Cosmetic or dermatological compositions comprising polylysine dendrimers and uses thereof

Abstract

The present invention relates to a cosmetic or dermatological composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one cosmetically and / or dermatologically acceptable carrier. The invention also relates to a non-therapeutic cosmetic care method comprising applying to the skin or mucous membranes a cosmetic composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one cosmetically and / or dermatologically acceptable carrier. The invention also relates to the use of the dermatological composition for the treatment of dermatological diseases.

Description

Technical Field

[0001] The present invention relates to a cosmetic or dermatological composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one cosmetically and / or dermatologically acceptable carrier.

[0002] The invention also relates to the cosmetic use for acting on the skin or mucous membranes.

[0003] The invention also relates to the use of the dermatological composition for treating skin diseases.

[0004] The invention is particularly suitable for use in the fields of cosmetics and / or dermatology. Background Art

[0005] The skin is one of the most complex organs in the human body, and its surface area varies depending on the size and weight of the subject. The skin of each individual occupies approximately 2m 2 Surface area.

[0006] The skin is made up of three very distinct layers, with associated appendages such as sweat glands and sebaceous follicles.

[0007] More precisely, from the outside in, it consists of:

[0008] - the epidermis including the stratum corneum, which is the outermost cell layer of the skin and plays an important role in the skin due to its structure and its contact with the external environment. It is the main barrier of the skin against external aggressors, such as physical (ultraviolet rays, etc.), chemical (organic solvents, acids, alkalis, etc.) and mechanical (cutting, pinching, etc.),

[0009] - Dermis, a fibroelastic connective tissue composed of fibroblasts and immune cells (macrophages, lymphocytes, eosinophils) and an intercellular matrix. This matrix is ​​composed of: fibrin (collagen, elastin, reticulin) and an interfibrous gel composed of proteoglycans, glycoproteins, salts and water. The dermis also includes extensive blood vessel branches, nerve fibers and skin appendages. It ensures skin softness, hydration, nutrition and elasticity.

[0010] - Subcutaneous tissue, a loose connective tissue, similar in structure to the dermis, mainly composed of collagen fibers, proteoglycans and tissues. It separates the dermis from the fibrous membranes that encase the underlying parts such as muscles.

[0011] Each of the elements that make up the skin has different or complementary functions and metabolisms, closely related to their structure and their surroundings. Their age- and / or environment-related inherited or acquired metabolic dysfunctions lead to physiopathological consequences, resulting in diseases of the skin and subcutaneous tissue, aging and skin degeneration.

[0012] The vitamin and its metabolites are known to have time- and dose-dependent effects on epithelial cell proliferation and differentiation, epithelial and mesenchymal cell synthetic capacity, immune regulation, and defense against cancer and other diseases, including autoimmune and infectious diseases.

[0013] There are cosmetic products and / or compositions comprising vitamins and their derivatives which can be applied to the skin in order to restore and protect the skin. These include in particular cosmetic products, in particular compositions for topical use, comprising vitamins and their derivatives, such as vitamin A, in particular retinol and its derivatives; vitamin C, in particular ascorbic acid and its derivatives; and / or vitamin E, in particular tocopherol. These compositions can be used in anti-aging, antioxidant or anti-inflammatory treatments.

[0014] However, the efficacy of these compositions is limited, in particular in the skin, for example in anti-aging, anti-inflammatory and / or antioxidant treatments, due in particular to the low bioavailability of the vitamins present in the known compositions. In particular, users perceive the known compositions containing vitamins as having a low efficacy, in particular because the vitamins do not actually penetrate into the skin tissue.

[0015] There is therefore a real need to find new compositions with good cosmetic or dermatological efficacy which would allow, for example, to improve the appearance and surface quality of the skin, in particular for obtaining moisturizing, anti-aging, anti-inflammatory and / or antioxidant effects.

[0016] There are also cosmetic compositions containing vitamins, in particular vitamin A, which can be effectively used in anti-aging cosmetic treatments, for example by reducing the appearance of wrinkles and / or improving the evenness of skin tone and / or increasing the firmness and elasticity of the skin. However, these compositions may induce undesirable side effects, for example in connection with inflammatory reactions and / or skin intolerance and / or skin irritation.

[0017] Therefore, there is a real need to find new cosmetic or dermatological compositions having cosmetic and / or dermatological efficacy which do not induce undesirable side effects, such as skin inflammation and / or skin irritation and / or skin allergy.

[0018] There are also cosmetic compositions containing preservatives such as benzoic acid and its salts, benzyl alcohol, salicylic acid and its salts, sorbic acid and its salts, dehydroacetic acid and its salts, which are used in particular to prevent the growth of microorganisms such as bacteria and / or fungi in the cosmetic composition. However, these compounds may induce undesirable side effects such as inflammatory reactions and / or skin intolerance and / or skin irritation when using said compositions.

[0019] Document CN108743452 discloses a method for preparing a cosmetic composition, which in particular comprises crosslinked and hyperbranched dendritic polylysine obtained by crosslinking lysine hydrochloride by thermal polymerization in the presence of a caustic base. The synthesis of the dendritic polylysine used in this document is an uncontrolled synthesis, described in particular in the document (Scholl, Markus et al. "The thermal polymerization of amino acids revisited; Synthesis and structural characterization of hyperbranched polymers from 1-lysine." Journal of Polymer Science Part A: Polymer Chemistry 45.23 (2007): 5494-5508

[10] ), and the polylysine polymers obtained and used in this document are poorly structured, polydisperse and hyperbranched. This document also mentions the use of a composition comprising said crosslinked and hyperbranched dendritic polylysine for skin care, but confirms no significant differences in terms of cosmetic effects, for example with regard to skin elasticity and / or hydration, between the use of a composition comprising or not comprising crosslinked and hyperbranched dendritic polylysine.

