NEW COSMETIC COMPOSITIONS FOR SKIN REPAIR
A dermo-cosmetic composition using polyglyceryl-3 polyricinoleate and hydrogenated vegetable oil in a stable water-in-oil emulsion addresses instability and sensory issues, providing effective skin lesion repair and long-lasting moisturization.
Patent Information
- Application Number
- FR2024005580
- Authority / Receiving Office
- FR · FR
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-05-30
- Publication Date
- 2025-12-05
AI Technical Summary
Existing water-in-oil emulsions for skin repair are unstable, sensitive to cold, and often leave a shiny or oily appearance, with poor sensory experience and inadequate moisturizing properties, making them unsuitable for effective skin lesion repair.
A dermo-cosmetic composition comprising polyglyceryl-3 polyricinoleate as the primary emulsifier and hydrogenated vegetable oil, combined with polyols and other specific ingredients, forming a stable water-in-oil emulsion that provides a robust film-forming effect and long-lasting moisturization.
The composition achieves stability, insulating properties, and a pleasant sensory experience, with effective skin lesion repair and moisturization lasting up to 24 hours, without a sticky or oily residue.
Abstract
Description
Title of the invention: NEW COSMETIC COMPOSITIONS FOR SKIN REPAIR
[0001] 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.
[0002] More particularly, 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.
[0003] The skin is made up of different tissues forming a vital barrier for the body against the external environment. This barrier protects the body against external aggressions, particularly chemical or mechanical ones.
[0004] The skin consists of three main parts, a superficial one, the epidermis, an internal part, the dermis, and a deeper layer, the hypodermis, which interact with each other.
[0005] The human epidermis is composed of four to five distinct layers (depending on the anatomical site) and four types of cells: keratinocytes (the most numerous), melanocytes, Langerhans cells, and Merkel cells. Each of these cell types contributes, through 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 spinous layer, the granular layer, and finally the stratum corneum, which is the outermost layer of the epidermis.
[0006] Wound healing is a set of local defense mechanisms that occur after an injury: wound, burn, dermatological procedure, surgical intervention. Wound healing is a complex and dynamic biological process involving the interaction of numerous local and systemic factors in normal tissue repair.
[0007] The progression of wound healing involves several interdependent phases: hemostasis and inflammation, proliferation and remodeling. Proliferation involves three clearly observable processes: granulation, contraction, and re-epithelialization.
[0008] Wound healing also poses aesthetic problems when defects in healing, or poor healing, can occur, for example with age. The healing and recovery process of skin lesions thus becomes less efficient, and unsightly and almost permanent visible marks may remain.
[0009] All surgical, cosmetic medicine, dermatological interventions as well as non-medical traumatic lesions such as scrapes, cuts, scratches, burns, but also pathological ones, such as acne, involve a healing phenomenon and result in scars, more or less marked depending on the quality of this healing.
[0010] Several dermo-cosmetic or dermatological formulations exist that are suitable for repairing skin lesions, particularly those designed to promote proper healing. Water-in-oil emulsion-based cosmetic products are frequently used in this area of skin repair. However, emulsions of this type suffer from a problem of long-term stability. Furthermore, they are known to be very sensitive to cold, which also often leads to problems with stability and phase separation of the emulsion.
[0011] Thus, obtaining new water-in-oil emulsions that are truly stable and insensitive to cold is a real challenge.
[0012] Furthermore, there is always a need to develop new formulations to promote the repair of damaged skin, particularly to ensure effective skin lesion repair while maintaining a pleasant sensory experience. Certain criteria appear 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 or oily appearance on the skin, which is both visible and undesirable to the user. Prior art dermo-cosmetic formulations useful for treating damaged skin are often difficult to spread and have a significant sticky effect.
