Medicine 9999:1-7. 2018. technique. Yoo MA, Seo YK, Shin MK
4) Human skin-depigmenting effects of and Koh JS. Skin Research and
resveratryl triglycolate, a hybrid Technology. 22(1) 69-74. Feb. 2016.
compound of resveratrol and glycolic 11) Facial skin physiology recovery
acid. D. J. Jo, J. K. Seok, S. Y. Kim, W. kinetics during 180 min post-washing
Park, J. H. Baek, Y. M. Kim and Y. C. with a cleanser. Eo J, Seo YK, Baek
Boo. International Journal of JH, Choi AR, Shin MK and Koh JS.
Cosmetic Science, 40, 256–262. 2018 Skin Research and Technology. 22(2)
5) 3‑Bromo‑5‑(ethoxymethyl)‑1,2‑benz 148–151. May 2016.
enediol inhibits LPS-induced pro- 12) Analysis of comedone, sebum and
inflammatory responses by preventing porphyrin on the face and body for
ROS production and downregulating comedogenicity assay. Baek JH, An
NF-κB in vitro and in a zebrafish SM, Choi KM, Jung MK, Shin MK,
model. Eun-Yi Ko, Soo-Jin Heo, Su- Koh JS. Skin Research and Technology.
Hyeon Cho, WonWoo Lee, Seo-Young 22(2):164-169. May 2016.
Kim, Hye-Won Yang, Ginnae Ahn, 13) A proposal of a standardized protocol
Seon-Heui Cha, Seung-Hae Kwon, to evaluate waterproof effect of
Myeong Seon Jeong, Kang Pa Lee, eyeliner and mascara. Kim MJ, Seo
You-Jin Jeon, Kil-Nam Kim. YK, Boo YC, Koh JS. International
InternationalImmunopharmacology.20 Journal of Cosmetic Science.
18. 38(3):266-271. Jun. 2016.
6) Twelve-point scale grading system of 14) The effect of physically applied alpha
scanning electron microscopic hydroxyl acids on the skin pore and
examination to investigate subtle comedone. Kim SJ, Baek JH, Koh JS,
changes in damaged hair surface. Lee Bae MI, Lee SJ and Shin MK.
SY, Choi AR, Baek JH, Kim HO, Shin International Journal of Cosmetic
MK, Koh JS. Skin Research and Science. 37(5): 519–525, Oct. 2015.
Page 9 of 13
15) The Atopic Dermatitis Antecubital 23) A validation study to find highly
Severity score: validity, reliability, and correlated parameters with visual
sensitivity to change in patients with assessment for clinical evaluation of
atopic dermatitis. Baek JH, Park CW, cosmetic anti-cellulite products. Yoo
Choi KM, Yang YS, Lee SY, Koh JS, MA, Seo YK, Ryu JH, Back JH, Koh
Chung BY, Kim HO, Park GH. JS. Skin Research and Technology.
International Journal of Dermatology. 20(2):200-207. May 2014.
54(12):1382-1389. Dec. 2015. 24) A quantitative evaluation method of
16) Dermal matrix affects translucency of skin texture affected by skin ageing
incident light on the skin. Kim HJ, using replica images of the cheek. Ryu
Baek JH, Eo JE, Choi KM, Shin MK, JH, Seo YK, Boo YC, Chang MY,
Koh JS. Skin Research and Technology. Kwak TJ, Koh JS. International
21(1):41-46. Feb. 2015. Journal of Cosmetic Science.
17) A study of the human skin-whitening 36(3):247-252. Jun. 2014.
effects of resveratryl triacetate. Ryu JH, 25) Investigation of the Study Plan and
Seok JK, An SM, Baek JH, Koh JS, Statistical Method of Functional
Boo YC. Archives of Dermatological Cosmetics on Human Skin. Seo YK,
Research. 307(3):239-247. Apr. 2015. Koh JS. Lee WC. Journal of the
18) The quantitative analysis of Society of Cosmetic Scientists of Korea.
spreadability, coverage, and adhesion 39(2):105-115. Jun. 2013.
effect after application of the base 26) Acute Modulations in Stratum
make-up product. Lee SY, Baek JH, Corneum Permeability Barrier
Shin MK, Koh JS. Skin Research and Function Affect Claudin Expression
Technology. 20(3):341-346. Aug. 2014. and Epidermal Tight Junction Function
19) Screening for anti-inflammatory via Changes of Epidermal Calcium
activities in extracts from Korean herb Gradient. Baek JH, Lee SE, Choi KJ,
medicines. An SM, Kim HG, Choi EJ, Choi EH, Lee SH. Yonsei Medical
Hwang HH, Lee E, Baek JH, Boo YC, Journal. 1;54(2):523-528. Mar. 2013.
Koh JS. Journal of the Society of 27) Reduction of facial wrinkles depth by
Cosmetic Scientists of Korea. sleeping on copper oxide-containing
40(1):95-108 Mar. 2014. pillowcases: a double blind, placebo
20) Primary irritation index and safety controlled, parallel, randomized. Baek
zone of cosmetics: retrospective JH, Yoo MA, Koh JS, Borkow G.
analysis of skin patch tests in 7440 Journal of Cosmetic Dermatology.
Korean women during 12 years. An 11(3):193-200. Sep. 2012.
SM, Ham H, Choi EJ, Shin MK, An 28) Instrumental Assessments of Sub-
SS, Kim HO and Koh JS. clinical Skin Reactions induced by
International Journal of Cosmetic Cosmetic Ingredients. An SM, Lee MY,
Science. 36(1): 62-67. Feb. 2014. Baek JH, Ham H, Boo YC, Koh JS.
21) Pore volume is most highly correlated Journal of the Society of Cosmetic
with the visual assessment of skin Scientists of Korea. 38(1):43-50. Mar.
pores. Kim SJ, Shin MK, Back JH, 2012.
Koh JS. Skin Research and Technology. 29) Cosmetic efficacy evaluation of an
20(4):429-434. Nov. 2014. anti-acne cream using the 3D image
22) Bioengineering methods and analysis system. Choi KM, Kim SJ,
instrumentation of the skin color. Baek Baek JH, Kang SJ, Boo YC, Koh JS.
JH, Shin MK, Koh JS. Korean Journal Skin Research and Technology.
of Cosmetic Dermatology. 11:9-13. 18(2):192-198. Sep. 2012.
Jun. 2014.
Page 10 of 13
30) Assessment of the Breast-Firmming melanocytes. Sang Mi An, Jae-Sook