[0020] Therefore, there is a real need to find new compositions with good cosmetic or dermatological efficacy, which make it possible, for example, to improve the appearance and surface quality of the skin, in particular for obtaining moisturizing, anti-aging, anti-inflammatory and / or antioxidant effects, and / or without inducing undesirable side effects. DETAILED DESCRIPTION

[0021] The present invention is precisely designed to meet these needs and shortcomings of the prior art.

[0022] The present inventors are the first to combine at least one polylysine dendrimer and at least one vitamin specifically to meet the above needs.

[0023] The inventors of the present application have highlighted the properties of this combination which have never been described or suggested in the prior art.

[0024] Surprisingly and unexpectedly, the inventors have demonstrated in particular that the combination of at least one polylysine dendrimer and at least one vitamin advantageously improves the appearance and surface quality of the skin, in particular for obtaining anti-aging and soothing effects.

[0025] Surprisingly and unexpectedly, the inventors have demonstrated in particular that a cosmetic composition comprising at least one polylysine dendrimer and at least one vitamin advantageously increases skin hydration, in particular advantageously allows a rapid increase in skin hydration, and advantageously a long-term hydration effect, for example over a period of at least 28 days.

[0026] Surprisingly and unexpectedly, the inventors have demonstrated in particular that a cosmetic composition comprising at least one polylysine dendrimer and at least one vitamin advantageously increases skin hydration, reduces skin tightness and / or improves skin softness, for example via a nourishing effect on the skin.

[0027] The present inventors have also demonstrated that the combination of at least one polylysine dendrimer and at least one vitamin advantageously increases skin hydration, for example by reducing skin tightness, increasing skin suppleness and increasing skin nutrition.

[0028] The inventors have also demonstrated that the combination of at least one polylysine dendrimer and at least one vitamin advantageously improves the appearance of the skin, for example in the case of eczematous lesions, and advantageously reduces itching, in particular itching of the scalp.

[0029] The inventors have also demonstrated that the combination of at least one polylysine dendrimer and at least one vitamin advantageously modulates the release of the vitamin present in the composition, accelerates the dissolution of the vitamin, and thus advantageously allows an increase in the rate of percutaneous absorption of the vitamin and its vectorization on the skin via the hair follicle route.

[0030] The inventors have also surprisingly demonstrated that the combination of at least one polylysine dendrimer and at least one vitamin provides a very high skin tolerance, in particular compared to known vitamin-containing compositions, thus advantageously making it possible to avoid the use of topical antiseptic compounds and antibiotics, for example when used to treat skin diseases.

[0031] As used herein, "subject" means any animal, such as a mammal, including but not limited to humans, non-human primates, rodents, etc., who is to be the recipient of a particular treatment. In general, the terms "subject" and "patient" are used interchangeably herein to refer to a human subject.

[0032] A first object of the present invention relates to a cosmetic or dermatological composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one cosmetically and / or dermatologically acceptable carrier.

[0033] Polylysine is used herein to mean any polymer in which the majority of the unit elements are lysine.

[0034] Dendrimers are used herein to refer to synthetic polymers characterized by repeated chain branching originating from a central core, resulting in a fractal topology and a large number of chain ends. Dendrimers consist of a core, one or more layers (or one or more generations) of branching monomers, and a layer of terminal groups that increase with each "generation" and terminate the various chains. For example, a first generation polylysine dendrimer (G1) may include 8 branching monomers, a second generation polylysine dendrimer (G2) may include 48 branching monomers, a third generation polylysine dendrimer (G3) may include 123 branching monomers, a fourth generation polylysine dendrimer (G4) may include 365 branching monomers, and a fifth generation polylysine dendrimer (G5) may include 963 monomers.

[0035] According to the present invention, the polylysine dendrimer may be any suitable polylysine dendrimer known to the skilled person. One example is a poly-L-lysine dendrimer (DGL) comprising L-lysine monomers associated in a dendritic process around a multifunctional central core. One example is a polylysine dendrimer as described in patent WO2015 / 104589.

[0036] For example, the dendrimer according to the present invention can be represented according to formula (I) as follows:

[0037]

[0038] in:

[0039] (a) A represents the core of a dendrimer of polyvalent k, wherein:

[0040] -k represents the number of dendrites and is preferably equal to 3;

[0041] -A represents a core synthetic element having the structure of the following formula (II):

[0042]

[0043] or

[0044] The core synthetic element having the structure of the following formula (III)

[0045]

[0046] (b) Mi represents the i-th generation monomer, wherein:

[0047] -i is an integer from 2 to G, G is the number of generations of the dendron;

[0048] -When i=0, Mi represents: The terminal branch BT is then connected directly to the base synthetase A:

[0049] -When i>0, Mi represents the structure of formula (IV):

[0050]

[0051] The structure of formula (V):

[0052]

[0053] The symbol * indicates the attachment point of the monomer Mi to the next-generation monomer;

[0054] (c) BT represents the terminal branch, and t represents the number of terminal fragments, where:

[0055] t is an integer from 1 to 3, preferably, t is 2 or 3;

[0056] Each occurrence of BT independently represents a hydrogen atom, a carboxyl fragment (COOH), a carboxylate (COO-R), a hydroxyl group (OH); a thiol group (SH) or a thiol ester fragment (SR), wherein each occurrence of R independently represents a C1-C6 alkyl group or a C6 aryl group.