[0013] The present invention thus aims to provide a dermo-cosmetic or dermatological composition in the form of a water-in-oil emulsion, for topical application, which exhibits good efficacy for the treatment of damaged and / or irritated skin, in particular for the repair of skin lesions and for the protection and / or treatment of sensitive skin, and which exhibits good stability, whether over time or in cold environments. The invention further aims to ensure that this composition exhibits a good, robust, and persistent film-forming effect, giving it strong insulating properties, particularly 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.
[0014] 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.
[0015] More specifically, the inventors have developed a new dermo-cosmetic / dermatological composition in the form of a particularly stable water-in-oil emulsion, comprising a combination of a specific emulsifier, polyglyceryl-3 polyricinoleate, which is essentially the only emulsifier in the composition, and a hydrogenated vegetable oil. Unexpectedly, this combination has not only given the composition 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 composition, including at least one polyol, ensures a long-lasting moisturizing effect of up to 24 hours.
[0016] Thus, according to the present invention, a topically applicable dermo-cosmetic or dermatological composition is proposed, in the form of a water-in-oil emulsion, which comprises, by weight relative to the total weight of the composition: - at least 50% water, - at least 5%, preferably 5 to 20%, of 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%, preferably greater than or equal to 3.5% - 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.
[0017] As indicated above, such a composition, even without an active agent for repairing skin lesions, possesses in itself a significant action for repairing skin lesions. It is particularly effective, on its own, for the re-epithelialization of skin lesions as well as for repairing the skin barrier. Furthermore, it has a strong moisturizing capacity, combined with highly advantageous sensory properties, notably in terms of its non-sticky effect, ease of application, absence of a greasy or oily residue on the skin's surface, and its film-forming ability.
[0018] Throughout the remainder of this description, the term "skin" includes both the skin itself and mucous membranes. The term "cutaneous" includes both what relates to the skin and what relates to mucous membranes.
[0019] 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 particular emulsifier, namely polyglyceryl-3 polyricinoleate.
[0020] 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.
[0021] The composition according to the invention comprises at least one polyol.
[0022] According to the present invention, "polyol" (also called polyalcohol) is understood, in a classical manner, as a compound comprising a hydrocarbon chain with at least two carbon atoms and comprising at least two hydroxyl groups.
[0023] 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.
[0024] The polyol(s) used according to the invention can in particular be chosen from glycerin and its derivatives, and glycols and its 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 their constituents. mixtures.
[0025] 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.
[0026] 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.
[0027] In particular embodiments of the invention, the composition comprises 5 to 20% by weight, preferably 8 to 20% by weight, for example 8 to 15% by weight, or even 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.
[0028] 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.
[0029] The composition according to the invention comprises at least one oily emollient other than a hydrogenated vegetable oil.
[0030] In the present description, the term emollient is understood in a classical sense to mean a compound with properties of hydrating and softening the epidermis, when applied topically.
[0031] For convenience, in this description, "oily emollient" will refer to oily emollients other than hydrogenated vegetable oils.
[0032] Preferably, the composition according to the invention comprises less than 5 oily emollients, more particularly less than 4 oily emollients and more particularly still less than 3 oily emollients.
[0033] 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.
[0034] The oily emollient(s) contained in the composition according to the invention may be chosen from: - 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; - non-hydrogenated vegetable oils, such as sunflower, safflower, corn, olive, sweet almond, coconut, palm, soybean, pumpkin, grapeseed, sesame, hazelnut, apricot, macadamia, avocado, jojoba, and other oils borage, rapeseed, wheat germ, flax, evening primrose, argan, calendula, cotton, castor, Limnanthes alba, Silybum marianum, oats, etc. ; - 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; - synthetic esters and ethers, particularly of fatty acids, such as oils with the formulas RiCOOR2 and RiOR2, 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, triisocetyl citrate, 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; - and mixtures thereof.
[0035] 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 contained in the composition.
[0036] 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 not at all necessary to obtain the performance intended for the composition according to the invention.
[0037] 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.
