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FINAL REPORT

CLINICAL EVALUATION OF THE EFFICACY


OF A COSMETIC PRODUCT
STUDY UNDER DERMATOLOGICAL CONTROL

Report (version 1): DA16A042, April 22, 2016

Price proposal: DA16A042

Product(s): Acnoc Acneser Spot Gel

Form(s) and application zone: Light brown gel

Face

Sponsor: Quality Plus Aesthetic International Co., Ltd.


179/20 Na Wong Pracha Phatthana Rd,
Si Kan, Don Mueang,
Bangkok 10210
THAILAND

Investigation site: Dermscan Asia Co., Ltd.


th
3300/46-47 29 Flr., Tower A
Elephant Tower, Phaholyothin Rd.,
Chomphon, Chatujak,
Bangkok,10900
THAILAND

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TABLE OF CONTENTS

QUALITY CONTROL STATEMENT ...................................................................................................4

SUMMARY OF THE STUDY REPORT #DA16A042 .........................................................................5

1. AIMS ............................................................................................................................................7

1.1. Primary objective .............................................................................................................7

1.2. Secondary objective ........................................................................................................7

2. METHODS ...................................................................................................................................7

2.1. Trial period........................................................................................................................7

2.2. Study design .....................................................................................................................7

2.3. Assessment criteria .........................................................................................................7


2.3.1. Primary criteria ...................................................................................................................7
2.3.2. Secondary criteria ..............................................................................................................7
2.3.3. Principles and measurement instruments ..........................................................................8

2.4. Subject selection............................................................................................................11


2.4.1. Number of subjects ..........................................................................................................11
2.4.2. Inclusion criteria ...............................................................................................................11
2.4.3. Exclusion criteria ..............................................................................................................11
2.4.4. Compliance assessment ..................................................................................................12
2.4.5. Associated treatment during the study ............................................................................12

2.5. Operational aspect .........................................................................................................12


2.5.1. Trial schedule ...................................................................................................................12
2.5.2. Study flow chart................................................................................................................13
2.5.3. Adverse Events/Serious Adverse Events ........................................................................13
2.5.4. Premature termination of the study ..................................................................................15
2.5.5. Collection and validation of data ......................................................................................15
2.5.6. Audit and trial monitoring visit ..........................................................................................15
2.5.7. Quality management ........................................................................................................15

2.6. Studied product..............................................................................................................16


2.6.1. Studied product description .............................................................................................16
2.6.2. Labelling ...........................................................................................................................16
2.6.3. Product(s) issue ...............................................................................................................16
2.6.4. Product(s) future ..............................................................................................................16

2.7. Method of product attribution to the subjects ............................................................17


2.7.1. Randomization method for the application zones ............................................................17
2.7.2. Product attribution ............................................................................................................17

2.8. Data analysis ..................................................................................................................17


2.8.1. Calculation formulas ........................................................................................................17
2.8.2. Statistical method .............................................................................................................17
2.8.3. Statistical software ...........................................................................................................18

2.9. ARCHIVING .....................................................................................................................18

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3. TEST FOLLOW-UP ...................................................................................................................19

3.1. Population .......................................................................................................................19

3.2. Protocol non-adherences ..............................................................................................19

3.3. Audit / Trial monitoring visit .........................................................................................19

4. SUBJECT CHARACTERISTICS ...............................................................................................20

4.1. Demographic data ..........................................................................................................20

4.2. Concomitant treatments ................................................................................................20

5. RESULTS...................................................................................................................................21

5.1. Anti-acne effect ..............................................................................................................21

5.2. Whitening and depigmenting/anti-blotch effects .......................................................22


5.2.1. Whitening/lightening effect ...............................................................................................22
5.2.2. Depigmenting/Anti-blotch effect .......................................................................................23

5.3. Cutaneous tolerance .....................................................................................................24

5.4. Subjective evaluation questionnaire ...........................................................................25

6. CONCLUSION AND SIGNATURE(S) .......................................................................................27

7. CERTIFICATION .......................................................................................................................30

8. BIBLIOGRAPHY ........................................................................................................................31

8.1. Regulatory ......................................................................................................................31

8.2. Data analysis ..................................................................................................................31

8.3. Anti-acne /Comedogenic potential ...............................................................................31

8.4. Evaluation of skin color ................................................................................................31

8.5. Cutaneous tolerance .....................................................................................................32

9. APPENDIX .................................................................................................................................33

9.1. Daily log ..........................................................................................................................33

9.2. Results of acne lesions .................................................................................................34


9.2.1. Individual results ..............................................................................................................34
9.2.2. Statistical analysis ............................................................................................................35

9.3. Individual results of measurement of color skin ........................................................36


9.3.1. Individual results of color skin on normal skin (without blotch/acne mark) ......................36
9.3.2. Individual results of color skin on acne mark ...................................................................39

9.4. Subjective evaluation questionnaire ...........................................................................42

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QUALITY CONTROL STATEMENT

Clinical study number : DA16A042

Study start date : February 12, 2016

Study completion date : March 16, 2016

The study listed above was conducted in conformance with Good Clinical
Practice (GCP-ICH) and DERMSCAN ASIA standard operating procedures. The study has
been conduct according to the study protocol defined with the sponsor. All the case report
forms and the data were checked.

The Quality inspection Auditor testifies to the respect of the rules, the standards
and procedures listed above.

Last name :

First name :

Date :

Signature :

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SUMMARY OF THE STUDY REPORT #DA16A042

Sponsor: Quality Plus Aesthetic Investigator: Dermscan Asia Co., Ltd.


International Co., Ltd.

Address: Address:
th
179/20 Na Wong Pracha Phatthana Rd, 3300/46-47 29 Flr., Tower A
Si Kan, Don Mueang, Elephant Tower, Phaholyothin Rd.,
Bangkok 10210 Chomphon, Chatujak, Bangkok,10900
THAILAND THAILAND
CLINICAL EVALUATION OF THE EFFICACY OF A COSMETIC PRODUCT
Study Title
STUDY UNDER DERMATOLOGICAL CONTROL
Reference: Type:
Product(s)
Acnoc Acneser Spot Gel Light brown gel

Study date(s) From January 12, 2016 to March 16, 2016


- To evaluate the anti-acne effect of a cosmetic product.
- To evaluate its lightening and depigmenting effects.
Objective(s)
- To evaluate its cutaneous tolerance.
- To subjectively evaluate its properties, its efficacy, its tolerance and its future use.
Experimental
- Open and intra-individual study.
plan

- Anti-acne effect (counting of acne Kinetics D0-D28


lesions by the dermatologist),
Methodology Before / After
- Measurements of skin color (MINOLTA
CM700-d Spectrophotometer )
Zone Face
Assessment
Criteria - Cutaneous tolerance (clinical
examination and collection of signs Application Twice -daily
reported by the subject), frequency (morning and night)
- Subjective evaluation (questionnaire)

Number of analysed subjects: 23 subjects.

Age: 28 1 (average SEM) 19 to 40 years old.


Studied Main inclusion criteria:
population Sex: Asian female or male.
Age: between 18 and 40 years old.
Subject present at least 5 inflammatory acne lesions and 10 retentional acne
lesions.
Subject present at least 1 acne mark.

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Under these study conditions, after 28 days of use the product "Acnoc Acneser
Spot Gel":

is considered as anti-acne effect,

whitening and depigmenting/anti-blotch effects:

presents a significant whitening effect, characterized by:


a significant increase in L* parameter, on the normal skin (without
spot), of +1% on average (p<0.001). This effect is observed in 82% of
the subjects;
a significant increase in ITA parameter, on the normal skin (without
spot), of +4% on average (p=0.002). A whitening effect is observed in
Results - 55% of the subjects.
Conclusion
presents a significant depigmenting/anti-blotch effect, characterized by:
a significant increase in L* parameter, on spot, of +3% on average
(p<0.001). This effect is observed in 100% of the subjects;
a significant increase in ITA parameter, on spot, of +37%on average
(p<0.001). A depigmenting/anti-blotch effect is observed r in 91% of the
subjects;

is very well-tolerated on the cutaneous level,

is appreciated by the majority of the subjects for its properties, its efficacy
during the application. 78% of the subjects would like to continue its use,
70% of the subjects might buy it regardless of its price and 83% of the
subjects would recommend it to a friend.
Investigator:
Date Signature
Dr. Napakul ROTJANASUPAK
(Dermatologist)

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The study was conducted under the following conditions.

