IT202100016286A1 - COSMETIC AND PHARMACEUTICAL COMPOSITION TO TREAT DERMATITIS - Google Patents

Description

COSMETIC AND PHARMACEUTICAL COMPOSITION TO TREAT

DERMATITIS

COSMETIC AND PHARMACEUTICAL COMPOSITION FOR TREATMENT

DERMATITIS

Technical field

The present invention relates to a cosmetic and pharmaceutical composition for treating dermatitis, in particular atopic dermatitis.

Known art

The term dermatitis identifies various skin diseases, largely characterized by inflammatory phenomena. If understood in its meaning pi? broad, dermatitis ? a rather common disorder, which affects about 30% of the pediatric population. Atopic dermatitis or constitutional eczema? the cutaneous expression of atopy, a genetically determined condition, which predisposes to the development of reactive/allergic manifestations affecting various organs and systems. Atopic dermatitis presents itself with chronic-relapsing eczematous skin lesions, extremely itchy which occur in the infant mainly at the level of the extensor regions of the limbs, and of the face with sparing of the perioral area (around the mouth) and in older children large to the flexor folds of the body. The cause of the disease is not still well known, multiple causes are likely at play. The reasons that make managing dermatitis difficult are numerous, including:

Chronic-relapsing course;

Intense itching with impact on daily school/work life;

Insomnia and restlessness;

Psychological implications for the child and the family; (https://www.Ospedalebambinogesu.it/dermatitis-atopica-ed-educazioneterapeutica-80047/)

In fact, there are different types of dermatitis, such as atopic dermatitis, but despite the great variability due to causes and manifestations, dermatitis are united by some characteristic symptoms, such as itching, redness and small swellings of the skin, sometimes of a vesicular nature up to actual lesions.

Dermatitis ? a pretty common condition, isn't it? contagious and all in all it does not heavily affect the general health of the individual; despite this?, pu? be somewhat uncomfortable for those who suffer from it, sometimes with negative repercussions on social life.

Dermatitis mainly afflicts subjects with dry or xerotic skin which? very common in the general population and especially in infants and the elderly.

Xerosis causes roughness, desquamation, loss of flexibility, hyperkeratosis, fissures, inflammation and above all itching.

The atopic skin condition ? a skin disease now widespread even in very young children, and is one of the causes of the first dermatological visits. Dermatitis for children and infants is therefore particularly uncomfortable and the creams currently on the market are often not suitable for being applied to their delicate skin, in addition to not providing a valid solution as a maintenance procedure.

At the basis of the pathology c?? a skin which, being very dry, becomes permeable, drastically reducing its barrier function against external aggressions and allergens.

Skin dryness which then evolves into atopic dermatitis is characterized by red, itchy spots. These red spots can be covered by small vesicles (little "bubbles"), which break when scratched and can lead to minor skin infections. Although not ? contagious, atopic dermatitis pu? evolve into inflammation of atopic eczema: these acute phases have an important impact on the quality? of life and are often the cause of insomnia.

The causes of atopic dermatitis are not yet known. Among the many, it is hypothesized a genetic factor deriving from one or both parents, or external factors such as allergens, present for example in food or in the environment. Another triggering factor can? be having a deficient immune system.

Normally atopic dermatitis is treated with drugs and creams containing cortisone in its various forms, lotions and creams, with different percentages of the presence of the active ingredient in each of them. This type of treatment leads the skin to remove the inflammation in quite a short time, but it is not? decisive, as the inflammation of the skin is treated only temporarily.

Creams and lotions containing cortisone are then very often formulations that also contain components such as petrolatum and silicones, components that only promise to hydrate the skin, as:

?The petrolatums, why? in addition to not being biodegradable, they have recently been included among the class II carcinogens

Silicones, why? are non-biodegradable substances, and are used to give that nice feeling of silkiness? and softness. The skin treated with these substances, will not be? nourished but simply covered by a sort of film which could lead to the occlusion of the epidermis and therefore to desquamation. In the long run there will be severe dehydration?

http://www.lablue.it/it/blog/derivati-dal-petrolio-e-siliconi-sono-i-maggiorinemici-della-pelle-vero-b11.html

At the end of the treatment which is generally prescribed, therefore, by removing the anti-inflammatory factor and the sensation of hydration given by creams containing cortisone and petrolatum and/or silicones, the skin becomes inflamed again, dehydrated and dry, and often more ? stronger than the first time, and without having acquired any type of hydration and/or nutrition from the treatment just finished. The skin, in addition to returning to being dry, permeable and vulnerable,? much more reactive of the initial state and this represents one, and among the pi? deleterious side effects resulting from the use of cortisone on this skin type.

Therefore, there ? a clear need? of an improving composition, for this type of skin, a composition that intervenes in a targeted and delicate way, composed of moisturizing, nourishing and restorative agents, as well as? as active agents capable of giving relief from itching, to a very tested skin. The target ? to provide a complete treatment in favor of delicate skin, and which is safe and effective, suitable for alleviating the side effects of dermatitis, such as above all itching and the impoverishment of dehydrated and defenseless skin against external attacks. The composition must be suitable for application on delicate skins, not only those of children and infants, but also the elderly.

Summary of the Invention

The present invention provides a cosmetic and pharmaceutical composition for topical application to be used for the treatment of dermatitis in general and for relieving the itching caused by the occurrence of such affections.

The composition comprises extracts of St. John's wort and calendula in combination with sodium lactate and allantoin, in a cosmetically and pharmaceutically acceptable vehicle.

An object of the present invention ? therefore the topical administration of the composition of the invention above all for children or newborns and the elderly.

