EP3746040A1

EP3746040A1 - Cosmetic use of vegetation water

Info

Publication number: EP3746040A1
Application number: EP19707482.6A
Authority: EP
Inventors: Gianni LO FRANCO; Antonio LO FRANCO; Bandino LO FRANCO; Thomas Michael Schmidts; Michael Merzhäuser
Original assignee: Fattoria La Vialla di Gianni Antonio e Bandino Lo Franco Societa Agricola Semplice
Current assignee: Fattoria La Vialla di Gianni Antonio e Bandino Lo Franco Societa Agricola Semplice
Priority date: 2018-01-31
Filing date: 2019-01-31
Publication date: 2020-12-09
Also published as: IT201800002266A1; WO2019150292A1

Abstract

The present invention relates to a composition comprising at least one phytocomplex derived from the water from pressing olives for oil and/or pomace oil residues of the olive milling process, a polyphenolic residue and optionally olive oil, and the cosmetic use thereof.

Description

DESCRIPTION

"COSMETIC USE OF VEGETATION WATER"

*******

The present invention relates to a composition comprising at least one phytocomplex derived from the water from pressing olives for oil and/or pomace oil residues of the olive milling process, and/or a polyphenolic residue and/or olive oil and the cosmetic use thereof.

PRIOR ART

The bodily tissues of the human body are subjected to stress daily due to the outside environment. In particular, the skin is the outermost tissue, which covers both the external and internal body surfaces. The skin is the organ with the most extensive surface, and it has a protective, sensory, secretory, thermoregulating, absorption, permeability and aesthetic function. Skin hygiene and skin care against causes of potential damage (the sun's rays, contaminating agents, detergents etc.) represent essential elements of prevention. However, the skin is also affected by dietary, addictive and work habits, and the intake of drugs. Furthermore, many diseases of an internal type have skin manifestations.

The interaction between the skin and the outside environment can lead to increased oxidative stress, that is, an imbalance between the production and elimination of the oxidising substances produced by our body, better known as free radicals.

It is not in itself a cause of direct damage, but leads to secondary pathologies, some of which are very serious. Free radicals, or more correctly reactive oxygen species ( OS), form inside the body as a result of numerous biochemical processes in which is oxygen is present. The free radicals thus produced are unstable species that need to bind with cell structures in order to be able to stabilise. In fact, when one of them binds to a cell (for example to DNA, proteins or lipids) the cell structure is oxidised. Oxidation renders the cell sensitive to premature aging processes and degradation. Preventing the onset of oxidative stress is thus fundamental in order to reduce the effects of time on the body and combat any degenerative diseases. This places attention on a preventive and therapeutic approach in which it is possible to intervene by helping the body to combat increases in oxidative stress due to various external causes, but also due to a physiological or even para-pathological oxidative capacity of the body, which, as we have already noted, can cause damage to the structure and functionality of cells and accelerate natural aging processes and the evolution of degenerative diseases, in particular of the skin.

The present invention fits into this context; it relates to a composition comprising at least one phytocomplex or concentrate derived from the water from pressing olives for oil and/or pomace oil residues of the olive milling process comprising high quantities of hydroxytyrosol and oleuropein-aglycone di-aldehyde (3,4-DHPA-EDA), a polyphenolic residue and olive oil and the use thereof in the cosmetic field for the prevention and/or treatment of skin aging.

In fact, the Applicant has surprisingly found that, by applying the composition of the invention, in particular in the form of a cream, it is possible to improve/attenuate the signs of skin aging. In particular, the application of the cream favours cell renewal, and combats and mitigates the oxidative stress caused by free radicals.

Finally, the Applicant has found that the composition acts against pathogenic agents, for example against bacteria and/or against fungi.

BRIEF DESCRIPTION OF THE FIGURES

The present invention is described in detail below and exemplified with reference to the appended figures, in which:

- Figure 1 shows a graph of the pre-analysis of the production of IL-8 by HaCaT cells following treatment with 10 ng/mL TNF-α pr 24, 48 and 72 hours and in co-stimulation with hydrocortisone;

- Figure 2 shows the survival of HaCaT cells in relation to the dilution of the polyphenolic concentrate (1 :100 - 1 :1000) after 72 hours mean value ± standard value, n = 3 (6 respective versions). The indication of survival is represented in relation to the untreated control (=survival at 100 %);

- Figure 3 shows the production of IL-8 in HaCaT cells after treatment with 10 ng/mL TNF-a (control without TNF-a) and incubation with polyphenolic concentrate for 72 hours, mean value ± standard value, n = 3; *single value;

- Figure 4 shows the production of IL-8 relative to the control with TNF-a (72 hours) in HaCaT cells after the treatment with 10 ng/mL TNF-a and incubation with polyphenolic concentrate by reverse osmosis for 72 hours mean value ± standard value, n = 3 (3 respective versions);

- Figure 5 shows the analysis of the antimicrobial activity of the polyphenolic concentrate by reverse osmosis on different microorganisms;

- Figure 6 shows the quantification of the zones of inhibition formed, according to the microorganism tested and its initial mass in the perforation test and the plate test.

DETAILED DESCRIPTION OF THE INVENTION

A first aspect of the present invention relates to a composition comprising at least one excipient acceptable for pharmaceutical and/or cosmetic use, a phytocomplex or concentrate rich in hydroxytyrosol and oleuropein- aglycone di-aldehyde (3,4-DHPA-EDA), and a polyphenolic residue and optionally olive oil.

The phytocomplex or natural concentrate of the present invention is derived from the water from pressing olives for oil and/or pomace oil residues of the olive milling process. Hereinafter, reference will be made to this concentrate or phytocomplex as a "concentrate" or "polyphenolic concentrate" or "Olea Europaea Fruit Extract. As mentioned, the concentrate is particularly rich in hydroxytyrosol and oleuropein-aglycone di-aldehyde (3,4-DHPA-EDA). The amount of hydroxytyrosol preferably ranges from 0.2 to 2 grams per litre of vegetation water (g/L), more preferably from 0.25 to 1 g/L, even more preferably from 0.3 to 0.9 g/L. The amount of 3,4-DHPA-EDA is preferably comprised from 0.2 to 3 g/L, more preferably from 0.3 to 2 g/L, even more preferably from 0.4 to 1.5 g/L.

The vegetation water is preferably derived from a three-phase (oil, vegetation water and pomace), and/or a two-phase (oil and pomace + vegetation water) olive milling process.

According to a preferred aspect of the invention, the vegetation water generated by the mill can be treated with a solution with an acidic pH preferably ranging from 3 to 5; more preferably, the pH is about 4-5. The pH is preferably optimised by adding a strong acid and/or pectolytic enzymes, i.e. enzymes that hydrolyse the cellulose matrix of olive skins. According to a preferred embodiment of the invention, the pomace is pitted, diluted and/or pre-filtered. The pomace preferably has a particle size ranging from 0.5 to 1 millimetre (mm), more preferably about 0.7 mm. An example of a particle size is the one obtained by sieving with a vibrating screen. The pitted pomace may optionally be solubilised and/or dispersed in an aqueous matrix with a pH comprised preferably from 3 to 5, more preferably from 3.5 to 4.