1. AIMS

1.1. Primary objective

The primary objectives of this study are to evaluate, after 28 days of twice-daily use of product
Acnoc Acneser Spot Gel:

its anti-acne effect


its lightening and depigmenting effect.

1.2. Secondary objective


The secondary objectives of this study are to evaluate, for the studied product:

its cutaneous tolerance,


the subjective appreciation of its properties, of its efficacy, of its tolerance and its future use.

2. METHODS

2.1. Trial period

Product reception January 7, 2016


Beginning of the test February 12, 2016
End of the test March 16, 2016

2.2. Study design

This is an open, intra-individual study; each subject is her/his own control.

2.3. Assessment criteria

2.3.1. Primary criteria


Evaluation of the anti-acne effect by the counting of acne lesions by the dermatologist in charge of
the study.
Evaluation of the lightening and depigmenting effect of the studied product by skin color

measurements using MINOLTA CM700-d Spectrophotometer .

2.3.2. Secondary criteria


Evaluation of the cutaneous tolerance by clinical examination by the dermatologist.
Analysis of the subjects' answers to a subjective evaluation questionnaire.

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2.3.3. Principles and measurement instruments

2.3.3.1. Anti-acne effect

The comedogenic potential is assessed after 28 days of use, in comparison with the number of lesions
on the face before use (D0).
On D0 and D28, the dermatologist counts blackheads and microcysts (retentional lesions) as well as
papules and pustules (inflammatory lesions) on the whole face (except nasal pyramid, the vermillion
border, the crease of the chin and the rim of the scalp).

The variations (D28-D0) in the number of lesions are calculated for each kind of lesions. Descriptive
statistics are done on purpose to determine the variation significance.

The product is considered anti-acne if it induced a significant decrease in the number of


retentional lesions or/and inflammatory lesions.

2.3.3.2. Lightening and depigmenting/anti-blotch effects


Skin colorimetric measurements are done with a MINOLTA CM700-d Spectrophotometer , equipped
with a 3 mm diameter head.

The Spectrophotometer converts colors perceived by man to a digital code composed of three
parameters:

L*: for clarity (from dark to light),


a*: for the green-to-red spectrum,
b*: for the blue-to-yellow spectrum.

a* and b* are chrominance parameters and L* is a luminance parameter.

It is therefore possible to express in the slightest details the differences between two cutaneous zones
that appear to be the same color. After a calibration phase, measurements are done directly on the
skin using a pulsed Xenon light source and a dual beam system designed to measure the light
transmitted and to correct any slight deviation.

This instrument is commonly used in cosmetics and medicine to measure skin color.

The parameters L* (luminance) and b* (cutaneous melanin yellow color) are studied during a
whitening product study.

Both parameters are exploited through the calculation of the Individual Typological Angle, which
defines the skin pigmentation degree of a subject according to the following formula:

ITA = Arc tan((L*-50)/b*) x 180 /

The higher the ITA is, the lighter the skin is.

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Representation of Individual Typological Angles


Different categories of skin pigmentation are defined by dividing the projection of the
L* and b* parameters in areas limited by the categories of the angles

L* parameter
80
78
76 55
74
very light
72
70 41
light
68
66
64
28
62 medium
60
58
dark
56 (dark)
10
54
52 ITA
very dark
50
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28
b* parameter

Representation of Minolta measurement principle


Light

color
space
L*a*b*
L* luminance
+ b*
yellow

- a* + a*
green red

- b*
blue

Dark

Color is a sensation, a sensory impression transmitted by the eye. In order to perceive color, one
needs light, an object and eyes. The combination of these three elements produces a stimulus that the
brain transforms into a color sensation. This is what can pose problems when visually evaluating
colors.

As opposed to a subjective and sometimes uncertain evaluation of color by eye, instrumental


colorimetry precisely defines as well as objectively measures and controls colors by quantitative

parameters. Easy to use, manageable and perfectly controlled, CM700-d Spectrophotometer
provides precise, stable, reproducible, immediate and objective color measurements. It uses the
L*a*b* color space to bring closer measured color intervals to color intervals that are perceived by the
human eye.

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2.3.3.3. Cutaneous tolerance

Before and after product use, the subjects face is examined by the dermatologist who assesses each
of the following parameters:

none very mild mild moderate severe


Erythema
Edema
Dryness
Desquamation
Roughness
Others:
Please define:.....................................................................................

On D0, the subjects are also asked about their usual sensations:

none very mild mild moderate severe


Tightness
Stinging
Itching
Warm, burning
sensation
Others:
Please define:.....................................................................................

On D28, the cutaneous tolerance of the product is assessed by a clinical examination conducted
under dermatological control.
This evaluation takes into account the relevant elements reported by the subject (functional and
physical signs) as well as those noted during the examination (clinical signs). The confrontation of
these signs is used to conclude the final tolerance of the studied product.

The cutaneous tolerance of the studied product is defined as the least favourable result.

The relevance of a sign is defined as follows:


- sign lasting more than five minutes and,
- not clearly attributable, likely or very likely imputable with the studied product and,
- length of time superior or equal to a quarter of the total duration of the study.

This leads to the exclusion of null or unlikely signs of imputability as well as signs that last only a few
days during the study (notably at the beginning of the study).
All signs of not clearly attributable, likely or very likely imputable that appear during the final days of
the study are retained, providing there is no ulterior follow-up.

2.3.3.4. Subjective evaluation questionnaire

A subjective evaluation questionnaire, prepared by the clinical trial center and approved by the
sponsor, is filled by the subjects at the end of the study to subjectively evaluate the properties of the
studied product, its global efficacy, its tolerance and its future use.

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2.4. Subject selection

2.4.1. Number of subjects

The study is done on 20 subjects minimum, at sponsor request.

2.4.2. Inclusion criteria

General criteria
Healthy subjects
Subject having given her informed, written consent
Cooperative subject, aware of the necessity and duration of controls so that compliance with the
protocol established by the clinical trial center could be expected

Specific criteria
Sex: Asian female or male
Age: between 18 and 40 years old.
Subject present at least 5 inflammatory acne lesions and 10 retentional acne lesions.
Subject present at least 1 acne mark.

2.4.3. Exclusion criteria

Pregnant or nursing woman or woman planning to get pregnant during the study
Subject having a known allergy to cosmetic or dermopharmaceutical products.
Cutaneous pathology on the test zone(s) other than acne (eczema, etc).
Woman having changed, having begun or having stopped its oral contraceptive or any hormonal
treatment begun or modified since less than 3 months.

,
Taking of Diane 35 Jasmine , Holgyme , Minerval , Tricilest , Belara , Triafmi < 6 months
(unstable treatment).


Taking of Androcur .
Any topical acne treatment (AHA type ) <1 month and for the duration of the study.
Any systemic acne treatment <3 month and for the duration of the study.
Taking of retinoids < 6 months and for the duration of the study.
Use of topical or systemic treatment susceptible to interfere with the evaluation of the tolerance in
the month which precedent the study and for the duration of the study:
- any antihistamines and/or anti-inflammatories < 1 week,
- anti-cough and/or corticoids < 4 weeks,
- immune suppressives < 6 months.
Subject having touched, pricked or scratched his/her elements before the beginning of the study
and for the duration of the study.
Professional facial care within the previous month and for the duration of the study.
Use scrub product, peeling or mask on the face during the study.
Excessive exposure to sunlight or UV-rays within the previous month and during the study.
Subject having had a surgery with general anesthesia the month before the beginning of the study.
Subject enrolled in another clinical trial during the study period.
Subject who has been deemed by the screener as potentially unable or unwilling to comply with the
protocol.

