Hyperbranched dextrins for topical use in the prevention or treatment of at least one symptom of skin inflammation
Patent Information
- Application Number
- EP2023716766
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-03-30
- Filing Date
- 2023-03-30
- Publication Date
- 2025-02-05
AI Technical Summary
Current treatments for skin and mucosal inflammation, such as redness, heat, swelling, and pain, often involve irritating ingredients in cosmetic or dermatological compositions, which can cause adverse reactions, especially in sensitive skin, and there is a need for effective natural or plant-derived agents to prevent or treat these symptoms.
Hyperbranched dextrins, particularly hydrogenated hyperbranched dextrins, are used topically to reduce inflammation markers like IL-1α, IL-1β, RANTES, and VEGF, and improve skin hydration by maintaining the integrity of skin membranes, similar to betamethasone, while minimizing the irritant effects of composition ingredients.
Hyperbranched dextrins effectively reduce symptoms of skin and mucosal inflammation, including redness and transepidermal water loss, maintaining skin hydration and barrier function, and can be used to mitigate the irritant effects of composition ingredients, making them suitable for sensitive skin.
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Abstract
Description
Description Title: HYPERBRANCHED DEXTRINS FOR THEIR TOPICAL USE FOR THE PREVENTION OR TREATMENT OF AT LEAST ONE SYMPTOM OF SKIN INFLAMMATION. Technical field
[0001] The present invention relates to hyperbranched dextrins, preferably hyperbranched and hydrogenated dextrins for their topical use for the prevention or treatment of at least one symptom chosen from redness, heat, swelling and pain, as well as for the prevention or treatment of symptoms of skin inflammation and inflammation of the mucous membranes. It also relates to the use of these hyperbranched dextrins, and preferably hyperbranched and hydrogenated dextrins, for preventing or reducing or eliminating the irritant effect induced by ingredients contained in cosmetic or dermatological or other compositions. State of the art
[0002] The skin constitutes both a living anatomical barrier and an exchange zone between the body and its environment, the effectiveness of which determines the maintenance of a good homeostatic balance. It comprises a superficial layer made up of the epidermis, and deeper layers forming the dermis and the hypodermis. Each of these layers has specific properties allowing the whole to react and adapt to the conditions of its environment.
[0003] The mucous membranes covered by this application are the membranes that line the internal cavities of the body, chosen from the mouth and the genitals. This lining is a stack of cells called epithelium. Within this epithelium are specific cells that produce mucus, hence their name. This mucus serves to lubricate and protect the organ that is lined with it. The mucous membranes therefore play a protective role and are connected to the skin. We can thus sometimes observe inflammation of the mucous membrane, a fold of the mucous membrane, or lesions of the mucous membranes.
[0004] As the body's protective barrier, the skin and mucous membranes are subject to numerous attacks which can lead to uncomfortable reactions or even, in the case of very intense or more serious reactions, to skin or mucous membrane inflammation.
[0005] Skin inflammation can be induced in particular by skin irritation that occurs when the skin comes into contact with irritants, such as chemical substances like cleaners, or such as mechanical actions like shaving, BR874 - NUTRIOSE / SOOTHING / THERAPEUTIC-WO exfoliation, peeling, hair removal. Skin irritation can also be caused by temperature, climate, ultraviolet radiation, or air pollution.
[0006] Irritation of the mucous membranes, for example the oral mucosa, can also be induced by certain foods or drinks leading, for example, to the formation of mouth ulcers, or by friction, for example from brushing with a toothbrush. The genital mucosa can also be irritated locally, following repeated friction, overly aggressive soap, an excess of eggs, very close intercourse on a slightly dry mucosa or an unbalanced flora.
[0007] These irritants cause irritation of the skin or mucous membranes, which activates the innate immune response, the first step of which is inflammation of the irritated tissues or mucous membranes. Skin or mucous membrane inflammation can also be caused by pathologies involving an inflammatory process.
[0008] The action of an irritating chemical substance depends on its ability to penetrate the upper layer of the skin, the stratum corneum, which acts as a protective barrier. Regarding mucous membranes, the penetration of an irritating chemical substance is much easier because mucous membranes do not have a physical barrier made of keratin cells, but are simply made of non-keratinized epithelial cells into which the substance can easily penetrate. Once the skin barrier has been crossed, or once it has penetrated the mucous membrane, the irritating substance then comes into contact with living cells and interacts with the endogenous substances naturally present in the latter, thus leading to disruptions in the biological functioning of the skin or mucous membrane cells, or even tissue damage. The first biological response is an acute inflammatory reaction of the cells of the damaged tissue.This reflects a defense of the cells against the invasive product in order to accelerate its elimination according to the innate immune response.
[0009] Irritants cause reversible skin damage. By applying them directly to the epidermal surface, their irritant potential can be assessed through various parameters such as the expression levels of key biomarkers involved in skin inflammation.
[0010] The inflammatory phenomenon is composed of four symptoms: pain, heat, redness and swelling of the tissue. Its intensity is proportional to the degree of irritation (dose-dependent response) as well as to the quantity of cytokines produced by the keratinocytes of the epidermis in order to induce and control the early inflammatory response. Cytokines having a major role in the inflammatory cellular response are interleukins IL-1α, IL-6 and IL-8 and tumor necrosis factor α (TNF-α). IL-1β, IL-8, RANTES and VEGF are also biomarkers of inflammation.
[0011] There is a continuing need for new agents, of natural or plant origin, capable of effectively preventing or treating a symptom chosen from redness, heat, pain and swelling as well as effectively preventing or treating skin or mucous membrane inflammation.
[0012] Furthermore, compounds known to be irritants to the skin, such as oxidizing products used for example in hair coloring, abrasive products such as synthetic microplastics, mineral powders or pigments in cosmetic creams, surfactants and solvents used in washing or cleaning compositions, acids such as salicylic acid used in peels, compositions for exfoliating the skin or promoting cell renewal, or even retinoids used in anti-aging compositions, are generally used in low doses. However, the use of even small quantities of these compounds can cause irritation in the case of sensitive skin.
[0013] It is therefore also necessary to identify compounds which make it possible to prevent, reduce or eliminate the irritant effect of ingredients, in particular ingredients contained in topical compositions for cosmetic, dermocosmetic, dermatological, pharmaceutical, medicinal, veterinary or domestic use. Summary
[0014] The applicant has demonstrated, using a two-dimensional reconstructed human epidermis model, that the hydrogenated hyperbranched dextrins according to the invention induce a reduction in 4 biomarkers involved in inflammation (IL-1α, IL-1β, RANTES and VEGF).
[0015] The dosage of the inflammation markers IL-1α and IL-8 (following inflammation by sodium lauryl sulfate (SLS) in aqueous solution at 0.5% by weight for 6 hours) showed an action profile of hydrogenated hyperbranched dextrins similar to the action of Betamethasone at 0.05%, a positive reference control for the anti-inflammatory effect.
[0016] Following these results, additional research was carried out and revealed additional inflammation biomarkers, also impacted by the treatments carried out.
[0017] In this subsequent study, IL-1α assay confirmed the previously obtained results. Indeed, overexpression of IL-1α upon treatment with SLS was compensated by treatment with hydrogenated hyperbranched dextrins and allowed to fall below the threshold value of interleukin overexpression. A decrease in the expression of RANTES and VEGF was also observed by treatment with hydrogenated hyperbranched dextrins after SLS inflammation. In addition, it was also shown that IL-1 β is underexpressed in the presence of treatment with hydrogenated hyperbranched dextrins.
[0018] Thus, it was found that, for these 4 biomarkers involved in the mechanism of inflammation, treatment with hydrogenated hyperbranched dextrins induced a reduction in these signals.
[0019] The applicant has also demonstrated that hyperbranched dextrins according to the invention make it possible to maintain the integrity of the membranes of the cells of the reconstructed human epidermis, and this in a manner as effective as betamethasone.
[0020] It has also been demonstrated by the applicant that the application of an aftershave lotion comprising hyperbranched and hydrogenated dextrins according to the invention made it possible to reduce intracellular water loss compared to the placebo lotion.
[0021] Finally, the applicant has shown that the dextrins according to the invention significantly reduce the redness caused by SLS from 10 minutes compared to the placebo group and the reference group, this reduction being maintained for up to 7 days. It has also been demonstrated that the dextrins according to the invention make it possible to significantly reduce transepidermal water loss from 30 minutes after application, then in a progressively increased manner over the treatment period ranging from 2 to 7 days, to reach a value of reduction in water loss compared to the placebo group greater than approximately 6.6 units (i.e. a difference of approximately 195%). The dextrins according to the invention therefore make it possible to maintain skin hydration by maintaining the skin's barrier function.
[0022] Thus, the present invention relates to hyperbranched dextrins, preferably hyperbranched and hydrogenated dextrins for their topical use for the prevention or treatment of at least one symptom chosen from redness, heat, swelling and pain.
[0023] The present invention also relates to the use of hyperbranched dextrins, preferably hyperbranched and hydrogenated dextrins, to prevent or reduce or eliminate the irritant effect of ingredients contained in topical compositions for cosmetic, dermocosmetic, dermatological, pharmaceutical, medicinal, veterinary or domestic use (for example detergents). Detailed Description
[0024] Hyperbranched dextrin
[0025] According to a first embodiment, the dextrins useful for the therapeutic use which is the subject of the present application are hyperbranched dextrins.
[0026] By "dextrin", the applicant means glucose polymers obtained from granular starch by pyroconversion, usually by the action of an acid in a generally dry medium, that is to say on granules in the form of dry solid particles, containing residual moisture imposed by the conditions of physical equilibrium at a given temperature and pressure. Thus, maltodextrins and pyrogenic dextrins fall within the general family of dextrins useful in the invention when they have been modified to be hyperbranched.
[0027] In the context of the invention, by "dextrin", the applicant also means glucose polymers resulting from the liquefaction or hydrolysis of starch by acid or enzymatic means and generally called "maltodextrin", "starch hydrolysate" or "glucose syrup", provided that these polymers have been additionally modified by chemical or enzymatic means, in particular by branching enzymes, to have glucosidic bonds between the anhydroglucose molecules, significantly different in terms of nature from those of the starch from which they are derived. Thus, maltodextrins, starch hydrolysates, glucose syrups and pyrogenic dextrins fall within the general family of dextrins useful for the invention provided that they differ in terms of carbohydrate bonds from the starch from which they are derived, including "atypical" bonds.
[0028] By "hyperbranched dextrin", the applicant means a "dextrin" having glucosidic bonds between the anhydroglucose molecules, significantly different in terms of nature and quantity, from those naturally constituting the starch from which it is derived. It contains glucosidic bonds between anhydroglucose molecules naturally present, the 1-6 bonds, but in greater quantity, and glucosidic bonds not naturally present in starch, called "atypical", the 1-3 and 1-2 bonds. Thus, a hyperbranched dextrin is a dextrin containing a large proportion of branching glucosidic bonds compared to the total number of glucosidic bonds present in said dextrin. The term "hyperbranched" can also be replaced by the term "highly branched".
[0029] By "large proportion" is meant a proportion of branching glucosidic bonds greater than or equal to 5% relative to the sum of branching glucosidic bonds and linear glucosidic bonds, preferably greater than or equal to 10%, more preferably greater than or equal to 20%, more preferably greater than or equal to 30%, more preferably greater than or equal to 40%, more preferably greater than or equal to 50%. Branching glucosidic bonds are bonds generating non-linear chains, in proportions greater than the normal values of a native starch. The glucosidic bonds generating non-linear chains are the 1-6, 1-3, and 1-2 glucosidic bonds, as illustrated in Figure 1 [FIG 1]. The 1-3 and 1-2 bonds are the atypical glucosidic bonds. The normal values for these bonds in a native starch are approximately 5% for the 1-6 bonds, and approximately 0% for the 1-2 and 1-3 bonds. The remainder is composed of the 1-4 glucosidic bonds, or approximately 95%. The 1-4 bond is a bond that creates a linear bond.
[0030] For the 1-6 glucosidic bonds, characteristic values of the hyperbranched dextrins useful in the invention are values greater than 5% relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds, preferably greater than or equal to 10%, relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds and more preferably greater than or equal to 12% relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds, and most preferably greater than or equal to 15% relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds.
[0031] Thus, according to one embodiment, the hyperbranched dextrins comprise at least 5%, preferably at least 10%, preferably at least 12%, preferably at least 15% of 1-6 glucosidic bonds relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds.
[0032] For the 1-2 and 1-3 glucosidic bonds, the values useful for the invention are values greater than 1% relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds, preferably greater than or equal to 5% relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds, and more preferably greater than or equal to 10% relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds.
[0033] Thus, according to one embodiment, the hyperbranched dextrins comprise at least 1%, preferably at least 5%, preferably at least 10%, and preferably at least 20% of 1-2 glucosidic bonds relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds.
[0034] According to one embodiment, the hyperbranched dextrins comprise at least 1%, preferably at least 5%, preferably at least 10% and preferably at least 20% of 1-3 glucosidic bonds relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds.
[0035] For the 1-4 glucosidic bonds, the values useful for the invention are values less than 90%, preferably less than 70%, preferably less than 60%, preferably less than 50%, relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds and preferably between 42 and 50%, relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds.
[0036] Thus, according to one embodiment, the branched dextrins comprise at most 90%, preferably at most 70%, preferably at most 50% of 1-4 glucosidic bonds relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds.
[0037] Preferably, the hyperbranched dextrins, preferably hyperbranched and hydrogenated, useful in the invention have a content of 1-6 glucosidic bonds of between 5% and 40%, preferably between 10% and 30%, more preferably between 12% and 22%, and most preferably between 15 and 20% relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds.
[0038] According to one embodiment, the hyperbranched dextrins, preferably hyperbranched and hydrogenated, useful in the invention, comprise: - at most 90% of 1-4 glycosidic bonds, - at least 5% of 1-6 glucosidic bonds, relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds.