[0038] Preferably, the composition according to the invention contains only one hydrogenated vegetable oil, or it contains 2 or 3 hydrogenated vegetable oils in total.
[0039] 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.
[0040] Preferably, the composition according to the invention comprises, as hydrogenated vegetable oil(s), at least rapeseed oil and / or palm oil.
[0041] 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 able to constitute the only hydrogenated vegetable oil present in the composition.
[0042] As examples of hydrogenated vegetable oil(s) that may be included in the composition according to the invention, hydrogenated vegetable oils composed of saturated and unsaturated fatty acids, preferably in the Cl6-C18 group, particularly those composed mainly of palmitic acid, oleic acid, and stearic acid, may be mentioned. 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 even 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.
[0043] The composition according to the invention may further comprise at least one waxy consistency factor other than a hydrogenated vegetable oil.
[0044] A waxy consistency factor is defined as a solid fat having a melting point above 45°C. For the purposes of the present invention, waxy consistency factors are not considered to be oily emollients.
[0045] 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.
[0046] Preferably, the composition according to the invention does not, however, contain any waxy consistency factor other than one or more hydrogenated vegetable oils.
[0047] 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.
[0048] 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.
[0049] 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.
[0050] 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.
[0051] Polyglyceryl-3 polyricinoleate may in particular be the only emulsifier in the composition according to the invention.
[0052] 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.
[0053] 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.
[0054] 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.
[0055] In particular embodiments, the composition according to the invention is devoid of emulsifiers such as: - polyglyceryl-2 sesquiisostearate, - polyglyceryl-3 diisostearate, - polyglyceryl-2 dipolyhydroxystearate, - potassium cetyl phosphate, - sorbitan olivate, - polyglyceryl-4 oleate.
[0056] The composition according to the invention may contain one or more gelling and / or thickening agents, or may be free of them. A gelling and / or thickening agent is defined as 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, and other similar substances. carob, Tamarindus indica seed gum, acrylates, and mixtures thereof.
[0057] The composition according to the invention is further 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. Moreover, petrolatum is comedogenic, flammable, and frequently suspected of causing skin burns.
[0058] 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.
[0059] 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 crosslinked structure, obtained by polymerization and / or polycondensation of functionalized silanes, and consisting essentially of a repetition of principal motifs in which the 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.
[0060] The composition according to the invention may contain one or more preservatives, or be free of them.
[0061] The composition according to the invention is also preferably free of phenoxyethanol, which is suspected of being an endocrine disruptor.
[0062] 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 should generally be avoided in compositions intended for application to skin with lesions.
[0063] Preferably, all substances having exfoliating properties, such as retinoids, are also avoided in the composition according to the invention.
[0064] In particular embodiments of the invention, the composition is devoid of ethylenediaminetetraacetic acid (EDTA). Alternatively, it may contain such an acid.
[0065] In particular embodiments of the invention, the composition is devoid of essential oil. Indeed, most essential oils contain Allergens, which can cause skin irritation and intolerance, should be avoided. Dyes with the same characteristics are also preferably avoided for similar reasons.
[0066] 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.
[0067] 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.
[0068] 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.
[0069] 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. For example, this viscosity may 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. This dynamic viscosity may, for example, be measured using a Brookfield viscometer by applying the following parameters: moving part 3, speed 100 rpm, for 1 minute.
[0070] In particular 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 a more complex tank cleaning procedure. The sanitizing effect of the composition, conventionally provided by zinc oxide, can, for example, advantageously be 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.
[0071] The composition according to the invention may further contain one or more emulsion stabilizers, such as magnesium sulfate, in particular in a content of between 0.1 and 2% by weight relative to the total weight of the composition.
[0072] 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 may be of any other type.
[0073] Each of such 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.
[0074] Healing agents may in particular be present in the composition according to the invention, alone or in combination, such as madecassoside, panthenol, allantoin, zinc sulfate, extracts of Aloe vera 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.