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2.4.4. Compliance assessment

If the protocol is not respected and if the deviation is minor, the technician or the investigator in charge
of the study warns the subject of the importance of respecting the instructions. If the subject persists or
if the deviation is major, the subject is declared non-compliant. In this case, the subject is removed from
the study for non-compliance.

Under normal conditions of use (application of the product at home), no compliance control could be
carried out during the study. However, the subjects fill in every day the daily log and notice the number
of use.

2.4.5. Associated treatment during the study

No systemic treatment likely to modify the skin condition is authorized during the study.

Only the usual products (hygiene product, make-up, make-up remover ) are authorized on the face
during the study (except the visits at the laboratory).

No excessive exposure to sunlight or UV-rays during the study is authorized.

2.5. Operational aspect

2.5.1. Trial schedule

On D0:

The subjects come to the laboratory without having applied any product to the face since the
previous evening (except the morning wash).
They read, sign and date the information sheet (instructions on the product use and restrictions
related to the study) and informed consent forms in duplicate. These documents are also signed
and dated by the person who conducted the informed consent discussion. The subjects receive a
copy.
Verification of inclusion and non-inclusion criteria by the technician.
The subjects wash their face and then they are allowed to equilibrate in the controlled room
condition for 15 minutes.
Clinical examination is performed by the dermatologist who counts the lesions (blackheads,
microcysts, papules and pustules) on the whole face (except nasal pyramid) and also assess the
initial cutaneous state on the face.
Definition of two zones on the face: one zone with a normal skin and one zone with acne mark.
Measurement of the skin color using Spectrophotometer CM700-d (with a 3mm diameter head)

on the two zones defined.


Definition of one zone on temple.
The product is distributed to the subjects. They use it twice -daily on the face for 28 days.
The subjects receive a daily log on purpose to write down their possible intolerance sensations or
others (Appendix 9.1).

On D28 (the last application of products is done the previous day):

The subjects return to the laboratory without having applied any product to the face since the
previous evening (except the morning wash).
The subjects bring back the daily log and the tested product.
The subjects wash their face and then they are allowed to equilibrate in the controlled room
condition for 15 minutes.

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New clinical examination is performed by the dermatologist in charge of the study: she counts
lesions on the whole face (except nasal pyramid), assess the final cutaneous state on the face and
ask the subjects about the unpleasant sensations they felt during the study.
New measurement of the skin color using Spectrophotometer CM700-d (with a 3mm diameter

head) on the two zones defined on D0.


The subjects fill in the subjective evaluation questionnaire.

Ambient condition during measurements is:


Room temperature: 24 2C,
Relative humidity: between 40% and 60%.

2.5.2. Study flow chart

D0 D0 to D28
D27
Informed consent, medical background and previous treatment.

Verification of inclusion and non-inclusion criteria.

Clinical examination by the dermatologist to assess the cutaneous state


and count acne lesions

Skin color measurement using Spectrophotometer CM700-d on one
normal skin zone and one acne mark.
Distribution/collection of product and daily log.

Application of the product by the subjects at home.

Subjective evaluation questionnaire

Collection of returned product and completed daily log.

Record of possible adverse events and intolerance sensations.

2.5.3. Adverse Events/Serious Adverse Events

2.5.3.1. Definitions

An Adverse Event (AE) is defined as any noxious symptom, occurring in a subject taking part in a
clinical trial, whether or not this symptom is related to the study or the studied product(s) (e.g. flu,
headache, abnormal biological analysis).

An adverse reaction of a cosmetic product is defined as any noxious reaction that might be related to
the normal or reasonably foreseeable use of the cosmetic product(s).

There are 5 levels of imputability: very likely, likely, not clearly attributable, unlikely and excluded
(ANSM methodology).

A Serious Adverse Event (SAE) is defined as any event that:


results in death (note: death is the outcome, not the event),
is life threatening,
requires in-patient hospitalization (at least one night) or prolongation of existing hospitalization
(does not include hospitalization scheduled before the inclusion),
results in functional incapacity or handicap,,
is a congenital anomaly,
is considered like by the investigator.

The severity/intensity of adverse events can be graded on a three-point scale:


Mild or Grade 1: discomfort noted, that does not disturb normal daily activities.

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Moderate or Grade 2: discomfort sufficient to reduce or affect normal daily activities.


Severe or Grade 3: inability to work or have normal daily activities.

2.5.3.2. Documentation

All concomitant treatments are reported in the CRF and the study report.
All Adverse Effects are reported in the CRF and the study report. If it requires the temporary or
definitive termination of the studied product, the need for a corrective treatment or the withdrawal of
the subject, an AE form is completed.
All Serious Adverse Events are reported in the CRF and the study report.

2.5.3.3. Notification

The investigator declares to the sponsor, by fax or e-mail, the occurrence of adverse reactions
according to their severity and their unexpectedness (according to the investigator's advice).

All Serious Adverse Events (SAE) are transmitted by e-mail to the sponsor without delay, at the latest
24 hours after knowledge of their occurrence.
A SAE declaration form signed by a physician is sent, within 48 hours, by fax or e-mail with
acknowledgement of receipt.

2.5.3.4. Follow-up

When an adverse event linked to the studied product or the protocol persists at the end of the study,
the Investigator ensures that the subject is followed up until total resolution of the event or stabilization
of the symptoms without releasing the Sponsor of any obligation or responsibility.

2.5.3.5. Occurrence of pregnancy

The occurrence of a pregnancy (reported or diagnosed) after inclusion in the study is considered as an
intercurrent event not related to the studied product(s) nor the protocol and induces the immediate
dropping out of the subject.
A follow-up will be done according to the current internal procedures up to the end of the pregnancy or
to its interruption.

2.5.3.6. Premature termination of the study

Study exit conditions

* In compliance with the Helsinki Declaration (2008) and its successive, subjects have the right to
exit from the study at any time and for any motive.

* The investigator also could have interrupted the study prematurely in the case of an intercurrent
disease or undesirable effect.

* The sponsor could have demanded that any subject be excluded from the study for major
infringements of the protocol, for administrative reasons or any other motive.

Nevertheless, premature removal of a high percentage of subjects from the study could have made
the study difficult or impossible to interpret. Consequently, any premature exit without valid motives
should have been avoided as much as possible and is carefully documented in the case report form,
the final report and if necessary in the Adverse Event form.

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Every premature exit must have been classified under one of the following headings:
Adverse Event occurrence,
Serious Adverse Event occurrence,
Withdrawal of consent,
Untraceable panellist,
Appearance of non-inclusion criteria,
Non-adherence to the protocol,
Other reasons

Replacement conditions

No replacement is foreseen as 10% additional subjects are planned to be included in the study.

2.5.4. Premature termination of the study

The sponsor reserves the rights to terminate the study prematurely for persistent protocol violations, or
any other valid and ethical reasons. Should this be the case, the necessary procedures will be
arranged after review and consultation between both parties to ensure protection of the subjects
interests.

2.5.5. Collection and validation of data

An identification code is attributed to each subject for the purpose to keep her identity confidential.
This code consists of: the first three letters of the subject's name and the first two letters of her first
name.

The personnel in charge of the study (technician, physician, ) adds data to subject case report form
and to a computerized data base.
The simple data entry is done from the case report forms by the designed technician(s) or operator(s),
without any interpretation, in specific MS EXCEL databases.

Then the Project Manager or assistant checks at least 10% of data to insure the coherence between
computed data and information in the case report forms or the questionnaires. He/She also checks
formulas used in the EXCEL tables (calculation formulas, selected data).
The coherence of data coming directly from measurement software(s) is also checked and validated
by the Project Manager or assistant, taking into account the potential acquisition errors.
When all CRF are computed and all controls done, the databases are frozen.

