Composition for the treatment of inflammatory skin diseases

Abstract

The present invention relates to a dermatological or cosmetic skin composition in the form of a paraffin-free emulsion, particularly suitable for the treatment of inflammatory skin diseases, especially sensitive or atopic skin. The composition comprises an aqueous phase containing at least one emollient selected from polyols, and an oil phase containing an oily emollient system comprising at least 70% by weight of safflower oil and a second oily emollient.

Description

Technical Field

[0001] The present invention belongs to the field of dermatological or skin cosmetic compositions for the treatment of sensitive skin, particularly sensitive skin with inflammatory disorders such as atopic skin or skin having an atopic predisposition.

[0002] More particularly, the present invention relates to dermatological or skin cosmetic compositions in the form of emulsions, particularly oil-in-water emulsions, which are particularly suitable for the above-mentioned treatment, and to the use of such compositions for the treatment of the skin, particularly inflammatory skin diseases.

Background Art

[0003] For more than half a century, the use of skin care and hair care products has gradually become an everyday practice for reasons such as a pleasant feeling, immediate comfort, ease of use, and improvement in the quality of the skin and hair. As a result, a large number of products, particularly emulsions, have been developed, which are available in various textures and galenic formulations. With the development of chemistry, new and more natural raw materials have been introduced, enabling an improvement in the feel of cosmetics and enhanced product protection due to preservation.

[0004] Cosmetic emulsions are composed of the following two phases, namely: an aqueous phase composed particularly of water and aqueous extracts, and an oil phase composed particularly of oils, waxes, butters, and aliphatic alcohols. Both of these two phases are emulsified using a surfactant or an emulsifier. Thereafter, active ingredients, solvents, humectants, texture modifiers, emollients, gelling agents, antioxidants, sequestering agents, fillers, preservatives, fragrances, dyes, pigments, sunscreen agents, etc. are added. All of these components are essential for the sensory experience, namely comfort and perception, color, fragrance of the product, overall stability, long-term protection, and immediate and long-term efficacy as a cosmetic.

[0005] However, some of these ingredients have been shown to be unsuitable for use on the skin, or even harmful to the skin, potentially causing rashes, allergies, or even endocrine disruptors. The skin and scalp are permeable biological membranes. Therefore, some molecules can penetrate the skin and scalp, altering them, and even potentially entering the subcutaneous bloodstream. In Europe in particular, regulations have in recent years required the prohibition or reduction of the use of some ingredients for which associated risks have been proven or suspected. Furthermore, consumers have become increasingly cautious about the composition of the products they purchase. More and more ingredients are being questioned, sometimes in a controversial way, and these are favored by the media, whether conventional or not. Therefore, petrochemical ingredients such as paraffin or petrolatum are considered harmful to the environment. However, they are still widely used in cosmetics because they can form a protective layer on the skin. They also impart viscosity and texture to the compositions they are incorporated into, giving those compositions excellent sensory properties.

[0006] Non-patent documents 1 and 2, and patent document 1, which are excerpts from the GNPD database, describe cosmetic compositions for skincare in the form of paraffin-free emulsions. These compositions contain an aqueous phase comprising at least one aqueous emollient and an oily emollient system comprising safflower oil in an amount of 50% by weight or less relative to the total weight of the system. None of these compositions are indicated for the treatment of inflammatory skin diseases. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] International Publication No. 2016 / 051086 [Non-patent literature]

[0008] [Non-Patent Document 1] Mintel No.9882210 [Non-Patent Document 2] Mintel No.8424973 [Overview of the Initiative] [Problems that the invention aims to solve]

[0009] The present invention aims to provide a dermatological or cosmetic skin composition in the form of an emulsion that is gentle on the skin, does not contain controversial substances such as paraffin, has at least as good sensory properties as conventional compositions containing such substances, and is not expensive.

[0010] More specifically, the present invention aims to provide compositions that can benefit sensitive skin, such as atopic skin or skin with an atopic predisposition, and that can particularly effectively treat inflammatory disorders of the skin. [Means for solving the problem]

[0011] The skin is the protective outer layer that covers the entire body. It is covered by a protective water-lipid film consisting of a mixture of secretions such as sweat and sebum. Besides performing important protective functions, the skin also functions as a communication interface between the body and its surrounding environment, as it contains numerous tactile, thermal, and pain receptors. The skin consists of three layers (from the outside inward): the epidermis, dermis, and subcutaneous tissue.

[0012] The epidermis is primarily composed of multilayered, keratinized squamous epithelium. This is mainly made up of keratinocytes, which constantly proliferate and differentiate. The epidermis has four distinct layers, corresponding to the differentiation stages of the keratinocytes that make it up: the basal layer (where it connects to the dermis), the spinous layer, the granular layer, and the stratum corneum, also called the epithelial stratum corneum, which is the layer that is in contact with the external environment. In this stratum corneum, keratinocytes adhered by a lipid matrix form a protective barrier, which is reinforced by a hydrate-lipid film.

[0013] Dermatological disorders such as atopic dermatitis, pruritus, eczema, psoriasis, and rosacea are increasing, particularly in children. Atopic dermatitis, in particular, is the cutaneous manifestation of atopic dermatitis. Atopic dermatitis is a chronic inflammatory skin disease that occurs in genetically determined sites. Because the quality of life of patients with atopic dermatitis is significantly impaired, it is now considered a major public health concern. This condition most commonly develops in early childhood and is characterized by recurrent rashes over several years, progressing with alternating periods of severe exacerbations and spontaneous remissions. In atopic dermatitis, the skin's barrier function is weakened and impaired, promoting the invasion and colonization of pathogens such as bacteria or viruses, especially Staphylococcus aureus. Staphylococcus aureus is known to become dominant over the normal flora of the skin.

[0014] In the context of these dermatological conditions, it is understood that maintaining and even improving the skin's barrier function is crucial for highly sensitive skin, and especially for atopic skin or skin with an atopic predisposition. Skin prone to atopic dermatitis is extremely fragile. This type of skin is characterized by alterations in the epidermal barrier, which leads to dry skin that is even more vulnerable to external attacks, and a tendency towards allergies, making it particularly sensitive to allergens.

[0015] Surprisingly, the inventors have discovered that a dermatological or cosmetic skin composition in the form of a specific emulsion, rich in oily emollients, particularly safflower oil, and free of paraffin (INCI name: liquid paraffin), satisfies the objectives set forth in this invention and is particularly suitable for administration to sensitive skin, and even atopic skin, due to its effect of preventing a decrease in epidermal barrier function and / or strengthening this barrier function.

[0016] Accordingly, according to the first aspect, the present invention proposes a dermatological or cosmetic composition specifically intended for the treatment of inflammatory disorders or inflammatory skin diseases of any type of skin, particularly sensitive skin, and even atopic skin, by topical administration. This composition is: - An aqueous phase containing at least one emollient agent selected from polyols, more specifically glycerin and its derivatives, and glycols and their derivatives, - An oil phase containing an oily emollient agent system including safflower oil and a second oily emollient agent In the form of an emulsion, and this composition, in terms of weight ratio with respect to the total weight of the composition: - At least 50% by weight of water, - 10 - 20% of the total of one or more emollient agents contained in the aqueous phase, - 10 - 25% of the above oily emollient agent system, provided that 8 - 18% is safflower oil, and the safflower oil accounts for more than 70% by weight of the above oily emollient agent system Contains.

