Novel cosmetic compositions for skin repair

Abstract

The invention relates to a dermal-cosmetic or dermatological composition that can be applied topically in the form of a water-in-oil emulsion and is particularly suitable for repairing damaged and / or irritated skin. This composition contains water, at least one polyol, at least one oily emollient other than a hydrogenated vegetable oil, 3-10 wt % of hydrogenated vegetable oil and more than 3 wt % of polyglyceryl-3 polyricinoleate. The polyglyceryl-3 polyricinoleate is substantially the only emulsifying agent.

Description

[0001] NEW COSMETIC COMPOSITIONS FOR SKIN REPAIR

[0002] The present invention falls within the field of dermo-cosmetic or dermatological compositions for the treatment of damaged and / or irritated skin, in particular to promote the repair of skin lesions.

[0003] More specifically, the present invention relates to a dermo-cosmetic or dermatological composition in the form of a water-in-oil emulsion, of the type applicable topically, particularly suitable for the treatment of damaged and / or irritated skin. The invention also relates to the use of such a composition for the treatment, in particular the repair, of damaged and / or irritated skin.

[0004] The skin is made up of different tissues that form a vital barrier for the body against the external environment. This barrier protects the body against external aggressions, particularly chemical or mechanical ones.

[0005] The skin is made up of three main parts: a superficial layer, the epidermis; an inner layer, the dermis; and a deeper layer, the hypodermis, which interact with each other.

[0006] The human epidermis is composed of four to five distinct layers (depending on the anatomical site) and four cell types: keratinocytes (the most numerous), melanocytes, Langerhans cells, and Merkel cells. Each of these cell types contributes its specific functions to the essential role played by the skin in the body, particularly its role in protecting the body from external aggressions. Epidermal cells proliferate in the deepest layer, the basal layer, and differentiate during their migration to the upper layers to successively form the stratum spinosum, the stratum granulosum, and finally the stratum corneum, which is the outermost layer of the epidermis.

[0007] Wound healing is a set of local defense mechanisms that occur after an injury: wound, burn, dermatological procedure, or surgical intervention. Wound healing is a complex and dynamic biological process involving the interaction of numerous local and systemic factors in normal tissue repair.

[0008] The healing process involves several interdependent phases: hemostasis and inflammation, proliferation, and remodeling. Proliferation involves three easily observable processes: granulation, contraction, and re-epithelialization.

[0009] Wound healing can also pose aesthetic problems, as defects or poor healing can occur, for example, with age. The healing and recovery process of skin lesions becomes less efficient, potentially leaving unsightly and almost permanent visible marks.

[0010] All surgical, cosmetic medicine, and dermatological procedures, as well as non-medical traumatic injuries such as scrapes, cuts, scratches, and burns, but also pathological conditions such as acne, involve a healing process and result in scars, more or less pronounced depending on the quality of this healing.

[0011] Several dermo-cosmetic or dermatological formulations exist that are suitable for repairing skin lesions, aiming in particular to promote proper healing. Water-in-oil emulsion cosmetic products are frequently used in this area of ​​skin repair. Examples of such products include the compositions described in the Mintel entries of the GNPD database, accessible under numbers 11491838 and 11618524, respectively. However, emulsions of this type suffer from a problem with long-term stability. Furthermore, they are known to be very sensitive to cold, which also often leads to stability issues and phase separation problems within the emulsion.

[0012] Thus, obtaining new water-in-oil emulsions that are truly stable and insensitive to cold is a real challenge.

[0013] Furthermore, there is always a need to develop new formulations to promote the repair of damaged skin, particularly to ensure effective repair of skin lesions while maintaining a pleasant sensory experience. Certain criteria are especially advantageous for users of formulations applied to damaged and / or irritated skin: the protective film provided by the formulation upon application must be perceptible to the user, and the formulation must not be too resistant to application on already painful, damaged and / or irritated skin. It is also desirable that the formulation not leave a shiny and / or oily appearance on the skin, which is both visible and undesirable to the user. Previous dermo-cosmetic formulations used for treating damaged skin are often difficult to spread and have a significant sticky effect.

[0014] The present invention aims to provide a dermo-cosmetic or dermatological composition in the form of a water-in-oil emulsion for topical application, which offers good efficacy for the treatment of damaged and / or irritated skin, particularly for the repair of skin lesions and for the protection and / or treatment of sensitive skin, and which exhibits good stability over time and in cold environments. The invention further aims to ensure that this composition has a good, robust, and persistent film-forming effect, giving it strong insulating properties, in order to minimize water loss from the skin, and good moisturizing properties.The invention also aims to ensure that this composition has an advantageous sensory profile, meeting user expectations in this area, in particular: good perception of the protective film provided by the composition upon application, no shiny or oily appearance on the skin, and no sticky effect, so that the user encounters little resistance when applying the composition to the skin. A further objective of the invention is that this composition contains no, or as few as possible, petroleum-based ingredients.

[0015] It has now been discovered by the present inventors that all of these objectives are achieved by a dermo-cosmetic or dermatological composition combining specific ingredients.

[0016] More specifically, the inventors have developed a novel dermo-cosmetic / dermatological composition in the form of a particularly stable water-in-oil emulsion. This composition comprises a specific emulsifier, polyglyceryl-3 polyricinoleate, which is essentially the only emulsifier in the formula, and a hydrogenated vegetable oil. Each of these ingredients is present in a specific concentration within the formula. Unexpectedly, this combination has not only provided the formula with a particularly effective insulating and film-forming effect, but also a very pleasant consistency, without compromising its skin-repairing efficacy. Furthermore, the film-forming effect, combined with the presence of other specific ingredients in the formula, including at least one polyol, ensures a long-lasting moisturizing effect of up to 24 hours.

[0017] Thus, according to the present invention, a dermo-cosmetic or dermatological composition applicable topically, in the form of a water-in-oil emulsion, is proposed, which comprises, by weight relative to the total weight of the composition:

[0018] - at least 50% water,

[0019] - at least 5%, preferably 5 to 20%, of polyol(s),

[0020] - 10 to 40% oily emollient(s) other than hydrogenated vegetable oils,

[0021] - 3 to 10% hydrogenated vegetable oil(s),

[0022] - polyglyceryl-3 polyricinoleate, in a content greater than 3%, preferably greater than or equal to 3.5%

[0023] - and optionally, one or more emulsifiers other than polyglyceryl-3 polyricinoleate, polyglyceryl-3 polyricinoleate then representing at least 90% by weight of the total weight of emulsifiers contained in the composition.

