vivi-max® · test the possibility of a formulation of natural ingredients (vivi-max tablets), on a...

34
1 SOCIETA’ ITALIANA DI BIOLOGIA PRECLINICA VIVI-MAX® A NOVEL FOOD SUPPLEMENT FOR THE TREATMENT OF HAIR LOSS *Mestre (VE) – via Teatro Vecchio 1 – Padova – via Betti 22

Upload: phamcong

Post on 18-Apr-2019

215 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

1

SOCIETA’ ITALIANA DI BIOLOGIA PRECLINICA

VIVI-MAX®

A NOVEL FOOD SUPPLEMENT FOR THE TREATMENT OF HAIR LOSS

*Mestre (VE) – via Teatro Vecchio 1 – Padova – via Betti 22

Page 2: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

2

INTRODUCTION The loss of hair, a rather common phenomenon due to various causes, involves a number of people. At least 80% of men and 60% of women are thought to be affected by different forms of alopecia during their lifetime. Owing to the social and emotional effect of the problem, research has long tried to solve it, though with unsteady success up to now. Many remedies of different origin --animal, vegetal, synthetic or mixed-- have been attempted. From a pharmacological point of view, the latest attempt that has given some result was Minoxidil, a strong vasodilator, not free from unpleasant side effects. Actually the causes of the various forms of loss of hair are numerous and greatly differentiated: hormonal, nutritional, iatrogenic, psychosomatic, etc.. In order to stop the loss and stimulate a new growth, after removing the causes and independently of them, an adequate stimulation of hair structure will be necessary anyway, along with a full nutritional availability. Practically speaking, there are two possible ways to deal with the problem. A strictly specific -- extremely diversified-- action in order to remove any single cause of alopecia and only that; a second way, with a wider field of action, directed to improve the vital and nutritional features of hair and to stimulate its growth, with a possible action, also in extremely different situations. From the latter point of view, we wanted to test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3, B5, B6, B9, E, H and Copper, Iron, Selenium, Zinc inn new formulated bisglycinates and an increased amount of marine proteins) to stop the loss of hair in various forms of alopecia and eventually stimulate a new growth. MATERIALS AND METHODS 60 male and female subjects took part in the test, after the informed consent signature. They consciously accepted the possibility to have a placebo, therefore without any efficacy. The features of the subjects participating in the test are shown in Tables 1,2.

Page 3: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

3

Page 4: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

4

STUDY DESIGN 60 subjects with different forms of hair loss were devised in 2 categories: - 20 men and 20 women not in menopause At the enrolment visit, they were randomly assigned in group A and B. One group was randomly designed to receive active product for 3 months and the other one to receive a placebo looking like the active product also for 3 months - 20 women in menopause At the enrolment visit, they were randomly assigned in group C and group D. One group was randomly designed to receive active product for 3 months and the other one to receive a placebo looking like the active product also for 3 months At the second visit (3 months), all the subjects were evaluated and they all receive active product for 3 additional months cure. A third evaluation was performed at the 6th month. Therefore, this protocol was designed to address 3 issues : * efficacy of the product in a mix group (men and non menopausal women) on 3 months versus placebo * efficacy of the product in menopausal women on 3 months versus placebo * efficacy of the product in all the subjects on 3 additional months At each visit, the following evaluations were performed: - Ratio anagen-telogen - Progressive tensile strength with definition of maximum tensile stress - Estimation of seborrhea if present - Estimation of hairs lost on the pillow, on the comb and after the shampoo: the numerical datum results from the average of 7 surveys made in the week before the check - Assessments new growth: considered at T3 and T6 with the computation of the new hairs present in a sample area of 1cm2 in the forehead, temple dx and sin and occipital areas.(calculations at intermediate times, which are not shown , for the sake of brevity, were carried out). - The general humoral condition was investigated by: Hemochrome, Glycemia, Nitremia, Fe, Cu, Ferritine, Cholesterol, Cholesterol HDL, Triglycerides, Creatinine, and Proteidemia. The above mentioned surveys were made before beginning the test, at the end of the 3rd month of treatment, at the end of the test.