The solubilisation step has the purpose of solubilising the polyphenols that would otherwise remain trapped in the solid matrix of the olive skins.

In a preferred embodiment of the invention, the concentrate comprises:

- a further phenolic compound preferably selected from: tyrosol, hydroxytyrosol, hydroxytyrosol glucoside, caffeoyl secologanoside, oleuropein, p-coumaroyl-secologanoside, chlorogenic acid, β-hydroxy verbascoside, rutin, verbascoside, luteolin and combinations thereof; and/or

- at least one metal, preferably selected from: sodium, calcium, magnesium and potassium and combinations thereof; and/or - at least one anion, preferably selected from: chlorides, sulphates, phosphates and nitrates and combinations thereof; and/or

- at least one glucide selected from: glucose, fructose, mannitol and sucrose and combinations thereof.

In a further embodiment of the invention, the concentrate comprises nitrogenous substances (proteins, amino acids), preferably in an amount comprised from 15 to 60 mg/kg, more preferably from 20 to 40 mg/kg (mg of nitrogen per litre of active solution).

The amount of the hydroxytyrosol glucoside preferably ranges from 0.2 to 2 grams per litre of vegetation water (g/L), more preferably from 0.25 to 1 g/L, even more preferably from 0.3 to 0.9 g/L.

The amount of caffeoyl secologanoside is preferably comprised from 0.05 to 0.6 g/L, more preferably from 0.08 to 0.5 g/L.

The amount of oleuropein is preferably comprised from 0.05 to 0.6 g/L, more preferably from 0.08 to 0.5 g/L.

The amount of p-coumaroyl-secologanoside is preferably comprised from 0.05 to 0.6 g/L, more preferably from 0.08 to 0.5 g/L.

The amount of tyrosol is preferably comprised from 0.1 to 0.7 g/L, more preferably from 0.15 g/L and 0.5 g/L.

The amount of chlorogenic acid is preferably comprised from 0.06 to 0.7 g/L, more preferably from 0.1 to 0.6 g/L.

The amount of β-hydroxy verbascoside is preferably comprised from 0.1 to 1.5, more preferably from 0.3 to 1 g/L.

The amount of rutin is preferably comprised from 0.05 to 0.6 g/L, more preferably from 0.08 to 0.5 g/L.

The amount of verbascoside is preferably comprised from 0.1 to 1.5 g/L, more preferably from 0.3 to 1 g/L.

The amount of luteolin is preferably comprised from 0.1 to 1.5 g/L, more preferably from 0.3 to 1 g/L.

The amount of sodium is preferably comprised from 75 to 300 mg/L, more preferably from 120 to 180 mg/L. The amount of calcium is preferably comprised from 5 to 10 g/L, more preferably from 2 to 5 g/L.

The amount of magnesium is preferably comprised from 220 to 900 mg/L, more preferably from 400 to 500 mg/L.

The amount of potassium is preferably comprised from 3 to 15 g/L, more preferably from 6 to 9 g/L.

The amount of chlorides is preferably comprised from 1.5 to 7 g/L, more preferably from 2.5 to 4.5 g/L.

The amount of sulphates is preferably comprised from 12 to 45 g/L, more preferably from 18 to 28 g/L.

The amount of phosphates is preferably comprised from 1.5 to 7 g/L, more preferably from 2.5 to 5 g/L.

The amount of nitrates is preferably comprised from 12 to 50 mg/L, more preferably from 18 to 30 mg/L.

The amount of glucose is preferably comprised from 15 to 60 g/L, more preferably from 25 to 35 g/L.

The amount of fructose is preferably comprised from 3.5 to 15 g/L, more preferably from 5 to 9 g/L.

The amount of mannitol is preferably comprised from 1 to 4 g/L, more preferably from 1.5 to 3 g/L.

The amount of sucrose is preferably comprised from 4 to 16 g/L, more preferably from 6 to 10 g/L.

The composition comprises at least one excipient acceptable for pharmaceutical and/or cosmetic use and:

- the polyphenolic concentrate in an amount comprised from 0.01 to 30 wt%, preferably from 0.05 to 25 wt%; and

- the polyphenolic residue in an amount comprised from 2 to 98 wt%, preferably from 4 to 96 wt%; and

- optionally the olive oil in an amount comprised from 1 wt% to 10 wt%, preferably from 3 wt% to 7 wt%. In a further particularly preferred embodiment, the composition of the present invention comprises the polyphenolic concentrate in an amount comprised from 0.01 to 30 wt%, preferably from 0.05 to 25 wt%, and olive oil in a concentration comprised from 1 wt% to 10 wt%, more preferably from 3 wt% to 7 wt%.

In a preferred embodiment of the invention, the concentrate is obtained/obtainable by means of a process comprising the steps of:

(i) microfiltrating a sample of vegetation water and/or pomace so as to obtain a concentrate and a microfiltration permeate; and

(ii) concentrating the microfiltration permeate obtained from step (i) by means of reverse osmosis.

According to a preferred aspect of the invention, the microfiltration is performed after the solubilisation step as described before.

The microfiltration has the purpose of separating a concentrate, i.e. the concentrated fraction of the content of the vegetation water/pomace in suspension, for example micro fragments, fibres and corpuscular material such as cells and bacteria. It is carried out under the standard conditions for this type of matrix.

Following the microfiltration step, in addition to the concentrate, one obtains a permeate, i.e. a clear fraction, characterised by a colour that varies according to the starting material and contains the dissolved components of the vegetation water/pomace, e.g. proteins, sugars, salts, polyphenols, organic acids and various soluble organic molecules.

The microfiltration is preferably carried out with at least one, preferably two, ceramic membrane(s). The membrane is characterised by a preferably tubular shape. In a preferred embodiment the membrane is made of alumina and zirconia oxide. According to a preferred aspect of the invention, the membrane has the following characteristics:

an outer diameter ranging from about 20 to about 40 mm, preferably of about 25 mm; and/or a length ranging from about 500 to about 1500 mm, preferably of about 1200 mm; and/or

a series of channels with a diameter, preferably a hydraulic diameter, ranging from about 2.5 to about 5 mm, preferably of about 3.5 mm; and/or

a filtering surface ranging from about 0.15 to about 0.7 m², preferably of about 0.35 m²; and/or

a molecular size ranging from about 0.1 micron to about 300 kDa. In particular, when the membrane is made of ceramic material it is extremely resistant to high temperatures and/or extreme pH conditions and is thus particularly suitable for the vegetation water treatment process, which, as it causes a high degree of "dirtying" on the membrane, requires high-temperature washing under severe pH conditions (e.g. pH 13-14). Furthermore, when the membrane has a tubular conformation, it allows back pulse washing, which is a further system for reconditioning and long- term operation.