Another purpose of the invention ? the development of an ointment that can? be applied topically, in combination with the cosmetic and pharmaceutical composition, the combination being able to be applied in a sequential or delayed manner, as indicated below.

These and other objects, advantages and features of the present invention will be described later. fully in a detailed description of the preferred embodiments which follows, moreover the claims describe preferred variants of the invention, forming an integral part of the present description.

Brief description of the Figures

The objects and advantages of the present invention will become clear from the detailed description that follows, of an embodiment of the same (and of its variants) and from the attached drawings given for purely explanatory and non-limiting purposes, in which:

Figure 1 and Figure 2 show a form of significant stress dyshidrosis, which appears on the palms of the hands (Figure 1 - left hand and Figure 2 - right hand) with red bubbles, some with the presence of exudate;

Figure 3 and Figure 4 show the palms of the left and right hands of Figures 1 and 2 2 days after application of the W/O (W/O) cream alone;

Figure 5 (left hand) and Figure 6 (right hand) are photos taken 14 days after the start of applying the cream. The hands are completely healed.

Figure 7 and Figure 8 show the face of a 7 month old girl before and after application of the cream according to the invention. The picture of figure 8 ? taken 14 days after the start of applying the cream. The face ? fully healed.

Detailed description

The following describes an all-natural topical formulation for the treatment of dermatitis and potentially other dry skin disorders such as dyshidrosis and eczema. The formula ? composed of a unique combination of extracts derived from plants and other natural components with properties? anti-inflammatory, nourishing, restorative and healing. The main active ingredients in the formula include oily extracts of St. John's wort, calendula and chamomile, aloe gel, tocopherol and tocopheryl acetate, in combination with allantoin and sodium lactate.

The topical formulation of the invention ? usable as a cosmetic for dry skin and in the treatment of dermatitis in general and atopic dermatitis in particular; uses vegetable and naturally derived substances, vegetable oils and butters, also vegetable oleolites, products with different types of plants, making full use of the properties of the latter. The union of the entire group of substances, each chosen for a specific function, acts synergistically, making itself? that the final emulsion results in a complete formulation, which acts beneficially on the skin, not just momentarily. In fact, all those elements are made which, in a situation of irritation and inflammation, allow the skin to hydrate, nourish itself, and regenerate itself.

The components of the formulation, in fact, are selected substances, each with a precise task to be found in the three main purposes of the emulsion, therefore hydration, nutrition and regeneration. ? born to give the skin help, the pi? possible natural, in order to start a process of regeneration of the same, which will lead? then to have the optimal conditions for its recovery, with the positive consequence of improving the life of the subject affected by dermatitis or reactions similar to dermatitis, such as dyshidrosis and eczema.

The emulsion chosen to implement the formulation of the invention, ? that of water-in-oil A/O (W/O Water in Oil). How?? It is known that emulsions consist of two liquid phases, in which the dispersed phase is incorporated uniformly in the form of small droplets, in a dispersing phase.

The two phases consist, one of oily substances, the other of aqueous substances. Normally oil and water would separate, but emulsified creams are stabilized by the use of emulsifying agents. The emulsifier favors the fragmentation into drops of the liquid which is dispersed in another liquid.

Fats are used in this type of emulsion to obtain water-resistant emulsions, fluids, milks and creams. Water in Oil W/O emulsions (W/O Water in Oil) are also called hydrophobic emulsions, where the dispersed phase ? the water and the dispersing phase? oil, considering the dispersion, a very fine mixing, in the form of droplets of one liquid in another. Basically, the water is absorbed by the oil. This will allow, while the cream is being applied, a penetration of the water into the skin, while the oil will remain? on the surface (on the skin) to prevent the water (just penetrated the skin and some of the cream) from evaporating. This will allow to bring strong hydration, as well as giving way to all the other components, including the active ingredients of which the cream is made up, to have time to make their properties, for a longer period. long, compared to a normal emulsion, for example an O/W (oil in water) where hydration evaporates quickly. The strong value of this cream, and these emulsions W / O (water in oil W / O) therefore, ? to make a lasting hydration as they remain more? on the skin for a long time, reducing the loss of transdermal water, allowing constant and intense hydration.

The compositions of the present invention include an oil component, an aqueous component, an emulsifier and optionally one or more between hydrophilic components, preservatives, active agents, propellants, buffers or salts, viscosity modifiers? or other agents such as fragrances.

The concentrations of the aqueous component, the oil component and the emulsifier are selected and mixed in combination with the other components.

The composition ? formulated in emulsions such as fluid lotions, foams, gels, milks and creams suitable for application to human skin, and stable at room temperature. Particularly suitable? the cream formulation.

The wording? obtained from an aqueous component and an oily component that are mixed together, how will it be? specified below and the active components, individually or in mixture, are added to the resulting mixture. Does the formulation include one or more? cosmetically and pharmaceutically acceptable adjuvants and carriers.

The formulation can also contain one or more: antibiotic agents, antimicrobial agents, antibacterial agents, antifungal agents, anti-inflammatory agents; preservatives and antioxidants. You can add: pH regulating agents in the quantities? necessary to obtain the desired pH, generally a physiological pH between 5 and 7, preferably between 6 and 7, where the preferred is? lactic acid; viscosity modifiers, such as xanthan gum.

The components used for the formulation are selected from the following groups.

The oily component, preferably present between 30% and 45%, therefore between 30 and 45 grams out of a total of 100 grams of emulsion, of the total composition includes, but is not? limited to, one or more? of the following components: straight or branched chain hydrocarbons, fatty acids, mineral oil, oils of natural origin, waxes, saturated, mono- or poly-unsaturated aliphatic alcohols; vegetable based oils such as jojoba oil, sunflower oil, rice oil, (rice bran oil) shea butter, cocoa butter, olive oil. Particularly preferred are vegetable oils, such as olive oil, jojoba oil, sunflower oil, corn oil, moringa oil, and waxes and butters, such as candelilla wax, beeswax, shea butter, cocoa butter.