Page 5: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

5

- Estimation of the compliance of the product taken. - Statistic assessments by T of Student. Level chosen p=0.05 for all variables. Comparison T0-T3-T6 and comparison between groups A vs B, C vs D During the whole treatment no subject took drugs or used local treatments. One only type of shampoo was used (Baby Shampoo Johnson for delicate hair). The instructions for use for the 6 months study were to take 2 green tablets in the morning and 2 red tablets in the evening. RESULTS The results found are shown in the following tables and diagrams. The mean values observed are shown in Tables for sake of clarity.

Table 3 – Variations of parameters during the test: means and standard deviations. (Red = statistically significant)

Table 4 - % variations during the test (Red = statistically significant)

Page 6: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

6

Diagram 1 - Ratio anag/telog - variations (vertical lines = statistically significant)

Diagram 2 - Ratio anag/telog - % variations during the test (vertical lines = statistically significant)

Page 7: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

7

Diagram 3 - Resistance - variations during the test - vertical lines = statistically significant

Diagram 4 - Resistance - % variations during the test -vertical lines = statistically significant

Page 8: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

8

Diagram 5 – Seborrhea – Variations during the test – Vertical lines = statistically significant

Diagram 6 – Seborrhea - % variations during the test - – Vertical lines = statistically significant

Page 9: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

9

Diagram 7 – Hair on the pillow – Variations during the test – Vertical lines = statistically significant

Diagram 8 – Hair on the pillow - % variations during the test – Vertical lines = statistically significant

Page 10: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

10

Diagram 9 – Hair loss after shampoo – Variations during the test – Vertical lines = statistically significant

Diagram 10 – Hair loss after shampoo – % variations during the test – Vertical lines = statistically significant

Page 11: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

11

Diagram 11 – Hair on the comb –Variations during the test – Vertical lines = statistically significant

Diagram 12 – Hair on the comb –% variations during the test – Vertical lines = statistically significant

Page 12: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

12

Table 5 – Regrowth during the test – Means and standard deviations

Diagram 13 – Means of regrowth during the test

Page 13: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

13

DISCUSSION A few interesting data emerge from the results presented. 1.- First of all, it is evident that groups A,C had the active product since the very beginning, while groups B,D had it only at the beginning of the 4° month of test, having taken a placebo in the previous three months. 2.-The product tested shows a good activity: in groups A,C already in the 3°month of treatment there is an evident stop of loss, with a remarkable reduction of seborrea when present. 3.- The ratio anagen/telogen which somehow means hair vitality in the same groups and in three months only, shows a sudden rise that takes it from seriously low values to approximately normal values. (p=0,001) 4.- Also the progressive relevant increase of the progressive weight resistance of hair is of great interest: extremely weak at the beginning, testifies the structure fragility; at the 3°month , in groups A;C, it is almost normal and it is quite brought back to normal at the end of the test. (p=0,05) 5.- Similarly, a quick decrease of hairs on the pillow, on the comb and after the shampoo, shows the ready inhibitory action of loss which progressively slows down until it stops and then gives rise to a more and more rapid new growth, up to normalization. (p=0,05) 6.-These data, observed in groups A,C are confirmed by the behaviour of the same parameters in groups B,D, at the end of the test. In the later, which evidently took the placebo for the first 3 months, the improvement of An/Tel ratio, the increase of the tensile strength and the stop of loss occur with a trend virtually parallel to groups A,B, in the 2°quarter of treatment with Vivi-Max. 7.- Also the results achieved by groups C,D are significant, (p=0,05) since they are somehow better than what those recorded in the other groups, meaning that the complex menopause hormonal and nutritional situation is very favourably influenced by the preparation. 8.- For groups A,B the number of growing hairs (0 for A at time T0 and for B at time T0,T3) presents a considerable increase in only 3 months- which in group A is considerable at the 6th month of therapy. 9.- Also for groups C,D the new growth substantially behaves the same way as groups A,B. There is in fact a remarkable new growth at the 6° month for group A, C and similar increase for group B, D at the end of the 2° quarter of use of the preparation.