[0057] G may be in the range of 2 to 10. For example, G may be equal to 2, 3, 4 or 5; preferably, G may be equal to 2 or 3.

[0058] This may be, for example, a poly-L-lysine dendrimer of the following formula (VI):

[0059]

[0060] Poly-L-lysine dendrimer of formula (VII)

[0061]

[0062] or a poly-L-lysine dendrimer of formula (VIII)

[0063]

[0064] The poly-L-lysine dendrimer of formula (VIII) is also shown in Figure 8 middle.

[0065] In the generation of the present invention, G means the number of layers in the dendron, and Z is the number of terminal groups on the outer surface of the dendron. As used herein, the core is generation 0 (GO), and the monomers directly attached to the core can be considered to be generation 1 monomers (G1); monomers attached to G1 monomers are generation 2 monomers (G2), etc. In this numbering system, 2(G+1) is used. Therefore, in this numbering system 2(G+1) for a dendron with 2 functional groups in the core, 2(0+1) for G02, 2(1+1) for G14, etc.

[0066] Advantageously, the generation value of the dendron according to the invention is at least 2, the core being designated as generation zero.

[0067] According to the present invention, the substituted or unsubstituted polylysine dendrimer may be a polylysine dendrimer of generation 2 (G2) to generation 10 (G10). For example, the generation value of the dendrimer may be 2, 3, 4, 5, 6, 7, 8, 9 or 10. Advantageously, the generation value of the dendrimer may be 2, 3, 4, 5, 6, 7; preferably 2, 3.

[0068] It may be, for example, a polylysine dendrimer comprising 48 to 963 lysines, such as a polylysine dendrimer comprising 48 to 123 lysines, such as a polylysine dendrimer comprising 48 lysines or a polylysine dendrimer comprising 123 lysines.

[0069] It may be, for example, a polylysine dendrimer with an average molecular weight of 11 kDa to 250 kDa, such as 11.80 kDa to 249.80 kDa, such as a polylysine dendrimer with an average molecular weight of 11.80 kDa to 32.10 kDa, such as a polylysine dendrimer with an average molecular weight of 11.80 kDa to 32.10 kDa.

[0070] It may be, for example, a polylysine dendrimer of generation number 2 comprising, for example, 48 lysines and having a molecular weight of 11.80 kDa or a polylysine dendrimer of generation number 3 comprising, for example, 123 lysines and having an average molecular weight of 32.10 kDa.

[0071] According to the invention, the polylysine dendrimers may be substituted or unsubstituted.

[0072] According to the invention, when the polylysine dendrimer is unsubstituted, it may comprise at these ends a cationic ammonium group of lysine and optionally a counterion. According to the invention, the counterion may be, for example, a trifluoroacetic acid or TFA group, acetate or C2H5OO - or chloride Cl - .

[0073] According to the present invention, when the polylysine dendrimer is substituted, it may be substituted with at least one group selected from aspartate, succinate, guanidino, acetate or fluorine. Preferably, the polylysine dendrimer is substituted with acetate groups.

[0074] According to the present invention, the polylysine dendrimer, for example poly-L-lysine, may be a commercially available dendrimer. It may be, for example, a commercially available dendrimer from COLCOM under the trade name COL-DGL2-NH2 or having the molecular formula [H(C6H 13 N2O+) 48 OH](CF3CO2 - ) 48 Dendri Graft poly-L-lysine-2nd generation-amino surface commercially available poly-L-lysine dendrimers, and / or commercially available poly-L-lysine dendrimers manufactured by COLCOM under the trade name COL-DGL3-NH2 or having the molecular formula [H(C6H 13 N2O+) 123 OH](CH3CO2 - ) 123 Dendri Graft poly-L-lysine-3rd generation-amino surface commercially available poly-L-lysine dendrimers. They can be, for example, poly-L-lysine dendrimers obtained according to the method described in WO2006114528A1 and / or reference An Expeditious Multigram-Scale Synthesis of Lysine Dendrigraft (DGL) Polymers by Aqueous N-Carboxyanhydride Polycondensation. H. Collet and co-authors: Chem. Eur. J. 2010, 16, 2309-2316 [2].

[0075] Advantageously, the dendrimers are monodisperse and have a known uniform spherical structure and a well-defined diameter, for example for polylysine dendrimers of generation number 2: diameter 4.5 nm, for example for polylysine dendrimers of generation number 3: diameter 7 nm.

[0076] Advantageously, the polylysine dendrimer has an estimated free volume of 80%. Advantageously, the polylysine dendrimer allows the vectorization of small molecules, such as at least one vitamin, for example, with a diameter of 4.5 nm to 8.5 nm.

[0077] Advantageously, the polylysine dendrimers are obtained according to the method described in WO2006114528A1 and / or in the reference An Expeditious Multigram-Scale Synthesis of Lysine Dendrigraft (DGL) Polymers by Aqueous N-Carboxyanhydride Polycondensation. H. Collet and co-authors: Chem. Eur. J. 2010, 16, 2309-2316 [2].

[0078] The composition of the present invention may contain 0.01% to 10% by weight of substituted or unsubstituted polylysine dendrimers relative to the total weight of the composition. For example, the composition may contain 0.02% to 5% by weight, 0.02% to 3% by weight, 0.02% to 0.05% by weight of substituted or unsubstituted polylysine dendrimers relative to the total weight of the composition.

