Technical Field The present invention relates to a dermatological composition and its uses in the cosmetic field and in the treatment of dermatological diseases.

Background Art

As is well known, the skin is an organ having fundamental importance to the human organism, as it protects from the external environment, is responsible for each person’s aesthetic appearance and tactile sensations.

The skin structure functions as an essential barrier to maintain skin hydration within physiological values. The main factors in this barrier that preside over the maintenance of hydration are: the stratum corneum, epidermal lipids, the Natural Moisturizing Factor (NMF) and the surface hydrolipidic film. These components undergo a continuous renewal process related to the ability of keratinocytes in the epidermis to continuously reproduce and differentiate, thus shaping the various layers that make up the epidermis.

Various exogenous and endogenous factors can alter these delicate defense mechanisms, causing more or less pronounced states of skin dehydration. The level of skin hydration varies depending on moisture, the hygroscopic properties of the stratum corneum and the presence of naturally moisturizing factors, in the absence of which the phenomenon of skin dryness sets in.

In addition to age and genetic predisposition for skin aging, numerous external factors can cause more or less pronounced states of skin dehydration. The main factors of dehydration are of the chemical type (e.g., the solvent and delipidizing action related to the repeated application of surfactants) or related to unfavorable climatic and environmental conditions: wind, cold and humidity of environments, when intervening separately or jointly, cause dehydration of the stratum corneum with the formation of dry, rough, flaky, cracked skin, redness, itching and other irritative phenomena.

In addition to exogenous factors, age and genetic predisposition, dry skin can be caused by endogenous factors of hormonal, dietary and pharmacological origin. The management of the adverse effects related to endogenous factors of a pharmacological origin, is considerably complicated since, the occurrence of skin disorders, often turns out to be a secondary aspect to the patient’s main clinical picture.

In addition, it should be considered that the severity of skin dryness increases as the concomitant causes increase.

This is the case for oncology patients, where the use of anti-cancer therapies causes damaging effects on patients’ skin that, however, are of less clinical importance than the management of an oncological framework of main importance, but which also contributes to increased dehydration and skin sensitivity.

Precisely this type of patients needs products that are effective but, at the same time, contain natural ingredients characterized by the absence of heavy metals, parabens, synthetic chemicals and the presence of ingredients with high antioxidant power which can fight the oxidative stress brought about by free radicals produced in abundance by the pharmacological treatments to which oncology patients are subjected.

At present, there are known dermatological compositions suitable for the treatment of dry, reddened and cracked skin that are alcohol-based but comprising additives of synthetic origin that do not meet the requirements of tolerability, safety and efficacy needed for the skin of oncology patients.

Thus, there is a particular need to develop dermatological compositions specifically formulated for the prevention and treatment of dermatitis caused by anti-cancer therapies such as chemotherapy and radiation therapy.

Description of the Invention

The main aim of the present invention is to devise a dermatological composition that meets the requirements of tolerability, safety and efficacy needed for dry and cracked skin, particularly but not limited to oncology patients.

Another object of the present invention is to devise a dermatological composition free of synthetic substances and entirely consisting of natural components.

Another object of the present invention is to devise a dermatological composition which is easily applicable and rapidly absorbed.

Another object of the present invention is to devise a dermatological composition which allows the aforementioned drawbacks of the prior art to be overcome within the framework of a simple, rational, easy and efficient to use as well as cost-effective solution.

The aforementioned objects are achieved by this dermatological composition having the characteristics of claim 1.

In addition, the aforementioned objects are achieved by the dermatological kit having the characteristics of claim 10.

Embodiments of the Invention

In a first aspect, the present invention relates to a dermatological composition.

The composition in accordance with the present invention comprises: water present in a concentration by weight, evaluated with respect to the total weight of the composition, greater than 30%; at least one hydrolyzed extract of silk proteins present in a concentration by weight, evaluated with respect to the total weight of the composition, greater than 15%; at least one antioxidant agent; at least one preservative agent present in a concentration by weight, evaluated with respect to the total weight of the composition, less than 5%.

In accordance with a preferred embodiment, the hydrolyzed extract of silk proteins consists of a fibroin hydrolyzed extract.

Preferably, the fibroin hydrolyzed extract is present in a concentration by weight, evaluated with respect to the total weight of the composition, greater than 25%.

It is specified that within the scope of this disclosure the expression “thermal water” refers to water obtained from thermal sources.