Page 14: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

14

CONCLUSIONS A.- The product is able to stop the fall and stimulate a new growth, with a double confirmation already after three months of treatment. Striking results in the normalization of hair resistance and in an almost complete control of seborrhea are moreover recorded. B.- The formula, maybe for its great richness in nutritional elements and for the presence of sea proteins, proves active on different forms of alopecia, with virtually identical results, but particularly efficacious in situations of menopause alopecia , in which a new growth appears particularly rich and abundant. C.- The capacity of the product to normalize fragility conditions of hair, bringing it back to a normal resistance, shows that its action not only affects its growth, but radically modifies all the structure features as well. D.- Similarly the intense normalizing action on seborrhea shows that the effects of the formula also involve a number of aspects of head cutis in a normalizing way. SUMMARY The efficacy of a new preparation based on nutritional elements and sea proteins on different forms of alopecia is researched in a double blind vs placebo instrumentally controlled test. The product proves active with statistically relevant results (p=0,05) on the an/tel ratio, on the tensile strength, on reducing seborrhea and in stopping loss. The result on the new growth is particularly evident and statistically significant (p= 0,001)

Mestre 17/05/2003 Dott. Mario Casarotto – Medico Chirurgo – Nutrizionista – Specialista Medicina di Laboratorio - Direttore Divisione Ricerca Società Italiana di Biologia Preclinica Mestre –Via Teatro Vecchio 1 - Padova – Via Betti 22 – e-mail: [email protected]

Page 15: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

15

REFERENCES Lassus A., Eskelinen E. - A comparative study of a new food supplement, Viviscal, with fish extract for the treatment of hereditary androgenic alopecia in young males. J Int Med Res. 1992, 20- 445-453 Hamilton JB. - Patterned loss of hair in man: types and incidence. Ann. NY Acad. Sci. 1951; 53 708-711 Lassus A.,Santalahati J., Sellmann M.- Treatment of hereditary androgenic alopecia in middle-aged males by combined oral and topical administration of special marine extract-compound. Nouv.Dermatol. 1994: 13 254-255 Weiss VC., West DP. et al. - Alopecia treated with topical Minoxidil. Arch. Dermat.1984; 120:457-463

Lo studio è stato eseguito presso la Divisione Ricerca della Società Italiana di

Biologia Preclinica –

Sedi operative : Mestre Via Teatro Vecchio 1 (VE) – Padova - Via Betti 22,

email – [email protected]

dal dottor Mario Casarotto, Medico Chirurgo, Nutrizionista, Specialista in Medicina

di Laboratorio – Direttore Divisione Ricerca della società Italiana di Biologia

Preclinica

Mestre 17/05/003

Page 16: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

16

Vivi – Max®

TREATMENT OF DIFFERENT FORMS OF ALOPECIA

androgenetic alopecia

diffuse alopecia

alopecia areata

Histological survey

Page 17: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

17

INTRODUCTION

The causes of the various forms of hair loss are numerous and greatly differentiated:

hormonal, nutritional, iatrogenic, psychosomatic, etc. In order to stop the loss and

stimulate a new growth after removing the causes and independently of them, an

adequate stimulation of hair structure will be necessary anyway, along with a full

nutritional availability. Practically speaking, there are two possible ways to deal with

the problem. A strictly specific – extremely diversified – action in order to remove

any single cause of alopecia and only that; a second way, with a wider field of

action, directed to improve the vital and nutritional features of hair and to stimulate

its growth, with a possible action, also in extremely different situations.

In an earlier research dealing with the problem from this point of view, we had taken

into consideration a mixed group of different forms of alopecia, treating them with a

new formulation of natural principles (FHF) which, after a six-month treatment, gave

very interesting results. Of course, the results observed reflected the mean behaviour

of the various forms of alopecia’s which had been assessed according to mainly

clinical parameters. The quality of results led us to carry on our research taking into

consideration small homogeneous groups of alopecia’s chosen among the

undoubtedly most frequent forms and rather different from one another as to

etiology and pathogenesis. We thought it appropriate to put a histological survey –

made before beginning consumption of FHF and after a three-month treatment –

beside the assessment of the related clinical data.