The oil component also includes emulsifiers suitable for stabilizing the final emulsion, which are selected, but are not limited to:

Cetearyl Olivate, Sorbitan Olivate, Glyceryl Stearate, Triglyceryl Diisostearate, Polyglyceryl Trans-Esterified with Sorbitol, Polyglyceryl Olivate, Cetyl Alcohol, Methylglucose Sequistearate, Cetearyl Olivate

The oily component includes the active components of the formulation chosen from: hypericum oleolith, calendula oleolith, chamomile oil, chamomile extract, to which can be added: moringa oil, aloe gel, bisabolol, Vitamin E (Tocopherol), Tocopheryl Acetate, Lecithin, Ascorbyl Palmitate, Citric Acid, Sodium Lactate, Ascorbic Acid, Allantoin, taken individually or in mixtures.

An important component of the composition ? lactate, preferably sodium lactate in solution, and allantoin

In the final composition, the sum of the active components will be? between 23 and 26%, both oily and aqueous active ingredients.

The essential oil, how?? known, ? an ethereal extract of the plant, which brings together the most? volatile. For this he mainly develops two types of action: an immediate and strong one, aimed at the most ?birds? of the disease, that is? the symptoms more traceable and direct; the other on the ethereal body, i.e. mainly on emotional states. Its action on symptoms? fast and incisive, while the one on emotional states? more sweet and much more deep. The essential oil lends itself well to intervene on physical ailments with an immediate and strong action, as well as to quickly change emotional states.

The composition of the invention also includes, but is not limited to, one or more? preservatives, such as: Potassium Sorbate, Phenoxyethanol, Ethylhexylglycerin, Propanediol, Phenethyl alcohol, Undecyl alcohol, Benzyl alcohol, Ethylhexylglycerin, Benzyl alcohol, Dehydroacetic acid

The aqueous component also includes, but is not limited to, one or more? of the following hydrophilic components: humectants, emollients, water-soluble vegetable extracts, water-soluble active agents, and water-soluble viscosifiers, among which the preferred ones are glycerin, allantoin, xanthan gum, stereatic acid, in a percentage ranging from 50% to 65 %, therefore from 50 to 65 g out of a total of 100 g of emulsion.

The active ingredients of the composition in their range of quantities? between 23% and 26%, therefore from 23 to 26 g in a total of 100 g of emulsion are as follows:

St. John's wort oil from 5% to 7%

calendula oil from 5% to 7%

sodium lactate 1% to 3%

allantoin from 0.1% to 2% by weight

To these can be added one or more? of the following components: chamomile oil from 2% to 5%

Bisabolol 0.5 to 3%

3% to 5% aloe gel

1% to 3% moringa oil

tocopherol from 1% to 3.5%

tocopheryl acetate 0.5% to 2%

lavender essential oil 0 to 1%

0 to 1% chamomile essential oil

The remainder of the composition being a cosmetically and pharmaceutically acceptable carrier.

The basic stages of the formulation preparation method are as follows:

Phase A

The aqueous phase is prepared by mixing allantoin with water, an emulsifier such as xanthan gum and glycerin at a temperature of 25-30°C.

Phase B

The oily phase is prepared by mixing one or more? oils selected from: jojoba oil, rice oil, shea butter, cocoa butter, and an emulsifier.

Phases A and B are heated separately up to a temperature of 60°C, and are then joined together and vigorously mixed to form a stable emulsion.

Phase C

Allow the formed emulsion to cool down to a temperature between 35?C and 40?C, then add the active components. Lastly, preservatives are added.

The preparation of the ointment ? composed of 2 phases, compared to the 3 of the emulsion (cream).

PHASE D

In phase D the wax (which can be candelilla wax) is heated in a container in a percentage ranging from 10% to 35% and therefore from 10 to 35 g out of a total of 100 g of ointment, until it reaches the point of smelting, around 70?C. Will you leave? then drop the temperature below 60?C in order to add the shea butter? in a percentage ranging from 10% to 20%, then from 10 to 20 gr in an ointment of a total of 100 gr.

PHASE E

The temperature is then expected to drop below 40?C in order to be able to insert, in the same container of phase D, the St. John's Wort oil in a percentage ranging from 20% to 33%, therefore from 20 to 33 g in a total of 100 g of ointment, and calendula oil in a percentage ranging from 39% to 44%, therefore from 39 to 44 g in a total of 100 g of ointment. The ointment can be enriched with, and not only, with chamomile oil in a percentage ranging from 0% to 18%, therefore from 0 to 18 g in a total of 100 g of ointment, tocopherol in a percentage ranging from 0% at 2%, therefore from 0 to 2 g in a total of 100 g of ointment, and tocopheryl acetate in a percentage ranging from 0% to 1%, therefore from 0 to 1 g in a total of 100 g of ointment.

The oil vehicle ? made up of oils, waxes and oleolites which will allow the active ingredients contained therein to have an effect on the skin, which will have to? necessarily be wet.

