WO2022180651A1 - Composition for preventing and or treating skin and hair disorders - Google Patents

Composition for preventing and or treating skin and hair disorders Download PDF

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WO2022180651A1
WO2022180651A1 PCT/IT2021/000007 IT2021000007W WO2022180651A1 WO 2022180651 A1 WO2022180651 A1 WO 2022180651A1 IT 2021000007 W IT2021000007 W IT 2021000007W WO 2022180651 A1 WO2022180651 A1 WO 2022180651A1
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Nicola Tito Pierluca ANTONUCCI TAROLLA
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Antonucci Tarolla Nicola Tito Pierluca
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9789—Magnoliopsida [dicotyledons]
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    • A61K31/19—Carboxylic acids, e.g. valproic acid
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    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
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    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016—Disaccharides, e.g. lactose, lactulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
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    • A61K33/42—Phosphorus; Compounds thereof
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    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
    • A61K8/365—Hydroxycarboxylic acids; Ketocarboxylic acids
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
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    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
    • A61K8/368—Carboxylic acids; Salts or anhydrides thereof with carboxyl groups directly bound to carbon atoms of aromatic rings
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    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4973—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom
    • A61K8/498—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom having 6-membered rings or their condensed derivatives, e.g. coumarin
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
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    • A61P17/14—Drugs for dermatological disorders for baldness or alopecia
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    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/08—Anti-ageing preparations
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q7/00—Preparations for affecting hair growth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/92—Oral administration

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Abstract

The present invention refers to a composition comprising one or more ellagitannin, one or more phenolic acid, one or more flavonoid, wherein: said one or more ellagitannin is selected from the group consisting of: castalagin, agrimoniin, vescalagin, and mixture thereof; said one or more phenolic acid is selected from the group consisting of: caffeic acid, ellagic acid, gallic acid, p-coumaric acid, ad mixture thereof; said one or more flavonoids are selected from the group consisting of: cyaniding, procyanidin, quercetin, catechin, epicatechin, kaempferol, delphinidin, pelargonidin, peonidin and mixture thereof. The present invention refers to a cosmetic use of the composition of the present invention for stimulating hair growth and/or preventing or treating hair loss and/or for skin anti-age effect. The present invention refers to the composition of the present invention for use in the prevention and/or treating of skin disorders and/or alopecia. The present invention refers to the composition of the present invention, wherein said composition is in a form for oral administration or topic application.

Description

TITLE
COMPOSITION FOR PREVENTING AND OR TREATING SKIN AND HAIR DISORDERS
FIELD OF THE INVENTION
The present invention relates to a composition useful for preventing and/or treating skin and/or hair disorders.
In particular, the present invention relates to a composition useful for preventing and or treating hair loss and for stimulating the hair growth.
BACKGROUND OF THE INVENTION
Hair is one of the characteristic features of mammals and has various functions such as protection against external factors, producing sebum, apocrine sweat and pheromones, impact on social and sexual interactions, thermoregulation and being a resource for stem cells.
Cyclicity is a hair particular feature. Hair cycle consists of four phases: anagen (growth), catagen (involution), telogen (resting), and exogen (shedding of hair). Usually, 80-90% of hair is in the anagen phase, which lasts from 2 to 6 years and determines the hair length; less than five percent are in catagen, and the rest are in telogen. Shedding of 100 hairs a day (exogen) is normal.
Hair disorders hit a growing number of people all over the world and affects individuals' physical, psychological, and social well-being. Hair growth disorders are a common problem, particularly in male population, and it may be hard to face for many people; in fact, people suffering from said disorders undergo emotional stress, embarrassment, and even depression that worsen their quality of life.
Different and several factors, among which stress, lack of nutrients, ageing and genetic predisposition, negatively affect the hair bulb life cycle, thus determining a reduction of the number of hair, their thinning, and baldness. One of the most spread hair disorders is represented by alopecia .
Alopecia is the medical term to indicate acute hair loss and baldness and can be caused by a variety of factors; it is found in both adults and children.
While many individuals will view hair loss and baldness as a singular ailment, there are in fact several forms of alopecia.
The most common form of alopecia is Androgenetic Alopecia (AGA).
AGA is a polygenic hair disorder with variable penetrance (both maternal and paternal genes are involved) due to an excessive response of follicular units to androgens, which affects up to 50% of males and female (1,2,3).
