ITTO20100418A1 - COMPOSITIONS FOR THE TREATMENT OF SCALP LEATHER - Google Patents

Description

"Compositions for the treatment of the scalp"

Object of the invention

The present invention relates to various compositions usable for the topical treatment of the scalp and particularly suitable for the treatment of androgenetic alopecia and other forms of baldness.

Description of the invention

The most common form of hair thinning (baldness) is represented by androgenetic alopecia or AGA (acronym for Andro Genetic Alopecia) which affects about 80% of the male population and 50% of the female one. AGA is not due to pathological processes and does not produce symptoms that are harmful to health and therefore cannot be considered a disease.

However, on a psychological level, the aesthetic alterations that characterize AGA are often experienced with profound discomfort and with negative social and psychosomatic repercussions such as to justify the search for remedies to prevent and treat this paraphysiological condition.

The greater frequency of AGA in men compared to women is due to its double pathogenetic origin, i.e. the presence of male hormones (androgens) and the genetic predisposition of the hair follicles to undergo involutionary stimuli. However, blood levels of testosterone (the main male sex hormone) are not necessarily elevated in AGA. Instead, the sensitivity of the cells of the hair matrix to androgens is increased.

This phenomenon of a genetic nature is not uniformly distributed throughout the scalp, but mainly affects the frontal areas and the vertex and does not concern the occipital area from which the typical M-shaped distribution of AGA derives. Another very important genetic factor is the presence in the hair follicles of the frontal area and the vertex of type 2 5-alpha-reductase, an enzyme that transforms testosterone into dihydrotestosterone (DHT), much more powerful than testosterone in accelerating the evolution of the hair from the anagen (growth) phase to the involution (catagen) and the rest and apoptosis (telogen) phase. Due to the effect of DHT, the hair becomes shorter and thinner, until it is unable to adequately cover the scalp. Furthermore, the follicles take on increasingly synchronized growth and involution cycles, with episodes of abundant hair loss in the telogen phase (telogen effluvium).

In women, AGA almost never occurs during fertile age but in menopause, when the endocrine activity of the ovary ceases with the consequent lack of estrogen hormones. In fact, estrogen hormones counterbalance the androgenic hormones also present in women which are mainly of adrenal origin and continue to occur even in menopause.

The dominance of androgens causes the typical virilism phenomena that are often observed in menopausal women. The supply of hormones or estrogenic substances to the postmenopausal woman restores the balance between estrogen and androgenic hormones and is effective in maintaining normal hair growth and preventing climacteric AGA.

The supply of estrogenic substances is useful to fight AGA also in humans, because these substances compete with DHT at the level of the cells of the hair matrix and neutralize its effects.

Based on these pathophysiological premises, the remedies to prevent or slow down AGA can be focused on three main addresses, namely:

1) inhibit 5-alpha-reductase to prevent the conversion of testosterone to DHT;

2) provide hormones or estrogenic substances to counteract the effects of androgens; And

3) bring substances capable of stimulating the differentiation and activity of the cells of the hair matrix to promote growth and maintenance in the anagen phase.

As for the method of administration of the active ingredients, the topical one should be preferred on the areas of the skin affected by AGA to obtain the maximum concentration of the active ingredients in the site where they are needed and not to cause adverse systemic effects. This route of administration requires a careful choice of the active substances and the verification that they have physico-chemical properties suitable for being absorbed at the scalp level.

The purpose of the present invention is therefore to provide a composition comprising a combination of active ingredients, suitable for exerting the aforementioned actions, particularly in topical application and also suitable for jointly determining a synergistic effect in the prevention and control of leather dysfunctions. scalp and in particular for the prevention, slowdown and treatment of AGA.

In view of these purposes, the subject of the invention is a composition as defined in the attached claims, which form an integral part of the present description.

Experimental part

Rational

The efficacy of the substances object of the present invention was evaluated by means of the technique developed by Michael Philpott on human hair bulbs grown in vitro.

This technique offers many advantages because: a) it uses human biological material taken from areas of the scalp subject to AGA and therefore very representative of the conditions in which AGA clinically occurs;

b) allows to study the effects of the substances under examination directly on the cells of the hair matrix and therefore in conditions very similar to what happens after topical application;

c) allows to evaluate also morphologically the state of activity of the bulb;

d) it is a standardized and validated technique that allows to obtain reproducible and consistent quantitative results; And

e) does not use animals and therefore complies with the recommendation of the European directive to reduce as much as possible the use of experimental animals in the study and development of cosmetic preparations.

The formulations described in the present invention are based on natural compounds capable of interrupting the pathophysiological mechanisms of AGA at different levels.

For this purpose, the following were used:

1. substances capable of inhibiting 5-alpha-reductase and preventing the conversion of testosterone into DHT; 2. substances with estrogenic action capable of counteracting the activity of androgenic hormones chosen from those included in the International Nomenclature of Cosmetic Ingredients (INCI) lists for cosmetics, also taking care that their nature and the doses applied did not expose the subjects to effects unwanted systemic;

3. substances capable of stimulating the differentiation and activity of the cells of the hair matrix and favoring their growth and maintenance in the anagen phase.

Substances used

Blend of fatty acids (MA)

It is known that various aliphatic fatty acids are able to inhibit 5-alpha-reductase in the cells of the follicle and of the hair matrix and that for saturated fatty acids the greatest activity is carried out by those with chains from C12 to C16, in descending order. These fatty acids also provide useful energy support for the synthetic and multiplicative activities of the cells of the hair matrix and stimulate hair growth.

On the basis of the results of a preliminary study not reported here, lauric acid (dodecanoic acid) with 12 atoms of C, palmitic acid (acid hexadecanoic) with 16 C atoms and stearic acid (octadecanoic acid) with 18 C.

Some unsaturated fatty acids are also recognized as effective in inhibiting 5-alpha-reductase in the cells of the follicle and hair matrix, namely oleic acid (Z-9-octadecenoic acid) monounsaturated with 18 C atoms and acid linoleic (Z, Z-9,12-octadecadecadienoic acid) biunsaturated with 18 atoms of C.

To obtain the best results, a mixture of the aforementioned fatty acids was used consisting of: 50% linoleic acid, 20% lauric acid, 10% oleic acid, 10% stearic acid and 10% palmitic acid.

Soy isoflavones (IS)

Soy isoflavones (IS) are natural plant substances, present in dietary soy, which exert estrogenic properties and are therefore called "phytoestrogens". They are less potent than the main female estrogenic hormone, estradiol, but have the advantage that, at adequate doses, they do not generate adverse side effects.

