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Title:
DERMATOLOGICAL COMPOSITION FOR REBALANCING THE SKIN, FOR INCREASING ITS HYDRATION AND ELASTICITY AND FOR REDUCING DYNAMIC DISORDERS
Document Type and Number:
WIPO Patent Application WO/2022/013897
Kind Code:
A1
Abstract:
A dermatological composition is described which allows rebalancing the skin, increasing the degree of hydration and the degree of elasticity of the skin, and at the same time reducing skin discoloration. The composition comprises a mixture of the bacterial lysates Lactobacillus acidophilus ferment lysate, Lactobacillus casei ferment lysate, Lactobacillus plantarum ferment lysate and Streptococcus thermophilus lysate, titanium dioxide, hydrogenated lecithin, vitamin C with a title of about 50% in phytocomplex extracted from Rosa caniria, hyaluronic acid sodium salt, Althaea Officinalis leaf/root extract, Malva Sylvestr is extract in specified amounts.

Inventors:
ROMAGNOLI SILVIA (IT)
MANZONI VIVIANA (IT)
DONATI ALBERTO (IT)
Application Number:
PCT/IT2021/050196
Publication Date:
January 20, 2022
Filing Date:
June 24, 2021
Export Citation:
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Assignee:
O F I OFFICINA FARM ITALIANA S P A (IT)
International Classes:
A61K8/29; A61K8/67; A61K8/73; A61K8/9789; A61K8/99; A61Q1/02; A61Q19/08
Domestic Patent References:
WO2019122776A12019-06-27
Foreign References:
US20150093462A12015-04-02
CN110772433A2020-02-11
US10682306B12020-06-16
GB2542873A2017-04-05
Other References:
DATABASE GNPD [online] MINTEL; 6 November 2019 (2019-11-06), ANONYMOUS: "Ampoule Pact SPF 50+ PA+++", XP055781053, retrieved from https://www.gnpd.com/sinatra/recordpage/7012549/ Database accession no. 7012549
DATABASE GNPD [online] MINTEL; 29 October 2019 (2019-10-29), ANONYMOUS: "Ampoule Concealer SPF 20 PA++", XP055781048, retrieved from https://www.gnpd.com/sinatra/recordpage/6979419/ Database accession no. 6979419
DATABASE GNPD [online] MINTEL; 9 May 2019 (2019-05-09), ANONYMOUS: "Brilliant Matte Primer", XP055781043, retrieved from https://www.gnpd.com/sinatra/recordpage/6500867/ Database accession no. 6500867
Attorney, Agent or Firm:
CASCIANO, Lidia (IT)
Download PDF:
Claims:
CLAIMS

1. Dermatological composition comprising:

0.1% to 1% (w/w) of a mixture of the following bacterial lysates:

- Lactobacillus acidophilus ferment lysate, - Lactobacillus case/ferment lysate,

- Lactobacillus plantarum ferment lysate,

- Streptococcus thermophHus lysate,

0.1% to 11% (w/w) of Titanium Dioxide,

0.1% to 2% (w/w) of hydrogenated lecithin, 0.1% to 2% (w/w) of Vitamin C with a title of about 50% in phytocomplex extracted from

Rosa canina,

0.1% to 1% (w/w) of hyaluronic acid sodium salt,

0.05% to 0.5% (w/w) of Althaea Officinalis leaf/root extract and Malva Sylvestris extract blend. 2. Dermatological composition according to claim 1, comprising one or more of the following further components:

50% to 75% (w/w) of water, 5% to 10% (w/w) of coco-caprylate,

1% to 5% (w/w) of C15-19 alkanes,

1 % to 5% (w/w) of ethyl esters of Shea Butter,

1 % to 5% (w/w) of dicapryl ether, 1 % to 5% (w/w) of polyglyceryl-6-polyhydroxystearate,

1% to 5% of magnesium stearate,

1% to 5% (w/w) of iron oxide (yellow dye),

1% to 5% (w/w) of polyglyceryl-6-polyricinoleate,

0.1% to 1% (w/w) of magnesium sulfate, 0.1% to 1% (w/w) of sodium chloride,

0.1% to 1% (w/w) of phenoxyethanol,

0.1% to 1% of silica,

0.1% to 1% (w/w) of iron trioxide (red dye),

0.1% to 1% (w/w) of perfume, 0.1 % to 1 % (w/w) of iron tetroxide (black dye),

0.1% to 1% (w/w) of ethylhexylglycerin, 0% to 0.1% (w/w) of maltodextrin,

0% to 0.1% (w/w) of polyglyceryl-2-caprate,

0% to 0.1% (w/w) of glycerin,

0% to 0.1% (w/w) of alumina, 0% to 0.1% (w/w) of Simmondsia Chinensis seed oil,

0% to 0.1% (w/w) of stearic acid,

0% to 0.1% (w/w) of sucrose stearate,

0% to 0.1% (w/w) of ascorbic acid,

0% to 0.1% (w/w) of glyceryl caprylate, 0% to 0.1 % (w/w) of Squalane.