The reverse osmosis step for concentrating the permeate obtained from the microfiltration of the vegetation water/pomace as described before is carried out under the standard conditions for this type of matrix, preferably by using a polymeric membrane, more preferably made of polyamide. The membrane preferably has a spiral-wound conformation and/or a molecular weight cut-off with high salt rejection, i.e. capable of rejecting sodium chloride molecules at a percentage of 99.9 %. This means that the osmosis membrane holds back the molecules of biomedical interest and allows only water molecules to pass through.

The polymeric membrane preferably has a filtering surface ranging from about 5 to about 15 m², more preferably of about 7 m².

The reverse osmosis step enables the permeate obtained by microfiltration to be concentrated preferably by about 4 times; this means that from 100 L of microfiltration permeate 25 L of concentrate are obtained. In this case the volume concentration ratio (VCR) is 4, i.e. 100/25.

The VCR can change based on the starting matrix (vegetation water) and above all based on its salt content, because the reverse osmosis process must offset the osmotic pressure of the matrix which is going to be concentrated.

The polyphenolic residue or "Olea Europaea Fruit Water" (hereinafter "polyphenolic residue") is preferably derived from a three-phase (oil, vegetation water and pomace) and/or two-phase (oil and pomace + vegetation water) olive milling process, microfiltered and concentrated by reverse osmosis with the process as described above.

Following microfiltration and reverse osmosis, therefore, one obtains a polyphenolic concentrate on the one hand, and on the other hand a solute residue containing polyphenols, albeit in a minimal amount.

Said polyphenolic residue is a clear, limpid fraction which contains the dissolved components of the vegetation water/pomace, e.g. proteins, sugars, salts, polyphenols, organic acids and various soluble organic molecules in limited amounts.

Following the concentration of the vegetation water and/or pomace, therefore, one obtains a polyphenolic concentrate and a residual liquid portion (polyphenolic residue) containing the above-mentioned active ingredients.

In a preferred embodiment of the invention, the polyphenolic residue comprises: at least one phenolic compound preferably selected from: tyrosol, hydroxytyrosol, hydroxytyrosol glucoside, caffeoyl secologanoside, oleuropein, p-coumaroyl-secologanoside, chlorogenic acid, β-hydroxy verbascoside, rutin, verbascoside, luteolin and combinations thereof.

Said polyphenolic residue, mainly composed of water, in which numerous active ingredients are dissolved, as described above, can be used as a solvent to partially replace water for the preparation of the composition. The olive oil is an edible oil extracted from olives, i.e. the fruits of the olive tree (Olea europaea), preferably by mechanical pressing. Said olive oil is obtained by means of standard milling and/or extraction and/or separation and/or storage and/or clarification techniques.

In a preferred embodiment of the invention, the olive oil comprises squalene, saturated, monounsaturated and polyunsaturated fatty acids, omega 3 and omega 6 fatty acids, phthalates, mineral oils, alkyl esters, tocopherols, polycyclic aromatic hydrocarbons and combinations thereof. The fatty acids are preferably selected from: palmitic acid (C16:0), palmitoleic acid (C16:1 ), heptadecanoic acid (C17:0), heptadecenoic acid (C 17:1 ), stearic acid (C18:0), oleic acid (C18:1 n-9), vaccenic acid (C18:1 n-7), linoleic acid (C18:2 n-6), alpha-linolenic acid (C18:3 n-3), arachidic acid (C20:10), eicosenoic acid (C20:1 n-9), behenic acid (C22:0) and combinations thereof.

The phthalates are preferably selected from butyl-benzyl-phthalate, di- isononyl phthalate and combinations thereof.

The mineral oils are preferably selected from: MOAH (Mineral Oil

Aromatic Hydrocarbons) C10-35, MOSH (Mineral Oil Satured

Hydrocarbons) C10-35 and combinations thereof.

The alkyl esters are preferably selected from: ethyl linoleate, ethyl oleate, ethyl stearate, methyl oleate and combinations thereof.

In one embodiment of the invention, the olive oil comprises squalene in an amount comprised from 1000 mg/kg to 5000 mg/kg, more preferably from

2000 mg/kg to 4000 mg/kg.

The ratio between polyunsaturated fatty acids and monounsaturated fatty acids is preferably comprised from 0.08 to 0.2, preferably from 1 to 1.7. The ratio between polyunsaturated fatty acids and saturated fatty acids is preferably comprised from 0.06 to 1 , preferably from 0.1 to 0.9.

The amount of palmitic acid is preferably comprised from 8 to 20 wt%, more preferably from 10 to 18 wt%.

The amount of palmitoleic acid is preferably comprised from 0.4 to 4 wt%, more preferably from 0.8 to 2 wt%. The amount of heptadecanoic acid is preferably comprised from 0.01 to 1 wt%, more preferably from 0.03 to 0.3 wt%.

The amount of heptadecenoic acid is preferably comprised from 0.07 to 1 wt%, more preferably from 0.09 to 0.5 wt%.

The amount of stearic acid is preferably comprised from 1 to 7 wt%, more preferably from 1.3 to 4 wt%.

The amount of oleic acid is preferably comprised from 40 to 90 wt%, more preferably from 50 to 80 wt%.

The amount of vaccenic acid is preferably comprised from 1 to 7 wt%, more preferably from 1.3 to 4 wt%.

The amount of linoleic acid is preferably comprised from 3 to 15 wt%, more preferably from 5 to 12 wt%.

The amount of alpha-linolenic acid is preferably comprised from 0.2 to 2 wt%, more preferably from 0.3 to 1 wt%.

The amount of arachidic acid is preferably comprised from 0.1 to 2 wt%, more preferably from 0.2 to 1 wt%.

The amount of eicosenoic acid is preferably comprised from 0.1 to 2 wt%, more preferably from 0.2 to 1 wt%.

The amount of behenic acid is preferably comprised from 0.07 to 1 wt%, more preferably from 0.09 to 0.5 wt%.

The saturated fatty acids are preferably present in an amount comprised from 8 g/100g to 30 g/100g, more preferably from 10 g/100g to 20 g/100g. The monounsaturated fatty acids are preferably present in an amount comprised from 40 g/100g to 90 g/100g, more preferably from 50 g/100g to 80 g/100g.

The polyunsaturated fatty acids are preferably present in an amount comprised from 3 g/100g to 20 g/100g, more preferably from 7 g/100g to 17 g/100g.

The omega 3 fatty acids are preferably present in an amount comprised from 0.1 wt% to 2 wt%, more preferably from 0.3 wt% to 1 wt%. The omega 6 fatty acids are preferably present in an amount comprised from 3 to 15 wt%, more preferably from 5 to 12 wt%.

The ratio between omega 3 and omega 6 is preferably comprised from 0.07 to 1 , more preferably from 0.09 to 0.5.

The amount of butyl-benzyl-phthalate is preferably comprised from 0.2 to 2 wt%, more preferably from 0.3 to 1 wt%.