MATERIAL AND METHOD

Two groups of 25 subjects each took part in the test. One (group A) being treated

with FHF and the other (group B) serving as control. Both group A and Group B

consisted of: 10 subjects with androgenetic alopecia, 10 subjects with diffuse

alopecia and 5 subjects with alopecia areata with the features described in table 1

Page 18: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

18

Tab 1

GROUP A Range

Male 19

Female 6

Mean age (Years) 35,6 20 - 50

Mean weight (Kg) 68 55 – 80

Mean length (Cm) 173 160 – 186

Mean duration of loss (Months) 6 3 – 11

Type of hair loss

Alopecia areata 5

Alopecia androgenetic 10

Alopecia diffuse 10

Hamilton scale

Type II 3

Type III 5

Type IV 2

GROUP B Range

Male 20

Female 5

Mean age (Years) 36,5 22 - 51

Mean weight (Kg) 70 58 – 87

Mean length (Cm) 172 158 – 183

Mean duration of loss (Months) 4,9 2 – 9

Type of hair loss

Alopecia areata 5

Alopecia androgenetic 10

Alopecia diffuse 10

Hamilton scale

Type II 4

Type III 5

Type IV 1

Page 19: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

19

STUDY DESIGN

Having ascertained in our earlier research the effectiveness of Vivi-Max in causing

the stop of loss, new growth and relevant improvement in the parameters

observed, this study – aiming at comparing the behaviour of three very frequent

types of alopecia with the histological control – is carried out with the simple

scheme of “treated v/s non treated”.

The following surveys were considered for the two groups at times T0 – T3:

! Ratio anagen-telogen

! Progressive tensile strength with definition of maximum tensile stress

! Estimation of seborrhea, if present, with sebometer

! Assessments new growth: considered at T0 and T3 with the computation of the

new hairs (no vellus) present in the sample area of 1 cm2 in the forehead, temple

Dx and Sn and occipital areas.

! Histological test at T0 and T3 on a sample taken from the maximum loss area

! The general humoral condition was investigated by :

Hemochrome, Glycemia, Nitremia, Fe, Cu, Ferritine, Cholesterol, Cholesterol HDL,

Triglycerides, Creatinine, Protidemia, T3, T4, TSH.1

! Loss index: mean value observed by assessment during four days of the hairs

found on the pillow on awaking, on the comb after use and after shampoo.

Evaluated at T0 and T3

! Dermal thickness measured with Dermascan C at T0 and T3 (normal value : 2,50 – 3)

The histologic test appeared to be the only scientifically acceptable means to have a

precise monitoring of the phenomena studied. We are aware that any form of even

slightly invasive survey is nowadays tendentially avoided; the free and total consent

of the volunteers studied allowed us to carry out our research. As to technique

applied, we preferred the use of traverse sections, in accordance with the most up-

to-date trends (Whithing). Actually the usual vertical section technique appears to

be of very little value since the number and types of items found for each section

1 G.R. –erythrocytes – x 1000000 – 4 – 5,2 ; G.B. – leukocytes – effective number – 3,5 – 11; Hb – haemoglobin – g/dl –12 - 16

Fe – serum iron - micg/dl – 37-145; Ferritina – ferritin – ng/ml – 13-135; Glicemia – glycemia – mg/dl – 75-110;

Azotemia – nitremia – mg/dl10-50; Colesterolo totale – total cholesterol - mg/dl 80 – 200; Trigliceridi – triglycerides – mg/dl

30 – 170; HDL – HDL cholesterol – mg/dl 35 – 130; Creatinina – creatinine – mg/dl 0,7 – 1,3; Protidemia – proteidemia tot. g/dl

6,0 – 8,0; T3 (immunochemil.)2,0 – 4,0; T4 (immunochemil.)0,7 – 1,8 ; TSH(immunochemil.)0,25 – 5.

Page 20: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

20

brings with it a high sample error. Moreover not all follicles of every sample are

pathologic; picking the pathologic follicle in a vertical section no good chance and

above all does not allow to know the ratio between pathologic and non pathologic

follicles, which is absolutely necessary for a correct diagnosis of the situation.

During the whole treatment no subject took drugs or used local treatments. One only

type of shampoo was used (Baby shampoo Johnson for delicate hair)

RESULTS

The experiment did not exceed three months owing to obvious ethical reasons, since

prolonging the lack of therapy for the controlling group was not possible.