[0017] Furthermore, this composition does not contain paraffin and preferably does not contain petrolatum either.

[0018] In this description, "8 - 18% being safflower oil" is to be understood as the composition containing 8 - 18% by weight of safflower oil with respect to the total weight of the composition. Since the total concentration of the entire oily emollient agent system in the composition is from 10 - 25% by weight, when combining the components other than safflower oil in this oily emollient agent system, it will account for at most about 7% by weight of the composition, and the total concentration of these varies according to the safflower oil content in the oily emollient agent system and in the composition.

[0019] As described above, although the composition according to the present invention does not contain paraffin, advantageously, it has sensoriality at least equivalent to that of paraffin - based compositions, and the efficacy of nourishing and repairing the skin is also equally good, if not better. In particular, the above composition is particularly effective in improving the skin barrier function. In particular, the inventors have discovered that the composition according to the present invention emphasizes and further improves the organization of the lipid matrix of the epidermal stratum corneum, and that the above composition stimulates the synthesis of endogenous ceramides within the stratum corneum.

[0020] Although intercellular lipids account for only 10% of the total mass of the epidermal stratum corneum, they play an important role in the skin's barrier function. For example, when lipids are removed, water is lost by diffusion. The barrier function is due to the complex and specific architecture of the intercellular lipid matrix of keratinocytes, which is composed of a mixture of ceramides, cholesterol, and long-chain fatty acids. By using electron microscopy and diffraction techniques to study the ultrastructure of the epidermis, it has been shown that these lipids are organized mainly as stacked bilayers parallel to the skin surface. Some of these lipids are covalently bound to keratinocytes, and the others are free lipids. Therefore, the skin lipid barrier can be strengthened by improving the organization of the lipid matrix of the epidermal stratum corneum induced by topical administration of the composition according to the present invention.

[0021] Furthermore, about half of the intercellular lipids consist of ceramides. Ceramides constitute a biologically very important lipid family because they enable the binding of the epidermal stratum corneum and, as a result, the formation of the skin barrier.

[0022] A variety of ceramides form part of the lipid composition of the epidermal stratum corneum. Biochemically, these are sphingolipids formed by the amidation of sphingosine with fatty acids. They may be free or covalently bound to the proteins of the epidermal stratum corneum. Currently, 14 ceramides have been identified and named according to their chemical structure: Ceramides are those in which an ω-hydroxy (EO or O), α-hydroxy (A), or non-hydroxy (N) fatty acid with an alkyl chain of different lengths is bound to a sphingosine (S), dihydrosphingosine (dS), phytosphingosine (P), or 6-hydroxysphingosine (H) base.

[0023] Ceramides play a crucial role in the organization of lamellar bilayers, with ultra-long-chain esterified ceramides such as EOS, EOP, and EOH ceramides being particularly important (Bouwstra et al., Biochim Biophys Acta 1996, 1300(3), 177-186). The importance of esterified ceramides due to their extremely long carbon chains has been demonstrated in relation to lamellar repeat distance and chain conservation (Kessner et al., Chem Phys Lipids, 2010, 163(1), 42-50). Furthermore, the polar heads of ceramides, especially CER EOS and CER EOP, significantly influence the structural properties required for functional lipid matrices.

[0024] Non-esterified ceramides are key components, important not only for barrier function but also for skin hydration and nutrition. Studies have shown that dry skin in winter correlates with decreased total ceramide levels, more specifically with NP and NH ceramide levels (Ishikawa et al., J. Cosmet Dermatol 2013, 12(1), 3-11). In patients with atopic dermatitis, a significant decrease in total ceramide levels, particularly NP, NS, and NH ceramide levels, has been reported, as well as an inverse correlation with measured insensible water loss, an indicator of impaired barrier function (Ishikawa et al., J Invest Dermatol, 2010, 130(10), 2511-2514).

[0025] The decrease in very long-chain esterified ceramides, as well as the shortening of the chain lengths of free fatty acids and ceramides in general, alters the lipid organization to a less dense state (Kessner et al., Skin Pharmacol Physiol 2008, 21(2), 58-74). This creates gaps in the lipid arrangement between keratinocytes, which leads to a decrease in skin barrier function and an increase in skin permeability. Therefore, an increase in these lipids induces an enhancement of skin barrier function. Advantageously, the compositions according to the present invention induce such an increase acting on all ceramides, particularly very long-chain esterified ceramides.

[0026] Furthermore, the compositions according to the present invention may have one or more of the following features, which can be implemented individually or in any technically functional combination.

[0027] Preferably, the composition according to the present invention contains at least 50% by weight, preferably at least 55% by weight, and more preferably at least 60% by weight of water based on the total weight of the composition.

[0028] In certain embodiments of the present invention, the composition contains 50 to 70% by weight, preferably 55 to 70% by weight, and more preferably 60 to 70% by weight, of water relative to the total weight of the composition.

[0029] The composition according to the present invention is in the form of an emulsion containing an aqueous phase and an oil phase, wherein one of these phases, the so-called dispersed phase, is homogeneously dispersed in the other of these layers, the so-called continuous phase, in the form of fine droplets. This emulsion may be water in oil. Preferably, the composition according to the present invention is in the form of an oil-in-water emulsion, that is, an emulsion in which the oil phase is maintained in a state of homogeneous dispersion in the aqueous phase.

[0030] The composition according to the present invention preferably contains at least one consistency factor, which may be contained in the aqueous phase and / or the oil phase, and preferably in the oil phase.

[0031] These one or more consistency factors are preferably selected from aliphatic alcohols, fatty acids, hydrogenated vegetable oils, and other waxy substances.

[0032] The composition according to the present invention, in particular, has the following as a consistency factor: - At least one aliphatic alcohol, preferably C16-C22, such as cetyl alcohol, stearyl alcohol, arachidyl alcohol, and / or behenyl alcohol; and / or - At least one fatty acid, preferably C16-C18, such as lauric acid, palmitic acid, or stearic acid; and / or - At least one hydrogenated vegetable oil, in particular hydrogenated castor oil; and / or - At least one other waxy substance having a melting point of 45°C or higher, preferably strictly above 45°C, such as glycol palmitate, vegetable waxes (carnauba wax, sunflower wax, jojoba wax, etc.), beeswax, or a mixture of tribehenin / glyceryl dibehenate / glyceryl behenate (substance with the INCI name tribehenin / glyceryl dibehenate / glyceryl behenate) found in the commercially available material COMPRITOL® 888. It may contain.

[0033] Preferably, the composition according to the present invention contains only one type of consistency factor.

[0034] The total content of one or more consistency factors in the composition is preferably 5% by weight or less, for example 4% by weight or less, and particularly 3% by weight, based on the total weight of the composition.

[0035] In certain embodiments of the present invention, the consistency factor is present in a total content of 0.1 to 5% by weight, particularly 0.5 to 4% by weight, for example, 1 to 4% by weight, or 1 to 3% by weight, relative to the total weight of the composition.

[0036] In certain embodiments of the present invention, the composition does not contain a foaming surfactant.

[0037] In certain embodiments of the present invention, the composition further contains no emulsifier. In this case, the composition necessarily contains at least one consistency factor in a concentration sufficient to ensure the emulsion form of the composition.