The active ingredients of the ointment, in their range of quantities? between 60% and 80%, therefore from 60 to 88 g in a total of 100 g of ointment are as follows:

hypericum oil from 20% to 33% by weight

calendula oil from 39% to 44% by weight

To these can be added one or more? of the following ingredients: chamomile oil from 0% to 18%, then from 0 to 18 g in a total of 100 g of ointment,

tocopherol from 0% to 2%, then from 0 to 2 g in a total of 100 g of ointment

tocopheryl acetate in a percentage ranging from 0% to 1%, then from 0 to 1 g in a total of 100 g of ointment

The waxes and butters are in quantity? between 20% and 55% Preferably they are:

candelilla wax in the percentage ranging from 10% to 35% therefore from 10 to 35 gr out of a total of 100 gr of ointment

shea butter? in a percentage ranging from 10% to 20%, then from 10 to 20 gr in an ointment of a total of 100 gr

The remainder of the ointment composition being constituted by a cosmetically and pharmaceutically acceptable carrier.

According to a further embodiment of the invention, the active components in the form of oil, possibly with the addition of natural waxes to make them more? easy to apply, they can be mixed together and applied to moist skin in the form of an ointment. The cream obtained in phase (C) is then applied.

In situations of dermatitis in the form pi? serious, yes d? way for the skin to prepare to receive the cream treatment (Phase C), providing it with preventive nourishment in a very delicate way, through the application of an ointment (Phase E) which will allow also to soften the skin and make it more? predisposed to receiving a cream. The application of the ointment will be preferably carried out on damp or wet skin, as the water present on wet skin facilitates the penetration of the ointment through the skin itself.

Remember that ointments are usually oil-based formulations, ie? of a fatty ingredient, and are low in water, if not close to zero, and mainly made up of oils and butters. Thanks to this characteristic they are particularly suitable for dry skins as they are very emollient and nourishing. Once spread on the skin they are not absorbed immediately, but leave a layer of oils on the surface which softens dry skin in need of nourishment, trapping the water. as a vehicle for the absorption of oils and butters, facilitating hydration and nutrition. The fact that this ointment has a fat base makes s? that the active substances contained in it can exert their nourishing and soothing action on the skin, for a longer period of time. long compared to other preparations such as pi? watery, which are instead absorbed pi? quickly from the skin. Furthermore, containing less water, if at all, they are preparations that require fewer preservatives, since they do not promote the growth of microorganisms.

The ointment of the invention, based on oily wax active ingredients, will be? applied to damp or wet skin and massaged until completely absorbed.

The ointment does not replace the cream, which will applied in combination or after treatment with the ointment.

AND? important to underline that the binomial allantoin ? lactate, as active components, ? fundamental since? goes to mitigate and make the itching disappear. The itch? a very annoying factor in a subject with dermatitis, and also a bearer of important side effects. The continuous scratching, in fact, cos? as the continuous rubbing, with nails or through clothes, causes lesions to be created on the skin which will most likely lead to the creation of scabs due to wounding and bleeding of the skin. If we combine the itch to the fact that a very young subject of age? can not control himself in scratching, means that the risk of creating injuries is very high. The continuous itching can cause disturbances even in the normal continuation of daily life, as ? always present, has no schedules, also becoming a determining factor in the sleep disturbance of the child himself, who sleeps badly and/or wakes up often due to the need to scratch. The lactate+allantoin combination, thanks to their hydrating, soothing, re-epitilizing and humectant action, eliminates itching, providing relief from these annoying side effects. The other components (mainly hypericum and calendula, as well as bisabolol) carry out a curative action of dermatitis as phytotherapeutic agents, and if these were not in the form of oil, there would be less activity? of the component. The form ?oleolito? ? more other forms of extraction. Without the active components St. John's wort, calendula, and possibly moringa and bisabolol, the composition is not ? effective.

Oleolites are oily solutions of the curative phytocomplexes of medicinal plants. They can be obtained by solution from fat-soluble fluid extracts, by solar digestion, infusion and decoction, by heating the plant until all the water is eliminated. The oil? an extract of the fat-soluble principles of plants and can? harvest aspects of the plant that the tincture fails to extract. The long exposure to the sun and heat during the maceration period brings to the oil, in addition to the properties of the plant, also the energy and solar heat.

Oleolites are ancient and effective preparations, mainly used topically. Anyone can? to try with ease? and success in their preparation. Modern times tend to complicate things, so? a simple herbal preparation can? be left aside why? understated and sophisticated. This ? success to oleolites, excellent extracts, which are absorbed well by the skin and offer great results. They were valued by Father Vittorio Baroni, who advised them for various ailments, up to the treatment of tumors. A mode? of preparation of oleolites ? described in: B?sch, Hubert. Handbook of flowers and herbs (Italian Edition). The Age? of Aquarius. The oleoliths are vegetable oils enriched with herbal extracts macerated in them, facilitating the extraction from the exposure of the mixture to the sun. The oil typically formulated in a 2:1 ratio between oil and drug (the plant) the oil more? used ? that of sunflower, but other vegetable oils can also be used, such as corn oil, olive oil, jojoba oil, castor oil, sesame oil.

? Is it advisable to use an oil of excellent quality? that does not change easily. One of the best oils for this purpose in our range? the extra virgin olive oil, both for its properties both for its stability?. Usually, freshly harvested plants are used for the preparation of oleoliths, placed in a glass container that is no longer filled with water. by three quarters. ? good to leave a bit? of? heaven?, that? of empty space. The plants, shredded where necessary, must be arranged with care and compacted well, especially if fresh. So we can moisten them with a small amount? of pure ethyl alcohol (10% compared to the oil) or add a handful of coarse salt to facilitate the escape of water from the tissues and avoid alterations. Then the plants are covered with oil. By definition, the relationship between dry drug and oil? 1:10 by weight. Considering that plants contain an average of 80% water, the ratio between fresh herbs and oil is ? about 1:2. However with this relationship not always ? It is possible to cover the herbs with the oil, especially if they are not chopped well. In this case and for personal use, you can? add more oil to cover them completely. Maceration usually takes place in the sun, for at least 40 days of effective sun. In this period ? important that the plants are covered with oil. In the first few days, the herbs must be mixed daily so that no part remains in the air for a prolonged time. These precautions help to avoid the formation of molds. The water contained in the plants gradually settles on the bottom, or can it? also cover the container with the herbs in maceration with a gauze, so? at least in part the water evaporates. In this case the container must be protected from rain. Once maceration is complete, the oil is separated from the water, deposited on the bottom, pressed and then filtered with a fine-mesh sieve. At this point, for 1-2 days, the residues are left to settle on the bottom and then they must be eliminated to improve their shelf life. The oleolites are applied locally one to three times a day, in small quantities, with a light massage. If you don't exaggerate in the quantity? they are absorbed by the skin within a few minutes.