Effects of a Cosmetic Preparation with Koh & Yong Chool Boo, BMB reports,
Moiré Tophography in Combination 2008
with 2D and 3D Digital Image 38) Comparision between ultrasonography
Analyses. Seo YK, Yoo MA, Ryu JH, (Dermascan C version 3) and
Kim SJ, Cho SA, Nam GW, Cho JC, transparency profilometry (Skin
Boo YC, Koh JS. Journal of the Visiometer SV600). Lee HK, Seo YK,
Society of Cosmetic Scientists of Korea. Baek JH, Koh JS. Skin Research and
38(4):289-296. Dec. 2012. Technology. 14(1):8-12. Feb. 2008.
31) Complementary and Alternative 39) Electrical assessments of skin
Medicine - Botanical Cosmeceuticals. moisturization. Baek JH, Koh JS.
Chapter 2. Safety testing of cosmetics. Korean Journal of Aesthetics and
Koh JS. Transworld Research Network. Cosmetics. 4(1):147-154. 2006.
23-47. 2011. 40) Correlation between skin roughness
32) Relationship between clinical features and dermal density of skin wrinkle
of facial dry skin and biophysical evaluation. Lee HK, Baek JH, Koh JS,
parameters in Asians. Baek JH, Lee Park DH, Lee JS, Jung ES. Journal of
MY, Koh JS. International Journal of the Society of Cosmetic Scientists of
Cosmetic Science. 33(3):222-227. Jun. Korea. 32(2):123-127. Jun. 2006.
2011. 41) Safety evaluation of cosmetics on
33) Effects of a new mild shampoo for human. Koh JS. Korean Journal of
preventing hair loss in Asian by a Cosmetic Dermatology. 2(1):56-66.
simple hand-held phototrichogram 2005.
technique. Baek JH, Lee SY, Yoo M, 42) Evaluation of age-dependent crow's
Park WS, Lee SJ, Boo YC, Koh JS. feet in korean women. Lee MY, Kim
International Journal of Cosmetic EJ, Lee HK, Seo YK, Lee MS, Koh JS.
Science. 33(6):491-496. Dec. 2011. Journal of the Society of Cosmetic
34) p-Coumaric acid not only inhibits Scientists of Korea. 30(1):85-91. May
human tyrosinase activity in vitro but 2004.
also melanogenesis in cells exposed to 43) Wrinkle reduction using a topical
UVB . Sang Mi An, Jae-Sook Koh, herbal cream in subjects with greater
Yong Chool Boo. Phytother. Res. 24: yin (Tae- eumin) type: A randomized
1175–1180. 2010 double-blind placebo-controlled study.
35) Effects of plant extract-containing A-Rang Im, Jiho Nam, Seongwon Cha,
creams on UVB radiation-induced Young Kyoung Seo, Sungwook Chae,
inflammatory responses in mice. An Jong Yeol Kim. European Journal of
SM, Lee SJ, Koh J-S, Park KM, Boo Integrative Medicine 20. 173-181.
YC. Journal of the Society of Cosmetic 2018.
Scientists of Korea. 36(4):271-280. 44) Wrinkle Pattern in Korean and
2010. Mongolian Wamen Population. 서영경,
36) Effects of p-coumaric acid on 김민지, 김소정, 백지훈, 고재숙,
erythema and pigmentation of human 양성민, 김종현, 임유리, 최성원. J.
skin exposed to ultraviolet radiation. Soc. Cosmet. Sci. Korea. 2018.
Seo YK, Kim SJ, Boo YC, Baek JH, 45) Two-phase dilivery using a horse oil
Lee SH, Koh JS. Clinical and and adenosine-loaded dissolving
Experimental Dermatology. 36(3):260- microneedle patch for skin barrier
266. Apr. 2011. restoration moisturization and wrinkle
37) Inhibition of melanogenesis by improvement. Huisuk Yang, Suyong
tyrosinase siRNA in human Kim, Mingyu Jang, Hyeonjun Kim,
Page 11 of 13
Seunghee Lee, Youseong Kim, placebo-controlled clinical Study. Lee