[0038] In another embodiment of the present invention, the composition comprises at least one emulsifier selected from emulsifiers capable of forming an oil-in-water emulsion. For example, emulsifiers can be selected from: ethoxylated aliphatic alcohols, products marketed under the names Montanov® 68 (cetearyl alcohol (and) cetearyl glucoside) and Montanov® 82 (cetearyl alcohol (and) coco-glucoside); potassium cetyl phosphate; glucoside waxes; glyceryl stearate citrate; lauryl glucoside and polyglyceryl-2 dipolyhydroxystearate, especially products marketed under the name Eumulgin® VL75; lecithins, especially hydrogenated soybean lecithin; glycerol monostearate; sorbitan monostearate; sodium dilauroyl glutamate lysine; sodium stearoyl glutamate, especially products marketed under the name Eumulgin® SG; sodium stearoyl lactate; sucrose stearate; etc.

[0039] In certain embodiments of the present invention, the emulsifier comprises at least a mixture of cetearyl alcohol / cetearyl glucoside, which is available, in particular, under the trademark name MONTANOV® 68.

[0040] The composition according to the present invention may, for example, contain a mixture of cetearyl alcohol / cetearyl glucoside, glycerol monostearate, and sodium stearoyl glutamate as an emulsifier.

[0041] In certain embodiments of the present invention, the emulsifier is present in a total content of 2 to 11% by weight, preferably 2 to 8% by weight, preferably 2 to 7% by weight, more preferably 2 to 6% by weight, and particularly 2 to 5% by weight, for example, 3 to 5% by weight, based on the total weight of the composition. This composition allows for good stability and excellent functional properties of the emulsion without excessive saponification, and prevents skin whitening when the composition is applied.

[0042] Preferably, the composition according to the present invention contains four or fewer, preferably three or fewer, for example, two or fewer emulsifiers. In other specific embodiments, the composition according to the present invention contains a single emulsifier.

[0043] In this explanation, the term "emollient" itself refers, as in the conventional sense, to a compound that, when administered via a local route, has the property of replenishing moisture to the epidermis and softening the epidermis.

[0044] The composition according to the present invention comprises one or more emollients in its aqueous phase, at least one of which is selected from polyols, more specifically from glycerin and its derivatives, and glycols and their derivatives. These one or more emollients present in the aqueous phase, which are soluble in or miscible with water, are referred to in this description for convenience as "aqueous emollients."

[0045] According to the present invention, a "polyol" (sometimes called a polyhydric alcohol) means a compound comprising a hydrocarbon chain having at least two carbon atoms and at least two hydroxyl groups. The polyols used in accordance with the present invention are preferably diols or triols.

[0046] Polyols selected from glycerin and its derivatives, and glycols and their derivatives, which have emollient properties and are used in accordance with the present invention, may be natural or synthetic. They may have linear, branched, or cyclic molecular structures.

[0047] In particular, polyols used in accordance with the present invention may be selected from the group consisting of glycerin, diglycerin, polyglycerin, diethylene glycol, propylene glycol, dipropylene glycol, butylene glycol, pentylene glycol, hexylene glycol, 1,3-propanediol, 1,5-pentanediol, 1,2-hexanediol, octane 1,2-diol, and polyethylene glycols having 5 to 50 ethylene oxide groups. Furthermore, or alternatively, compositions according to the present invention may contain as aqueous emollients erythritol, treitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fusitol, iditol, inositol, boremitol, isomalt, maltitol, lactitol, maltotriitol, maltotetrol, polyglycitol, and mixtures thereof.

[0048] Preferably, the aqueous emollient selected from polyols is glycerin.

[0049] The composition according to the present invention contains one or more emollients in the aqueous phase in a total weight ratio of 10 to 20% of the total weight of the composition. In particular, the composition contains one or more emollients in the aqueous phase in a total weight ratio of 10 to 15%, for example, 12 to 15%, of the total weight of the composition.

[0050] The composition according to the present invention comprises an oily emollient system, which contains at least safflower oil (Carthamus tinctorius) as an oily emollient in an amount of at least 70% by weight, preferably 70-99% by weight, for example 70-95% by weight, relative to the weight of the oily emollient system, and also comprises at least one second oily emollient. In particular, such a high content of safflower oil (especially Carthamus tinctorius seed oil) in the oily emollient system is advantageous and surprising, as it ensures good sensory properties of the composition, particularly with respect to the rate of penetration into the skin, which are not found in compositions with similar components but in which safflower oil accounts for less than 70% by weight of the total weight of the oily emollient system. Part of the composition's high efficacy against the skin's barrier function can be attributed to the combination of all its features, namely, the combination of polyols selected from glycerin and its derivatives, glycols and their derivatives, safflower oil, and a second oily emollient, and the respective amounts of each in the composition.

[0051] The composition according to the present invention contains 8 to 18% by weight, preferably 8 to 15% by weight, for example 9 to 14% by weight, of safflower oil based on the total weight of the composition.

[0052] The second oily emollient and other emollients, different from safflower oil, that may be included in the oil phase may be selected from the following: - Triglycerides. Triglycerides are composed of three fatty acids bonded to a glycerol molecule by ester bonds. In particular, triglycerides suitable for the present invention may be selected from the group consisting of triglycerides esterified with C8-C18 fatty acids, especially C10-C18 fatty acids, and more specifically, caprylic / capric triglycerides; - Non-hydrogenated vegetable oils such as sunflower oil, corn oil, olive oil, sweet almond oil, coconut oil, palm oil, soybean oil, pumpkin oil, grapeseed oil, sesame oil, hazelnut oil, apricot oil, macadamia nut oil, avocado oil, jojoba oil, borage oil, rapeseed oil, wheat germ oil, linseed oil, evening primrose oil, argan oil, calendula oil, and cottonseed oil; -Solid fats with a melting point of 45°C or less, preferably strictly below 45°C, such as butter, for example, shea butter; - Synthetic esters and ethers, especially synthetic esters and ethers of fatty acids, such as oils of formulas R1COOR2 and R1OR2 (where R1 represents the remainder of a fatty acid containing 8 to 29 carbon atoms, and R2 represents a branched or unbranched hydrocarbon chain containing 3 to 30 carbon atoms), such as parcelin oil, isononyl isononanoate, isopropyl myristate, ethylhexyl palmitate, octyl-2-dodecyl stearate, octyl-2-dodecyl erucate, isostearyl isostearate; isostearyl lactate, hydroxystearin Hydroxylated esters such as octyl acid, octyldodecyl hydroxystearate, diisostearyl malate, and triisocetyl citrate; heptanoic acid esters, octanoic acid esters, or decanoic acid esters of aliphatic alcohols; polyol esters such as propylene glycol dioctanoate, neopentyl glycol diheptanoate, and diethylene glycol diisononanoate; and pentaerythritol esters such as pentaerythrityl tetraisostearate or dipentaerythrityl pentaisononanoate; and -These mixtures.

[0053] In the sense of the present invention, the second oily emollient agent is not a wax, just like all other oily emollient agents contained in an oily emollient agent system other than safflower oil, where the wax is characterized by having a melting point of 45°C or higher, generally higher than 45°C.

[0054] The oily emollient system is present in the composition in an amount of 10 to 25% by weight, particularly 10 to 20% by weight, for example, 10 to 18% by weight, based on the total weight of the composition.

[0055] Preferably, the composition according to the present invention, more particularly the oily emollient system thereof, contains fewer than six oily emollients, including safflower oil. The above composition preferably contains fewer than five oily emollients, preferably fewer than four oily emollients, and more preferably fewer than three oily emollients.