[0039] According to one embodiment, the hyperbranched dextrins, preferably hyperbranched and hydrogenated, useful in the invention, comprise: - at most 70% of 1-4 glucosidic bonds, - at least 5% of 1-6 glucosidic bonds, relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds.
[0040] According to one embodiment, the hyperbranched dextrins, preferably hyperbranched and hydrogenated, useful in the invention have: - from 5% to 40%, preferably between 10% and 30%, more preferably between 12% and 22%, and most preferably between 15 and 20% of 1-6 glucosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 42 to 50% of 1-4 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 1 to 20% of 1-3 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 1 to 20% of 1-2 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds.
[0041] According to one embodiment, the hyperbranched dextrins, preferably hyperbranched and hydrogenated, useful in the invention have: - at least 5% of 1-6 glucosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at least 10%, more preferably at least 12%, and most preferably at least 15%, - at most 70% of 1-4 glucosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at most 60%, and most preferably at most 50%, - at least 1% of 1-3 glucosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at least 5%, more preferably at least 10%, and most preferably at least 20%, - at least 1% of 1-2 glucosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at least 5%, more preferably at least 10%, and most preferably at least 20%.
[0042] According to one embodiment, the hyperbranched dextrins, preferably hyperbranched and hydrogenated, useful in the invention have: - from 5 to 40%, preferably from 10 to 30%, more preferably from 12 to 22%, and most preferably from 15 to 20% of 1-6 glucosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 42 to 70%, preferably from 42 to 60%, of 1-4 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 1 to 20%, preferably from 1 to 10%, more preferably from 5 to 15%, and most preferably from 5 to 10%, of 1-3 glucosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 1 to 20%, preferably from 1 to 10%, more preferably from 5 to 15%, and most preferably from 5 to 10%, of 1-2 glucosidic bonds relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds.
[0043] Apart from the use of a well-known pyroconversion process applied to granular starch to prepare dextrins, i.e. by using an acid on a granular starch, typically at high temperature in a dry environment, these branching bond contents of a starch can also be obtained by the action of a so-called "branching" or "rebranching" enzyme on a liquefied starch, such as a maltodextrin, a starch hydrolysate or a glucose syrup, possibly previously or subsequently hydrogenated.
[0044] These branching bond contents can therefore be obtained both by the action of a so-called "branching" or "rebranching" enzyme on a starch liquefied and / or by the action of an acid, typically at high temperature in a dry environment, on a granular or liquefied starch.
[0045] The determination of the contents of 1-2, 1-3, 1-4 and 1-6 glucosidic bonds can be carried out by using the classical methylation technique described in HAKOMORI, S., 1964, J. Biochem., 55, 205. “A rapid Permethylation of Glycolipid, and Polysaccharide Catalyzed by Methylsulfinyl Carbanion in Dimethyl Sulfoxide”. This method allows the chemical characterization of glucosidic bonds by differentiating between free OH groups and bound groups. It is a destructive method comprising the steps of methylation, hydrolysis, reduction with NaBD4, acetylation and analysis by mass spectrometry.
[0046] According to one embodiment, said hyperbranched dextrins have a number-average molecular mass Mn less than or equal to 10,000 g / mol, preferably less than or equal to 4,500 g / mol, more preferably between 1,000 and 3,500 g / mol, even more preferably between 1,500 and 3,500 g / mol, and most preferably between 1,800 and 3,200 g / mol.
[0047] According to one embodiment, said hyperbranched dextrins have a polymolecularity index, ratio of the weight-average molar mass to the number-average molar mass, noted IP, less than or equal to 15, preferably less than or equal to 10, more preferably less than or equal to 5, and most preferably less than or equal to 3.
[0048] The values of Mn, Mw and IP are measured by size exclusion chromatography, based on the selective retention of solute molecules according to their size, due to their penetration or not into the pores of the stationary phase. The size exclusion chromatography columns used are the PSS SUPREMA 100 and the PSS SUPREMA 1000 connected in series and coupled to a light scattering detector.
[0049] According to one embodiment, said hyperbranched dextrins have a reducing sugar content of less than or equal to 20%, preferably less than or equal to 15%, more preferably less than or equal to 10%, even more preferably less than or equal to 6%, and most preferably less than or equal to 3% relative to the total mass of the hyperbranched dextrin. The reducing sugar content, expressed as glucose, by weight relative to the dry weight of the product analyzed, is determined by the BERTRAND method.
[0050] According to one embodiment, the hyperbranched dextrins useful in the invention have a relatively high content of residual 1-4 glucosidic bonds. This content of 1-4 glucosidic bonds is between 42 and 50% relative to the sum 1-2, 1-3, 1-4 and 1-6 bonds, in combination with a content of 1-6 glucosidic bonds of between 12 and 22% relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds. Preferably, the hyperbranched dextrins useful in the invention have a ratio of 1-4 / 1-6 glucosidic bonds of between 1.9 and 4.2 and in particular of between 2.3 and 3.5.
[0051] According to one embodiment, the hyperbranched dextrins useful in the invention have a content of 1-3 glucosidic bonds of between 1 and 10% relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds, in combination with a content of 1-4 glucosidic bonds of between 42 and 50% relative to the sum of the 1-2, 1-3, 1-4 and 1-6 bonds. Preferably, the hyperbranched dextrins useful in the invention have a ratio of 1-4 / 1-3 glucosidic bonds of between 0.02 to 0.24 and in particular of between 0.1 and 0.2. According to one embodiment, the hyperbranched dextrins useful in the invention have a content of 1-2 glucosidic bonds of between 1 and 10%, in combination with a content of 1-4 glucosidic bonds of between 42 and 50%.Preferably, the hyperbranched dextrins useful in the invention have a ratio of 1-4 / 1-2 glucosidic bonds of between 0.02 and 0.24 and in particular of between 0.1 and 0.2.
[0052] According to one embodiment, the hyperbranched dextrins useful in the invention have: - from 5% to 40% of 1-6 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - a reducing sugar content less than or equal to 20% relative to the total mass of the hyperbranched dextrin, - a polymolecularity index less than or equal to 15, - and a number-average molecular mass Mn less than or equal to 4500 g / mole.
[0053] According to one embodiment, the hyperbranched dextrins useful in the invention have: - from 10% to 30% of 1-6 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 42 to 70% of 1-4 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - a reducing sugar content less than or equal to 10% relative to the total mass of the hyperbranched dextrin, - a polymolecularity index less than or equal to 10, - and a number-average molecular mass Mn between 1000 and 3500 g / mole.
[0054] According to one embodiment, the hyperbranched dextrins useful in the invention have: - from 12% to 22% of 1-6 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 42 to 50% of 1-4 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 1 to 20% of 1-3 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 1 to 20% of 1-2 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - a reducing sugar content less than or equal to 6% relative to the total mass of the hyperbranched dextrin, - a polymolecularity index less than or equal to 5, - and a number-average molecular mass Mn between 1500 and 3000 g / mole.
[0055] Hyperbranched dextrins useful for the invention are commercially available, such as the products “Nutriose® FM 06”, “Nutriose® FM 10” and “Nutriose® FM15S from Roquette®, or the product range “Promitor® Soluble fiber” from Tate & Lyle.
[0056] Other commercial products available under the names “STA-LITE® Polydextrose” from Tate & Lyle, or “Oliggo-fiber®” from Cargill, are hyperbranched polysaccharides or oligosaccharides which, as such or after possible hydrogenation, could presumably exhibit a soothing property like the hyperbranched dextrins according to the subject matter of the present application.
[0057] Hyperbranched and hydrogenated dextrins
[0058] According to a second embodiment, the dextrins useful for the non-therapeutic use which is the subject of the present application are hyperbranched and hydrogenated dextrins. Such dextrins can be obtained by subjecting the hyperbranched dextrins according to the subject of the present application to hydrogenation, or by applying a “branching” or “rebranching” process to a previously hydrogenated dextrin. The hydrogenation can for example be carried out by subjecting an aqueous solution of hyperbranched dextrin to gaseous hydrogen in the presence of a catalyst such as Raney nickel.
[0059] To the embodiments previously presented for hyperbranched dextrins, an additional characteristic can thus advantageously be added, namely, a reducing sugar content of less than or equal to 5% by weight, preferably less than or equal to 3% by weight, more preferably less than or equal to equal to 2% by weight, more preferably less than or equal to 1% by weight, more preferably less than or equal to 0.5% by weight, and most preferably less than or equal to 0.15% by weight.
[0060] According to one embodiment, the hyperbranched and hydrogenated dextrins useful in the invention have: - from 5% to 40% of 1-6 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - a reducing sugar content less than or equal to 4% relative to the total mass of the hyperbranched dextrin, - a polymolecularity index less than or equal to 15, - and a number-average molecular mass Mn less than or equal to 4500 g / mole.
[0061] According to one embodiment, the hyperbranched and hydrogenated dextrins useful in the invention have: - from 10% to 30% of 1-6 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 42 to 70% of 1-4 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - a reducing sugar content less than or equal to 3% relative to the total mass of the hyperbranched dextrin, - a polymolecularity index less than or equal to 10, - and a number-average molecular mass Mn between 1000 and 3500 g / mole.
[0062] According to one embodiment, the hyperbranched and hydrogenated dextrins useful in the invention have: - from 12% to 22% of 1-6 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 42 to 50% of 1-4 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 1 to 20% of 1-3 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 1 to 20% of 1-2 glucosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - a reducing sugar content less than or equal to 2% relative to the total mass of the hyperbranched dextrin, - a polymolecularity index less than or equal to 5, - and a number-average molecular mass Mn between 1500 and 3000 g / mole.
[0063] Hyperbranched and hydrogenated dextrins useful for the invention are commercially available, such as “Nutriose® HM 06” from the Roquette company.
[0064] Biomarkers involved in inflammation (IL-1α, IL-1β, RANTES and VEGF)
[0065] Inflammation is essentially an innate immune response of self-defense against harmful stimuli, including infectious agents and physical or chemical challenges. It is an orchestrated and adaptive temporary modification of cellular functions in order to return, if possible, to the previous state before the insult. The temporal expression profile of cytokines in epidermal keratinocytes is important in the orchestration of inflammatory responses (Kataru et al., 2009). IL-1, 6, 8, and TNF-a are known to be potent inducers of keratinocyte-derived VEGF (Detmar et al., 1995).
[0066] IL-1 is a key proinflammatory cytokine that mediates the acute phase of inflammation by inducing local and systemic responses. IL-1α functions as an “alarm.” Upon necrotic cell death, IL-1α is released into the extracellular space where it stimulates chemokine production, leading to the infiltration of neutrophils and then monocytes. IL-1α is constitutively present in various epithelial cell types of healthy subjects, whereas IL-1β is primarily induced under pathological conditions.
[0067] The mediators RANTES and VEGF, on the other hand, are growth factors for connective tissue and vessels.
[0068] RANTES has been shown to induce endothelial cell spreading and migration and participate in the formation of vascular networks through VEGF secretion. VEGF is a key mediator of cutaneous angiogenesis and vascular permeability, occurring in physiological processes such as wound repair and hair growth, as well as in pathological conditions including skin inflammation, skin cancer, and psoriasis. In many skin conditions such as psoriasis, contact dermatitis, wound healing, and skin neoplasias, which are closely associated with angiogenesis or chronic inflammation, significant induction of VEGF is observed in epidermal keratinocytes, suggesting that increased VEGF plays a key role in these skin conditions.
[0069] The chemokine RANTES is a chemoattractant for eosinophils, memory T cells, and monocytes. This chemokine plays an important role in chronic inflammatory and allergic diseases.
[0070] Advantageously, it was found that, for these 4 biomarkers involved in the mechanism of inflammation, IL-1α, IL-1β, RANTES and VEGF, treatment with hyperbranched dextrins induces a reduction in these signals.
[0071] These results allow us to conclude that hyperbranched dextrins, preferably hyperbranched and hydrogenated, are effective for the prevention or treatment of at least one symptom chosen from redness, heat, swelling, pain, as well as for the prevention or treatment of skin inflammation and inflammation of the mucous membranes.
[0072] Redness, warmth, swelling, pain
[0073] The present invention relates to hyperbranched dextrins, preferably hyperbranched and hydrogenated, for their use in the prevention or treatment of at least one symptom, chosen from redness, heat, swelling and pain.
[0074] Prevention of at least one symptom chosen from redness, heat, swelling and pain means prevention of the appearance of at least one of these symptoms, but also delaying the appearance of at least one of these symptoms, as well as prevention of the worsening of at least one of these symptoms.
[0075] The treatment of at least one symptom chosen from redness, heat, swelling and pain means the disappearance of at least one of the symptoms, or at least the reduction in the intensity of at least one of the symptoms, for example the reduction in the intensity of the redness and / or heat and / or swelling and / or pain.
[0076] Epithelial tissues
[0077] According to one embodiment, the at least one symptom is located at the level of at least one epithelial tissue chosen from keratinized multi-stratified squamous epithelium, non-keratinized multi-stratified squamous epithelium, stratified columnar epithelium, ciliated or non-ciliated pseudo-stratified columnar epithelium
[0078] The epidermis is a keratinized multi-stratified squamous epithelium.
[0079] The oral cavity, vaginal mucosa, and urogenital mucosa are non-keratinized, multi-stratified squamous epithelia.
[0080] The nostrils and conjunctival fornices are stratified columnar epithelia.
[0081] The nasal mucosa is a pseudostratified columnar epithelium, ciliated or non-ciliated.
[0082] Thus, according to one embodiment, the at least one symptom is located at the level of the epidermis or the oral cavity or the vaginal mucosa or the nostrils or the conjunctival cul-de-sacs or the nasal mucosa.
[0083] According to one embodiment, the at least one symptom is located on the epidermis, preferably the epidermis of the skin or the scalp.
[0084] According to one embodiment, the epidermis of the skin or scalp is a sensitive epidermis.
[0085] Skin inflammation
[0086] Skin inflammation is defined as the presence of four symptoms on the epidermis: redness, heat, swelling and pain.
[0087] The epidermis is preferably that of the skin or the scalp.
