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FINAL REPORT
05/09/2008
Study n °: 062.124.001.08
title:Evaluation of Effective anti-dandruff and fall under normal conditions of use of hair-care
products with attributes of personal hygiene and cleanliness
goal:assess the effectiveness anti-dandruff and anti-fall of Restorative Tonic Walter Silva fall
arresters anti-dandruff legitimate of Amazon relative to combat dandruff and sensory improvement
– clinical aspects fall and dandruff in real conditions of use.
Product tested: TÔNICO RESTAURADOR WALTER SILVA ANTI-QUEDA ANTICASPA O LEGÍTIMO DA AMAZÔNIA
responsible:Clinical Director – Dr. by RIVELINO AIELLO RITTO
Research Scientist – Prof. °. Dr. JOSÉ LUIZ AIÉLLO RITTO
Researcher – Farm. PRISCILLA ALBONETI MASINI
sponsor:Ellix Indústria e Comércio de Cosmetics
Rua Qd. 04 10 Batch 62 and
Aparecida de Goiânia-GO
Contact: Flavia Azevedo Costa
Sample data:
Sample name: Restorative Tonic Walter Silva fall arresters anti-dandruff legitimate from Amazon
Sample identification: liquid
Batch: 080128
Sample receipt date: 19/05/2008
Date of commencement of the trial: 14/07/2008
End date: 11/08/2008
Code sample: 05.107.08 Scientia
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DECLARATION FOLLOW-UP TESTING AND APPROVAL
This report represents a true and accurate record of the results obtained, referring only to samples
submitted for analysis. Are prohibited the partial reproduction and modification of contents of this
document, unless documented consent under the Scientia Laboratories Ltd.
All data, medical records, photographic records and comments, as well as the test aliquots of
substance for that test were recorded and are archived.
DECLARATION OF CONFIDENTIALITY
This Protocol was executed according to guidelines established by I.C.H. Harmonised Tripartite
Guideline for Good Clinical Practice (1996) – ICH Topic E6 – including post Step 4 errata
Sept./1997. Is confidential in nature and can only be seen by people who are responsible for its
evaluation and implementation.
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1. SUMMARY of PROTOCOL 4
2. PRODUTOTESTE 5
3. INSTITUTIONS RESPONSIBLE and ENVOIVIDAS. 5
4. INTRODUCTION 6
5. MATERIAL and METHODS 7
5 .1 7 Equipment
5 7 2 experimental procedure
5.2.1 Assessment clinico Dermatological 7
5.3 Area taste 7
5.3.1 8 Sensory Evaluation
5.3.2 quantitative evaluation 9
5.3.3 population 9
5.3.3.1 Studied 9 PopuIação description
5.3.3.2 Criteria of 10 volunteer lnclusão
5.3.3.3 criteria of non-inclusion of Volunteer 10
5.3.3.4 Requirements by studying 10
5.3.4 minimal risks Mentioned 11
5.3.5 Conduct against 11 adverse reactions and Events
5.3.5.1 Data Handling and maintenance of 11 Records
5.3.6 12 statistical analysis
5.3.7 composition of Shampoo Base (Placebo) 12
6.13 RESULTS
6.1 Aderônc4a to Study 13
6. Evaluation 13 Dermatological Clinic 2
6 3 Perception of Volunteers 13
6.4 evaluation of counting and weighing scales 15
6.5 evaluation of yarn count 17
6 evaluation of Greasy hair 18
6. DISCUSSION 19
7. CONCLUSION 21
B BIBLIOGRAPHIC REFERENCE 22
ATTACHMENTS
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title: Evaluation of Effective anti-dandruff and fall under normal conditions of use of hair-care
products with attributes of personal hygiene and cleanliness
goal:assess the effectiveness anti-dandruff and fall of Restorative Tonic Walter Silva fall
arresters anti-dandruff legitimate da Amazônia in relation to combat dandruff and sensory
improvement – clinical aspects fall and dandruff in real conditions of use.