Younghyon Andrew Eom, Geonwoo C, Yang H, Kim S, Kim M, Kang H,
Kang, Liching Chiang, Ji Hwoon Baek, Kim N, An S, Koh J, Jung H.
Ja Hyun Ryu,Ye Eun Lee, Jaesuk Koh, International Journal of Cosmetic
Hyungil Jung. J Cosmet Dermatol.;1– Science. 38(4):375-81. Aug. 2016.
8.2018. 52) 4-n-butylresorcinol dissolving
46) Diagnostic utility of skin microneedle patch for skin
autofluorescence when patch test depigmentation: a randomized,
results are doubtful. E.-J. Shin, J.-K. double-blind, placebo-controlled trial.
Seo, E. J. Lee, E. S. Lee, M. K. Shin. Kim S, Yang H, Kim M, Baek JH,
Skin Res Technol.;1–4. 2018. Kim SJ, An SM, Koh JS, Seo R, Jung
47) Combinatorial application of H. Journal of Cosmetic Dermatology.
dissolving microneedle patch and 15(1):16-23. Mar. 2016.
cream for improvement of skin 53) The seasonal variation in skin
wrinkles, dermal density, elasticity, hydration, sebum, scaliness, brightness
and hydration. Geonwoo Kang, and elasticity in Korean females. G. W.
Suyong Kim, Huisuk Yang, Mingyu Nam, J. H. Baek, J. S. Koh and J.-K.
Jang, Liching Chiang, Ji Hwoon Baek, Hwang. Skin Research and
Ja Hyun Ryu, Go Woon Choi, Hyungil Technology. 2015.
Jung. J Cosmet Dermatol.;1–9. 2018. 54) Identification of a possible
48) Adenosine-loaded dissolving microneedle susceptibility locus for UVB-induced
patches to improve skin wrinkles, skin tanning phenotype in Korean
dermal density, elasticity and females using genomewide association
hydration. G. Kang, T.N.T.Tu, S. Kim, study. Kwak TJ, Chang YH, Shin YA,
H. Yang. M. Jang, D. Jo, J. Ryu, J. Shin JM, Kim JH, Lim SK, Lee SH,
Baek and H. Jung. International Lee MG, Yoon TJ, Kim CD, Lee JH,
Journal of Cosmetic Science, 40, 199– Koh JS, Seo YK, Chang MY, Lee Y.
206. 2018. Experimental Dermatology.
49) Enhanced Transdermal Delivery by 24(12):942-6. Dec. 2015.
Combined Application of Dissolving 55) Clinical evidence of effects of
Microneedle Patch on Serum-Treated Lactobacillus plantarum HY7714 on
Skin. Suyong Kim, Manita Dangol, skin aging: a randomized, double blind,
Geonwoo Kang, Shayan F. Lahiji, placebo-controlled study. Lee DE,
Huisuk Yang, Mingyu Jang, Yonghao Huh CS, Ra J, Choi ID, Jeong JW,
Ma, Chengguo Li, Sang Gon Lee, Kim SH, Ryu JH, Seo YK, Koh JS,
Chang Hyun Kim, Young Wook Choi, Lee JH, Sim JH, Ahn YT. Journal of
So Jeong Kim, Ja Hyun Ryu, Ji Microbiology and Biotechnology.
Hwoon Baek, Jaesuk Koh, and 28;25(12):2160-8. Dec. 2015.
Hyungil Jung. pubs.acs.org/ 56) Inhibitory effect of corn silk on skin
molecularpharmaceutics. 2017. pigmentation. Choi SY, Lee YM, Kim
50) Scutellaria radix Extract as a Natural SS, Ju HM, Baek JH, Park CS and Lee
UV Protectant for Human Skin. Seok DK. Molecules. 19(3), 2808-2818.
JK, Kwak JY, Choi GW, An SM, Mar. 2014.
Kwak JH, Seo HH, Suh HJ, Boo YC. 57) Effects of resveratrol, oxyresveratrol,
Phytotherapy Research. 30(3):374-9. and their acetylated derivatives on
Mar. 2016. cellular melanogenesis. Park J, Park
51) Evaluation of the anti-wrinkle effect of JH, Suh HJ, Lee IC, Koh J, Boo YC.
an ascorbic acid-loaded dissolving Archives of Dermatological Research.
microneedle patch via a double-blind, 306(5):475-87. Jul 2014.
Page 12 of 13
58) Protective effects of skin permeable the screening of anti-melanogenic