[0024] As indicated above, such a composition, even without an active agent for skin lesion repair, possesses significant skin lesion repair properties. In particular, it proves highly effective, on its own, for the re-epithelialization of skin lesions and for repairing the skin barrier. Furthermore, it has a strong moisturizing capacity, combined with highly advantageous sensory properties, notably in terms of its lack of stickiness, ease of application, absence of a greasy or oily residue on the skin surface, and its film-forming ability. In particular, and quite surprisingly, the composition according to the invention leaves far fewer greasy / oily traces on the skin after application than similar compositions containing less than 3% by weight, or more than 10% by weight, relative to the total weight of the composition, of hydrogenated vegetable oil(s).Furthermore, it is very easy to spread on the skin, which proves particularly advantageous in the context of the invention's intended purpose of repairing damaged skin. Indeed, difficult spreading would be all the more painful for such skin.

[0025] Throughout this description, the term "skin" encompasses both the skin proper and the mucous membranes. The term "cutaneous" encompasses both what relates to the skin and what relates to the mucous membranes.

[0026] 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, referred to as the dispersed phase, being homogeneously dispersed in the other of these phases, referred to as the continuous phase, in the form of fine droplets. This emulsion is more particularly of the water-in-oil type, that is to say, in which the aqueous phase is kept homogeneously dispersed in the oily phase. In the context of the present invention, this form of emulsion, referred to as an inverted emulsion, is obtained by the action of the specific emulsifier, polyglyceryl-3 polyricinoleate.

[0027] The composition according to the invention comprises at least 50% by weight, preferably at least 60% by weight, even more preferably at least 70% by weight, of water relative to the total weight of the composition.

[0028] The composition according to the invention comprises at least one polyol.

[0029] According to the present invention, "polyol" (also called polyalcohol) is understood, in a classical sense, as a compound comprising a hydrocarbon chain with at least two carbon atoms and comprising at least two hydroxyl groups.

[0030] The polyol(s) used according to the invention may be of natural or synthetic origin. They may have a linear, branched or cyclic molecular structure.

[0031] The polyol(s) used according to the invention can in particular be chosen from glycerin and its derivatives, and glycols and their derivatives. In particular, they can 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, especially those having 5 to 50 ethylene oxide groups, but also erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, iditol, inositol, volemitol, isomalt, maltitol, lactitol, maltotriitol, maltotetrol, and polyglycitol, alone or in any one of them. of their mixtures.

[0032] In preferred embodiments of the invention, at least one polyol contained in the composition is glycerin. Glycerin may, in particular, be the only polyol contained in the composition according to the invention.

[0033] The composition according to the invention preferably comprises, in total, from 5 to 20% by weight, preferably from 8 to 20% by weight, for example from 8 to 15% by weight, or even from 10 to 12% by weight, of polyol(s), relative to the total weight of the composition.

[0034] In particular embodiments of the invention, the composition comprises from 5 to 20% by weight, preferably from 8 to 20% by weight, for example from 8 to 15% by weight, or even from 10 to 12% by weight, of glycerin, relative to the total weight of the composition, glycerin then preferably being the only polyol contained in the composition.

[0035] The composition according to the invention may alternatively comprise another polyol other than glycerin, preferably in a content of less than 5% by weight, preferably less than 3% by weight, relative to the total weight of the composition.

[0036] The composition according to the invention comprises at least one oily emollient other than a hydrogenated vegetable oil.

[0037] In this description, the term emollient is classically understood to mean a compound with properties of hydrating and softening the epidermis, when applied topically.

[0038] For convenience, in this description, the term "oily emollient" will refer to oily emollients other than hydrogenated vegetable oils. Preferably, the composition according to the invention comprises fewer than 5 oily emollients, more particularly fewer than 4 oily emollients, and even more particularly fewer than 3 oily emollients.

[0039] The composition according to the invention comprises, in total, from 10 to 40% by weight, preferably from 15 to 35% by weight, for example from 15 to 30% by weight, or even from 15 to 25% by weight, of oily emollient(s), relative to the total weight of the composition.

[0040] The oily emollient(s) contained in the composition according to the invention may be chosen from:

[0041] - triglycerides. Triglycerides are molecules composed of three fatty acids linked by ester bond to a glycerol molecule. Triglycerides suitable for the invention may in particular be chosen from the group comprising triglycerides based on C8-C18 fatty acids, in particular C10-C18 fatty acids, and more particularly caprylic / capric acid triglycerides;

[0042] - non-hydrogenated vegetable oils, such as sunflower, safflower, corn, olive, sweet almond, coconut, palm, soybean, pumpkin, grapeseed, sesame, hazelnut, apricot, macadamia, avocado, jojoba, borage, rapeseed, wheat germ, flaxseed, evening primrose, argan, calendula, cottonseed, castor, Limnanthes alba, Silybum marianum, oat, etc.;

[0043] - solid fats having a melting point less than or equal to, preferably strictly less than, 45°C, such as butters, for example Shea butter, Cupuaçu butter, cocoa butter;

[0044] - synthetic esters and ethers, particularly of fatty acids, such as oils with the formulas R1COOR2 and R1OR2, in which Ri represents the remainder of a fatty acid containing 8 to 29 carbon atoms, and R2 represents a hydrocarbon chain, branched or unbranched, containing 3 to 30 carbon atoms, such as 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, citrate of triisocetyl, heptanoates, octanoates or decanoates of fatty 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;

[0045] - and their mixtures.

[0046] Preferably, the composition according to the invention comprises at least triglycerides, in particular caprylic / capric acid triglycerides, as an oily emollient. Caprylic / capric acid triglycerides may, in particular, constitute the sole oily emollient in the composition.

[0047] Preferably, the composition according to the invention is free of jojoba oil. Such an ingredient, frequently used in prior art compositions for skin repair, is in fact entirely unnecessary to achieve the performance intended for the composition according to the invention.