3. Dermatological composition according to any one of claims 1 to 2, comprising one of the following further components:

0.5% to 4% (w/w) of a mixture of iron oxide (yellow dye), iron trioxide (red dye), iron tetroxide (black dye); or 0.5% to 2% (w/w) of capryloyl glycine or cranberry seed oil or undecylenoyl phenylalanine or ceramide NP or Phophyra Umbilicalis seaweed.

4. Dermatological composition according to any one of claims 1 to 3, wherein the lysates are derived from bacterial cultures respectively of:

- Lactobacillus acidophilus HA- 122,

- Lactobacillus casei HA-108, - L actobacWus plantarum H A- 119 ,

- Streptococcus thermophilus HA-110, where said bacteria are inactivated by heat by means of the tindalization method.

5. Dermatological composition according to any one of claims 1 to 4 wherein the titanium dioxide is microencapsulated in lecithin. 6. Dermatological composition according to any one of claims 1 to 5 wherein, the mixture of leaf/root extract of Althaea Officinalis and Malva Sylvestris extract comprises a mucopolysaccharide of which more than 30% (w/w) has a weight molecular greater than 20,000 Daltons.

7. Dermatological composition according to any one of claims 1 to 6 wherein the leaf/root extract of Althaea Officinalis and the Maiva Sylvestris Officinalis extract are in a weight ratio of approximately 1:1.

8. Process for the preparation of the dermatological composition according to any one of claims 1 to 7 comprising the following steps:

A) preparation of an aqueous solution or suspension comprising: - Lactobacillus acidophilus ferment lysate,

- Lactobacillus casei ferment lysate,

- Lactobacillus plantarum ferment lysate,

- Streptococcus thermophHus lysate, B) preparation of a mixture comprising:

- titanium dioxide,

- hydrogenated lecithin,

- vitamin C with a title of about 50% in phytocomplex extracted from Rosa canina,

- hyaluronic acid sodium salt; C) preparation of an aqueous solution comprising a mixture of Althaea Officinalis leaf/root extract and Malva Sylvestris extract;

D) preparation of an emulsion by adding the aqueous solution prepared in step C) to the mixture prepared in step B);

E) addition of the solution or suspension from step A) to the emulsion prepared in step D). 9. Process according to claim 8, wherein step A) and/or step B) is also carried out by sonication at about 20 KHz for a time ranging from 3 to 15 minutes.

10. Process according to any one of claims 8 to 9, wherein step C) and/or D) is carried out at a temperature of about 75 °C.

11. Dermatological composition obtainable from the process according to any one of claims 8 to 10. 12. Use of the dermatological composition according to any one of claims 1 to 7 or 11, for skin rebalancing, for increasing the degree of hydration and for increasing the degree of elasticity of the skin.

Description:
DERMATOLOGICAL COMPOSITION FOR REBALANCING THE SKIN, FOR INCREASING ITS HYDRATION AND ELASTICITY AND FOR REDUCING DYNAMIC DISORDERS

The present invention deals with a dermatological composition which allows to rebalance the skin, to increase the degree of hydration of the skin, the degree of elasticity and at the same time to reduce the discoloration of the skin. Therefore the present invention is in the field of dermatology and cosmetics.

In the cosmetics sector, and in particular in that of classic foundations, the first products to be placed on the market were BB creams and CC creams, all in one foundations with moisturizing and basic coloring purposes.

From our market analysis we have not identified any brand or product that has gone so far as to deal with the fusion of skincare and make-up and in particular, analyzing more in depth the foundation market that represents the (make) UP part of a possible product, FUSION, and identifying different areas of investigation, the presence of a product that combines the effects of rebalancing, hydration, skin elasticity and homogenization of skin dichromies was not highlighted. The state of the art of cosmetic brands placed on the market therefore indicates that an "ad hoc" dermatological performance has not been obtained so far from this type of 2-in-1 products.

An immunoprotective, rebalancing and normalizing purpose of the microbiome was not sought, in which a real fusion is achieved between a non-occlusive and light skin feel, natural and with soothing properties and for the treatment of the various types of epidermis and the necessary color coverage, to standardize "the bottom of the face" to make the discolorations homogeneous. Furthermore, on these premises a naturalness of 99% was not sought.