The amount of di-isononyl phthalate is preferably comprised from 1 to 7 wt%, more preferably from 1.3 to 4 wt%.

The amount of MOAH is preferably comprised from 0.4 to 4 wt%, more preferably from 0.8 to 2 wt%.

The amount of MOSH is preferably comprised from 2 to 10 wt%, more preferably from 3 to 8 wt%.

The ethyl linoleate is preferably present in an amount comprised from 0.5 wt% to 3 wt%, more preferably from 1 wt% to 2.5 wt%.

The ethyl oleate is preferably present in an amount comprised from 1 wt% to 3.5 wt%, more preferably from 1.5 wt% to 3 wt%.

The ethyl stearate is preferably present in an amount comprised from 0.5 wt% to 3 wt%, more preferably from 1 wt% to 2.5 wt%.

The methyl oleate is preferably present in an amount comprised from 1 wt% to 10 wt%, more preferably from 3 wt% to 8 wt%.

The composition of the present invention comprises at least one excipient acceptable for pharmaceutical use and/or cosmetic use, which is useful in the preparation of the composition and is generally biologically safe and non-toxic.

Said excipient can be at least one conditioning agent, preferably a skin humectant, occlusive or emollient conditioning agent.

Said conditioning agent is preferably selected in the group consisting in: glycerine, hyaluronic acid, caprylic/capric triglyceride, aspartic acid, decyl cocoate, soybean oil, lactic acid, glyceryl stearate, beeswax, glyceryl behenate, glyceryl dibehenate, tribehenin, betaine and stearic acid and combinations thereof. The concentration of said conditioning agent preferably ranges from 5 to 45 wt%, preferably from 10 to 30% wt.

The concentration of said glycerine preferably ranges from 0.25 to 15 wt%; more preferably, it ranges from 0.3 to 13 wt%.

The concentration of said hyaluronic acid preferably ranges from 0.05 to 5 wt%; more preferably, it ranges from 0.7 to 4 wt%.

The concentration of said decyl cocoate preferably ranges from 0.5 to 10 wt%; more preferably, it ranges from 0.7 to 7 wt%.

The concentration of said beeswax preferably ranges from 0.05 to 5 wt%; more preferably, it ranges from 0.7 to 4 wt%.

The concentration of said stearic acid preferably ranges from 0.05 to 10 wt%; more preferably, it ranges from 0.7 to 7 wt%.

The concentration of said glyceryl stearate preferably ranges from 0.05 to

10 wt%; more preferably, it ranges from 0.2 to 7 wt%.

The concentration of said caprylic/capric triglyceride preferably ranges from 0.5 to 10 wt%; more preferably, it ranges from 0.7 to 7 wt%.

The concentration of said lactic acid preferably ranges from 0.005 to 5 wt%; more preferably, it ranges from 0.008 to 3 wt%.

The concentration of said soybean oil preferably ranges from 0.005 to 5 wt%; more preferably, it ranges from 0.008 to 3 wt%.

The concentration of said glyceryl behenate preferably ranges from 0. 05 to 5 wt%; more preferably, it ranges from 0. 08 to 3 wt%.

The concentration of said glyceryl dibehenate preferably ranges from 0.1 to 7 wt%; more preferably, it ranges from 0.2 to 5 wt%.

The concentration of said tribehenin preferably ranges from 0.1 to 7 wt%; more preferably, it ranges from 0.2 to 5 wt%.

The concentration of said betaine preferably ranges from 0.05 to 5 wt%; more preferably, it ranges from 0.08 to 3 wt%.

Said excipient can further be a surfactant agent, preferably an emulsifying or cleansing surfactant agent.

Said surfactant agent is preferably selected in the group consisting in: cetyl stearyl alcohol, cetyl alcohol, polyglyceryl-3 dicitrate/stearate and combinations thereof. The concentration of said surfactant agent preferably ranges from 0.5 to 10 wt%; more preferably, it ranges from 0.7 to 7 wt%.

The concentration of said cetyl stearyl alcohol preferably ranges from 0.5 to 10 wt%; more preferably, it ranges from 0.7 to 7 wt%.

The concentration of said plolyglyceryl-3 dicitrate/stearate preferably ranges from 1 to 10 wt%; more preferably, it ranges from 2 to 7 wt%.

Said excipient can further be a binder, preferably selected from dextrins, preferably distarch phosphate, or else a stabilising agent, preferably an emulsifying stabilising agent, such as, for example, xanthan gum. The concentration of said binder preferably ranges from 0.05 to 10 wt%; more preferably, it ranges from 0.07 to 7 wt%; the concentration of said stabilising agent preferably ranges from 0.05 to 5 wt%; more preferably, it ranges from 0.07 to 3 wt%.

The concentration of said distarch phosphate preferably ranges from 0.05 to 10 wt%; more preferably, it ranges from 0.07 to 7 wt%.

The concentration of said xanthan gum preferably ranges from 0.05 to 5 wt%; more preferably, it ranges from 0.07 to 3 wt%.

Said excipient can further be a preservative, preferably a glycol, even more preferably pentylene glycol.

The concentration of said preservative preferably ranges from 0.5 to 10%; more preferably it ranges from 0.75 to 7%.

Furthermore, said excipient can be an antioxidant, preferably selected from: tocopherol, tocopherol acetate, vitamin E, vitamin C, sodium lactate and combinations thereof. The concentration of said antioxidant preferably ranges from 0.05 to 5 wt%; more preferably, it ranges from 0.08 to 3 wt%.

Moreover, said excipient can be a fragrance and/or perfume, preferably selected from: linalool, limonene, geraniol, citronellol and combinations thereof. The concentration of said fragrance and/or perfume preferably ranges from 0.005 to 10 wt%; more preferably, it ranges from 0.01 to 7 Wt%.

A further aspect of the present invention relates to the composition of the invention which is formulated, preferably for topical use, as a cream, gel cream, gel, serum, oil, emulsion, emulsion gel (emulgel), ointment, spray or stick (such as cocoa butter). The formulation of the composition as an intensive face serum or as a cream, preferably as a hand cream and/or face cream, is particularly preferred.

A further aspect of the present invention relates to the cosmetic use of the composition as described above, preferably for preventing and/or attenuating and/or combating the signs of skin aging, wherein the signs of aging are preferably selected in the group consisting of wrinkles, preferably expression wrinkles, skin spots, reddening, cracking or loss of skin tone and/or elasticity and combinations thereof.

A further aspect of the present invention relates to the composition as described above for use as a medicament.

A further aspect of the present invention relates to the composition as described above for use in the treatment and/or prevention of pathological conditions affecting the skin, preferably in order to prevent and/or treat skin aging, preferably reddening, irritations, topical inflammation and/or cracking.

Another aspect of the present invention relates to the use of the composition according to the present invention in personal care and/or hygiene, preferably for disinfecting the skin/epidermis, more preferably for the prevention and/or treatment of infections by pathogens, preferably infections by bacteria and/or yeasts and/or moulds.