Table 01.product Synopsis
type of studyclinical study and open objective effectiveness
study planStudy monocêntrico, opened
Populationhealthy normal volunteers, both sexes, all races, adults between 18 and 65 years of age and
diagnosed with steady fall and Seborrheic Dermatitis or exacerbated.
number of volunteersminimum of 20 volunteers
Test Product and dosagetonic, as directed and wordings labelling by the manufacturer.
reference product and dosageWas used a Shampoo Base (Placebo)
duration of study28 days with 4 visits and period of up to 2 hours
Test schedule
Commencement of the trial 14/07/2008
End of the test 11/08/2008
Final report 05/09/2008
Sponsor: Ellix Indústria e Comércio de Cosmetics
Rua Qd. 04 10 Batch 62 and
Aparecida de Goiânia-GO
Contact: Flavia Azevedo Costa
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2 TEST PRODUCT
Table 02.Characterization of product test
Product test
tradeRestorative Tonic Walter Silva fall arresters anti-dandruff legitimate from Amazon
QuantitativeAloe barbadensis – 1.6%; Ricinius comunis oil – 1.4%; Cinchona succirubra extract –
3.2%; Melissa officinalis extract – 1.6%; Apartamentos sabinas Alfonso potato extract –2.0%;
Zinziber officinale extract – 2.0%; Hustle cilyndrica extract – 1.0%; Sodium benzoate – 0.2%; Aqua
qsp – 100%; Rosmarinus officinalis extract – 2.8%.
Form galênicaLiquid
batch number080128
SCINTIA Date of entry into05/20/2008
Date issue Report05/09/2008
sample code05.107.08
3. INSTITUTIONS INVOLVED and responsible
Table 03.Characterization of the Institute
STEP
LOCATION
RESPONSIBLE
Scientia Laboratories
Rua Dr. Leonardo Cavalcanti,
314 – Centro
Jundiaí-SP
Dr By Rivelino Aiélio Ritto
Prof. Dr. José Luiz Aiélo Ritto
Clinical Director
Scientific Researcher
Priscilla Alboneti Masini
Researcher
Dr By Rivelino Aiélio Ritto
Prof. Dr. José Luiz Aiélo Ritto
Priscilla Alboneti Masini
Clinical Director
Scientific Researcher
Researcher
Doctor Dermatologist
Pharmacist (Doctor)
Pharmaceutical
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Clinical evaluation
Team professional
qualification
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In recent years, the cosmetic industry comes deserving much attention of the consumer protection
bodies and Health regulators in the country. This awareness has provided the search of scientific
evidence to appeals cosmetics assigned to products by industries.
On the other hand, the development trends of new releases of assets and opportunities offered to
researcher, provides reliable tools to establishments, for the verification of security attributes,
effectiveness and quality of cosmetics.
The employment study on actual conditions of use gives you the ability to detect allergic reactions
(BARAN and MAIBACH, 2005), beyond the sensory characteristics of the product, detecting
additional complaints and comments regarding desired attributes or found on the final formulation.
These studies provide important business tool, supporting their customer information strategies,
marketing and security in itself make the market for a product previously assessed by specialists
(BARAN and MAIBACH, 2005).
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5. Equipment 1
Does not apply
5. experimental Procedure 2
5.2.1 clinical Dermatological Assessment
The volunteers were supervised by doctor dermatologist throughout the research and evaluated in
the event of any symptom or sign, for confirmation of the actual and correct use of the product and
detection of possible adverse reactions.
The volunteers were told to report to the doctor in case of adverse reactions. In these cases would
be forwarded for evaluation and steering of medico dermatologist responsible, carrying out
examinations, classification of the reaction and performing appropriate conduct (orientation and/or
medication and photographic documentation when necessary).
5. experimental Area 3
The efficacy of the product has been verified by Clinical and scientific researchers, with
experience, education and appropriate professional under their responsibility, aided by a
researcher experienced and qualified.
Product/Application
Usage mode
area
Application at
Duration
the Office
Shake before use. Apply on the scalp 4
Capillary Area
times a day. Massage gently with your
There was no
28 days
fingertips. It is not necessary to rinse
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The Subject search after receiving clarification, information and guidance about the study read and
signed the deed of free and informed consent (TCLE) and followed to the checking of the criteria
for lnclusão and not lnclusão.
In the first week, the volunteer took home a Shampoo Base (placebo) for performing wash-out. At
the end of the same week the volunteers made a vigorous brushing (50 times in the right sidebar.
left side and front) of hair under urn scale visual background covered with cellophane of 24X30crn
where did the counting of wires and scales and weighing the end thereof. This procedure was
repeated in the second week and fourth week, used the product fall arresters and anti-dandruff.
The product was used, as guidelines (motifs, labelling) constant in manufacturer's packing
delivered to volunteers. Volunteers have made use of the product Restorative Tonic Walter Silva
fall arresters anti-dandruff the legitimate demand from Amazon and received a Final questionnaire
after 21 days of product use to evaluate the acceptability of the same
The perception was assessed after 21 days of use of the product, through responses to a
questionnaire padrao, dedicated to the type of study. As attachment model, where they were
considered the following aspects:
In relation to the product
-Perfume
-Color
-Consistency
-Espalhabilidade
In relation to the effects of the product:
-Pruritus (itching);
-Hair loss;
-Oils:
-Softness
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5,worst and 5 being best 1. Once grouped, the criterion of acceptability was assigned as the
percentage of answers obtained according to the Table 1 below.