Human skin is not only a neurosensory organ and a body temperature regulator but above all it performs an important protective physical barrier function by exercising various functions such as immune, metabolic and primary protection against infections. It is the anatomical layer located above the dermis and subcutaneous tissue and is a particular type of epithelial tissue, histologically defined as keratinized multi-layered paving epithelial tissue. Its state of health depends both on intrinsic, natural factors, connected to the processes of general somatic aging and susceptibility to diseases, which affect all organs, tissues and all individuals (chrono-aging), and external or environmental factors involving the skin as an external covering organ, the main responsibility of which is attributable to the cumulative alterations produced by the sun's rays (photoaging).

Chrono-aging determines in the skin, as in most tissues, hypotrophic alterations, with loss of compactness and cellular malnutrition, which are opposed to the hypertrophic alterations of photoaging, with aspects of proliferative disorder.

In the dermatological management of skin reactions involving itching, redness, skin rash, folliculitis, hyper-dryness and fissures, the protection and defense of the hydrolipidic mantle therefore plays a primary role. Patent publication GB2542873 (A) comprises a composition comprising at least one stimulator of the Pro-resolution pathway. Preferably, the stimulators of the pro-resolution pathway are chosen from omega- 3/omega-6 fatty acids, salicylic acid, resveratrol, resveratrol salicylate, PeriHa ocymoides seed oil, Camellia japonica extract, Poria coria extract, seed extract of Aleurites mo!uccana (Kukui), CameHna sativa seed oil, Dongbaek oil (Tsubaki),

Bifida ferment lysate and L actobaciiius fe rm e nt lysate.

Choi, Y. M. et al. have disclosed the hypolipidemic effect of the lactobacillus ferment as a functional food supplement. Object of the present invention is a new generation dermatological composition of intermediate products between skin care and colored makeup base for the needs of those who do not like to weigh down their skin with covering foundations, but instead want a "hybrid" solution that is halfway between skin care and make up.

The dermatological composition has an immunoprotective, rebalancing and normalizing purpose of the microbiome, in which a real fusion is achieved between a non occlusive and light skin feel, natural and with soothing properties and for the treatment of the various types of epidermis, and the color coverage necessary for uniform "the bottom of the face" to make the discolorations homogeneous.

The dermatological composition of the present invention has the advantage of supporting the qualitative-quantitative composition of the normal skin commensal microflora, responsible for a delicate chemical-physical balance, offering immediate moisturizing, soothing and re-epithelizing action as well as not damaging the optimal pH, keeping under control the loss of transepidermal water, the thinning of the lipid barrier and the altered composition of fatty acids. The dermatological composition of the present invention allows the improvement of the epidermal imbalance and the coverage of skin discolorations.

Therefore, the problem addressed by the present invention is the provision of a dermatological composition which simultaneously allows to effectively increase the degree of hydration of the skin, the degree of elasticity of the skin, to rebalance the skin microbiome and to standardize skin discolorations.

Another object is the procedure for the preparation of the dermatological composition with which the components of the ingredients have been processed and stabilized.

Another object is the use of the composition for the rebalancing of the skin, increasing the degree of hydration and elasticity.

The dermatological composition, the procedure for its preparation and use will be described as defined in the attached claims, the definitions of which are an integral part of this description.

Further characteristics and advantages of the dermatological composition, the preparation process and its use will result from the description of the examples of embodiment of the invention, provided as an indication of the invention.

The present invention refers to a dermatological composition based on curative topical compositions having the purpose of rebalancing the skin microbiome or allowing the treatment of skin imbalances including dermatitis, eczema, itching, redness, psoriasis, atopic dermatitis, vitiligo and skin diseases caused by microbial and fungal agents.

The object of the present invention is a dermatological composition that acts as a rebalancing and modulator of the microbiome, improving the immune defenses of the skin and, at the same time, increasing the degree of hydration and elasticity of the skin and reducing skin discoloration. Furthermore, the present composition also has immunoprotective action.

It was in fact found that a dermatological composition comprising:

0.1% to 1% (w/w) of a mixture of the following bacterial lysates: - Lactobacillus acidophilus ferment lysate,

- Lactobacillus casei ferment lysate,

- Lactobacillus plantarum ferment lysate,

- Streptococcus thermophHus lysate, from 0.1 % to 11 % (w/w) of Titanium Dioxide,

0.1% to 2% (w/w) of hydrogenated lecithin, from 0.1% to 2% (w/w) of Vitamin C with title about 50% in phytocomplex extracted from Rosehip

0.1% to 1% (w/w) of hyaluronic acid sodium salt, 0.05% to 0.5% (w/w) of Althaea Officinalis leaf/root extract and Malva Sylvestris extract blend. allows achieving the aforementioned advantages at the same time.