[0088] According to one embodiment, the epidermis is a sensitive epidermis.
[0089] Skin inflammation is also known as dermatitis or dermatitis.
[0090] Thus, according to one embodiment, the present invention relates to hyperbranched dextrins, preferably hyperbranched and hydrogenated dextrins for their topical use for the prevention or treatment of symptoms of skin inflammation.
[0091] For the purposes of the present invention, the term “topical use” means in particular use on a surface of the body, such as the skin or mucous membranes.
[0092] Prevention of skin inflammation symptoms means preventing the onset of the four symptoms of skin inflammation, but also delaying the onset of the four symptoms of skin inflammation, as well as preventing the worsening of the four symptoms of skin inflammation.
[0093] Treatment of skin inflammation symptoms means the disappearance of the four symptoms of skin inflammation, or at least the reduction in the intensity of the four symptoms of skin inflammation, for example, the reduction in the intensity of redness and heat and of swelling and pain.
[0094] Non-pathological causes
[0095] The cause(s) for the appearance of one or all of the symptoms, chosen from redness, heat, swelling and pain, are numerous.
[0096] Thus, the at least one symptom is induced by at least one of the conditions chosen from infectious agents, chemical products, ingredients contained in topical compositions for cosmetic, dermocosmetic, dermatological, pharmaceutical, medicinal, veterinary, domestic use (for example detergents), mechanical aggressions, environmental factors, thermal aggressions, food and drinks. Another non-pathological cause could be a therapeutic treatment administered orally or intravenously generating one or more secondary cutaneous reactions.
[0097] Infectious agents include bacteria, yeasts, molds, parasites, viruses, and even mites, lice, and insects when they attack the skin through bites or stings. For example, ringworm caused by parasites can be mentioned.
[0098] Mechanical aggressions include friction, brushing, shaving, cuts, micro-cuts, physical aggression, hair removal, abrasion, exfoliation, frequent washing, hard water with a high concentration of limescale, etc.
[0099] Friction can be caused by clothing on skin or skin on skin. For example, woolen clothing or clothing worn close to the skin, such as socks or scarves, rub against the skin, and can thus cause skin irritation. Friction can also be caused by prolonged wearing of helmets, masks, including surgical masks, protection against the weather, protection against microorganisms such as bacteria or viruses, protection against chemicals or solvents, or even against dust.
[0100] Abrasion means bringing the skin or mucous membranes into contact with abrasive agents, i.e. solid particles, generally irregularly shaped and not smooth. For the skin, abrasive agents can be gravel, sand, magnesia. For the oral mucous membranes, abrasive agents can be calcium carbonate.
[0101] Brushing means the action of a brush, especially the action of a toothbrush on the gums.
[0102] Environmental factors include pollution, sun exposure, radiation such as X-rays and UV radiation, cold, wind, drought, humidity, etc.
[0103] Among the thermal attacks we will cite, overexposure to the sun, exposure near a source of heat or cold, . . .
[0104] Foods and drinks include spices, dairy products, dried fruits, nuts, pineapples, acidic foods, vinegar, alcohol, etc.
[0105] Chemicals include irritants or pollutants such as detergents, pollution, cigarette smoke, household products, and especially household cleaning products.
[0106] Among the ingredients contained in topical compositions for cosmetic, dermocosmetic, dermatological, pharmaceutical, medicinal, veterinary, or domestic use, we will cite cosmetic active ingredients, dermatological active ingredients, surfactants, solvents, preservatives, perfumes, acids, exfoliants, detergents.
[0107] These active ingredients with irritant potential have been described in document FR2902998. Thus, as dermatological or cosmetic active ingredients, we can cite certain desquamating agents which can also be peeling agents.
[0108] Specifically peeling agents include abrasive / exfoliating particles from mineral, organic, natural, or synthetic sources. Examples include pumice and silica particles, polyethylene and nylon beads, and fruit stone powders.
[0109] Among these desquamating agents the following are likely to cause skin irritation: saturated (acetic acid) and unsaturated monocarboxylic acids, saturated and unsaturated dicarboxylic acids, saturated and unsaturated tricarboxylic acids; α-hydroxy acids and p-hydroxy acids of monocarboxylic acids; α-hydroxy acids and p-hydroxy acids of dicarboxylic acids; α-hydroxy acids and p-hydroxy acids of tricarboxylic acids, keto acids, α-keto acids, p-keto acids of polycarboxylic acids, polyhydroxymonocarboxylic acids, polyhydroxy bicarboxylic acids and polyhydroxy tricarboxylic acids. Particularly among the α-hydroxy acids or their esters, we can cite: glycolic acids, dioic acids such as octadecene dioic acid, citric, lactic, tartaric, malic or mandelic acids, their esters such as dialkyl tartrate (C12 / C13), branched C12-13 tri-alcohol citrate.
[0110] Among the p-hydroxy acids we can cite: salicylic acid and its derivatives (including n-octanoyl 5-salicylic acid).
[0111] Among the α-keto acids we can cite ascorbic acid and its derivatives.
[0112] Other desquamating agents include: pyruvic, gluconic, glucuronic, oxalic, malonic, succinic, acetic, gentisic acids, cinnamic, azelaic; phenol; resorcinol; urea and its derivatives, hydroxyethyl urea; oligofucoses; jasmonic acid and its derivatives; ascorbic acid and its derivatives, trichloroacetic acid; Saphora japonica extract and resveratrol.
[0113] Among desquamating agents, those capable of acting on enzymes involved in desquamation or degradation of corneodesmosomes may also be likely to cause skin irritation.
[0114] These include mineral salt chelating agents such as EDTA; N-acyl-N,N',N'ethylene diaminetriacetic acid; aminosulfonic compounds, particularly (N-2 hydroxyethylpiperazine-N-2-ethane) sulfonic acid (HEPES); 2-oxothiazolidine-4-carboxylic acid derivatives (procysteine); glycine-type alpha amino acid derivatives; honey; sugar derivatives such as O-octanoyl-6-D-maltose, O-linoleyl-6-D-glucose, and N-acetyl glucosamine.
[0115] Retinoids are also compounds that can cause skin irritation. Examples include retinol and its esters, retinal, retinoic acid and its derivatives, and adapalene.
[0116] Salts and derivatives, such as cis or trans forms, racemic mixtures, dextrorotatory or levorotatory forms of the compounds mentioned above are also considered to be compounds likely to cause skin irritation.
[0117] Other dermatological or cosmetic active ingredients that may cause skin irritation are also listed below: -urea and its derivatives such as hydroxyethyl urea, - certain vitamins such as vitamin D and its derivatives such as vitamin D3, vitamin D2, calcitriol, calcipotriol, tacalcitol, 24,25-diOH vitamin D3, 1-OH vitamin D2 and 1,24-diOH vitamin D2; vitamin B9 and its derivatives, - peroxides such as benzoyl peroxide, hydrogen peroxide, - anti-hair loss drugs such as minoxidil and its derivatives such as aminexyl, - hair dyes and colorants such as aminophenols and their derivatives such as para-phenylenediamine (p-PDA), N-phenyl p-PDA, toluene 2,5-diamine sulfate, meta-phenylenediamine (m-PDA), toluene 3,4-diamine and ortho-phenylenediamine (o-PDA), - antiperspirant agents such as aluminum salts, such as aluminum hydroxychloride, - deodorants, - depilatory and / or permanent active ingredients such as thioglycolates, ammonia, - thioglycolate and its salts, - phenoxyethanol, - 1,2-pentanediol, - alcoholic perfume solutions (perfumes, eau de toilette, aftershave, deodorants) - anthralins (dioxyanthranol), - anthranodes - lithium salts, - depigmenting agents (e.g. hydroquinone, high concentration vitamin C, kojic acid), - certain slimming active ingredients with a heating effect, - nicotinates and their derivatives, - capsaicin, anti-lice active ingredients (pyrethrin), - antiproliferatives such as 5-fluorouracil or methotrexate, - antiviral agents, - antiparasitics, - antifungals, - antipruritics, - anti-seborrheic drugs, - certain sunscreens, - propigmentants such as psoralens and methylangecilins, and - their mixtures.
[0118] Preservatives that may be mentioned include propionic acid, calcium propionate, formaldehyde, paraformaldehyde, o-phenylphenol or its salts, zinc pyrithione, sodium, ammonium, potassium sulfites, bisulfites or metabisulfites, chlorobutanol, methylparaben, ethylparaben, propylparaben, butylparaben, formic acid and its salts such as sodium formate, benzoic acid and its salts such as sodium benzoate, sorbic acid and its salts, such as calcium sorbate, sodium sorbate, potassium sorbate, salicylic acid and its salts, dehydroacetic acid and its salts such as sodium dehydroacetate, undecylenic acid and its salts such as calcium undecylenate, potassium undecylenate, sodium undecylenate, phenoxyethanol, 1,2-Dimethylol-5,6-dimethylhydantoin, benzyl alcohol, chlorhexidine, chlorhexidine diacetate, chlorhexidine digluconate,chlorhexidine dihydrochloride, behentrimonium chloride, cetrimonium chloride, cetrimonium bromide, laurtrimonium chloride, laurtrimonium bromide, steartrimonium chloride, steartrimonium bromide, hexamidine, hexamidine diisethionate, chlorphenesin, benzalkonium chloride, benzalkonium bromide, benzalkonium saccharin, ethyl lauroyl arginate.,
[0119] Surfactants that may be mentioned include anionic, cationic and amphoteric surfactants, more particularly anionic surfactants such as alkyl sulfates and alkyl ether sulfates such as lauryl sulfate and lauryl ether sulfate, and their salts, particularly sodium salts.
[0120] According to a preferred embodiment of the invention, the compound capable of causing skin irritation is chosen from surfactants, bases and acids. The acids may be chosen from citric acid, lactic acid, acetic acid, dehydroacetic acid, formic acid, gluconic acid, succinic acid, salicylic acid, glucuronic acid, retinoic acid, glycolic acid, phytic acid, ascorbic acid, and levulinic acid. The bases may be chosen from sodium hydroxide, potassium hydroxide, triethanolamine, amino methyl propanol.
[0121] Preferably, at least one symptom chosen from redness, heat, swelling and pain is induced by chemicals, ingredients contained in cosmetic or dermatological formulations, mechanical aggression, thermal aggression, environmental factors.
[0122] More preferably, the at least one symptom chosen from redness, heat, swelling and pain or skin inflammation is induced by exposure to chemicals or ingredients contained in topical compositions for cosmetic or dermatological use chosen from surfactants, detergents, hair oxidizing or bleaching agents, or is induced by mechanical aggressions chosen from friction, shaving, cuts, micro-cuts, hair removal, abrasion and exfoliation.
[0123] The non-pathological cause(s) of skin inflammation are also numerous. Indeed, skin inflammation can be induced by at least one of the causes previously described and chosen from infectious agents, chemical products, ingredients contained in topical compositions for cosmetic, dermocosmetic, dermatological, pharmaceutical, medicinal, veterinary, or domestic use, mechanical aggressions, environmental factors, thermal aggressions, food and beverages, but also by skin irritation, skin corrosion, skin inflammation of endogenous origin, or a combination of these causes.
[0124] Skin irritation Skin irritation includes acute skin irritation (or acute irritant contact dermatitis), cumulative skin irritation (or cumulative irritant contact dermatitis), and phototoxicity (or phototoxic dermatitis).
[0125] Acute skin irritation or acute irritant contact dermatitis is a reversible local inflammatory response of the skin of a normal living being to a direct injury caused by the single application of a toxic substance, without the intervention of an immunological mechanism.
[0126] Cumulative skin irritation or cumulative irritant contact dermatitis means reversible irritation resulting from repeated or continuous exposures to materials that do not themselves cause acute irritation.
[0127] Phototoxicity or phototoxic dermatitis refers to irritation resulting from light-induced molecular changes in the structure of chemicals applied to the skin.
[0128] Thus, according to one embodiment, the skin irritation is selected from cumulative irritant contact dermatitis, acute irritant contact dermatitis and phototoxic dermatitis.
[0129] In a preferred embodiment, the skin irritation is cumulative irritant contact dermatitis.
[0130] Skin corrosion is the direct chemical action on normal living skin that results in its disintegration and irreversible damage at the point of contact. Corrosion manifests itself as ulceration and necrosis with subsequent scarring.
[0131] According to one embodiment, phototoxicity is induced by chemicals, ingredients contained in topical compositions for cosmetic or dermatological use.
[0132] According to a preferred embodiment, skin inflammation is induced by exposure to chemicals and ingredients contained in topical compositions for cosmetic or dermatological use, mechanical aggressions, thermal aggressions.
[0133] According to a preferred embodiment, skin inflammation is induced by exposure to chemicals and ingredients contained in topical compositions for cosmetic or dermatological use and preferentially by ingredients contained in topical compositions for cosmetic or dermatological use.
[0134] The term "endogenous cutaneous inflammation" means inflammation induced by one or more biological factors internal to the human body, or by one or more pathogenic agents endogenous to the human body, i.e. pathogenic agents synthesized by the human body itself.
[0135] Causes of inflammation of the mucous membranes
[0136] According to one embodiment, the invention relates to hyperbranched dextrins, preferably hydrogenated hyperbranched dextrins for their use in the prevention or treatment of symptoms of inflammation of the mucous membranes.
[0137] According to one embodiment, the inflammation is chosen from inflammations of the oral mucosa, preferably inflammation of the oral mucosa by anionic surfactants, or inflammation of the oral mucosa due to irritation caused by toothbrushing. Said anionic surfactants can be applied to the oral mucosa by means of a toothpaste, generally with concomitant brushing, or a mouthwash, generally without concomitant brushing.
[0138] Thus, according to one embodiment, the inflammation of the mucous membranes is induced by ingredients contained in topical compositions for cosmetic, dermocosmetic, dermatological, pharmaceutical, medicinal, veterinary, or domestic use such as surfactants or by mechanical aggression such as brushing.
[0139] Pathological causes
[0140] According to one embodiment, the skin inflammation is induced by a dermatological pathology involving an inflammatory process.