Table 05 rating scale for the subjective Appreciation of panelists
Percentage of volunteers who
Percentage of volunteers who
liked the product attributes
liked the effects of the product
Very Good
80 – 100%
80 – 100%
Good
60 – 80%
60 – 80%
Moderate
40 – 60%
40 – 60%
Bad
> 40%
> 40%
Volunteer appreciation
5.3.2 quantitative assessment
Counting scales (ci held second quarteamento technique which are arranged in evenly on black
checkered sheet previously (22cmx22cm) with 16 quarters of 5, 5cm2 each urn. Rejected the
portions contained in 2 opposite quadrants in a square diagonals. Joined the two remaining
portions and the process was repeated The escarnas rejected were transferred to the Petri dish
identified
Following are the scale contained in the Petri dish were weighed on analytical balance and
subsequently discarded.
To the count of yarn, precedes manually counting each thread contained in cellophane and later
discard them.
5.3.3 Population study
5.3.3.1 description of study population
The study population was made up of volunteers analyzed, adults of both sexes, age between 18corn 65 years and all races and with diagnosing hair falling or exacerbated.
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• Aged 18 to 65 years:
• Both genders
• All races:
• With a diagnosis of seborrheic dermatitis and thinning hair falling or exacerbated
• Able to understand the nature and purpose of the study, including risks and adverse effects and
who intend to cooperate with the researcher and act according to the requirements of the whole
study, what comes to be confirmed upon signature of the term of free and informed consent.
5.3.3.3 criteria of non-inclusion of Voluntary
The positive answer to any of the following criteria did not include the volunteer study
• Psoriase;
• Atopic Dermatitis,
• Pregnancy/Lactation;
• Scalp topical treatment with antifungal medications or with corticosteroids in 2 weeks prior to the
commencement of the study;
• Use chemical methods and/or physical with cosmetic purpose and potential change of integrity of
hair or induction of Allergic Dermatitis-Irritant of the scalp (Tinctures/Relaxers/permanent) in the
last 30 days;
• Introduction of systemic drugs in the last 4 weeks ...
6.3.3.4 requirements by studying
The requirements for volunteers, laid down in the Protocol were:
• Non-application of a different product tested in experimental area for a period that preceded the
study within 30 days.
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• delivery of questionnaires
• Readings;
5.3.4 minimal risks provided for
Risks provided for this type of study are possible manifestation allergic to a particular cosmetic or
the possible emergence of an irritation at the site of application in the form of skin redness, itching,
scabs, or other signs of irritation.
5.3.5 Conduct face-to-face events/adverse reactions
Any event or adverse reaction reported voluntarily by subject search, discovered by researcher's
questions (monitoring of study) or detected by physical examination or other type of assessment
will be recorded and well monitored.
5.3.5.1 Data Handling and maintenance of records
Researchers shall keep all documents related to this study by the time defined in ICH-GCP
guidelines. All data and documents are available if requested by sponsor or authorities. The
documents shall be kept for a minimum period of 15 years.
The sponsor shall also keep all documents related to study for a period of at least 15 (fifteen) years
or during the time the product find themselves on the market.
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5.3.6 statistical analysis
The criteria employed in the evaluation was the sum of the percentages of replies to the
questionnaires of subjective assessment on the part of the panelists, adopting scores between I
(worst) to 5 (best) for each attribute. The final ranking was expressed as Table 5. (The data were
analyzed using-if Microsoft Excel spreadsheets).
5.3.7 composition of Shampoo Base (Placebo)
the product employee under the denomination of Shampoo Base (placebo) has the following
composition centesimal: Laurit have Sôdio sulfate (26-28%) — 25%;
Coconut Dietanolarnida — 3.5%; Cocamidopropilbetaina — 4.0%; Propylene glycol — 3%;
EDTA dissôdico — 0.05%, Sôdio chloride (Sun. 25%) 2.0%: (70-Phenoxiethanol
74%), proplparabeno (7.5-8.5%), metiltparabeno (15-17%), etillparabeno (3.5-4.5%)0.50%; Citric Acid (sot. 40%) — 0.20%; water (q.s.p) — 100.0%.
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6. Results
6 .1 Adhesions to Study
Commenced the study 25 (twenty five) voluntary and completed the study within established 20
volunteers, corresponding to 80.0% of initial group.
6.2 Reviews dermatological clinic
During the study, no volunteer has any adverse reaction type cutâriea.
6.3 perceptions of Volunteers
The results concerning the perception of volunteers are presented in graphs and discussed below:
Table 06.results of the FINAL EVALUATION of PERCEPTION of VOLUNTARY — Effectiveness to
prevent falls and anti-dandruff (n20) — affection to the product,
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Chart 01. Evaluation of perception of the volunteer in relation to the effects of the product
Table 7. Results of the FINAL EVALUATION of PERCEPTION of the VOLUNTEER –
Effectiveness to prevent falls and anti-dandruff shampoos (n = 20) – affection to the product
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Chart 02. Evaluation of perception of volunteering on the characteristics of the product.
6.4 reviews of counting and weighing scales
Table 08.results of counting and weighing scales (dandruff) in 1 week (starting), 2nd week (after 7
days of use of the product test) and 4th week (after 21 days of use)
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Chart 03. Average number of flakes in three time intervals
Table 09.analysis of variance of the distribution of the medium in the measures of counting time
scales (1 = final Variable and Variable 2 = home; N = 20)
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6.5 Reviews of count of yarn
table 10.average results of the assessment of Effectiveness fall arresters – (n = 20)
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Table 11.analysis of variance of the distribution of the count of hair in time (1 = final Variable and
Variable 2 = home; N = 20)
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6. DISCUSSION
Dandruff flaking is characterized by a thin, white, furfurácea on the scalp. Is usually asymptomatic,
although some people complain about the presence of rash on the scalp. The Pityriasis capitis,
also known as dandruff, brings great social discomfort to the individual.
Evaluation of the evolution of using a product with anti-Government dandruff can be accomplished
through various methodologies, and the most common is for visual observation and graduation in
ticks.
We seek to demonstrate the reduction of scales through evaluation and counting scales,
empregrando yourself a maneuver standardized brushing and collecting the scales on a dark
background feedback and graduated.
You can verify that the conditions tested, as directed frequency and use of the product
recommended by the manufacturer, decrease in counting scales present at significance level of
95% (alpha = 0.05) (n = 20)
The hair intensified brings individuals the possibility of having image affected, causing a great deal
of discomfort. More and more cosmetics carrying calls fall arresters. In the objective assessment of
effectiveness of these products we seek to demonstrate through quantification of hair disposed of
under mechanical action, through standardized maneuver brushing in the areas laid down in the
scalp (BERGER et al., 2003 OLSEN et al. 2006).
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Hair eliminated were collected and packed in suitable material and followed by counting the time
intervals: TO-start, after 5 days of "wash out" .com shampoo neutral default; T1-after 14 days of
use of the product to T2-after 21 days of use of the product.
Another important way to characterize the benefits of products with attribute to prevent falls and is
employment, antidandruff measure greasy hair and scalp, accomplished by Colorimetry at specific
role containing the smear of the region pariental of the scalp. Through these measures, we opted
for L-shaped chromaticity scale to observe the nuances of colors ranging from 100-0 according to
the intensity of black (brightness).
The measures were collected in the times T1 (7 days) and T2 (21 days) and noted
reduction of oil on the scalp of volunteers, featuring the
increase the numeric value of 1.
The assessment focusing perception doe volunteers in relation to the product in the attributes:
Perfume, colour, consistency and espalhabilidade showed a good acceptance, how great the
espalhabilidade (n = 1; 50.0%). For the item color and perfume, 30.0% (n6) volunteers found ideal
40.0% (n = 8) of the same consistency as great pointed
Improvement of pruritus (itching) and hair loss was evaluated as excellent (n = 12;
80.0%) by the total Panel after 21 days of use of the product test. The decrease in oil was realized
at 55.0% (n = 11) and the softness of hair has been increased to 30.0% (n 6) volunteers after 21
days of use of the product under test.
The statistical evaluation has shown that the conditions tested, with duration and frequency
recommended by the manufacturer was noticed significant differences (alpha 0.05. N = 2) between
the count in the hair removed counting scales found in the range of 3 weeks studied
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7. conclusion
• A real deuso, according to the frequency and mode of application of product determined by the
manufacturer, any volunteer presented any cutaneous related to the use of the product.
-The product Restorative Tonic Walter Silva fall arresters anti-dandruff the Legitimate Amazonian
presented efficacy fall arresters and anti-dandruff at 95% confidence (alpha 0.05; n20)
• Affection to the product by panelists (n20), had the following results
the Perfume-moderate) Good;
b) color of the product — moderate to good;
c) Espalhabilidade-Good;
d) consistency — Good.
-The Appreciation by Panelists (n. 20) in relation to perceived light effects
the following results
a) Absence pruritus (itching)-Good;
b) decrease in hair loss-Very Good;
c) reduction of oil-Good.
d) Softness — moderate to Good
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