[0075] 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), in particular 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.
[0076] A method for preparing the composition according to the invention includes mixing its constituent ingredients, in particular in liquid form or dissolved in water.
[0077] The presence of polyglyceryl-3 polyricinoleate, as the predominant emulsifier, in the composition, proves particularly advantageous in such a process, as its incorporation into the composition is energy-efficient. This substance, which is liquid at room temperature, does not require any additional heating for its integration into the composition.
[0078] 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.
[0079] 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. Skin can be that of a mammal, particularly a human. It can notably refer to an area of skin on the body or face.
[0080] The term treatment encompasses in the present context both the repair, that is to say the attenuation of at least one of the physical signs of the 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.
[0081] Skin lesions may appear as a result of trauma or as a result of medical or surgical procedures, invasive or non-invasive, curative or for aesthetic purposes.
[0082] Damaged skin is defined herein 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.
[0083] Lesions following a dermatological, aesthetic or aesthetic medicine procedure may result from cryotherapy, mesotherapy, waxing, intense pulsed light treatment (hair removal) or laser treatment (hair removal, ablative laser, vascular laser, particularly for the treatment of rosacea, etc.), peeling, etc.
[0084] Irritated skin is defined as dry skin, tight skin, sensitive skin, or even atopic or atopic-prone skin.
[0085] 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, in particular, be an area of skin on the body or face.
[0086] 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 rays. There are also factors associated with age and skin type. Thus, sensitive skin is more common among dry skin types. or oily than among normal skin. For the purposes of the present invention, sensitive skin covers irritable and intolerant skin.
[0087] 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.
[0088] The application of the composition according to the invention may in particular consist of spreading the composition over the entire surface of the damaged and / or irritated skin area, in particular sensitive, for example at a rate of 2 g / cm2 of skin.
[0089] The invention is also expressed in terms of a method for the therapeutic treatment of an area of damaged and / or irritated skin of a subject in need of it, in particular a human, this method comprising the topical application, on this area of skin, of an effective quantity of a composition according to the invention.
[0090] 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.
[0091] The present invention also relates to a method for 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.
[0092] 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.
[0093] 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, in particular 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.
[0094] The features and advantages of the invention will become more apparent in the light of the following implementation examples, provided for illustrative purposes only and in no way limiting the invention.
[0095] 1 / Example 1 - Composition according to the invention and comparative compositions
[0096] A composition according to the invention, named Invl, and comparative compositions not in accordance with the invention, Cl 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.
[0097] 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.
[0098] The hydrogenated vegetable oil (INCI name: Hydrogenated vegetable oil) used is composed of saturated and unsaturated fatty acids, mainly palmitic, oleic and stearic acids.
[0099] Castor oil (INCI name: Ricinus communis seed oil) and jojoba oil (INCI name: Simmondsia chinensis oil) are non-hydrogenated.
[0100] [Tables] Ingrédient (nom INCI) Cl C2 C3 C4 C5 C6 Invl Sorbitan olivate 5 Polyglyceryl-4 oleate and Polyglyceryl-3 polyricin oleate 5 4 Polyglyceryl-3 diisostear ate 1 1 1 Polyglyceryl-3 polyricino leate 4 5 3 5 Caprylic / capric triglyceri des 15-25 15-25 15-25 15-25 15-25 15-25 15-25 Hydrogenated vegetable o il 4 4 4 4 4 4 4 Glycerin 5-20 5-20 5-20 5-20 5-20 5-20 5-20 Aqua Qsp (> 50) Qsp (> 50) Qsp (> 50) Qsp (> 50) Qsp (> 50) Qsp (> 50) Qsp (> 50) Magnésium sulfate 0,1-2 0,1-2 0,1-2 0,1-2 0,1-2 0,1-2 0,1-2
[0101] Tableau 1 - Composition selon l’invention Invl et compositions comparatives Cl à C6
[0102] [Tableaux2] Ingrédient (nom INCI) C7 C8 Polyglyceryl-3 polyricinoleate 5 5 Caprylic / capric triglycérides 15-25 15-25 Ricinus communis seed oil 5 Simmondsia chinensis oil 5 Glycerin 5-20 5-20 Aqua Qsp (>50) Qsp (>50) Magnésium sulfate 0,1-2 0,1-2
[0103] Tableau 2 - Compositions comparatives C7 et C8
[0104] For comparative compositions comprising 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: - C2: 15-30%, - C3: 12-24%, - C4: 80%, - C5: 83%. The composition according to the Invl invention contains no other emulsifier than polygyceryl-3 polyricinoleate.