Furthermore, it should be emphasized that there are two basic types of estrogen receptors, namely alpha receptors (Alpha ER) and beta receptors (Beta ER) which have a very different distribution in the various tissues and organs of our body. Alpha ERs are mainly present in the endometrium, ovarian stroma and mammary gland. Beta ERs are instead present in the cells of the kidney, brain, intestinal mucosa, bone marrow and skin. In the cells of the follicles and the hair matrix we find above all the Beta ER.

Due to this peculiar distribution of estrogen receptors, the stimulation of the Alpha ERs causes effects on the endometrium and on the breast, useful for procreative functions, but dangerous if in excess. The stimulation of Beta ER is instead useful for the trophism of the sensitive tissues mentioned above and in particular for the trophism of the skin and hair, both in women and in men.

In particular, the stimulation of the Beta ER of the follicles and the hair matrix antagonizes the AGA-gene effects of androgens and promotes hair growth and its maintenance in the anagen phase. IS mainly stimulate Beta ERs and do not cause estrogenic effects that can be harmful for women and annoying for men (gynecomastia and erectile dysfunction).

Another chemical characteristic of IS should also be mentioned. They can be present in soybeans in conjugated form with glucose (glucosidic form) and in free form (aglyconic form). The glycosides have very polar properties, do not pass through the epidermis and therefore are poorly bioavailable at the follicular level after topical skin application.

Conversely, IS in aglyconic form have hydro / lipophilic properties very suitable for transcutaneous penetration, so that and after topical application on the scalp they are bioavailable at the follicle and hair matrix level. The aglyconic IS therefore have optimal physicochemical properties for the topical application of an AGA-contrasting preparation.

The main isoflavones in aglyconic form that are best documented are genistein (4â € ², 5,7-trihydroxyisoflavone) and daidzein (4 ', 7â € “dihydroxyisoflavone).

Genistein: In addition to exerting beta-estrogenic effects, it is also endowed with a strong antiandrogenic power and therefore performs a double action to fight AGA. Genistein also has a "quenching" effect on ROS (reactive oxygen species) and "turns off" reactive oxygen radicals known to be harmful to the skin and cause its premature aging. Finally, genistein also exerts inhibiting properties on 5-alpha-reductase in the cells of the hair follicle and matrix and further contributes with this action to prevent and counteract AGA.

Daidzein: In turn, it is particularly interesting because it is converted by the intestinal bacterial flora into its most important metabolite and that is Equole (4 ', 7â € "dihydroxy-isoflavian) which, according to studies carried out at the University of Colorado, occupying the DHT receptor, manages to block its activity, thus opposing the excess of testosterone and consequently contributing to maintaining an environment favorable to normal hair trophism.

In the composition according to the invention, the isoflavonic phytoestrogens can be used in the form of plant extract, in particular as soybean or red clover extract, or as single active agents, i.e. as genistein and dazein and their mixtures . The term soy isoflavones is therefore to be understood as including the extracts and individual active agents mentioned above.

Chondramine (CA)

Premise: The hair bulb, which regulates and determines the entire life cycle of the hair (anagen, catagen and telogen phases), is located in the dermis and any type of irregularity both in the structure and in the correct functioning of the components of this tissue can have a pathological impact on the scalp causing the onset of various dysfunctions including, for example, AGA.

The dermis is located just below the epidermis and represents the connective tissue of the skin. The elasticity, thickness and support capacity of the skin itself depend on it.

In the dermis, three fundamental constituents can be distinguished, namely:

The fundamental substance: a gel that permeates the entire dermis, the main constituents of which are:

- hyaluronic acid (AI) composed of disaccharide structural units which in turn consist of N-acetyl-glucosamine monosaccharides and D-glucuronic acid; AI has the ability to recall water in quantities equal to hundreds of times its weight and is the main responsible for skin tone;

- glycosaminoglycans (GAGs) which in turn consist of long disaccharide chains in which the monomers are represented by glucosamine or galactosamine and uronic acids; GAGs carry negative charges due to the presence in the molecule of sulphonic groups and this structure explains their powerful ability to attract positive ions and enormous quantities of water. They attach themselves to protein chains to form proteoglycans and, together with AI, to which they bind covalently, and collagen fibers, constitute the extracellular structure of the connective tissue and therefore of the skin.

Fibers: they are composed of two main constituents of a glyco-protein nature, namely:

- the already mentioned collagen which constitutes up to 75% of the dermis and is, together with AI, responsible for the tone and elasticity of the skin;

- elastin whose fibers, much less numerous than collagen fibers, intertwining with the collagen itself, give elasticity to the entire skin structure.

Cells: among the cells that populate the dermis, the important ones from a structural point of view are the fibroblasts responsible for producing the constituent elements of the collagen and elastin fibers as well as the proteoglycans (and therefore AI and GAG) and the glycoproteins of the fundamental substance.

Characteristics of Chondramine (CA)

CA consists of a molecular composition whose constituents are N-acetyl-glucosamine (NAG) and Sodium Sulphate (SS). In the ROTTAPHARM patent application WO2008 / 113819 an advantageous synergism of action between the two components is demonstrated and highlighted in exercising a stimulating action in the production of substances useful for the trophism of the skin and such as to recommend a useful use in dermocosmetics.

The synergism of action between NAG and SS, as demonstrated in the aforementioned patent, reaches its maximum when the molecular ratio between NAG and SS is equal to 2: 1, corresponding to a percentage by weight of the NAG of 75.7% (MW = 221.21) and 24.3% (MW = 142.04) of the SS, and it is precisely in these molecular / weight ratios that the composition in question is called Chondramine.

Within the scope of the invention, however, the use of mixtures of NAG and SS (in particular anhydrous sodium sulphate) in a molecular ratio between 1: 0.25 and 1: 1.5 is contemplated.