[0056] Accordingly, in certain embodiments of the present invention, the composition contains exactly five types of oily emollients, or four types of oily emollients, or three types of oily emollients, or two types of oily emollients, the number of which includes safflower oil. The fewer the number of oily emollients, the lower the risk of skin irritation from the composition according to the present invention.

[0057] Preferably, the composition according to the present invention contains one or more oily emollients other than safflower oil in a total amount of 0.5 to 7% by weight, more preferably 0.5 to 5% by weight, and even more preferably 1 to 4% by weight, based on the total weight of the composition. For example, the composition may contain 0.5 to 5% by weight, preferably 1 to 4% by weight, of triglycerides such as caprylic / capric acid triglyceride or ethylhexyl palmitate, based on the total weight of the composition, or a mixture of triglycerides such as caprylic / capric acid triglyceride and shea butter in an amount of 2 to 7% by weight, based on the total weight of the composition.

[0058] The compositions according to the present invention may further contain any conventional additives for dermatological or cosmetic skin compositions, which, like all other components of the compositions according to the present invention, are dermatologically and / or cosmetically acceptable. It should be understood here that, as conventionally, these components are suitable for use in contact with human and animal skin cells and do not cause any problems that would cause discomfort to the user or interfere with the use of the composition.

[0059] In particular, the compositions according to the present invention may contain one or more gelling agents and / or thickening agents selected from the group consisting of, for example, alginate esters, carrageenan, cellulose and its derivatives, starch, xanthan gum, scleroglucan gum, succinoglucan gum, gellan gum, diutan gum, acacia gum, Caesalpinia spinosa gum, locust bean gum, tamarind (Tamarindus indica) seed gum, acrylic acid esters, and mixtures thereof.

[0060] A gelling agent and / or thickening agent, such as xanthan gum, may be included in the composition in an amount of, for example, 0.1 to 1% by weight relative to the total weight of the composition.

[0061] The compositions according to the present invention preferably do not contain silicone. In the context of the present invention, silicone, or polysiloxane, means any organosilicon polymer or oligomer having a linear and / or cyclic, branched and / or crosslinked structure, which is obtained by polymerization and / or polycondensation of functionalized silanes as conventionally, and essentially consists of repeating main units in which silicon atoms are connected to one another by oxygen atoms, and hydrocarbon radicals which may be substituted in particular by hydroxyl groups are directly bonded to these silicon atoms by carbon atoms.

[0062] More preferably, the cosmetic composition according to the present invention does not contain phenoxyethanol, which is suspected to be an endocrine disruptor.

[0063] Preferably, the compositions according to the present invention do not contain alpha-hydroxy acids, or AHAs (Alpha Hydroxy Acids). These are carboxylic acids mainly derived from fructose. The main fruit acids are lactic acid, malic acid, glycolic acid, citric acid, and tartaric acid. Because AHAs promote exfoliation of the skin, these components should rather be avoided in compositions intended for administration to atopic skin or skin with an atopic predisposition. In fact, skin with an atopic predisposition is an extremely fragile skin type. Such skin is characterized by alterations in the epidermal barrier, which leads to dry skin that is even more vulnerable to external attacks, and a tendency towards allergies, making it particularly sensitive to allergens. Atopic skin is more specifically called atopic dermatitis.

[0064] Preferably, any substance having exfoliating properties, such as retinoids, is also avoided in the composition according to the present invention.

[0065] The composition according to the present invention may contain one or more preservatives, or it may not contain them.

[0066] In preferred embodiments of the present invention, the composition does not contain preservatives. The polyol constituting the composition is particularly selected from polyols that do not have preservative properties. In such embodiments, the composition according to the present invention is preferably sterilized in accordance with the EN556 standard and the European Pharmacopoeia, in particular, to obtain a sterility level with a sterility value of F0 = 22 minutes. A method for sterilizing an emulsion that can obtain such a level of sterility without destabilizing the composition is described in particular in International Publication No. 2013 / 007755.

[0067] The composition according to the present invention may, for example, not contain the following components: benzoic acid, 2-hydroxybenzoic acid, sorbic acid, benzyl alcohol, ethyl alcohol, phenylethyl alcohol, sodium benzoate, cetrimonium bromide, ethyl lauroyl arginate hydrochloride. Hydrochloride), clobutol, chlorphenesin, benzalkonium chloride, diazolidinyl urea, chlorhexidine gluconate, ethyl hydroxybenzoate, glyceryl caprylate, glycerol monocaprylate, imidazolidinyl urea, iodide propynyl butylcarbamate, methylisothiazolinone, methylparaben, octoxyglycerin, orthophenylphenol, butyl parahydroxybenzoate, methyl parahydroxybenzoate, sodium parahydroxybenzoate, propyl parahydroxybenzoate, sodium parahydroxybenzoate, phenoxyethanol, phenoxyethanolparaben, piroctone olamine, potassium sorbate, sodium propionate, propylparaben, zinc pyrithione, salicylic acid, sodium dehydroacetate, potassium sorbate, sorbic acid, trichlorohydroxydiphenyl ether.

[0068] The composition according to the present invention may contain at least one preservative that is conventional in the field of dermatology or skin cosmetics, for example, selected from the preservatives listed above.

[0069] In certain embodiments of the present invention, the composition does not contain essential oils. In fact, most essential oils contain allergens that can cause rashes or skin intolerance. For similar reasons, dyes with similar characteristics should also be avoided.

[0070] In certain embodiments of the present invention, the composition does not contain ethylenediaminetetraacetic acid (EDTA). Alternatively, the composition may contain such an acid.

[0071] The composition according to the present invention may be in any conventional form, which is adapted for topical administration to the skin and mucous membranes. The composition may be in the form of a fluid emulsion, a thick emulsion, a cream, a milk, a serum, an ointment, or a balm, but is not limited thereto.

[0072] The composition may be in the form of a liquid or semi-liquid, a soft semi-solid or solid, or a microemulsion. Advantageously, by changing the proportions of the components, a variety of different viscosities and fluidities can be obtained as needed.

[0073] The compositions according to the present invention may be intended for administration to the skin of the face and / or body.

[0074] For example, the composition may be in the form of a cream or balm for the protection, treatment, or care of the face, hands, and / or body, or a body milk for protection, treatment, or care.

[0075] For example, the composition may be of a sprayable type, particularly for use in sunscreen products or lotions.

[0076] The packaging device for the composition according to the present invention may be an airless tube with a pump, a Precitube-type tube, a sprayer, a bead applicator, or an airless jar, etc.

[0077] Therefore, the composition according to the present invention, in its basic formulation which does not contain any cosmetic or dermatological active ingredients, has beneficial effects on skin affected by inflammatory skin diseases such as atopic dermatitis.

[0078] The composition may further contain one or more skin cosmetic active ingredients. Each of these active ingredients may consist of any active ingredient having dermatological, cosmetic, or skin cosmetic properties. These may be selected from natural products, particularly plant extracts, biotechnology-derived extracts such as plant cells or microalgae cultures, chemicals, or postbiotics, or any combination thereof.