2.5.6. Audit and trial monitoring visit

An audit and/or trial monitoring visit may be carried out at the sponsor's request or by the appropriate
regulatory authority. The aim of the monitoring visit is to verify that the study is conducted according to
the determined protocol and current regulations.

2.5.7. Quality management

In order to ensure that the clinical trials are in compliance with the sponsors requirement,
DERMSCAN Asia has implemented quality procedures including Good Clinical Practices (GCP) and
regulation requirements.

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Each study report is subjected to a quality inspection by a member of the DERMSCAN Proofreading
Committee. The proof reader is chosen because he (she) is not involved in the audited study. The
inspection of the study report allows us to confirm that the results reflect exactly the study raw data.

A certificate of quality inspection, signed by the person who checked the report is enclosed in each
study report to certify that the study report reflects the study raw data and fulfils any standard and
regulatory requirements.

2.6. Studied product

2.6.1. Studied product description

Reference Acnoc Acneser Spot Gel


Aspect Light brown gel
96 samples of 10 ml (4 samples per subject) + 1 sample of 10 ml for
Packaging
archives
Confidentiality
Encoded
procedure
Before the beginning of the study, the products are kept at room
Storage temperature in a dedicated air-conditioned room. This room is
locked and access controlled
Application frequency Twice- daily (morning and night) for 28 days
Application sites Face
Under normal conditions of use, gentle apply the product on
Application method cleaned facial skin. (Can also be apply on acne lesions as much as
desired)

2.6.2. Labelling

Example of labelling of product by the clinical trial center and translation:

# DERMSCAN Study #
.:. Product:
: Emergency telephone number:
..
: ..................... Dermscan ref.:.


Conservation: room temperature

Keep out of reach and sight of children.
To be used only under strict medical
supervision for clinical trial.

2.6.3. Product(s) issue

The product is delivered to the subjects by the technician with an explanation of the application
conditions.

2.6.4. Product(s) future

One sample of the studied product is kept by the laboratory for a period of one year after its receipt.

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By default, the products (used and not used) are destroyed at the end of the study according to the
current internal procedures.

2.7. Method of product attribution to the subjects

2.7.1. Randomization method for the application zones

Not applicable.

2.7.2. Product attribution

Not applicable. All the subjects receive the same product reference.

2.8. Data analysis

2.8.1. Calculation formulas

The raw variations () and in percentage (%) of the different studied parameters are calculated
according to the following formulas:

= (TZti - TZt0)

% = (TZti - TZt0) x 100


TZt0
with:
TZ: value obtained on the treated zone,
t0: before application,
ti: at each measurement time after application.

Remarks:
The percentage of the variation (%) is expressed in percentage of the variation on the
measurement's zone (TZti - TZt0). These variations are balanced at the initial value TZ t0 (before
application).

This expression (%), therefore, gives the variation, in percentage, on the measurements zone
compared to the initial conditions (TZt0).

Measured values are presented in raw value tables. These tables also show the descriptive statistics:
means, medians, minima, maxima, standard errors of the means (SEM) and confidence intervals of
95% (95% CI).

Also, raw variations, percentage variations, descriptive statistics and the results of the statistical
analysis (p) are presented in the variation tables.

2.8.2. Statistical method

The statistical analysis determines the significance of the measurement variations obtained under the
effect of the studied product.

The comparison is on the values obtained before and at the different times of kinetics after treatment.

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Data are analyzed with a paired t-test. This method tests whether the mean of sample differences
between pairs of data is significantly different from the hypothetical mean, zero under the null
hypothesis (H0).

The alternative hypothesis (H1) is that the average difference is either greater or less than 0 (two-
tailed test). Before carrying out a test, a type I error of 5% is chosen (which corresponds to the risk of
rejecting a true null hypothesis).

If p0.05, H0 is rejected. There is a significant difference between before and after the
treatment.

If p>0.05, H0 is accepted, the mean is not different from 0. Data do not show a significant
difference between before and after the treatment.

2.8.3. Statistical software

The softwares used are:


EXCEL version 2010,
SPSS 21

2.9. Archiving
Data will be securely archived digitally and on paper for ten years from the date of dispatch of the final
report.

DERMSCAN Asia
Paper documents relating to this study are stored maximum during one year at Dermscan before
being transmitted for archiving to the ASIA WAREHOUSE COMPANY LIMITED (office located at 49,
th
6 fl. Asia Sermkij Tower Building, Silom Road soi 3, Silom, Bangrak District, Bangkok). The
warehouse is at 1019/1 Chong Nonsri, Klongtoey, Klongkoey District, Bangkok.

At the end of this period of ten years, the study archives will be destroyed unless otherwise stipulated
in writing by the sponsor.

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3. TEST FOLLOW-UP

3.1. Population

Number of subjects Reasons


Subjects who Subjects who did
Included Analyzed Non-analyzed
completed not complete the
subjects subjects subjects
the study study
Subject #11
Count acne lesions
22 presented aberrant
/Cutaneous tolerance
value.

Spectrophotometer Subject #5 Subject #23
CM 700-d 24 23 22 withdrawn her presented aberrant
measurement consent on D28 value.

Questionnaire 23 -

3.2. Protocol non-adherences

None of the protocol non-adherences present in the following table invalidate the data obtained for the
subjects.

Data kept into the


Type of non-adherence
Subject Description of the non-adherence analysis
(minor / major)
(yes/no)
3 Came to lab on D33 instead of D28. minor yes
4 Came to lab on D33 instead of D28. minor yes
8 Forgot to use product for 3 times minor yes
9 Forgot to use product for 7 times minor yes
13 Forgot to use product for 3 times minor yes
21 Forgot to use product for 3 times minor yes
22 Forgot to use product for 3 times minor yes
23 Forgot to use product for 7 times minor yes

3.3. Audit / Trial monitoring visit

Trial monitoring visit: no visit took place

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4. SUBJECT CHARACTERISTICS

4.1. Demographic data

The table below presents the observations concerning the subjects included in the study.

Last First
Subject Age Sex Skin type Phototype Comments Inclusion date End date
name name

1 SAE NA 21 F G III None February 12, 2016 March 11, 2016


2 CHA SO 22 F G III None February 12, 2016 March 11, 2016
3 AOM CH 33 F C IV Minor protocol non-adherence February 12, 2016 March 16, 2016
4 BUT SU 25 F C III Minor protocol non-adherence February 12, 2016 March 16, 2016
(5)* (SAN)* (PO)* (40)* (F)* (C)* (IV)* (Withdrawal of consent on D28)* (February 12, 2016)* (March 11, 2016)*
6 LEN SO 21 M C III None February 12, 2016 March 11, 2016
7 WAI AP 32 F C IV None February 12, 2016 March 11, 2016
8 THA TH 23 F G III Minor protocol non-adherence February 12, 2016 March 11, 2016
9 PHA EK 19 M C IV Minor protocol non-adherence February 12, 2016 March 11, 2016
10 VIC PI 24 F C IV None February 12, 2016 March 11, 2016
11 SAN PR 25 F G III None February 12, 2016 March 11, 2016
12 HAK TA 35 F C IV None February 12, 2016 March 11, 2016
13 SAN PE 23 M D IV Minor protocol non-adherence February 12, 2016 March 11, 2016
14 PLA NI 28 F C IV None February 12, 2016 March 11, 2016
15 PHO WE 32 M C IV None February 17, 2016 March 16, 2016
16 SAL WA 36 F C IV None February 17, 2016 March 16, 2016
17 KHU WO 40 F C IV None February 17, 2016 March 16, 2016
18 IAM SO 40 M C III None February 17, 2016 March 16, 2016
19 POR SU 36 F C IV None February 17, 2016 March 16, 2016
20 PEE NA 35 F C III None February 17, 2016 March 16, 2016
21 MON AC 21 M C IV Minor protocol non-adherence February 17, 2016 March 16, 2016
22 PAK DE 25 M C IV Minor protocol non-adherence February 17, 2016 March 16, 2016
23 SRI AE 22 M C IV Minor protocol non-adherence February 17, 2016 March 16, 2016
24 KAE TO 37 F C III None February 17, 2016 March 16, 2016
Mean 28 F 15 N 0 I 0
Median 25 M 8 D 1 II 0
Minimum 19 C 18 III 9
Maximum 40 G 4 IV 14
SEM 1 V 0
CI 95% 3 VI 0

Legend: Un: untraceable subject D: dry skin


DO: subject dropped out during the study N: normal skin
()*: values not included in data analysis C: combination skin
G: greasy skin
F: female
M: male

4.2. Concomitant treatments

None of the concomitant medications present in the following table invalidate the data obtained for the
subjects.