All percentage values shown in this text refer to weight-to-weight percentages (abbreviated w/w) and refer to the total weight of the entire dermatological composition. In fact, the dermatological composition comprising a mixture of four probiotics consisting of Lactobacillus plantarum, Lactobacillus casei, Lactobacillus acidophilus and Streptococcus thermophHus, together with Titanium Dioxide, lecithin, Vitamin C in phytocomplex derived from Rosehip, Hyaluronic acid sodium salt and a sodium mucopaccharide high/medium molecular weight present in the mixture of natural mucilage extracted from Mallow and Altea, allows rebalancing the skin microbiome, increasing the degree of hydration and skin elasticity, and reducing skin discoloration. Lactobacillus is a genus of rod-shaped facultative anaerobic or microaerophilic Gram positive bacteria. In nature there are at least 60 species and they make up the majority of the group of lactic bacteria, so called because almost all of their members convert lactose and other sugars into lactic acid through lactic fermentation. Inactivated cultures of Lactobacillus bacterium or Streptococcus thermophilus bacterium can be prepared by heat, according to the tindalization method.

The Lactobacillus bacterium can originate from a variety of species, and is an organism that is referred to as a "probiotic".

The species object of the present invention are Lactobacillus acidophilus, Lactobacillus casei and Lactobacillus plantarum, which are those which give the designation "probiotic".

More specific examples of Lactobacillus bacteria are referred to by their INCI names, for example Lactobacillus lysate, Lactobacillus ferment lysate, Lactobacillus filtrate, and so on. In particular, Lactobacillus acidophilus ferment lysate, Lactobacillus casei ferment lysate and Lactobacillus plantarum ferment lysate.

Lactobacillus extracts are also exploitable, which are an extract obtained from the fermentation of the bacterium Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus plantarum, and the filtrate of the Lactobacillus ferment which is a filtrate of the product obtained from the fermentation of Lactobacillus. More preferably, it is Lactobacillus ferment lysate which is a product obtained from the fermentation of Lactobacillus.

Streptococcus is a genus of gram-positive spherical bacteria, cocci, which usually grow in pairs or form chains. They are facultative anaerobic bacteria, with a predilection for the condition of anaerobiosis.

Mixtures containing inactivated cultures of the bacterium Streptococcus thermophHus or its enzymes are also usable.

Streptococcus thermophHus can be in the form of ferments, lysates, or filtered, either alone or in combination. The fermentation product of Streptococcus thermophHus is preferred.

Streptococcus thermophHus can also be part of a mixture with other probiotic ingredients, ferments, filtered or lysates, and the like.

According to a preferred embodiment, the Streptococcus thermophHus lysate is preferred. Preferably, the bacterial strains used in the present invention are derived from bacterial cultures of Lactobacillus plantarum HA-119, Lactobacillus acidophilus HA-122, Lactobacillus casei HA-108 and Streptococcus thermophHus HA-110, heat inactivated by the tindalization method.

These probiotics interact with the skin microbiome of the person and modulate the rebalancing protective response giving health benefits to the epidermis, allowing the prevention and treatment of skin imbalances including eczema, atopic dermatitis, acne, allergic inflammation or skin hypersensitivity. These probiotics can help modulate the skin microflora, the lipid barrier and the skin immune system, leading to the preservation of skin homeostasis and keeping the skin pH under control, the increase of which is associated with various skin dysreactivity.

The microflora of the skin plays a significant role in the competitive exclusion of pathogens that are aggressive and cause not only skin infections but are involved in the processing of proteins, free fatty acids (FFA) and sebum. It is interesting to note how the resident microbiota can be considered "beneficial" for the normal and healthy host, but it can become dangerous for the host in which the integrity of the skin is lacking, resulting in cracked, wounded, inflamed skin also play a role in atopic dermatitis (AD), eczema, rosacea, psoriasis and acne Topical probiotic application of the dermatological composition of the invention is useful for preventing or treating skin diseases associated with altered microflora.

Titanium dioxide is the mineral used in the present invention with a coating of emulsifying lipophilic substances to increase its dispersibility and skin dermal affinity. Such substances offer allow stabilizing the composition of the present invention.

The natural phytocomplex of Vitamin C used in the present invention derives from a freeze-dried aqueous dry extract of fruit titrated at 50% in vitamin C supported on maltodextrin, consisting of a particle size of 20 mesh to improve its solubilization in aqueous base and stabilized by title with acid ascorbic (vit. C exogenous) since the natural source of Vit. C from fruit is dependent on climatic conditions, rain, harvest time and organic composition of the soil. Its antioxidative activity counteracts free radicals and regulates excesses of melanin production by epidermal keratinocytes, preventing and attenuating skin spots.