Water consists of thermal water comprising at least two of: calcium, magnesium, iron, manganese, silicon, copper and zinc. Preferably, thermal water in accordance with the present invention comprises: calcium, magnesium, iron, manganese, silicon, copper and zinc.

The presence of thermal water greatly increases the functional value of the invention, as the synergistic presence of the aforementioned elements allows the skin to be hydrated and purified, thus accelerating the healing processes thereof from dermatitis.

In addition, the presence of iron increases skin oxygenation.

Still, the presence of silicon increases the antioxidant power of the composition in accordance with the present invention, thus stimulating cell regeneration.

In addition, the presence of silicon tones the skin, allowing an anti- aging effect, the presence of copper alleviates inflammatory processes and finally, zinc alleviates skin irritation.

Preferably, thermal water is present in a concentration by weight, evaluated with respect to the total weight of the composition, greater than 35%.

Advantageously, the hydrolyzed extract comprises fibroin in a concentration by weight, evaluated with respect to the total weight of the extract, comprised between 2% and 15%.

Precisely, the hydrolyzed extract comprises fibroin in a concentration by weight, evaluated with respect to the total weight of the extract, comprised between 4% and 12%.

The presence of fibroin in the composition in accordance with the present invention allows oxygen exchanges with the outside world, thus ensuring optimal skin homeostasis.

In addition, the presence of a fibroin hydrolyzed extract allows sterilization of the composition in accordance with the present invention, thus preventing degradation of the components contained therein.

Finally, the presence of a fibroin hydrolyzed extract allows the stimulation of collagen production and thus the reproduction of fibroblasts so it performs a regenerative activity on the skin, synergistically with antibacterial, antifungal and antiviral activity by attacking and destroying the membrane of the pathogenic microorganisms on the skin. Finally, it should be emphasized that the presence of a fibroin hydrolyzed extract fights against skin redness and erythema, performs a reparative function on scars and keloids, deeply moisturizing the tissues and allowing its use even in the presence of viral and herpetic infections.

Preferably, the antioxidant agent comprises tocopherols.

In detail, the antioxidant agent is Vitamin E or, alternatively, tocopheryl acetate. Advantageously, the preservative agent comprises at least one of citric acid, benzyl alcohol, benzoic acid, capryloyl glycol, or mixtures thereof, present in a concentration by weight, evaluated with respect to the total weight of the composition, of less than 1%.

In addition, the composition according to the invention comprises at least one emollient agent selected from the list comprising: ethylhexyl palmitate, glycerin, ethylhexyl stearate, undecane, tridecane, ethylhexyl palmitate, caprylic/capric triglyceride, ethylhexylglycerin or mixtures thereof.

Advantageously, the at least one emollient agent is present in a concentration by weight, evaluated with respect to the total weight of the composition, of less than 8%.

In addition, the composition comprises at least one emulsifying agent selected from the list comprising: cetyl alcohol, cetylstearyl alcohol, glyceryl stearate citrate, shea butter or mixtures thereof.

In addition, the composition comprises at least one thickening agent present in a concentration by weight, evaluated with respect to the total weight of the composition, of less than 3%.

Preferably, the at least one thickening agent comprises: xanthan gum, propylene glycol or mixtures thereof.

Again, the composition according to the invention comprises at least one chelating agent present in a concentration by weight, evaluated with respect to the total weight of the composition, of less than 5%.

In accordance with a preferred embodiment, the chelating agent comprises tetrasodium glutamate diacetate.

In addition, the composition comprises at least one antimicrobial agent comprising, in turn, at least one of: phenoxyethanol and lactic acid.

Still, the composition in accordance with the present invention comprises at least one of freeze-dried annone pulp extract, beeswax, alba wax, turmeric essential oil, rice starch and vitamin A.

In accordance with a first embodiment according to the invention, the composition is in creamy form and comprises: freeze-dried annone extract, one of either beeswax or Alba wax, Turmeric essential oil and rice starch.

Advantageously, the presence of freeze-dried annone extract has the following properties: anti- aging; antioxidant due to the presence of polyphenols having anti-cancer action; healing and cell regeneration; antiviral.

In addition, the freeze-dried annone extract comprises folic acid and vitamins C and B.