The results achieved are shown in Tables 2,3,4,5 and the corresponding diagrams.

Tab. 2

Tab 3

Page 21: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

21

Tab 4

Diagram 1

Page 22: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

22

Diagram 2

Diagram 3

Page 23: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

23

Diagram 4

Diagram 5

Page 24: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

24

Diagram 6

Tab 5

Diagram 7

Page 25: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

25

At T3, group A (treated with Vivi-Max) shows evident variations in all parameters considered

and an evident tendency to a new growth in the tested areas. The controlling group shows

no noteworthy variation and above all no evidence of a new growth is present. In particular,

moreover, interesting differences in the behaviours of the three pathologies considered were

noticed in group A:

In group “Alopecia androgenetic” the most marked variations occur between T0

and T3

-increase of 141,84 % in a/t ratio

-increase of 273,29 % in resistance

-increase of 27,77% in dermal thickness

-decrease of 63,41 % in seborrhoea

-decrease 46,66% in loss index

- presence of a fair new growth in the areas considered

The variations of group “Alopecia diffuse” are slightly inferior, but all the same

very evident

-increase of 120,0% in a/t ratio

-increase of 266,12 % in resistance

-increase of 26,63% in dermal thickness

-decrease of 69,23 % in seborrhoea

-decrease of 46,0% in loss index

- presence of a fair new growth in the areas considered

The results achieved by group “Alopecia areata” are definitely less evident, even

though appreciable anyway

-increase of 133,80 % in a/t ratio

-increase of 338,11 % in resistance

-increase of 20,72% in dermal thickness

-decrease of 63,15 % in seborrhoea

-decrease of 44,68% in loss index

- presence of a fair new growth in the areas considered

At the histological control the subjects of all groups A show evident aspects of

normalization clearly contrasting with the histologic data observed at T0 with the

reorganization of the structures and appearance of new normal items. In the subjects of

group B no noteworthy variations can be noticed and the histologic outlines are quite

unchanged. All blood figures showed no sensible variations from T0 to T3

Page 26: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

26

Vivi-Max – HISTOLOGIC DATA BIOPSY

Picture 1 - Alopecia areata - After treatment the structures look fairly

reorganized with normalised aspects – Magnification x40

1 A - Peribulbar mononuclear cell infiltrate. Inflammatory cells into bulbar

epithelium. Intracellular oedema, vacuole formation terminal telogen hairs.

1 B - Normality

Picture 2 - Alopecia androgenetic - The remarkable structural variations

present at T0 are almost completely disappeared giving rise to normal images –

Magnification x40

2 A - Normal total number of follicles. Presence of fibrous streamers below

miniaturized hairs

2 B – Normality

Page 27: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

27

Picture 3 - Alopecia diffuse – The situation of serious disorders present at T0,

with lymphocitic inflammation, appears virtually got over. Magnification X 40

3 A - Decreased hair density; miniaturization of hairs; chronic lymphocytic

inflammation with perifollicular fibroplasias.

3 B - Normality

Page 28: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

28

DISCUSSION AND CONCLUSIONS

The clinical data we assessed -however in a rather short test - totally confirm what had

already observed in our earlier research. In particular, the total assessment of the 25 cases

shows figures that are quite super imposable on as those observed at T3 of our earlier

trial, while the behaviours of the controlling groups are basically the same as the data of

the groups then treated with a placebo.

The impressive variations in the histologic data go along and partially go before clinic

variations, as the dermal elasticity data assessed with Dermascan is confirmed by the

histologic improvement of the skin connective structures.

As to the different pathologies studied, we can state that the undoubtedly most brilliant

results were achieved in the group of androgenic alopecia, the results shown by diffuse

alopecia’s are slightly less evident while those achieved by alopecia areata were the least

evident, however very good anyway. The differences in response of the three groups may

possibly be due to different times of reaction for each situation in addition to a different

sensibility to the integrator.

We therefore think we can state that:

1.-Treatment with Vivi-Max brings about a remarkable tendency to normalization

of all altered parameters already ever since the end of the first three months

2.-The histologic test shows that the normalization is strictly related to an actual

reorganization of hair and skin structures (Pictures.1,2,3)

3.- At T3 assessment the loss is remarkably slowed down while there are evident

signs of an initial stage of regrowth which shows the appearance of new healthy

items.