[0079] According to the present invention, vitamins are intended to mean any suitable vitamins known to the skilled person and / or commercially available. They may be, for example, vitamins selected from the group comprising water-soluble vitamins and fat-soluble vitamins.

[0080] According to the present invention, water-soluble vitamins refer to vitamins selected from the group consisting of vitamin C, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B8, vitamin B9, vitamin B12.

[0081] According to the present invention, the fat-soluble vitamins mean vitamins selected from the group consisting of vitamin A, vitamin D, vitamin E, vitamin K1 and vitamin K2.

[0082] According to the present invention, the vitamin can be selected from the group comprising vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B8, vitamin B9, vitamin B12, vitamin C, vitamin A, vitamin D, vitamin E, vitamin K1 and vitamin K2, preferably from the group comprising vitamin C and vitamin A.

[0083] As used herein, the vitamin may be vitamin C (L-ascorbic acid [CAS number: 50-81-7]) commercially available from Sigma-Aldrich laboratories, vitamin A (retinyl acetate) [CAS number: 127-47-9] commercially available from Sigma-Aldrich laboratories, France.

[0084] Advantageously, when the composition comprises vitamin C, the composition may advantageously have a soothing effect, for example, via the anti-free radical and anti-inflammatory effects of vitamin C, for example, when applied to the skin.

[0085] The composition of the present invention can include 0.01% to 10% by weight of the at least one vitamin relative to the gross weight of the composition. For example, the composition can include 0.01% to 5% by weight, 0.01% to 3% by weight, 0.01% to 2% by weight, 0.05% to 1% by weight, or 0.05% to 0.5% by weight of the vitamin relative to the gross weight of the composition.

[0086] As used herein, "cosmetic composition" means any composition intended for cosmetic, i.e. aesthetic use, which may come into contact with surface parts of the human body, such as the epidermis, hair and capillary system, external organs, nails and external mucous membranes. Advantageously, the cosmetic composition may be used exclusively or primarily to protect them, maintain them in good condition, adjust their appearance or correct surface defects. The cosmetic composition may comprise a cosmetically acceptable carrier.

[0087] As used herein, "dermatological composition" means any composition intended for dermatological use, i.e., a composition that can be contacted with a surface portion of the human body for the treatment of the skin, mucous membranes, and appendages such as nails, hair, and / or body hair. The dermatological composition may comprise a dermatologically acceptable carrier.

[0088] The dermatological or cosmetic compositions according to the invention may comprise one or more dermatologically and / or cosmetically acceptable carriers.

[0089] As used herein, "dermatologically and / or cosmetically acceptable carrier" means any cosmetic carrier known to those skilled in the art, such as any cosmetic carrier that can be cited in the dictionary of International Standard Chinese Name Directory of Cosmetic Ingredients (INCI) published by the Personal Care Products Council (PCPC); it can be, for example, a carrier suitable for contact with human skin cells, especially epidermal cells, without excessive toxicity, irritation, allergic reaction, etc., and in proportion to a reasonable benefit / risk ratio. The cosmetically and / or dermatologically acceptable carrier can be selected from water, petrolatum, beeswax, carnauba wax, stearic acid, cetearyl alcohol, cetyl alcohol, diethylene glycol, isohexadecane, lanolin, glyceryl monostearate, propylene glycol monostearate, cetyl palmitate, this list is non-limiting.

[0090] As used herein, "cosmetically acceptable carrier" means any cosmetic carrier known to those skilled in the art, which may, for example, be any cosmetic carrier that can be cited in the dictionary of International Standard Chinese Name Directory of Cosmetic Ingredients (INCI) published by the Personal Care Products Council (PCPC); it may, for example, be a carrier suitable for contact with human skin cells, especially epidermal cells, without excessive toxicity, irritation, allergic reaction, etc., and in proportion to a reasonable benefit / risk ratio. The cosmetically acceptable carrier may be selected from water, petrolatum, beeswax, carnauba wax, stearic acid, cetearyl alcohol, cetyl alcohol, diethylene glycol, isohexadecane, lanolin, glyceryl monostearate, propylene glycol monostearate, cetyl palmitate, and this list is non-limiting.

[0091] Advantageously, the cosmetically and / or dermatologically acceptable carrier may be petrolatum.

[0092] The dermatological or cosmetic composition according to the present invention may also include at least one solvent. It may be any solvent suitable for use in dermatological or cosmetic compositions known to those skilled in the art. It may be, for example, a compound or a mixture of compounds that dissolves and can destroy molecular aggregation in a soluble body. It may be, for example, a primary alcohol such as ethanol (ethanol / ethyl alcohol) or isopropanol or a polyol such as ethylene glycol, propylene glycol, triethylene glycol, tripropylene glycol, polyethylene glycol (PEG) or sorbitol. Advantageously, the solvent may be selected from the group comprising ethanol, propylene glycol or a combination thereof, preferably, the solvent may be ethanol.

[0093] The composition of the present invention may comprise 0.5 wt % to 5 wt % of solvent, such as 1 wt % to 5 wt %, 1 wt % to 2 wt % of solvent, relative to the total weight of the composition.

[0094] Advantageously, the solvent, preferably ethanol, can be used to dissolve the at least one vitamin in the composition according to the invention.

[0095] The dermatological or cosmetic composition according to the invention may comprise one or more adjuvants known to those skilled in the art. Examples may include one or more adjuvants selected from the group consisting of ester-type agents, hydrating agents, emollients, mineral thickeners, organic thickeners (whether or not associated), water-soluble and fat-soluble organic sunscreens, mineral sunscreens, silicone compounds, fragrances, preservatives, ceramides and pseudoceramides, vitamins and provitamins, proteins, chelating agents, alkalizing agents, acidifying agents, reducing agents, oxidizing agents, mineral fillers, coloring agents or any other adjuvant listed in the International Cosmetic Ingredient Standard Chinese Name Directory (INCI) dictionary published by the Personal Care Products Council (PCPC).