Said pathogens are preferably selected from: Staphylococcus epidermidis, Propionibacterium acnes, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Aspergillus brasiliensis and combinations thereof.

EXAMPLES

Test on the antiinflammatory effect of the polvphenolic concentrate bv reverse osmosis on lines of human keratinocvtes

Cultured HaCaT human keratinocyte cells were stimulated with TNF-a for 24, 48 and 72 hours. At the end of the treatments, the production of proinflammatory interleukin-8 (IL-8) and hydroxycortisone (anti-inflammatory) was assessed. The levels of IL-8 were assessed by ELISA (Enzyme- Linked Immunosorbent Assay) and are shown in Fig.1.

TNF- a induces the maximum release of IL-8 after 72 hours of treatment and co-stimulation with hydroxycortisone is capable of partially inhibiting the release of IL-8. The 72-hour treatment with TNF- a was chosen in order to assess the anti-inflammatory effect of the polyphenolic concentrate.

Different dilutions of the polyphenolic concentrate on HaCaT cells were assessed by means of a cytotoxicity test; in particular, 1 :100, 1 :200, 1 :400, 1 :600, 1 :800 and 1 :1000 dilutions were tested. (Fig.2) The 1 :200, 1 :400 and 1 :600 concentrations were chosen for the experiments on the antiinflammatory activity of the concentrate.

As shown in Figs. 3 and 4, the 1 :200 dilution of the polyphenolic concentrate is capable of inhibiting the release of IL-8 by 78% compared to the control treated with TNF- a for 72 hours.

Test on the effect of the polyphenolic concentrate against pathogenic agents on the skin

The tests conducted indicate whether the reverse osmosis polyphenolic concentrate has an anti-bacterial and anti-mycotic action on various pathogens (bacteria and yeasts and moulds), in particular causes of skin diseases, such as, for example, acne. The effect of the reverse osmosis polyphenolic concentrate was analysed in relation to the following pathogens:

Bacteria: Staphylococcus epidermidis, Propionibacterium acnes, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Yeasts: Candida albicans

Moulds: Aspergillus brasiliensis. The test procedure follows the standards indicated in the European Pharmacopoeia - test for adequate antimicrobial activity. 10 mL of reverse osmosis polyphenolic concentrate are inoculated respectively in cultures of bacteria, yeasts or moulds, with an initial number of microorganisms comprised from 10⁴ to 5-10⁶ KBE/g. (Figure 5)

The antimicrobial activity of the concentrate was assessed with two other tests: perforation test and plate test. The culture plates are injected in such a way as to have an initial number of germs between 10⁵ and 1.2-10⁷ KBE per plate.

In the perforation test, a hole with a diameter of 11 mm is punched and filled with 0.5 mL of concentrate. (Figure 6).

In the plate test, the concentrate is applied on an absorbent test plate for antibiotics (diameter 9 mm, 0.25 mL). (Figure 6, column).

The plates are incubated as described in the European Pharmacopoeia. As shown in Figures 5 and 6, the concentrate shows a good antibacterial activity and a fairly good antimycotic activity.

Preparation of an Intensive Serum

All the ingredients used are of natural origin.

Table 1

Production of intensive serum:

The gelling agent, for example hyaluronic acid, is initially dispersed in a solvent. In parallel, the remaining ingredients are dissolved. The two phases are thus combined until obtaining a homogeneous substance. The pH of the solution is then adjusted so that it is neutral for human skin. Hand cream:

Table 2

A modified dextrin is dispersed in the polyphenolic concentrate and incubated at a temperature comprised from 70°C to 100°C°. The remaining water-soluble substances are added and mixed at a temperature comprised from 70°C to 100°C°.

In parallel, the substances soluble in oil are mixed so as to obtain an emulsion and melted at a temperature comprised from 70°C to 100°C°. During this step a gelling agent is dispersed, for example hyaluronic acid. The aqueous solution is then added slowly to the emulsion and homogenized in a homogenizer, preferably a rotor-stator homogenizer. At the end of homogenization, the emulsion obtained is cooled to room temperature (<30°) while mixing. Finally, the PH values are adjusted with the aid of lactic acids so as to render them neutral for skin and perfumes and/or fragrances are added.

Face cream:

Table 3

Production of hand cream:

Tolerabilitv test

Subjects

The test group was made up of 40 adult female subjects.

Inclusion criteria

Persons over 18 years of age with healthy skin, which is dry and sensitive in the parts to be tested.

Exclusion criteria

- Severe or chronic skin inflammation - severe internal or chronic diseases

- intake of medicines that could suppress the skin reaction (glucocorticoid, anti-allergy, topical immunomodulators, etc.)

- application of preparations containing active ingredients up to 7-10 days before of the start of the study

- allergies or severe side effects manifested at least once due to cosmetic products

- sun exposure or solarium sessions during the study

- cancer

- pregnancy and breastfeeding

Subjects tested

20 female subjects,

Age comprised from 22 to 79 years,

Type of skin: dry/sensitive

Preparations: Face cream and Intensive serum

20 female subjects,

Age comprised from 22 to 73 years,

Type of skin: dry/sensitive

Dermatoloaical studies

Before the application test, all subjects had healthy skin in the test part. No abnormalities of any type were detected.

During the four weeks, none of the persons tested showed any pathological alterations of the skin in the tested part. In no cases were there any interruptions of the test a need for dermatological treatment. At the final dermatological examination at the end of the application of the product, none of the subjects tested showed any pathological alterations of the skin in the tested part. The selected preparations were well tolerated and did not cause any unwelcome alterations of the skin in any of the subjects tested.

Epicutaneous tests of the tolerabilitv of the composition of the invention on human skin The aim of the study was to precisely verify the tolerability of the face cream and of the intensive serum according to clinical and dermatological criteria. The subjects tested could consult the dermatologist accompanying the study every day regarding objective and subjective skin alterations. All of the subjects were dermatologically examined before the start of the application test. Only participants in the study group who did not show any pathogenic alterations of the skin in the tested parts were accepted.

Each subject subsequently applied an intensive serum on the right part of the face and a face cream on the left part of the face twice a day, in the morning and evening, for a period of 4 weeks. In particular, a serum "A" comprising 5 wt% of the polyphenolic concentrate and a serum "B" comprising 10 wt% of the polyphenolic concentrate were applied on the right part of the face, and a face cream "A" comprising 1 wt% of the polyphenolic concentrate and a face cream "B" comprising 5 wt% of the polyphenolic concentrate on the left part of the face, twice a day, in the morning and evening, for a period of 4 weeks.

The subjects were instructed to use exclusively the tested preparation on the tested part during the period of the test.

After 4 weeks, at the end of the period of application, final epicutaneous tests were performed to rule out that any subjects may have developed sensitisation during the period of application.