Page 29: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

29

We think therefore we can infer that:

a) Vivi-Max can bring back to normal head skin altered features, as shown by the

histologic data assessed.

b) Parallely hair structural and functional features get back to normal - a

histological confirmed datum.

c) The loss percentage decreases ever since the third month of treatment at a

statistically significant rate

d) An impressive new growth starts along with the loss decrease

e) The histologic test of the data assessed appears to be the determinant factor of

our research as it can supply an objective confirmation of the remarkable

variations caused by Vivi-Max in hair and skin structures.

SUMMARY

Three groups with different forms of alopecia (androgenic, areata,

diffuse) were treated for for three months with Vivi-Max -a food

integrator with sea proteins- and clinically and histologically controlled.

The assessments showed: stop of loss, appearance of a new growth and

histologic skin and hair normalization.

No variation was noticed in the controlling group.

Page 30: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

30

REFERENCES

Hamilton JB. - Patterned loss of hair in man: types and incidence. Ann. NY Acad. Sci. 1951; 53 708-711 Hordinsky M.,Sawaya M.,Roberts JL. – Hair loss and hirsutism in the elderly. Clin Ger.Med. 2002 18:12-33 Lassus A., Eskelinen E. - A comparative study of a new food supplement, Viviscal, with fish extract for the treatment of hereditary androgenic alopecia in young males. J Int Med Res. 1992, 20- 445-453 Lassus A.,Santalahati J., Sellmann M.- Treatment of hereditary androgenic alopecia in middle-aged males by combined oral and topical administration of special marine extract-compound. Nouv.Dermatol. 1994: 13 254-255 Sperling L.C. – The evaluation of hair loss – Curr. Probl.dermatol. 1996;8:99-136 Weiss VC., West DP. et al. - Alopecia treated with topical Minoxidil. Arch. Dermat.1984; 120:457-463 Whithing D.A. – The histopathology of alopecia areata : a new look. Poster presentation at the 4th International Research Workshop on Alopecia areata. November 2002. Washington DC : in press.

Page 31: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

31

VIVI-MAX®- product information A dietary supplement with an optimized mix of hair nutrients

VIVI-MAX ® helps in regenerating and maintaining hair quality, thanks to its unique combination of nutrients. These are working at 4 complementary levels: 1. A MARINE COMPLEX (fish gelatin, shark cartilage): several studies with similar ingredients have shown their effects in normalizing excessive hair loss and in stimulating hair growth. This beneficial effect was observed both for men and women and generally after 3 to 4 months cure. 2. Milk proteins rich in amino acids: VIVI-MAX® is a source of all essential amino acids, mainly sulphur-containing amino acids (Methionine and Cysteine) which are important for keratin synthesis. 3. Vitamins: VIVI-MAX® contains 8 vitamins (A, B2, B3, B5, B6, B9, E et H) that are essential for a hair root optimal metabolism. Thus they influence hair quantity, quality and growth rate. 4. Trace elements : VIVI-MAX® contains 3 important trace elements ( Zinc, Copper and Selenium ) . Zinc and Copper are necessary for enzymatic , reactions , including keratin synthesis. Selenium is an antioxidant protecting cells-including hair root cells against free radicals. TO BE USED IN THE EVENT OF Dull and brittle hair as a result of various factors: * frequent exposure to sunlight, wind, salt-water, ... * aggressive treatments (dyeing, bleaching, perms) Excessive hair loss due to *hormonal changes (e.g. menopause) * excessive grease production or dandruff * metabolic imbalances, unbalanced diet (dietary treatment) * stress, exhaustion * side-effects of certain drugs Thanks to its unique combination of ingredients that operate on four different levels, VIVI-MAX® is the first choice for combating excessive hair loss and regenerating/maintaining hair quality (shiny, good-looking and elastic).