[0048] The composition according to the invention contains, as a waxy consistency factor, at least one hydrogenated vegetable oil, the total content of hydrogenated vegetable oil(s) being between 3 and 10% by weight, preferably between 3 and 8% by weight, or between 3 and 6% by weight, and preferably between 4 and 5% by weight, relative to the total weight of the composition.

[0049] Preferably, the composition according to the invention contains only one hydrogenated vegetable oil, or it contains 2 or 3 hydrogenated vegetable oils in total.

[0050] In preferred embodiments of the invention, the hydrogenated vegetable oil or oils are chosen from hydrogenated rapeseed, palm, soybean and castor oils, as well as mixtures thereof.

[0051] Preferably, the composition according to the invention comprises, as hydrogenated vegetable oil(s), at least rapeseed oil and / or palm oil.

[0052] In particular embodiments of the invention, the composition comprises at least one hydrogenated vegetable oil having a melting point above 52°C, such a hydrogenated vegetable oil being the only hydrogenated vegetable oil present in the composition. Examples of hydrogenated vegetable oils that may be included in the composition according to the invention include hydrogenated vegetable oils composed of saturated and unsaturated fatty acids, preferably C16-C18, and in particular composed predominantly of palmitic acid, oleic acid, and stearic acid. Such hydrogenated vegetable oils are designated by the INCI name Hydrogenated Vegetable Oil.Preferably, at least one, and preferably all, of the hydrogenated vegetable oils contained in the composition according to the invention have a melting point between 50 and 85°C, preferably between 50 and 57°C or between 60 and 65°C, or alternatively between 75 and 85°C. Examples of such hydrogenated vegetable oils are found in the commercial products CEGESOFT® HF 52 and CEGESOFT® HF 62 from BASF.

[0053] The composition according to the invention may further comprise at least one waxy consistency factor other than a hydrogenated vegetable oil.

[0054] A waxy consistency factor is defined as a solid fat with a melting point above 45°C. For the purposes of this invention, waxy consistency factors are not considered oily emollients.

[0055] The composition according to the invention may in particular contain, as waxy consistency factor(s), one or more waxy substances having a melting point above 45°C, such as glycol palmitate, resins, such as copaiba resin, vegetable waxes (such as carnauba wax, sunflower wax, candelilla wax), beeswax or the mixture of tribehenin / glyceryl dibehenate / glyceryl behenate (substances with INCI names Tribehenin / Glyceryl Dibehenate / Glyceryl behenate) which can, among other things, be found in the commercial material COMPRITOL® 888.

[0056] Preferably, the composition according to the invention does not, however, contain any waxy consistency factor other than one or more hydrogenated vegetable oils.

[0057] In preferred embodiments of the invention, the total content of hydrogenated vegetable oil(s) and any other waxy consistency factor(s) in the composition is between 3 and 10% by weight, preferably between 3 and 8% by weight, in particular between 3 and 6% by weight, and preferably between 4 and 5% by weight, relative to the total weight of the composition.

[0058] The composition according to the invention further comprises at least one emulsifying agent, which is polyglyceryl-3 polyricinoleate, as notably contained in the product marketed under the name Cithrol® PG3PR.

[0059] The total content of polyglyceryl-3 polyricinoleate in the composition is strictly greater than 3% by weight, relative to the total weight of the composition. It is also preferably less than or equal to 8% by weight relative to the total weight of the composition.

[0060] Preferably, the polyglyceryl-3 polyricinoleate content is greater than or equal to 3.5% by weight, preferably greater than or equal to 4% by weight, and even more preferably greater than or equal to 4.5% by weight, relative to the total weight of the composition. This content may, in particular, be between 3.5% and 8% by weight, preferably between 3.5% and 6% by weight, and for example between 4% and 5.5% by weight, relative to the total weight of the composition.

[0061] Polyglyceryl-3 polyricinoleate may in particular be the only emulsifier in the composition according to the invention.

[0062] In alternative particular embodiments of the invention, the composition comprises at least one other emulsifying agent, polyglyceryl-3 polyricinoleate then representing at least 90% by weight of the total weight of the emulsifiers of the composition according to the invention.

[0063] The other emulsifying agent(s) that may be contained in the composition according to the invention may be of any type that is conventional in itself in the field of dermo-cosmetic / dermatological compositions.

[0064] The total concentration of emulsifier(s), including polyglyceryl-3 polyricinoleate, in the composition according to the invention is preferably greater than 3% by weight and less than or equal to 8% by weight, preferably between 3.5 and 8% by weight, and preferably between 4 and 6% by weight, relative to the total weight of the composition.

[0065] In particular embodiments, the composition according to the invention is devoid of emulsifiers such as: - polyglyceryl-2 sesquiisostearate,

[0066] - polyglyceryl-3 diisostearate,

[0067] - polyglyceryl-2 dipolyhydroxystearate,

[0068] - potassium cetyl phosphate,

[0069] - sorbitan olivate,

[0070] - polyglyceryl-4 oleate.

[0071] The composition according to the invention may contain one or more gelling and / or thickening agents, or be free of them. By gelling and / or thickening agent, we mean an agent selected 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.

[0072] The composition according to the invention is preferably free of paraffin (INCI name: paraffinum liquidum), and preferably free of petrolatum. Such substances, in addition to being petroleum-based, have the disadvantage of being occlusive. Furthermore, petrolatum is comedogenic, flammable, and frequently suspected of causing skin burns.

[0073] According to the present invention, "free of" an ingredient means that the composition contains less than 0.01% by weight, preferably less than 0.001% by weight, of that ingredient, relative to the total weight of the composition, or, even more preferably, that it does not contain that ingredient.

[0074] The composition according to the invention is also preferably free of silicone. For the purposes of the present invention, silicone, or polysiloxane, classically means any organosilicon polymer or oligomer with a linear and / or cyclic, branched and / or cross-linked structure, obtained by polymerization and / or polycondensation of functionalized silanes, and consisting essentially of a repetition of principal motifs in which silicon atoms are linked together by oxygen atoms, hydrocarbon radicals, possibly substituted, in particular by hydroxyl groups, being directly linked by a carbon atom to these silicon atoms.