Going into the details of the functional characteristics of the two components, the CA should be highlighted that:

- NAG constitutes the fundamental substrate for the biosynthesis of AI by fibroblasts of the dermis and, at the same time, it is also a source of glucosamine, the starting point for the biosynthesis of GAGs, in turn, fundamental components of proteoglycans which, together with collagen they are mainly responsible for the rheological characteristics of the fundamental substance of the dermis. Glucosamine also:

1) counteracts the expression of COX-2 and cytokines (IL-1β, NFκB) responsible for the denaturation processes of the fundamental substance of the dermis and of collagen and elastin fibers;

2) it reduces the activity of PLA2 (phospholipase A2), an enzyme that hydrolyzes phospholipids and which gives rise to free fatty acids and pro-inflammatory substances such as arachidonic acid;

3) it reduces the expression of elastase, an enzyme that attacks, denatures and depolymerizes the elastin fibers, thus compromising the elasticity of the skin and causing it to sag;

4) as already mentioned, glucosamine is a precursor of hyaluronic acid, the biopolymer with a very strong hydration capacity that prevents sagging and withering of the skin, makes fine wrinkles disappear and gives the skin a healthy and youth; The right hydration of the dermis is also necessary for the inflow of nutrients to the epidermis, the hair follicle and other skin appendages;

- the SS, or the other component of the CA, acts as a source of Sulphate ions (SO4 <-2>) destined for the biosynthesis of GAGs and proteoglycans present in the dermis, thus functioning as a useful synergistic support to the already described beneficial effects of NAG and glucosamine.

In conclusion, chondramine constitutes the molecular substrate in the biosynthesis of many substances necessary for the trophism of the skin and hair. CA also exerts a mild anti-inflammatory action that counteracts the sub-inflammatory processes that are observed in the scalp affected by AGA and that aggravate its evolution.

Experimental procedure

As previously mentioned for the evaluation of the object of the present invention, the Philpott technique was used. The hair follicles with hair in the anagen phase were obtained by means of targeted collection with a 0.3 mm punch from subjects who had undergone hair micro-transplantation and who had agreed to join the experiment.

The sampling was carried out both from the occipital area naturally free from AGA, and from the frontal and vertex area clinically affected by AGA. The bulb complex consisting of dermal papilla, matrix, internal and external epithelial sheaths and emerging hair shaft for a length of 1 mm were isolated by controlled microdissection under a stereoscopic microscope. The microdissection was performed taking great care to isolate the bulb intact, without damage to any of its parts.

The isolated bulbs were stored in 500 µl of William E culture medium with the addition of 10 ng / ml of hydrocortisone, 10 µg / ml of insulin, 2mM of L-glutamine, 100 µg / ml of streptomycin and 100 U / ml of penicillin. The follicles were kept free to float individually in the soil inside wells at 37 ° C, in an atmosphere of 5% CO2.

Under these conditions a bulb in the anagen phase can maintain its active state for over 96 hours. During this period of culture there are no changes in the structure of the follicle, nor in its normal mechanisms of cell proliferation and migration. The matrix also retains the synthesis capacity of keratin which promotes normal hair growth for about 0.3 mm per day, comparable to normal growth in vivo.

Various works have shown that the addition to the culture medium of various substances with activating or inhibiting action (FCS, IGF1, EGF, TGFß, minoxidil, etc.) the growth of the bulbs can be prolonged or inhibited depending on the substance or its concentration in the medium, thus validating the usefulness of the method for testing the compounds under examination.

For each single bulb, the persistence of the bulbs in the anagen phase and the growth of the stem in mm was evaluated by means of an optical microscope in the days following the explantation up to the sixth day, at intervals of 24 hours.

With this procedure, 60 "normal" bulbs were isolated from 5 subjects, ie coming from the occipital area free from AGA and 25 bulbs from frontal or vertex areas obviously affected by A-GA.

The effects of the test substances were evaluated by adding the substances to the culture medium at the following concentrations:

MA (Mixture of fatty acids) 8 µg ml <-1>

CA (Chondramine) 10 µg ml <-1>

IS (Soy isoflavones) 10 µg ml <-1>

POOL (Pool of 3 active ingredients) 28 µg ml <-1>.

The concentrations of the individual active ingredients were chosen on the basis of the results of a previous indicative study, conducted with the Philpott technique, with the aim of identifying the most suitable conditions for obtaining follicle stimulation in cosmetic formulations for topical application on the scalp.

Results

The effects on the activity of the hair matrix were evaluated on the occipital bulbs (normal) and on the frontal ones (affected by A-GA), by measuring the growth of the hair shaft in the 4 days following the removal of the bulb, during the which in the culture medium the bulb maintains all its metabolic functions even after the explant.

Effect on "normal" bulbs

Table 1 shows the effects of the substances under examination on "normal" bulbs, ie taken from the occipital area of the scalp, not affected by baldness.

Table 1 - "normal" bulbs

Stem length (mm) after 96 hours of cultivation Substance N bulbs Length mm Difference mm Control 15 0.92 ± 0.05

MG 15 0.94 ± 0.03 0.02 ± 0.03 CA 15 0.99 ± 0.05 0.07 ± 0.05 IS 15 0.97 ± 0.04 0.05 ± 0.04 Pool 15 1.22 ± 0.03 0.30 ± 0.03 Legend:

Difference = Difference vs Controls in mm ± ES MG = Mixture of fatty acids 8 µg ml <-1>

CA = Chondramine 10 µg ml <-1>

IS = Soy isoflavones 10 µg ml <-1>

POOL = Pool of the 3 active 28 µg ml <-1>.

Table 2 allows to better evaluate the effects of the substances under examination as they are reported as a percentage of growth increase compared to the controls and are combined with the probability of Student's t which allows to estimate the statistical significance of the growth increase.

Based on the above test, MG caused a modest growth increase of 2.2% statistically insignificant. While CA and IS caused decidedly greater increases in growth, ie 7.6% and 5.4% respectively, at the limit of statistical significance (p = 0.10). But the surprising and unexpected result was seen with the Pool of 3 substances, which resulted in an increase in growth of 32.6%, more than double what would have been expected based on the sum of the growth increases. due to individual substances.

This increase was also statistically very significant (p <0.001), confirming the surprising and unexpected effect of MG, CA and IS, far superior to that of the single effects of the three components. This is a phenomenon known as the "synergistic" effect. It is surprising and very useful because it multiplies the effectiveness of the individual components and allows them to keep their concentration within optimal formulation limits.

Table 2 - "Normal" bulbs

% Increases in stem growth after 96 hours of culture

Substance Difference% P MG 2.2 ± 3.1 0.50 CA 7.6 ± 4.8 0.10 IS 5.4 ± 3.7 0.10 Pool 32.6 ± 2.8 <0.001% Difference = % Difference vs Control ± ES Effect on "AGA" bulbs

Table 3 shows the effects of the substances under examination on "AGA" bulbs, ie taken from the frontal and vertex area of subjects clinically affected by AGA. The bulbs taken were in the anagen phase, ie with a full potential of functionality, but genetically susceptible to undergo the involutional processes that characterize AGA. Table 3 - "AGA" bulbs

Stem length (mm) after 96 hours of cultivation Substance N bulbs Length mm Difference mm Control 5 0.93 ± 0.05

MG 5 1.05 ± 0.04 0.12 ± 0.06 CA 5 1.00 ± 0.03 0.07 ± 0.06 IS 5 1.04 ± 0.04 0.11 ± 0.06 Pool 5 1.26 ± 0.03 0.33 ± 0.06 Key: see key of table 1

The effects of the substances under examination can be evaluated well in table 4 which reports the growth percentages and combines them, also in this case, with the probability in the Student's t test which allows to estimate the statistical significance of the growth increase.

Table 4 shows that MG caused a significant increase in growth of 12.9%, well above that observed in "normal" bulbs and statistically significant (p <0.01). CA resulted in an increase of 7.5%, comparable to that induced in "normal" bulbs. IS resulted in an increase in growth of 11.8% much greater than that observed in "normal" bulbs and statistically very significant (p <0.01).

Table 4 - "AGA" bulbs

% Increases in stem growth after 96 hours of culture

Substance Difference% P

MG 12.9 ± 4.8 <0.01

CA 7.5 ± 4.2 0.10

IS 11.8 ± 2.9 <0.01

Pool 35.5 ± 4.1 <0.001

Difference% = Difference% vs Control ± ES The effect on the growth of the Pool of the three components was unexpected and unpredictable, much higher than what one would have expected from the sum of the single effects and which is therefore a surprising and advantageous effect "synergistic".

It is also important that MG and IS were more effective on the "AGA" bulbs than on the "normal" ones, a characteristic especially evident for the pool of components in question. This further surprising and unexpected effect makes it possible to consider the pool of MG, IS and CA or mixture of NAG / SS in the previously mentioned ratios as a very effective and specific remedy for the scalp affected by AGA.

Conclusions

The effects of three substances that scientific literature data indicated as potentially effective in stimulating hair growth were evaluated, namely a mixture of fatty acids (MG), chondramine (CA) or a mixture of NAG / SS in the ratios cited and soy isoflavones (IS) whose characteristics are reported in detail in the "Substances used" section. The effects of the mixture of the three substances (pool) were also evaluated according to the proportions described above.

The experimental results described demonstrate a clear positive effect of the three substances, tested individually, but above all an unpredictable and important reciprocal synergistic effect, verifiable on normal bulbs and even more markedly on AGA ones.

These experimental evidences therefore justify the advantageous use of the pool of substances, object of the present invention, in the topical treatment of the scalp not only to maintain its normal functionality but also and even more so, given the experimental evidence, on AGA bulbs, in the treatment of AGA and / or other forms of baldness.

Examples

The formulations, hereinafter reported, together with the description of the operating procedures cited in the specific examples, illustrate possible practical applications of the present invention and being purely exemplary, they should not be considered in any way limitative of the invention itself.

Particular reference is made to some cosmetic components, well known and of normal application in the specific sector of scalp health and not claimable in the present application, since they are devoid of inventive originality and to the excipients that can be used as alternatives to those explicitly mentioned in present description, depending on the formulation-technological needs and which, in any case, can be chosen from a very wide range of products, present on the market, regularly approved by the International Nomenclature of Cosmetic Ingredients (INCI), well known to experts in cosmetic technologies and therefore of no inventive originality.

Going into the detail of the present invention, a sequence of 5 formulations is described below, to be used topically on the scalp, belonging to a complete cycle of interventions on AGA for both female and male use and precisely:

- single-dose vials for shock treatment - example 1: the content should be applied to dry scalp with relative friction until completely absorbed. The application must be repeated daily for a period of at least three months;

- mousse (M) - example 2: in multi-dose air spray bottle to be used in humans in the post-shock treatment maintenance phase for a further three months; to be applied 2-3 times a week, preferably in the evening, on the scalp by rubbing until completely absorbed; Do not rinse and avoid contact with eyes;

- mask (F) - example 3: in multi-dose tube with ophthalmic applicator to be used in women in the post shock treatment maintenance phase for a further three months; to be applied by massaging on dry scalp 2-3 times a week, leave to act for a few minutes and wash off with shampoo (F);

- women's (F) and men's (M) shampoo - examples 4 and 5: multi-dose bottle whose contents are to be used as a normal shampoo; To be used both in the post-shock treatment and in the maintenance phase (see below); It should be applied to wet hair with subsequent abundant rinsing avoiding contact with the eyes.

Each example consists of a tabular part, containing the qualitative-quantitative composition of each formulation, expressed both in centesimal and percentage form, accompanied by the commercial and INCI name of each constituent with relative technological or cosmetic / therapeutic function, and by a descriptive part in which the steps of the processes that lead to obtaining the various formulations, exemplifying the present patent application, are briefly explained.

As far as the dosage of the active ingredients is concerned, purely indicative quantities are reported in the examples described, the variation of which does not bring about any substantial modification to the preparation methods illustrated and in any case in full agreement with the purpose and function of the exemplified formulations. More precisely, and according to the claims of the present patent application, the mixture of NAG and SS and in particular the chondramine and the mixture of fatty acids can be advantageously used at concentrations not exceeding 5% (preferably 0.1â € "2, 0%) while isoflavones should be used in percentages not exceeding 0.1 (preferably 0.01-0.1%), referring to the weight of the composition including vehicles and excipients.

Note 1: To avoid unnecessary repetitions, in all the examples described, the term "MA" will indicate the mixture of fatty acids, already characterized in the experimental part, whose qualitative-quantitative composition is explained in the following table.

Note 2: All materials to be used in primary packaging must comply with current international standards for application in the pharmaceutical, food and cosmetic sectors.

Table A - Qualitative and quantitative composition of MA Trade name INCI name Composition (%) Perifrac 2922 lauric acid 20 Perifrac 2960 palmitic acid 10 Prestyrene 9559 stearic acid 10 Priolene 6928 oleic acid 10 Vitamin F strong linoleic acid 50

B. Operating procedure

1. Aqueous phase: In a turboemulsifier of adequate capacity, equipped with a heating / refrigeration system and vacuum connection, add: â € ¢ Set the heating to 50 ± 5 ° C and add demineralized water, in order, cetrimonium chloride and chondramine.

â € ¢ Stir with shovels at a speed equal to 80% of the maximum speed until complete homogenization (mix A).

2. Pre-melting: In a melter of adequate capacity, equipped with a stirring system, heating / cooling and vacuum connection:

â € ¢ heat PEG-40 Hydrogenated Castor oil and PEG 120 Methyl Glucose Dioleate at 70 ± 5 ° C until completely melted;

â € ¢ Add the MA to the melted mixture and mix until completely homogenized, maintaining the temperature at 70 ± 5 ° C;

â € ¢ Add Lipobelle Soyaglicone and Gen 90 S and shake until completely dispersed / homogenized until a clear, pale yellow mixture is obtained (mix B).

3. Transfer phase:

â € ¢ Check that the temperature in the turbo emulsifier is 50 ± 5 ° C and that the mix B in the fuser is clear.

â € ¢ Vacuum and transfer mix B from the fuser to the turbo emulsifier.

â € ¢ Engage the agitation at 80% of the maximum speed and the turbine at the lowest one by activating the vacuum.

â € ¢ At the end, deactivate the system, start the cooling up to 40 ± 5 ° C and add the Lactoglobulins.

â € ¢ Shake for 10 minutes, under vacuum, with the blades at 80% of the maximum speed and the turbine at the lowest speed.

Activate the cooling and, once reached 30 ± 5 ° C, add 96% ethyl alcohol.

Engage the stirring at 50% of the maximum speed for 15 minutes, keeping the cooling running.

Add the Trichogen Veg perfume and shake with paddles at 50% of the maximum speed until a homogeneous, cloudy, slightly yellow and fragrant liquid is obtained.

Final mix control:

Check that the final mixture is homogeneous. Check the pH which must be between 3.9 and 4.4 and, if not, correct with lactic acid.

If the product complies with the specifications, proceed with unloading into the primary prepackaging container / s.

Primary packaging:

The final product is packaged in single-dose vials from 5 ml to 3.5 ml, on an automatic filling line having the necessary production capacity.

Example 2 - Mousse for application in humans

From what is reported in the tabular part, yes

assumes that the Mousse man formulation is qualitatively identical to that of the vials (see example

1) with the only variant of the addition of tween 20

to make the final product softer and so

to be packaged and dispensed from a bottle equipped with an air spray device.

The substantial difference between the two formulations

resides in a different dosage of the active ingredients

and consequently of the excipients (including the introduction of tween 20) due to the difference in

function and type of application.

A. Qualitative - quantitative composition

commercial Name Formula% ingredient

% final INCI function centesim.

PEG-120 Methyl Glucose Emulsifier / 120 0.100 100 0.10000

Dioleate / Thickener PEG-120 Hydrogenated Emulsifier /

2.000 100 2.00000

Castor oil / Antistatic thickener / Cetrimonium Chloride 25 0.25000

1,000 Emulsion./Tensioatt. Aqua 75 0,75000 Solvent Perfume 0,300 100 0,30000 Fragrance Polysorbate 20 2,000 100 2,00000 Emulsion./Tensioatt Alcohol Denat. 96 19,20000 Solvent

20,000

Aqua 4 0,80000 Lactic Acid solvent 0,28 100 0,28000 Buffering agent Demineralised water Aqua 64,158 100 64,15790 Solvent

Active

MA (Mix Ac.grassi) See table A Active works -1,00 100 1,00000

le / Emollient Butylene Glycol 98.95 5.48183 Solvent / Conditioner 90S 5.54

Genistein 1.05 0.05817 Functional active N-Acetyl Glucosamine 75.64 1.0000

1.3221 Functional active Sodium Sulphate 24.36 0.3221

Soy Isoflavones 5 0.05000 Functional active Emoll.

Lecithin 0.3 0.00300 / Skin condition / Emulsions 1.000 onant Polysorbate 80 10 0.10000 Emulsifier Alcohol 21 0.21000 Solvent

Aqua 63.7 0.63700 Solvent

Whey Protein 0.300 100 0.30000

Aqua 56.2

Panax ginseng Root e-17.5

xtract

Arginine 3

Acetyl Tyrosine 3

Arctium majus Root 3

Extr.

See Explanatory Notes - Hydrolyz. Soy Protein 3

ve (1) - (2) Polyquaternium-11 1,000 3

PEG-12 Dimethicone 3

Calcium Pantothenate 3

Zinc Gluconate 3

Niacinamide 0.55 0.00550

Ornithine HCl 0.55 0.00550

Citrulline 0.55 0.00550

Glucosamine HCl 0.55 0.00550

Biotin 0.1 0.00100

100,000 100,000

(1) - Lactoglobulins: Whey proteins that participate in the phosphorylation process

and keratocytic and fibroblastic proliferation during the anagen phase of the hair. Their positive action in prolonging is demonstrated

hair growth phase.

(2) - Tricogen Veg. : Blend composed of molecules that regulate cell metabolism and the biosynthesis of proteins that strengthen the extracellular matrix and stimulate microcirculation

B. Operating procedure

The operating procedure is substantially identical to that described for the vials (example 1)

with the following differences:

- addition of tween 20 in the pre-melting phase

final pH which must be between 3.2 and 3.6,

to be corrected if necessary with lactic acid;

- the final formulation looks like a turbid and perfumed liquid to be packaged in one

automatic line in 150 ml air spray bottle.

Example 3 - Female application mask

A. Composition such as - quantitative

Formula name

commercial% ingredient% final Function

INCI cents.

Cetearyl Alcohol 3,000 100 3,00000 Emollient / Emulsifier Geleol Glyceril Stearate 1,000 100 1,00000 Emollient / Emulsifier Glyceril Stearate 34 1.02000 Emollient / Emulsifier Cetearyl Alcohol 34 1.02000 Emollient / Emulsifier Stearic Acid 14 0.42000 Emulsifier

ENS 3,000 Tensio-Sodium Lauroyl

14 0.42000 act./antistatic / Glutamate condition

Aqua 4 hair product 0.12000 Solvent

E-Dimethicone 3,000 100 3,00000 moll./Skin condition / Skin protection / Antifoam PEG / PPG-4/12 Dime-1,500 100 1,50000 Emulsifier

thcone

Cetrimonium Chlo-25 2.00000 Antistatic / Surfactant ride 8.000

Aqua 75 6.00000 Isopropyl Mirista Solvent - Emollient / Conditioner 78.95 0.23685

skin tea / Solvent Triticum Vulgare Emollient / Conditioning 17.5 0.05250

Wheat Germ Oil 0.300 cutaneous BHT 3 0.00900 Antioxidant Antioxidan-Tocopheryl Acetate 0.55 0.00165

tea / skin conditioner Glycerin 1,000 100 1,00000 Antistatic humectant / Film-Polyquaternium agent 7 1,000 100 1,00000

geno

Preservative Methylparaben 0.200 100 0.20000

Phenoxyethanol 0.300 100 0.30000 Preservative Imidazolidiny Urea 0.400 100 0.40000 Preservative

BSG

Perfume 0,200 100 0,20000 Fragrance

Sodium Hydroxide. 20 0.02400 Alkalizing agent 0.120

Aqua 80 0.09600 Solvent

Aqua 69.558 100 69.55790 Solvent

Active

cosamine 75,64 1,00004 Functional active Chondramine <R> Acetyl Glu

1.3221

Sodium Sulfate 24.36 0.32206

Isoflavones of Glycine Soja Ex-0,100 100 0,10000 Functional active 90% tract

Acids Functional active See tab. A 1,000 100 1,0000

cosmetics

LAC 0.300 100 0.30000

Panthenol 0.200 100 0.20000

Butyrospermum par-

2.000 100 2.00000

kii Butter See explanatory notes Hydrogenated Leci- (1) - (6)

0.500 100 0.50000

thin

Oryza Sativa Bran

2.000 100 2.00000

Oil

100 100.0000

(1 Lactoglobulins: whey proteins that participate in the process of phosphorylation and keratocytic and fibroblastic proliferation during

the anagen phase of the hair. An action is demonstrated

in prolonging the growth phase of the hair.

(2 Panthenol or provitamin B5, is the precursor

pantothenic acid, an important component of acetylcoenzyme A that plays a fundamental role in the metabolism of both skin and hair

(3 It is obtained from the fruit of Butyrospermum parkii.

It is a butter that contains high percentages of acids

oleic stearic, palmitoleic, linoleic, vitamins

A, D and E and a saponifiable fraction (about 17%) which acts on the cells responsible for the production of collagen and elastin, essential for improving skin tone and elasticity. Its components work as a useful support on the health of the skin and hair.

(4) It is a liposome with a high transdermal penetration gradient that carries the active ingredients present in the formulation.

(5) Obtained from the grain of rice, it maintains its emollient, nourishing and restorative properties. The high quantity of vitamins helps to restore tone to the hair, protects it from UVA rays thanks to the natural shielding activity of gamma oryzanol.

B. Operating procedure

Premise: The equipment used, apart from those intended for primary packaging, are substantially identical to those described in the previous examples.

1. Aqueous phase:

- in the turboemulsifier set the temperature to 65 ± 5 ° C and add: demineralized water, glycerin, panthenol, cetrimony chloride, protelan ENS and chondramine;

- stir with paddles at a speed, equal to 80% of the maximum speed, until a homogeneous dispersion is obtained.

2. Pre-melting:

- in the melter set the temperature to 70 ± 5 ° C and load: cetylstearyl alcohol, glycerylstearate, dimethicone, PEG / PPG-4/12 dimethicone, Butyrospermum Parkii butter, hydrogenated lecithin, methylparaben and oryza sativa brain oil;

- melt the MA separately on a plate at 70 ± 5 ° C until a homogeneous phase is obtained and transfer it to the melter;

- add the 90% soy isoflavones to the melter and, keeping the temperature unchanged, mix until a yellow-beige mixture is obtained, clear and free of suspended particles.

3. Emulsion:

- activate the vacuum and transfer the clear mixture from the melter to the turboemulsifier while maintaining the temperature at 70 ± 5 ° C;

- operate the turbine at the minimum speed keeping that of the blades at 80% of the maximum speed for 20 minutes.

4. Addition of the cosmetic components and preservatives: - once a homogeneous emulsion is obtained, bring the temperature to 45 ± 5 ° C and add the whey;

- operate the turbine at minimum speed, with stirring of the blades at 80% of the maximum, until complete homogenization.

5. Addition of preservatives, conditioners, antioxidants:

- bring the temperature to 30 ± 5 ° C while keeping the speed of the blades unchanged;

- once the set temperature has been reached, deactivate the refrigeration system and agitation and add imidazolidinyl urea, phenoxyethanol, polyquaternium 7 and antioxydol;

- shake at 50% of the maximum speed of the blades, reactivating the vacuum.

6. Fragrance:

- bring the temperature to 25 ° C, deactivate the vacuum and add the perfume;

- shake for 15 minutes, at the minimum speed of the blades, under vacuum, until the formation of a compact and perfumed cream.

7. pH adjustment:

- at the end of the operation referred to in point 6, restore the ambient pressure, take a sample of the product obtained and measure the pH which must be between 3.8 and 4.3;

- any corrections must be made by subsequent additions of lactic acid, shaking, after each addition, for 5 seconds with blades kept at a

speed equal to 80% of the maximum;

- when a product complies with the specifications, proceed with the transfer to the primary prepackaging container / s.

8. Primary packaging:

- the final product that comes in the form of

compact and fragrant cream, is packaged in

tubes, of the desired volume and equipped with ophthalmic applicator, on an automatic tube filling machine having the necessary production capacity.

Example 4 - Shampoo for female application

A. Composition such as - quantitative

Name Formula% commercial input% final INCI function centesim. diente

Tensio-Cocamydopropylamine

36 0.36000 att./Foamag./Condition. Oxide 1,000

for hair

Aqua 64 0.64000 Solvent

Glycerin 2,000 100 2,00000 Humectant

Magnesium Laureth Sul-23 4,60000 Surfactant

make 20,000

Aqua 77 15,40000 Solvent

Cetrimonium Chloride 25 0.25000 Antistatic / Surfactant 1.000

Aqua 75 0.75000 Solvent

Sodium Myreth Sulfate 18,000 26.5 4,77000 Surfactant

Aqua 73.5 13.23000 Solvent surfactant / Foaming agent / re-Cocamide agent DEA 84.5 1.69000

Purton CFD 2,000 hologic

Aqua 15.5 0.31000 Solvent

Emollien-Glycol Distearate 17.5 0.17500 te / Emulsion. / Skin conditioning /

1,000 Matting

Steareth-4 7,5 0,07500 Emulsion./Surfactant Aqua 75 0,75000 Solvent

Cocamydopropyl Betaine 28.5 0.57000 Surfactant / Foaming Ag. B4C 2,000

Aqua 71.5 1.43000 Solvent

PEG-4 Rapeseedamide 92.5 1.38750 Rheological agent

1.5000

Aqua 7.5 0.11250 Solvent

Disodium EDTA 0.1000 100 0.10000 Chelating agent

BSG LF Perfume 0.300 100 0.30000 Fragrance

Lactic Acid 0,100 100 0,10000 Buffering agent

so-Sodium Methylparaben 0.100 100 0.10000 Preservative

Potassium Sorbate 0.200 100 0.20000 Preservative Diazolidinyl Urea 0.150 100 0.15000 Preservative

Aqua 48.508 100 48.50779 Solvent

Glucosamine 75,64 0,10000 Functional active

0.13221

24.36 0.03221

0.010 100 0.01000 Functional active

0.100 100 0.01 Functional active

0.200 100 0.20000

See explanatory notes (1) -

0.500 100 0.50000 (4)

1,000 37.5 0.37500

LS8846 <(3)> PEG-12 Dimethicone 37.5 0.37500

Hydroxycetyl Hydroxyethyl Dimonium Chlori- 7.5 0.07500

de

Aqua 17.5 0.17500

excel <(4)> Guar Hydroxypropyl-

0.100 100 0.10000

Trimonium Chloride

100,000 100.0000

(1) Lactoglobulins: whey proteins that participate in the process of phosphorylation and keratocytic and fibroblastic proliferation during the anagen phase of the hair. It has demonstrated an action in prolonging the growth phase of the hair.

(2) Panthenol or provitamin B5, is the precursor of pantothenic acid, an important component of acetylcoenzyme A which plays a fundamental role in the metabolism of both skin and hair.

(3) Protein fractions extracted from soy, selected on the basis of their ability to protect and repair existing damage in the hair keratins. The particular amino acid composition and the small size (molecular weight of about 2000 Dalton) make these peptides highly substantive and able to attach themselves to the keratins of the hair shaft, both at the cuticle level (protective effect) and in the cortex (repaired effect). .

(4) Polymer that forms a protective film. Once deposited on the hair, due to the molecular weight and the charge distribution, it assumes the particular loop shape that allows it to retain the water molecules longer.

B. Operating procedure

Premise: The equipment used, apart from those intended for primary packaging, are substantially identical to those described in the previous examples.

1. Aqueous phase:

- load demineralized water and glycerin into the turboemulsifier;

- bring the temperature to 60 ± 5 ° C and add Guar hydroxypropyltrimonium chloride;

- stir with blades at maximum speed and, in case of difficulty in forming a homogeneous dispersion, operate the turbine at minimum speed; - once the gel has formed, add: disodium EDTA, chondramine, panthenol, potassium sorbate and sodium methylparaben;

- shake with shovels at a speed equal to 80% of the maximum for 10 minutes.

2. Pre-melting:

- load the mix of fatty acids (MA) into the melter, set the temperature to 70 ± 5 ° C and melt to obtain a homogeneous mixture; - after having checked that the temperature of the aqueous phase is 70 ± 5 ° C and that the fat phase is completely melted and homogeneous, transfer MA from the melter to the turboemulsifier;

- activate the vacuum and shake at the maximum speed of the blades for 15 minutes.

3. Tenside phase:

- in the turboemulsifier set the temperature to 40 ± 2 ° C, maintaining the vacuum and maximum agitation of the blades;

- once the set temperature has been reached (40 ± 2 ° C), deactivate, cool, vacuum and shake and add: sodium myreth sulfate, cocamidopropyl betaine, magnesium laureth sulfate, cocamidopropylamide oxide, PEG-4 rapeseedamide, hydrotricosyl, tegopearl, cetrimonium chloride, diazolidinyl urea and perfume;

- activate the vacuum and shake the blades at medium speed for 20 minutes.

4. Final mix control:

- at the end of the established period of time, suspend vacuum and agitation and take a sample of the contents;

- the product must appear as a liquid

viscous, transparent and light yellow in color;

- measure the pH which must be between 5.3

and 5.8 and if necessary correct with Lactic Acid

operating the blades at speed after each addition

equal to 80% of the maximum;

- if the product complies with the specifications, proceed with unloading into primary prepackaging containers.

5. Primary packaging:

- the product, compliant with the specifications, is packaged in a multi-dose bottle of the desired volume on an automatic filling line having the

necessary production capacity.

Example 5 - Shampoo for male application

B. Composition such as - quantitative

trade- Name Formula% ingre-% final Function

INCI cents. diente

Cocamydopropylamine Surfactant / Foaming Ag. / Condition.

36.00 0.36

1,000 oxide for hair

Aqua 64.00 0.64 Solvent

PEG 120-Methyl Glu-0,100 100 0,10000 Emulsifier / Thickener things Dioleate

Glycerin 3,000 100 3,0000 Humectant

Magnesium Laureth

20,000 23 4,60000 Surfactant

Sulfate

Aqua 77 15,40000 Solvent

Sodium Myreth Sul-26.5 3,10050 Surfactant

Zetesol ME I fairies 11,700

Aqua 73.5 8.59950 Solvent Surfactant / Foaming Agent / Reo Agent-Cocamide DEA 84.5 1.69000

Logical 2,000 CFD

Aqua 15.5 0.31000 Solvent

Cocamidopropyl Be-28.5 0.57000 Surfactant / Foaming agent

B4C taine 2,000

Aqua 71.5 1.43000 Solvent

Lactic Acid 0.250 100 0.25000 Buffering agent Disodium EDTA 0.100 100 0.10000 Chelating agent Perfume 89.892 0.22473

Amyl Cinnamal 3 0.00750

Citronellol 1.5 0.00375

Eugenol 0.3 0.00075

Geraniol 1.5 0.00375

0.250 Fragrance

Hydroxyisohexyl-3

Cyclohexene Carbo- 0.2 0.00050

xaldehyde

Benzyl Alcohol 0.108 0.00027

Linalool 3.5 0.00875

Aqua 57.758 100 57.75779

Acetyl Glucosamine 75,64 0,10000 Functional active

0.13221

Sodium Sulphate 24.36 0.03221 Functional active Glycine Soja E-0.010 100 0.01000 Functional active

xtract

See table A 0.1 100 0.1 Functional active

0.200 100 0.20000

See explanatory notes (1) - (4) Olamine 0.250 100 0.25000

0.500 100 0.50000

Butylene Glycol 48 0.09600

Pentylene Glycol 48 0.09600

Symcalmin <(4)> 0.200

Gydroxyphenyl Pro-

4 0.00800

pamidobenzoic Acid

100,000 100.0000

(1) Lactoglobulins: whey proteins that participate in the milk process that participate in the process of phosphorylation and keratocytic and fibroblastic proliferation during the anagen phase of the hair. It has demonstrated an action in prolonging the growth phase of the hair.

(2) It is an imidazolidine derivative that is commonly used in the treatment of dandruff and seborrheic dermatitis.

(3) Panthenol or vitamin B5 is the precursor of pantothenic acid, an important component of acetylcoenzyme A that plays a fundamental role in the metabolism of both skin and hair.

(4) - It is a synthetic derivative of the functional portion of oats with soothing and anti-inflammatory activity.

B. Operating procedure

Premise: The equipment used, apart from those intended for primary packaging, are substantially identical to those described in the previous examples.

1. Aqueous phase:

- load demineralized water, disodium EDTA, glycerin, chondramine, potassium sorbate, sodium methyl paraben and panthenol into the turboemulsifier;

- bring the temperature to 60 ± 5 ° C and start stirring with blades at a speed equal to 80% of the maximum speed until a homogeneous dispersion is obtained.

2. Pre-melting:

- load the mix of fatty acids (MA), PEG-120 methylglucosedioleate, piroctone olamine and cocamide DEA into the melter, set the temperature to 70 ± 5 ° C and melt to obtain a homogeneous mixture;

- add 90% soy isoflavones to the melter and, keeping the temperature constant, stir until a homogeneous mixture free from suspended particles is obtained;

- after checking the homogeneity of the mixtures in the melter and in the turboemulsifier, bring the temperature in the turboemulsifier to 60 ± 5 ° C, insert the vacuum and transfer the fat phase from the melter into the turboemulsifier;

- start the stirring at the maximum speed of the blades, cool to 50 ± 2 ° C, add whey and keep stirring at the average speed of the blades for 15 minutes under vacuum.

3. Tenside phase:

- in the turboemulsifier set the temperature to 40 ± 2 ° C, suspend vacuum and stirring and add: sodium myreth sulfate, cocamidopropyl betaine, magnesium laureth sulfate, cocamidopropylamine oxide, symcalmin, diazolidinyl urea and perfume;

- activate the vacuum and shake the blades at medium speed for 20 minutes.

4. Final mix control:

- at the end of the established period of time, suspend vacuum and agitation and take a sample of the contents;

- the product must appear as a viscous, transparent and light yellow liquid.

- measure the pH which must be between 5.3 and 5.8 and if necessary correct with lactic acid by operating, after each addition, the blades at a speed equal to 80% of the maximum;

- if the product complies with the specifications, proceed with unloading into primary prepackaging containers.

5. Primary packaging:

- the product, compliant with the specifications, is packaged in a multi-dose bottle of the desired volume on an automatic filling line having the necessary production capacity.

Claims (15)

CLAIMS 1. Composition for topical application on the scalp, comprising, as active agents capable of jointly exerting a synergistic effect on hair growth, a mixture of fatty acids, soy isoflavonic phytoestrogens and a mixture of N-acetylglucosamine and sodium sulphate in molecular ratio of N-acetylglucosamine / sodium sulphate between 1: 0.25 and 1: 1.5, in a vehicle or in excipients for topical application. 2. Composition according to claim 1, characterized in that said mixture of fatty acids comprises 2 or more fatty acids selected from the group consisting of lauric acid, palmitic acid, stearic acid, oleic acid and linoleic acid. 3. Composition according to claims 1 or 2, characterized in that said mixture of fatty acids comprises lauric acid in a quantity from 10% to 30% by weight, palmitic acid in a quantity between 5% and 15% by weight, stearic acid in a quantity between 5% and 15%, oleic acid in quantities between 5% and 15% and linoleic acid in quantities between 30% and 70%. 4. Composition according to any one of claims 1 to 3, characterized in that the aforementioned mixture of fatty acids consists of 20% lauric acid, 10% palmitic acid, 10% stearic acid, 10% oleic acid and 50% linoleic acid by weight. 5. Composition according to any one of claims 1 to 4, characterized in that said mixture of fatty acids is present in an amount not exceeding 5% by weight referred to the weight of the composition, including said excipients and / or vehicles, preferably in amount from 0.1% to 2.0% by weight. 6. Composition according to any one of claims 1 to 5, comprising a mixture of N-acetylglucosamine and anhydrous sodium sulfate in a molecular ratio 2: 1, corresponding to a percentage by weight of N-acetylglucosamine of 75.7% and sodium sulphate of 24.3%. 7. Composition according to any one of claims 1 to 6, characterized in that said mixture of N-acetylglucosamine and anhydrous sodium sulphate is present in quantities not exceeding 5% by weight and preferably from 0.1% to 2.0% by weight, referred to the weight of the composition including vehicles and / or excipients. 8. Composition according to any one of claims 1 to 7, characterized in that said isoflavonic phytoestrogens are present in the form of vegetable extract of soy isoflavones or of red clover, containing genistein and daidzein, or in the form of the single active agents genistein and daidzein or their mixtures. 9. Composition according to any one of claims 1 to 8, characterized in that said isoflavonic phytoestrogens are present in quantities not exceeding 0.1% by weight and preferably from 0.01% to 0.1% by weight based on the weight of the inclusive composition of vehicles and / or excipients. 10. Composition according to any one of claims 1 to 9, further including cosmetic components selected from the group consisting of emollient, soothing, nourishing, skin and scalp toning agents, stimulating the differentiation and activity of the cells of the hair matrix with protection of the anagen phase or agents useful for the well-being of the skin and scalp and their mixtures. 11. Composition according to any one of claims 1 to 10, characterized in that said vehicles or excipients comprise components for dermocosmetic use, adapted to be applied to the hair and scalp, selected from the group consisting of surfactants, antistats, foaming agents, solvents , humectants, thickeners, film-forming, chelating, buffering, flavoring and their mixtures. Composition according to any one of claims 1 to 11, depending on its use in topical application, in the maintenance of good health and in the prevention and control of scalp dysfunctions, in particular androgenetic alopecia and other forms of hair loss. 13. Composition according to any one of claims 1 to 12, for applications in dermocosmetics in the form of vials for topical application, both in men and women, in the shock treatment of scalp dysfunctions, such as androgenetic alopecia and hair loss in general. 14. Composition according to any one of claims 1 to 12, in the form of a mousse for topical application in humans. Composition according to any one of claims 1 to 12, in the form of a composition useful as a mask in women, or in the form of a shampoo for washing the scalp, or in the form of a shampoo for rinsing mousse compositions for male use or of masks for female use.