An epicutaneous test performed at the end of a four-week treatment provides information not only about irritant reactions on the skin, but also about the sensitisation potential of the preparation used. The epicutaneous test is a model of testing for primary irritations of the skin caused by the tested product and/or any existing sensitisation against the tested product. The tested substances are applied in suitable concentrations occlusively on the skin. The epicutaneous contact with the tested product is thus only local and limited in time, intensified by the occlusive condition, which favours the absorption of the tested substances. The skin is examined after 24, 48 and 72 hours. The occlusion favours the penetration of the probable topical allergen through the horny layer, enabling it to reach the effector T cells, which provoke a local reaction of the immune system. In order to be able to provoke a positive reaction, it is necessary to exceed the threshold value of irritation or sensitivity. A positive reaction to a correctly applied epicutaneous test serves as evidence of a primary irritation caused by the tested substance, but is not necessarily evidence of sensitisation. Allergic reactions of the skin are provoked through the epicutaneous test if sensitisation already exists. 5 mg/15 μΙ of the tested product are applied undiluted on a self-adhesive patch (Curatest® F Folien-Testpflaster, Fa. Lohmann & Rauscher GmbH & Co. KG), which is applied and fixed on clinically healthy skin on the upper part of the back. The patch is removed after a 24-hour period of exposure and evaluated dermatologically and allergologically for the first time. A second and third evaluation takes place after 48 and 72 hours. The evaluation of the reaction takes place 30 minutes after the removal of the patch. In cases of reactions where there is uncertainty as to the type of reaction (allergic or irritative), evaluations are performed some time later. All the evaluations are performed under standardised lighting.

Dermatoloaical assessment criteria

Reddening

Peeling

Dryness

Results

The face creams A and B and the intensive serums A and B were well tolerated by a total of 40 persons tested during the four-week study period of use thereof according to dermatological and clinical criteria. No case of an undesirable or even pathological alteration of the skin occurred in the tested part.

At the end of the one-month period of application following international guidelines, the epicutaneous tests assured that no subject tested became sensitised to the preparations during the application test.

The epicutaneous tests did not give rise to any type of skin alteration in the tested part in any subject after 24, 48 and 72 hours.

It can therefore be deduced that, in practical application, the face creams

A and B and the intensive serums A and B do not cause undesirable skin reactions due to irritative or sensitising effects.

Test of tolerabilitv of the composition of the invention on human skin with optical 3D with PRIMOS

3D recording and evaluation of the surface of the human skin is an important task of dermatological examinations, from both a medical and cosmetic point of view. For exact diagnoses, therapeutic decisions or also in order to evaluate the progress of medicinal or cosmetic therapies, an exact knowledge of the skin surface in 3D is an important tool. A reading of the 3D profile of the surface of the skin can be made by creating a cast of the skin (replica) or also via direct in vivo measurements.

Measurement

In the PRIMOS device for 3D measurement of the skin, the so-called structured light projection technique is applied. For this method of measurement, a pattern of parallel stripes is projected onto the surface of the skin, which is then represented on a CCD chip.

The 3D measurement effect is achieved because even the slightest height differences on the skin's surface create deflections of the parallel stripes. These deflections represent a qualitative and quantitative measurement for the skin profile. The CCD camera records them, digitises them and enters them into the computer for a quantitative interpretation. Mathematical algorithms originally developed and used for exact optical measurement of precision mechanical components are applied for the interpretation. Now it can also be used for 3D optical skin measurements to obtain a very precise 3D profile of the surface of the skin.

The 3D optical skin measurement instrument PRIMOS (from: Phaseshift Rapid In vivo Measurement Of Skin) is characterised by the fact that as in the case of signal processing it applies a digital projection of structured light.

The digital projection of light is based on the development of digital projectors with micromirrors, invented and introduced to the market in the 1990s by Texas Instruments/Dallas.

The compact version of the PRIMOS device used consists of an optical sensor (with an integrated micromirror projector, projection and recording optics, CCD camera), a computer for measurement and data interpretation, and a mount for moving the sensor freely and taking photographs of different areas of the skin. A further element of the PRIMOS instrument is a software package for measurement and the interpretation of skin surface data.

The PRIMOS instrument enables both a completely contactless measurement of skin profile data and the measurement of replicas. Each measurement method has advantages and disadvantages. Anyone who is not experienced in creating replicas may easily cause minimal mechanical loads which lead to changes in the 3D micro structure. Direct in vivo measurement of the skin, on the other hand, poses difficulties due to subjects "wobbling" or because of the involuntary movements listed below. The two methods can lead to different results in measuring the roughness or smoothness of the skin.

The surface of the human skin is continually exposed to movements caused by blood circulation and the autonomic nervous system. Particularly as regards the analysis of hard-to-reach areas of the body (for example lips, eyelids or folds), there is always the risk of slight shifts or movements occurring at the surface of the skin during the acquisition of data. These changes can cause different degrees of disturbance, depending on the phase of exposure to light. In the case of large movements, the 3D data can become completely unusable. A series of slight movements during the acquisition of data can still be identified relatively well in the results. However, errors caused by series of submicroscopic movements during the acquisition of data are often difficult to identify and pose the risk of distorting the results measured on the skin surface.

3D optical measurement are performed in order to observe the action of a medicinal or cosmetic therapy on the surface of the skin. This objective presupposes that the treated skin, both before and after treatment, must be exactly assessable from a quantitative and qualitative point of view. Given that the human skin has fairly irregular surface structure, in order to measure skin roughness it is particularly important that before and after the treatment exactly the same area of the skin is measured.

Material used

With the measurement of replicas (analysis of skin casts made of silicone) one can avoid errors during the measurement process. The material used for the cast (silicone-based malleable precision material) is equivalent to DIN 13 913 A 2, ISO 4823, Type 1 category B, colour: white.

After a time of preparation of 45 seconds, the mass is evenly applied without pressure on the test area and hardens after 2-3 minutes. This elastic cast can then be detached from the skin surface and is fixed lying flat on a glass plate with a solvent-free glue.

Interpretation of the data

Once a point density has been selected for the x and y axes respectively, the program creates a realistic 3D representation of the skin profile on the colour display. Afterwards, the values recorded by the computer are processed and analysed. The analysis entails the following steps:

- Deduction of the roughness profile from the surface through positioning and filtration

- Calculation of the standard values of skin roughness (DIN 4768ff)

- With the PRIMOS software, structural changes of the skin can be quantitatively categorised according to DIN (German industrial standards) and ISO (International Standard Organisation) criteria. The calculations follow the respective DIN standards. A wave filter and Gauss filter are applied where necessary. The most widely used surface measurement parameters that were used to evaluate the surface structure of the skin are the following:

Rz(DIN) =

Arithmetical mean of five roughness values from five sections of the same length and adjacent to one another, measured independently on the digital profile

Rz(ISO) =

Sum of the means of the absolute heights, calculated on the basis of the five highest peaks and the five lowest valleys of the profile over the measured length

Results of 3D optical measurement of the skin surface

A comparison is made between the Rz-DIN values in the tested area before/after and the relative change (negative values indicate an improvement, hence a reduction in skin roughness)

Table 4

Preparation: Face cream A

The improvement in skin roughness after 4 weeks of use of face cream A was on average -15.09 %.