[0141] According to one embodiment, the dermatological pathology involving an inflammatory process is chosen from psoriasis, cutaneous atopy, atopic dermatitis, allergic reactions of immediate hypersensitivity type, allergic reactions of delayed hypersensitivity type, inflammatory hyperpigmentations, immune dermatoses, actinic elastosis, alopecia areata, vitiligo, systemic lupus erythematosus, pemphigus vulgaris, dystrophic epidermolysis bulbosa and canities of autoimmune origin, erythemas,
[0142] Among the allergic skin reactions of the immediate hypersensitivity type we can cite urticaria, light eruption (or sun allergy), allergies due to exposure to surfactants.
[0143] Delayed allergic skin reactions include contact dermatitis, seborrheic dermatitis, acne, and eczema.
[0144] Among the erythemas, we will mention erythemas due to ultraviolet rays, or friction, or micro-cuts.
[0145] According to one embodiment, the atopic dermatitis is an atopic dermatitis of sensitive skin.
[0146] Preferably, dermatological pathologies are chosen from erythema, psoriasis, cutaneous atopy, atopic dermatitis, allergic reactions of immediate hypersensitivity type, allergic reactions of delayed hypersensitivity type, inflammatory hyperpigmentations.
[0147] Preferably, erythema is due to ultraviolet rays.
[0148] Preferably, the immediate hypersensitivity type allergic reaction is urticaria.
[0149] Preferably, delayed hypersensitivity type allergic reactions are chosen from contact dermatitis and eczema.
[0150] According to one embodiment, the inflammation of the mucous membranes is induced by a dermatological pathology involving an inflammatory process.
[0151] According to one embodiment, the dermatological pathologies are chosen from pathologies of the oral mucosa, vaginal mucosa, urogenital mucosa, preferentially from pathologies of the oral mucosa.
[0152] According to one embodiment, the pathologies of the oral mucosa are chosen from gingivitis, oral lichen planus, canker sores, etc.
[0153] The terms "prevention" or "treatment" or "prevention method" or "treatment method" are not absolute terms and refer to a procedure or action plan designed, even with a low probability of success, but which should induce an overall beneficial effect such as the disappearance of the pathology, but also the delay in the appearance of the symptoms of the pathology, or the reduction in the severity of one or more symptoms. Typically, in the case of skin inflammation induced by a dermatological pathology involving an inflammatory process, prevention means the prevention of symptoms of the pathology but also the prevention of the worsening of the symptoms of the pathology.
[0154] The present invention also relates to a method for the prevention or treatment of symptoms of skin inflammation induced by a dermatological pathology involving an inflammatory process comprising the administration of hyperbranched dextrins, preferably hyperbranched and hydrogenated dextrins, to a patient in need thereof.
[0155] The present invention also relates to the use of hyperbranched dextrins, preferably hyperbranched and hydrogenated dextrins, for obtaining a medicament intended for the prevention or treatment of the symptoms of inflammation. cutaneous induced by a dermatological pathology involving an inflammatory process.
[0156] The present invention also relates to a composition comprising hyperbranched dextrins, preferably hyperbranched and hydrogenated dextrins, for their therapeutic use for the prevention or treatment of the symptoms of skin inflammation induced by a dermatological pathology involving an inflammatory process.
[0157] Prevention and / or reduction of the irritant effect of chemicals or ingredients contained in topical compositions for cosmetic, dermocosmetic, dermatological, pharmaceutical, medicinal, veterinary, or domestic use
[0158] According to one embodiment, the invention relates to the use of hyperbranched dextrins, preferably hyperbranched and hydrogenated, to prevent, reduce or eliminate the irritant effect of chemical products coming into contact with the skin and mucous membranes, or of ingredients applied topically, contained in topical compositions for cosmetic, dermocosmetic, dermatological, pharmaceutical, medicinal, veterinary or domestic use.
[0159] An irritant effect means the appearance of at least one symptom in the epithelial tissue or mucous membranes, chosen from redness, heat, swelling and pain following exposure of the skin or mucous membrane to one or more chemical products, or following the topical application of cosmetic, dermocosmetic, dermatological, pharmaceutical, medicinal, veterinary or domestic compositions, comprising ingredients that irritate epithelial tissue or mucous membranes.
[0160] Hyperbranched dextrins, preferably hyperbranched and hydrogenated, may be applied before or after the use of these ingredients or active ingredients having an irritant effect in order to prevent, significantly reduce, or even eliminate this irritant effect. In both cases, the hyperbranched dextrin, preferably hyperbranched and hydrogenated, will be in a topical formulation for cosmetic, dermocosmetic or dermatological, pharmaceutical, medicinal, or veterinary use, which, in fact, will not contain any ingredient or active ingredient having an irritant effect.
[0161] The presence of hyperbranched dextrins, preferably hyperbranched and hydrogenated, in a topical composition for cosmetic, dermocosmetic, dermatological, pharmaceutical, medicinal, veterinary, or domestic use, preferably in a topical composition for cosmetic, dermocosmetic, or dermatological use, comprising one or more ingredient(s) or active ingredient(s) having an irritant effect also makes it possible to significantly reduce, or even eliminate, this irritant effect. This makes it possible furthermore to increase the amount of product with an irritating side effect compared to the amount of product normally used, with a view to improved efficacy. This also makes it possible to administer products with an irritating effect to sensitive skin.
[0162] Topical compositions for cosmetic, dermocosmetic, dermatological, pharmaceutical, medicinal, veterinary or domestic use may in fact contain one or more ingredients or active ingredients likely to cause skin irritation, such as cosmetic or dermatological active ingredients, surfactants, solvents, preservatives, perfumes, detergents.
[0163] These ingredients or active ingredients with irritant potential are as previously described.
[0164] Dermatological composition or dermatologically acceptable composition
[0165] Hyperbranched dextrins, preferably hyperbranched and hydrogenated, may be incorporated into a dermatological composition, or more generally into any composition made from a dermatologically acceptable medium and being brought into contact with an epithelial tissue chosen from keratinized multi-stratified squamous epithelium, non-keratinized multi-stratified squamous epithelium, stratified columnar epithelium, ciliated or non-ciliated pseudo-stratified columnar epithelium, preferably, preferably being brought into contact with the epidermis, the oral cavity, the oral mucosa, the vaginal mucosa, the nostrils, the nasal mucosa, and all preferentially being brought into contact with the skin or the oral mucosa.
[0166] Thus, the present invention also relates to a composition, dermatological or dermatologically acceptable, comprising hydrogenated and hyperbranched dextrins and a dermatologically acceptable medium.
[0167] The term “dermatologically acceptable composition” or “dermatologically acceptable” means any composition which does not present, or very rarely, harmful side effects and in particular which does not produce unacceptable redness, heating, tightness or tingling, or more generally inflammation, for a user who brings said dermatologically acceptable composition into contact with epithelial tissue, preferably with his skin or mucous membranes. The dermatologically acceptable composition is thus compatible with human epithelial tissues and the mucous membranes of human beings. Dermatologically acceptable compositions include pharmaceutical, medicinal and domestic compositions including detergent compositions.
[0168] The composition according to the invention may also be another topical composition intended to treat or care for, preventively or curatively, at least one epithelial tissue chosen from keratinized multi-stratified squamous epithelium (epidermis), non-keratinized multi-stratified squamous epithelium (oral cavity, vaginal mucosa), stratified columnar epithelium (nostrils, conjunctival cul-de-sacs), ciliated or non-ciliated pseudostratified columnar epithelium (nasal mucosa). Therefore, this composition can be a topical composition for dermatological, pharmaceutical, medicinal or veterinary use, skin care and epithelial tissues.
[0169] Galenic
[0170] The dermatological composition according to the invention can be presented in all the galenic forms normally used for topical application such as aqueous, hydroalcoholic or oily solutions, solutions or dispersions of the lotion or serum type, emulsions of liquid or semi-liquid consistency of the milk type, obtained by dispersion of a fatty phase in an aqueous phase (O / W) or vice versa (W / O), or suspensions or emulsions, of soft, semi-solid or solid consistency, of the cream, aqueous or anhydrous gel type, anhydrous compositions, solid compositions of microemulsions, microcapsules, microparticles, or vesicular dispersions of the ionic and / or non-ionic type.
[0171] These compositions are prepared by the usual methods known to those skilled in the art.
[0172] The composition may be applied before, during or after the appearance of at least one symptom chosen from redness, heat, swelling and pain, or inflammation of the skin or mucous membranes, and this application may be repeated or renewed as necessary.
[0173] This composition, when applied to the skin, can be more or less fluid and have the appearance of a cream, an emulsion or microemulsion, an ointment, a milk, a lotion, a serum, a paste, a mousse, a mask, a fluid, a balm, an oil, a gel, an ointment. It can possibly be applied to the skin in the form of an aerosol. It can also be in solid form, for example in the form of a stick or patch, dry soaps, cleansing bars.
[0174] It can be used as a care product, in particular for leave-on application, such as a day or night care cream for the skin of the face and / or body, as a cleaning product, as a makeup product, as a deodorant product, as a shaving product, as an aftershave product, as an after-sun product, as a sunscreen product, or as a lip balm protecting the lips from the cold and / or the sun and / or the wind.
[0175] The composition according to the invention may also be a composition for scalp and hair care and perhaps in galenic forms for application rinsed, called "rinse-off" in English, or for non-rinsed application. Examples of these forms are shampoos, hair conditioners, hair masks, serums, mousses, balms, creams, sprays, conditioners, detanglers, hair creams and also in the form of treatment lotion, dye composition, coloring shampoos, perm composition, anti-hair loss lotion or gel, anti-parasitic shampoo, or conditioner.
[0176] The amount of hyperbranched dextrins in the compositions may vary so as to administer an effective amount of hyperbranched dextrins to achieve the desired therapeutic response for a particular patient.
[0177] An "effective amount" or "therapeutically effective amount" of a compound means a non-toxic but sufficient amount of the compound to provide the desired effect.
[0178] Typically, the amount administered or dose depends on the activity of the hyperbranched dextrins, the route of administration, the severity of the pathology, as well as the health status and medical history of the patient being treated, various factors such as body weight, diet, and possible combination with other therapeutic agents. However, it is within the skill of the person skilled in the art to determine the appropriate dosage and to initiate treatment at a dosage lower than that required to achieve the desired therapeutic effect and to gradually increase the dose until the desired effect is achieved.
[0179] According to one embodiment, the content of hyperbranched dextrins ranges from 0.5 to 50% by weight, preferably from 1 to 25% by weight, more preferably from 1 to 15% by weight, even more preferably from 2 to 10% by weight, relative to the total weight of the cosmetic, dermatological or dermatologically acceptable composition.
[0180] Formulation ingredients
[0181] According to one embodiment, the hyperbranched dextrins are administered topically.
[0182] Hyperbranched dextrins can be administered in several doses.
[0183] The dermatological composition or topical formulation according to the invention may also comprise a solvent chosen according to the different ingredients and the administration form.
[0184] According to one embodiment, the composition according to the invention may comprise an aqueous phase comprising water and optionally, one or more water-miscible organic solvents.
[0185] "Water-soluble solvent" means a compound that is liquid at room temperature and miscible with water (miscibility in water greater than 50% by weight at 25°C and atmospheric pressure).
[0186] The water-soluble solvents that can be used in the compositions according to the invention can be volatile.
[0187] Among the water-soluble solvents which may be used in the compositions in accordance with the invention, mention may be made of mono-alcohols having from 1 to 5 carbon atoms such as ethanol and isopropanol, C3-C4 ketones and C2-C4 aldehydes and polyols such as glycerol or glycerin, sorbitol or isosorbide.
[0188] The cosmetic composition may also include, in addition to hydrogenated and highly branched dextrins:
[0189] - One or more humectant(s):
[0190] The humectant(s) will be chosen from polyols and / or esters of fatty acids and polyethylene glycol.
[0191] The term "polyols" means any molecule having at least two free hydroxyl (-OH) groups in its structure. These polyols are preferably liquid at room temperature (25°C).
[0192] Typically, the polyol will be selected from maltitol, mannitol, xylitol, erythritol, sorbitol, isosorbide, glycerol or glycerin, glucose, sucrose, polydextrose, hydrogenated glucose syrups, dextrins, maltodextrins, glucose syrups, and mixtures thereof.
[0193] For example, we can cite the product Beauté by Roquette® PO 071 (INCI: Sorbitol), the product Beauté by Roquette® PO 260 (INCI: Mannitol), the product Beauté by Roquette® PO 370 (INCI: Xylitol), the product Beauté by Roquette® PO 455 (INCI: Hydrogenated starch hydrolysate), the product Beauté by Roquette® PO 500 (INCI: Isosorbide), all marketed by the company ROQUETTE, glycerin (INCI: glycerin) sold by the company COOPER, propylene glycol (INCI: propylene Glycol) from the company COOPER, Butylene Glycol (INCI: 1,3-BUTANEDIOL)
[0194] Among the fatty acid esters of polyethylene glycol, we can mention the product sold under the name Glucamate SSE-20 (INCI: PEG-20 METHYL GLUCOSE SESQUI STEARATE) by the company LUBRIZOL ADVANCED MATERIALS, Inc.
[0195] The composition comprises from 0.5 to 25% by weight of one or more humectants, preferably from 1 to 15% by weight, and even more preferably from 2 to 10% by weight of polyols, relative to the total weight of the composition.
[0196] - One or more oil(s)
[0197] For the purposes of the present invention, the term "oil" means a compound which is liquid at room temperature (25°C), and which, when introduced at a rate of at least 1% by weight into water at 25°C, is not at all soluble in water, or soluble to a level of less than 10% by weight, relative to the weight of oil introduced into the water.
[0198] According to one embodiment, the oil will be chosen from volatile oils, non-volatile oils and their mixtures. Preferably, these oils are vegetable or of vegetable origin.
[0199] “Non-volatile oil” means an oil remaining on keratin materials at room temperature and atmospheric pressure for at least several hours and in particular having a vapor pressure of less than 10 -3 mm of Hg (0.13Pa).