In the present invention, the term hyaluronic acid refers to a mucopolysaccharide formed by D-Glucuronic acid and N-Acetylglucosamine joined by a 1-3 glycosidic bond. The compound used is a sodium salt of hyaluronic acid whose molecular weight is between 1,000,000 and 1 ,800,000 Daltons. Hyaluronic acid is a polymer traditionally used as an ocular lubricant in ophthalmology and joint lubricant in orthopedic surgery and which, from a dermatological point of view, is very well tolerated at concentrations up to 2%. It regulates the water content of the intracellular substance and the permeability of the connective tissue, acts as a cementing substance of the tissues to which it gives the typical plasticity, has anti inflammatory and healing properties. It is present in the dermatological composition, of which it regulates three-dimensional scaffolding, turgor and hydration. Its presence involves tissue hydration due to water retention, in fact it has the ability to increase its initial molecular weight by about 1000 times due to swelling in water, it also develops a barrier effect protecting the damaged skin on the surface (film forming capacity).

Marshmallow and Mallow were used in the form of freeze-dried aqueous extracts from leaves and roots from cultivars of European origin, rich in natural polysaccharide mucilages (mucopolysaccharides), mainly represented by arabinogalactans and galactide - ramnans, arabans and heteropolysaccharide glucans with a molecular weight about 30,000 Daltons containing D-galactose, L-rhamnose, D-glucuronic acid and D-galacturonic acid in molar ratios 1.2:1.0:1.0:1.0; L-arabinans and D-glucans. The dominant component of the mucilaginous fraction is (1- 6)-a-D-glucan. These mucilages used for topical use, with the moisture of the skin, form a viscous colloidal solution indicated as calming, emollient, soothing, anti-inflammatory for protection from irritation. The molecular weight of the Mallow and Altea phytocomplex was characterized to correlate its moisturizing, protective and adhesive mucus capacity in synergy with hyaluronic acid. The study reveals that more than 30% (w/w) of the phytotherapeutic mucilages contained have a molecular weight > 20,000 Daltons, which confirms the film-forming capacity that adheres to the unbalanced epidermis and protects it from contact with irritants (barrier effect).

It was in fact surprisingly found that the combination between the effect given by probiotics and the film-forming capacity given by the synergy between hyaluronic acid and a mixture of leaf/root extract of Althaea Officinalis and Maiva Syivestris extract, allows reaching the rebalancing effect, the moisturizing effect, the elasticizing effect of the present invention.

The mixture of Althaea Officinalis leaf/root extract and Maiva Syivestris extract is therefore an essential ingredient of this dermatological composition.

According to a preferred embodiment, the dermatological composition comprises:

0.3% to 0.7% (w/w) of a mixture of the following bacterial lysates: - Lactobacillus acidophilus ferment lysate,

- Lactobacillus casei ferment lysate,

- Lactobacillus p!antarum ferment lysate,

- Streptococcus thermophi!us lysate, According to a preferred embodiment, the dermatological composition can comprise one or more of the following further components:

50% to 75% (w/w) of water,

5% to 10% (w/w) of coco-caprylate, 1 % to 5% (w/w) of C15-19 alkanes,

1 % to 5% (w/w) of ethyl esters of Shea Butter,

1 % to 5% (w/w) of dicapryl ether,

1 % to 5% (w/w) of polyglyceryl-6-polyhydroxystearate,

1% to 5% of magnesium stearate, 1 % to 5% (w/w) of iron oxide (yellow dye),

1% to 5% (w/w) of polyglyceryl-6-polyricinoleate,

0.1% to 1% (w/w) of magnesium sulfate,

0.1% to 1% (w/w) of sodium chloride,

0.1% to 1% (w/w) of phenoxyethanol, 0.1 % to 1 % (w/w) of silica,

0.1% to 1% (w/w) of iron trioxide (red dye), 0.1% to 1% (w/w) of perfume,

0.1% to 1% (w/w) of iron tetroxide (black dye),

0.1% to 1% (w/w) of ethylhexylglycerin,

0% to 0.1% of maltodextrin,

0% to 0.1 % of polyglyceryl-2-caprate,

0% to 0.1 % (w/w) of glycerin,

0% to 0.1 % (w/w) of alumina,

0% to 0.1 % (w/w) of Simmondsia Chinensis seed oil,

0% to 0.1% (w/w) of stearic acid,

0% to 0.1% (w/w) of sucrose stearate,

0% to 0.1 % (w/w) of ascorbic acid,

0% to 0.1 % (w/w) of glyceryl caprylate,

0% to 0.1 % (w/w) of Squalane.

According to a preferred embodiment, the dermatological composition comprises all the ingredients listed above.