Table 5

Preparation Face cream B

The improvement in skin roughness after 4 weeks of use of Face cream A was on average -14.75 %.

Table 6

Preparation: Intensive serum A

The improvement in skin roughness after 4 weeks of use of Intensive serum A was on average -24.77 %.

Table 7

Preparation: Intensive serum B

The improvement in skin roughness after 4 weeks of use of Intensive serum B was on average -23.60 %.

Evaluation of the results

Overall, in the 4 weeks of the application test according to the dermatological-clinical criteria, the face creams A and B and the intensive serums A and B were well tolerated by 40 probands. In no case did any undesirable or even pathological changes in the skin manifest themselves in the tested area.

Skin roughness was measured in order to study the action of the face creams A and B and intensive serums A and B on 40 probands before and after 4 weeks of regular application of the preparations. The roughness values were measured with the aid of 3D measurements of the skin surface (skin replica). In the treated area, an improvement in skin roughness of -15.09 % occurred on left half of the face and -14.75 % on the right side. In conclusion, from a dermatological point of view, it can be confirmed that the face creams A and B and intensive serums A and B, when applied according to the clinical-dermatological criteria, were very well tolerated and improved skin roughness according to standard DIN 4768ff.

Test of tolerabilitv of the composition of the invention on human skin with the VISIA system

With the VISIA™ system, digital images of the face are compared. It gives the possibility of comparing skin properties and features. For example, pores and porphyrins can be precisely represented and thus compared in an objective manner, not only a subjective one as was the case until now. Accordingly, quantitative assessments on the features of facial skin can be given. At the basis of the system there is an imaging unit that sends high quality recordings to a high-performance computer. This computer interprets the images taken and demonstrates the results through analysis software. After this, many parameters can be compared. The device enables images to be taken of the state of the skin under constant conditions, such as, for example, the distance to the imaging machine, light exposure, perspective and the precision of the measured area. In this manner, "before" and "after" situations can be perfectly compared.

Table 8: parameters that can be visualised, analysed and compared with the VISIA® system.

Interpretation of data with the Visia system

In order to visualise and analyse the parameters, the face is illuminated with three different types of light, on the right, left and front: IntelliFlash® (standard light), polarised light and UV light (365 nm). Imaging with UV light enables the best interpretation and analysis of skin damage caused by the sun and visualisation of porphyrins. Imaging with polarised light increases contrast and saturation and reduces the reflections and glare of shiny surfaces. Furthermore, with the aid of Canfield's RBX® Technology, it is possible to differentiate the red and brown areas of the skin in order to perfectly visualise telangiectasia, hyperpigmentation, rosacea and acne. Data interpretation takes place automatically in the following modes:

"Feature counts": Count of the frequency of a specific feature. This analysis enables a precise count of the features to be analysed (for example, evenness, pores etc.). Only the frequency is indicated, independently of the size or intensity of the feature.

"Value": complete interpretation of a specific feature. In this analysis, the algorithm takes account not only of the frequency of the feature, but also the size, intensity and consequences for the skin structure.

Three images are taken for each measurement (left side, right side and front).

Subjects

The test group is made up of 5 adult female probands.

Inclusion criteria

Persons of legal age with skin that is healthy, dry and sensitive in the tested areas. Exclusion criteria

- severe or chronic skin inflammation

- severe or chronic diseases

- intake of medicines that could influence the skin reaction (glucocorticoid, anti-allergy, immunomodulators, etc.)

- application of preparations or cosmetics containing active ingredients 7-10 days before the start of the test

- severe allergies or previous severe adverse effects caused by cosmetic preparations

- sunbathing or solarium during the study

- known tumour pathology

- pregnancy and breastfeeding

Preparations: Face cream A and B

5 female subjects,

Age comprised from 31 to 69 years,

Type of skin: dry/sensitive

Preparations: Intensive serum A and B

20 female subjects,

Age comprised from 31 to 56 years,

Type of skin: dry/sensitive

Digital interpretation of data

Preparation: Face cream A

Table 9: Feature: Pores ("values"). Representation of the individual results measured of the 5 probands before and after the four weeks of application of the preparation. Only the left half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 3.78 % in the "Pores" feature in the tested area.

Table 10: Feature: Pores ("Features count"). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the left half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 1.02 % in the "Pores" feature in the tested area.

Table 11 : Evenness ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of

application of the preparation. Only the left half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 2.87 % in the "Evenness" feature in the tested area.

Table 12: Evenness ("Features count"). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the left half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 5.11 % in the "Evenness" feature in the tested area.

Table 13: Porphyrins ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the left half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of

2.95 % in the "Porphyrins" feature in the tested area. Table 14: Porphyrins ("Features count"): Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the left half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 3.37 % in the "Porphyrins" feature in the tested area.

Preparation: Face cream B

Table 15: Pores ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of

application of the preparation. Only the right half of the face was

analysed.

After 4 weeks of application, there was a mean percentage change of 2.65 % in the "Pores" feature in the tested area.

Table 16: Pores ("Features count"). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 4.45 % in the "Pores" feature in the tested area. Table 17: Evenness ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of

application of the preparation. Only the right half of the face was

analysed.

After 4 weeks of application, there was a mean percentage change of 10.08 % in the "Evenness" feature in the tested area.

Table 18: Evenness ("Features count"). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of -

7.95 % in the "Evenness" feature in the tested area.

Table 19: Porphyrins ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of

application of the preparation. Only the right half of the face was

analysed.

After 4 weeks of application, there was a mean percentage change of - 0.36 % in the "Porphyrins" feature in the tested area.

Table 20: Porphyrins ("Features count"): Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 5.02 % in the "Porphyrins" feature in the tested area.

Preparation: Face cream A

Table 21 : Pores ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of

application of the preparation. Only the right half of the face was

analysed.

After 4 weeks of application, there was a mean percentage change of 4.72 % in the "Pores" feature in the tested area in the tested area.

Table 22: Pores ("Features count"). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 5.32

% on average in the "Pores" feature in the tested area.

Table 23: Evenness ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of

application of the preparation. Only the right half of the face was

analysed.

After 4 weeks of application, there was a mean percentage change of 5.96 % in the "Evenness" feature in the tested area.

Table 24: Evenness ("Features count"). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 3.45

% in the "Evenness" feature in the tested area.

Table 25: Porphyrins ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 24.73 % in the "Porphyrins" feature in the tested area.

Table 26: Porphyrins ("Features count"): Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the right half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 24.58 % in the "Porphyrins" feature in the tested area.

Table 27: Pores ("values"). Representation of the individual results measured for the 5 probands before and after the four weeks of

application of the preparation. Only the left half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 12.40 % in the "Pores" feature in the tested area.