Beginning of End of
Medication treatment treatment
Subject Indication
(sales name) (compared to the (compared to the
kinetics) kinetics)
16 Paracetamol Headache D 8 D 8
Ponstan Dysmenorrhea D 2 D 2
20
Paracetamol Headache D 8 D 8
Paracetamol Headache D 6 D 6
21 Paracetamol Headache D 18 D 18
Paracetamol Headache D 27 D 27
Paracetamol Headache D 13 D 13
23
Paracetamol Headache D 20 D 20

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5. RESULTS

5.1. Anti-acne effect

The individual numbers of lesions are presented in Appendix 9.2.1


The statistical analysis is presented in Appendix 9.2.2

Statistical analysis
D0 D28 D28
p significance
(mean SEM) (mean SEM) (mean SEM)
Blackheads 1.7 1.1 1.0 0.6 -0.7 0.6 NA -
Microcysts 15.1 1.6 9.6 2.5 -5.5 2.1 0.038 Yes
Papules 8.9 1.3 5.9 1.1 -3.0 1.2 0.025 Yes
Pustules 0.1 0.1 0.4 0.2 0.2 0.2 0.301 No

NA : less of 1/3 of the subject presented a variation

After 28 days of twice-daily use, a significant decrease is observed in the number of microcysts,
papules and no significant increase is observed in the number of pustules.

Globally, according to these results, product "Acnoc Acneser Spot Gel" is considered as anti-
acne effect.

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5.2. Whitening and depigmenting/anti-blotch effects

Tables in the Appendix 9.3 present the individual results of colorimetric parameters L*, b* and ITA.

The three studied parameters were:

- L* (from dark to light). This is lightness parameter of the skin. An increase in this parameter
characterizes a whitening of the skin.

- b* (from the blue to yellow). A decrease in this parameter characterizes a decrease in the yellow
constituent of the skin.

- ITA (Individual Typological Angle). This parameter shows the skin pigmentation degree of a subject
using the lightness (L*) and cutaneous melanin parameters (b*). An increase in the ITA
characterizes a decrease in skin pigmentation and a lighter skin.

5.2.1. Whitening/lightening effect

A synthesis of the results is presented below.

Variations of colorimetric parameters on the area without spots


after 28 days of use of product
(comparison with the initial state)

Statistical analysis

% on the % of subjects with % of subjects with


Parameter Kinetic p Significance
(mean SEM) average the expected effect a visual effect

L* parameter D28 +0.57 0.11 +1% < 0.001 Yes 82% 23%

b* parameter D28 -0.05 0.20 -0% 0.824 No 50% 18%

ITA parameter D28 +1.33 0.38 +4% 0.002 Yes 55% 23%

After 28 days of twice-daily use, product "Acnoc Acneser Spot Gel" presents a significant
whitening effect, characterized by:

- a significant increase in L* parameter of +1% on average (0.57 0.11, p<0.001). This effect is
observed in 82% of the subjects;

- a significant increase in ITA parameter of +4% on average (1.33 0.38, p=0.002),


characterizing a decrease in skin color. A whitening effect is observed in 55% of the subjects.

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5.2.2. Depigmenting/Anti-blotch effect

A synthesis of the results is presented below.

Variations of colorimetric parameters on the area with spot


after 28 days of use of product
(comparison with the initial state)

Statistical analysis

% on the % of subjects with % of subjects with


Parameter Kinetic p Significance
(mean SEM) average the expected effect a visual effect

L* parameter D28 +1.73 0.21 +3% < 0.001 Yes 100% 68%

b* parameter D28 +0.31 0.22 +2% 0.176 No 32% 14%

ITA parameter D28 +5.64 0.80 +37% < 0.001 Yes 91% 91%

After 28 days of twice-daily use, product "Acnoc Acneser Spot Gel" presents a significant anti-
blotch effect, characterized by:

- a significant increase in L* parameter of +3% on average (1.73 0.21, p<0.001). This effect is
observed in 100% of the subjects;

- a significant increase in ITA parameter of +37% on average (5.64 0.80, p<0.001),


characterizing a decrease in skin colour. A depigmenting/anti-blotch effect is observed in 91%
of the subjects.

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5.3. Cutaneous tolerance

The individual results of cutaneous tolerance are presented below (relevant signs are presented in
bold types):

Signs reported by the subjects on D28 Clinical signs observed by the


Subject
Physical signs Functional signs dermatologist on D28

Very slight desquamation around


1 None None mouth from scratched acne
(without imputability).
2 None None None
3 None None None
4 None None None
(5)* Dropped out
6 None None None
7 None None None
8 None None None
More acne lesions on face on D7-D12
9 None None
(without imputability)
10 None None None
11 None None None
12 None None None
Very slight itching and stinging on
13 None acne area when applied product for a None
minute on D1 (without imputability).
14 None None None
15 None None None
Slight itching on acne area for 2
Slight desquamation on application
16 minutes on D1, D2, D4-D7 None
area on D8 (without imputability).
(doubtful imputability).
17 None None None
18 None None None
19 None None None
20 None None None
21 None None None
22 None None None
23 None None None
24 None None None

After 28 days of twice-daily use:


- two subjects (#9,#16) report physical signs and two subjects (#13, #16) report functional signs
but not retained as relevant,
- one subject (#1) present clinical signs but not retained as relevant.

Under the conditions of this study conducted by the dermatologist, product "Acnoc Acneser
Spot Gel" is very well-tolerated on the cutaneous level.

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5.4. Subjective evaluation questionnaire

The subjects' answers (in percentage) to the subjective evaluation questionnaire are presented in the
Appendix 9.4.

To be easier to read, the percentages are rounded off. The sum of these percentages may be different
from 100%.
In this study (n=23), one subject represents 4.35%.

A synthesis of the answers is presented in the table below.

AFTER 28 DAYS OF USE THE PRODUCT

GENERAL APPRECIATION OF THE PRODUCT AND ITS PROPERTIES

very pleasant

pleasant
% of subjects
(very pleasant /
pleasant)

General appreciation (very pleasant / pleasant) 96% 13% 83%

somewhat
% of subjects

agree

agree
( agree / agree
somewhat)

Pleasant texture 74% 17% 57%


Pleasant aspet 74% 26% 48%
Pleasant color 65% 17% 48%
Pleasant fragrance 73% 30% 43%
Non-sticky texture 56% 13% 43%
Easy to apply 91% 43% 48%

PRODUCT EFFICACY
somewhat

% of subjects
agree

agree

( agree / agree
somewhat)

Skin less oily 70% 13% 57%


Dark spots are lighter 78% 26% 52%
Complexion is more uniform 70% 9% 61%
Product help to reduce the appearance of dark spots 60% 17% 43%
Product is suitable for my skin type 70% 22% 48%

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% of subjects (yes)

Improvement of acne lesions (yes) 91%

decreased

decreased
% of subjects

much
(much decreased
/decreased)

Number of retentional acne lesions were decreased 48% 9% 39%


Number of inflammatory lesions were decreased 52% 4% 48%

TOLERANCE

% of subjects (yes)

During use product,intolerance sensations 9%


Stop the treatment 26%
Stop because of an intolerance reaction 0%

FUTURE USE OF THE PRODUCT

% of subjects (yes)

Would like to continue use the product 78%


Would like to buy the product 70%
Would like to recommend the product to a friend 83%

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6. CONCLUSION AND SIGNATURE(S)

The primary objectives of this study are to evaluate, after 28 days of twice-daily use of product
Acnoc Acneser Spot Gel:
its anti-acne effect
its lightening and depigmenting effect.