AGA has a genetic predisposition and requires androgen to occur; AGA is likely due to an excessive response to androgen (4,5). It develops only after puberty. Males with androgen insensitivity syndromes do not have pattern baldness. Androgens metabolism and androgen receptors play a key role in pattern alopecia.
Activation of the androgen receptor shortens the anagen or growth phase in the normal hair growth cycle.
In AGA, the excessive activation of the androgen receptor activation leads to follicular "miniaturization" through a progressively shorter anagen phase, resulting in thinner and shorter hairs, which in the end disappear to naked eye. Pathological specimens show a decreased ratio of anagen to telogen hair of 5:0 where the norm is 12:1 (8,9).
There is a reduction in the duration of the anagen phase along with the miniaturization of the dermal papilla. Miniaturization is the progressive transformation of terminal hair follicles (large, thick, pigmented) to vellus-like hair follicles (short, thin, nonpigmented) and is the hallmark feature in AGA. These vellus-like hair follicles have a shortened hair cycle because of the reduction in the anagen phase, which leads to the production of fine and short hair shafts. Thus, premature termination of the anagen phase is the key event in the development of AGA. In addition, there is a delay between the end of the telogen phase and the beginning of the new anagen phase—the so-called kenogen phase, in which the hair follicle remains empty.
The diameter of the hair follicle is determined by the size of the dermal papilla and thus miniaturization process is due to a decrease in the volume of the papilla, which takes place between the catagen and the formation of new hair.
A possible mechanism leading to miniaturization is a decrease in the number of papilla cells due to apoptosis. The follicular regression in the catagen phase is the outcome of the diffuse apoptosis of follicular keratinocytes, which occurs as a result of an imbalance between various growth factors and cytokines that promote apoptosis.
Genetic predisposition may be involved in AGA. Patients often report family members affected by the disease (40-54%), especially in cases with early clinical presentation (< 30 years). The fact that AGA manifests with varying degrees of intensity and has its onset at different ages suggest a polygenic pattern with incomplete penetrance. The strongest evidence of genetic involvement in the development of baldness comes from studies involving the androgen receptor (AR) gene. Single nucleotide polymorphism in the first exon known as STUL was associated with baldness. In women with Female Pattern Hair Loss (FPHL, especially in younger women), non functioning single nucleotide polymorphism (rs4646) was identified in the gene that encodes aromatase (CYP19A1).
Usually, AGA patients have:
• higher production of dihydrotestosterone (DHT); and • higher levels of 5 alpha-reductase and androgen receptors in balding scalp: it converts testosterone to dihydrotestosterone (DHT); Type 1 acts in sebaceous glands, keratinocytes, and sweat glands. Type 2 acts in the outer root sheath of hair follicles, epididymis, vas deferens, seminal vesicles, and prostate, ad plays a greater role in AGA.
Also, thyroxin and prolactin interfere with androgen metabolism, hence they may contribute to the clinical picture of FPHL.
Two main factors are implied in AGA:
- microinflammation; and
- oxidative stress.
Microinflammation in baldness is mild to moderate with an lymphohistiocytic inflammatory infiltrate in the peri- infundibular region that is present along with miniaturization. The term "microinflammation" has been used to differentiate it from the inflammation that occurs in scarring alopecia. The inflammatory process occurring in the upper part of the follicle suggests that the causal factor may affect this region. Various factors such as ultraviolet radiation, environmental pollutants, inhabitants of the skin microbiota and follicle may be involved in the induction of the microinflamation process.
Oxidative Stress in AGA patients causes premature senescence in vitro suggesting that dermal papilla cells (DPCs) from balding scalp are more sensitive to environmental stress than nonbalding cells. In vitro findings on balding and occipital scalp DPCs suggest that there may be a role for oxidative stress in the pathogenesis of AGA in relation to cell senescence, migration and secretion of known hair follicle inhibitory factors (13). At present treatments for pattern baldness consist mainly of drugs and surgical interventions (autologous hair transplant), with hair restoration being the most effective method.