[0096] The dermatological or cosmetic composition according to the invention may also comprise one or more additional compounds selected from the group comprising at least one amino acid, polypeptide, desquamative agent, cell stimulant, firming agent, extensor, anti-aging agent, free radical scavenger and sunscreen, mixtures or combinations thereof.

[0097] In this context, amino acid means any amino acid known to those skilled in the art that is suitable for cosmetic use. It may be, for example, an amino acid of the L or D series, preferably an amino acid of the L series. Examples include citrulline, histidine, methionine, serine, tyrosine, cystine, cysteine ​​and / or any mixture thereof.

[0098] As used herein, polypeptide means any polypeptide suitable for cosmetic use known to those skilled in the art. It can be, for example, tripeptide-1, palmitoyl tripeptide-1, myristoyl hexapeptide-16, myristoyl pentapeptide-17, hexanoyl dipeptide-3, Rh-polypeptide, Sh-polypeptide and / or any mixture thereof.

[0099] As used herein, desquamation agents are intended to mean any desquamation agent known to those skilled in the art that is suitable for cosmetic or dermatological use. It may be, for example, alpha-hydroxy acid (AHA), papain, bromelain, stratum corneum chymotrypsin (SCCE) and / or any mixture thereof.

[0100] As used herein, a cell stimulator means any cell stimulator known to a person skilled in the art and suitable for cosmetic or dermatological use. It can, for example, be any cell stimulator known to a person skilled in the art that acts on fibroblasts and their synthetic capacity. It can, for example, be melanocyte stimulating hormone (MSH), leukotrienes and / or any mixture thereof.

[0101] As used herein, a firming agent means any firming agent known to those skilled in the art to be suitable for cosmetic or dermatological use. For example, any firming agent that may improve the mechanical properties of the skin. It may, for example, be Crithmum maritimum.

[0102] As used herein, extensor means any extensor known to those skilled in the art that is suitable for cosmetic or dermatological use. It can be, for example, any extensor that may reduce or eliminate surface wrinkles and / or fine lines on the skin. It can be, for example, arginine and serine.

[0103] As used herein, an anti-aging compound means any anti-aging compound suitable for cosmetic or dermatological use known to those skilled in the art. It can, for example, be any estrogenic anti-aging compound known to those skilled in the art that binds to epidermal receptors. It can, for example, be 17-β estradiol, estradiol benzoate, estradiol valerate and / or mixtures thereof.

[0104] As used herein, an anti-radical compound means any anti-radical compound known to those skilled in the art to be suitable for cosmetic or dermatological use. It may be, for example, pro-tocopheryl glucoside, vitamin C, vitamin E and / or any mixture thereof.

[0105] As used herein, a sunscreen compound means any sunscreen compound suitable for cosmetic or dermatological use known to a person skilled in the art. It may, for example, be any sunscreen compound that protects the skin from actinic radiation and / or ultraviolet rays. It may, for example, be water-soluble or fat-soluble organic sunscreens and mineral sunscreens. It may, for example, be a sunscreen selected from the group comprising ethylhexyl methoxycinnamate, octocrylene, bis-ethylhexyloxyphenol methoxyphenyl triazine, ethylhexyl salicylate, butyl methoxydibenzoylmethane, titanium dioxide, zinc oxide and / or any mixture thereof.

[0106] In this context, the cosmetic or dermatological composition may comprise 0.2 to 10 wt. % of adjuvants and / or additional compounds, for example 0.2 to 5 wt. % of adjuvants and / or additional compounds relative to the total weight of the composition.

[0107] Herein, the adjuvant and / or additional compound may be selected from the group comprising xanthan gum, allantoin, oleic acid, sorbitan trioleate, sorbitan monostearate, soy lecithin, sorbitan monolaurate, polyoxyethylene sorbitan trioleate, polyoxyethylene sorbitan monooleate, potassium oleate and / or any mixture thereof.

[0108] The cosmetic or dermatological composition of the present invention can be obtained by any suitable method known to a person skilled in the art for the manufacture of cosmetic or dermatological compositions. It can be, for example, a simple mixture. It can be, for example, a method comprising the step of incorporating the internal phase into the external phase by an emulsifier, such as a rotor-stator turbine. It can also be a method using the phase transition temperature (PIT), which is usually used by a person skilled in the art to obtain oil-in-water emulsions whose dispersed droplets are particularly fine, for example 0.1 μm to 1 μm in diameter.

[0109] The cosmetic or dermatological composition of the invention may be in any form suitable for cosmetic or dermatological application. Advantageously, the composition is a composition for topical use.

[0110] It may be, for example, a composition in a form selected from the group comprising gel, ointment, cream, oil, milk, salves, powders, soaking pads, solutions, serums, balms, butters, lotions, suspensions, soaps and emulsions. Advantageously, the cosmetic or dermatological composition is in the form of a gel, cream or salves.

[0111] The cosmetic or dermatological composition of the invention may, for example, be in a form selected from the group comprising aqueous or hydroalcoholic gels, aqueous or hydroalcoholic creams and aqueous or hydroalcoholic lotions. These formulations that can be used to implement the invention are known to the formulator in the prior art.

[0112] According to the invention, the cosmetic or dermatological composition according to the invention may be free of preservatives.

