clinical study evaluation of the efficacy of a food ... · 1.4.10. if any unexpected ... will use a...

________________________________________________________________________________________________ Farcoderm srl

Head office: Via Angelini angolo Via dalla Chiesa - 27028 San Martino Siccomario - Pavia Legal office: Via Don Natale Fedeli 3 - 20020 Arese - Milano

C.F. - P.iva 03893350961 - Tel. 0382 25504 - Fax 0382 536006 - Mail: [email protected] www.farcoderm.com

With the collaboration of: UNIVERSITA’ DEGLI STUDI DI PAVIA Prof. FULVIO MARZATICO

LABORATORIO di FARMACOBIOCHIMICA

Sezione di SCIENZE FARMACOLOGICHE e TOSSICOLOGICHE

CLINICAL STUDY

Evaluation of the efficacy of a food supplement to

strengthen and support hair growth

BIOCYTE

KERATINE FORTE®

_______________________________________________________________ __ out of 17 Farcoderm srl

Sede operativa: Via Angelini angolo Via dalla Chiesa - 27028 San Martino Siccomario - Pavia Sede legale: Via Don Natale Fedeli 3 - 20020 Arese - Milano


Protocollo n°/Record no°: FU.05.DS.L_2009/1061

date: 29/01/2010

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KEY PERSONNEL

Customer

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8 avenue Louis Gallet

06160 Juan Les Pins - France

Scientific Supervisor

Prof. Fulvio MARZATICO

Professor at the University of Pavia.

Laboratory of Pharmacobiochemistry

Pharmacology and Toxicology Division

Via Ferrata, 1 . 27100 Pavia. Italy

Tel. (0382) 986.390

Fax (0382) 986.390

Experimenter

Dr. Michela QUAGLINI

Dermatologist and Venereologist

Consultant to Farcoderm s.r.l.

Dermatological Cosmetic Service for Wellness

Via Angelini angolo via Dalla Chiesa.

Farcoderm srl 27028 San Martino Siccomario (PV). Italy

Technical Director: Dr. Angela MICHELOTTI

(Biologist)





date: 29/01/2010

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STUDY DESIGN

1.1. Title

Evaluation of the efficacy of a food supplement to strengthen and support hair growth.

1.2. Aim of the study

The study evaluates the efficacy of a food supplement to strengthen and support hair growth; in particular it was

evaluated whether the food supplement was able to positively interact with the hair ultra structure. To this end a

clinical-instrumental study was carried out on 20 healthy females with damage, fragile and stressed hair as a

consequence of endogenous (stress, genetic) and external (styling, aggressive treatments, UV exposure, etc) causes.

The study was carried out in accordance with User test method. Evaluations were performed after 30, 60 and 90 days

of daily product intake.

1.3. Tested products

1.3.1. Information provided by the Customer

Product name:

KERATINE FORTE®

The dietary supplement to be tested was manufactured in accordance with the laws in force and it is safe for

the human health.

How to use the product:

1) KERATINE FORTE®

: Take two capsules a day with a big glass of water.

Qualitative formula: Filed

1.4. Ethical requirements

The study was carried out in accordance with the following ethical requirements.

1.4.1. All the subjects participating in the study are healthy volunteers of at least 18 years old.

1.4.2. All of the subjects participating in the study are selected with the supervision of a dermatologist according to

inclusion/not inclusion criteria

1.4.3. The volunteers’ participations in the study are free.

1.4.4. All of the subjects participating in the study are informed of the aim and the design of the study.

1.4.5. All of the subjects participating in the study are informed of the possible risk involved in the study execution.

1.4.6. All of the subjects participating in the study give their informed consent signed at the beginning of the study.

1.4.7. Before volunteer exposure to the tested product, all relevant safety information about the product itself and

each ingredient were collected and evaluated.

1.4.8. All of the study procedures are carried out in compliance with the ethical principles for the medical research

(Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General

Assembly Helsinki, Finland, June 1964 and successive amendments)

1.4.9. All of the precautions are taken in consideration in order to avoid excessive skin reactions.

1.4.10. If any unexpected/adverse skin reaction occurres, medical investigating specialist evaluates the severity of

the reaction (reporting it in the volunteer’s data collecting sheet) and proceeds with appropriate therapy.





date: 29/01/2010

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1.5. Test subjects

1.5.1. Selection of the test subjects

The subjects participating in the study were selected by a dermatologist from a panel of healthy female subjects

(older than 18 years old) in accordance with the following inclusion/non inclusion criteria.