The secondary objectives of this study are to evaluate, for the studied product:
its cutaneous tolerance,
the subjective appreciation of its properties, of its efficacy, of its tolerance and its future use.

Study conditions:

Reference: Type:
Product(s)
Acnoc Acneser Spot Gel Light brown gel

Study date(s) From January 12, 2016 to March 16, 2016


- To evaluate the anti-acne effect of a cosmetic product.
- To evaluate its lightening and depigmenting effects.
Objective(s)
- To evaluate its cutaneous tolerance.
- To subjectively evaluate its properties, its efficacy, its tolerance and its future use.
Experimental
- Open and intra-individual study.
plan

- Anti-acne effect (counting of acne Kinetics D0-D28


lesions by the dermatologist),
Methodology Before / After
- Measurements of skin color (MINOLTA
CM700-d Spectrophotometer )
Zone Face
Assessment
Criteria - Cutaneous tolerance (clinical
examination and collection of signs Application Twice -daily
reported by the subject), frequency (morning and night)
- Subjective evaluation (questionnaire)

Number of analysed subjects: 23 subjects.

Age: 28 1 (average SEM) 19 to 40 years old.


Studied Main inclusion criteria:
population Sex: Asian female or male.
Age: between 18 and 40 years old.
Subject present at least 5 inflammatory acne lesions and 10 retentional acne
lesions.
Subject present at least 1 acne mark.

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Under these study conditions, after 28 days of use the product "Acnoc Acneser Spot Gel":

is considered as anti-acne effect,

whitening and depigmenting/anti-blotch effects:

presents a significant whitening effect, characterized by:


a significant increase in L* parameter, on the normal skin (without spot), of +1% on
average (p<0.001). This effect is observed in 82% of the subjects;
a significant increase in ITA parameter, on the normal skin (without spot), of +4% on
average (p=0.002). A whitening effect is observed in 55% of the subjects.

presents a significant depigmenting/anti-blotch effect, characterized by:


a significant increase in L* parameter, on spot, of +3% on average (p<0.001). This
effect is observed in 100% of the subjects;
a significant increase in ITA parameter, on spot, of +37%on average (p<0.001). A
depigmenting/anti-blotch effect is observed r in 91% of the subjects;

is very well-tolerated on the cutaneous level,

is appreciated by the subjects:

its organoleptic properties

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its efficacy

its future of use

April 22, 2016

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7. CERTIFICATION

The study is conducted according to Helsinki Declaration (1964) and its successive updates. Data are
obtained using the study protocol, current internal procedures and as closely as possible to the
guidance on Good Clinical Practice CPMP / ICH / 135 / 95, January 1997.

This study is totally performed under the responsibility of DERMSCAN.

All the observations and numerical data collected throughout the study are reported in this document.
We certify that these data are in accordance with the obtained results.

Date and signature:

Name Aeumporn SRIGRITSANAPOL, Ph.D.


Function Scientific Director

Any modifications are the sole responsibility of the author of the modification, whether he/she is acting
for the sponsor or independently. Any partial or total reproduction of this study report requires prior
written agreement from DERMSCAN.

The on-line publishing, on the Internet, of this study report with the signatures is strictly prohibited.

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8. BIBLIOGRAPHY

8.1. Regulatory

1. ICH TOPIC E6/ Note for guidance on Good Clinical Practice- CPMP / ICH / 135 / 95, January
1997.

2. WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI/ Ethical Principles for


Medical Research Involving Human Subjects- Helsinki Declaration (1964) and its successive
updates.

8.2. Data analysis

1. SOKAL R. R., ROHLF F. J. / Biometry: the principles and practice of statistics in biological
research - 3nd edn.W.H. Freeman and company, New York, 1995.

8.3. Anti-acne /Comedogenic potential

1. DURUPT G., LEGER E., MONTASTIER/ Etude du pouvoir comdogne des produits
cosmtiques- Nouv. Dermatol., 1985, 4, 5, 216-219.

2. FULTON J.E., BRADLEY S., AQUNDEZ A., BLACK Th./ Non comedogenic cosmetics.- Cutis,
1976, 17, 344-351.

3. KLIGMAN A.M., MILLS O.H/ Acne cosmetica- Arch. Dermatol., 1972, 106, 843-850.

4. KLIGMAN A.M, WHEATLEY V.R, MILIS O.H/ Comedogenicity of human sebum- Arch Derm,
1970, 102, 267-275.

8.4. Evaluation of skin color

1. CHARDON A., DUPONT G., MOYAL D., HOURSEAU G. GROLLIER JF. / Colorimetric
determination of sun protection factors. 15th IFSCC Congress, sept. 26-29, LONDON, 1988.

2. CHARDON A., CRETOIS I., HOURSEAU C. / Skin color typology and suntanning pathways.
16th IFSCC Congress, oct. 8-10, NY, 1990.

3. MUIZZUDDIN N., MARENUS K., MAES D., SMITH W.P. / Use of a chromameter in assessing
the efficacy of anti-irritants and tanning accelerators. - Journal of the Society of Cosmetic
Chemists. 1990; 41: 369-378.

4. ARRESE ESTRADA J., PIERARD G.E., DEWANDRE L. / Evaluation colorimtrique du


blanchiment obtenu par un topique cosmto-dermatologique: Eryskin crme. - Journal
d'Actualits Dermatologiques Belges. 1993; 5, tir part: 1-4.

5. PIERARD G. E. / EEMCO Guidance for the assessment of skin colour J. eur. Acad. Venereol.
1998, 10: 1-11.

6. DE RIGAL J. and al. / The effect of age on skin color and color heterogeneity in four ethnic
groups. Skin Research and Technology. 2010, 16: 168-178.

7. ABELLA M. L., DE RIGAL J;, NEVEUX S. / A single experimental method to study depigmenting
agent; - Int. Journal of Cosmetic Science. 2007, 29: 311-317.

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8. Guidelines for evaluation of Cosmetic Functions: guidelines for evaluation of quasi-drug


whitening products for new efficacy claims Journal of Japanese Cosmetic Science Society.
Vol. 31, N4, supplement, December 2007.

9. Guidelines for evaluation of Cosmetic Functions: guidance for pigmentation measurements


Journal of Japanese Cosmetic Science Society. Vol. 31, N4, supplement, December 2007.

10. HUIXIA Q. and al. / Instrumental and clinical studies of the facial skin tone and pigmentation of
Shanghaies women. Changes induced by age and a cosmetic whitening product - Int. Journal of
Cosmetic Science. 2012, 34: 49-54.

8.5. Cutaneous tolerance

1. BROECKS W., BLONDEEL A.,DOOMS-GOOSSENS A., ACHTEN G. / Cosmetic intolerance


- Contact Dermatitis. 1987; 16: 189.

2. ROBERT P. and coll. / Dermopharmacologie clinique - EDISEM MALOINE, 1985.

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9. APPENDIX

9.1. Daily log

Example:

DAILY LOG
D0-D28

THIS TABLE MUST BE COMPLETED EVERY DAY


Please tick in the box of your choice. If there is any adverse event, please immediately contact Dermscan Asia at 085-154-2844 or
083-138-6062.
Do not stop using product without notice.

In case of discomfort and/or intolerance, please note the nature (stinging, itching, burning sensations,.), the zone, the intensity
(very slight, slight, moderate, severe) and duration of these sensations as well as the time of appearance regarding product application
(immediately after application, 5 minutes after.)