Page 32: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

32

These properties have been confirmed by the results of a clinical study: after 3 months cure with VIVI-MAX®, a dramatic decrease of hair loss- and an improvement of pulling resistance were observed. INSTRUCTIONS FOR USE Hair loss: 1. Excessive hair loss Daily dose: take 1 tablet in the morning and 1 tablet in the evening before meals with a 1/2 glass of water 2. Serious hair loss: In this case one should immediately start with a daily dose of 2 tablets in the morning and 2 tablets in the evening, to be taken before meals with a 1/2 glass of water. Dull and brittle hair, loss of elasticity: Daily dose: take 1 tablet 'in the morning and 1 tablet in the evening before meals with1/2 glass of water. Duration of the treatment: Hair growth is a slow process: any loss in hair quality will only become visible after weeks or even months. Conversely, it will take some time before the positive effects of the treatment are discernible. Therefore, to achieve optimal results, VIVI-MAX® must be taken without interruption for at least three months. Packaging: VIVI-MAX® is available in a pack of 60 tablets Store in a dry and cool place. Warning: VIVI-MAX ® does not contain hormones and therefore does not cause the growth of unwanted hair. VIVI-MAX® may not be used by persons who are sensitive to fish products. Pregnant women: do not exceed the recommended daily dose of vitamin A. VIVI-MAX® is sold by pharmacies INGREDIENTS:

polyethylene glycol (filler), milk serum proteins (WPC 80), fish proteins rich in collagen, Shark cartilage, silicon dioxide (anticlotting agent), magnesium stearate (anticlotting agent), iron bisglycinate, zinc bisglycinate, glycerides, selenium yeast (0,2%), Tocopherol acetate (Vit E), hydroxypropylmethylcellulose (coating), Polydextrose (coating), nicotinamide

Page 33: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

33

(vit B3), Titanium dioxide (opacifier), copper bisglycinate, Biotine, Calcium Pantothenate (vit B5), retinyl acetate (vit A), Iron oxide (colorant), Pyridoxine hydrochlorate (Vit B6), Riboflavine (Vit B2), Folic acid.

NUTRITIONAL VALUES per tablet per 100 g per 2 tablets per 4 tablets Energy (Kcal) 2.24 228.57 4.48 8.96 Energy (Kj) 9.52 971.44 19.04 38.08 Proteins 0,538 54,89 1.076 2.152 Carbohydrates 0,000 0,00 0,00 0,00 Lipids 0,010 1,02 0,02 0,04

per

tablet

Per100g 2

tablets

%

RDA*

4

tablet

s

%

RDA*

Milk serum

proteins

(WPC 80)

with high

concentrati

on on

sulphonate

d amino

acids

200

mg

20,41 g 400 mg --- 800

mg

---

Marine

complex

(fish

gelatin and

shark

cartilage)

337,5

mg

34,44 g 675 mg --- 1.350

mg

---

Selenium 12.5

mcg

1.28

mg

25mcg 45,5% 50

mcg

91%

Biotin (vit

H)

37.5

mcg

3,83

mg

75 mcg 150% 150

mcg

300 %

Vitamin B2 0.4 40.8 0,8 mg 57,2% 1.6 114,3%

Page 34: VIVI-MAX® · test the possibility of a formulation of natural ingredients (VIVI-MAX tablets), on a basis of a well-controlled pool of nutritional ingredients (Vitamins A, B2, B3,

34

mg mg mg

Folic acid 50

mcg

5,1 mg 100

mcg

25 % 200

mcg

50%

Vit B6 0.5

mg

51 mg 1 mg 71,5% 2 mg 143%

Vit A 200

mcg

RE

20,4

mg

400mcg

RE

50 % 800

mcg

RE

100 %

Iron 2.5

mg

255 mg 5 mg 35,7% 10

mg

71,4%

copper 0.5

mg

51 mg 1 mg 100

%

2 mg 200%

Vit B5 1.5

mg

153 mg 3 mg 50% 6 mg 100%

vit B3 4.5

mg

0,46 g 9 mg 56,3% 18

mg

112,5%

vit E 2.5

mg

255 mg 5 mg 41,5% 10

mg

83 %

zinc 3.75

mg

383mg 7,5 mg 75% 15

mg

150 %

*According to Directive 2008/100/EC Distributed by: EuroLibano La Pergola Center - Jounieh - Lebanon. E-mail: [email protected]