[0105] The dynamic viscosity at 25°C of the composition according to the invention Invl and that of the comparative composition C8 are measured by a Brookfield viscometer applying the following parameters: speed 100 rpm, for 1 minute. The following results are obtained: - Invl: > 30,000 mPa.s (moving 3), - C8: < 3,000 mPa.s (moving 2).
[0106] 2 / Example 2 - stability tests
[0107] Two different stability tests are performed.
[0108] 2.1 / Freezing test - effect of emulsifiers
[0109] Reverse-phase emulsions are sensitive to cold, and therefore a freeze / thaw test allows the least sensitive emulsions to be selected.
[0110] The compositions are placed in a pillbox and put in the freezer at a temperature of -18°C for 48 hours. Then the compositions are brought to room temperature and thoroughly examined.
[0111] Very often a 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 an exudate, the result of the freezing stability test is satisfactory ("OK").
[0112] The results of this test are shown in Table 3.
[0113] [Tables3] Composition Cl C2 C3 C4 C5 C6 Invl Freezing test KO KO KO KO KO KO OK
[0114] Table 3 - Freezing test results
[0115] It is observed that compositions having sorbitan olivate (Cl) 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.
[0116] 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.
[0117] Composition C6, which contains only 3% by weight of polyglyceryl-3 polyricinoleate, is also considered unstable.
[0118] Only the composition according to the Invl invention, which contains 5% by weight of polyglyceryl-3 polyricinoleate, is stable after the freezing test.
[0119] 2.2 / Time stability test - effect of vegetable oil
[0120] 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").
[0121] The results obtained are shown in Table 4.
[0122] [Tables4] Composition C7 C8 Invl Stability test KO KO OK
[0123] Table 4 - Stability test results
[0124] 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 to be stable when placed for 3 months at 40°C.
[0125] In particular, composition C8, based on an ingredient used in many compositions for the healing of anterior art, jojoba oil, proves to be unsatisfactory both in terms of stability over time and its viscosity (less than 3,000 mPa.s).
[0126] 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 contained 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.
[0127] 3 / Example 3 - In vitro evaluation of an insulating effect of a composition according to the invention
[0128] An acid and base protection test is carried out on a cellulose membrane.
[0129] The purpose of this test is to evaluate the amount of acid (hydrochloric acid HCl IN) and base (sodium hydroxide NaOH IN) that has passed through a cellulose membrane mounted on a Franz cell after 4 hours of contact. The membrane has been previously treated with the composition to be tested: either the composition according to the invention Invl or pharmaceutical-grade white petrolatum (positive control). The acid-base titration is performed by colorimetric titration using a colored indicator (bromothymol blue).
[0130] The model used is a 0.45 µm cellulose membrane. 20 mg / cm² of the composition to be tested is deposited on the membrane (Invl, n=6), then 1 mL of 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.
[0131] The results of this evaluation 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.
[0132] [Tables5] % base or acid / dose applied Negative control Vaseline Invl Base 79.8 + 2.0 15.8 + 7.3 *** 18.1 + 6.3 *** Acid 93.5 + 2.9 6.7 + 3.5 *** 1.3 + 0.3 ***
[0133] Table 5 - Barrier effect to HCl acid and NaOH base - ***P < 0.0001 versus negative control
[0134] 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.