[0113] In this context, "preservative" means any preservative known to those skilled in the art to be suitable for use in cosmetic or dermatological compositions. It may be any preservative listed in the International Cosmetic Ingredient Standard Chinese Name Directory (INCI) dictionary published by the Personal Care Products Council (PCPC).

[0114] As used herein, the composition can be administered topically. Administration can also depend on the area and / or biological tissue to be treated.

[0115] According to the invention, the cosmetic or dermatological composition of the invention can be administered, for example, once or several times.

[0116] According to the present invention, the composition can be further administered, for example, once a day, twice a day, and once a week or less. It can be administered, for example, once a day, twice a day, three times a day, or less, for example, once every two days or once a week. Advantageously, the composition can be administered every day, twice a day.

[0117] According to the present invention and the mode of administration, the composition can be, for example, a composition in the form of a gel administered once a day, twice a day, once a week or less. It can be administered, for example, once a day, twice a day or less.

[0118] According to the present invention, the composition can be administered, for example, in a time period of 1 to 21 days, for example, 3 to 15 days, for example, 3 to 7 days. For example, the composition can be administered, for example, in a time period of 15 days, for example, once a day or twice a day.

[0119] In other words, the composition can be administered, for example, in a period of 1 to 45 days, for example, 1 to 28 days, for example, 3 to 15 days, for example, 3 to 7 days. For example, the composition can be administered in a period of at least 15 days, for example, with a frequency of administration of daily and twice daily.

[0120] According to the invention, the composition of the invention can be applied topically by simple application to the skin or by application accompanied by massaging the skin and / or the area where the composition is applied.

[0121] Another object of the invention is a non-therapeutic cosmetic care method comprising applying to the skin or mucous membranes a cosmetic composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one cosmetically acceptable carrier.

[0122] The substituted or unsubstituted polylysine dendrimer is as defined above.

[0123] The vitamins are as defined above.

[0124] The cosmetically acceptable carrier is as defined above.

[0125] According to the invention, the mode and / or route of administration of the cosmetic composition of the invention may be as defined above, preferably by topical application.

[0126] According to the present invention, the frequency of administration of the cosmetic composition of the present invention may be as defined above, preferably once a day and twice a day.

[0127] According to the invention, the cosmetic treatment may be chosen from hydration, improvement of appearance and soothing of the skin and / or its appendages and / or mucous membranes.

[0128] According to the invention, the cosmetic treatment may be chosen from hydration, improvement of appearance, improvement of skin suppleness, reduction of skin tightness, soothing of the skin and / or its appendages and / or mucous membranes.

[0129] Advantageously, the hydration effect may be entirely or partly related to an improved nutritional functioning of the stratum corneum, an improved cohesion between the corneocytes responsible for retaining water, advantageously through a large amount of hydrophilic keratin.

[0130] Advantageously, the improved skin appearance may be related, in whole or in part, to a reduction in fine lines and wrinkles and / or an increase in skin thickness and / or elasticity.

[0131] Advantageously, the relief may be a reduction in pain and / or itching and / or redness and / or skin lesions.

[0132] Advantageously, improved skin suppleness and / or elasticity may be related in whole or in part to increased synthesis of collagen and / or elastin at the dermal-epidermal junction and in the dermis.

[0133] Another object of the present invention is the non-therapeutic cosmetic use of a cosmetic composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one cosmetically acceptable carrier.

[0134] The substituted or unsubstituted polylysine dendrimer is as defined above.

[0135] The vitamins are as defined above.

[0136] The cosmetically acceptable carrier is as defined above.

[0137] According to the invention, the mode and / or route of administration of the cosmetic composition of the invention may be as defined above, preferably by topical application.

[0138] Another object of the present invention is the topical non-therapeutic cosmetic use of a cosmetic composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one cosmetically acceptable carrier.

[0139] According to the present invention, the frequency of administration of the cosmetic composition of the present invention may be as defined above, preferably once a day and twice a day.

[0140] According to the invention, the non-therapeutic cosmetic use may be improvement of hydration, improvement of appearance, skin soothing, reduction of tightness of the skin and / or its appendages and / or mucous membranes.

[0141] Advantageously, the non-therapeutic cosmetic use of the cosmetic composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one cosmetically acceptable carrier is its use for improving the hydration of the skin and / or its appendages and / or mucous membranes.

[0142] Advantageously, the hydration may be entirely or partially related to an improvement in the trophic functioning of the stratum corneum, an improvement in the cohesion between the corneocytes responsible for retaining water, advantageously through a large amount of hydrophilic keratin. Advantageously, the hydration may also be related to a reduction in transepidermal water loss by restoring the integrity of the stratum corneum and the correct functioning of the skin barrier.

[0143] Advantageously, the improved skin appearance may be related, in whole or in part, to a reduction in fine lines and wrinkles and / or an increase in skin thickness and / or elasticity.

[0144] Advantageously, the relief may be a reduction in pain and / or itching and / or redness.

[0145] Advantageously, improved skin suppleness and / or elasticity may be related in whole or in part to increased synthesis of collagen and / or elastin at the dermal-epidermal junction and in the dermis.

[0146] The inventors have also demonstrated in a surprising and unexpected manner that the compositions according to the invention advantageously allow a rapid reduction of scalp pathologies and / or irritations, for example associated with actinic keratosis.

[0147] The inventors have also demonstrated in a surprising and unexpected manner that the composition according to the invention advantageously allows to reduce to eliminate common skin warts or seborrheic eyelid warts.