Source: Handbook of flowers and herbs (Italian Edition). The Age? of Aquarius.

The difference between oil and oleolite.

The oil? the generic name of substances of various chemical composition, liquid at ordinary temperature, with greasiness?, density? less than water and relative immiscibility? with the same (technically, liquid fats at room temperature); the oils have vast fields of application both in food and in the most? various industries: olive oil, seeds; whale oil, cod liver oil; sun oil; almond oil, castor oil; mineral oils, essential oils, lubricants.

Sunflower oil for example? a fat that is obtained by squeezing the seeds of the sunflower, a plant that belongs to the Asteraceae family.

For example, olive oil? a substance extracted from the crushing of olives, a typical ingredient of the cuisine of Mediterranean countries, also used in the preparation of canned food products or, in the past, to power lamps.

The oil lith differs from simple oil in that it contains the healing phytocomplexes of medicinal plants, transmitted to it thanks to the drug maceration process, which allows it to be released inside.

The oil becomes oily when it absorbs the active ingredients of the drug that is macerating inside. https://it.wikipedia.org/wiki/Oleoliti At the beginning of the process, therefore, there are two raw materials, oil and the plant, also called drug, chosen. The drug can present themselves in various ways, in the form of flowers or buds, leaves, which will vary? based on the chosen plant and the type of oil you want to obtain. For the hypericum oil, for example, fresh flowers and buds are used, for other types of oil, dried flowers, fruits or roots can be used.

St. John's Wort oil? known and described in https://it.wikipedia.org/wiki/Olio_di_iperico

St. John's Wort oil? clear with a ruby red colour. In the present invention ? the oil marketed by Glamor Cosmetics https://www.glamourcosmetics.it/it/estratto-liposoluble-iperico was used and the Drug/Extract ratio corresponds to 1:2

Even the calendula oil? known and in the present invention ? the oil marketed by Glamor Cosmetics https://www.glamourcosmetics.it/it/estratto-liposoluble-calendula was used and the Drug/Extract ratio corresponds to 1:2

The present invention treats atopic dermatitis using all vegetable and naturally derived substances, vegetable oils and butters, also vegetable oleolites, produced with different types of plants, making full use of the properties of the atopic dermatitis. of the latter. All substances are bio, defined in their naturalness? ?greens?. The union of the entire group of substances, each chosen for a specific function, acts in a synergistic way, making sure that the final emulsion is a complete cream, which acts on the skin not only momentarily. In fact, all those nutritional elements are provided which, in a situation of irritation and inflammation, allow the skin to regenerate itself in the moment of severe irritation and acute dermatitis.

The components of the emulsion, in fact, are substances selected to give the skin as much help as possible. as natural as possible, in order to deeply hydrate it, nourish it and allow it to regenerate. Will the regeneration bring? then to have the optimal conditions for a correct recovery of the skin.

When the acute form of dermatitis is attenuated and the skin rebuilt, it will be possible to apply the W/O cream for maintenance, at least once a day or at least twice a week. This can prevent the recurrence of dermatitis.

All this treatment with the A / O cream can? allow you to have an? alternative to the normal treatment with creams and / or solutions containing cortisone, which is generally prescribed in these situations, and which, especially in the age? neonatal and pediatric should be avoided. The use of cortisone, in fact, brings momentary benefits, often leading to addiction to the active ingredient itself, and does not allow the problem to be solved in the long term.

The following examples are provided to illustrate the invention and are not to be considered as limiting its scope.

EXAMPLES

Example 1

Preparation of the cream

Phase A - Aqueous component:

the. The first step will be that of preparing a container in which to insert the water, weighing it, at a temperature of 60?C. The allantoin is then added, stirring until it is completely dissolved. The water must be clear;

ii. The second step consists in mixing, in a separate container, the excipients/adjuvants, ie? the glycerin and the xanthan powder, ensuring that all the powder is incorporated into the glycerin. This will do? start the gelling phase. The raw materials will be at room temperature

iii. The third step involves the union of the two preparations in the first container containing water and allantoin. Not C?? need to heat the preparation, andr? the temperature resulting from the first heating phase well, at whatever temperature it may have reached, at this point of the preparation. The mixing of the two preparations, in fact, can? also be done at room temperature.

Phase A? complete, and will you leave it? stand to allow gelling to continue while preparing phase B.

Phase B - Oil component

Prepare the oily component (phase B) by inserting the oils, the butters (except shea butter), and the emulsifier, weighed at a temperature of 80?, into a second container. Wait for the temperature to drop to 60?C to insert the karit? butter.

Phase C

the. Heat the two preparations (phase A and phase B) to a temperature of about 60°C and mix them under vigorous stirring until the emulsion is ? formed to prepare a W/O emulsion

ii. Cool the previously obtained mixture below 40°C; to the emulsion obtained, add the active components, alone or mixed together as indicated above. The active components can be added one at a time (individually) or premixed together.