[0079] In this specification, the term "postbiotic" refers to a mixture of factors, products, or metabolites secreted by or released after the lysis of living microorganisms (most often living bacteria). Specifically, postbiotics include a variety of elements, such as enzymes, peptides, teichoic acid, muropeptides derived from peptidoglycans, polysaccharides, lipoproteins, cell surface proteins, and organic acids. Thus, postbiotics correspond to a mixture of molecules obtained from the culture process of probiotics (bacteria and / or enzymes), or more broadly, to any more or less soluble metabolic factors, products, or by-products secreted by microorganisms and excreted or released into the culture medium after lysis. In general, the exact composition of postbiotics is not strictly determined and depends on the microorganisms, culture conditions, and lysis and purification conditions.

[0080] The specific postbiotics that can be used in the present invention may be extracts derived from cultures and / or lysates in the cultivation of microorganisms, particularly bacteria.

[0081] In preferred embodiments of the present invention, if a skin cosmetic active ingredient is present, it is a postbiotic, which is a bacterial extract derived from bacteria belonging to the phylum Proteobacteria, particularly the class Betaproteobacteria. Preferably, the bacterial extract is derived from bacteria belonging to the family Neisseriaceae. More preferably, the postbiotic is a bacterial extract derived from the bacterium named LMB64, or one of its variants, which was deposited with the CNCM (Collection Nationale de Cultures de Microorganismes, Institut Pasteur, 25 rue du Docteur Roux, 75724 Paris Cedex 15) on April 8, 2010, under reference number CNCM I-4290 and described in International Publication No. 2012 / 085182.

[0082] Accordingly, in certain embodiments of the present invention, the composition contains, as a skin cosmetic active ingredient, one of the nonpathogenic bacteria of the Neisseriaceae family deposited with the CNCM as CNCM number I-4290, or a variant thereof, and / or a bacterial extract obtained from a suspension of the above bacteria or one of its variants. This extract consists of membrane proteins, particularly porins, OmpA, lipopolysaccharides and / or lipoproteins, lipopolysaccharides, periplasmic proteins, flagellar-derived protein fragments, and primary and secondary metabolites produced by the bacteria, and may particularly include an ES0 fraction, which can be obtained by incubating the bacterial culture medium in a basic medium (pH 9-11) at 4°C for approximately 5 hours, centrifuging, filtering through 0.2 μm to obtain a clear ES0 solution. In particular, the above extract may have three main bands corresponding to molecular weights in the ranges of 30 kDa-36 kDa, 41 kDa-45 kDa, and 47 kDa-51 kDa.

[0083] For example, the concentration of the skin cosmetic active ingredient in the composition according to the present invention may be 0.01 to 2% by weight relative to the total weight of the composition.

[0084] The compositions according to the present invention can be manufactured by any method known to those skilled in the art.

[0085] In a preferred embodiment of the present invention, the scent of the composition is derived from the components of the composition itself, and no additional fragrance substances are included.

[0086] Another aspect of the present invention relates to the use of dermatological or cosmetic compositions according to the present invention, preferably embodiments containing cosmetic active ingredients, for the treatment of inflammatory skin diseases.

[0087] The above-mentioned inflammatory skin disease may be atopic dermatitis, pruritus, eczema, psoriasis, or rosacea. Preferably, the above-mentioned inflammatory skin disease is atopic dermatitis.

[0088] In this explanation, “treating” shall be understood as the prevention or partial prevention of one or more symptoms of a disease, and / or the partial or complete cure of a disease, and / or the complete or partial disappearance of one or more symptoms of a disease.

[0089] The compositions according to the present invention can be administered to any subject who needs them, i.e., who has or may have an inflammatory skin disease. This subject may be a mammal, in particular a human.

[0090] The administration is preferably carried out topically, particularly on areas of skin on the face and / or body where it is needed, especially sensitive or intolerant skin resulting from, for example, atopic dermatitis, and especially on atopic skin or skin with an atopic predisposition.

[0091] The composition according to the present invention is preferably administered to a subject in a therapeutically effective amount. "Therapeutically effective amount" means an amount of the composition sufficient to provide treatment for a disease when administered to a subject for the treatment of the disease.

[0092] The dosage may be, for example, once or twice a day, for example, in the morning and evening, and the duration of administration may be, for example, one to two weeks or more.

[0093] The therapeutic effect of the composition according to the present invention on inflammatory skin diseases is exerted by preventing a decline in epidermal barrier function and / or strengthening the epidermal barrier function. Therefore, the composition according to the present invention can be used to prevent a decline in epidermal barrier function and / or strengthen the epidermal barrier function, particularly in atopic skin or skin with an atopic predisposition.

[0094] The present invention may also be expressed as a method for therapeutically treating a subject who has or may have an inflammatory skin disease, the method comprising the step of topically administering a therapeutically effective amount of a composition according to the present invention, preferably an embodiment containing a skin cosmetic active ingredient, to an area of ​​the subject's skin that requires it. The method may satisfy one or more of the features described above with respect to the use of the cosmetic composition according to the present invention for treating inflammatory skin diseases.

[0095] The present invention also relates to the use of compositions according to the present invention as non-therapeutic cosmetics for the care of skin, particularly the skin of the face and / or body. Such use particularly benefits from the nourishing effect and the effect of improving the moisture status and texture of the skin, as well as its overall barrier function. Accordingly, the present invention also relates to a method of non-therapeutic cosmetic treatment of the skin of a subject, particularly mammals, particularly human, the method comprising the administration of compositions according to the present invention to the skin, particularly for improving the moisture status and / or texture of the skin.

[0096] The composition according to the present invention can be administered topically in an effective amount to a skin area of ​​an individual of interest, particularly a healthy skin area, i.e., a skin area free from pathological conditions. Therefore, in certain embodiments of the present invention, the composition does not need to contain any skin cosmetic active ingredients. The skin area may be, for example, dry skin, tight-feeling skin, or sensitive skin that is not atopic or does not have an atopic tendency.

[0097] The dosage of the composition according to the present invention may be, for example, once or twice a day, for example, in the morning and evening, and the duration of administration may be, for example, one to two weeks or more.

[0098] In general, in both therapeutic and cosmetic contexts, the compositions according to the present invention provide protection that maintains comfort throughout the day. The compositions can be administered particularly to sensitive skin, reactive skin, and especially infant skin.

[0099] Preferably, the compositions according to the present invention are used for the protection and / or treatment of sensitive skin. Sensitive skin is defined by the specific reactivity of the skin. This skin reactivity typically manifests as the development of signs of discomfort in response to the subject coming into contact with triggering elements that may have various origins. Examples include the application of certain cosmetic products to the surface of sensitive skin, the ingestion of certain foods, exposure to sudden temperature changes, air pollution, and / or exposure to ultraviolet or infrared radiation. Factors related to age and skin type also exist. Consequently, sensitive skin is more common in dry or oily skin than in normal skin. In the sense of the present invention, sensitive skin includes skin that is easily irritated and skin that is intolerant.

[0100] The features and advantages of the present invention will become more apparent by considering the following exemplary embodiments with the supplementary use of Figures 1-4. These exemplary embodiments are provided for illustrative purposes only and are not intended to limit the invention. [Brief explanation of the drawing]

[0101] [Figure 1] Figure 1 shows the X-ray diffraction pattern obtained from an untreated epithelial stratum corneum sample (a / WAXS signal, b / SAXS signal). [Figure 2] Figure 2 shows the X-ray diffraction pattern obtained from an epithelial stratum corneum sample treated with composition C1 according to the present invention (a / WAXS signal, b / SAXS signal). [Figure 3]Figure 3 shows the X-ray diffraction pattern obtained from an epithelial stratum corneum sample treated with composition Comp1, which is not according to the present invention (a / WAXS signal, b / SAXS signal). [Figure 4] Figure 4 shows the sensory analysis profiles of composition C1 according to the present invention and comparative composition Comp1, which is not according to the present invention, as evaluated by 15 panelists 5 minutes and 15 minutes after application to the skin. [Modes for carrying out the invention]

[0102] A / Example 1 - Composition according to the present invention Composition C1 according to the present invention, in the form of a cream, has the formulation shown in Table 1.