Number of use per day


Specify DISCOMFORT AND/OR INTOLERANCE MEDICATION (why?, which one? which
Day Date
the SENSATIONS FELT dosage? how long?)
morning night
reason, if
forgotten
No Yes No Yes
If yes, specify: ___________________ If yes, specify: ___________________
D0
_______________________________ _______________________________

No Yes No Yes
If yes, specify: ___________________ If yes, specify: ___________________
D1
_______________________________ _______________________________

No Yes No Yes
If yes, specify: ___________________ If yes, specify: ___________________
D2
_______________________________ _______________________________

/ D28

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9.2. Results of acne lesions

9.2.1. Individual results

Global Global
Blackheads Microcysts retentional Papules Pustules inflammatory
lesions lesions

Subject D0 D28 D28 D0 D28 D28 D0 D28 D0 D28 D28 D0 D28 D28 D0 D28
1 0 0 0 10 8 -2 10 8 5 3 -2 0 0 0 5 3
2 0 0 0 16 29 13 16 29 26 6 -20 0 0 0 26 6
3 0 0 0 25 40 15 25 40 8 1 -7 0 0 0 8 1
4 0 0 0 10 1 -9 10 1 5 2 -3 0 0 0 5 2
(5)* (0)* DO DO (10)* DO DO (10)* DO (61)* DO DO (0)* DO DO (61)* DO
6 0 0 0 11 0 -11 11 0 5 8 3 0 0 0 5 8
7 0 0 0 34 21 -13 34 21 26 19 -7 0 3 3 26 22
8 0 0 0 11 6 -5 11 6 9 6 -3 0 0 0 9 6
9 0 0 0 10 30 20 10 30 6 4 -2 0 1 1 6 5
10 0 0 0 12 2 -10 12 2 6 4 -2 0 0 0 6 4
11 (0)* AV AV (12)* AV AV (12)* AV (11)* AV AV (0)* AV AV (11)* AV
12 0 0 0 15 1 -14 15 1 5 0 -5 0 0 0 5 0
13 0 0 0 12 3 -9 12 3 10 11 1 0 0 0 10 11
14 0 0 0 22 8 -14 22 8 7 1 -6 0 1 1 7 2
15 20 8 -12 7 8 1 27 16 4 5 1 1 0 -1 5 5
16 0 1 1 10 0 -10 10 1 7 5 -2 0 0 0 7 5
17 5 0 -5 11 11 0 16 11 7 3 -4 0 0 0 7 3
18 13 11 -2 11 7 -4 24 18 12 5 -7 2 0 -2 14 5
19 0 0 0 20 6 -14 20 6 5 2 -3 0 1 1 5 3
20 0 0 0 34 25 -9 34 25 7 13 6 0 0 0 7 13
21 0 0 0 15 1 -14 15 1 9 8 -1 0 0 0 9 8
22 0 0 0 11 2 -9 11 2 8 18 10 0 2 2 8 20
23 0 2 2 12 3 -9 12 5 10 1 -9 0 0 0 10 1
24 0 0 0 13 0 -13 13 0 9 5 -4 0 0 0 9 5
Mean 1.7 1.0 -0.7 15.1 9.6 -5.5 16.8 10.6 8.9 5.9 -3.0 0.1 0.4 0.2 9.0 6.3
Median 0.0 0.0 0.0 12.0 6.0 -9.0 14.0 6.0 7.0 5.0 -3.0 0.0 0.0 0.0 7.0 5.0
Minimum 0.0 0.0 -12.0 7.0 0.0 -14.0 10.0 0.0 4.0 0.0 -20.0 0.0 0.0 -2.0 5.0 0.0
Maximum 20.0 11.0 2.0 34.0 40.0 20.0 34.0 40.0 26.0 19.0 10.0 2.0 3.0 3.0 26.0 22.0
SEM 1.1 0.6 0.6 1.6 2.5 2.1 1.6 2.5 1.3 1.1 1.2 0.1 0.2 0.2 1.3 1.2

Legend: ( )* : value not taken in the data analysis


AV : aberrant value
DO: dropped out
MV: missing value

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9.2.2. Statistical analysis

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9.3. Individual results of measurement of color skin

9.3.1. Individual results of color skin on normal skin (without blotch/acne


mark)

L* parameter

Normal zone
(D28-D0)
Subject D0 D28
1 68.64 68.60 -0.04
2 63.40 64.39 0.99
3 59.78 60.38 0.60
4 63.59 65.25 1.66
(5)* (57.49)* DO DO
6 55.10 55.80 0.71
7 58.51 58.66 0.15
8 64.85 65.58 0.73
9 52.81 53.40 0.60
10 64.65 65.52 0.87
11 61.15 62.44 1.30
12 62.38 63.59 1.20
13 60.99 62.07 1.08
14 60.01 59.70 -0.31
15 55.38 55.64 0.26
16 64.14 64.82 0.68
17 55.75 55.29 -0.47
18 60.24 60.63 0.39
19 54.59 54.83 0.24
20 64.59 65.64 1.05
21 56.75 57.09 0.34
22 53.69 53.71 0.01
23 (55.12)* AV AV
24 65.18 65.62 0.43
Mean 60.28 60.85 0.57
Median 60.61 61.35 0.60
Minimum 52.81 53.40 -0.47
Maximum 68.64 68.60 1.66
SEM 0.95 0.99 0.11
IC 95% 1.97 2.07 0.24
p= <0.001
% 1%

% of subjects with the expected


effect 82%
(NB : if variations 0.1)

% of subjects with a visual effect


23%
(NB : if variations 1)

Legend: ( )* : value not taken in the data analysis


AV : aberrant value
DO: dropped out
MV: missing value

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b* parameter

Normal zone
(D28-D0)
Subject D0 D28
1 13.18 13.72 0.54
2 15.49 13.95 -1.54
3 19.14 19.29 0.16
4 15.78 16.30 0.52
(5)* (15.91)* DO DO
6 17.22 18.05 0.82
7 16.28 15.50 -0.78
8 15.65 15.52 -0.13
9 17.41 17.75 0.34
10 16.22 16.12 -0.11
11 15.60 14.36 -1.23
12 16.10 17.68 1.58
13 18.59 17.22 -1.37
14 19.79 18.38 -1.41
15 17.26 18.10 0.84
16 15.71 15.89 0.18
17 19.21 18.40 -0.80
18 16.52 15.68 -0.84
19 19.49 19.15 -0.34
20 12.68 14.09 1.41
21 17.81 19.34 1.53
22 20.09 19.74 -0.34
23 (19.79)* AV AV
24 14.63 14.59 -0.04
Mean 16.81 16.77 -0.05
Median 16.40 16.76 -0.07
Minimum 12.68 13.72 -1.54
Maximum 20.09 19.74 1.58
SEM 0.43 0.41 0.20
IC 95% 0.90 0.86 0.42
p= 0.824
% 0%

% of subjects with the expected


effect 50%
(NB : if variations -0.1)

% of subjects with a visual effect


18%
(NB : if variations -1)

Legend: ( )* : value not taken in the data analysis


AV : aberrant value
DO: dropped out
MV: missing value

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ITA parameter

Normal zone
(D28-D0)
Subject D0 D28
1 54.74 53.59 -1.16
2 40.86 45.90 5.04
3 27.08 28.29 1.21
4 40.74 43.08 2.35
(5)* (25.21)* DO DO
6 16.48 17.83 1.34
7 27.60 29.20 1.60
8 43.50 45.11 1.61
9 9.16 10.85 1.69
10 42.09 43.93 1.84
11 35.55 40.90 5.35
12 37.57 37.55 -0.02
13 30.58 35.02 4.44
14 26.83 27.82 1.00
15 17.32 17.32 -0.01
16 42.00 43.01 1.02
17 16.68 16.03 -0.65
18 31.80 34.15 2.35
19 13.25 14.14 0.89
20 49.01 47.99 -1.02
21 20.76 20.14 -0.62
22 10.42 10.63 0.21
23 (14.52)* AV AV
24 46.06 46.94 0.88
Mean 30.91 32.25 1.33
Median 31.19 34.59 1.11
Minimum 9.16 10.63 -1.16
Maximum 54.74 53.59 5.35
SEM 2.85 2.90 0.38
IC 95% 5.92 6.04 0.79
p= 0.002
% 4%

% of subjects with the expected


effect 55%
(NB : if variations 1)

% of subjects with a visual effect


23%
(NB : if variations 2)

Legend: ( )* : value not taken in the data analysis


AV : aberrant value
DO: dropped out
MV: missing value

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9.3.2. Individual results of color skin on acne mark

L* parameter

Spot
(D28-D0)
Subject D0 D28
1 65.82 66.68 0.86
2 62.00 62.98 0.98
3 54.69 56.56 1.87
4 58.11 62.32 4.21
(5)* (49.83)* DO DO
6 50.84 51.81 0.97
7 52.45 54.74 2.29
8 52.47 54.43 1.96
9 45.26 46.64 1.39
10 54.88 55.91 1.03
11 52.25 55.79 3.54
12 56.49 56.89 0.40
13 51.97 54.84 2.87
14 45.42 48.14 2.72
15 48.95 50.69 1.74
16 57.01 58.54 1.53
17 48.44 50.57 2.13
18 58.66 59.09 0.43
19 51.56 52.43 0.87
20 60.34 62.49 2.15
21 53.17 54.02 0.85
22 60.34 62.49 2.15
23 (53.17)* AV AV
24 63.73 64.79 1.06
Mean 54.77 56.49 1.73
Median 53.93 55.85 1.63
Minimum 45.26 46.64 0.40
Maximum 65.82 66.68 4.21
SEM 1.19 1.16 0.21
IC 95% 2.48 2.41 0.44
p= <0.001
% 3%

% of subjects with the


expected effect 100%
(NB : if variations 0.1)

% of subjects with a visual


effect 68%
(NB : if variations 1)

Legend: ( )* : value not taken in the data analysis


AV : aberrant value
DO: dropped out
MV: missing value

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b* parameter

Spot
(D28-D0)
Subject D0 D28
1 14.03 12.75 -1.27
2 14.98 14.54 -0.44
3 17.81 17.79 -0.02
4 16.26 15.15 -1.12
(5)* (13.68)* DO DO
6 15.23 15.59 0.36
7 16.57 16.18 -0.39
8 14.54 13.74 -0.80
9 14.08 14.79 0.71
10 19.09 19.79 0.71
11 14.41 14.57 0.16
12 17.60 18.77 1.17
13 15.08 16.59 1.51
14 12.95 15.09 2.14
15 14.52 16.97 2.45
16 18.44 17.12 -1.33
17 14.90 15.40 0.50
18 16.79 16.17 -0.62
19 17.34 18.50 1.16
20 15.51 15.44 -0.07
21 13.49 14.03 0.55
22 15.13 15.82 0.69
23 (13.13)* AV AV
24 11.90 12.61 0.71
Mean 15.48 15.79 0.31
Median 15.10 15.52 0.43
Minimum 11.90 12.61 -1.33
Maximum 19.09 19.79 2.45
SEM 0.39 0.40 0.22
IC 95% 0.81 0.82 0.46
p= 0.176
% 2%

% of subjects with the


expected effect 32%
(NB : if variations -0.1)

% of subjects with a visual


effect 14%
(NB : if variations -1)

Legend: ( )* : value not taken in the data analysis


AV : aberrant value
DO: dropped out
MV: missing value

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ITA parameter

Spot
(D28-D0)
Subject D0 D28
1 48.44 52.61 4.17
2 38.69 41.75 3.06
3 14.77 20.25 5.49
4 26.50 39.12 12.61
(5)* (-0.70)* DO DO
6 3.16 6.62 3.46
7 8.40 16.32 7.92
8 9.63 17.86 8.23
9 -18.62 -12.79 5.83
10 14.35 16.63 2.28
11 8.87 21.68 12.81
12 20.24 20.15 -0.09
13 7.46 16.28 8.82
14 -19.46 -7.02 12.45
15 -4.15 2.32 6.47
16 20.82 26.52 5.70
17 -5.98 2.13 8.11
18 27.28 29.34 2.05
19 5.14 7.49 2.35
20 33.69 38.96 5.27
21 13.23 15.97 2.75
22 34.35 38.29 3.93
23 (13.5)* AV AV
24 49.09 49.55 0.46
Mean 15.27 20.91 5.64
Median 13.79 19.00 5.38
Minimum -19.46 -12.79 -0.09
Maximum 49.09 52.61 12.81
SEM 4.01 3.73 0.80
IC 95% 8.35 7.75 1.66
p= <0.001
% 37%

% of subjects with the


expected effect 91%
(NB : if variations 1)

% of subjects with a visual


effect 91%
(NB : if variations 2)

Legend: ( )* : value not taken in the data analysis


AV : aberrant value
DO: dropped out
MV: missing value

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9.4. Subjective evaluation questionnaire

AFTER 28 DAYS OF USE

GENERAL APPRECIATION OF THE PRODUCT AND ITS PROPERTIES

very
very pleasant pleasant unpleasant
unpleasant
1 General appreciation 13% 83% 4% 0%

agree disagree
agree disagree
somewhat somewhat
2 Pleasant texture 17% 57% 26% 0%
3 Pleasant aspect 26% 48% 26% 0%
4 Pleasant color 17% 48% 26% 9%
5 Pleasant fragrance 30% 43% 22% 4%
6 Non-sticky texture 13% 43% 26% 17%
7 The product is easy to apply 43% 48% 9% 0%

PRODUCT EFFICACY

agree disagree
agree disagree
somewhat somewhat
8 The skin less oily 13% 57% 22% 9%
9 The dark spots are lighter 26% 52% 17% 4%
10 The complexion is more uniform 9% 61% 26% 4%
The product help to reduce the
11 17% 43% 35% 4%
appearance of dark spots
The product is suitable for my skin
12 22% 48% 26% 4%
type

13 Did you find an improvement of the acne lesion on your face?


yes no
91% 9%

If you answered ''no'' pass to the question 16


If yes, can you specify this improvement?

14 The number of retentional acne lesion were decreased


much slightly
decreased no change
decreased decreased
9% 39% 43% 0%

15 The number of inflammatory acne lesions were decreased


much slightly
decreased no change
decreased decreased
4% 48% 39% 0%

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TOLERANCE

16 During this study, did you feel discomfort, irritation or intolerance sensations (cutaneous )?
yes no
9% 91%

If yes, please complete your daily log.

Subject Sensation
Slight itching and stinging on acne area for 1
13
day.
Slight itching and desquamation on acne area
16
for 8 days.

17 Did you stop the treatment?


yes no
26% 74%

If yes, how long did you stop for? ______________________________________________

Subject Time(s)
8 3 times ( onD8, D16, D21)
9 7 times (on D13-D15, D18-D19, D26)
13 3 times (on D3, D17, D23)
21 3 times (on D8, D11, D24)
22 3 times (on D2, D8, D14)
23 7 times (on D5-D6, D11, D14, D18-D19, D25)

If you stopped, what was the reason?

18 Because of an intolerance reaction?


yes no
0% 26%

19 For other reasons?


yes no
26% 0%

If yes, why ? : _____________________________________________________________

Subject Reason
8 For got to use
9 For got to use
13 For got to use
21 For got to use
22 For got to use
23 For got to use

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FUTURE USE OF THE PRODUCT

20 Would you like to continue to use this product?


yes no
78% 22%

21 At the end of this study would you like to buy this product (regardless of the price)?
yes no
70% 30%

22 Would you recommend this product to a friend?


yes no
83% 17%

Subject Comment
3 The color should be modified.
8 The product show good adhere on acne lesion.
14 Product make a skin more oily
16 The color should be lighter
19 The texture is too sticky
24 The odor should be modified.

Final Report Version 1.0_April 22, 2016

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