epidermal and fibroblast growth factor agents. Kim M, An SM, Koh JS, Jang
against ultraviolet-induced skin DI, Boo YC. Journal of cosmetic
damage and human skin wrinkles. An science. 62(5):515-23. Sep-Oct. 2011.
JJ, Eum WS, Kwon HS, Koh JS, Lee 65) Retinyl retinoate, a novel hybrid
SY, Baek JH, Cho YJ, Kim DW, Han vitamin derivative, improves
KH, Park J, Jang SH, Choi SY. photoaged skin: a double-blind,
Journal of Cosmetic Dermatology. randomized-controlled trial. Kim H,
12(4):287-95. Dec. 2013. Koh J, Baek J, Seo Y, Kim B, Kim J,
59) Characterization of Microthermal Lee J, Ryoo H, Jung H. Skin Research
Zones Induced by Fractional and technology. 17(3):380-385. Aug.
Radiofrequency Using Reflectance 2011.
Confocal Microscopy A Preliminary 66) Comparison of the antimelanogenic
Study. Min Kyung Shin, MD, PhD, effects of p-coumaric acid and its
Jong Min Park, MD, PhD, Hee methyl ester and their skin
Kyeong Lim, MD, Jeong Hwee Choi, permeabilities. Kyosun Song, Sang Mi
MD,, Ji Hwoon Baek, PhD, Han Jo An, Mijin K, Jae-Sook Koh, Yong
Kim, PhD, Jae Sook Koh, PhD, and Chool Boo. Journal of Dermatological
Mu-Hyoung Lee, MD, PhD. Lasers in Science 63. 17–22. 2011.
Surgery and Medicine. 45:503–508 . 67) Quercus glauca extract and rutin
2013. inhibit the UVB-induced expression of
60) Characteristic features of aging in matrix metalloproteinase-1 in human
Korean women's hair and scalp. Kim dermal fibroblasts. Lee SJ, Koh JS, Ha
SN, Lee SY, Choi MH, Joo KM, Kim BJ, Boo YC. Journal of the Korean
SH, Koh JS, Park WS. The British Society for Applied Biological
Journal of Dermatology. 168(6):1215- Chemistry. 53(6):677-684. 2010.
23. Jun. 2013. 68) Inhibitory Effects of Neo Muscat
61) Analysis of the temporal change in Grape Vine Extracts on Melanin
biophysical parameters after fractional Biosynthesis. Choi SY, Kong YH, Lee
laser treatments using reflectance Y, Baek JH, Lee SH, Lee P. Journal of
confocal microscopy. Min-Kyung Shin, Applied Biological Chemistry.
Min-Joong Kim, Ji-Hwoon Baek, Mi- 53(5):566-569. 2010.
Ae Yoo, Jae-Sook Koh, Sang-Jun, Lee 69) Acanthopanax koreanum Fruit Waste
and Mu-Hyoung Lee. Skin Research Inhibits Lipopolysaccharide-Induced
and Technology.19: e515–e520. 2013. Production of Nitric Oxide and
62) Screening of plant extracts for human Prostaglandin E2 in
tyrosinase inhibiting effects. Kim M, RAW264.7Macrophages. Yang EJ,
Park J, Song K, Kim HG, Koh JS, Boo Moon JY, Lee JS, Koh JS, Lee NH,
YC. International Journal of Cosmetic Hyun CG. Journal of Biomedicine and
Science. 34(2):202-8. Apr. 2012. Biotechnology. doi:
63) Evaluation of the clinical efficacy of 10.1155/2010/715739. Mar. 2010.
fractional radiofrequency microneedle 70) Oenothera laciniata inhibits
treatment in acne scars and large facial lipopolysaccharide induced production
pores. Cho SI, Chung BY, Choi MG, of nitric oxide, prostaglandin E2, and
Baek JH, Cho HJ, Park CW, Lee CH, proinflammatory cytokines in
Kim HO. Dermatologic Surgery. 38(7 RAW264.7 macrophages. Yoon WJ,
Pt 1):1017-1024. Jul. 2012. Ham YM, Yoo BS, Moon JY, Koh JS,
64) Use of non-melanocytic HEK293 cells Hyun CG. Journal of Bioscience and
stably expressing human tyrosinase for
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Bioengineering. 107( 4), 429-438, 75) Preliminary screening of some jeju