According to a preferred embodiment, the dermatological composition can further comprise one of the following further components:

- from 0.5% to 4% (w/w) of a mixture of iron oxide (yellow dye), iron trioxide (red dye), iron tetroxide (black dye); or

- 0.5% to 2% (w/w) of capriloyl glycine or cranberry seed oil or undecylenoyl phenylalanine or ceramide NP or Phophyra Umbilicalis seaweed. The dermatological composition mentioned above, in fact, has the advantage that, simply by adding one of the ingredients listed below, it is possible to obtain different compositions having specific uses and effects, in addition to the basic effects of moisturizing, elasticising and rebalancing the skin data from the dermatological composition itself. The dermatological composition, in addition to the above ingredients, may comprise one of the following additional components:

0.5% to 4% (w/w) of a mixture of iron oxide (yellow dye), iron trioxide (red dye), iron tetroxide (black dye), to attenuate discolored skin spots; or 0.5% to 2% (w/w) of capriloyl glycine, for oily and/or acne-prone skin, or 0.5% to 2% (w/w) of blueberry seed oil for eczematous and/or psoriasis skin, or 0.5% to 2% (w/w) of undecylenoyl phenylalanine for the treatment of melasma, or 0.5% to 2% (w/w) of NP ceramide for the improvement of barrier function of dry and/or alipic skin, or

0.5% to 2% (w/w) of Phophyra Umbilicalis seaweed, to confer antioxidant and/or photoprotective action. According to a preferred embodiment, the dermatological composition comprises lysates which are derived from bacterial cultures respectively of:

- Lactobacillus acidophilus HA-122,

- Lactobacillus casei HA- 108,

- Lactobacillus plantarum HA-119, - Streptococcus thermophilus HA-110, where said bacteria are inactivated by heat, by means of the tindalization method.

According to a preferred embodiment, the dermatological composition comprises titanium dioxide microencapsulated in lecithin. According to a preferred embodiment of the dermatological composition, the mixture of leaf/root extract of Althaea Officinalis and of Maiva Syivestris extract comprises a mucopolysaccharide of which more than 30% (w/w) has a molecular weight greater than 20,000 Daltons. According to a preferred embodiment of the dermatological composition, the leaf/root extract of Althaea Officinalis and the Maiva Syivestris Officinalis extract are in a weight ratio of approximately 1:1.

Another object of the present invention is obtaining a probiotic dermatological composition which includes emollient, lubricating, emulsifying, thickening, humectant agents which allows to have a filming action for the seal and duration of the color coverage on the face, without resorting to the presence of silicones, petrolatum, PEG and other occluding factors that worsen the effects deriving from the interaction with the surface moisture of the skin, sweat and relative salinity, dust particles and city life smog.

A further advantage of the dermatological composition is the definition of a dermatological composition which, based on the ingredients as described in claims 1 and 2, can generate a matrix of possible topical combinations to improve the curative performance and to reduce skin discoloration of new cosmetic products " fusion "between skin care and makeup.

Preparations based on these compositions must be able to form a non-occlusive film- forming film on unbalanced skin and be able to exert a protective barrier action against attacks from the external environment, for example dust, germs, small insects, which can worsen the skin. In fact, the insulted skin is no longer able to fully play its role: the protective barrier, partially destroyed, is less efficient both internally and externally. From the inside there is a dispersion of body fluids rich in water, proteins and mineral salts, from the outside micro-cracks open which make the passage to impurities and bacteria from the surrounding environment open, and this creates a situation of difficulty since it becomes the main one. cause of infections.

Based on the type of aqueous continuous phase emulsion chosen, the bioadhesive characteristics of the polymers, the emollient oils, the antioxidant system, the viscosifying excipients to obtain a thick cream or fluid milk and the consequent conservation system selected to avoid contamination microbial, it is therefore necessary to focus on ingredients with a high tolerability profile and low percutaneous absorption, to prevent the onset of allergic reactions that would entail important contraindications to a soothing and anti- reddening treatment.

Mucoadhesive biopolymers, viscosity stabilizers and skin emollients and conditioners should be selected with particular attention, preferring those that have the advantage of offering a formation of protective films homogeneously dispersed on the skin for the protection and strengthening of the skin barrier, where dermatitis can generate acute phenomena of dehydration, desquamation with signs of irritation, redness, itching, infections. The soothing function also provides that the preparation has a highly moisturizing and emollient efficacy, particularly suitable for combating the dryness typical of sensitized and reactive skin. The prerogative of an optimal spreadability and softness of the preparation, and immediate absorption, is a necessary condition for the compliance of the product, which must neither "hold back" on the skin nor have an excessive need for excessive massaging, which would lead to a too prolonged mechanical insult, but flow, be quickly reabsorbed, moisturize and soothe to help give immediate relief in case of burning, cover discolored spots evenly and with perfect bioadhesion. Table 1 shows the dermatological composition of the invention with the active dermatological variants and the rheological additives and basic excipients.

Table 1

Where, in Table 2, C77492 is iron oxide (yellow dye), Cl 77491 is iron trioxide (red dye), CI77499 is iron tetroxide (black dye).