[0075] The composition according to the invention may contain one or more preservatives, or be free of them.

[0076] The composition according to the invention is also preferably free of phenoxyethanol, which is suspected of being an endocrine disruptor.

[0077] Preferably, the composition according to the invention is free of alpha hydroxy acids, also known as AHAs (Alpha Hydroxy Acids). These are carboxylic acids, derived primarily from fruit sugars. The main fruit acids are lactic, malic, glycolic, citric, and tartaric acids. AHAs promote skin exfoliation; therefore, these ingredients are best avoided in compositions intended for application to skin with lesions.

[0078] Preferably, all substances having exfoliating properties, such as retinoids, are also avoided in the composition according to the invention.

[0079] In particular embodiments of the invention, the composition is devoid of ethylenediaminetetraacetic acid (EDTA). Alternatively, it may contain such an acid.

[0080] In certain embodiments of the invention, the composition is devoid of essential oil. Indeed, most essential oils contain allergens, which can cause skin irritation and intolerance. Dyes with the same characteristics are also preferably avoided for similar reasons.

[0081] In particular embodiments, the composition according to the invention comprises an amount of C1-C4 monoalcohols, such as ethanol and isopropanol, which is less than or equal to 1% by weight, preferably less than or equal to 0.5% by weight, in particular less than or equal to 0.2% by weight, in particular less than or equal to 0.1% by weight, relative to the total weight of the composition.

[0082] Preferably, the composition according to the invention is free of monoalcohols, in particular C1-C4 monoalcohols such as ethanol and isopropanol. Monoalcohols, such as ethanol, are known to dry out the skin, and it is therefore preferable to avoid incorporating them into the composition according to the invention, which is intended to be applied to damaged and / or irritated skin.

[0083] The composition according to the invention may further contain any conventional additive / excipient suitable for a dermatological or dermo-cosmetic composition, and, like all other ingredients of the composition according to the invention, be dermatologically and / or dermo-cosmetically acceptable. By this, "conventionally acceptable" means that these ingredients are suitable for use by contact with human and animal skin cells, and that they do not generate unacceptable discomfort likely to deter a user from using the composition.

[0084] In particularly preferred embodiments of the invention, the composition according to the invention has a dynamic viscosity at 25°C ± 2°C greater than or equal to 20,000 mPa.s, preferably greater than or equal to 25,000 mPa.s, and even more preferably greater than or equal to 30,000 mPa.s. Its viscosity is preferably less than or equal to 80,000 mPa.s, preferably even less than or equal to 70,000 mPa.s, preferably less than or equal to 60,000 mPa.s, and even more preferably less than or equal to 50,000 mPa.s. For example, this viscosity can be between 20,000 and 80,000 mPa·s, preferably between 25,000 and 70,000 mPa·s, and even more preferably between 30,000 and 60,000 mPa·s, and for example between 30,000 and 50,000 mPa·s. This dynamic viscosity can, for example, be measured using a Brookfield viscometer by applying the following parameters: moving part 3, speed 100 rpm, for 1 minute.

[0085] In certain embodiments of the invention, the composition is free of zinc oxide (in powder form). During the manufacturing process of the composition, the presence of zinc oxide in powder form generally necessitates more complex tank cleaning. The sanitizing effect of the composition, conventionally provided by zinc oxide, can, for example, be advantageously achieved by the presence in the composition of water-soluble copper sulfate, for example, at a concentration of approximately 0.2% by weight relative to the total weight of the composition. The composition according to the invention may further contain one or more emulsion stabilizers, such as magnesium sulfate, particularly at a concentration of between 0.1% and 2% by weight relative to the total weight of the composition.

[0086] The composition according to the invention may additionally contain one or more active agents. Each such active agent may consist of any active ingredient possessing dermatological, cosmetic, and / or dermo-cosmetic properties. These properties may be of the type that contribute to skin protection or repair, thus complementing the existing effect of the composition as defined above, or they may be of any other type.

[0087] Each of these active agents can be chosen from natural products, including plant extracts, extracts from biotechnologies, such as plant cell or microalgae cultures, chemicals, or postbiotics, or any combination thereof.

[0088] In particular, healing agents may be present in the composition according to the invention, alone or in combination, such as madecassoside, panthenol, allantoin, zinc sulfate, Aloe vera extracts or honey, or the healing complex described in application WO 2014 / 167039, comprising L-alanyl-L-glutamine, hyaluronic acid or one of its salts and an oat extract.

[0089] The composition according to the invention can be in any conventional form, this form being suitable for topical application to the skin (including mucous membranes), particularly human or animal skin. It can, in particular, but not limited to, be in the form of a fluid emulsion, a rich emulsion, a cream, a lotion, a serum, an ointment, or a balm.

[0090] A method for preparing the composition according to the invention includes mixing its constituent ingredients, in particular in liquid form or dissolved in water.

[0091] The presence of polyglyceryl-3 polyricinoleate, as the predominant emulsifier in the composition, proves particularly advantageous in this process, as its incorporation requires little energy. This substance, liquid at room temperature, does not require additional heating for its integration into the composition.

[0092] The composition according to the invention is intended more particularly for topical application, on any area of ​​damaged and / or irritated skin, in particular on an area of ​​skin on the body or face.

[0093] Another aspect of the invention relates to the use of a composition according to the invention for the treatment of an area of ​​damaged and / or irritated skin. This use preferably includes the topical application of the composition to this area of ​​skin. The skin may be that of a mammal, in particular a human. It may specifically be an area of ​​skin on the body or face.

[0094] The term treatment encompasses both the repair, that is to say the alleviation of at least one of the physical signs of damaged and / or irritated skin, in particular the repair of one or more skin lesions, and the protection of the skin against the appearance of such physical signs.

[0095] Skin lesions can appear as a result of trauma or as a result of medical or surgical procedures, invasive or non-invasive, curative or for cosmetic purposes.

[0096] Damaged skin is defined here as skin with cutaneous lesions, including grazes, scratches, cuts, scrapes, stings (e.g., from insects), grazes, burns, abrasions (e.g., from friction), sutures, excoriated acne lesions, post-traumatic lesions, post-surgical lesions, lesions following a dermatological procedure, lesions following an aesthetic procedure, lesions following an aesthetic medicine procedure, a tattoo (e.g., less than six weeks old), or a combination thereof.