2009. island native plants for whitening and
71) Evaluation of the effects of a antioxidant activity. Moon JY, Kim JH,
preparation containing asiaticoside on Hyun JW, Kang KG, Koh JS, Seo YK,
periocular wrinkles of human Baek JH, Park DH, Lee JS, Jung ES,
volunteers. Lee J, Jung E, Lee H, Seo Yoo BS. Journal of the Society of
Y, Koh J, Park D. International Cosmetic Scientists of Korea.
Journal of Cosmetic Science. 30, 167- 32(3):161-171. Sep. 2006.
173. Feb. 2008. 76) Herbal extracts as a NF-kappa B. Lee
72) Evaluating the nickel content in metal JS, Jung ES, Hyun CG, Lee JY, Koh
alloys and the threshold for nickel- JS, Lee HK, Baek JH, Yoo BS, Moon
induced allergic contact dermatitis. JY, Kim JH and Park DH. Journal of
Yoon Young Kim, Mi-Yeon Kim, the Society of Cosmetic Scientists of
Young Min Park, Hyung Ok Kim, Jae Korea. 32(3):135-140. 2006.
Sook Koh, and Hae Kwang Lee. J 77) Physiological effects of Jaeum-Dan
Korean Med Sci 23: 315-9. 2008. essence on human skin. Park SK, Nam
73) Effect of Camellia japonica oil on GW, Lee HK, Bae JH, Kim JH, Kim
human type I procollagen production YJ, Koh JS, Kang SJ, Moon SJ, Chang
and skin barrier function. Jung E, Lee IS. Korean Journal of Oriental
J, Baek J, Jung K, Lee J, Huh S, Koh J, Physiology and Pathology. 18(3):729-
Park D. Journal of ethnophamacology. 733. 2004.
112(1):127-131. May, 2007. 78) Effects of oriental herbs on human
74) The measurement of SPF in water- skin with non-invasive methods. Park
resistant sunscreen. Yoon TJ, Park SY, SK, Nam GW, Lee HK, Ahn SY, Kim
Koh JS. Korean journal of EJ, Lee SI, Kim YJ, Koh JS, Moon SJ,
inbestigative dermatology 13(4):105- Chang IS. The Korean Journal of
110. 2006. Herbology. 19(3):91-97. 2004.