[0103] [Table 1] Table 1 - Composition C1

[0104] Composition C2 according to the present invention, in the form of a balm, has the formulation shown in Table 2, and is characterized by comprising at least 70% by weight of a mixture of Carthumus tinctureus seed oil, caprylic / capric triglyceride, and shea butter.

[0105] [Table 2] Table 2 - Composition C2

[0106] B / Example 2 - Effects of various oily emollients on perceived sensory properties The purpose of this study is to compare the sensory properties of various compositions. These will be evaluated by individuals trained in sensory evaluation techniques for cosmetic products, and the satisfaction of the sensory profile will be judged more specifically based on criteria such as the presence or absence of an oily appearance, the rate of skin penetration, and the film-forming effect. The appearance of the emulsions will be examined under a microscope.

[0107] Table 3 details the various compositions tested (compositions Comp2, Comp3, and Comp4 do not conform to the present invention because they contain a single oily emollient or a mixture of oily emollients containing less than 70% by weight of safflower seed oil, while compositions C3 and C4 conform to the present invention).

[0108] [Table 3] Table 3 - Tested Compositions

[0109] In this experiment, 0.1 ml of each test composition is applied to the back of the hand.

[0110] The results obtained are shown in Table 4 below.

[0111] [Table 4] Table 4 - Sensory properties of the tested compositions

[0112] It has been observed that only compositions C3 and C4, which contain two oily emollients including safflower oil, and in which safflower oil accounts for more than 70% by weight (more specifically, 83% by weight) of the total oily emollients, possess satisfactory sensory characteristics. Composition Comp4, which contains a mixture of safflower oil and triglycerides, but in which safflower oil accounts for only 50% by weight of the mixture, does not possess satisfactory sensory characteristics, particularly in terms of insufficient penetration into the skin.

[0113] Compositions C3 and C4 according to the present invention are both considered satisfactory and have equivalent sensory characteristics, but of these, C3 is preferred because the second oily emollient is of the triglyceride type, has a smooth appearance under a microscope, and has a low risk of destabilization due to temperature.

[0114] C / Example 3 - X-ray diffraction analysis of the effect of cosmetic composition on lipid organization of the epithelial stratum corneum The purpose of this study is to characterize the effects on the epidermal stratum corneum of two cosmetic compositions, namely: composition C1 according to the present invention as described in Example 1, and comparative composition Comp1, which is not according to the present invention, and which contains paraffin in particular and satisfies the formulation shown in Table 5.

[0115] [Table 5] Table 5 - Comparative composition Comp1

[0116] The technique used to analyze the lipid organization in the epithelial stratum corneum is X-ray diffraction. This experiment is performed on epithelial stratum corneum (SC) isolated from the abdomen.

[0117] X-ray diffraction provides information about the organized or partially organized arrangement of atoms, molecules, or macromolecules. In particular, this technique allows for the study of lipid and protein organization in the skin, more specifically in the epidermal stratum corneum. A key feature of this technique is the ability to characterize and compare the effects of compositions after application to the epidermal stratum corneum.

[0118] Epithelial stratum corneum samples (anatomical site: abdomen) were provided by Novitom. A 0.75 × 1.5 cm sample was placed on a polymer substrate selected to have sufficient adhesion to prevent movement of the epithelial stratum corneum during application of the composition, while also allowing for removal without any damage after treatment. 2 A piece of epithelial stratum corneum of the specified dimensions was placed. The outer surface of the sample was treated with a spatula at a density of approximately 5 mg / cm². 2 Each composition was applied to the sample to cover the entire sample. Approximately 45 minutes after application, the sample was folded at least four times to increase the amount of epithelial stratum corneum sheet in the X-ray beam. X-ray diffraction analysis was performed 3 hours after application. An untreated control sample was also analyzed.

[0119] X-ray diffraction experiments were performed using an X-ray diffractometer at the SOLEIL Proxima 2 synchrotron beamline. This configuration is particularly suitable for detecting SAXS / WAXS signals. The parameters used are shown in Table 6 below.

[0120] [Table 6]

[0121] In this configuration, the diffraction signal of the epithelial stratum corneum is integrated over the entire thickness of the layered sheet.

[0122] For data acquisition, 120 to 180 diffraction patterns were obtained per sample. The exposure time per dot was 20 ms.

[0123] The data was processed using ESRF FIT2D software. The background model (diffraction of air) was subtracted from the diffraction model of all samples.

[0124] The obtained results (wide-angle X-ray diffraction signal (WAXS) and small-angle X-ray diffraction signal (SAXS) for the outer, inner, and internal surfaces of the sample are shown in Figure 1 for the control sample, Figure 2 for the sample treated with composition C1, and Figure 3 for the sample treated with composition Comp1) are shown in Figure 3.

[0125] The presented intensity profiles correspond to the meridian-integrated angular profile (SAXS profile) and the equatorial profile (WAXS profile). The WAXS profile is normalized (intensity and peak position) for easier comparison.

[0126] Generally, the SAXS signal provides information about the crystalline structure of lipids within a layer. The broadest band originates from the fluid portion of intercellular lipids, while the sharp peaks originate from hexagonal or orthorhombic structures. The strongest peak at approximately 4.1 angstroms is due to both of these structures, and the peak at approximately 3.7 angstroms is characteristic of orthorhombic structures. The broad peak at 9.5 angstroms is generated by intermediate keratin filaments and reflects changes in unit cell size. The stronger and sharper the reflection, the more organized the lipids are. The SAXS signal provides information about intercellular stacks of lipids, such as the number of layers. The resulting X-ray diffraction model shows a series of peaks at approximately 125 angstroms, 62 angstroms, 45 angstroms, and 33 angstroms, which provide information about the quality of the lamellar stacks.

[0127] All of these peaks can be seen in Figure 1 for the control sample.

[0128] The results obtained for samples treated with composition C1 according to the present invention are shown in Figure 2 (signals obtained for the inner, inner, and outer surfaces of the sample, respectively, and for the surface composition). The WAXS signal shows two fine peaks at 4.15 angstroms and 3.76 angstroms, which are typical for lipid chains in hexagonal and orthorhombic tissues. In SAXS, the signal changes in the outer and inner surfaces of the epithelial stratum corneum, with peaks detected at 58 angstroms and 64 angstroms, respectively. These peaks are likely due to the crystallization of composition C1 within the epithelial stratum corneum in the lamellar stack. Note that the location of these additional peaks is the same as the location of the peaks characterizing the surface composition. Composition C1, upon entering the epithelial stratum corneum, appears to form a "pure" domain on the outer surface of the epithelial stratum corneum (where composition C1 is located), generating a new lamellar system. On the outer surface of the epithelial stratum corneum, additional rings were detected at 49 angstroms and 65 angstroms, which are thought to be due to the crystallization of composition C1 and its interaction with the epithelial stratum corneum. Near the inner surface of the epithelial stratum corneum, no shift of the main peak at 61.5 angstroms was observed, but a decrease in intensity was observed around 44.5 angstroms, and a weak peak shift was observed at 31.5 angstroms. Thus, composition C1 appears to partially alter the lamellar structure.

[0129] In conclusion, composition C1 according to the present invention appears to penetrate the entire thickness of the epidermal stratum corneum and form "pure" domains within it. Composition C1 interacts with the epidermal stratum corneum to generate new lamellar domains. Furthermore, composition C1 appears to alter the lamellar structure of physiological lipids near the inner surface of the epidermal stratum corneum, slightly increasing the relative amount of crystallized lipids in the orthorhombic network.

[0130] The results obtained for samples treated with composition Comp1 (containing paraffin), which is not according to the present invention, are shown in Figure 3 (signals obtained for the inner, inner, and outer surfaces of the sample, respectively, and for its surface composition). These results are similar to those obtained for composition C1. These results indicate that composition Comp1 also penetrates the entire thickness of the epithelial stratum corneum and, possibly interacting with the epithelial stratum corneum, generates domains organized as a new lamellar system different from the system observed in the control. Composition Comp1 can also alter the structure of physiological lipids by slightly increasing the size of the lamellae and the relative amount of crystallized lipids in the orthorhombic network.

[0131] The results of this experiment clearly demonstrate that the paraffin-free composition C1 can strengthen the lipid barrier by improving the organization of the lipid matrix in the epidermal stratum corneum. This effect of protecting the epidermal barrier is at least equivalent to that of the proven paraffin-containing composition Comp1.

[0132] D / Example 4 - Effects of cosmetic element organisms on the synthesis of total lipids and ceramides in a reconstructed epidermal model Quantifying ceramides provides information about the integrity or incompleteness of the skin's barrier function, enabling the evaluation of the value of skin cosmetics.

[0133] The purpose of this study is to evaluate the effects of two cosmetic compositions (composition C1 according to the present invention as described in Example 1, and composition Comp1 not according to the present invention as described in Example 3) on the synthesis of skin lipids, particularly ceramide, a major component of the epithelial stratum corneum, from a lipid perspective, and to evaluate the nutritional effects for the treatment and improvement of barrier function.

[0134] The efficacy of the cosmetic compositions was evaluated in three batches of reconstructed epidermis, with n=3 (triple) evaluation for each experimental condition and for each batch.

[0135] The model used in this study is a reconstructed epidermal model derived from a skin excision site obtained by cosmetic surgery, as described by Frankart et al. (Frankart et al., Exp. Dermatol. 2012, 21(11), 871-875).

[0136] Cells (keratinocytes) were isolated from the skin excision site and cultured. They were then seeded onto culture inserts by immersion in culture medium (standard medium supplemented with ThermoFisher's commercially available EpiLife® Defined Growth Supplement). The culture inserts were then placed at the air / liquid interface in a 37°C incubator under a 5% CO2 humidified atmosphere to form the epithelial stratum corneum. The culture medium was replaced every 24 hours. After 14 days, the area reached 0.6 cm². 2 The reconstructed epidermis was reformed.

[0137] Three reconstructed epidermis were used for each condition. The conditions tested were as follows: - Negative control: 0.01% Tween® 20 in pH 7.4 phosphate buffer (PBS); - 1% composition C1 in 0.01% Tween® 20 in pH 7.4 phosphate buffer (PBS); - 1% of Composition Comp1 in 0.01% of Tween® 20 in phosphate buffer (PBS) of H7.4; - Positive control: Commercially available Dexeryl® cream based on glycerol, petrolatum, and paraffin (composition: glycerol, petrolatum, liquid paraffin, glyceryl monostearate, stearic acid, dimethicone, macrogol 600, trolamine, acrylamide / acryloyl-dimethyl taurate copolymer, isohexadecane, polysorbate, pentylene glycol, ethylhexylglycerin, carbomer, purified water).

[0138] On day 9 of the protocol, 2 mg of the composition under study was topically applied to the reconstructed epidermis, which was the first application to the reconstructed skin. A 24-hour incubation period was followed. A second application (under the same conditions) was performed on day 10, followed by a 48-hour incubation period. A third application (under the same conditions) was performed on day 13, followed by a 24-hour incubation period. Finally, a fourth application (under the same conditions) was performed on day 14 (to the fully reconstructed epidermis), followed by a 24-hour incubation period.

[0139] On day 15, the reconstructed skin was removed from the culture insert, and the epithelial stratum corneum was isolated from the remaining epidermis using trypsin. Subsequently, the epithelial stratum corneum was extracted using an organic solvent (a mixture of chloroform and methanol), and the lipids constituting it were recovered. These lipids were then concentrated under liquid nitrogen and analyzed.

[0140] Ceramides, free fatty acids, and cholesterol in the epithelial stratum corneum were analyzed using high-performance thin-layer chromatography (HPTLC), a rapid technique widely used for the separation of complex mixtures such as lipids (Fuchs et al., J. Chromatography A 2011, 1218(19), 2754-2774). The method used is described in Jamin et al.'s publication Eur J Mass Spectrum, 2019, 25(3), 278-290. Details of the analytical conditions are as follows: -Plate: Lichrospher(registered trademark) HPTL silica gel 60 F254S; - Spot application: 6mm width, dried under a nitrogen stream; - Expansion: Gradient: See Table 7; -Post-derivatization: aqueous copper sulfate solution (10%CuSO4, 8%H3PO4, 5%MeOH); -Detection: λ scanner: 450nm.

[0141] [Table 7] Table 7 - Gradient applied to HPTL analysis

[0142] The results indicate that the positive control (Dexeryl® cream) induces lipid synthesis as expected, which is associated with increases in free fatty acids, cholesterol derivatives, and ceramides. These results confirm the validity of the experimental conditions.

[0143] Compositions C1 and Comp1 do not affect free fatty acid synthesis, but they induce a significant increase in total cholesterol.

[0144] Table 8 shows the detailed effects of the composition on the synthesis of total ceramides:

[0145] [Table 8] Table 8 - Effect of tested compositions on total ceramide synthesis in reconstructed epidermis - NS = No significant difference

[0146] As can be confirmed, only composition C1 according to the present invention significantly increases the synthesis of total ceramide.

[0147] These results lead to the conclusion that this paraffin-free composition has an important protective effect on the skin. In fact, ceramides are present as major lipids in the epidermal stratum corneum and play an important role in barrier function, consequently limiting dehydration and moisture retention in particular.

[0148] The effects of composition C1 on various specific subclasses of ceramides (Cer 5 AS and OH, Cer 9 EOP, Cer 10 NdS and 2NS, Cer 1 EOS) were studied in more detail. Table 9 below shows the percentage of induction of these ceramides by application of composition C1 compared to the negative control.

[0149] [Table 9] Table 9 - Percentage-t-test values ​​for the induction of ceramide production by composition C1 according to the present invention compared to the control, NS = no significant difference.

[0150] Thus, composition C1 induces statistically significant synthesis of all ceramides in this reconstructed epidermal model compared to untreated reconstructed epidermis (negative control).

[0151] Interestingly, it is noteworthy that the synthesis of Cer 5 AS and OH ceramides, which are known to decrease in amount in eczematous and atopic dermatitis skin, increases by more than 50%. Furthermore, the amount of ceramides involved in the lamellar organization of epidermal stratum corneum lipids, i.e., very long-chain esterified ceramides such as Cer 9 EOP ceramide, increases significantly by more than 180%. The amount of non-esterified ceramides, such as Cer 10 NS and 2NS ceramides, which are one of the major ceramides in the epidermal stratum corneum, also increases.