[0200] Non-volatile oils include fatty esters such as cetearyl isononoate, isotridecyl isononoate, isostearyl isostearate, isopropyl isostearate, isopropyl myristate, isopropyl palmitate, butyl stearate, hexyl laurate, isononyl isononate, 2-ethylhexyl palmitate, 2-hexyldecyl laurate, 2-octyl decyl palmitate, 2-octyldodecyl myristate or lactate, 2-diethylhexyl succinate, diisostearyl malate, tracetin, tricprin, caprylic / capric triglycerides, coco caprate and caprylate mixture, benzoates of C12 to C15 alcohols, glycol esters such as butylene glycol cocoate, glycerin triisostearate, tocopherol acetate, higher fatty acids such as myristic acid, palmitic acid, stearic acid, behenic acid, oleic acid, linoleic acid, linolenic acid or isostearic acid,higher fatty alcohols such as oleyl alcohol, vegetable oils such as avocado oil, camellia oil, hazelnut oil, tsubaki oil, cashew nut oil, argan oil, soybean oil, grape seed oil, sesame oil, corn oil, wheat germ oil, rapeseed oil, sunflower oil, cottonseed oil, jojoba oil, peanut oil, macadamia oil, sweet almond oil, olive oil and mixtures thereof.,
[0201] These non-volatile oils can also be hydrocarbon or silicone type oils such as paraffin oil, squalane, petrolatum, dimethyl siloxanes and their mixtures.
[0202] According to one embodiment, the non-volatile oil is chosen from stearic acid, jojoba oil (INCI: simmondsia Chinensis Seed Oil), grape seed oil (INCI: vitis vinifera seed oil), macadamia oil (INCI: Macadamia ternifolia seed oil), refined oleic sunflower oil (Helianthus annuus seed oil), the mixture of coconut caprate and caprylate such as the product Miglyol Coco 810 (INCI: Coco-Caprylate / Caprate), sweet almond oil (INCI: Prunus Amygdalus Dulcis Oil), sesame oil (INCI: Sesamum indicum seed oil).
[0203] Volatile oil is defined as an oil that can evaporate from the skin in less than an hour at room temperature and atmospheric pressure. Volatile oils can be chosen, for example, from silicone oils or short fatty acid triglycerides to reduce the greasy feel.
[0204] According to one embodiment, the oil(s) is / are present in a content ranging from 0.5 to 70% by weight, preferably from 1 to 60% by weight, preferably from 2 to 50% by weight, preferably from 5 to 40% by weight, preferably from 5 to 30% by weight relative to the total weight of the composition.
[0205] - One or more wax(es) and / or one or more pasty compound(s).
[0206] The term "wax" means a fatty substance with a reversible liquid / solid state change, having a melting point above 25°C, generally between 30°C and 90°C, which can be made liquid under the conditions of preparation of the composition and has an anisotropic crystalline organization in the solid state. The waxes used according to the invention may consist of polar or apolar waxes or a mixture of the two. The term "apolar" means a wax containing only carbon, hydrogen and / or phosphorus atoms and in particular a hydrocarbon.
[0207] Polar waxes may in particular be chosen from animal waxes, vegetable waxes and synthetic or silicone waxes containing polar groups such as esters. Mention may thus be made of Carnauba wax, Candelilla wax, beeswax (Cera alba), Chinese insect wax (Ericerus pela), Japanese wax, Sumac wax, Montan wax, C8-C20 acid triesters and glycerin such as glycerin tribehenate, acetylated glycol stearate marketed in particular by the company VEVY under the trade name CET ACENE, and mixtures thereof. These waxes may in particular be used in pre-dispersed form in an oil, as is the case with the mixture of candelilla wax and jojoba seed oil. Preferably, these waxes are vegetable or of vegetable origin.
[0208] According to one embodiment, the wax or waxes is / are present in a content ranging from 0.5 to 50% by weight, preferably from 1 to 25% by weight, preferably from 5 to 10% by weight, relative to the total weight of the composition.
[0209] “Pasty compound” means lipophilic fatty substances which, like waxes, are capable of undergoing a reversible liquid / solid state change and have an anisotropic crystalline organization in the solid state, but which differ from waxes in that they contain, at a temperature of 23°C, a liquid fraction and a solid fraction. These Pasty compounds are preferably vegetable or plant-based butters, such as shea butter or camellia butter.
[0210] According to one embodiment, the pasty compound(s) is / are present in a content ranging from 0.5 to 50% by weight, preferably from 1 to 25% by weight, preferably from 5 to 10% by weight, relative to the total weight of the composition.
[0211] - One or more qualifying agent(s)
[0212] A gelling agent is a compound which, in the presence of a solvent, creates more or less strong inter-macromolecular bonds, thus inducing a three-dimensional network which freezes the said solvent. A gelling agent is also a thickening or rheological agent, acting on the viscosity and flow properties of an aqueous phase or a fatty phase.
[0213] The gelling agent makes it possible in particular to increase the viscosity of the continuous phase, for example to adjust the viscosity of the continuous phase to a value ranging from 100 mPa.s to 20,000 mPa.s.
[0214] The gelling agent may be chosen from polymers of synthetic or plant origin, preferably of plant origin, chemically modified or not.It can thus be chosen from gums derived from plants such as gum arabic, konjac gum, guar gum or their derivatives, gums extracted from algae such as alginates; gums derived from microbial fermentation such as xanthans, for example, the product Keltrol CG (INCI: xanthan gum), sold by the company CP KELCO or the product Xanthan Gum FNCS-PC (INCI: xanthan gum) sold by the company JUNGBUNZLAUER INTERNATIONAL AG, mannans, scleroglucans or their derivatives; cellulose and its derivatives such as carboxymethylcellulose or hydroxyethylcellulose; starch and its derivatives such as in particular native starches and modified starches, in particular pregelatinized, acetylated, hydroxypropylated, carboxymethylated, cationic, octenylsuccinate, crosslinked, possibly several times modified starches; synthetic polymers such as polyacrylic acids or carbomers, and their mixtures.
[0215] Starches and starch-based mixtures include Beauté by Roquette® ST 118 (INCI: Carboxymethyl starch), Beauté by Roquette® ST 720 (INCI: Hydroxypropyl starch) and Beauté by Roquette® DS112 (INCI: Starch acetate (and) Hydroxyethylcellulose (and) Xanthan gum), all sold by Roquette.
[0216] Examples of carbomers include the product Carbopol Ultrez 30 (INCI: carbomer) from LUBRIZOL ADVANCED MATERIALS, Inc. or CARBOPOL ETD 2050 POLYMER (INCI: carbomer).
[0217] We will also mention mixtures of gum arabic and xanthan gum such as the product Solagum AX (INCI: Acacia Senegal Gum (and) Xanthan Gum), sold by the company SEPPIC, mixtures of starch and cellulose derivatives such as the product Beauté by Roquette® DS 112 (INCI: Starch acetate (and) Hydroxyethylcellulose (and) Xanthan gum), sold by the company ROQUETTE.
[0218] The gelling agent may be a mineral gelling agent selected from magnesium and / or aluminum silicates. An example of such a mineral gelling agent is Veegum® Pure from Vanderbilt Minerals LLC, which is a magnesium aluminum silicate.
[0219] According to one embodiment, the gelling agent(s) is / are present in a content ranging from 0.1 to 50% by weight, preferably from 0.5 to 25% by weight, preferably from 0.3 to 15% by weight, relative to the total weight of the composition.
[0220] - One or more binders
[0221] The term "binder" refers to compounds that provide increased cohesion to the cosmetic composition. This cohesion can be adjusted depending on the quantity and chemical affinity of the binding agent in relation to the ingredients of the cosmetic composition.
[0222] Typically, the binder will be chosen from caprylic / capric acid triglycerides such as the product Labrafac CC (INCI: capric / caprylic triglicerides) or Cetyl Dimethicone (INCI).
[0223] The binder(s) is / are present in the composition according to the invention at a content ranging from 0.5% to 20%, preferably from 1 to 15%, preferably from 5 to 12%, by weight relative to the total weight of the composition.
[0224] - One or more emulsifying agent(s)
[0225] The cosmetic composition according to the invention may also comprise one or more oil-in-water (O / W) or water-in-oil (W / O) emulsifiers.
[0226] The oil-in-water (O / W) emulsifier is an emulsifying agent with an HLB greater than or equal to 8 and chosen from optionally polyethoxylated sorbitan esters, fatty acid esters of glycerol, fatty acid esters or polyesters of sucrose, fatty acid esters of polyethylene glycol, polyether-modified polysiloxanes, fatty alcohol ethers of polyethylene glycol, alkylpolyglycosides and hydrogenated lecithin, fatty alcohols, sorbitan esters without this list being limiting, and mixtures thereof.
[0227] Examples include, for example, the product Montanov 68 (INCI: CETEARYL ALCOHOL (AND) CETEARYL GLUCOSIDE), marketed by the company SEPPIC, the product Montanov L (INCI: C14-C22 Alcohols & C12-20 Alkyl Glucoside), marketed by the company SEPPIC, Montanov 202 (INCI: Arachidyl Alcohol (and) Behenyl Alcohol (and) Arachidyl Glucoside), Citrol GMS 40 (INCI: Glyceryl stearate), sold by the company CRODA, or the product Imwitor 960K (INCI: Glyceryl stearate), sold by the company BIESTERFELD, the product Imwitor 372P (INCI: Glyceryl stearate citrate), sold by the company BIESTERFELD, the product Glucate SS (INCI: Methyl Glucose Sesquistearate), sold by the company LUBRIZOL ADVANCED MATERIALS, Inc, the stearic plural (Polyglyceryl-6 Distearate), Natragem E145 (INCI: Polyglyceryl-4 Laurate / Succinate (and) Aqua), sold by the company CRODA, the product Span 60 (INCI: sorbitan stearate), sold by the company SIGMA ALDRICH.
[0228] Among the sorbitan esters, we can cite, for example, the product Span 20.
[0229] Among the fatty alcohols, we can cite for example the product sold under the name Promulgen D (INCI: Cetearyl alcohol (and) Ceteareth-20).
[0230] The O / W emulsifier may advantageously be chosen from emulsifying systems composed of a cyclodextrin and a water-in-oil emulsifier of natural origin, such as the emulsifying system marketed by Roquette Frères under the name Beauté by Roquette® DS 146, or from emulsifying systems based on modified starches and vegetable gums, such as Beauté by Roquette® DS 421 sold by the applicant.
[0231] The water-in-oil (W / O) emulsifier is an emulsifying agent with an HLB of less than 8 and chosen from non-ethoxylated fatty esters of polyols, and in particular from non-ethoxylated fatty esters of glycerol, polyglycerols, sorbitol, sorbitan, anhydrodrohexitols such as in particular isosorbide, mannitol, xylitol, erythritol, maltitol, sucrose, glucose, polydextrose, hydrogenated glucose syrups, dextrins and hydrolyzed starches.
[0232] The emulsifying agent(s) is / are present in the composition according to the invention at a content ranging from 0.5% to 20%, preferably from 1 to 15%, preferably from 2 to 12%, by weight relative to the total weight of the composition.
[0233] One or more surfactants
[0234] According to one embodiment, the composition according to the invention comprises at least one surfactant chosen from ionic, non-ionic, anionic, cationic or amphoteric or zwitterionic surfactants. These surfactants are chosen for their detergent and foaming function.
[0235] According to another embodiment, the composition according to the invention comprises at least one surfactant chosen from anionic surfactants, amphoteric or zwitterionic surfactants.
[0236] The anionic surfactants are chosen from carboxylic anionic surfactants, sulfated anionic surfactants, sulfonate surfactants, phosphate anionic surfactants, and mixtures thereof, preferably from sulfonate anionic surfactants, carboxylic anionic surfactants, and mixtures thereof.
[0237] By "anionic surfactant" is meant a surfactant comprising only anionic groups as ionic or ionizable groups. In the present description, an entity is described as being "anionic" when it has at least one permanent negative charge or when it can be ionized into a negatively charged entity, under the conditions of use of the composition of the invention (medium, pH for example) and not comprising a cationic charge. By "sulfated anionic surfactant" is meant an anionic surfactant comprising at least one sulfate function (- OSO3H or -OSO3 ), and which may optionally also comprise one or more other functions derived from acids, such as carboxylic acid or carboxylate functions (-COOH or -COO ), sulfonate functions (-SO3H or -SO3 ) and / or phosphate functions.For example, alkyl sulfates, alkyl ether sulfates, alkylamido ether sulfates, alkylaryl polyether sulfates, monoglyceride sulfates, and the salts of these compounds are sulfated anionic surfactants. The alkyl groups of these exemplary compounds contain from 6 to 30 carbon atoms, and the aryl group denotes a phenyl or benzyl group. These exemplary compounds may be polyoxyalkylenated, in particular polyoxyethylenated, and contain from 1 to 50 ethylene oxide units. The term "non-sulfated anionic surfactant" means a surfactant that does not fall within the definition of "sulfated anionic surfactant" as defined above.
[0238] It is also understood according to the invention that: - carboxylic anionic surfactants comprise at least one carboxylic or carboxylate function (-COOH or -COO), but do not comprise a sulfonic or sulfonate function (-SO3H or -SO3), nor a sulfate function (-OSO3H or -OSO3); - the anionic sulfonate surfactants comprise at least one sulfonic or sulfonate function (-SO3H or -SO3), and may optionally also comprise one or more carboxylic or carboxylate functions (-COOH or -COOj and / or phosphates, but do not comprise a sulfate function (-OSO3H or -OSO3). - phosphate anionic surfactants comprise at least one phosphoric or phosphate function (-OPO3H2 or -OPO3 2 ), but do not include a carboxylic function or carboxylate (-COOH or -COO ), nor sulfonic or sulfonate function (-SO3H or -SO3 ), nor sulfate function (-OSO3H or -OSO3 ).
[0239] In other words:
[0240] - an anionic surfactant comprising at least one sulfate function (-OSO3H or -OSO3), and at least one carboxylic or carboxylate function (-COOH or -COO), is considered, within the meaning of the invention and unless otherwise indicated, as a sulfated anionic surfactant;
[0241] - an anionic surfactant comprising at least one sulfate function (-OSO3H or -OSO3), and at least one sulfonic or sulfonate function (-SO3H or -SO3), is considered, within the meaning of the invention and unless otherwise indicated, as a sulfated anionic surfactant;
[0242] - an anionic surfactant comprising at least one sulfonic or sulfonate function (-SO3H or -SO3), and at least one carboxylic or carboxylate function (-COOH or -COO), is considered, within the meaning of the invention and unless otherwise indicated, as a non-sulfated sulfonate anionic surfactant; • an anionic surfactant comprising at least one sulfate function (-OSO3H or -OSO3), and at least one sulfonic or sulfonate function (-SO3H or -SO3 j, and at least one carboxylic or carboxylate function (-COOH or -COO), is considered, within the meaning of the invention and unless otherwise indicated, as a sulfated anionic surfactant.
[0243] The carboxylic anionic surfactants may be chosen from the following compounds: acylglycinates, acyllactylates, acylsarcosinates, acylglutamates; alkyl-D-galactoside-uronic acids, alkyl ether carboxylic acids, alkyl(aryl) ether carboxylic acids, alkylamido ether carboxylic acids; as well as the salts of these compounds. The alkyl and / or acyl groups of these compounds contain from 6 to 30 carbon atoms, more preferably from 8 to 28, even more preferably from 10 to 24, even better still from 12 to 22, carbon atoms. The aryl group preferably denotes a phenyl or benzyl group. These compounds may be polyoxyalkylenated, in particular polyoxyethylenated, and then preferably comprise from 1 to 50 ethylene oxide units, better still from 2 to 10 ethylene oxide units.Also useful are C6-C24 alkyl monoesters of polyglycoside-polycarboxylic acids such as C6-C24 alkyl polyglycosidecitrates, C6-C24 alkyl polyglycoside tartrates, and their salts.
[0244] According to one embodiment, the carboxylic anionic surfactants are chosen from: - acylglutamates, particularly C6-C24, or even C12-C20, such as stearoylglutamates, and in particular sodium or disodium stearoylglutamate or cocoylglutamates, in particular sodium or disodium cocoyl glutamate; - acylsarcosinates, particularly C6-C24, or even C12-C20, such as cocoyl sarcosinates and in particular sodium cocoyl sarcosinate, lauroyl sarcosinates and in particular sodium lauroyl sarcosinate, palmitoylsarcosinates, and in particular sodium palmitoylsarcosinate; - acyllactylates, particularly C12-C28, or even C14-C24, such as behenoyllactylates, and in particular sodium behenoyllactylate, (iso)stearoyl lactylates, and in particular sodium (iso)stearoyl lactylate; - C6-C24 acylglycinates, in particular C12-C20 such as cocoyl glycinates and in particular sodium cocoyl glycinate; - alkyl(C6-C30)ethercarboxylic acids, in particular alkyl(C6-C24)ethercarboxylic acids; - alkyl(C6-C30) aryl ethercarboxylic acids, in particular alkyl(C6-C24) aryl ethercarboxylic acids; - alkyl(C6-C30)amidoethercarboxylic acids, in particular alkyl(C6-C24)amidoethercarboxylic acids; - and their mixtures; and in particular in the form of salts of alkali or alkaline-earth metals, ammonium, or amino alcohol.
[0245] The anionic sulfonate surfactants may be chosen from the following compounds: alkylsulfonates, alkylamidesulfonates, alkylarylsulfonates, C6-C24 alkyl polyglycoside sulfosuccinates, alpha-olefinsulfonates, paraffinsulfonates, alkylsulfosuccinates, alkylethersulfosuccinates, alkylamidesulfosuccinates, alkylsulfoacetates, N-acyltaurates, acylisethionates; alkylsulfolaurates; as well as the salts of these compounds; the alkyl groups of these compounds comprising from 6 to 30 carbon atoms, in particular from 12 to 28, even better from 14 to 24, or even from 16 to 22, carbon atoms; the aryl group preferably denoting a phenyl or benzyl group; these compounds may be polyoxyalkylenated, in particular polyoxyethylenated and then preferably comprising from 1 to 50 ethylene oxide units, better still from 2 to 10 ethylene oxide units.
[0246] According to one embodiment, the anionic sulfonate surfactants are chosen from: C6-C24 alkylsulfosuccinates, in particular C12-C20, in particular laurylsulfosuccinates; C6-C24 alkylethersulfosuccinates, in particular C12-C20; (C6-C24)acylisethionates, preferably (C12-C18)acylisethionates; alpha-olefinsulfonates; and mixtures thereof; and in particular in the form of alkali or alkaline-earth metal, ammonium, or aminoalcohol salts.
[0247] According to one embodiment, the anionic surfactants may be chosen from C6-C24 alkyl monoesters of polyglycoside dicarboxylic acids such as alkyl glucoside citrates, alkyl polyglycoside tartrates and alkyl polyglycoside sulfosuccinates, alkyl sulfosuccinamates, acylisethionates and N-acyltaurates, the alkyl or acyl group of all these compounds preferably comprising from 12 to 20 carbon atoms. Another group of anionic surfactants usable in the compositions of the present invention is that of acyllactylates whose acyl group comprises from 8 to 20 carbon atoms.In addition, mention may also be made of alkyl-D-galactosideuronic acids and their salts as well as polyoxyalkylenated (C6-C24 alkyl)ethercarboxylic acids, polyoxyalkylenated (C6-24 alkyl)(C6-C24 aryl)ethercarboxylic acids, polyoxyalkylenated (C6-24 alkyl)amidoethercarboxylic acids and their salts, in particular those comprising from 2 to 50 ethylene oxide units, and mixtures thereof.
[0248] The anionic phosphate surfactants are chosen from: C6-C24 alkyl phosphates, in particular C12-C20; C6-C24 alkyl ether phosphates, in particular C12-C20; and mixtures thereof.
[0249] The amphoteric or zwitterionic surfactants may be chosen from derivatives of secondary or tertiary or quaternary aliphatic amines, in which the aliphatic group is a linear or branched chain comprising from 8 to 22 carbon atoms and containing at least one anionic group such as, for example, a carboxylate, sulfonate, sulfate, phosphate or phosphonate group. Mention may also be made of: alkyl(C8-C20)betaines, for example cocobetaine; sulfobetaines; alkyl(C8-C20)sulfobetaines; alkyl(C8-C20)amidoalkyl(C3-C8)betaines, for example cocamidopropylbetaine; or alkyl(C8-C20)amidoalkyl(C6-C8)sulfobetaines.
[0250] Cationic surfactants can be chosen from Cetrimonium Chloride marketed under the reference Microcare Quat CTC 30.
[0251] The surfactant(s) is / are present in the composition according to the invention at a content ranging from 0.1% to 40%, preferably from 0.5 to 30%, preferably from 1 to 20%, preferably from 2 to 12% by weight relative to the total weight of the composition.
[0252] - One or more film-forming agent(s)
[0253] The film-forming agent may be chosen from polymers of natural origin such as hydroxypropyl methylcellulose (HPMC), hydroxypropylcellulose (HPC), or synthetic polymers such as polyvinyl alcohol (PVA), and / or plasticizers other than polyols, such as polyethylene glycol, triethylcitrate, polysorbate, or waxes such as Carnauba wax, or hydrogenated castor oil.
[0254] Another film-forming agent of plant origin is hydroxypropylated pea starch Beauté by Roquette® ST 720, sold by the company ROQUETTE.
[0255] The film-forming agent(s) is / are present in the composition according to the invention at a content ranging from 0.1% to 20%, preferably from 0.5 to 15%, preferably from 1 to 12%, by weight relative to the total weight of the composition.
[0256] - One or more coloring matter(s)
[0257] The cosmetic composition according to the invention may also comprise at least one coloring matter chosen from water-soluble or fat-soluble dyes, fillers having the effect of coloring and / or opacifying the composition and / or coloring keratin materials, preferably the skin or the hair, such as pigments, pearlescent agents, lakes (water-soluble dyes adsorbed on an inert mineral support), and mixtures thereof. These coloring matters may optionally be surface-treated with a hydrophobic agent such as silanes, silicones, fatty acid soaps, C9-15 fluoroalcohol phosphates, acrylate / dimethicone copolymers, mixed C9-15 fluoroalcohol phosphate / silicone copolymers, lecithins, carnauba wax, polyethylene, chitosan and optionally acylated amino acids such as lauroyl lysine, disodium stearoyl glutamate and aluminum acyl glutamate, phytic acid.Another natural colorant is Beauté by Roquette® CC 001 caramel colorant, sold by the company ROQUETTE.
[0258] “Pigments” are white or colored particles, mineral or organic, intended to color and / or opacify the cosmetic composition.
[0259] Pigments include mineral or organic pigments, whether natural or synthetic. Examples of pigments include iron, titanium or zinc oxides, as well as composite pigments and goniochromatic, pearlescent, interference, photochromic or thermochromic pigments, but this list is not exhaustive.
[0260] Among the pigments surface-treated with lecithins, we can mention the products UNIPURE WHITE LC981 HLC (INCI: Cl 77891 (and) Hydrogenated Lecithin, UNIPURE YELLOW LC182 HLC (INCI: Cl 77492 (and) Hydrogenated Lecithin), UNIPURE BLACK LC989 HLC (INCI: Cl 77499 (and) Hydrogenated Lecithin, UNIPURE RED LC381 HLC (INCI: Cl 77491 (and) Hydrogenated Lecithin) from the company Sensient Cosmetic Technologies.
[0261] Among the pigments surface-treated with phytic acid, we can mention the products Unipure White LC 985 PHY (INCI: Cl 77891 (and) Phytic Acid (and) Sodium Hydroxide), Unipure Yellow LC 188 PHY (INCI: Cl 77492 (and) Phytic Acid (and) Sodium Hydroxide), Unipure Red LC 388 PHY (INCI: Cl 77491 (and) Phytic Acid (and) Sodium Hydroxide), Unipure Black LC 998 PHY (INCI: Cl 77499 (and) Phytic Acid (and) Sodium Hydroxide), from the company Sensient Cosmetic Technologies.
[0262] The term “mother-of-pearl” refers to any colored particles, iridescent or not, which present a color effect through optical interference.
[0263] Among the nacres, we can cite titanium mica covered with metallic oxide such as iron oxide or titanium oxide.
[0264] According to one embodiment, the makeup and / or care composition according to the invention comprises at least colored particles, preferably pigments such as iron oxide pigments and / or mother-of-pearl.
[0265] The coloring matter(s) is / are present in the composition according to the invention at a content ranging from 0.05% to 20%, preferably from 0.1% to 15%, preferably from 0.5 to 12%, by weight relative to the total weight of the composition.
[0266] One or more sensory fillers or powders
[0267] This term means any particle of any shape (in particular spherical or lamellar), mineral or organic, insoluble in the composition. Examples of sensory fillers or powders are talc, boron nitride, starch such as the granular starches Beauté by Roquette® ST 005 and Beauté by Roquette® ST 012 sold by the company ROQUETTE, polyamides, silicone resins, silicone elastomer powders and acrylic polymer powders, in particular poly(methyl methacrylate) or styrene acrylate copolymer powders (Sunsphere Powders from Dow).
[0268] The filler(s) is / are present in the composition according to the invention at a content ranging from 0.5% to 20%, preferably from 1 to 15%, preferably from 3 to 12%, by weight relative to the total weight of the composition.
[0269] One or more sensory agent(s)
[0270] Sensory agents allow the sensory profile of the cosmetic or dermatological composition to be modified, to make it more pleasant to use on the skin. Sensory agents can be chosen from modified starches such as carboxymethyl starches, for example Beauté by Roquette® ST 118 from Roquette, silicas, or talcs, or their mixtures. These sensory agents provide softness to the touch for solid compositions, or a cushion effect for compositions in liquid or gel form.
[0271] The sensory agent(s) is / are present in the composition according to the invention at a content ranging from 0.1% to 20%, preferably from 1 to 15%, preferably from 3 to 12%, by weight relative to the total weight of the composition.
[0272] - One or more active ingredient(s)
[0273] In addition to hyperbranched dextrins, the cosmetic composition may include one or more active ingredients.
[0274] These active ingredients may be of a very broad chemical nature due to the fact, as the applicant has been able to observe, that hyperbranched dextrin, preferably hyperbranched and hydrogenated dextrin, is rather inert, has low reactivity and very good compatibility with most of the active ingredients used in dermatological compositions / topical formulations. These active ingredients may be chosen from moisturizing, emollient, film-forming, barrier, anti-pollution, tensor, anti-aging, anti-oxidant, exfoliating, collagen stimulating, anti-acne, sebum reducing, blood circulation stimulating, refreshing, antibacterial, antifungal, anti-inflammatory, soothing, anti-irritant, healing, slimming, pigmenting, coloring, mattifying and perfuming agents.
[0275] Among the soothing agents, those extracted from plants will be preferentially used. Mention will be made in particular as soothing agents of C-glycosides such as those described in document FR2902998.
[0276] Preferably, hyperbranched dextrins can be combined with another anti-inflammatory cosmetic active ingredient or a soothing active ingredient.
[0277] Among the active ingredients, we can cite those described in the following table:
[0278] [Table 1]
[0279] The active ingredient(s) is / are present in the composition according to the invention at a content ranging from 0.05% to 20%, preferably from 0.1 to 10%, preferably from 0.5 to 6%, by weight relative to the total weight of the composition.
[0280] The dermatological compositions according to the invention are particularly suitable for intolerant and / or irritable skin as well as sensitive scalps.
[0281] Irritated or intolerant skin has been defined in patent FR2918886.
[0282] Intolerant skin is skin that reacts with sensations of heating, tightness, tingling and / or redness to various factors such as the application of cosmetic or dermatological products. These signs are generally associated with erythema and hyperseborrheic or acne-prone skin, or even rosacea, with or without scabs.