Table 28: Pores ("Features count"). Representation of the individual results measured for the 5 probands before and after the four weeks of application of the preparation. Only the left half of the face was analysed.

After 4 weeks of application, there was a mean percentage change of 11.62 % in the "Pores" feature in the tested area.

Evaluation of the results

Overall, in the 4 weeks of the application test according to the dermatological-clinical criteria, the face creams A and B and the intensive serums A and B were very well tolerated by 5 probands. In no case did any undesirable or even pathological changes in the skin manifest themselves in the tested area.

It can be deduced that, in practical application, the face creams A and B and the intensive serums A and B will not cause any undesirable skin reactions due to irritating or sensitising actions.

The action of the preparation as regards the parameters pores, evenness and porphyrins was determined with the VISIA® system (Canfield Scientific, Inc.). It was possible to demonstrate changes in the pore, evenness and porphyrin parameters in the tested area.

Claims

1. A composition comprising at least one excipient acceptable for pharmaceutical and/or cosmetic use and:

- a polyphenolic concentrate of vegetation water and/or pomace in a concentration comprised from 0.01 to 30 wt%, preferably from 0.05 to 25 wt%;

- a polyphenolic residue of vegetation water and/or pomace in a concentration comprised from 2 to 98 wt%, preferably from 4 to 96 wt%; and

- optionally olive oil in a concentration comprised from 1 wt% to 10 wt%, more preferably from 3 wt% to 7 wt%.

2. The composition according to claim 1 , wherein said concentrate comprises hydroxytyrosol and oleuropein-aglycone di-aldehyde (3,4- DHPA-EDA), wherein the amount of 3,4-DHPA-EDA is preferably comprised from 0.2 to 3 g/L, preferably from 0.3 to 2 g/L, more preferably from 0.4 to 1.5 g/L; and the amount of hydroxytyrosol is preferably comprised from 0.2 to 2 grams per litre of vegetation water (g/L), more preferably from 0.25 to 1 g/L, and even more preferably from 0.3 to 0.9 g/L.

3. The composition according to claim 1 or 2 wherein:

- said concentrate further comprises 1 ) at least one phenolic compound selected from: tyrosol, hydroxytyrosol, hydroxytyrosol glucoside, caffeoyl secologanoside, oleuropein, p-coumaroyl-secologanoside, chlorogenic acid, β-hydroxy verbascoside, rutin, verbascoside, luteolin and combinations thereof; and/or 2) at least one metal, preferably selected from: sodium, calcium, magnesium, potassium and combinations thereof; and/or 3) at least one anion, preferably selected from: chlorides, sulphates, phosphates, nitrates and combinations thereof; and/or 4) at least one carbohydrate selected from: glucose, fructose, mannitol, sucrose and combinations thereof; and/or 5) nitrogen; and/or

- said polyphenolic residue comprises at least one phenolic compound, preferably selected from: tyrosol, hydroxytyrosol, hydroxytyrosol glucoside, caffeoyl secologanoside, oleuropein, p-coumaroyl-secologanoside, chlorogenic acid, β-hydroxy verbascoside, rutin, verbascoside, luteolin and combinations thereof, and/or

- said olive oil comprises fatty acids, preferably selected from: saturated, monounsaturated and polyunsaturated, more preferably selected from: palmitic acid (C16:0), palmitoleic acid (C16:1 ), heptadecanoic acid (C17:0), heptadecenoic acid (C 17:1 ), stearic acid (C18:0), oleic acid (C18:1 n-9), vaccenic acid (C18:1 n-7), linoleic acid (C18:2 n-6), alpha- linolenic acid (C18:3 n-3), arachidic acid (C20:10), eicosenoic acid (C20:1 n-9), behenic acid (C22:0) and combinations thereof, omega 3/6, phthalates, preferably butyl-benzyl-phthalate and/or di-isononyl phthalate, mineral oils, preferably selected from: MOAH (Mineral Oil Aromatic Hydrocarbons) C10-35, MOSH (Mineral Oil Saturated Hydrocarbons) C10- 35 and combinations thereof, alkyl esters, preferably selected from: ethyl linoleate, ethyl oleate, ethyl stearate, methyl oleate and combinations thereof, tocopherols, polycyclic aromatic hydrocarbons and combinations thereof.

4. The composition according to any one of claims 1 -3, wherein the at least one excipient acceptable for pharmaceutical use and/or cosmetic use is selected from:

- at least one conditioning agent, preferably in a concentration ranging from 5 to 45 wt%, more preferably from 10 to 30 wt%, wherein said conditioning agent is preferably selected from: glycerine, hyaluronic acid, caprylic/capric triglyceride, aspartic acid, decyl cocoate, soybean oil, lactic acid, glyceryl stearate, beeswax, glyceryl behenate, glyceryl dibehenate, tribehenin, betaine and stearic acid and combinations thereof; and/or

- a skin emollient, occlusive or humectant conditioning agent; and/or

- a binder, preferably present in a concentration ranging from 0.05 to 10 wt%, more preferably ranging from 0.07 to 7 wt%, wherein said binder is preferably a dextrin; and/or - a stabilising agent, preferably an emulsifying stabilising agent, preferably present in a concentration ranging from 0.05 to 5 wt%, more preferably ranging from 0.07 to 3 wt%; and/or

- a preservative, preferably present in a concentration ranging from 0.5 to 10 wt%, more preferably ranging from 0.75 to 7 wt%, wherein said preservative is preferably glycol, even more preferably pentylene glycol; and/or

- an antioxidant selected from tocopherol, tocopherol acetate, vitamin E, vitamin C, sodium lactate and combinations thereof; and/or

- a fragrance and/or a perfume, preferably present in a concentration ranging from 0.005 to 10 wt%, more preferably ranging from 0.01 to 7 wt%, wherein said fragrance and/or perfume is preferably selected from: linalool, limonene, geraniol, citronellol and combinations thereof.

5. The composition according to any one of the preceding claims, formulated, preferably for a topical use, as a cream, gel cream, gel, serum, oil, emulsion, emulsion gel, ointment, spray or stick.

6. A use of the composition according to any one of claims 1 -5 as a cosmetic.

7. A use of the composition according to any one of claims 1 -5 as a cosmetic for preventing and/or attenuating and/or combating signs aging, wherein the signs of aging are selected from wrinkles, skin spots, reddening, cracking, loss of skin tone and/or elasticity and combinations thereof.

8. A use of the composition according to any one of claims 1 -5 as a cosmetic in personal care and/or hygiene.

9. The composition according to any one of claims 1 -5, for use as a medicament, preferably for the prevention and/or treatment of infections by pathogens, said pathogens being preferably bacteria and/or yeasts and/or moulds, preferably selected from: Staphylococcus epidermidis, Propionibacterium acnes, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Aspergillus brasiliensis and combinations thereof.

10. The composition according to any one of claims 1 -5, wherein said concentrate and/or said polyphenolic residue are obtained by means of a process comprising the steps of: