Composition for the treatment of inflammatory skin disorders

A safflower oil-based emulsion composition addresses the challenge of treating inflammatory skin disorders by enhancing skin barrier function and sensoriality without using harmful paraffins, offering improved ceramide synthesis and hydration for effective skin protection.

WO2025008278A1PCT designated stage expired Publication Date: 2025-01-09PIERRE FABRE DERMO COSMETIQUE SA
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Patent Information

Application Number
PCT/EP2024/068285
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-07-06
Filing Date
2024-06-28
Publication Date
2025-01-09

AI Technical Summary

Technical Problem

Current dermatological and dermo-cosmetic compositions for treating inflammatory skin disorders, such as atopic dermatitis, often contain harmful ingredients like paraffin that can irritate the skin and compromise its barrier function, while alternatives lacking these ingredients may not provide adequate sensoriality or effectiveness.

Method used

A dermatological composition in the form of an oil-in-water emulsion rich in safflower oil, glycerin, and other emollients, specifically designed to strengthen the skin's barrier function by enhancing the lipid matrix and stimulating ceramide synthesis, without using paraffin or petroleum jelly.

Benefits of technology

The composition effectively improves and maintains the skin's barrier function, providing sensoriality comparable to paraffin-based products while being safer and more effective in treating inflammatory skin disorders, particularly atopic dermatitis, by increasing ceramide levels and maintaining skin hydration.

✦ Generated by Eureka AI based on patent content.

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Abstract

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

[0001] COMPOSITION FOR THE TREATMENT OF INFLAMMATORY SKIN DISORDERS

[0002] The present invention falls within the field of dermatological or dermo-cosmetic compositions for the treatment of sensitive skin, in particular skin with inflammatory disorders, such as atopic or atopic-prone skin.

[0003] More particularly, the present invention relates to a dermatological or dermo-cosmetic composition in the form of an emulsion, in particular of the oil-in-water type, particularly suitable for such treatment, as well as its use for the treatment of the skin, in particular of an inflammatory skin disorder.

[0004] For more than half a century, the use of skin and hair care products has gradually become a daily routine, due to the pleasant sensation they provide, the immediate comfort they provide, the ease of use and the improvement in the quality of the skin and hair. Thus, a large number of products, particularly emulsions, have been developed, which appear in the form of different textures and galenics. Developments in chemistry have made it possible to provide new raw materials, more or less natural, to enhance the cosmetic appeal and improve the protection of these products through preservation.

[0005] Cosmetic emulsions are composed of two phases: an aqueous phase composed of water and aqueous extracts, among other things, and an oily phase composed of oils, waxes, butters and fatty alcohol, among other things. The two phases are emulsified using surfactants or emulsifying agents. Then, active ingredients, solvents, humectants, texturizing agents, emollients, gelling agents, antioxidants, sequestering agents, fillers, preservatives, perfumes, colorants, pigments, sunscreens, etc. are added. All these ingredients are essential for the sensory experience, that is to say, the pleasure and perception, the color, the smell of the product, the stability of the whole, its protection over time, and its immediate and longer-term cosmetic effectiveness.However, it has recently been shown that some of these ingredients are not useful for the skin, or even that they can be harmful to it, sometimes causing irritation, allergies, or even being endocrine disruptors. The skin and scalp are living and permeable membranes. There is therefore a risk that certain molecules penetrate them, alter them and even pass into the subcutaneous blood network. Regulations, especially in Europe, have recently aimed to prohibit or reduce the use of certain of them, whose associated risks are proven or suspected. Furthermore, in recent years, consumers have become increasingly vigilant about the composition of the products they buy. A growing number of ingredients are the subject of sometimes controversial questions, encouraged by the media, whether conventional or not.Thus, petrochemical ingredients, such as paraffin or petroleum jelly, are considered harmful to the environment. However, they are still widely used in cosmetics, as they help produce a protective layer for the skin. They also add thickness and texture to the compositions in which they are incorporated, and give them good sensory properties.

[0006] The extracts from the GNPD database, Mintel No. 9882210 and Mintel No. 8424973, and the document WO 2016 / 051086 describe cosmetic compositions for skin care, in emulsion form, devoid of paraffin. These compositions contain an aqueous phase comprising at least one aqueous emollient, and an oily emollient system containing safflower oil in an amount less than or equal to 50% by weight relative to the total weight of this system. None of these compositions is indicated for the treatment of inflammatory skin disorders.

[0007] In general, the present invention aims to provide a dermatological or dermo-cosmetic composition in the form of an emulsion which is respectful of the skin, and in particular does not contain controversial substances, such as paraffin, while having sensorial properties at least as good as those of the compositions of the prior art containing such substances, and whose cost price is not higher. More specifically, the invention aims to provide such a composition capable of providing benefits to sensitive skin, such as atopic or atopic-prone skin, and in particular capable of effectively treating inflammatory skin disorders.

[0008] The skin is a protective envelope that covers the entire body. It is covered with a protective hydrolipidic film, made from a mixture of secretions such as sweat and sebum. The skin plays an essential protective role, and it also acts as a communication interface between the body and its surrounding environment, thanks to the numerous tactile, thermal, and nociceptor receptors it contains. The skin is composed of three layers: the epidermis, the dermis, and the hypodermis (going from the outside to the inside of the body).

[0009] The epidermis in particular is formed of a stratified, squamous, keratinized epithelium. It is mainly composed of keratinocytes, which proliferate and differentiate continuously. There are 4 different layers in the epidermis, depending on the stage of differentiation of the keratinocytes that compose them: the basal layer (at the junction with the dermis), the spinous layer, the granular layer and the cornea, also called stratum corneum, which is the layer in contact with the external environment. At the level of this layer, the corneocytes, welded by a lipid matrix, form a protective barrier, reinforced by the hydrolipidic film.

[0010] Dermatological diseases such as atopic dermatitis, pruritus, eczema, psoriasis, and rosacea are becoming increasingly common, particularly in young children. Atopic dermatitis, in particular, is the cutaneous manifestation of atopy. It is a chronic inflammatory dermatosis, occurring on a genetically determined basis. It is now considered a major public health concern, as the quality of life of patients affected by it is profoundly disrupted. This condition most often appears during early childhood and is characterized by repeated eruptions over several years, evolving in flare-ups interspersed with spontaneous remissions. In atopic dermatitis, the skin's barrier function is weakened and impaired, which promotes the invasion and colonization of pathogens such as bacteria or viruses, particularly Staphylococcus aureus.The latter is known to take over commensal bacteria on the skin.

[0011] In the context of such dermatological diseases, it is important to preserve, and even improve, the skin's barrier function, especially for the most sensitive skin, even atopic or atopic-prone skin. Atopic-prone skin is an extremely fragile skin type. It is characterized by an alteration of the epidermal barrier, which leads to dry skin that is more vulnerable to external aggressions and a predisposition to allergies that make it particularly sensitive to allergens.

[0012] Surprisingly, the present inventors have discovered that dermatological or dermo-cosmetic compositions in the form of an emulsion of particular constitution, rich in oily emollients, and in particular rich in safflower oil, and devoid of paraffin (INCI name: paraffinum liquidum), meet the objectives set by the present invention, and are particularly suitable for application to sensitive skin, and even atopic skin, in particular by their action of preventing the reduction of the epidermal barrier function, and / or of strengthening this barrier function.

[0013] Thus, according to a first aspect, the present invention provides a dermatological or dermo-cosmetic composition intended in particular for the treatment of an inflammatory skin disorder or inflammatory dermatosis, by topical application, on any type of skin and particularly on sensitive skin, and even atopic skin. This composition is in the form of an emulsion comprising:

[0014] - an aqueous phase containing at least one emollient chosen from polyols, more specifically chosen from glycerin and its derivatives and glycols and their derivatives,

[0015] - and an oily phase containing an oily emollient system comprising safflower oil and a second oily emollient, this composition containing, by weight relative to the total weight of the composition:

[0016] - at least 50% by weight of water,

[0017] - 10 to 20% in total of emollient(s) contained in the aqueous phase,

[0018] - 10 to 25% of said oily emollient system, including 8 to 18% of safflower oil, the safflower oil representing more than 70% by weight of said oily emollient system,

[0019] This composition is furthermore free of paraffin, and preferably also free of petroleum jelly.

[0020] In the present description, the term "including 8 to 18% safflower oil" means that the composition contains 8 to 18% by weight of safflower oil, relative to the total weight of the composition. The concentration of the entire oily emollient system in the composition being between 10 and 25% by weight, it follows that the components of this oily emollient system other than safflower oil together represent at most approximately 7% by weight of the composition, their total concentration being variable depending on the safflower oil content, in the oily emollient system on the one hand, and in the composition on the other hand.

[0021] As indicated above, the composition according to the invention, although devoid of paraffin, advantageously has a sensoriality at least as good as that of paraffin-based compositions, and an effectiveness that is also as good, or even better, in nourishing and repairing the skin. It is particularly effective in improving the barrier function of the skin. It has in particular been noted by the present inventors that the composition according to the invention respects, and even increases, the organization of the lipid matrix of the stratum corneum, and that it stimulates the synthesis of endogenous ceramides within the latter.

[0022] Despite representing only 10% of the total mass of the stratum corneum, intercellular lipids play a major role in the skin's barrier function. For example, the removal of lipids results in water loss by diffusion. The barrier function results from the complex and specific architecture of the inter-corneocyte lipid matrix composed of a mixture of ceramides, cholesterol, and long-chain fatty acids. Studies of the ultrastructure of the epidermis using electron microscopy and diffraction techniques have revealed that these lipids are organized in stacked bilayers that are predominantly parallel to the skin surface. A portion of these lipids is covalently bound to the corneocytes, while another portion represents free lipids.The increase in the organization of the lipid matrix of the stratum corneum, as induced by the topical application of the composition according to the invention, thus makes it possible to strengthen the cutaneous lipid barrier.

[0023] Furthermore, approximately half of intercorneocyte lipids are made up of ceramides. Ceramides constitute a lipid family of great biological importance because they enable the cohesion of the stratum corneum and, consequently, the formation of the skin barrier.

[0024] A wide variety of ceramides are included in the lipid composition of the stratum corneum. Biochemically, they are sphingolipids resulting from the amidation of sphingosine with a fatty acid. They can be free or covalently bound to proteins in the stratum corneum. Currently, 14 classes of ceramides have been identified and are named according to their chemical structure: ceramides can have a sphingosine (S), dihydrosphingosine (dS), phytosphingosine (P), or 6-hydroxysphingosine (H) base, to which is attached an œ-hydroxy (EO or O), α-hydroxy (A), or non-hydroxy (N) fatty acid with an alkyl chain of varying length.

[0025] Ceramides play a key role in the organization of lamellar bilayers, particularly ultra-long chain esterified ceramides such as EOS, EOP, and EOH ceramides (Bouwstra et al., Biochim Biophys Acta 1996, 1300(3), 177-186). The importance of esterified ceramides, due to their very long carbon chains, has been demonstrated in the lamellar repeat distance and chain ordering (Kessner et al., Chem Phys Lipids, 2010, 163(1), 42-50). In addition, the polar head groups carried by ceramides, particularly CER EOS and CER EOP, exert a considerable influence on the structural properties required for a functional lipid matrix.

[0026] Non-esterified ceramides are predominant and are also important for the barrier function, but also for the hydration and nutrition of the skin. Studies have shown that, during winter, states of skin dryness have been correlated with a decrease in total ceramide levels and more particularly with the levels of NP and NH ceramides (Ishikawa et al., J. Cosmet Dermatol 2013, 12(1 ), 3-1 1 ). In patients with atopic dermatitis, a significant decrease in total ceramide levels and more particularly with the levels of NP, NS and NH ceramides has also been reported, and an inverse correlation with the measurement of transepidermal water loss indicating an alteration of the barrier function (Ishikawa et al., J Invest Dermatol, 2010, 130(10), 251 1 -2514).

[0027] The reduction of ultra-long chain esterified ceramides as well as the shortening of the chain lengths of free fatty acids and ceramides in general leads to a change in the lipid organization towards a less dense state (Kessner et al., Skin Pharmacol Physiol 2008, 21 (2), 58-74). This creates spaces in the lipid arrangement between corneocytes leading to a reduction in the skin barrier function and increased skin permeability. Thus, an increase in these specific lipids induces a strengthening of the skin barrier function. The composition according to the invention advantageously induces such an increase, acting on all ceramides, and in particular on ultra-long chain esterified ceramides.

[0028] The composition according to the invention may also meet one or more of the characteristics described below, implemented in isolation or in each of their technically effective combinations.

[0029] The composition according to the invention comprises at least 50% by weight, preferably at least 55% by weight, and preferentially at least 60% by weight, of water relative to the total weight of the composition.

[0030] In particular embodiments of the invention, the composition comprises 50 to 70% by weight, preferably 55 to 70% by weight, and preferentially 60 to 70% by weight, of water relative to the total weight of the composition.

[0031] The composition according to the invention is in the form of an emulsion, containing an aqueous phase and an oily phase, one of these phases, called the dispersed phase, being dispersed homogeneously in the other of these phases, called the continuous phase, in the form of fine droplets. This emulsion may be of the water-in-oil type. Preferably, the composition according to the invention is in the form of an emulsion of the oil-in-water type, that is to say in which the oily phase is kept homogeneously dispersed in the aqueous phase. The composition according to the invention preferably comprises at least one consistency factor, which may be contained in the aqueous phase and / or in the oily phase, and preferably contained in the oily phase.

[0032] This or these consistency factors are preferably chosen from fatty alcohols, fatty acids, hydrogenated vegetable oils and other waxy bodies.

[0033] The composition according to the invention may in particular contain, as consistency factor(s):

[0034] - at least one fatty alcohol, preferably C16-C22, such as cetyl alcohol, stearyl alcohol, arachidyl alcohol and / or behenyl alcohol;

[0035] - and / or at least one fatty acid, preferably C16-C18, such as lauric acid, palmitic acid, stearic acid;

[0036] - and / or at least one hydrogenated vegetable oil, in particular hydrogenated castor oil;

[0037] - and / or at least one other waxy body, having a melting point greater than or equal to 45°C, preferably strictly greater than 45°C, such as glycol palmitate, vegetable waxes (such as carnauba wax, sunflower wax, jojoba wax), beeswax or the mixture of tribehenin / glyceryl dibehenate / glyceryl behenate (substances with the INCI name Tribehenin / Glyceryl Dibehenate / Glyceryl behenate) which can be found, among others, in the commercial material COMPRITOL® 888.

[0038] Preferably, the composition according to the invention contains only one consistency factor.

[0039] The total content of consistency factor(s) in the composition is preferably less than or equal to 5% by weight, for example less than or equal to 4% by weight, in particular less than or equal to 3% by weight, relative to the total weight of the composition.

[0040] In particular embodiments of the invention, the consistency factor(s) are present in a total content of between 0.1 and 5% by weight, in particular between 0.5 and 4% by weight, for example between 1 and 4% by weight, or between 1 and 3% by weight, relative to the total weight of the composition. In particular embodiments of the invention, the composition is free of foaming surfactant.

[0041] In particular embodiments of the invention, it is also devoid of emulsifying agent. It then necessarily contains at least one consistency factor, in a concentration sufficient to ensure the composition has its emulsion form.

[0042] In alternative embodiments of the invention, the composition comprises at least one emulsifying agent, in particular chosen from emulsifying agents capable of forming oil-in-water emulsions.The emulsifying agent(s) may, for example, be chosen from ethoxylated fatty alcohols, the 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, in particular the product marketed under the name Eumulgin® VL75, lecithins, in particular hydrogenated soy lecithin, glycerol monostearate, sorbitan monostearate, sodium dilauramidoglutamide lysine, sodium stearoyl glutamate, in particular the product marketed under the name Eumulgin® SG, sodium stearoyl, sucrose stearate, etc.

[0043] In particular embodiments of the invention, the emulsifying agent(s) comprise at least the cetearyl alcohol / cetearyl glucoside mixture, available among others under the trade name MONTANOV® 68.

[0044] The composition according to the invention may, for example, contain, as emulsifying agents, a mixture of cetearyl alcohol / cetearyl glucoside, glycerol monostearate and sodium stearoyl glutamate.

[0045] In particular embodiments of the invention, the emulsifying agent(s) are present in a total content of 2 to 11% by weight, preferably 2 to 8% by weight, preferentially 2 to 7% by weight, more preferably 2 to 6% by weight, in particular 2 to 5% by weight, for example 3 to 5% by weight, relative to the total weight of the composition. Such a content advantageously makes it possible to obtain good stability of the emulsion and good sensoriality, without soaping too much, thus avoiding whitening of the skin when applying the composition.

[0046] Preferably, the composition according to the invention does not contain more than four, preferably not more than three, and for example not more than two, emulsifying agents. In other particular embodiments, the composition according to the invention comprises a single emulsifying agent.

[0047] In the present description, the term emollient is understood to mean, in a conventional manner in itself, a compound with hydrating and softening properties for the epidermis, applied topically.

[0048] The composition according to the invention comprises, in its aqueous phase, one or more emollients, at least one of which is chosen from polyols, more precisely from glycerin and its derivatives and glycols and their derivatives. This or these emollients present in the aqueous phase, which are by nature soluble or miscible in water, will be designated in the present description, for convenience, by the expression "aqueous emollient".

[0049] According to the present invention, the term "polyol" (otherwise known as polyalcohol) means a compound comprising a hydrocarbon chain with at least two carbon atoms and comprising at least two hydroxyl groups. The polyol(s) used according to the invention are preferably diols or triols.

[0050] The polyol(s) chosen from glycerin and its derivatives and glycols and their derivatives, with emollient properties, used according to the invention may be natural or synthetic. They may have a linear, branched or cyclic molecular structure.

[0051] The polyol(s) used according to the invention may in particular be chosen 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, polyethylene glycols, in particular having from 5 to 50 ethylene oxide groups. Additionally or alternatively, the composition according to the invention may contain, as aqueous emollient, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, liditol, inositol, volemitol, isomalt, maltitol, lactitol, maltotriitol, maltotetrol, polyglycitol, and mixtures thereof.

[0052] Preferably, an aqueous emollient chosen from polyols is glycerin. The composition according to the invention contains, by weight relative to the total weight of the composition, 10 to 20% in total of emollient(s) of the aqueous phase. It contains in particular, in total, from 10 to 15% by weight, for example from 12 to 15% by weight, relative to the total weight of the composition, of emollient(s) of the aqueous phase.

[0053] The composition according to the invention comprises an oily emollient system, comprising, as oily emollients, at least safflower oil (Carthamus tinctorius), in a content of at least 70% by weight, preferably between 70 and 99% by weight, for example between 70 and 95% by weight, relative to the weight of the oily emollient system, as well as at least one second oily emollient. Such a high content of safflower oil (in particular Carthamus tinctorius seed oil) in the oily emollient system ensures in particular advantageously, and surprisingly, good sensoriality of the composition, in particular in terms of speed of skin penetration, a sensoriality which is not exhibited by compositions comprising similar ingredients but in which the safflower oil represents less than 70% by weight relative to the total weight of the oily emollient system.Its high effectiveness on the barrier function of the skin is attributable to the combination of all the characteristics of the composition, that is to say the combination of the polyol chosen from glycerin and its derivatives and glycols and their derivatives, safflower oil and the second oily emollient, and their respective contents in the composition. The composition according to the invention comprises from 8 to 18% by weight, preferably from 8 to 15% by weight, for example from 9 to 14% by weight, of safflower oil, relative to the total weight of the composition.

[0054] The second oily emollient, as well as other emollients other than safflower oil that may be contained in the oily phase, may be chosen from:

[0055] - triglycerides. Triglycerides are composed of three fatty acids linked by ester bond to a glycerol molecule. The triglycerides suitable for the invention may be chosen in particular from the group comprising triglycerides esterified by C8-C18 fatty acids, in particular by C10-C18 fatty acids, more particularly still the triglycerides of caprylic / capric acids;

[0056] - non-hydrogenated vegetable oils, such as sunflower, corn, olive, sweet almond, coconut, palm, soybean, pumpkin, grape seed, sesame, hazelnut, apricot, macadamia, avocado, jojoba, borage, rapeseed, wheat germ, evening primrose, argan, calendula and cotton oils;

[0057] - solid fatty substances having a melting point less than or equal to 45°C, preferably strictly less than 45°C, such as butters, for example shea butter;

[0058] - synthetic esters and ethers, in particular of fatty acids, such as oils of formulas R1COOR2 and R1OR2, in which Ri represents the residue of a fatty acid containing from 8 to 29 carbon atoms, and R2 represents a hydrocarbon chain, branched or not, containing from 3 to 30 carbon atoms, such as for example Purcellin oil, isononyl isononanoate, isopropyl myristate, ethylhexyl palmitate, octyl-2-dodecyl stearate, octyl-2-dodecyl erucate, isostearyl isostearate;hydroxylated esters such as isostearyl lactate, octylhydroxystearate, octyldodecyl hydroxystearate, diisostearylmalate, triisocetyl citrate, fatty alcohol heptanoates, octanoates or decanoates, polyol esters, such as propylene glycol dioctanoate, neopentyl glycol diheptanoate and diethylene glycol diisononanoate, and pentaerythritol esters such as pentaerythrityl tetraisostearate or dipentaerythrityl pentaisononanoate;

[0059] - and their mixtures.

[0060] For the purposes of the present invention, the second oily emollient, like all the oily emollients other than safflower oil contained in the oily emollient system, is not a wax, the wax being characterized by a melting point greater than or equal to 45°C and generally greater than 45°C. The oily emollient system is present in the composition in a content of 10 to 25% by weight, in particular 10 to 20% by weight, and for example 10 to 18% by weight, relative to the total weight of the composition.

[0061] Preferably, the composition according to the invention, and more particularly its oily emollient system, contains less than 6 oily emollients, including safflower oil. It preferably contains less than 5 oily emollients, more preferably less than 4 oily emollients and preferentially less than 3 oily emollients.

[0062] Thus, in particular embodiments of the invention, the composition contains exactly 5 oily emollients, or 4 oily emollients, or 3 oily emollients, or 2 oily emollients, safflower oil being included in these numbers. A lower number of oily emollients is associated with a lower risk of skin irritation by the composition according to the invention.

[0063] Preferably, the composition according to the invention comprises from 0.5 to 7% by weight, more preferably from 0.5 to 5% by weight, and even more preferably from 1 to 4% by weight, in total, of oily emollient(s) other than safflower oil, relative to the total weight of the composition. It may for example contain from 0.5 to 5% by weight, preferably from 1 to 4% by weight, relative to the total weight of the composition, of triglycerides, such as caprylic / capric triglycerides, or ethyl hexyl palmitate, or from 2 to 7% by weight, relative to the total weight of the composition, of a mixture of triglycerides, such as caprylic / capric triglycerides, and shea butter.

[0064] The composition according to the invention may further contain any additive conventional in itself for a dermatological or dermo-cosmetic composition, and, like all the other ingredients of the composition according to the invention, dermatologically and / or dermo-cosmetically acceptable. This means, in a manner conventional in itself, that these ingredients are suitable for use by contacting with human and animal skin cells, and that they do not generate unacceptable discomfort likely to deter a user from the composition.

[0065] The composition according to the invention may in particular contain one or more gelling and / or thickening agents, for example chosen from the group consisting of alginates, carrageenans, cellulose and its derivatives, starch, xanthan gum, scleroglucan gum, succinoglucan gum, gellan gum, diutan gum, acacia gum, Caesalpinia spinosa gum, locust bean gum, Tamarindus indica seed gum, acrylates, and mixtures thereof. The gelling and / or thickening agent(s), for example xanthan gum, may for example be contained in the composition in a content of between 0.1 and 1% by weight relative to the total weight of the composition. The composition according to the invention is preferably free of silicone.For the purposes of the present invention, silicone, or polysiloxane, conventionally in itself, means any organosilicon polymer or oligomer with a linear and / or cyclic, branched and / or crosslinked structure, obtained by polymerization and / or polycondensation of functionalized silanes, and consisting essentially of a repetition of main units in which the silicon atoms are linked together by oxygen atoms, hydrocarbon radicals, optionally substituted, in particular by hydroxyl groups, being directly linked by a carbon atom to these silicon atoms.

[0066] The cosmetic composition according to the invention is also preferably free of phenoxyethanol, suspected of being an endocrine disruptor.

[0067] Preferably, the composition according to the invention is free of alpha hydroxy acids or AHAs (Alpha Hydroxy Acids). These are carboxylic acids, derived mainly from fruit sugars. The main fruit acids are lactic, malic, glycolic, citric and tartaric acids. AHAs promote skin exfoliation, so these ingredients should be avoided in compositions intended to be applied to atopic or atopic-prone skin. Atopic-prone skin is indeed an extremely fragile skin type. It is characterized by an alteration of the epidermal barrier, which leads to dry skin that is more vulnerable to external aggressions and a predisposition to allergies that make it particularly sensitive to allergenic agents. Atopic skin is what is more precisely called atopic dermatitis.Preferably, all substances having exfoliating properties, such as retinoids, are also avoided in the composition according to the invention. The composition according to the invention may contain one or more preservatives, or be free of them.

[0068] In preferred embodiments of the invention, the composition is free of preservatives. The polyol(s) that constitute it are then chosen in particular from polyols that have no preservative effect. In such embodiments, the composition according to the invention is preferably sterile, in particular according to standard EN 556 and the European Pharmacopoeia, with a level of sterility as obtained for a sterilizing value FO = 22 minutes. A method for sterilizing emulsions, making it possible to obtain such a level of sterility without destabilizing them, is described in particular in document WO 2013 / 007755.

[0069] The composition according to the invention may, for example, be free of the following ingredients: benzoic acid, 2-hydroxybenzoic acid, sorbic acid, benzyl alcohol, ethyl alcohol, phenylethyl alcohol, sodium benzoate, cetrimonium bromide, ethyl lauroyl arginate hydrochloride, chlobutol, chlorphenesin, benzalkonium chloride, diazolidinyl urea, chlorhexidine digluconate, ethyl hydroxybenzoate, glyceryl caprylate, glycerol monocaprylate, imidazolidinyl urea, iodopropynyl butylcarbamate, methylisothiazolinone, methylparaben, octoxyglycerin, ortho phenyl phenol, butyl parahydroxybenzoate, methyl parahydroxybenzoate, sodium methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, phenoxyethanol, phenoxyethanol paraben, piroctonolamine, potassium sorbate, sodium propionate, propyl paraben, zinc pyrithione,salicylic acid, sodium dehydroacetate, potassium sorbate, sorbic acid, trichlorohydroxy diphenyl ether.,

[0070] The composition according to the invention may otherwise contain at least one preservative, chosen from conventional preservatives in themselves in the field of dermatology or dermo-cosmetics, for example from the preservatives listed above. In particular embodiments of the invention, the composition is free of essential oil. Indeed, most essential oils contain allergens, sources of irritation and skin intolerance. Dyes with the same characteristics are preferably also avoided for similar reasons.

[0071] In particular embodiments of the invention, the composition is free of ethylenediaminetetraacetic acid (EDTA). Alternatively, it may contain such an acid.

[0072] The composition according to the invention may be presented in any conventional form in itself, this form being suitable for topical application to the skin and mucous membranes. It may in particular, but not limited to, be presented in the form of a fluid emulsion, a rich emulsion, a cream, a milk, a serum, an ointment or a balm.

[0073] In particular, it can be of liquid or semi-liquid consistency, or of soft, semi-solid or solid consistency, or of the micro-emulsion type. Advantageously, the variation in the proportion of its ingredients makes it possible to obtain very different viscosities and fluidities, as desired.

[0074] The composition according to the invention may be intended to be applied to the skin of the face and / or body.

[0075] For example, it can be presented in the form of a protective, treatment or care cream or balm for the face, hands and / or body, or a protective, treatment or care body lotion.

[0076] For example, it can be sprayable, particularly to make a sunscreen or lotion.

[0077] The device for packaging the composition according to the invention may be an airless tube with pump, a Precitube tube, a sprayer, a ball applicator or an airless pot, etc.

[0078] The composition according to the invention presents, in itself, in its basic formula devoid of dermo-cosmetic or dermatological active ingredient, a beneficial effect for skin affected by an inflammatory skin disorder, such as atopic skin.

[0079] It may additionally contain one or more dermo-cosmetic active ingredients. Each such active ingredient may consist of any active ingredient with dermatological, cosmetic or dermo-cosmetic properties. It may be chosen from natural products, including plant extracts, extracts derived from biotechnology, such as plant cell cultures or microalgae, chemical products, or even postbiotics, or any combination thereof.

[0080] The term postbiotic here refers to a mixture of factors, products or metabolites, secreted by a living microorganism (most often a living bacterium) or released after lysis of said microorganism. Concretely, a postbiotic includes various elements such as, for example, enzymes, peptides, teichoic acids, muropeptides derived from peptidoglycan, polysaccharides, lipoproteins, cell surface proteins and organic acids, for example. Postbiotics thus correspond to mixtures of molecules originating from a probiotic culture process (bacteria and / or yeasts) and more broadly to all more or less soluble factors, products or metabolic by-products secreted by microorganisms, then excreted or released into the environment after their lysis.Generally, the exact composition of a postbiotic is not precisely determined and depends on the microorganism, the culture conditions and also the lysis and purification conditions.

[0081] A particular postbiotic that can be implemented in the present invention can in particular be an extract derived from a culture and / or from the lysis of a microbial culture, in particular a bacterial culture.

[0082] In preferred embodiments of the invention, the dermo-cosmetic active ingredient, when present, is a postbiotic and is a bacterial extract originating from a bacterium belonging to the proteobacteria class, in particular the beta-proteobacteria class. Preferably, the bacterial extract originates from a bacterium belonging to the Neisseriaceae subfamily. Even more preferably, the postbiotic is a bacterial extract originating from a bacterium named LMB 64, deposited at the CNCM (National Collection of Microorganism Cultures, Institut Pasteur, 25 rue du Docteur Roux, 75724 Paris Cedex 15) on April 8, 2010 under the reference CNCM I-4290 and described in patent application WO 2012 / 085182, or one of its mutants.Thus, in particular embodiments of the invention, the composition contains, as a dermo-cosmetic active ingredient, a non-pathogenic bacterium of the Neisseriaceae family as deposited with the CNCM under number CNCM I-4290 or one of its mutants, and / or a bacterial extract obtained from a suspension of such a bacterium or one of its mutants. This extract, composed of membrane proteins, in particular porins, OmpA, lipopolysaccharides and / or lipoproteins, lipopolysaccharides, periplasmic proteins, protein fragments from the flagellum and primary and secondary metabolites produced by the bacteria, may in particular comprise an ESO fraction which can be obtained by allowing the culture medium of the bacteria to incubate and react in a basic medium (pH 9 to 11) for approximately 5 hours at a temperature of 4°C, by centrifuging and filtering at 0.2 µm and obtaining a clear solution of ESO.In particular, it may comprise three main bands corresponding to molecular masses in the range between 30 kDa and 36 kDa, 41 kDa and 45 kDa, and 47 kDa and 51 kDa, respectively.

[0083] The concentration of the composition according to the invention in dermo-cosmetic active ingredient may for example be between 0.01 and 2% by weight relative to the total weight of the composition.

[0084] The composition according to the invention can be manufactured according to any process known to those skilled in the art.

[0085] In preferred embodiments of the invention, the odor of the composition is that of its own constituents, and it does not contain any additional odorant.

[0086] Another aspect of the invention relates to the use of a dermatological or dermo-cosmetic composition according to the invention, preferably in its embodiments containing a dermo-cosmetic active ingredient, for the treatment of an inflammatory skin disorder.

[0087] This inflammatory skin disorder can be atopic dermatitis, pruritus, eczema, psoriasis, or rosacea. Preferably, it is atopic dermatitis.

[0088] In this document, treatment means the prevention or partial prevention of one or more of the symptoms of the disease and / or the partial or total cure of the disease and / or the total or partial disappearance of one or more of its symptoms.

[0089] The composition according to the invention can be administered to any subject in need thereof, i.e. affected or likely to be affected by the inflammatory skin disorder. This subject may in particular be a mammal, and in particular a human.

[0090] Administration is preferably carried out topically, on an area of ​​skin in need, in particular on the face and / or body, in particular on sensitive or intolerant skin, for example caused by atopic dermatitis, and in particular on atopic or atopic-prone skin.

[0091] The composition according to the invention is preferably administered to the subject in a therapeutically effective amount. By "therapeutically effective amount" is meant the amount of the composition which, when administered to a subject to treat the disease, is sufficient to ensure such treatment of the disease. The dosage of administration may for example be once or twice daily, for example in the morning and in the evening, and the period of administration may for example be between 1 week and 2 months or more.

[0092] The effect of the composition according to the invention, for treating inflammatory skin disorders, is exerted in particular by preventing a reduction in and / or strengthening the epidermal barrier function. Thus, the composition according to the invention can be used to prevent a reduction in and / or strengthen the epidermal barrier function, in particular of atopic or atopic-prone skin.

[0093] The invention is also expressed in terms of a method for the therapeutic treatment of a subject suffering or likely to suffer from an inflammatory skin disorder, this method comprising a step of topical application, to an area of ​​skin of said subject in need thereof, of a therapeutically effective amount of a composition according to the invention, preferably in its embodiments containing a dermo-cosmetic active ingredient. This method may meet one or more of the characteristics described above with reference to the use of the composition according to the invention for the treatment of an inflammatory skin disorder.

[0094] The invention also relates to the non-therapeutic cosmetic use of the composition according to the invention for skin care, in particular for facial and / or body skin. Such use takes advantage in particular of the nutritive effects and the improvement of the hydration and texture of the skin, as well as its barrier function in general, of the composition according to the invention. Thus, the invention also relates to a method for non-therapeutic cosmetic treatment of the skin of a subject, in particular a mammal, in particular a human, this method comprising the application of a composition according to the invention to the skin, in particular to improve its hydration state and / or its texture.

[0095] The composition according to the invention can be applied, in an effective amount, topically, to an area of ​​skin of the individual concerned, in particular to an area of ​​healthy skin, that is to say an area of ​​skin not presenting a pathological condition. In particular embodiments of the invention, the composition may then not contain a dermo-cosmetic active ingredient. The area of ​​skin may for example be an area of ​​dry skin, skin that is tight, or sensitive but not atopic or atopic-prone skin.

[0096] The administration dosage of the composition according to the invention may for example be once or twice a day, for example in the morning and in the evening, and the administration period may for example be between 1 week and 2 months or more.

[0097] Generally speaking, in the context of its therapeutic and cosmetic use, the composition according to the invention provides protection that remains comfortable throughout the day. It can in particular be applied to sensitive skin, reactive skin, and in particular to baby skin.

[0098] Preferably, the composition according to the invention is used to protect and / or treat sensitive skin. Sensitive skin is defined by a particular reactivity of the skin. This skin reactivity is classically expressed by the manifestation of signs of discomfort in response to the subject coming into contact with a triggering element which can have various origins. This may involve the application of certain cosmetic products to the surface of sensitive skin, the intake of particular foods, exposure to sudden changes in temperature, atmospheric pollution and / or ultraviolet or infrared rays. There are also factors associated with age and skin type. Thus, sensitive skin is more common among dry or oily skin than among normal skin. For the purposes of the present invention, sensitive skin covers irritable skin and intolerant skin.

[0099] The characteristics and advantages of the invention will appear more clearly in light of the following examples of implementation, provided for purely illustrative purposes and in no way limiting the invention, with the support of figures 1 to 4, in which:

[0100] Figure 1 shows X-ray diffractograms obtained on an untreated stratum corneum sample (in a / , WAXS signals, in b / , S AXS signals).

[0101] Figure 2 represents X-ray diffractograms obtained on a sample of stratum corneum treated with a composition in accordance with the invention C1 (in a / , WAXS signals, in b / , SAXS signals).

[0102] Figure 3 represents X-ray diffractograms obtained on a sample of stratum corneum treated with a composition not in accordance with the invention Compl (in a / , WAXS signals, in b / , SAXS signals).

[0103] Figure 4 shows the sensory analysis profiles, evaluated by 15 panelists, of a composition in accordance with the invention C1 and of a comparative composition not in accordance with the invention Compl, 5 min and 15 min after their application to the skin.

[0104] A / Example 1 - Compositions according to the invention

[0105] A composition C1 according to the invention, in the form of a cream, corresponds to the formulation indicated in table 1.

[0106] Table 1 - Composition C1 A composition C2 according to the invention, in the form of a balm, corresponds to the formulation indicated in Table 2, with the condition that the Carthamus tinctorius seed oil represents at least 70% by weight of the mixture of Carthamus tinctorius seed oil, caprylic / capric triglycerides and shea butter.

[0107] Table 2 - Composition C2

[0108] B / Example 2 - Effects of different oily emollients on the perceived sensoriality The aim of this study is to compare the sensory characteristics of different compositions. These are evaluated by a person trained in sensory techniques for cosmetic products, in order to determine whether or not their sensory profile is satisfactory, more specifically on the criteria of oily or non-oily appearance, speed of penetration into the skin, film-forming effect. The appearance of the emulsion is also checked under a microscope.

[0109] The different compositions tested are detailed in Table 3 (compositions Comp2, Comp3 and Comp4 not in accordance with the invention, because they comprise a single oily emollient, or a mixture of oily emollients containing less than 70% by weight of safflower seed oil, and compositions C3 and C4 in accordance with the invention).

[0110] Table 3 - Compositions tested

[0111] For this experiment, 0.1 ml of each composition to be tested is applied to the back of the hand.

[0112] The results obtained are presented in Table 4 below. Table 4 - Sensoriality of the tested compositions

[0113] It is observed that only compositions C3 and C4, containing two oily emollients, including safflower oil, the latter also representing more than 70% by weight of all the oily emollients (more precisely 83% by weight), have satisfactory sensoriality. Composition Comp4, containing a mixture of safflower oil and triglycerides, in which the safflower oil represents only 50% by weight of the mixture, does not have satisfactory sensoriality, in particular with regard to its insufficient skin penetration.

[0114] Among the compositions in accordance with the invention C3 and C4, both deemed satisfactory, and of equivalent sensoriality, preference goes to C3, in which the second oily emollient is of the triglyceride type, which has a less coarse appearance under the microscope, with a lower risk of destabilization at temperature.

[0115] C / Example 3 - X-ray diffraction analysis of the effects of cosmetic compositions on the lipid organization of the stratum corneum

[0116] The aim of this study is to characterize the effects, on the stratum corneum, of two cosmetic compositions: composition C1 described in example 1, in accordance with the invention, and a comparative composition Compl, not in accordance with the invention, comprising in particular paraffin, corresponding to the formulation indicated in table 5:

[0117] Table 5 - Comparative composition Compl

[0118] The technique used to analyze the organization of lipids in the stratum corneum is X-ray diffraction. The experiment is performed on an isolated stratum corneum (SC) from the abdomen.

[0119] X-ray diffraction provides information on the ordered or partially ordered arrangements of atoms, molecules, or macromolecules. This technique is particularly useful for studying the organization of lipids and proteins in the skin, particularly in the stratum corneum. The main characteristics of this technique allow the effects of compositions to be characterized and compared after their application to the stratum corneum.

[0120] Stratum corneum samples (anatomical site: abdomen) were provided by Novitom. 0.75 x 1.5 cm stratum corneum pieces 2were deposited on polymeric supports chosen to be sufficiently adherent to prevent movement of the stratum corneum during application of the composition, while allowing detachment without any damage after treatment. The external face of the samples was treated with approximately 5 mg / cm 2 of each composition, by application using a spatula. The entire sample was covered. Approximately 45 min after application, the samples were folded on themselves at least four times to multiply the amount of stratum corneum layers in the X-ray beam. X-ray diffraction analysis was performed 3 h after application. Untreated control samples were also analyzed.

[0121] The X-ray diffraction experiments were performed using an X-ray diffractometer, by the SOLEIL Proxima 2 synchrotron beamline. This configuration is particularly well suited to detect the SAXS / WAXS signal. The parameters implemented are given in Table 6 below.

[0122] Table 6 - Parameters of X-ray diffraction analysis In this configuration, the diffraction signal from the stratum corneum is integrated over the entire thickness of the superimposed layers.

[0123] For data acquisition, between 120 and 180 diffraction patterns per sample were acquired. The exposure time per point was 20 ms.

[0124] Data processing was performed using ESRF FIT2D software. The background pattern (air diffraction) was subtracted from all sample diffraction patterns.

[0125] The results obtained (wide angle X-ray diffraction signals (WAXS) and small angle X-ray diffraction signals (SAXS), respectively from the external face, the internal face and the interior of the sample) are shown in Figure 1 for a control sample, in Figure 2 for a sample treated with composition C1, and in Figure 3 for a sample treated with composition Compl.

[0126] The intensity profiles presented correspond to integrated angular profiles on the meridian (SAXS profile) and equator profiles (WAXS profiles). The WAXS profiles are normalized to facilitate comparison (intensity and peak position).

[0127] Generally, the WAXS signal provides information about the crystalline organizations of lipids within the layers. The broadest band originates from the fluid portion of intercellular lipids, while the sharp peaks originate from hexagonal or orthorhombic crystal organizations. The most intense peak at about 4.1 Å is due to both organizations, while the peak at about 3.7 Å is characteristic of orthorhombic organization. The broad peak at 9.5 Å is produced by keratin intermediate filaments and reflects a change in the size of the unit cells. The more intense and sharp the reflections, the more organized the lipids are. The SAXS signal provides information about the intercellular packing of lipids, such as the number of layers. The resulting X-ray diffraction pattern shows a series of peaks at approximately 125 Å, 62 Å, 45 Å and 33 Å, which provide information on the quality of the lamellar stacking.

[0128] All of these peaks are visible in Figure 1, for the control sample.

[0129] The results obtained for a sample treated with composition C1 according to the invention are shown in Figure 2 (signals obtained respectively at the internal face, the interior and the external face of the sample, as well as for the surface composition of the latter). The WAXS signal shows 2 fine peaks at 4.15 Å and 3.76 Å, typical of lipid chains in hexagonal and orthorhombic organization. In SAXS, the signal changes on the external face and inside the stratum corneum for which peaks at 58 Å and 64 Å are respectively detected. These peaks are probably due to the crystallization of composition C1 inside the stratum corneum in the lamellar stack. We note that on the external face, the position of this additional peak is the same as that of the peak characterizing the surface composition.It is likely that composition C1 entering the stratum corneum forms "pure" domains in the outer face of the stratum corneum (where it is located) and produces a new lamellar system. At the outer surface of the stratum corneum additional rings at 49 Å and 65 Å are detected, probably due to crystallization of composition C1 or its interaction with the stratum corneum. Near the inner face of the stratum corneum, we do not observe a shift of the main peak to 61.5 Å but a decrease in intensity around 44.5 Å, and a shift of the weak peak to 31.5 Å. Therefore, composition C1 seems to partially modify the lamellar organization.

[0130] In conclusion, the composition C1 according to the invention penetrates into the entire thickness of the stratum corneum and probably forms "pure" domains there. It interacts with the stratum corneum to produce new lamellar domains. It also seems to modify the lamellar organization of physiological lipids near the internal face of the stratum corneum, and slightly increase the relative quantity of lipids crystallized in an orthorhombic network.

[0131] The results obtained for a sample treated with the Compl composition not in accordance with the invention (with paraffin) are shown in Figure 3 (signals obtained respectively at the internal face, the interior and the external face of the sample, as well as for the surface composition of the latter). They are close to those obtained for the composition C1. They show that the Compl composition also penetrates into the entire thickness of the stratum corneum and probably interacts with the latter to produce domains organized in a new lamellar system, different from the systems observed for the control. It is also possible that the Compl composition modifies the structure of physiological lipids, by slightly increasing the size of the lamellae and the relative quantity of crystallized lipids in the orthorhombic network.

[0132] The results of this experiment clearly demonstrate that the paraffin-free composition C1 increases the organization of the lipid matrix of the stratum corneum, thus strengthening the lipid barrier. This protective effect on the epidermal barrier is at least equivalent to that of a proven composition, Compl, containing paraffin.

[0133] D / Example 4 - Effects of cosmetic compositions on the synthesis of total lipids and ceramides on a reconstructed epidermis model

[0134] The quantification of ceramides provides information on the integrity or otherwise of the skin barrier function and provides a valorization of dermo-cosmetic products. The aim of this study was to evaluate the impact of two cosmetic compositions (composition C1 according to the invention, as described in example 1, and composition Compl not in accordance with the invention, as described in example 3) on the synthesis of skin lipids, and in particular on the synthesis of ceramides, the major constituents of the stratum corneum from a lipid point of view, and to evaluate the nutritive effect for the treatment and improvement of the barrier function.

[0135] The effect of the cosmetic compositions was evaluated on 3 batches of reconstructed epidermis with n=3 (triplicate) per experimental condition and per batch.

[0136] The model used in this study is a reconstructed epidermis model derived from skin excisions from cosmetic surgery according to the method described by Frankart et al. (Frankart et al., Exp. Dermatol. 2012, 21 (11), 871-875).

[0137] The cells (keratinocytes) were isolated from the skin excisions, then cultured before being seeded on culture inserts immersed in culture medium (standard medium supplemented with the supplement marketed under the name EpiLife® Defined Growth Supplement by ThermoFisher), then the culture inserts were placed at the air / liquid interface in an incubator at 37°C in a humidified atmosphere with 5% CO2, to form the stratum corneum. The culture medium was changed every 24 hours. After 14 days, a reconstructed epidermis with a surface area of ​​0.6cm 2 has been reformed.

[0138] Three reconstructed epidermis were used per condition. The conditions tested were as follows:

[0139] - negative control: Tween® 20 at 0.01% in phosphate buffer pH 7.4 (PBS);

[0140] - composition C1 at 1% in Tween® 20 at 0.01% in phosphate buffer pH 7.4 (PBS);

[0141] - 1% Compl composition in 0.01% Tween® 20 in phosphate buffer pH 7.4 (PBS);

[0142] - positive control: commercial Dexeryl® cream, based on glycerol, petrolatum and paraffin (composition: glycerol, petrolatum, liquid paraffin, glycerol monostearate, stearic acid, dimethicone, macrogol 600, trolamine, acrylamide / acryloyl-dimethyltaurate copolymer, isohexadecane, polysorbate, pentylene glycol, ethylhexylglycerin, carbomer, purified water).

[0143] At 9 èmeOn the day of the protocol, the compositions to be tested were applied topically at 2 mg / reconstructed epidermis, a first time on the reconstructed epidermis. An incubation of 24 ha was carried out. A second application (under the same conditions) was carried out on ème day, with an incubation of 48 hours. A third application (under the same conditions) was carried out on the 13th ème day, with 24 hours of incubation. Finally, a fourth application (under the same conditions) was carried out at I 4 ème day (epithelium completely reconstructed), with 24 hours of incubation.

[0144] At 15 èmeday, the reconstructed epidermis were removed from the culture inserts, the stratum corneum was isolated using trypsin from the rest of the epidermis. The stratum corneum was then extracted using organic solvents (mixture of chloroform and methanol) to collect the lipids constituting it. These lipids were then concentrated under liquid nitrogen before analysis.

[0145] Ceramides, free fatty acids, and cholesterol in the stratum corneum were analyzed by high-performance thin-layer chromatography (HPTLC), a rapid technique widely used to separate complex mixtures such as lipids (Fuchs et al., J. Chromatography A 201 1 , 1218(19), 2754-2774). The method used is as described in the publication by Jamin et al., Eur J Mass Spectrum, 2019, 25(3), 278-290. The analytical conditions are detailed below:

[0146] - plate: Lichrospher® HPTLC Silica gel 60 F254S; - deposit: 6 mm wide, dried under nitrogen flow;

[0147] - development: gradient: see Table 7;

[0148] - post-derivatization: aqueous solution of copper sulfate (10% CuSC, 8%H3PO4, 5%MeOH);

[0149] - detection: scanner At: 450 nm. Table 7 - Gradient applied for HPTLC analysis

[0150] The results obtained show that the positive control (Dexeryl® cream) induces, as expected, lipid synthesis, associated with an increase in free fatty acids, cholesterol derivatives and ceramides. These results validate the experimental conditions. Compositions C1 and Compl have no effect on the synthesis of free fatty acids, but both induce a significant increase in total cholesterol.

[0151] The effect of the compositions on the synthesis of total ceramides is detailed in Table 8:

[0152] As can be observed, only composition C1 according to the invention significantly increases the synthesis of total ceramides.

[0153] This result allows us to conclude that this paraffin-free composition has a significant protective effect on the skin. Indeed, ceramides are present as the dominant lipids in the stratum corneum, and they play a crucial role in the barrier function, thus limiting dehydration and water retention in particular.

[0154] The effect of composition C1 on different specific subclasses of ceramides (Cer 5 AS and OH, Cer 9 EOP, Cer 10 NdS and 2 NS, Cer 1 EOS) was further investigated. Table 9 below shows the percentage induction of the production of these ceramides by the application of composition C1, compared to the negative control.

[0155] Table 9 - Percentage of induction of ceramide production of composition C1 according to the invention compared to the control - Values ​​compared by a t test, NS = not significant

[0156] Thus, composition C1, compared to untreated reconstructed epidermis (negative control), induced a statistically significant synthesis of all ceramides in this reconstructed epidermis model. It is interesting to note that the increase in the synthesis of ceramide Cer 5 AS and OH, which is known to be in reduced quantity in the skin in cases of eczema and atopic dermatitis, exceeds 50%. Furthermore, the amount of ceramides involved in the lamellar organization of lipids in the stratum corneum, i.e., ultra-long chain esterified ceramides, such as ceramide Cer 9 EOP, is significantly increased to more than 180%. The amount of unesterified ceramides, such as ceramide Cer 10 NS and 2 NS, which is one of the major ceramides in the stratum corneum, is also increased.

[0157] The increase in the level of total ceramides and in particular ceramides which are major players in the barrier function such as NS and EOP ceramides, by the application of a paraffin-free composition, is very favorable for a strengthening effect on the epidermal barrier function.

[0158] E / Example 5 - Evaluation of the effect of two cosmetic compositions on the repair of the skin barrier

[0159] The objective of this study is to highlight a restorative effect or a protective effect of two cosmetic compositions on a pig ear skin model following Sodium Dodecyl Sulfate (SDS) stress: composition C1 according to the invention and composition Compl not in accordance with the invention, as described above.

[0160] Schematically, in this experiment, a 2-hour SDS (10%) stress is carried out on the skin explants, with the aim of damaging the outermost layers. After rinsing, the compositions are applied topically at 5 mg / cm 2 The explants are then incubated for 16 hours at 37°C in fresh supplemented medium. Any restorative effect is observed and quantified after incubation with Lucifer yellow (Sigma, reference L0144).

[0161] Specifically, two pig ears are used in this study. Eight 10 mm samples are formed with a punch after scraping the skin to a thickness of 450 ± 50 µm. The samples are then placed on inserts with 1.1 ml of fresh survival medium (DMEM) and incubated for 1 h at 37°C. The medium is changed with 1.1 ml of fresh survival medium.

[0162] An 8 mm diameter nylon mesh is placed, then 8 μl of 10% SDS are added to this mesh, and the explant is incubated for 2 h at 37°C. The mesh is then removed with small forceps, and the explant is rinsed successively in 3 baths of PBS (phosphate buffered saline) for 10 s each. Excess medium is removed by blotting the edge of the explant on a sterile compress. The survival medium is then changed. Before applying the compositions, the surface of the explant is dried with a cotton swab.

[0163] Each of the 2 compositions is applied topically to an explant at 5 mg / cm 2 with a cotton swab wrapped in a finger cot. Then the explant is incubated for 16 h at 37°C in fresh supplemented medium (MEM + Gentamicin, 50 mg / ml, penicillin / Streptomycin 5000 U).

[0164] The Lucifer Yellow (LY) permeability test, which quantifies the thickness of the damaged explant, is then performed. A 1 mM Lucifer Yellow solution in PBS is prepared. 8 μl of this solution is placed on a new 8 mm mesh, then the explant is incubated for 2 h at 37°C. The mesh is then gently removed and a 6 mm biopsy is taken. The biopsies are then placed in an Eppendorf tube containing 1.8 ml of 4% PFA (Paraformaldehyde), prepared in PBS, and incubated for 1 h at room temperature. Then the biopsies are rinsed in 2 successive baths of PBS and dried on the edge.

[0165] Biopsies are embedded in a mold filled with Optimal Cutting Temperature (OCT) compound, then frozen by immersion in isopentane cooled to -80°C using SnapFrost® and stored at -80°C.

[0166] Cryosections of 8 μm were taken and observed directly under a fluorescence microscope. For each image, the penetration of LY through the stratum corneum was analyzed using Octopus software with the Histo-Fluo module by measuring the average fluorescence intensity relative to the average surface area of ​​the stratum corneum layer.

[0167] The results obtained for each of the conditions tested (untreated control, explant treated with SDS, explant treated with SDS and composition C1, explant treated with SDS and composition Compl) are shown in Table 10.

[0168] Table 10 - Mean fluorescence intensity relative to the mean surface area of ​​the stratum corneum layer

[0169] It is observed that SDS, as expected, significantly damages the skin explant. The application of composition C1 or Compl allows effective repair of the epidermis, since the values ​​are at the same level as for the control group which has not suffered any damage.

[0170] Composition C1 according to the invention therefore has a barrier function repair effect at least equivalent to that of the composition of the prior art with paraffin Compl.

[0171] F / Example 6 - Sensory profiles of compositions C1 and Compl

[0172] A monadic evaluation of the sensory profiles of the composition C1 according to the invention and of the comparative composition Compl, as described above, is carried out by 15 panelists trained in the sensory methodology for evaluating topical products. For this purpose, 0.1 ml of each composition to be tested is applied to each cheek.

[0173] Three evaluation phases are assessed:

[0174] - during application,

[0175] - 5 minutes after application,

[0176] - 15 minutes after application.

[0177] During the test, the room temperature and humidity are checked, and the lightening is controlled.

[0178] The results obtained are presented in Figure 4. It is observed that the composition of the invention C1 is associated with a very good sensory profile, close to that of the composition Compl containing paraffin. Almost no significant difference is observed in the sensory characteristics of these two compositions. The composition according to the invention even provides a better shine to the skin 5 minutes after application and has a less oily appearance 15 minutes after its application. It is interesting to note that the composition according to the invention is also felt with better flexibility 5 minutes after application and allows better spreading during application.

[0179] Thus, the composition according to the invention without paraffin has a sensory profile entirely comparable to that of a composition with paraffin, even presenting some even more favorable indicators.

Claims

CLAIMS 1. Dermatological or dermo-cosmetic composition in the form of an emulsion comprising: - an aqueous phase containing at least one emollient chosen from glycerin and its derivatives and glycols and their derivatives, - and an oily phase containing an oily emollient system comprising safflower oil and a second oily emollient, said composition containing at least 50% by weight of water relative to the total weight of the composition, and being characterized in that it contains, by weight relative to the total weight of the composition: - 10 to 20% in total of emollient(s) contained in the aqueous phase, - 10 to 25% of said oily emollient system, including 8 to 18% of safflower oil, the safflower oil representing more than 70% by weight of said oily emollient system, and said composition being free of paraffin.

2. Composition according to claim 1, containing at least one consistency factor.

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

4. Composition according to any one of claims 1 to 3, containing an emulsifying agent.

5. Composition according to any one of claims 1 to 4, wherein said emollient selected from glycerin and its derivatives and glycols and their derivatives is glycerin.

6. Composition according to any one of claims 1 to 5, in which said second oily emollient is chosen from triglycerides.

7. Composition according to any one of claims 1 to 6, containing less than 6 oily emollients.

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

9. Composition according to any one of claims 1 to 8, containing a dermo-cosmetic active ingredient.

10. Composition according to claim 9, in which said dermo-active cosmetic is a non-pathogenic bacterium of the Neisseriaceae family as deposited with the CNCM under number CNCM 1-4290 or one of its mutants, and / or a bacterial extract obtained from a suspension of such a bacterium or one of its mutants.

11. Composition according to any one of claims 1 to 10 for its use for the treatment of an inflammatory skin disorder.

12. Composition for its use according to claim 11, according to which said inflammatory skin disorder is atopic dermatitis, pruritus, eczema, psoriasis or rosacea.

13. Composition for its use according to claim 11 or 12, to prevent a decrease in and / or strengthen the epidermal barrier function.

Citation Information

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