Preparation of the ointment:

The ointment is prepared by heating the wax until it is completely dissolved. The wax used, the candelilla, is choice why? has among the properties? that of being organoleptically similar to beeswax, but being completely vegetable, it is totally free of allergens as instead beeswax could have which instead could contain pollen, honey or propolis, which would be unsuitable for allergy sufferers. In the case of atopic skin, which is generally very reactive, of course ? it is best to avoid anything that could obviously lead to allergic reactions. We then wait for the temperature to drop to 40?C to insert the oleolites and vitamin E (tocopherol).

Example 2

With the modalities? described in example 1 the following compositions were prepared.

CREAM 1

(hypericum oleolite obtained from the sum of 7.22 g sunflower oil and 1.58 g hypericum extract)

(calendula oleolite obtained from the sum of 6.89 g sunflower oil and 1.51 g of calendula extract

CREAM 2

St. John's wort oil obtained from the sum of 6.07 g of sunflower oil and 1.33 g of St. John's wort extract)

(calendula oleolite obtained from the sum of 5.74 g sunflower oil and 1.26 g of calendula extract)

(chamomile oil obtained from the sum of 1.64 g sunflower oil and 0.36 g of chamomile extract)

CREAM 3

St. John's wort oil obtained from the sum of 4.59 g sunflower oil and 1.01 g of St. John's wort extract)

(calendula oleolite obtained from the sum of 4.43 g sunflower oil and 0.97 g of calendula extract)

(chamomile oil obtained from the sum of 1.64 g sunflower oil and 0.36 g of chamomile extract)

CREAM 4

St. John's wort oil obtained from the sum of 4.59 g sunflower oil and 1.01 g of St. John's wort extract)

(calendula oleolite obtained from the sum of 4.43 g sunflower oil and 0.97 g of calendula extract)

(chamomile oil obtained from the sum of 1.64 g sunflower oil and 0.36 g of chamomile extract)

The manufacturers of each component are:

Purified water manufacturer

Xanthan gum purchased from

Glycerin produced by

Allantoin purchased from site

Rice oil produced by

Shea butter? purchased from site

Cocoa butter bought from site

olivem 1000 bought on

Panthenol d.75% purchased on site

Aloe gel 3 purchased on site

St. John's wort oleolite

Calendula oleolite site

Moriveda moringa oil

Sodium lactate site

Chamomile oil

Tocopherol

Lavender Essential Oil

Tocopheryl acetate

Euxyl-k.900

10587 APEROXID TLA

Optfiphen BSB-W

Gosgard, produced by sito

Example 2

Application on the skin and results of the cream with and without lactate and allantoin.

A comparison ? dutiful among the versions ?crema 1? and ?cream 2?

The difference with the ?cream 2? version, ? the addition of assets, including those pi? important were sodium lactate and allantoin. AND? precisely the presence of sodium lactate and allantoin that makes the cream even more? effective. Version 1 has a moisturizing, soothing and repairing effect. The addition, in version 2 of the cream, of sodium lactate and allantoin, has added the anti-itching effect, due to the addition of another element of strong hydration, as in the case of sodium lactate, which is ? a very strong humectant capable of retaining water, which makes it a fantastic moisturizer, while also performing an antibacterial action. Being then, sodium lactate, derived from lactic acid, a substance naturally also produced by our body, for this reason it also has the property to be very tolerated by the skin. The Allantoin? chemically a by-product of the oxidation of uric acid, which is also naturally present in our body, as well as? in some plants. The allantoin? a multiactive compound as it has properties? moisturizing, soothing, repairing, anti-inflammatory and antioxidant. It is also considered an excellent astringent and favors the absorption of the other active ingredients, as it softens the stratum corneum, favoring their penetration.

The allantoin? an extremely interesting molecule for its set of beneficial effects on the skin accompanied by an excellent safety profile, as it is not? toxic, right? irritating n? sensitizing and ? effective at very low doses. In high percentages has properties? keratolytic and smoothing.

The combination of sodium lactate and allantoin significantly and decisively enriches the version of Cream n.1.

Example 3

The utility of this invention? demonstrated in two case studies. One concerns an adult dyshidrosis due to stress, the other a case of atopic dermatitis in a newborn.

Stress dyshidrosis? been treated with cream no. 2 what? such as atopic dermatitis of the newborn, treated with cream n.2.

First case Stress dyshidrosis

The initial symptoms appeared at first just as persistent and continuous itching on the hands, first on the sides of the fingers and then spread over the palm.

In addition to continuing the itching, the initial symptoms are accompanied by the presence of small rounded grazes (Figures 1 and 2), characterized by redness and grazes where the presence of exudate appears in the center of them. The dermatologist's diagnosis? state of dyshidrosis due to stress. The symptoms were treated with cortisones with partial effect on the growths and no effect on the itching. This led the subject to carry out allergy tests to verify that there were no ulterior reasons which did not allow the resolution of the disturbances, which remained unchanged such as excoriations and itching on the hands and feet. Not even with allergy tests, yes? arrived at a conclusion. The dermatologist then advised to combine a moisturizer with cortisone. The grazes continued to be present and itchy even with the addition of a moisturizer.

As the situation worsened, the dermatologist changed the cortisone cream with another, according to him, more? effective, which had a higher concentration of cortisone inside, recommending an even more effective moisturizer. stronger than that used up to that moment and adding an antihistamine by mouth. The length of time it took from the onset of symptoms until the change in medications and moisturizers is been about a month.

At this point the situation was debilitating, the subject constantly presented excoriations on the hands and fingers, with continuous itching, which also caused discomfort during the night's sleep, which was continuously disturbed.