1.5.1.1. Inclusion criteria

Healthy female subjects

Age: older than 18 years old

Subjects with fragile and stressed hair who have not been involved in any other similar study for at least the

last 6 months.

Commitment not to use/intake products with the same characteristics as those of the tested product

throughout the study.

Commitment not to change the usual daily routine

Subjects aware of the test procedure that have signed an informed consent form

1.5.1.2. Non inclusion criteria

Subjects who do not fit the inclusion criteria

Pregnant or breastfeeding women

Subjects that have shown allergies or sensitivity to cosmetic products, toiletries, food supplements and/or

topical drugs

Subjects with dermatological problems on the test area

Subjects under pharmacological treatment (both locally or systemically)

Positive anamnesis for atopy

1.6. Test Procedure

Test was carried out as follows:

1) Enrolment of 20 female subjects in accordance with the study inclusion criteria who will intake 2 capsule a day of

Keratine forte® and will use a neutral shampoo/conditioner throughout 90 days of test.

2) Checks before (T0) and after 30 (T30), 60 (T60) and 90 (T90) days of daily product intake.

3) Evaluation of product efficacy based on clinical – laboratory evaluations performed before and after product

intake.

1.7. Laboratory evaluations

1.7.1 Qualitative analysis of hair ultra structure (restructuring effect)

Hair morphology was qualitatively analyzed by means of Scanning Electronic Microscopy (SEM). To reach this

goal, 3 pieces of hair were taken from each volunteer and analysed before and at the end of treatment (T0 and

T90).

Sample preparation:

The test materials were placed in a specific sample holder (Stub) and fixed by means of a small quantity of

adhesive; then they were coated with 30nm of gold to make them conductive.

Analytical determination

The observation was conducted using a scanning electron microscope (Stereoscan S-360 Cambridge Instruments)

sets as follows:

► 10 KV

► 100 Pa

► LUD = 10 mm





date: 29/01/2010

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1.7.2. Analysis of the strengthening efficacy by means of wash test

This test consists in washing volunteers’ hair under standardized conditions and in counting the number of lost

hair during the washing. Subjects whose hair is fragile, damaged, stressed with tendency to break should loose a

superior quantity of hair than those with healthy hair.

Wash test: volunteers avoided washing their hair for 5 days before each wash test. They came to Farcoderm to

have their hair washed at T0, T30, T60 and T90. For each wash the Experimenter used 8 g of neutral shampoo

and 14 g of conditioner. After collection and division of lost hair, Experimenter counted them.

1.7.3. Analysis of the strengthening efficacy by means of a dynamometer

Hair break point was evaluated through dynamometric measurements. Stronger is the hair the more the

strength to break it.

The strength to break the hair was measured at T0 and T90 by means of a dynamometer (Tensolab 2512A, Mesdan

Lab - see figure 1). Each dynamometer reading was performed on a single hair ( a mean of 10 measurements

were kept for each volunteer at each experimental time) setting the instruments as follows:

- lengthening velocity: 50 mm/min;

- sample length: 50 mm

- pre-tension: 5 cN

Figure 1 - Dynamometer

1.8 Clinical evaluation

The dermatologist evaluated the following parameters:

-State of the volunteers’ hair at the beginning of the study

- Tolerability of the treatment

-Hair brightness: in accordance with the clinical scores reported in the table below:

Table 1 - Hair brightness classification Score

Hair is dull and devoid of brightness 1

Hair is basically dull and not so bright 2

Hair is shiny and bright 3

1.9. Self assessment

At the end of the study volunteers were asked to give their opinion about the treatment by answering a questionnaire

using the following scores: excellent, good, fairly good, sufficient, insufficient.





date: 29/01/2010

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1. How do you evaluate product tolerability?

2. How do you evaluate food supplement efficacy in strengthening hair?

3. How do you evaluate food supplement efficacy in improving hair brightness?

4. How do you evaluate food supplement efficacy in restoring hair brightness?

5. How do you evaluate food supplement efficacy in reducing hair loss?

1.10. Results and statistic

1.10.1 Results

1) The results are reported in their respective unit in tables.