The proposals are extremely diversified in the compositions as they are articulated both for the age target of the consumer and for the epidermal target and function as modulators of physiological functions altered for different causes (chrono-aging, diseases, photo-exposure).

Another object is a process for the preparation of the cosmetic composition which allows to obtain a stable composition.

The preparation process consists of some pre-mixing phases that must be carried out with accuracy, checking the temperatures and operating pressures or the vacuum control in the production equipment.

The procedure for preparing the dermatological composition includes the following steps:

A) preparation of an aqueous solution or suspension comprising: - Lactobacillus acidophilus ferment lysate, Lactobacillus casei ferment lysate, Lactobacillus plantarum ferment lysate, Streptococcus thermophHus lysate,

B) preparation of a mixture comprising: - titanium dioxide,

- hydrogenated lecithin,

- vitamin C with a title of about 50% in phytocomplex extracted from Rosa canina,

- hyaluronic acid sodium salt,

C) preparation of an aqueous solution comprising a mixture of Althaea Officinalis leaf/root extract and Malva Sylvestris extract;

D) preparation of an emulsion by adding the aqueous solution prepared in step C) to the mixture prepared in step B).

E) addition of the solution or suspension from step A) to the emulsion prepared in step D). According to a preferred embodiment of the process, step A) and/or step B) is also performed by sonication at about 20 KHz for a time ranging from 3 to 15 minutes.

According to a preferred embodiment of the process, step C) and/or D) is carried out at a temperature of about 75 °C. According to a preferred embodiment of the process, step E) is carried out at a temperature of about 35 °C.

The details of the preparation procedure will be described in detail below.

Step A): Preparation of the mix of lactic ferments (probiotic phase). The 4 lactic ferments ( Lactobacillus plantarum, casei, acidophils and Streptococcus thermophiius), after careful weighing, are introduced one at a time into a mixer-tank for sonification of the UIP 200 HBT type into which a weighed quantity of purified water of pharmaceutical grade 1 equal to 10 times the total weight of the enzymes.

After the introduction of the enzymes, the container is mechanically closed and a residual pressure of about 0.4 atm is created through a vacuum pump (preferably Edwards model).

The phase of slow stirring of the mixture then begins through the rotating blades of the mixer, preferably at a speed of 600 rpm for 4 minutes.

After this phase the sonication process begins with a power of 20 kHz for 15 minutes. After this time the sonication is interrupted while the stirring with rotating blades continues at a reduced speed of 400 rpm for a further 6 minutes.

Then follows the filtration process of the mixture thus obtained using the counterthrust of the vacuum tank hermetically connected to a closed filtering system consisting of two bell filters connected to each other, the first with a filtration degree of 2 microns and the second of 1. micron. All the dispersed mixture is passed through the two filters in such a way that the parts above 1 micron (which constitute the inert matrix of our lactic ferments) are retained.

The filtrate, always kept under vacuum, represents the biologically active and skin- compatible part of the composition, and is made up of 90% water and 10% lysate of tindalised probiotics. Step B): Production of the liposome containing Titanium Dioxide, hydrogenated lecithin and

Hyaluronic acid sodium salt (liposomal phase).

It is the most complex phase of the entire process, as the subsequent possibility of obtaining a product with excellent spreadability, skin-compatible and well tolerated by the skin depends on the good result of the formation of the liposome.

In a turboemulsifier - sonicator with double jacket for the recirculation of water, kept thermostated at 55 °C, a quantity of medium chain fatty acids C8-C18 (coco-caprylate) of between 5-10% is introduced and kept agitated at 50 °C for 5 minutes. The container is then placed under vacuum with a depression equal to -0.6 atm. The metered quantity of hydrogenated lecithin previously dispersed in coco-caprylate is then added in a ratio of 1:3. Mixing is activated at 800 rpm for 10 min.

The exact quantities of Hyaluronic acid sodium salt and Rosehip extract titrated in Vitamin C are then prepared separately and each dissolved separately in pharmaceutical grade 1 purified water and brought to a temperature of 50 °C under slow stirring. When the two solutions are visibly perfectly transparent (complete solution), always keeping them at 50 °C, first the sodium hyaluronate solution and then the one with the rosehip extract are sucked into the turboemulsifier-sonifier in sequence while the stirring continues at 800 rpm. for 3 minutes.

The turbine is then activated for 4 minutes and brought to a speed of 2800 rpm. At the end of this phase the turbine is turned off while the stirring continues at 800 rpm for a further 3 minutes. After this time the sonicator is activated for 3 minutes at 20 kHz of power. The implant is then stopped, while a sample is taken under microscopic observation at 4000 magnification by immersion to check the correct formation of our liposome containing titanium dioxide, sodium hyaluronate and Rosa Canina extract. We also proceed to a spreadability test on a glass plate to check the perfect stability, adhesiveness and coverage of our liposome.