[0148] The inventors have also demonstrated in a surprising and unexpected manner that the composition according to the invention advantageously allows to alleviate to eliminate skin eczema.

[0149] The inventors have also demonstrated in a surprising and unexpected manner that the composition according to the invention advantageously allows the reduction of cysts, such as Verneuil's disease. Surprisingly, the inventors have demonstrated that the composition according to the invention advantageously allows the reduction of inflammation-related symptoms, such as edema and pain-related symptoms, the inventors have also demonstrated that the composition according to the invention advantageously allows low cyst formation and advantageously allows a spontaneous development towards healing, advantageously without the use of any antibiotic treatment.

[0150] Another object of the present invention is a dermatological composition for use in the treatment of skin diseases, comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one dermatologically acceptable carrier.

[0151] The substituted or unsubstituted polylysine dendrimer is as defined above.

[0152] The vitamins are as defined above.

[0153] The dermatologically acceptable carrier is as defined above.

[0154] The inventors have surprisingly demonstrated that the composition according to the invention can be advantageously used for the treatment of skin diseases comprising skin inflammation and / or skin infection.

[0155] Another object of the present invention is a dermatological composition for use in the treatment of skin diseases selected from the group consisting of skin inflammations and / or skin infections, comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one dermatologically acceptable carrier.

[0156] The substituted or unsubstituted polylysine dendrimer is as defined above.

[0157] The vitamins are as defined above.

[0158] The dermatologically acceptable carrier is as defined above.

[0159] According to the present invention, the skin disease can be selected from the group comprising actinic keratosis, impetigo, pemphigus, dermatitis herpetiformis, atopic dermatitis, seborrheic dermatitis, allergic contact dermatitis, irritant contact dermatitis, lichen simplex chronicus and prurigo, pruritus, psoriasis, lichen planus, urticaria, sunburn, acute radiation dermatitis, hair loss, onycholysis, alopecia, acne, vitiligo, seborrheic keratosis, pressure sores, seborrheic warts, eczema, herpes, skin burns and Verneuil's disease.

[0160] According to the present invention, the skin disease can be selected from the group comprising the following: actinic keratosis, impetigo, pemphigus, dermatitis herpetiformis, atopic dermatitis, seborrheic dermatitis, allergic contact dermatitis, irritant contact dermatitis, simple lichen chronicus, prurigo, pruritus, psoriasis, lichen planus, urticaria, sunburn, acute radiation dermatitis, hair loss, nail peeling, alopecia, vitiligo, seborrheic keratosis, pressure sores, seborrheic warts, eczema, herpes, skin burns. Examples include actinic keratosis, seborrheic keratosis, seborrheic dermatitis, psoriasis and acute radiation dermatitis.

[0161] According to the present invention, the skin disease can be a condition comprising allergic or immunoallergic inflammation and / or inflammatory reaction. It can be, for example, a skin disease selected from the group comprising pemphigus, atopic dermatitis, seborrheic dermatitis, allergic contact dermatitis, irritant contact dermatitis, simple lichen chronicus, prurigo, pruritus, psoriasis, lichen planus, urticaria, alopecia, onycholysis, acne, vitiligo, seborrheic keratosis.

[0162] According to the invention, the skin disease may be a condition comprising inflammation of physical or chemical free radical origin, such as burns, such as chemical burns; acute radiation dermatitis, sunburn, skin burns due to exposure to ultraviolet rays, such as UVA, UVB, preferably UVB, pressure sores.

[0163] According to the present invention, the skin disease may be a condition caused by a microorganism, such as a bacterium or a virus. It may be, for example, a skin disease caused by a viral or bacterial infection. It may be, for example, a skin disease selected from the group comprising herpes, dermatitis herpetiformis and / or impetigo.

[0164] Other advantages may become apparent to those skilled in the art after reading the following examples given by way of illustration. BRIEF DESCRIPTION OF THE DRAWINGS

[0165] Figure 1 shows before application of an exemplary composition according to the present invention ( Figure 1 A) or after ( Figure 1 B) Photograph of a top view of the scalp. In the figure, the circles correspond to the areas of the scalp to which the composition was applied.

[0166] Figure 2 shows before application of an exemplary composition according to the present invention ( Figure 2 A) and 7 days later ( Figure 2 B) Photograph of a top view of a human arm including common warts. Figure 2 On A, the circle corresponds to the skin area that includes common warts.

[0167] Figure 3 shows before application of an exemplary composition according to the present invention ( Figure 3 A) After three days of application ( Figure 3 B) or 7 days after application ( Figure 3 C) Photograph of a human eyelid including seborrheic warts. Figure 3 A and Figure 3 In B, the circle corresponds to the skin area including the seborrheic wart.

[0168] Figure 4 Shown are top view photographs of the palm of the hand showing the appearance of the palm of the hand before application of an example composition according to the present invention ( Figure 4 A) After three days of application ( Figure 4 B) or 7 days after application ( Figure 4 C) eczema.

[0169] Figure 5 shows before application of an exemplary composition according to the present invention ( Figure 5 A) Four days after application ( Figure 5 B) Five days after application ( Figure 5 C) and 21 days after administration ( Figure 5 D) Photo of the groin showing the cyst,

[0170] Figure 6 shows before application of an exemplary composition according to the present invention ( Figure 6 A- Figure 6 B) and three days after application ( Figure 6 C- Figure 6 D) Photograph of a hand with skin burns on the back surface of the hand

[0171] Figure 7 shows before application of an exemplary composition according to the present invention ( Figure 7 A) and three days after application ( Figure 7 B) Photo of a mouth with a cold sore.