2) The mean values are calculated as:

20

20

1∑

=p

m [1]

where:

p is the value of the parameter analysed and 20 is the number of volunteers.

3) The standard error (SEM) of data is calculated as:

n

)1n(n

p)p(

SEM

n

1

2in

1

2i

−

−

=

∑∑

[2]

All the calculations are carried out by means of a Microsoft® Excel worksheet.

4) The mean percentage variations are calculated as:

∑−=

20

1 0

0T

X

XXVar(%) [3]

All the calculations are carried out by means of a Microsoft® Excel worksheet.

1.10.2 Statistical analysis

Data have been submitted to “ t-test” of bilateral student for pair data. The statistic significances are reported

as follows:

n.s. not significant p>0.05

* significant p<0.05

** very significant p<0.01

*** extremely significant p<0.001

The results of the study reported in this document are only referred to the tested samples and the specific experimental

conditions.

Any part of this report can only be reproduced with the consent of Farcoderm S.r.l.

A copy of this report is kept on file at Farcoderm S.r.l.

Both the informed consent and the information forms are kept on file at Farcoderm S.r.l. for 5 years after the date of issue of

the report





date: 29/01/2010

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RESULTS – SCANNING ELECTRONIC MICROSCOPY

TABLE 1 The table below shows some photographs taken with the electronic microscope at different enlargement

T0 -1000X T90-1000X

T0-5000X T90-5000X

T0-1000X T90-1000X

As images show, Keratine forte acts on hair ultra-structure; cuticle scales are improved (closer and more integrated)

after the treatment. The hair is thicker and more compact .





date: 29/01/2010

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RESULTS – STRENGTENING EFFICACY – WASH TEST

TABLE 2

The obtained data for each subject regarding number of lost hair during each wash test are reported in the table

below.

As images show, Keratine forte significantly reduces the number of lost hair during the wash test after both 60 and

90 days of product intake. The product co – adjuvant to reduce excessive hair loss by promoting trophism in the

hair .

n Vo l ID T 0 T 30 T 60 T 90 T 30 T 60 T 90

01 G032T 234 124 25 23 -47,0% -89,3% -90,2%02 C 091G 114 106 94 89 -7,0% -17,5% -21,9%03 B 019M 166 150 121 106 -9,6% -27,1% -36,1%04 C 063M 129 128 109 97 -0,8% -15,5% -24,8%05 I002S 148 138 120 113 -6,8% -18,9% -23,6%06 B 012G 132 135 120 100 2,3% -9,1% -24,2%07 P 068M 182 160 90 87 -12,1% -50,5% -52,2%08 R 022S 153 150 118 95 -2,0% -22,9% -37,9%09 B 002C 127 132 118 119 3,9% -7,1% -6,3%10 B 049L 148 126 121 100 -14,9% -18,2% -32,4%11 B 050R 158 138 130 114 -12,7% -17,7% -27,8%12 G019S 112 110 105 100 -1,8% -6,3% -10,7%13 S017G 125 120 118 98 -4,0% -5,6% -21,6%14 M 007D 236 220 189 150 -6,8% -19,9% -36,4%15 G070R 172 160 148 120 -7,0% -14,0% -30,2%16 O008R 160 170 152 130 6,3% -5,0% -18,8%17 S015R 127 130 116 96 2,4% -8,7% -24,4%18 G025M 124 126 112 92 1,6% -9,7% -25,8%19 G034S 114 110 98 70 -3,5% -14,0% -38,6%20 M 025A 162 165 150 130 1,9% -7,4% -19,8%

M ean 151,2 139,9 117,7 101,5 -5,9% -19,2% -30,2%SEM * 7,7 5,8 6,9 5,6t-test vs. T0 ---- 0,059 0,000 0,000

* mean standard erro r

WA SH T EST

WASH TEST

0,0

50,0

100,0

150,0

200,0

T0 T30 T60 T90

time (days)

mea

n va

lue

of lo

st h

air

thro

ugho

ut th

e w

ash

* * *

* p<0,05 vs T0 ** p<0,01 vs T0 *** p<0,001 vs T0

n.s

* * *





date: 29/01/2010

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RESULTS – STRENGTENING EFFICACY – BY MEANS OF DYNAMOMETER MEASUREMENTS