Yes ? then intervened with the application of the A/O invention on the hands and feet at least twice a day.

Yeah? from the first day of application, the itching? disappeared and the skin, receiving the strong hydration, began its consequent healing process. On the fourth day of application of the W/O emulsion of the present invention, the abrasions were completely reabsorbed, the skin completely inflamed (Figures 3 and 4). Furthermore, the skin appears to be in the recovery phase, as there are only points where there is a slight peeling, a symptom of a skin in the reconstruction phase.

After 7 days from the start of the treatment with the cream of the invention, the subject appeared free of itching and with the skin continuing its reconstituting phase, and ? after 15 days he shows himself free from the disorder (Figures 5 and 6) with completely healed skin of hands and feet.

Second case Atopic dermatitis on newborn

The first symptoms begin to appear on the belly of the newborn in the form of bubbles, they were red and scattered bubbles. The blisters started to intensify and within 15 days the affected areas were the belly, part of the back, back of the knees, elbows and face. The dermatitis presented with itching, very difficult to manage in the newborn, which was mitigated only by making sure that he did not scratch, always under the supervision of one of the parents, to avoid worse excoriations, as sometimes happened, with the presence of blood.

Consulted dermatologist, advice? the application of a cream with cortisone twice a day and a bath with an oily solution, for 7 days to follow. After the application the redness? disappeared, although the itching continued to persist as the skin dried out even more? leaving the itch.

The dermatologist then next? a moisturizer containing components such as petrolatum and silicones. The best situation? partially leaving flashes of itching attacks. The treatment with the cortisone solution was terminated after 7 days, with indications to interrupt the treatment, and the skin was inflamed. Does the redness come back after 7 days? and the? affected area was more? of the previous rash, with the affected area extending to the entire belly and entire back, as well as the inside of the elbows and the back of the knees. The face was also significantly affected with bubbles and redness on the cheeks (photo 7). All the affected areas showed strong and continuous itching, so much so that the newborn had sudden sleep interruptions due to necessity. to scratch.

Does the dermatologist recommend? to resume the first treatment, changing the cortisone cream and replacing it with another one with the same active ingredient in a higher percentage, with a duration of 7 days. The blisters flared up again and subsided, and the redness disappeared. After the end of the treatment, it continued? to apply the moisturizer as maintenance. However, the skin on the affected areas was visibly thinned and very very sensitive, and despite applying moisturizer, it looked dehydrated.

A second dermatologist was consulted, who noted, in agreement with the first colleague, a very serious case of atopic dermatitis, to be treated with another cortisone cream and another type of moisturizer still containing, among or among the components, also petrolatum and silicones. The treatment was carried out with the same procedure as the previous one: the skin flared up practically immediately for the entire duration of the application of the prescribed creams, then 7 days after the end of the treatment, especially of the prescribed medicine, the dermatitis returned and was in good shape. more and more serious, as also verified by dermatologists.

The dermatologist's proposal, after further consultation, was to continue the treatment with the cortisone cream for another 15 days.

In order to find an alternative to this situation, in the presence of an 8-month-old baby who was now continuing to absorb cortisone on an ongoing basis, yes? began to support the cortisone cream and the moisturizer with an oily compound (Phase D and phase E) made up of calendula oil and candelilla wax, with the aim of being able to give additional hydration in a natural way.

The application has given its effects. The oil compound? been enhanced with St. John's wort oleolite and the addition of tocopherol and tocopheryl acetate, as well as shea butter. The skin looked visibly improved. Yes ? At this point, I tried to apply the cortisone cream every other day, applying the ointment in its place on damp skin twice a day. The moisturizing cream prescribed by the dermatologist was always applied after the ointment. The results were good, the skin was de-inflammating even if the itching reappeared at times. The cortisone cream after 20 days of alternating application, one day yes and one day no, the application of the cortisone begins every 3 days, and every day, even on days when there is the application of the cortisone cream, continue the application of the oily compound and the moisturizer.

The skin no longer has sudden outbreaks of acute dermatitis, and it seems to begin to heal in part.

After 15 days, the cortisone cream is applied twice a week. The newborn's skin reacts well, it is almost healed, with occasional reactions to itching.

After another 15 days, the application of the cortisone cream is brought to once a week and interrupted for the following week. At this point, the application of the cortisone cream is replaced by the cream object of this invention W/O (cream 2).

The skin does not have any type of reaction, and reacts well to the application, which takes place twice a day, first applying the oily compound on damp skin, then once absorbed, on dry or slightly damp skin, the W/O cream.

The skin of the newborn heals quickly, the manifestations of itching are increasingly? rare and the newborn is able to rest better even at night.

After 15 days the double application of oily compound and W/O cream is stopped, maintaining only the W/O cream with application 2 times a day, morning and evening.

The A/O cream is applied to the skin, after a month, once a day as maintenance.

After 2 months, the skin of the newborn continues to be healthy.

Therefore, the application of the A/O cream is interrupted on a daily basis, and it is applied only when necessary, when the skin begins to show signs of the onset of dermatitis or redness or itching. The reaction times to the application on irritated skin at the initial stage? about 1-2 days.

The application of cream 3 and cream 4 gave similar results to cream 2 in both adults and newborns.

