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TABLE OF CONTENTS
1. AIMS ............................................................................................................................................7
2. METHODS ...................................................................................................................................7
5. RESULTS...................................................................................................................................21
7. CERTIFICATION .......................................................................................................................30
8. BIBLIOGRAPHY ........................................................................................................................31
9. APPENDIX .................................................................................................................................33
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 :
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
Under these study conditions, after 28 days of use the product "Acnoc Acneser
Spot Gel":
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)
1. AIMS
The primary objectives of this study are to evaluate, after 28 days of twice-daily use of product
Acnoc Acneser Spot Gel:
2. METHODS
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.
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:
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:
The higher the ITA is, the lighter the skin is.
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
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.
Before and after product use, the subjects face is examined by the dermatologist who assesses each
of the following parameters:
On D0, the subjects are also asked about their usual sensations:
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.
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.
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.
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.
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.
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.
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).
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)
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.
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
D0 D0 to D28
D27
Informed consent, medical background and previous treatment.
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).
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.
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.
* 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.
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.
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.
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.
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.
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.
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.
2.6.2. Labelling
# 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.
The product is delivered to the subjects by the technician with an explanation of the application
conditions.
One sample of the studied product is kept by the laboratory for a period of one year after its receipt.
By default, the products (used and not used) are destroyed at the end of the study according to the
current internal procedures.
Not applicable.
Not applicable. All the subjects receive the same product reference.
The raw variations () and in percentage (%) of the different studied parameters are calculated
according to the following formulas:
= (TZti - TZt0)
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.
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.
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.
2.9. 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.
3. TEST FOLLOW-UP
3.1. Population
Questionnaire 23 -
None of the protocol non-adherences present in the following table invalidate the data obtained for the
subjects.
4. SUBJECT CHARACTERISTICS
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
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
5. RESULTS
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
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.
Tables in the Appendix 9.3 present the individual results of colorimetric parameters L*, b* and ITA.
- 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.
Statistical analysis
L* parameter D28 +0.57 0.11 +1% < 0.001 Yes 82% 23%
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;
Statistical analysis
L* parameter D28 +1.73 0.21 +3% < 0.001 Yes 100% 68%
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;
The individual results of cutaneous tolerance are presented below (relevant signs are presented in
bold types):
Under the conditions of this study conducted by the dermatologist, product "Acnoc Acneser
Spot Gel" is very well-tolerated on the cutaneous level.
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%.
very pleasant
pleasant
% of subjects
(very pleasant /
pleasant)
somewhat
% of subjects
agree
agree
( agree / agree
somewhat)
PRODUCT EFFICACY
somewhat
% of subjects
agree
agree
( agree / agree
somewhat)
% of subjects (yes)
decreased
decreased
% of subjects
much
(much decreased
/decreased)
TOLERANCE
% of subjects (yes)
% of subjects (yes)
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
Under these study conditions, after 28 days of use the product "Acnoc Acneser Spot Gel":
its efficacy
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.
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.
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.
8. BIBLIOGRAPHY
8.1. Regulatory
1. ICH TOPIC E6/ Note for guidance on Good Clinical Practice- CPMP / ICH / 135 / 95, January
1997.
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.
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.
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.
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.
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.
9. APPENDIX
Example:
DAILY LOG
D0-D28
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.)
No Yes No Yes
If yes, specify: ___________________ If yes, specify: ___________________
D1
_______________________________ _______________________________
No Yes No Yes
If yes, specify: ___________________ If yes, specify: ___________________
D2
_______________________________ _______________________________
/ D28
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
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%
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%
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%
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%
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%
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%
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
TOLERANCE
16 During this study, did you feel discomfort, irritation or intolerance sensations (cutaneous )?
yes no
9% 91%
Subject Sensation
Slight itching and stinging on acne area for 1
13
day.
Slight itching and desquamation on acne area
16
for 8 days.
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)
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
21 At the end of this study would you like to buy this product (regardless of the price)?
yes no
70% 30%
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.