[0097] Lesions following a dermatological, aesthetic, or cosmetic procedure can result from cryotherapy, mesotherapy, waxing, intense pulsed light (IPL) or laser (hair removal, ablative laser, vascular laser, particularly for treating rosacea, etc.) treatments, peeling, etc. Irritated skin is defined as dry skin, tight skin, sensitive skin, or even atopic or atopic-prone skin.

[0098] Preferably, the composition according to the invention is used for the treatment, including the protection, of an area of ​​sensitive skin. This use preferably includes the topical application of the composition to this area of ​​skin. The skin may be that of a mammal, in particular a human. It may specifically be an area of ​​skin on the body or face.

[0099] Sensitive skin is defined by a particular reactivity of the skin. This cutaneous reactivity classically manifests as signs of discomfort in response to contact with a triggering element, which can have various origins. These may include the application of certain cosmetic products to the surface of sensitive skin, the consumption of certain foods, exposure to sudden temperature changes, air pollution, and / or ultraviolet or infrared radiation. Factors associated with age and skin type also play a role. Thus, sensitive skin is more common among dry or oily skin than among normal skin. For the purposes of this invention, sensitive skin encompasses irritable and intolerant skin.

[0100] The composition according to the invention can, for example, be applied topically to an area of ​​damaged and / or irritated skin, particularly sensitive skin, of the subject concerned, such as the skin of the body or face, in an effective quantity, once or twice a day, for example in the morning and evening, or even more, and for example for a period of between 1 day and 1 month or more.

[0101] The application of the composition according to the invention may notably consist of spreading the composition over the entire surface of the damaged and / or irritated skin area, particularly sensitive skin, for example at a rate of 2 g / cm² 2 of skin.

[0102] The invention is also expressed in terms of a method for the therapeutic treatment of an area of ​​damaged and / or irritated skin on a subject in need, particularly a human, this method comprising the topical application, to this area of ​​skin, of an effective quantity of a composition according to the invention. 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 damaged and / or irritated skin.

[0103] The present invention also relates to a method of non-therapeutic cosmetic treatment of an area of ​​damaged and / or irritated skin of a subject, in particular a human, by topical application, on this area of ​​skin, of an effective quantity of a composition according to the invention.

[0104] Here again, this process can 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 damaged and / or irritated skin.

[0105] Another object of the invention relates to the non-therapeutic cosmetic use of a composition according to the invention for the treatment of an area of ​​damaged and / or irritated skin on a subject, particularly a human. This use includes the topical application of this composition to this area of ​​skin. It may have one or more of the characteristics described above with reference to the use of the composition according to the invention for the treatment of damaged and / or irritated skin.

[0106] The features and advantages of the invention will become clearer in light of the following implementation examples, provided by way of illustration only and in no way limiting the invention, with the support of Figure 1, which shows photographs of absorbent paper sheets after their application to films obtained by applying, respectively, in A / a composition according to the invention, and in B / and C1, compositions not according to the invention, with a hydrogenated vegetable oil content lower than that recommended by the invention. Visible oily traces on the sheets are highlighted by circles.

[0107] 1 / Example 1 - Composition according to the invention and comparative compositions

[0108] A composition according to the invention, named Inv1, and comparative compositions not in accordance with the invention, C1 to C8, all in the form of a water-in-oil emulsion, are described in Tables 1 and 2. In these tables, the contents of each of the ingredients are indicated as % by weight relative to the total weight of the composition.

[0109] The ingredient "Polyglyceryl-4 oleate and Polyglyceryl-3 polyricinoleate" (INCI name) contains 70-85% by weight of Polyglyceryl-4 oleate and 15-30% by weight of Polyglyceryl-3 polyricinoleate.

[0110] The hydrogenated vegetable oil (INCI name: Hydrogenated vegetable oil) used is composed of saturated and unsaturated fatty acids, mainly palmitic, oleic and stearic acids.

[0111] Castor oil (INCI name: Ricinus communis seed oil) and jojoba oil (INCI name: Simmondsia chinensis oil) are non-hydrogenated.

[0112] Table 1 - Composition according to the invention Inv1 and comparative compositions C1 to C6

[0113] Table 2 - Comparative compositions C7 and C8

[0114] For comparative compositions including polygyceryl-3 polyricinoleate mixed with another emulsifier, the weight content of polygyceryl-3 polyricinoleate relative to the total weight of emulsifiers contained in the composition is therefore as follows:

[0115] - C2: 15-30%

[0116] - C3: 12-24%

[0117] - C4: 80%

[0118] - C5: 83%.

[0119] The composition according to the invention Inv1 contains no other emulsifier than polygyceryl-3 polyricinoleate.

[0120] The dynamic viscosity at 25°C of the composition according to the invention Inv1 and that of the comparative composition C8 are measured using a Brookfield viscometer with the following parameters: speed 100 rpm, for 1 minute. The following results are obtained:

[0121] - Inv1: > 30,000 mPa.s (mobile 3),

[0122] - C8: < 3,000 mPa.s (mobile 2).

[0123] 2 / Example 2 - stability tests

[0124] Two different stability tests are performed.

[0125] 2.1 / ​​Freezing test - effect of emulsifiers

[0126] Reversed-phase emulsions are sensitive to cold, so a freeze / thaw test helps to select the least sensitive emulsions. The formulations are placed in a pillbox and put in the freezer at -18°C for 48 hours. They are then brought to room temperature and carefully examined.

[0127] Very often, liquid exudate is visible on the surface: in this case, the result of the freezing stability test is not satisfactory ("KO"). In the absence of such exudate, the result of the freezing stability test is satisfactory ("OK").

[0128] The results of this test are shown in Table 3.

[0129] Table 3 - Results of the freezing test

[0130] It is observed that compositions with sorbitan olivate (C1) as an emulsifier, or the mixture "polyglyceryl-4 oleate (70-85%) and polyglyceryl-3 polyricinoleate (15-30%)" (C2) are not sufficiently stable to pass the freezing test.