[0135] The composition according to the Invl invention also presents a very important barrier effect: in fact, 82% protection against bases and almost 99% protection against acids is obtained.
[0136] 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 a high insulating power.
[0137] 4 / Example 4 - Evaluation of the moisturizing effect of a composition according to the invention
[0138] The skin hydration capacity of the Invl composition was determined. To do this, a study measuring a hydration index was carried out on 22 subjects. Skin capacitance was measured by corneometry. The corneometer is a simple device that, when applied to the skin, measures its dielectric capacity using a capacitor. This is directly related to its hydration level.
[0139] Measurements were taken at different times (1h, 2h, 4h, 6h and 24h) after application of the composition according to the invention, Invl, to the skin of the test subjects, and compared to those obtained for a group of untreated subjects. The results obtained, in terms of the % increase in the skin hydration index for subjects treated with the Invl composition, compared to untreated subjects, are summarized in Table 6 below.
[0140] [Tableauxô] Time + 1h + 2h + 4h + 6h + 24h % increase in hydration index g4*** 76*** 65*** 55*** 21***
[0141] Table 6 - Evaluation of the hydration index - ***P < 0.0001 versus untreated group
[0142] It therefore appears that the composition according to the invention is moisturizing, for at least 24 hours, with a single application.
[0143] 5 / Example 5 - Ex-vivo model of re-epithelialization
[0144] The aim of this study is to evaluate the efficacy of the composition according to the invention, Invl, on the re-epithelialization of the epidermis 40 hours after application to a wound. This study is carried out on human skin excipients; wound closure is quantified by confocal microscopy using specific dyes.
[0145] Human skin is obtained from patients undergoing abdominoplasty from 3 donors. After removal of the hypodermis, the skin expiants are 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.
[0146] 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.
[0147] The compositions to be tested are applied (2.5 mg / cm2) to the surface of the expiry samples. The biopsies are then kept alive at 37°C with 5% CO2 for 40 h.
[0148] After 40 h, the skin expiants 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 Hoesch stain (specific to cell nuclei) to visualize the nuclei of the keratinocyte layer that close the wound.
[0149] All biopsies are analyzed on the surface 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. Then, using Imaris image analysis software, the initial wound surface area and the remaining wound surface area are analyzed and quantified.
[0150] Statistical analyses are performed with GraphPad PRISM software using a Student's t-test.
[0151] The experiments are repeated on N=3 human skin donors and n=3 wounds / conditions.
[0152] Several groups are made: - Group 1: a control group without lesions; - 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; - 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, CI 77891 / Titanium Dioxide; - Group 4: a group with a lesion of the epithelium and the application of the composition according to the invention Invl.
[0153] The results, in terms of % lesion closure (mean values ± standard error to the mean esm), are summarized in Table 7 below.
[0154] [Tables7] Group 1 2 3 4 % closure of 1 lesion 0 + 0 24.6 + 2.7 56.0 + 3.2 65.9 + 1.5
[0155] Table 7 - Effect of applying the compositions to a skin wound after 40 h
[0156] After 40 h, the application to the epithelial lesion of a "standard" composition without a reparative aim (group 2) does not allow the wound to close (only 25% closure is observed).
[0157] With the application of a repairing balm (group 3), the percentage of lesion closure reaches 56%.
[0158] 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 note that this composition according to the Invl invention contains no skin-repairing active ingredient, yet demonstrates a particularly significant skin-repairing effect.
[0159] 6 / Example 6 - Ex-vivo model of skin barrier repair
[0160] 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 comeum, a chemical barrier with antimicrobial peptides and an acidic surface pH, and an immunological barrier with immune cells.
[0161] 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 the skin. It can then disrupt the structure of the stratum corneum and degrade its barrier properties.
[0162] 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.