At the same time, beeswax or Alba wax has the following properties: hydrophobic and protective on the stratum corneum by preventing excessive water loss from the skin; emollient; emulsifier between water and oil; soothing to the skin; antibacterial.

Advantageously, beeswax or Alba wax is present in a concentration by weight, evaluated with respect to the total weight of the composition, of less than 10%, preferably less than 5%.

In addition, it should be emphasized that the presence of Turmeric essential oil has the following properties: preservative, antioxidant, sebum regulator, antibacterial, antiviral, antifungal, anti-cancer, anti-allergic and anti-aging.

Preferably, the rice starch powder has the following properties: refreshing, soothing and anti-itching.

In addition, the presence of rice starch makes it possible to increase the density of the cream, acting as a natural thickener and avoiding the use of synthetic thickening agents.

In accordance with a second embodiment according to the invention, the composition is in liquid form and comprises vitamin A.

In detail, both embodiments of the composition according to the invention comprise thermal water, fibroin hydrolyzed extract, vitamin E and citric acid.

The dermatological composition in creamy form and that in liquid form differ from each other, the former, by the characteristic presence of annone pulp, beeswax or Alba wax, Turmeric essential oil and rice starch, while the latter by the presence of Vitamin A.

The following is a generic example of composition in accordance with this invention: fibroin hydrolysate: 20%. water: 50%-75%; fibroin hydrolysate: 20%; ethylhexyl palmitate: l%-5%; glycerin: 3%; ethylhexyl stearate: l%-5%; undecane and tridecane: 0.1 %- 1 %; caprylic/capric triglyceride: l%-5%; cetyl alcohol: l%-5%; cetylstearyl alcohol: l%-5%; glyceryl stearate citrate: l%-5%; shea butter: 1%; xanthan gum:0.1%-l%; benzyl alcohol, benzoic acid, caprylic glycol: 0.1%-1%; tetrasodium glutamate diacetate: 0.1 %- 1 % .

Two examples of the composition in accordance with the present invention are given below.

It is specified that the percentage concentrations given below are intended with respect to the total weight of the composition; in detail, by way of example, the aforementioned percentages refer to 100 ml of product.

EXAMPLE 1 - dermatological composition in creamy form. thermal water: 35%; fibroin hydrolyzed extract titrated to 4%: 30%; freeze-dried annone pulp extract: 10%; beeswax or Alba wax 2.5%;

Turmeric essential oil: 10%;

Vitamin E: 6% rice starch: 6% citric acid: 0.5%.

EXAMPLE 2 - dermatological composition in liquid form. thermal water: 35%; fibroin hydrolyzed extract titrated to 6%: 40%; vitamin A: 15%; vitamin E: 9.2%; citric acid: 0.8%.

In a further aspect, the present invention relates to the use of the composition in the prevention and treatment of dermatitis caused by anti-cancer drugs.

In another aspect, the present invention relates to the use of the composition in the cosmetic field.

Finally, the present invention relates to a dermatological kit comprising the dermatological composition in creamy form and the dermatological composition in liquid form.

The combined use of the aforementioned compositions surprisingly allows the drawbacks of known compositions to be overcome, namely the unsuitability for the treatment of sensitive and dehydrated skin characteristic of patients undergoing cancer therapies.

It has in practice been ascertained that the described invention achieves the intended objects.

It is emphasized that the synergistic combination of a fibroin freeze-dried extract in combination with thermal water and one or more of the components listed above makes it possible to obtain a dermatological composition that is neither sensitizing in the short, or medium, or long term but, rather, that is adapted to counteract skin hyperemia or erythema, dehydration and tissue changes brought about by antitumor therapies carried out in order to restore the hydrolipidic skin film.

In particular, the composition in accordance with the present invention gives high degree of hydration and oxygenation of the skin tissues that undergo biochemical and structural changes as a result of cancer therapies.

In detail, the composition according to the invention in creamy form has a particularly fluid texture compared to creams currently on the market, allowing it to be applied not only to the face but also to other areas such as, e.g., chest, legs, arms or back.

In addition, the composition according to the invention in liquid form has improved absorption, allowing its application even on sensitive skin altered by cancer treatments.

In addition, this composition has a high antibacterial and antifungal activity since the tissues are subjected to not only environmental but also therapeutic stresses, the skin of oncology patients being characterized by altered vascularization, fragility and having an altered pH due to the homeostatic skin alteration caused by anti-cancer therapies.