[0131] Similarly, formulas C3 to C5 which contain a mixture of at least 2 emulsifiers containing an amount of polyglyceryl-3 polyricinoleate lower than that recommended by the invention, do not appear to be stable.

[0132] Composition C6, which contains only 3% by weight of polyglyceryl-3 polyricinoleate, is also considered unstable.

[0133] Only the composition according to the invention Inv1, which contains 5% by weight of polyglyceryl-3 polyricinoleate, is stable after the freezing test.

[0134] 2.2 / Long-term stability test - effect of vegetable oil

[0135] The compositions are placed in an oven at 40°C for 3 months, then carefully examined. If unstable, a slight oily exudate appears on the surface ("KO"). If no such exudate is present, the stability test result is satisfactory ("OK").

[0136] The results obtained are shown in Table 4.

[0137] Table 4 - Stability test results

[0138] It is observed that compositions C7 and C8, which contain a non-hydrogenated vegetable oil, and are devoid of hydrogenated vegetable oil, do not appear stable when placed for 3 months at 40°C.

[0139] In particular, composition C8, based on an ingredient used in many compositions for the healing of anterior art, jojoba oil, proves unsatisfactory both in terms of stability over time and its viscosity (less than 3,000 mPa.s).

[0140] The inventors clearly demonstrate that only the reverse emulsion composition containing more than 3% w / w of polyglyceryl-3 polyricinoleate as an emulsifier, representing more than 90% by weight of the total weight of the emulsifiers in the composition, and hydrogenated vegetable oil, remains stable both after freezing and after 3 months at 40°C. The viscosity of this composition according to the invention is also advantageously greater than 30,000 mPa·s.

[0141] 3 / Example 3 - In vitro evaluation of the insulating effect of a composition according to the invention

[0142] An acid and base protection test is performed on a cellulose membrane.

[0143] The purpose of this test is to evaluate the amount of acid (hydrochloric acid HCl 1 N) and base (sodium hydroxide NaOH 1 N) that has passed through a cellulose membrane mounted on a Franz cell after 4 hours of contact. The membrane has been pre-treated with the test composition: either composition according to the invention Inv1 or pharmaceutical-grade white petrolatum (positive control). The acid-base titration is performed colorimetrically using a colored indicator (bromothymol blue).

[0144] The model used is a 0.45 µm cellulose membrane, 20 mg / cm² 2Samples of the composition to be tested are deposited onto the membrane (Inv1, n=6), and then 1 mL of a 1 M acid or base is applied to the coated surface. The same protocol is applied to pharmaceutical-grade white petrolatum (positive control, n=6). A negative control is also performed: no treatment (n=4). The receptors located under the membranes are collected after 4 h, and the amounts of acid or base that have passed through the membranes are determined by colorimetric analysis.

[0145] The results of this assessment of a barrier effect to acids and bases, in terms of % of base or acid having crossed the membranes, relative to the applied dose (mean ± esm), are summarized in Table 5 below.

[0146] Table 5 - Barrier effect to HCl and NaOH - ***P < 0.0001 versus negative control. Under negative control conditions (no treatment), 80% of the base and 93.5% of the acid were found in the receptor. In the presence of petrolatum, only 16% of the base and 7% of the acid crossed the membrane; this result was expected and validates the test.

[0147] The composition according to the invention Inv1 also presents a very important barrier effect: in fact, 82% protection against bases and almost 99% protection against acids is obtained.

[0148] The inventors clearly demonstrate that the compositions according to the invention, in the form of inverse emulsions which contain the combination of polyglyceryl-3 polyricinoleate as substantially the only emulsifier and hydrogenated vegetable oil, exhibit high insulating power.

[0149] 4 / Example 4 - Evaluation of the moisturizing effect of a composition according to the invention

[0150] The skin hydration capacity of the Inv1 composition was determined. To do this, a study measuring a hydration index was conducted on 22 subjects. Skin capacitance was measured by corneometry. The corneometer is a simple device that, when applied to the skin, measures its dielectric capacitance using a capacitor. This capacitance is directly related to the skin's hydration level.

[0151] Measurements were taken at various times (1 h, 2 h, 4 h, 6 h, and 24 h) after application of the composition according to the invention, Inv1, to the skin of the test subjects, and compared to those obtained for an untreated group of subjects. The results obtained, in terms of the percentage increase in the skin hydration index for subjects treated with the Inv1 composition, compared to untreated subjects, are summarized in Table 6 below.

[0152] Table 6 - Evaluation of the hydration index - ***P < 0.0001 versus untreated group

[0153] It therefore appears that the composition according to the invention is moisturizing, for at least 24 hours, with a single application.

[0154] 5 / Example 5 - Ex-vivo model of re-epithelialization

[0155] The aim of this study is to evaluate the efficacy of the composition according to the invention Inv1 on the re-epithelialization of the epidermis 40 hours after application to a wound. This study is conducted on human skin excipients; wound closure is quantified by confocal microscopy using specific dyes.

[0156] Human skin was obtained from patients undergoing abdominoplasty from 3 donors. After removal of the hypodermis, the skin excipients were cut using a punch (14 mm diameter) and stabilized in a chamber at 37°C in a humidified atmosphere with 5% CO2 for 1 hour.

[0157] Three superficial and standardized lesions in surface and depth are made by biopsy using a 2 mm diameter punch containing a stopper to normalize the depth of the wounds at the limit of the papillary dermis.

[0158] The compositions to be tested are applied (2.5 mg / cm²). 2 ) on the surface of the expiry samples. The biopsies are then kept alive at 37°C with 5% CO2 for 40 h.

[0159] After 40 h, the skin expungants are fixed in formalin to stop the re-epithelialization process, then they are labeled with WGA (wheat germ agglutinin), a dye specific to migrating cells, (Chen et al., Cell Discovery (2019) 5:13) and with Hoesch dye (specific to cell nuclei) to visualize the nuclei of the keratinocyte layer that close the wound.

[0160] All biopsies are analyzed superficially by confocal microscopy (RS-G4 microscope). This band mosaic image capture process is coupled with a proprietary image stitching algorithm to create cellular-level images with pixel-level precision and perfect homogeneity. Subsequently, using Imaris image analysis software, the initial and remaining wound surface areas are analyzed and quantified. Statistical analyses are performed with GraphPad PRISM software using a Student's t-test.