Among drugs, the most common known are the FDA approved topical minoxidil and the alpha-reductase type 2 inhibitor finasteride (12). However, these drugs show some drawbacks; in fact, both require at least a 4- to 6-month administration before noticing improvement and must be used indefinitely to maintain a response. For this reason, medication adherence often can be poor. Furthermore, initiation of minoxidil may cause an initial shedding phase (10,11). The most common adverse effects of minoxidil are pruritus and local irritation with resulting flaking. Finasteride is contraindicated in women for reproductive potential effect as it can cause a male fetus to develop ambiguous genitalia. Adverse effects include sexual dysfunction which usually reduces with time, increased risk of high-grade prostate cancer because PSA elevation is masked and detected later and case reports of persistent diminished libido and erectile dysfunction .
Other drugs, not FDA-approved, usually used for treating AGA, are spironolactone (oral antiandrogen) and dutasteride, with an adverse effect profile similar to finasteride.
Other proposed treatments include prostaglandin analogues like latanoprost and bimatoprost, but they are cost prohibitive.
Also, the use of nutritional oral supplements (such as amino acids and biotin) in AGA is controversial and doubtful.
Apart drugs, hair transplant is effective and cosmetically satisfactory to the patient. However, patients need to have a sufficient number of donor plugs (greater than 40 follicular units/cm2) to cover the bald area.
The Applicant has now unexpectedly found a composition effective for use in preventing and or treating skin and or hair disorders, particularly for alopecia. This composition show unexpected results in particular for hair growth. Advantageously, the present composition does not show side effects . In the following the present invention is explained in detailed.
SUMMARY OF THE INVENTION
The present invention refers to a composition comprising one or more ellagitannin, one or more phenolic acid, one or more flavonoid, wherein said one or more ellagitannin is selected from the group consisting of: castalagin, agrimoniin, vescalagin, and mixture thereof; said one or more phenolic acids is selected from the group consisting of: caffeic acid, ellagic acid, gallic acid, p-coumaric acid, ad mixture thereof; said one or more flavonoid is selected from the group consisting of: cyaniding, procyanidin, quercetin, catechin, epicatechin, kaempferol, delphinidin, pelargonidin, peonidin and mixture thereof. Another object of the present invention is a cosmetic use of said composition for stimulating hair growth and/or preventing or treating hair loss and/or for skin anti-age effect.
Another object of the present invention refers to the composition of the present invention for use in the prevention and/or treating of skin disorders and/or alopecia.
BRIEF DESCRIPTION OF THE FIGURES
Figures 1-12 refer to a trichoscopy evaluation of patients affected by a severe form of AGA (patients >50 years old, with a grade VI of AGA, according to Norwood-Hamilton scale):
- before;
- during; and
- at the end of a 8 months treatment with the composition of the present invention (daily oral intake and topical application) .
The instrument used for the trichoscopy evaluation is FOTOFINDER DERMOSCOPE 3.8.32/MADECAM 500.
Fig. 1: patient after 1 month of treatment.
Fig. 2: patient after 3 months of treatment showing vellus.
Fig. 3: 3A: patient showing vellus after 3 months of treatment; 3B: patient after the 8 months treatment.
Fig. 4: 4A: patient with vellus after 3 months of treatment; 4B: patient after the treatment. By comparing the areas indicated with 1 and 2 it is visible the hair growth.
Fig. 5: patient after 8 months: 5A left side; 5B right side; in the areas indicated with 4 and 5 it is visible the hair growth.
Fig. 6: patient after 1 month of treatment.
Fig. 7: patient after the 8 months treatment.
Fig. 8: patient after 3 months of treatment.
Fig. 9: patient after 8 months of treatment. In the area indicated with 5 it is more visible the hair growth.
Fig. 10: 10A: patient after 3 months of treatment; 10B: patient after 8 months of treatment showing an improvement in the hair growth.
Fig. 11: patient before (11A) and after the 8 months treatment (11B) showing an anti age effect.
Fig. 12: patient before (12A) and after the 8 months treatment (12B) showing an anti age effect. DETAILED DESCRIPTION OF THE INVENTION
The present invention refers to a composition comprising one or more ellagitannin, one or more phenolic acid, one or more flavonoid, wherein: said one or more ellagitannin is selected from the group consisting of: castalagin, agrimoniin, vescalagin, and mixture thereof; said one or more phenolic acid is selected from the group consisting of: acid, ellagic acid, gallic acid, p-coumaric acid, ad mixture thereof; said one or more flavonoid is selected from the group consisting of: cyanidin, procyanidin, quercetin, catechin, epicatechin, kaempferol, delphinidin, pelargonidin, peonidin and mixture thereof.
In the following the quantitative are expressed as daily quantitative.