These results indicate a proven beneficial effect on the skin, cream 2 has provided the skin with all the principles it needs to heal itself. Delicate skin must be toned down, hydrated, nourished and protected, giving it time to be able to do all this, with constant application of the cream. AND? a cream to counteract dehydration and itching that causes atopic dermatitis, acts against all these ailments and ensures that even maintenance continues the ?work? of skin restoration, providing moisturizing, nourishing and re-epithelizing substances, to allow the skin to become healthy again. The wording? to be applied locally, and its usefulness? ? for the treatment and maintenance of pathological conditions of the skin. Pathological conditions of the skin are defined as symptoms present anywhere on the skin, characterized by mild to extremely dry skin, with the presence of lumps and blisters, skin lesions that are generated as a result of rubbing and scratching, caused by itching, cracks, flaking , redness, bleeding, swelling, peeling, small wounds. In particular, these skin disorders affect the trunk, elbows and knees, but can include the entire arms, legs, back, neck, face. All of these disorders are classified under dermatitis, including but not limited to: atopic, contact, allergic, dyshidrosis, stress dyshidrosis.

Claims (10)

1. Composition for the cosmetic treatment of dry and dehydrated skin comprising, as % by weight with respect to the total composition: hypericum oil in quantity? from 5% to 7% calendula oil in quantity? from 5% to 7% sodium lactate in quantity? from 1% to 3% allantoin in quantity? 0.1 to 2% in a cosmetically acceptable vehicle. 2. Composition according to the preceding claim further comprising one or more? of the following components: chamomile oil in quantity? from 2% to 5% Bisabolol in quantity? 0.5 to 3% aloe gel in quantity? from 3% to 5% moringa oil in quantity? from 1% to 3% tocopherol in quantity? from 1% to 3.5% tocopheryl acetate in quantity? 0.5% to 2% quantity of lavender essential oil 0 to 1% quantity of chamomile essential oil 0 to 1% and that has an oily component present in quantity? between 30% and 45%. 3. Topical composition for use in the treatment of dermatitis in general and atopic dermatitis and stress dyshidrosis in particular comprising, as % by weight with respect to the total composition: hypericum oleolith in quantity? from 5% to 7% calendula oil in quantity? from 5% to 7% sodium lactate in quantity? from 1% to 3% allantoin in quantity? 0.1 to 2% in a pharmaceutically acceptable vehicle. 4. Composition according to the preceding claim further comprising one or more? of the following components: chamomile oil from 2% to 5% Bisabolol in quantity? 0.5 to 3% aloe gel in quantity? from 3% to 5% moringa oil in quantity? from 1% to 3% tocopherol in quantity? from 1% to 3.5% tocopheryl acetate in quantity? 0.5% to 2% quantity of lavender essential oil 0 to 1% quantity of chamomile essential oil 0 to 1% and which has an oily component present between 30% and 45% by weight. 5. Product for the cosmetic treatment of dry and dehydrated skin comprising: a) A composition according to any one of claims 1-2; b) An ointment comprising, as % by weight with respect to the total composition of the ointment: - hypericum oil in quantity? from 20% to 33% by weight, - calendula oil in quantity? from 39% to 44% by weight, - chamomile oil in quantity? from 0% to 18% by weight, - tocopherol in quantity? from 0% to 2% by weight, - tocopheryl acetate in quantity? from 0% to 1% by weight, - candelilla wax in quantity? from 10% to 35% by weight, - shea butter? in quantity? from 10% to 20% by weight, the remainder of the ointment composition being a cosmetically acceptable vehicle; for combined, sequential or delayed application. 6. Cosmetic product according to claim 5 which? supplied in the form of preparations for combined and sequential or delayed use. 7. Cosmetic use of: a) A composition according to any one of claims 1-2; b) An ointment comprising, as % by weight with respect to the total composition of the ointment: - hypericum oil in quantity? from 20% to 33% by weight, - calendula oil in quantity? from 39% to 44% by weight, - chamomile oil in quantity? from 0% to 18% by weight, - tocopherol in quantity? from 0% to 2% by weight, - tocopheryl acetate in quantity? from 0% to 1% by weight, - candelilla wax in quantity? from 10% to 35% by weight, - shea butter? in quantity? from 10% to 20% by weight, the remainder of the ointment composition being a cosmetically acceptable vehicle; for the combined and sequential or delayed application of said composition and said ointment on the skin to counteract dryness and dehydration of the skin. 8. A cosmetic method of promoting skin hydration comprising the topical application of at least one of the following compositions: a) A composition according to any one of claims 1-2; b) An ointment comprising, as % by weight with respect to the total composition of the ointment: - hypericum oil in quantity? from 20% to 33% by weight, - calendula oil in quantity? from 39% to 44% by weight, - chamomile oil in quantity? from 0% to 18% by weight, - tocopherol in quantity? from 0% to 2% by weight, - tocopheryl acetate in quantity? from 0% to 1% by weight, - candelilla wax in quantity? from 10% to 35% by weight, - shea butter? in quantity? from 10% to 20% by weight, the remainder of the ointment composition being a cosmetically acceptable carrier. 9. Pharmaceutical product including: a) A composition according to any one of claims 3-4; c) An ointment comprising, as % by weight with respect to the total composition of the ointment: - hypericum oil in quantity? from 20% to 33% by weight, - calendula oil in quantity? from 39% to 44% by weight, - chamomile oil in quantity? from 0% to 18% by weight, - tocopherol in quantity? from 0% to 2% by weight, - tocopheryl acetate in quantity? from 0% to 1% by weight, - candelilla wax in quantity? from 10% to 35% by weight, - shea butter? in quantity? from 10% to 20% by weight, the remainder of the ointment composition being a pharmaceutically acceptable carrier; for the combined sequential or delayed application of said composition and said ointment for use in the treatment of dermatitis, in particular atopic dermatitis and stress dyshidrosis. 10. Pharmaceutical product according to claim 9 which? supplied in the form of a preparation for combined and sequential or delayed use.