[0163] Human skin is obtained from patients undergoing abdominoplasty from 3 donors. After removal of the hypodermis, the skin excipients are sectioned to a thickness of 500 µm using a dermatome. The excipients are cut using a punch (10 mm diameter) and stabilized in a chamber at 37°C in a humidified atmosphere with 5% CO2 for 1 h.
[0164] A 10% SDS solution is applied to the surface of the skin biopsies for 2 h. After gentle washing with PBS (Phosphate buffered Saline), the composition according to the invention Invl is applied locally (5 mg / cm2) to the surface of the expiry, then the expirys are maintained at 37°C at 5% CO2 for 16 h.
[0165] 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 unaltered stratum corneum, which is 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.
[0166] 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.
[0167] Controls include untreated or SDS-treated skin biopsies.
[0168] Experiments are repeated with n=3 donors, each with n=10 images.
[0169] The penetration of Lucifer Yellow into the stratum corneum is quantified using confocal microscopy. For each image, the penetration of Lucifer Yellow through the stratum corneum is analyzed using Octopus software with the HistoFluo plugin via fluorescence thickness measurement. Statistical analyses are performed using GraphPad PRISM software with a Student's t-test.
[0170] Results 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.
[0171] Application of the composition according to the Invl invention 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). Application of the composition according to the invention thus allows for skin barrier repair of approximately 85%.
[0172] 7 / Example 7 - Sensory profile of a composition according to the invention
[0173] The aim of this study is to evaluate sensory characteristics of the composition according to the Invl invention.
[0174] This evaluation is carried out monadically by 15 volunteers trained in the sensory technique for topical compositions. Three evaluation phases are carried out: upon application of 0.5 mL of the Invl composition to the skin of a volunteer's forearm, and 5 minutes and then 15 minutes after application.
[0175] The tests are carried out in a room where the lighting, temperature and humidity are controlled.
[0176] 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).
[0177] [Tables8] Criteria Description Ease of Spreading Product's ability to spread easily on the skin Lathering Whiteness upon application (reminiscent of shaving soap), swirling generates a slightly foamy white Oily Like cooking oil between the fingers Stickiness Adhesion of the finger or hand to the application area
[0178] Table 8 - Descriptive criteria of phase (1): to the application
[0179] [Tables9] Criteria Description Film-forming Persistence of a film on the skin Oily Like cooking oil between the fingers Tightening Sensation of pulling Suppleness Skin elasticity Sticky Adhesion of the finger or hand to the product application area Linting Formation of small particles on the application area
[0180] Table 9 - Descriptive criteria for phases (2) and (3): 5 min and 15 min after application
[0181] A computer questionnaire presents unstructured analog measurement scales from 0 to 100, for each of the descriptive criteria of the different phases on the computer screen.
[0182] The results of the evaluation carried out are summarized in Table 10 below.
[0183] [TableauxlO] Descriptive criteria Composition according to the invention Invl Ease of spreading - application 42 Lathering - application 9 Oily - application 46 Oily - 5 min 26 Oily - 15 min 9 Tension - 5 min 18 Tension - 15 min 13 Suppleness - 5 min 59 Suppleness - 5 min 56 Sticky - application 48 Sticky - 5 min 23 Sticky - 15 min 13 Film-forming - 5 min 42 Film-forming - 15 min 28 Linty - 5 min 0 Linty - 15 min 0
[0184] Table 10 - Sensory evaluation of the Invl composition
[0185] 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.
[0186] The sticky effect, 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 at the time of application.
[0187] The composition according to the invention therefore presents a very interesting sensory experience.
Claims
Demands
1. Topically applicable dermo-cosmetic or dermatological composition 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 devoid 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, comprising at least one dermo-cosmetically and / or dermatologically active agent.
11. Composition according to any one of claims 1 to 10, for its use in the treatment of an area of damaged and / or irritated skin.
12. Composition for its use according to claim 11, for the treatment of 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.
Citation Information
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