【Final Report】 Whitening DEF-HSLIT004 (4) -18077

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CLINICAL EFFICACY TEST REPORT

A CLINICAL STUDY OF SKIN

March 14, 2019

DM-QW-702 DERMAPRO Ltd.

DM-QW-702 DERMAPRO Ltd.

Report Date March 14, 2019

Authentication DERMAPRO Ltd. was validated by receiving a “QUALITY MANAGEMENT

Result 1. Analysis of skin color grade

DM-QW-702 DERMAPRO Ltd.

5. Analysis of reflectance index of melanin

DM-QW-702 DERMAPRO Ltd.

Monitor: Chie Ino

Investigator: Min kyung Jeong

3. CLINICAL RESEARCH STANDARD

Start Date: October 22, 2018

5.1. Principle of recruitment

The study inclusion and exclusion criteria are as follows:

5.2. Inclusion criteria

DM-QW-702 DERMAPRO Ltd.

study are explained to subjects.

5.3. Exclusion criteria

5.4. Prohibition and restriction

DM-QW-702 DERMAPRO Ltd.

5.5. Subject withdrawal

6.1. Product information

6.2. Application method

7.1. Environmental condition

DM-QW-702 DERMAPRO Ltd.

7.2. Assessment of skin color

Bright & Clear

Figure.1 Criteria for visual assessment of hyper-pigmented region

7.3. Measurement of melanin index

DM-QW-702 DERMAPRO Ltd.

7.4. Measurement of skin lightness and color

[Arc Tangent ((L* - 50)/ b*)] 180 / 3.14159

7.5. Measurement of reflectance index of melanin

DM-QW-702 DERMAPRO Ltd.

pigmented region by Image-pro® plus (MediaCybernetics, USA) at baseline, 2, 4 and 8

Figure 2. Analyzed image of reflectance index of melanin by Image-pro® plus

7.7. Assessment of self-questionnaires

7.8. Safety evaluation

DM-QW-702 DERMAPRO Ltd.

7.9. Statistical analysis

DM-QW-702 DERMAPRO Ltd.

8.1. Information of subjects

Table 1. Information of subjects (n=24)

Skin type Oily 1 4.17

Dry and oily 3 12.50

III type 20 83.33

Hydration Normal 15 62.50

Sebum Normal 17 70.83

Surface Normal 19 79.17

Thickness Normal 17 70.83

Less than 1 hr 6 25.00

DM-QW-702 DERMAPRO Ltd.

Less than 5 hrs 1 4.17

Sleeping hours 5-8 hrs 14 58.33

More than 8 hrs 9 37.50

Smoking Less than 10 pieces 0 0.00

More than 10 pieces 0 0.00

8.2. Analysis of skin color grade

Table 2. Statistical analysis of skin color by visual assessment

2 weeks 24 4.18 1.16 0.162 0.48▼