TABLE 3

The data obtained for each subject regarding hair break point evaluated through dynamometric measurements are

reported in the table below.

n Vo l ID T 0 T 90 T 90

01 G032T 92,9 110,6 19,1%02 C 091G 51,8 55,8 7,8%03 B 019M 45,0 47,9 6,4%04 C 063M 46,6 48,7 4,5%05 I002S 85,7 94,6 10,4%06 B 012G 57,8 61,4 6,3%07 P 068M 94,5 104,3 10,4%08 R 022S 88,9 93,7 5,4%09 B 002C 109,6 122,1 11,4%10 B 049L 100,8 107,7 6,8%11 B 050R 101,6 115,0 13,2%12 G019S 71,2 75,9 6,7%13 S017G 69,8 85,9 23,1%14 M 007D 113,9 126,9 11,4%15 G070R 91,9 99,5 8,3%16 O008R 66,3 75,8 14,3%17 S015R 94,1 99,3 5,6%18 G025M 129,6 143,8 10,9%19 G034S 77,0 96,4 25,2%20 M 025A 103,3 134,0 29,7%

M ean 84,6 95,0 11,8%SEM * 5,2 6,2t-test vs. T0 ---- 0,000

* mean standard error

M EA N F OR C E T O B R EA K T H E H A IR

* p<0,05 vs T0 ** p<0,01 vs T0 *** p<0,001 vs T0

MEAN FORCE TO BREAK THE HAIR

0,0

20,0

40,0

60,0

80,0

100,0

120,0

T0 T90time (days)

mea

n fo

rce

(cN

)

* * *

As images show, Keratine forte significantly increases the mean force to break the hair after 90 days of product

intake. Hair is fortified and shows more resistance to mechanical stress.





date: 29/01/2010

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VOL ID G032T C 091G B 019M C 063M I002S B 012G P 068M R 022SB 002C B 050R B 049L G019S S017G M 007DG070R O008R S015R G025M G034SM 025A

Na tural X X X X X

Styled hair

(s tretching,

permanenet

wa ve,etc)

X X X X X X X X X X X X X X X

stressed/fragi le X X X X X X X X X

ruined X X X X X X X X

fairly good X X X

Dry X X

Norma l X X X X X X X X X X X X X X

Oily X X X

Short X X X X X X

Medium lenght X X X X X

Long X X X X X X X X

Thick X X X X

Normal s i ze X X X X X X X X X

Thin X X X X X X

HAIR CONDITION

HAIR TYPE

HAIR LENGHT

HAIR SIZE

HAIR CONDITION

45%

40%

15%

0%

20%

40%

60%

80%

100%

stressed /fragile ruined fairly good

HAIR CONDITION

25%

75%

0%

20%

40%

60%

80%

100%

Natural hair Styled hair

RESULTS – CLINICAL EVALUATION – STATE OF HAIR AT THE BEGINNING OF THE STUDY

TABLE 4

Volunteers hair condition at the beginning of the Study are described in the table below.





date: 29/01/2010

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HAIR TYPE

10%

75%

15%

0%

20%

40%

60%

80%

100%

Oi ly ha ir

Normal ha i r

Dry ha i r

HAIR LENGHT

30%

30%

40%

0%

20%

40%

60%

80%

100%

Long ha ir

Medium lenght

Short ha i r

HAIR SIZE

20%

50%

30%

0%

20%

40%

60%

80%

100%

Thin hair

Normal size hair

Thick hair





date: 29/01/2010

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RESULTS – CLINICAL EVALUATION – HAIR BRIGHTNESS

TABLE 5

The data obtained for each subject regarding hair brightness is reported in the table below..