[0283] Irritable skin is skin that reacts with pruritus, that is, itching or tingling, to various factors such as the environment, emotions, food, wind, friction, razors, hard water with a high concentration of limestone, temperature variations or wool. Most often, skin irritation results in visible signs such as skin redness, a feeling of heating of the skin or scalp which can lead to a feeling of pain.
[0284] Sensitive scalp refers to scalps in which the sensations of itching and / or tingling and / or heating are mainly triggered by local factors such as friction, soap, surfactants, hard water with a high concentration of limestone, shampoos or lotions. These sensations are also sometimes triggered by factors such as the environment, emotions and / or food. Erythema and hyperseborrhea of the scalp as well as a dandruff condition are frequently associated with the above signs. Examples
[0285] Example 1: In vitro determination of the effect of hyperbranched and hydrogenated dextrins on skin inflammation on a 2D reconstructed human epidermis model
[0286] The objective of the study is to determine the effect of hyperbranched and hydrogenated dextrins on inflammation biomarkers using a two-dimensional (2D) reconstructed human epidermis model after inflammatory pre-treatment. In this example, the hyperbranched and hydrogenated dextrin Nutriose® HM 06 sold by the Applicant was selected.
[0287] Materials and methods
[0288] Reconstructed human epidermis model
[0289] In vitro reconstructed human skin equivalents mimic normal human skin in a very similar way. Since these models reproduce, in a To a large extent, the barrier function properties of normal human skin, they can be used for screening potential skin irritants. The model used is a two-dimensional reconstruction of the human epidermis, adapted from the method Poumay et al., 2004 (1 Poumay, Y., Dupont, F., Marcoux, S., Leclerk-Smekens, M., Herin, M. And Coquette, A. (2004) A simple reconstructed human epidermis: preparation of the culture model and utilization in in vitro studies. Arch. Dermatol. Res. 296: 203-211 ). This model comprises a monolayer of normal human epidermal keratinocytes (NHEK, one of the major cell types of the skin), which were cultured on inert polycarbonate inserts.
[0290] Test substances can be applied topically, directly to the epidermal surface, and their irritant potential and / or efficacy can be assessed using a number of parameters, including expression levels of key cellular markers of inflammation.
[0291] Exposure of tissues to samples
[0292] The epidermis were treated with a 0.5% aqueous solution of Sodium Lauryl Sulfate (SLS) for 6 hours to create inflammation of the reconstructed epidermis, then the surface of the epidermis was rinsed with 500 μL of PBS. 20 μL of different concentrations of hydrogenated and highly branched dextrins (10 and 5% in ultrapure water) as well as 0.05% Betamethasone cream (Biogaran cream, a corticosteroid with an anti-inflammatory role) were applied topically to the epidermis for a period of 20 hours at 37°C. No application was made for the SLS control within 20 hours after rinsing with PBS.
[0293] The negative control (UTC) followed, under the same conditions, the different technical steps without the application of SLS or sample. Sodium lauryl sulfate (0.5% SLS in water) serves as a positive control for epidermal inflammation.
[0294] MTT cell proliferation assay
[0295] Irritating chemical compounds are capable of penetrating the stratum corneum and are cytotoxic to cells in the underlying layers. Cell viability has been shown to be directly correlated with the irritant potential of chemical compounds. Cell viability is measured upon metabolization, by mitochondrial succinic dehydrogenase, of the vital dye MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, thiazolyl blue; EINECS number 206-069-5, CAS number 298-93-1 )], into a blue formazan salt that is measured quantitatively after its extraction from tissues.
[0296] The colored solution is measured spectrophotometrically at 570 nm using Molecular Devices VMAX microplate reader. and absorbance values are recorded via SOFTmax PRO v4.7.1 software. Statistical analysis is performed using Graph Pad Prism v5.03 software.
[0297] According to the results of this test, - If the viability is less than 50%, then the ingredient is an irritant - If the viability is greater than 50%, then the ingredient is: - mild irritant if it activates inflammation biomarkers; - non-irritating if it does not activate inflammation biomarkers.
[0298] Assay of inflammation markers
[0299] Interleukins IL-1α and IL-8 and tumor necrosis factor-α (TNF-α) are measured to determine whether or not the treatment has induced an inflammatory reaction in the treated tissue.
[0300] For this, cell supernatants are collected after the required treatment time and commercially available ELISA kits are used to quantitatively determine the presence of inflammation markers.
[0301] [Table 2]
[0302] These ELISA kits are intended for quantitative measurements of the above-mentioned markers, particularly in culture supernatants, using specific human antibodies. Samples and a range of standards are placed in each well (96-well plate) in duplicate. The targeted marker present in a sample is bound by the antibody immobilized in the bottom of the well. The wells are washed and a biotinylated antibody is added. After washing, HRP-streptavidin is placed in the wells. These are washed again, a TMB substrate solution is added to the wells and the color develops in proportion to the amount of bound marker. A revealing solution changes the color from blue to yellow, and its intensity is measured at 450nm using the Molecular Devices VMAX microplate reader. Absorbance values are recorded and analyzed via the SOFTmax PRO v4.7.1 software. The inflammatory response is interpreted as a sample / untreated ratio greater than or equal to 2.
[0303] Semi-quantitative fluorescence cytokine assay
[0304] To obtain a more complete profile of the anti-inflammatory effect induced by hydrogenated and highly branched dextrins, a panel of cytokines was assayed on slides by semi-quantitative assay. Cell culture supernatants collected after epidermal treatment were tested using the Human Cytokines Array G3 kit (RayBiotech).
[0305] On a glass slide containing the different specific antibodies, the supernatants are deposited at a rate of 100 pL per well. A cocktail of secondary antibodies coupled with biotin is then added. Thanks to the addition of streptavidin, the signal intensities are detected by fluorescence. Each step is followed by several washes.
[0306] Results
[0307] MTT cell proliferation assay
[0308] Cytotoxicity of samples was tested using the epidermis model and is expressed as a percentage of untreated control tissue (UTC).
[0309] [Table 3] 0310] * Mean of 3 replicates; **SD: standard deviation
[0311] A significant difference in cell viability was observed between the untreated control and the treated areas, demonstrating the impact of inflammatory treatment with SLS.
[0312] After 20 hours, cell viability in the presence of 0.5% SLS and Nutriose HM 06 hyperbranched dextrin is greater than 50%: thus Nutriose HM 06 hyperbranched dextrin is not an acute irritant to the epidermis. As expected, this is the case even for the sample treated with 0.5% SLS and 0.05% betamethasone. Cell viability measured in the presence of 0.5% SLS and Nutriose® HM 06 hyperbranched dextrin is as good as in the presence of 0.5% SLS and betamethasone. This cell viability test having established that Nutriose HM 06 hyperbranched dextrin is not an acute irritant, tests on the expression of inflammation markers could be carried out in order to determine whether this dextrin can be qualified either as a mild irritant, in the case where there would be no reduction in the expression of an inflammation marker, or as an anti-irritant, in the case where the expression of at least one major inflammation marker would be reduced.
[0313] Test on the inflammation marker IL-1α, IL-8 and TNF-α
[0314] [Table 4] 0315] The mean concentrations of the inflammatory markers were calculated from two replicates of n=3 epidermis in an ELISA test (except for IL-8, n=2). The ratios (marker concentration in the presence of the samples / marker concentration of the untreated control) were calculated for each formulation tested.
[0316] A ratio greater than or equal to 2 reflects overexpression of the inflammation marker while a ratio less than 2 indicates non-expression of the inflammation marker.
[0317] The hyperbranched dextrin "Nutriose® HM 06" according to the invention significantly reduces the expression of IL-1α (decrease of 25 and 28%). Betamethasone also significantly reduces the expression of IL-1α (decrease of 33%). Thus, no significant difference is observed between the compound according to the invention and betamethasone, a positive control testifying to the anti-inflammatory effect of the compound according to the invention.
[0318] None of the concentrations of hydrogenated and highly branched dextrins were able to decrease the expression of interleukin IL-8 after epidermal inflammation. Similarly, betamethasone cream had no effect on the IL-8 ratio. TNF-α expression was not high enough to be detected according to the calibration curve of the ELISA kit.
[0319] Test on the 4 markers of inflammation IL-1α, IL-1β, RANTES and VEGF
[0320] Following the results obtained by ELISA test on the inflammation marker IL1-a, the effect of the concentration of hyperbranched dextrin “Nutriose® HM 06” at 5% was evaluated after inflammation of the epidermis reconstructed with 5% SLS.
[0321] [Table 5]
[0323] The ratios (intensity of the fluorescent signal of the marker in the presence of the samples / intensity of the fluorescent signal of the marker of the untreated control) were calculated for each treatment from n = 3 epidermal culture supernatants (except for the untreated control, n = 2).
[0324] A ratio > 1.5 reflects overexpression of the inflammatory marker.
[0325] A ratio < 0.65 reveals underexpression of the inflammation marker.
[0326] According to the supplier's criteria, signals are usable when they are above the mean of the background noise + 2SD. Overexpression or underexpression of 5 markers was observed with inflammation at 0.5% SLS. A decrease in the expression of these markers was also observed with the addition of the treatment based on hyperbranched dextrin "Nutriose® HM 06".
[0327] Thus, the hyperbranched dextrin “Nutriose® HM 06” reduces: - the expression of 11-1 a (vs SLS alone) and allows to pass below the critical limit of 1.5 - the expression of 11-1 p (vs SLS alone) and allows to go below 0.65 - the expression of 11-15 (compared to the untreated control) and allows to go below 0.65 - the expression of VEGF (compared to SLS alone) and allows to approach the threshold 1.5 review - the expression of RANTES (vs SLS alone).
[0328] Nutriose HM 06 hyperbranched dextrin therefore reduces the expression of major markers of inflammation (IL-1 alpha and IL-1 beta), and can therefore be described as an anti-irritant. This dextrin has anti-inflammatory properties.
[0329] Example 2: In vitro determination of the effect of hyperbranched dextrins on membrane integrity on a 3D reconstructed human epidermis model
[0330] The objective of the study was to assess the membrane integrity of skin cells in a three-dimensional (3D) reconstructed human epidermis model by measuring the amount of the enzyme lactate dehydrogenase (LDH) in the culture supernatant using colorimetry. LDH is an enzyme that is released in the event of cell death. The absence of LDH secretion is a sign that the integrity of epidermal cell membranes is preserved.
[0331] Protocol
[0332] Samples of 3D reconstructed human epidermis were immersed in an aqueous solution containing 0.5% by weight of sodium lauryl sulfate for 6 hours. Then the solution was removed, and the samples were immersed in different solutions for 20 hours: 1 sample in a 5% by weight aqueous solution of Nutriose® HM 06, another sample in a 0.5% by weight aqueous solution of bisabolol, and another sample in a 0.5% by weight aqueous solution of betamethasone. The amount of LDH secreted into the supernatant was then determined by colorimetry.
[0333] Results
[0334] Table 6] 0335] Roquette Nutriose® HM 06 hyperbranched dextrin helps maintain the integrity of the cell membranes of reconstructed human epidermis, as effectively as betamethasone.
[0336] Example 2: Clinical study on transepidermal water loss induced by shaving
[0337] The objective of the study is to determine the effect of a hyperbranched dextrin, sold under the reference Nutriose® HM 06 by Roquette, on transepidermal water loss (or TEWL according to the English term in use) induced by shaving of the facial skin through the topical application of said dextrin in the form of a lotion (aftershave), during a clinical study on volunteers.
[0338] Volunteers and products
[0339] This non-invasive, single-center study was conducted on sixty male volunteers aged between 30 and 55 years, with sensitive skin (based on their self-report), and a history of using mechanical razors and applying aftershave. The inclusion criteria for the volunteers are presented in the table.
[0340] [Table 7] 0341] The volunteers were divided into three homogeneous groups of 20 volunteers, and each group received a batch of double-blade razor, “commercial reference” shaving cream, and an aftershave lotion according to the table below.
[0342] Composition of aftershave creams
[0343] [Table 8] 0344] Material
[0345] The volunteers' faces were assessed by measuring transepidermal water loss (TEWL). This measurement allows an assessment of the skin's barrier function: the value of water loss is inversely proportional to the skin's barrier function. Measurements of transepidermal water evaporation, expressed in g / h / m2, were carried out on a Tewameter TM300® from the manufacturer "Courage & Khazaka electronics", using the open room diffusion technique. Approximately twenty successive measurements were taken on the surface of the face subjected to shaving, and an average value was retained.
[0346] Study Procedure
[0347] Volunteers replaced their usual razor and shaving cream with the study razor and shaving cream three days before the start of the study. The study was then initiated by performing a facial assessment of the volunteers in the laboratory after shaving and application of the aftershave lotion in the laboratory premises (measurement "day 0"). The measurement was repeated 10 minutes after the measurement "day 0".
[0348] Between Day 0 and Day 13, volunteers performed their daily shave at home using a new razor for each shave, the study shaving cream, and the study aftershave lotion. At Day 14 ème On day 0, the volunteers returned to the laboratory for a facial assessment following a protocol identical to that of day 0, i.e., an assessment after shaving followed by the application of aftershave lotion in the laboratory, followed by a second measurement 10 minutes after the first.
[0349] Between days 14 and 27, the volunteers resumed the same protocol as between days 0 and 13. Then on the 28th ème day, they returned to the laboratory for final evaluation of the face according to the same protocol as on day 0 and day 14: i.e. an assessment on day 28 after shaving and application of aftershave lotion, followed by a second measurement 10 minutes after the first.
[0350] Results
[0351] [Table 9] 0352] [Table 10] j0353] The study thus showed that the application of an aftershave lotion comprising the hyperbranched and hydrogenated dextrin according to the invention, Nutriose HMC 6, made it possible to reduce intracellular water loss compared to the placebo lotion from day 0 and on days 14 and 28. This also made it possible to reduce water loss on day 14 ème day in a manner equivalent to the reference product, and to reduce water loss at 28 èmeday more significantly than the reference product.