[0152] The application of a paraffin-free composition increases the level of total ceramides, particularly ceramides that play a major role in barrier function, such as NS and EOP ceramides, which is highly desirable for strengthening the epidermal barrier function.

[0153] E / Example 5 - Evaluation of the effects of two cosmetic biological elements on skin barrier repair The purpose of this study is to demonstrate the restorative or protective effects of two cosmetic compositions on a model of pig ear skin after stressing with sodium dodecyl sulfate (SDS): composition C1 according to the present invention and composition Comp1 not according to the present invention, as described above.

[0154] In summary, this experiment involved applying 2 hours of SDS stress (10%) to skin explants. This was intended to damage the outermost layer. After rinsing, the composition was applied at a concentration of 5 mg / cm³. 2The solution is then applied topically. Subsequently, the explants are incubated in fresh culture medium supplemented with the supplement at 37°C for 16 hours. After incubation with Lucifer Yellow (Sigma, reference no. L0144), the potential regenerative effect is observed and quantified.

[0155] More specifically, this study uses two pig ears. After scraping the skin to a thickness of 450 μm ± 50 μm, eight 10 mm samples are formed using a die. These samples are then placed in an insert containing 1.1 ml of fresh survival medium (DMEM) and incubated at 37°C for 1 hour. The medium is then replaced with 1.1 ml of fresh survival medium.

[0156] Place an 8mm diameter nylon net, then add 8μl of 10% SDS to the net and incubate the explant at 37°C for 2 hours. Afterwards, remove the net with small forceps and rinse the explant three times consecutively in a PBS (phosphate-buffered saline) bath for 10 seconds each time. Remove excess culture medium by pressing the explant slice onto sterile compression gauze with a sponge. Then replace the viability medium. Before applying the composition, dry the surface of the explant with a cotton swab.

[0157] Each of the two compositions was measured using a cotton swab wrapped in a finger cot, with a dose of 5 mg / cm³ applied to the explant. 2 The solution is then applied topically. The explants are then incubated in fresh medium supplemented with the supplement (MEM + gentamicin, 50 mg / ml, penicillin / streptomycin 5,000 U) at 37°C for 16 hours.

[0158] Next, a Lucifer Yellow (LY) permeability test is performed to quantify the thickness of the damaged explant. A 1 mM solution of Lucifer Yellow is prepared in PBS. 8 μl of this solution is dropped onto a new 8 mm net, and the explant is incubated at 37°C for 2 hours. The net is then carefully removed to prepare a 6 mm biopsy.

[0159] Next, the biopsy sample is placed in an Eppendorf test tube containing 1.8 ml of PFA (paraformaldehyde) prepared to a concentration of 4% in PBS, and incubated at room temperature for 1 hour. Subsequently, the biopsy sample is rinsed twice consecutively in a PBS bath and dried on a slice.

[0160] The biopsy sample is inserted into a mold filled with an optimal cutting temperature (OCT) compound, frozen by immersion in isopentane cooled to -80°C using SnapFrost®, and stored at -80°C.

[0161] 8 μm frozen sections were prepared and observed directly under a fluorescence microscope. For each image, the penetration of LY into the epithelial stratum corneum was analyzed by measuring the average fluorescence intensity relative to the average surface area of ​​the epithelial stratum corneum using Octopus software with the Histo-Fluo module.

[0162] The results obtained for each tested condition (untreated control, explants treated with SDS, explants treated with SDS and composition C1, and explants treated with SDS and composition Comp1) are shown in Table 10.

[0163] [Table 10] Table 10 - Average fluorescence intensity relative to the average surface area of ​​the epithelial stratum corneum

[0164] As expected, SDS was observed to cause significant damage to the skin explants. Since the values ​​were at the same level as the undamaged control group, the epidermis could be effectively repaired by applying composition C1 or Comp1.

[0165] Therefore, composition C1 according to the present invention has a barrier function restoration effect at least equivalent to that of the conventional composition Comp1 containing paraffin.

[0166] F / Example 6 - Functional Profiles of Compositions C1 and Comp1 The monadic evaluation of the sensory profiles of composition C1 and comparative composition Comp1 according to the present invention, as described above, will be performed by 15 panelists trained in sensory evaluation methods for topical products. For this purpose, 0.1 ml of each composition under test will be applied to both cheeks.

[0167] The following three evaluation stages will be assessed: -During application, - 5 minutes after application, - 15 minutes after application.

[0168] During the test, the room temperature and humidity will be checked, and the lighting will be controlled.

[0169] The results obtained are shown in Figure 4. It is observed that composition C1 of the present invention is associated with an extremely good sensory profile similar to that of paraffin-containing composition Comp1. There is almost no significant difference between these two sensory characteristics. Furthermore, the composition according to the present invention provides a relatively good sheen to the skin 5 minutes after application, and the oily appearance is reduced after 15 minutes after application. Interestingly, it is noteworthy that the composition according to the present invention also provides a supple feel 5 minutes after application and has good spreadability during application.

[0170] Thus, the paraffin-free composition according to the present invention has a functional profile that is completely equivalent to that of a composition containing paraffin, and furthermore, it has several more preferable indicators.

Claims

1. - An aqueous phase containing at least one emollient selected from glycerin and its derivatives and glycols and their derivatives, - An oil phase containing an oily emollient system comprising safflower oil and a second oily emollient agent, and A dermatological or cosmetic skin composition in the form of an emulsion containing: The composition contains at least 50% by weight of water relative to the total weight of the composition, and is a dermatological or cosmetic composition for skin use. The composition, in weight ratio to the total weight of the composition: -10 to 20% of the total amount of one or more emollients contained in the aqueous phase, -10 to 25% of the oily emollient agent system, wherein 8 to 18% is safflower oil, and the safflower oil accounts for more than 70% by weight of the oily emollient agent system. It contains, The composition does not contain paraffin. A dermatological or cosmetic skin composition characterized by the following features.

2. The composition according to claim 1, comprising at least one consistency factor.

3. The composition according to claim 1 or 2, in the form of an oil-in-water emulsion.

4. A composition according to any one of claims 1 to 3, comprising an emulsifier.

5. The composition according to any one of claims 1 to 4, wherein the emollient agent selected from glycerin and its derivatives and glycols and their derivatives is glycerin.

6. The composition according to any one of claims 1 to 5, wherein the second oily emollient is selected from triglycerides.

7. A composition according to any one of claims 1 to 6, comprising less than six types of oily emollients.

8. A composition according to any one of claims 1 to 7, in a form suitable for topical application.

9. A composition according to any one of claims 1 to 8, comprising a skin cosmetic active ingredient.

10. The composition according to claim 9, wherein the active ingredient in the skin cosmetic is a bacterial extract obtained from one of the nonpathogenic bacteria of the Neisseriaceae family or their variants deposited with CNCM under the number CNCM I-4290, and / or from a suspension of one of the said bacteria or its variants.

11. A composition according to any one of claims 1 to 10, for use in the treatment of inflammatory skin diseases.

12. The composition for use according to claim 11, wherein the inflammatory skin disease is atopic dermatitis, pruritus, eczema, psoriasis, or rosacea.

13. A composition for use according to claim 11 or 12, for preventing and / or strengthening the reduction of the epidermal barrier function.

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