HAIR BRIGHTNESS

35,0%25,0%

10,0%

65,0%

65,0%

35,0%

25,0%

10,0%

55,0%

75,0%

0,0%

20,0%

40,0%

60,0%

80,0%

100,0%

T0 T30 T60 T90

time (days)

Hair is dull and devoid of brightness Hair is basically dull and not so bright

Hair is shiny and bright

n Vo l ID T 0 T 30 T 60 T 90 Legend

01 G032T 1 1 2 2 102 C 091G 2 2 3 303 B 019M 1 1 1 204 C 063M 2 2 2 305 I002S 1 2 3 3 206 B 012G 2 2 2 307 P 068M 2 2 3 308 R 022S 2 3 3 309 B 002C 1 2 2 210 B 049L 2 2 3 3 311 B 050R 2 2 2 312 G019S 1 1 2 313 S017G 1 1 1 214 M 007D 2 2 3 315 G070R 1 1 2 216 O008R 2 2 3 317 S015R 2 2 3 318 G025M 2 2 3 319 G034S 2 3 3 320 M 025A 2 2 3 3

M ean 1,7 1,9 2,5 2,8

H air is shiny and bright

H air is dull and devo id o f brightness

H air is basically dull and no t so bright





date: 29/01/2010

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RESULTS – SELF ASSESSMENT

HOW DO YOU EVALUATE PRODUCT TOLERABILITY?

GOOD

40,0%

EXCELLENT

60,0%

HOW DO YOU EVALUATE FOOD SUPPLEMENT EFFICACY IN STRENGTHENING HAIR?

SUFFICIENT

15,0%

FAIRLY GOOD.

20,0%

GOOD. 35,0%

EXCELLENT

30,0%

Note: 40% of volunteers referred they did not tolerate well the food supplement when they took it on

an empty stomach but if they took it after eating, the food supplement was well tolerated.





date: 29/01/2010

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HOW DO YOU EVALUATE FOOD SUPPLEMENT EFFICACY IN IMPROVING HAIR BRIGHTNESS?

SUFFICIENT

10,0%

FAIRLY GOOD

10,0%

GOOD

45,0%

EXCELLENT

35,0%

HOW DO YOU EVALUATE FOOD SUPPLEMENT EFFICACY IN RESTORING HAIR BRIGHTNESS?

SUFFICIENT

10,0%

FAIRLY GOOD

10,0%

GOOD

45,0%

EXCELLENT

35,0%





date: 29/01/2010

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HOW DO YOU EVALUATE FOOD SUPPLEMENT EFFICACY IN REDUCING HAIR LOSS?

INSUFFICIENT

5,0%SUFFICIENT

5,0%

FAIRLY GOOD

20,0%

GOOD

30,0%

EXCELLENT

40,0%





date: 29/01/2010

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CONCLUSIONS

On the basis of the data here presented, it is possible to conclude that the treatment:

BIOCYTE

KERATINE FORTE®

� Determines a higher resistance to stress and mechanical actions (combing, brushing,

washing..etc)

� Promotes hair trophism counteracting the excessive hair loss, strengthening the hair and

improving hair ultra- structure;

� Improves hair brightness

In the enrolled subject who performed the treatment throughout 90 days.

Laboratory data is also confirmed by both Dermatologist clinical evaluations and subject self assessment.

S. Martino Siccomario, 29th

January 2010

Experimenter

Scientific Supervisor

Dott.ssa MichelaMichelaMichelaMichela Quaglini Prof. Dott. FuFuFuFulviolviolviolvio Marzatico

Quality control

Dott.ssa AngelaAngelaAngelaAngela Michelotti

CONCLUSIONI I CONCLUS





date: 29/01/2010

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BIBLIOGRAPHY

1. Seidenari A, Diagnostica non invasive in dermatologia. Edition January 1998. pp. 487-495

ONCLUSIONI I CONCLUSIONS

2. The scientific committee on cosmetic products and non-food (sccnfp/0321/00) adopted by the sccnfp during the

plenary meeting of 24 october 2000 products intended for consumers- notes of guidance for testing of cosmetic

ingredients for their safety evaluation-p.61

3. UNI EN ISO 5079:1998 Textiles - Fibres - Determination of breaking force and elongation at break of individual

fibres.

4. Manuale del Cosmetologo. Tecniche Nuove. Edition 2007. Cap.10.

CONCLUSIONI I CONCLUSIONS





COCONCLUSIONI I CONCLUSIONS

NCLUSIONI I CONCLUSIONS


clinical study evaluation of the efficacy of a food ... · 1.4.10. if any unexpected ... will use a...

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