[0354] Example 3: Clinical study on transepidermal water loss (TEWL) and redness induced by sodium lauryl sulfate
[0355] The objective of the study is to determine the effect of a hyperbranched dextrin, sold under the reference Nutriose® HM 06 by Roquette, on the redness created by irritation of the skin of the inner forearm by a 10% SLS patch test, during a clinical test on volunteers.
[0356] Volunteers and products
[0357] The volunteers were the same as for the clinical study in Example 2 (shaving study), divided into the same groups, with the same products (Table 6 of Example 2).
[0358] Materials
[0359] Skin color was assessed colorimetrically using a Minolta CM2600D TM spectrocolorimeter. Color measurements were made using the following parameters: standard field of view of 10°, D65 illumination corresponding to daylight, measurement on square areas of 8 mm on each side, L*a*b* color space used, SCI method (specular included) to free oneself from surface conditions.
[0360] The vertical dimension L* represents brightness (or luminance) with values ranging from 0 (black) to 100 (white). The parameter a* determines a range of 600 levels on the red axis (+299 positive values) through gray (value of 0) to green (-300 negative values). The parameter b* determines a range of 600 levels on the yellow axis (+299 positive values) through gray (value of 0) to blue (-300 negative values). For this study, the parameter a*, representing skin redness, was determined.
[0361] Study protocol
[0362] At the start of the study (day 0), skin color and TEWL measurements were taken on demarcated areas on both forearms of the volunteers. Then, 10% SLS patches were placed on the two demarcated areas on each volunteer's forearms. The volunteers kept the patches on for 20 hours, and removed them 4 hours before the day 1 measurement, so that on day 1, color and TEWL measurements were taken on both forearms of all volunteers. Immediately after the day 1 measurement, aftershave lotion was applied to the SLS patch-treated area on the right forearm, and then color and TEWL were measured 5, 10, and 30 minutes after this application. The left forearm received no treatment.
[0363] From day 1 to day 6, volunteers applied aftershave lotion daily in the evening to the SLS-treated area of the right forearm. The left forearm received no treatment. On days 2, 3, 4, and 7, the color and TEWL of the aftershave lotion-treated area and the control area were measured.
[0364] Results
[0365] [Table 1 1] 0366] To compare the changes in redness between the different groups, the variations in redness between the different measurement times were calculated, for example for a treated area of skin:
[0367] [Math. 1] ΔTreated((Day x) - Day 1) = (a* of the treated area on day x) - (a* of the treated area on day 1), for the three groups.
[0368] [Table 12] 0369] The table represents the differences in redness variations over time between treated and untreated skin areas.
[0370] Nutriose® HM 06 hyperbranched dextrin significantly reduced redness caused by SLS after 10 minutes compared to the placebo and reference groups, and this reduction was maintained for up to 7 days. The reduction in skin redness by applying Nutriose HM 06 hyperbranched dextrin showed that this dextrin reduced skin inflammation caused by the 10% SLS patch. Moreover, this reduction in inflammation is faster than for the reference group, therefore faster than for the known anti-inflammatory Bisabolol.
[0371] [Table 13] ;0372] The table represents the transepidermal water losses on the treated areas of the forearm
[0373] [Table 14] 0374] Table 14 represents the variations in transepidermal water losses on the treated areas of the forearm compared to day 1.
[0375] Nutriose® HM 06 hyperbranched dextrin significantly reduced transepidermal water loss from 30 minutes after application, then gradually increased over the treatment period ranging from 2 to 7 days, for achieve a water loss reduction value compared to the placebo group that was approximately 6.6 units greater (a difference of approximately 195%). This hyperbranched dextrin therefore helped maintain skin hydration by maintaining the skin's barrier function.
[0376] Example 4: Cosmetic product formulations comprising a hydrogenated and highly branched dextrin according to the subject of the application
[0377] Skin lover cream (SC-079-005)
[0378] [Table 15]
[0379] Preparation protocol: At 45°C, Nutriose® HM 06 was added to the water and mixed with a deflocculator at 500 rpm until a clear solution was obtained. The ingredients of phase A2 were then mixed together in water while stirring at 500-1000 rpm. Phase A3 was then added to phase A1 + A2, and mixed at 1500 rpm for 10 minutes. Separately, phase B was prepared by heating it to 45°C, then the liquid phase B was emulsified in phase A1 + A2 + A3 at 45°C while stirring at 2000-3000 rpm. for 15 minutes. It was then cooled to room temperature, and phases C and D were added. The final step was to add E and F, previously dissolved in a little water. This gave a blue-colored emulsion with a Brookfield viscosity of 4500-5500 mPa.s (SP3 mobile, 20 rpm, 20°C).
[0380] After-sun cream
[0381] [Table 16]
[0382] Preparation protocol: Phase A and phase B were prepared at 70°C in two separate beakers. Phase B was then emulsified in phase A under high shear stirring for 10 minutes. The mixture was then cooled to 20°C + / -2°C. Phase C was then added under stirring, followed by phase D. The pH was finally adjusted to 6. A white cream was obtained with a Brookfield viscosity of 3500 mPa.s + / - 700 (spindle no. 4 at 20 rpm).
[0383] Aftershave gel
[0384] [Table 17]
[0385] Preparation protocol: we first mix isosorbide, Nutriose HMC 06 in the quantity of water required for phase A, then the Beauté by Roquette DS 112 starch was dispersed in it at 80°C for 30 to 40 minutes. Phases B1 and B2 were then added successively, and the pH was adjusted to 6. A translucent gel was obtained, with a Brookfield viscosity of 3500 mPa. s + / -700 (spindle no. 4 at 20 rpm).
[0386] Soothing oil-in-water emulsion
[0387] [Table 18]
[0388] Preparation protocol: Nutriose HMC 06 was added to half the volume of water required for the formulation at 45°C while stirring with a deflocculator at 500 rpm until a clear solution was obtained. Separately, the ingredients of phase A2 were mixed in half the volume of water required for the formulation while stirring at 500-1000 rpm. Phase A1 and phase A2 were then mixed, and then phase A3 was added while stirring at 1500 rpm for 10 minutes. Separately, phase B was prepared by heating it to 45°C. Then, phase B was emulsified in phase A1+A2+A3 while stirring vigorously at 2000-3000 rpm for 15 minutes at 45°C. The mixture was cooled to 20°C + / -2°C, then phases C, D, E and F were successively added while stirring at 500 rpm, and the pH was adjusted to 5.3 + / -0.2. This gave a blue emulsion with a Brookfield viscosity of 4500-5500 mPa. s (spindle no. 3 at 20 rpm).
[0389] Soothing and restorative hand cream
[0390] [Table 19]
[0391] Preparation protocol: Nutriose HMC 06 was added to the volume of water required for the formulation at 45°C while stirring with a deflocculator at 500 rpm until a clear solution was obtained, then cooled to 20°C + / -2°C. Beauté by Roquette DS 421 was then dispersed in phase A while stirring with a deflocculator at 1000 rpm for about 10 minutes so that this ingredient was hydrated, which was visually observed by its opalescence. Separately, phase C was prepared. At room temperature (20°C + / - 2°C), phase C was added to phase A + B slowly and while stirring with a deflocculator at 2000-3000 rpm, then stirring was maintained for 10 minutes. Finally, phase D was added with stirring at 1000-2000 rpm and then adjusted to pH 4.5-4.7. A yellow cream was obtained, with a Brookfield viscosity of 8800 mPa. s (spindle 3 at 20 rpm).
[0392] Soothing Cleansing Cream (TQ-027-001)
[0393] [Table 20]
[0394] Soothing Hair Conditioning Gel (HC-040-001)
[0395] [Table 21] 0396] Soothing Conditioning Hair Cream (HC-040-002)
[0397] [Table 22]
Claims
Demands
1. Hyperbranch dextrins for their topical use for the prevention or treatment of at least one symptom selected from redness, heat, swelling, and pain, characterized in that the hyperbranch dextrins comprise: - at most 90% of 1-4 glycosidic bonds, - at least 5% of 1-6 glycosidic bonds, compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds.
2. Hyperbranched dextrins for their use according to claim 1, characterized in that they have: - at least 5% of 1-6 glycosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at least 10%, more preferably at least 12%, and most preferably at least 15% - at most 70% of 1-4 glycosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at most 60%, and most preferably at most 50%, - at least 1% of 1-3 glycosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at least 5%, more preferably at least 10%, and most preferably at least 20% - at least 1% of 1-2 glycosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at least 5%, more preferably at least 10%, and most preferably at least 20%.
3. Hyperbranched dextrins for their use according to claim 1, characterized in that the hyperbranched dextrins have: - 42 to 50% of 1-4 glycosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 5% to 40% of 1-6 glycosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - 1 to 20% of 1-3 glycosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - 1 to 20% of 1-2 glycosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds.
4. Hyperbranched dextrins for their use according to any one of claims 1 to 3, characterized in that the dextrins are hydrogenated hyperbranched dextrins.
5. Hyperbranched dextrins for their use according to any one of claims 1 to 4, characterized in that the symptom is localized at the level of at least one epithelial tissue selected from keratinized stratified squamous epithelium, non-keratinized stratified squamous epithelium, stratified columnar epithelium, ciliated or non-ciliated pseudostratified columnar epithelium.
6. Hyperbranched dextrins for their use according to any one of claims 1 to 5 for the prevention or treatment of symptoms of skin inflammation.
7. Hyperbranched dextrins for their use according to any one of claims 1 to 5, for the prevention or treatment of symptoms of inflammation of the mucous membranes.
8. Hyperbranched dextrins for their use according to claim 6, characterized in that skin inflammation is induced by skin irritation, skin corrosion, skin inflammation of endogenous origin, or a combination of these causes.
9. Hyperbranched dextrins for their use according to claim 7, characterized in that inflammation of the mucous membranes is induced by ingredients contained in cosmetic, dermocosmetic, dermatological, pharmaceutical, medicinal, veterinary, or domestic compositions or by mechanical aggressions.
10. Hyperbranched dextrins for their use according to any one of the preceding claims, characterized in that at least one symptom or skin irritation or skin corrosion or skin inflammation is induced by at least one of the following conditions selected from infectious agents, chemicals, ingredients contained in cosmetic, dermatological, pharmaceutical, veterinary, detergent or household compositions, mechanical aggressions, environmental factors, thermal aggressions, food and beverages.
11. Hyperbranched dextrins for their use according to any one of the preceding claims characterized in that the skin irritations are selected from cumulative irritant contact dermatitis, acute irritant contact dermatitis, and phototoxic dermatitis.
12. Hyperbranched dextrins for their use according to claim 6, wherein skin inflammation is induced by a dermatological pathology involving an inflammatory process.
13. Hyperbranched dextrins for their use according to claim 12, characterized in that the pathology is selected from among erythemas, psoriasis, cutaneous atopy, atopic dermatitis, immediate hypersensitivity type allergic reactions, delayed hypersensitivity type allergic reactions, inflammatory hyperpigmentations, immune dermatoses, actinic elastosis, alopecia areata, vitiligo, systemic lupus erythematosus, pemphigus vulgaris, dystrophic epidermolysis bulbosa and autoimmune canities, erythemas, .
14. Hyperbranched dextrins for their use according to claim 7 whereby inflammation of the mucous membranes is induced by a pathology involving an inflammatory process.
15. Use of hyperbranched dextrins to prevent, reduce, or eliminate the irritant effect of ingredients contained in cosmetic or dermatological, medicinal, veterinary, detergent, or household compositions, characterized in that the hyperbranched dextrins comprise: - at most 90% of 1-4 glycosidic bonds, - at least 5% of 1-6 glycosidic bonds, compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds.
16. Use of hyperbranched dextrins according to claim 15, characterized in that the hyperbranched dextrins have: - at least 5% of 1-6 glycosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at least 10%, more preferably at least 12%, and most preferably at least 15% - at most 70% of 1-4 glycosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at most 60%, and most preferably at most 50%, - at least 1% of 1-3 glycosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at least 5%, more preferably at least 10%, and most preferably at least 20% - at least 1% of 1-2 glycosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at least 5%, more preferably at least 10%, and most preferably at least 20%.
17. Use of hyperbranched dextrins according to claim 15, characterized in that the hyperbranched dextrins have: - 42 to 50% of 1-4 glycosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - 5% to 40% of 1-6 glycosidic bonds compared to the sum of 1-2 bonds, 1- 3, 1-4 and 1-6, - 1 to 20% of 1-3 glycosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - 1 to 20% of 1-2 glycosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds.
18. Use of hyperbranched dextrins according to any one of claims 15 to 17, characterized in that the ingredients are selected from surfactants, perfumes, solvents, preservatives, acids, bases, detergents.
19. Dermatological composition comprising, in a dermatologically acceptable medium, hyperbranched dextrins, preferably hydrogenated hyperbranched dextrins, characterized in that the hyperbranched dextrins comprise: - at most 90% of 1-4 glycosidic bonds, - at least 5% of 1-6 glycosidic bonds, compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds.
20. Dermatological composition according to claim 19, characterized in that the hyperbranching dextrins have: - at least 5% of 1-6 glycosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at least 10%, more preferably at least 12%, and most preferably at least 15% - at most 70% of 1-4 glycosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at most 60%, and most preferably at most 50%, - at least 1% of 1-3 glycosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at least 5%, more preferably at least 10%, and most preferably at least 20% - at least 1% of 1-2 glycosidic bonds relative to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, preferably at least 5%, more preferably at least 10%, and most preferably at least 20%.
21. Dermatological composition according to claim 19, characterized in that the hyperbranching dextrins have: - 42 to 50% of 1-4 glycosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - from 5% to 40% of 1-6 glycosidic bonds compared to the sum of 1-2, 1-3, 1-4 and 1-6 bonds, - 1 to 20% of 1-3 glycosidic bonds compared to the sum of 1-2, 1-3, 1- bonds 4 and 1-6, - 1 to 20% of 1-2 glycosidic bonds compared to the sum of 1-2, 1-3, 1- bonds 4 and 1-6.