[0161] The experiments are repeated on N=3 human skin donors and n=3 wounds / conditions.

[0162] Several groups are created:

[0163] - Group 1: a control group without lesions;

[0164] - Group 2: a group with an epithelial lesion with application of a composition without a repairing purpose, the composition of which is detailed below: (INCI names): Aqua, caprylic / capric triglyceride, dicaprylyl carbonate, C12-C15 benzoate, cetyl phosphate potassium, stearyl alcohol, glyceryl stearate PEG-100 stearate, glycerin, xanthan gum, capryl glycol;

[0165] - Group 3: a group with an epithelial lesion and the application of a skin repair balm, the composition of which is detailed below: (INCI names): Aqua, Hydrogenated Polyisobutene, Dimethicone, Glycerin, Butyrospermum Parkii Butter / Shea Butter, Butylene Glycol, Aluminium, Starch Octenyl Succinate, Propanediol, Panthenol, Cetyl PPG / PEG-10 / 1 Dimethicone, Tristearin, Zinc Gluconate, Madecassoside, Manganese Gluconate, Magnesium Sulfate, Disodium EDTA, Copper Gluconate, Acetylated Glycol Stearate, Polyglyceryl-4 Isostearate, Sodium Benzoate, Phenoxyethanol, Chlorhexidine Digluconate, Cl 77891 / Titanium Dioxide;

[0166] - Group 4: a group with a lesion of the epithelium and the application of the composition according to the invention Inv1.

[0167] The results, in terms of % lesion closure (mean values ​​± standard error to the mean esm), are summarized in Table 7 below.

[0168] 40 h

[0169] After 40 hours, applying a standard, non-repairing composition to the epithelial lesion (group 2) did not result in wound closure (only 25% closure was observed). With the application of a repairing balm (group 3), the wound closure rate reached 56%.

[0170] Surprisingly, the inventors show that with a composition according to the invention (group 4), wound closure is further improved, with 66% of the wound closed. This closure percentage is statistically significantly better than that obtained with the repairing balm (group 3). It is important to remember that this composition according to the invention Inv1 contains no skin-repairing active ingredients, yet demonstrates a particularly significant skin-repairing effect.

[0171] 6 / Example 6 - Ex-vivo model of skin barrier repair

[0172] The skin protects our body from external aggressions such as pathogens, xenobiotics, and UV rays, and it prevents the loss of water and solutes. The skin barrier that fulfills these functions consists of a physical barrier, with the stratum corneum; a chemical barrier with antimicrobial peptides and an acidic surface pH; and an immunological barrier with immune cells.

[0173] The physicochemical properties of the stratum corneum, and therefore of the skin barrier, can be affected by exogenous substances such as certain surfactants present in some cosmetic products. This is the case with the surfactant sodium dodecyl sulfate (SDS), which tends to remain in the stratum corneum after rinsing. It can then disrupt the structure of the stratum corneum and degrade its barrier properties.

[0174] The aim of this study is to evaluate the effectiveness of a composition according to the invention in repairing the barrier after SDS treatment on human skin expiants.

[0175] Human skin was obtained from three donors undergoing abdominoplasty. After removal of the hypodermis, the skin excipients were sectioned to a thickness of 500 µm using a dermatome. The excipients were then cut with a 10 mm diameter punch and stabilized in a chamber at 37°C in a humidified atmosphere with 5% CO2 for 1 hour.

[0176] A 10% SDS solution is applied to the surface of the skin biopsies for 2 hours. After gentle washing with PBS (phosphate-buffered saline), the composition according to the invention, Inv1, is applied topically (5 mg / cm²). 2 ) on the surface of the expiry, then the expiry are maintained at 37°C at 5% CO2 for 16 h.

[0177] Lucifer Yellow is a small hydrophilic fluorescent dye that is retained in the stratum corneum. The presence of fluorescence only in the stratum corneum indicates an undamaged stratum corneum, functioning perfectly as a barrier. In contrast, after treatment with SDS, Lucifer Yellow penetrates deeper into the epidermis, indicating some permeability of the stratum corneum due to barrier impairment.

[0178] Skin expiants are incubated with a Lucifer yellow solution for 2 h at 37°C. Then, 6 mm punch biopsies are made, fixed in 4% paraformaldehyde and washed in PBS buffer before being incorporated into OCT (a type of glue that allows the samples to solidify while holding them) and stored at -80°C.

[0179] The controls include untreated or SDS-treated skin biopsies.

[0180] The experiments are repeated with n=3 donors, each with n=10 images.

[0181] The penetration of Lucifer Yellow into the stratum corneum was quantified using confocal microscopy. For each image, the penetration of Lucifer Yellow through the stratum corneum was analyzed using Octopus software with the HistoFluo plugin via fluorescence thickness measurement. Statistical analyses were performed using GraphPad PRISM software with a Student's t-test.

[0182] Results

[0183] Under normal conditions (no alteration on SDS), the probe (Lucifer yellow) is found to a thickness of 8.18 ± 0.76 µm (mean value ± standard error of the mean, ESM). With SDS stress, the stratum corneum is altered, becoming more permeable; Lucifer yellow is found to a greater depth, with a mean thickness of 18.62 ± 2.26 µm.

[0184] The application of the composition according to the invention Inv1 significantly reduces the penetration of Lucifer Yellow; the thickness penetrated by this fluorescent agent is only 9.81 ± 1.21 pm (p<0.01 versus SDS stress). The application of the composition according to the invention thus allows for skin barrier repair of approximately 85%.

[0185] 7 / Example 7 - Sensory profile of a composition according to the invention

[0186] The aim of this study is to evaluate the sensory characteristics of the composition according to the invention, Inv1. This evaluation is conducted monadically by 15 volunteers trained in sensory techniques for topical compositions. Three evaluation phases are performed: upon application of 0.5 mL of the Inv1 composition to the skin of a volunteer's forearm, and 5 and 15 minutes after application. The tests are carried out in a room with controlled lighting, temperature, and humidity.

[0187] Different criteria are evaluated and are detailed in Table 8 (for phase (1): at application) and Table 9 (for phases (2) and (3): respectively 5 min and 15 min after application). Table 8 - Descriptive criteria of phase (1): to the application

[0188] Table 9 - Descriptive criteria for phases (2) and (3): 5 min and 15 min after application

[0189] A computer-based questionnaire presents unstructured analog measurement scales from 0 to 100 for each of the descriptive criteria of the different phases on the computer screen. The results of the evaluation are summarized in Table 10 below.

[0190] Table 10 - Sensory evaluation of the composition Inv1

[0191] It should be noted that the sensory analysis results of this composition according to the invention are favorable. The desired film-forming effect is indeed achieved, particularly 5 minutes after application.

[0192] The sticky feeling often mentioned as a drawback of prior art products is present upon application but disappears quickly. Similarly, an oily effect is only noted at the time of application. Neither a soapy effect nor a lint-like effect is observed during application. The composition according to the invention therefore offers a very appealing sensory experience.

[0193] 8 / Example 8 - variation in hydrogenated vegetable oil content

[0194] The tests are carried out on several compositions not conforming to the invention (C10 to C12) and on the composition conforming to the invention, Inv1, described in Table 1 above. Compositions C10 to C12 are described in Table 11 below, in which the ingredient contents are expressed as a percentage by weight relative to the total weight of the composition (the water content always being greater than 50% by weight).

[0195] Table 11 - Comparative compositions C10 to C12

[0196] Comparative compositions C10 to C12 differ from the composition according to the invention Inv1 only in the content of hydrogenated vegetable oil, which is higher (C12) or lower (C10, C11) than the range of 3 to 10% by weight recommended by the invention.

[0197] 8.1 / Test 1 - Ease of spreading

[0198] This test, known as the "film puller" test, aims to characterize the spreading and homogeneity of the film formed by each composition. The results are representative of their spreading ability on the skin.

[0199] The device used is a film puller. It is placed at the base of a contrast card along which a scale graduated every cm has been drawn, on the black area of ​​the card, with the slit size number oriented towards the experimenter (30 pm).

[0200] For each composition, 1.5 ml is drawn using a pipette and deposited into the opening of the device, along the slit. The composition is then spread upwards on the card at a rate of 100 beats per minute (and 1 cm per beat). The quality of the resulting film is evaluated according to several criteria: uniformity of the spread and quality of the film formed.

[0201] We observe that the quality of the film is in line with what was expected for the 4 compositions: the film is smooth.

[0202] The spreading is uniform for the composition according to the invention Inv1 and for the comparative compositions C10 and C11. It is not uniform, and therefore non-compliant, for the comparative composition C12.

[0203] 8.2 / Test 2 - Oily / greasy appearance of the film formed

[0204] In this trial, for each composition, a film is formed on a contrast card using a film puller, as described in Trial 1 above, and then left to dry for 1 min.

[0205] A sheet of absorbent paper is then placed on the film and covered with a specific weight. After 2 minutes, the weight is removed, the absorbent paper is retrieved, and visually inspected for any transfer of the composition.

[0206] Photographs of the absorbent papers obtained for compositions Inv1, C11 and C10 are shown in the figure, respectively in A / , B / and CZ. It can be observed that the absorbent paper associated with composition Inv1 according to the invention bears no greasy traces, unlike those associated with the comparative compositions C10 and C11, which both show significant greasy traces, highlighted by circles in the photographs.

[0207] 8.3 / Test 3 - Stability

[0208] The Inv1 and C10 to C12 compositions are placed in a pillbox and frozen at -18°C for 48 hours. They are then brought to room temperature and examined using a polarizing microscope (OLYMPUS BX 60 optical microscope) equipped with two polarizing filters, called the polarizer and analyzer. The polarizer is placed over the light source, and the analyzer is placed between the objective lens and the eyepiece. By rotating the polarizer relative to the analyzer, the two filters can be crossed so that all light is blocked. Only objects with a lamellar structure capable of depolarizing light are then visible.

[0209] This test shows that, at the end of the freezing period, only composition Inv1 according to the invention exhibits a microcrystalline structure under polarized light, demonstrating that it remained stable during freezing. No microcrystalline structure is observed for the comparative compositions C10 and C11, which were therefore destabilized by freezing. Comparative composition C12, on the other hand, shows the presence of clusters under microscopic observation, thus also demonstrating a lack of stability during the freezing period.

Claims

DEMANDS 1. Dermo-cosmetic or dermatological composition applicable topically, in the form of a water-in-oil emulsion, characterized in that it comprises, by weight relative to the total weight of the composition: - at least 50% water, - at least 5% polyol(s), - 10 to 40% oily emollient(s) other than hydrogenated vegetable oils, - 3 to 10% hydrogenated vegetable oil(s), - polyglyceryl-3 polyricinoleate, in a content greater than 3% - optionally, one or more emulsifiers other than polyglyceryl-3 polyricinoleate, polyglyceryl-3 polyricinoleate then representing at least 90% by weight of the total weight of emulsifiers contained in the composition.

2. Composition according to claim 1, wherein at least one polyol is glycerin.

3. Composition according to claim 1 or 2, which is devoid of jojoba oil.

4. Composition according to any one of claims 1 to 3, which is free from paraffin, petrolatum and / or silicone.

5. Composition according to any one of claims 1 to 4, which is free of monoalcohols.

6. Composition according to any one of claims 1 to 5, wherein polyglyceryl-3 polyricinoleate is the sole emulsifier.

7. Composition according to any one of claims 1 to 6, wherein the total content of emulsifier(s) is greater than 3% and less than or equal to 8%, by weight relative to the total weight of the composition.

8. Composition according to any one of claims 1 to 7, wherein the total content of emulsifier(s) is between 4 and 6% by weight relative to the total weight of the composition.

9. Composition according to any one of claims 1 to 8, comprising at least caprylic / capric acid triglycerides as an oily emollient.

10. Composition according to any one of claims 1 to 9, including at least one dermo-cosmetically and / or dermatologically active agent.

11. Composition according to any one of claims 1 to 10, for use in treating an area of ​​damaged and / or irritated skin.

12. Composition for use according to claim 11, for treating an area of ​​sensitive skin.

13. Composition for its use according to claim 11 or 12, wherein said composition is applied topically to said area of ​​skin.

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