Step C): Preparation of Hydrophilic phase.

The part of the hydrophilic ingredients of the dermatological composition, consisting of dry extracts of Altea and Mallow titrated in natural mucilage, is added to the total water to the mixture of the various hydrophilic components and kept under constant stirring at a temperature of 75 °C.

Step D): Emulsification.

The liposomal phase (prepared in step B)) is combined with the other lipophilic components and the emulsifier to proceed with the preparation of the dermatological composition with the direct emulsion technique under vacuum.

The preparation turboemulsifier is filled with the hot total lipophilic phase (liposomal phase prepared in step B + lipophilic ingredients). When the temperature of 75 °C is reached, the total hydrophilic phase (prepared in step C) + hydrophilic ingredients) is added to the lipophilic phase under stirring with a turbine at 3000 rpm for 20 minutes always at 75 °C.

Step E): Cooling and final.

At the end of step D) a slow cooling is carried out until the composition temperature is brought to a temperature of 35 °C. At this point the probiotic phase (prepared in step A) is added, stirring at low speed until complete homogenization.

The thermolabile components of the dermatological composition, such as preservatives and essences, are then added.

The quantities of the ingredients used in the process are the same as those of the dermatological composition described above, including the preferred embodiments. Another object is the dermatological composition obtainable from the process described above, including the various preferred embodiments.

Another object is the use of the dermatological composition described above, including the preferred embodiments, for the rebalancing of the skin, to increase the degree of hydration and to increase the degree of elasticity of the skin.

All the ingredients for the preparation of the dermatological composition are widely commercially available, including for the cosmetics sector.

EXPERIMENTAL PART

EXAMPLE OF OBSERVATIONAL DERMATOLOGICAL STUDY relating to the anti- aging rebalancing foundation with probiotics, whose dermatological composition corresponds to that of the first column of Table 1 above.

The purpose of the study is to evaluate the moisturizing, elasticizing and smoothing efficacy of skin discolorations of a probiotic-based foundation for daily treatment. The study includes 1 week of treatment. Inclusion criteria: The study was conducted on 10 healthy female Caucasian subjects aged 25 to 60 years with a skin pattern of dry, normal to dry, oily, normal to combination and with slight/medium-sized discolouration.

Non-inclusion criteria: all subjects who do not meet the inclusion criteria described above, pregnant or breastfeeding women, presence of allergies and sensitivity to topical cosmetic products, women on drug therapy and a history of atopy.

After enrollment, the subjects' compliance with the inclusion/non-inclusion criteria and the basal conditions (TO) of the skin parameters under study were assessed.

For the evaluation of the moisturizing effect and the elasticizing effect of the product, a skin area was selected at the level of the antero-internal surface of the forearm of each volunteer. After an acclimatization period of 15 minutes, the foundation under examination is applied in a quantity equal to 2 mg/cm 2 .

ENDPOINTS: 1 hour (T1h) and 8 hours (T8h) from application, the skin hydration index was evaluated. The instrument used is a MoistureMeterSC Compact. Each measurement is the expression of the average value of 5 measurements in succession on the area where the foundation was applied.

For the evaluation of the elasticizing effect (anti-aging) the Elastimeter instrument was used at a distance of 8 hours (T8h) from the control of the basal conditions at (TO). Each measurement is the expression of the average value of 5 measurements in succession on the area where the foundation was applied.

In addition to the skin parameter measurement tests, the observational study also collected the assessments administered to the subjects through a self-assessment questionnaire (see below).

Interpretation of results. The study was designed to confirm the moisturizing effect and the elasticising (anti will) effect. The positive effect of the foundation on the measured parameter is confirmed if more than 50% of the subjects registered an improvement and if in the self-assessment questionnaire administered the product performance was perceived by at least 60% of the subjects participating in the test. RESULTS: The results obtained in the observational study are reported in the following tables:

Table 2. Values of the skin hydration index Table 3. Values of the skin elasticity index

Table 4: Self-assessment test TABLE 2. Values of the skin hydration index

TABLE 3: Values of the skin elasticity index TABLE 4: Self-evaluation Test

Interpretation of results.

The study was designed to confirm the moisturizing effect, the elasticizing (anti-aging) and uniforming effect of the skin discolorations of the dermatological composition of the present invention. The positive effect of the dermatological composition (foundation) on the measured parameter is confirmed if more than 50% of the subjects registered an improvement and if in the self-assessment questionnaire administered the performance of the product was perceived by at least 60% of the subjects participating in the test..

Based on the results obtained above, it was possible to state how the dermatological composition determines an increase in the skin hydration index of +20% and the skin elasticity index of +14.9%.