In a preferred embodiment, said castalagin is present in the range of 0,01-0,1 mg, said agrimoniin is present in the range of 1-5 mg, said vescalagin is present in the range of 0,01-0,1 mg.
Preferably, said ellagitannin is agrimoniin.
Preferably, said caffeic acid is present in the range of 0,01- 0,5 mg, said p-coumaric acid is present in a range of 0,15-1 mg, said ellagic acid is present in a range of 3-10 mg, said gallic acid is present in a range of 1-5 mg.
Even more preferably, said one or more phenolic acid is selected from the group consisting of: ellagic acid, gallic acid, p-coumaric acid and mixture thereof.
Preferably, said cyanidin is present in a range of 2-10 mg, said procyanidin is present in the range of 0,01-0,1 mg, said quercetin is present in a range of 0,1-1 mg, said epicatechin is present in the range of 0,1-1 mg, said catechin is present in the range of 1-5 mg, said kaempferol is present in the range of 0,01-0,lmg, said delphinidin is present in the range of 0,01-0,05 mg, said pelargonidin is present in the range of 0,01-0,09 mg, said peonidin is present in the range of 0,01- 0,09 mg.
Even more preferably, said one or more flavonoid is selected from the group consisting of: cyanidin, quercetin, catechin, epicatechin, and mixture thereof.
The composition of the present invention further comprises one ore more ingredients selected from the group consisting of vitamins, minerals, sugars, nutrients and mixture thereof. Preferably, in the composition of the present invention said vitamins are selected from the group consisting of: Vitamin A, Vitamin C, Vitamin E, and mixture thereof. Even more preferably, said Vitamin A is present in the range of 0,05-2 mg, said Vitamin C is present in the range of 1-6 mg, said Vitamin E is present in the range of 0,01-1 mg. Even more preferably, said one or more vitamin is selected from the group consisting of: Vitamin A, Vitamin C, and mixture thereof .
Preferably, in the composition of the present invention, said minerals are selected from the group consisting of: sulphur, calcium, phosphorous, magnesium, potassium. Even more preferably, said sulphur is present in the range of 10-200 mg, said calcium is present in the range of 10-150 mg, said phosphorous is present in the range of 10-200 mg, said magnesium is present in the range of 10-100 mg, said potassium is present in the range of 50-300 mg.
Preferably, in the composition of the present invention, said sugars are selected from the group consisting of: fructose, glucose, lactose, maltose, sucrose, and mixture thereof. Even more preferably, said fructose is present in the range of 2000-8000 mg, said glucose is present in a range of 100-3000 mg, said lactose is present in the range of 10-100 mg, said maltose is present in the range of 50-300 mg, said sucrose is present in the range of 100-500 mg. Even more preferably, said one or more sugar is selected from the group consisting of: fructose, glucose, maltose, sucrose, and mixture thereof. As shown also in the Example, the Applicant has found that the composition of the present invention shows unexpected results in preventing and/or treating hair and/or skin disorders. Another object of the present invention is the cosmetic use of the composition of the present invention for stimulating hair growth and/or preventing or treating hair loss and/or for skin anti-age effect.
In addition, the composition of the present invention is used in the prevention and/or treating of skin disorders and/or hair loss. Preferably, said hair loss is alopecia. Even more preferably, said alopecia is Androgenetic Alopecia.
As pointed out in the Example, patients affected by a severe form of AGA (grade VI, according to Norwood-Hamilton scale) undergone 8 months treatment with the composition of the present invention (oral intake and topical application). After the treatment, unexpected hair regrowth by means of clinical and trichoscopy evaluation has been documented (see the
Example for an explanation of the technology).
The dermoscopic findings pointed out an increasing number of vellus and subsequently terminal hair. The increase of the hair thickness was visible in previously bald area. Moreover, peripilar signs and yellow dots were not visible. In addition, the trichoscopic findings were also associated with an improvement in the skin texture.
In particular, after the treatment:
• the lateral edges of the hair in the fronto-parietal area have approached towards the top of the head: from an initial distance of about 15 cm they were only 7 cm away, thus demonstrating a hair regrowth towards the top of the head of 4 cm each side;
• terminal hair and not only simple vellus hair was present;
• vellus hair previously present in the form of thin and white hair distributed on the top and the front of the head is evolved towards thicker hair and with increased pigmentation; • in the frontal area near to the hairline, the number of hairs has undergone an increase in the same way: first the vellus hair, then a slightly more robust hair and finally black hair;
• the scalp of the patients subjected to local treatment did not show any adverse or troublesome reactions during the 8 months treatment; on the contrary it became younger, lighter and smoother, thus revealing an anti aging effect.
These results are connected to the unexpected synergistic combination of the composition of the present invention in the anti-oxidant and anti-inflammatory capacities.
In addition, the composition of the present invention indicates epigenetic changes and to act on "multiple target".
The composition of the present invention can be used in oral administration or topic application. Preferably, the composition in form for oral administration is selected from the group consisting of: tablets, capsules, pills, granulated power, syrups, beverages, functional food, and fortified foods. Non limitative examples of such oral administration forms can be gel pills, candies, chewing gums, biscuits, snacks, yogurt, mousse, puddings, cereals, food supplements, fruit juice, extracts, essences, nutraceutical food.
Preferably, the composition in form for topical administration is selected from the group consisting of: solution, lotion, oil, shampoo, cream, foam, spray and ointment. Non limitative examples of such topical administration forms can be shower gel, soap, liquid soap, spray, serum, oil, hair conditioner, shaving foam, deodorant, aftershave, after sun cream.
In the following, some non-limitative examples are explained to better understand the advantages of the present invention. EXAMPLES
Patients affected by Androgenetic Alopecia grade VI (age > 50 years old, according to the Norwood-Hamilton scale) underwent a treatment 8 months long. Patients had not undergone any treatment for years and had a family history with of full-blown Androgenetic alopecia.
The scheduled treatment comprises
-the oral intake; and
-the topical application of an amount of the composition of the present invention, so as represented in the Table put below.
In particular, the patients
-took orally a daily quantity of the composition; and
- daily applied the same composition locally: the composition was applied by massage and tapped in the evening, kept overnight till the morning, when the patients washed the hair.
Figure imgf000014_0001
Figure imgf000015_0001
It is noted that the person skilled in the art knows, as a routine lab work, how to add other ingredients, such as stabilizers (microcrystalline cellulose, pregelatinised maize starch; calcium phosphate; silicon dioxide) and anti-caking agents (vegetable magnesium stearate, silicon) in order to get the final oral and topic composition.
After 8 months treatment, hair regrowth and skin anti-aging effect have been analysed by clinical examination and trichoscopy.
Trichoscopy
Trichoscopy is a method of hair and scalp evaluation and is used for diagnosing hair and scalp diseases. The method is based on dermoscopy. In trichoscopy hair and scalp structures may be visualized at many-fold magnification. Currently magnifications ranging from 10-fold to 70-fold are most popular in research and clinical practice .
This type of dermoscopy contributes to the diagnosis of AGA especially in the early stages of the disease. The main dermoscopic finding is the diversity in the thickness of the hairs with an increased number of miniaturized hairs, especially in the frontoparietal region. Short vellus hair (<0.03 mm) is a sign of severe miniaturization and their presence on the frontal scalp is a very useful clue.
A decrease in the number of hairs per follicular unit is another important element.
The peripilar sign, a light brown area, slightly atrophic around the follicle, usually occurs in the early stages of AGA which correlates with the inflammatory infiltrate. It can be brown sign, which is seen in early grades and white peripilar sign, seen in later grades.
Yellow dots may be seen in more advanced cases, probably as a result of sebum and keratin accumulation in dilated follicles. With increased thinning of the hairs, there is greater penetration of ultraviolet radiation into the scalp and changes typical of photoaging, such as the honeycomb pigmented network, may occur. These signs, when evaluated together, allow the early diagnosis of AGA.
In the following the findings obtained by trichoscopy evaluation of the treated patients:
- improvement in the skin texture of the scalp;
- increasing number of vellus and terminal hair;
-peripilar signs not present;
-yellow dots not present;
-the lateral edges of the hair in the fronto-parietal area have approached towards the top of the head: from an initial distance of about 15 cm they were only 7 cm away, thus demonstrating a hair regrowth towards the top of the head of 4 cm each side;
-terminal hair and not only simple vellus hair is present;
- vellus hair previously present in the form of thin and white hair distributed on the top and the front of the head is evolved towards thicker hair and with increased pigmentation (it can be hypothesized that if the hair regrowth will follow what happened in 8 months-treatment of the study the vellus hair will be progressively replaced by terminal hair); - in the frontal area near to the hairline, the number of hairs has undergone an increase in the same way as described above: first the vellus hair, then a slightly more robust hair and finally black hair.
- The scalp of the patients subjected to local treatment did not show any adverse or troublesome reactions during the 8 months treatment; on the contrary it became younger, lighter and smoother, thus revealing an anti aging effect. 2 . Food supplement formulation
Capsules of final weight of 500mg (capsule material: idroxypropylmethylcellulose) can be prepared using the formulation described in Example 1, without sugars and minerals. In order to get the final weight, stabilizers and anticaking agents have been modulated accordingly.
Bibliography
1. Sasaki GH. Review of Human Hair Follicle Biology: Dynamics of Niches and Stem Cell Regulation for Possible Therapeutic Hair Stimulation for Plastic
Surgeons. Aesthetic Plast Surg. 2019 Feb;43 (1):253- 266. [PubMed: 30324295]
2. Neuhaus K, Schiestl C, Adelsberger R, Weibel L, Meuli M,
Bottcher-Haberzeth S. Bold to do - bald to be? Outcomes decades after harvesting the scalp in burned children. Burns. 2019 May;45 (3):543-553. [PubMed:
30337156]
3. Almohanna HM, Perper M, Tosti A. Safety concerns when using novel medications to treat alopecia. Expert Opin Drug Saf. 2018 Nov;17(11):1115-1128. [PubMed: 30318935]
4. Chan L, Cook DK. Female pattern hair loss. Aust J Gen Pract. 2018 Jul;47(7):459-464. [PubMed: 30114864]
5. Tanaka Y, Aso T, Ono J, Hosoi R, Kaneko T. Androgenetic Alopecia Treatment in Asian Men. J Clin Aesthet Dermatol. 2018 Jul;11(7):32-35. [PMC free article: PMC6057731] [PubMed: 30057663]
6. Mahmoudi H, Salehi M, Moghadas S, Ghandi N, Teimourpour A,
Daneshpazhooh M. Dermoscopic Findings in 126 Patients with Alopecia Areata: A Cross-Sectional Study. Int J
Trichology. 2018 May-Jun;10(3):118-123. [PMC free article: PMC6028992] [PubMed: 30034191]
7. He H, Xie B, Xie L. Male pattern baldness and incidence of prostate cancer: A systematic review and meta analysis. Medicine (Baltimore). 2018
Jul;97 (28):ell379. [PMC free article: PMC6076190] [PubMed: 29995779]
8. Bienenfeld A, Azarchi S, Lo Sicco K, Marchbein S, Shapiro J, Nagler AR. Androgens in women: Androgen-mediated skin disease and patient evaluation. J Am Acad Dermatol. 2019 Jun;80(6):1497-1506. [PubMed: 30312644] 9. Sadick NS, Callender VD, Kircik LH, Kogan S. New Insight Into the Pathophysiology of Hair Loss Trigger a Paradigm Shift in the Treatment Approach. J Drugs Dermatol. 2017 Nov 01;16(11):sl35-sl40. [PubMed: 29141068] 10. Nast A, Gaskins M, Eisert L, Werner RN, Borradori L,
Marinovic B, Paul C, Dressier C. Prioritizing topics in guideline development: results of a two-phase online survey of dermatologist members of the EADV. J Eur Acad Dermatol Venereol. 2019 Jan;33(1):227-233 . [PubMed: 30317678]
11. Manabe M, Tsuboi R, Itami S, Osada SI, Amoh Y, Ito T, Inui S, Ueki R, Ohyama M, Kurata S, Kono T, Saito N, Sato A, Shimomura Y, Nakamura M, Narusawa H, Yamazaki M., Drafting Committee for the Guidelines for the Diagnosis and Treatment of Male- and Female-Pattern Hair Loss.
Guidelines for the diagnosis and treatment of male-pattern and female-pattern hair loss, 2017 version. J Dermatol. 2018 Sep;45(9):1031-1043. [PubMed: 29863806]
12. Zito PM, Bistas KG, Syed K. StatPearls [Internet]. StatPearls Publishing; Treasure Island (FL):
Apr 14, 2020. Finasteride. [PubMed: 30020701].
13. Upton JH, Hannen RF, Bahta AW, Farjo N, Farjo B, Philpott MP. Oxidative stress-associated senescence in dermal papilla cells of men with androgenetic alopecia. J. Invest. Dermatol. 2015 May;135(5):1244-1252
PubMed:25647436.

Claims

1. A composition comprising one or more ellagitannin, one or more phenolic acid, one or more flavonoid, wherein:
Said one or more ellagitannin is selected from the group consisting of: castalagin, agrimoniin, vescalagin, and mixture thereof; said one or more phenolic acid is selected from the group consisting of: caffeic acid, ellagic acid, gallic acid, p- coumaric acid, ad mixture thereof;
Said one or more flavonoids are selected from the group consisting of: cyaniding, procyanidin, quercetin, catechin, epicatechin, kaempferol, delphinidin, pelargonidin, peonidin and mixture thereof
2. The composition according to claim 1, wherein said castalagin is present in the range of 0,01-0,1 mg, said agrimoniin is present in the range of 1-5 mg, said vescalagin is present in the range of 0,01-0,1 mg.
3. The composition according to anyone of the preceding claims, wherein said caffeic acid is present in the range of 0,01-0,5 mg, said p-coumaric acid is present in a range of
0,15-1 mg, said ellagic acid is present in a range of 3-10 mg, said gallic acid is present in a range of 1-5 mg.
4. The composition according to anyone of the preceding claims, wherein said cyanidine is present in a range of 2- 10 mg, said procyanidin is present in the range of 0,01-0,1 mg, said quercetin is present in a range of 0,1-1 mg, said catechin is present in the range of 1-5 mg, said epicatechin is present in the range of 0,1-1 mg, said kaempferol is present in the range of 0,01-1 mg, said delphinine is present in the range of 0,01-0,05 mg, said pelargonidin is present in the range of 0,01-0,09 mg, said peonidin is present in the range of 0,01-0,09 mg.
5. The composition according to anyone of the preceding claims, wherein said one or more ellagitannin is agrimoniin; said one or more phenolic acid is selected from the group consisting of: ellagic acid, gallic acid, p- coumaric acid and mixture thereof; said one or more flavonoid is selected from the group consisting of cyaniding, quercetin, catechin, epicatechin, and mixture thereof.
6. The composition according to anyone of the preceding claims, wherein said composition further comprises one ore more ingredient selected from the group consisting of vitamins, minerals, sugars, nutrients and mixture thereof.
7. The composition according to claim 6, wherein said vitamins are selected from the group consisting of: Vitamin A, Vitamin C, Vitamin E and mixture thereof.
8. The composition of claim 7, wherein said Vitamin A is present in the range of 0,05-2 mg, said Vitamin C is present in the range of 1-6 mg, said Vitamin E is present in the range of 0,01-1 mg.
9. The composition according to anyone of the preceding claims 6-8, wherein said minerals are selected from the group consisting of: sulphur, calcium, phosphorous, magnesium, potassium, and mixture thereof.
10. The composition according to claim 9, wherein said sulphur is present in the range of 10-200 mg, said calcium is present in the range of 10-150 mg, said phosphorous is present in the range of 10-150 mg, said magnesium is present in the range of 10-100 mg, said potassium is present in the range of 50-300 mg.
11.The composition according to anyone of the preceding claims
6-10, wherein said sugars are selected from the group consisting of: fructose, glucose, lactose, maltose, sucrose, and mixture thereof.
12.The composition according to claim 11, wherein said fructose is present in the range of 2000-8000 mg, said glucose is present in a range of 100-3000 mg, said lactose is present in the range of 10-100 mg, said maltose is present in the range of 50-300 mg, said sucrose is present in the range of 100-500 mg.
13. Cosmetic use of the composition according to anyone of the preceding claims for stimulating hair growth and/or preventing or treating hair loss and/or for skin anti-age effect.
14.The composition according to anyone of claims 1-12 for use in the prevention and/or treating of skin disorders and/or alopecia.
15.The composition according to claim 14, wherein said alopecia is Androgenetic alopecia.
16.The cosmetic use and the composition for use according to anyone of claims 13-15, wherein the composition is in a form for oral administration or topic application.
17.The use according to claim 16, wherein said composition is in form for oral administration selected from the group consisting of: tablets, capsules, pills, granulated power, syrups, beverages, functional food, and fortified foods.
18.The use according to claim 16, wherein said composition is for topical administration, selected from the group consisting of: solution, lotion, oil, emulsion, shampoo, cream, foam, spray and ointment.
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