[0172] Figure 8 A third generation polylysine dendrimer of formula (VIII) is shown.

[0173] FIG. 9 shows a photograph of a vial comprising a composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one cosmetically and / or dermatologically acceptable carrier. Fig. 9A and Fig. 9B Photographs of the compositions after a) storage at 25°C for 1 month, b) storage at 4°C for 1 month, and c) storage at 45°C for 90 hours are shown.

[0174] Example

[0175] Example 1: Example of cosmetic and / or dermatological composition

[0176] The cosmetic composition is in the form of a gel comprising vitamin A (also known as retinol and derivatives) and / or vitamin C (also known as ascorbic acid and derivatives). The poly-L-lysine dendrimers used are those in vaseline (Cera microcristallina / liquid paraffin / paraffin) marketed by Aiglon. In particular, these dendrimers are those marketed by Colcom under the trade names DGL G2-TFA and DGL G3-acetate. These are poly-lysine dendrimers obtained and described in WO2006114528A1 or in An Expeditious Multigram-Scale Synthesis of Lysine Dendrigraft (DGL) Polymers by Aqueous N-Carboxyanhydride Polycondensation. H. Collet and co-authors: Chem. Eur. J. 2010, 16, 2309-2316.

[0177] The vitamins used were vitamin C (also known as ascorbic acid) or vitamin A (also known as retinyl acetate), respectively, commercially available from Sigma-Aldrich, France.

[0178] Each composition was prepared from a base of approximately 10 g of petrolatum weighed into a jar with a polypropylene (PP) screw cap. An olive-shaped magnetic bar (approximately 2 cm) was added to each jar and then heated to 55°C-65°C until the petrolatum was liquefied. While stirring, an aqueous solution comprising a mixture of poly-L-lysine dendrimers and vitamins previously homogenized by ultrasound was added to this liquid petrolatum. The formulation was continuously stirred for 2 hours. The magnetic bar was removed from the still liquid petrolatum and the samples were stored in a refrigerator at 2°C-6°C.

[0179] Examples of the compositions obtained are described below in Tables 1 and 2. In these tables, the percentages are given by mass relative to the total mass of the composition.

[0180] Table 1: Example compositions

[0181]

[0182] Table 2: Example compositions

[0183]

[0184] Example 2: Skin Tolerance of Exemplary Compositions Comprising Poly-L-Lysine Dendrimers and At Least One Vitamin Determination of sex

[0185] In this example, the skin tolerance of cosmetic and / or dermatological compositions is determined by measuring the primary irritation potential of the compositions in volunteers 15 minutes after a single application.

[0186] This was a single-center, open-label trial in adult volunteers with no direct individual benefit. The sample size required to test the tolerability of such compositions in an open-label design was 12 subjects. The main inclusion criteria were as follows: volunteers, aged 18 years or older, in good health, without allergies, without any skin lesions on the skin, and freely agreed to sign the Information and Consent Form.

[0187] All 12 subjects received the same composition, which was applied undiluted to the back up to the shoulder blades and then rinsed off with water after 15 minutes of contact under normal use conditions, only once, to the skin site on the back of each volunteer.

[0188] The clinical evaluation consisted of macroscopic skin examinations performed in daylight immediately, 30 minutes and 24 hours after removal of the composition.

[0189] The mean irritation score was determined: PII = Total Reaction Score, total number of volunteers, with reactions rated from 0 to 4.

[0190] The parameters checked are as follows:

[0191] - the morphological appearance of the skin, by dermatological examination, looking for erythema (redness), edema (swelling), papules (small solid red bumps, granular to the touch) and blisters (small detachments of the skin containing a drop of fluid), the subjective skin sensitivity of the volunteers according to the following five criteria graded from 0 to 3 (0 = absent, 1 = mild, 2 = moderate, 3 = severe),

[0192] -pain,

[0193] -burn,

[0194] - tingling sensation,

[0195] - itching, and

[0196] - Any “other events”.

[0197] Skin reactions (erythema, edema, etc.) were evaluated according to the International Contact Dermatitis Research Group (ICDRG) criteria and are presented as follows:

[0198] NT: Not tested

[0199] ? +: Suspected reaction. Only slight erythema.

[0200] +: Weak positive reaction (non-blister): erythema, infiltration, sometimes a few papules.

[0201] ++: Strong positive reaction: erythema, papules, and blisters are present.

[0202] +++: Very positive reaction, with bubbles present.

[0203] -: Negative reaction

[0204] IR: Irritation reaction: E0.5: Very slight erythema

[0205] E1: Mild erythema

[0206] E2: obvious erythema

[0207] E3: severe erythema

[0208] The results are explained as follows:

[0209] The primary stimulation index for each reading time was calculated according to the following ratio:

[0210] PII = Σ of erythema score / number of subjects.

[0211] The scale used to explain skin irritation is as follows:

[0212] If PII < 0.20, no stimulation

[0213] If 0.20≤PII<0.50, then slight stimulation

[0214] If 0.50≤PII<1, then medium stimulus

[0215] If PII ≥ 1, then there is stimulation

[0216] If a reaction is observed at both the control and treated sites, the magnitude of the product-induced reaction is given by the difference between the treated and control sites.

[0217] Therefore, the evaluation of possible skin reactions, i.e. erythema, edema, infiltration, papules, vesicles, necrosis and their intensity, was performed according to the protocol of the International Contact Dermatitis Research Group (ICDRG) as described in Fregert S. Manual of Contact Dermatitis. 2nd edition Munksgaard, Copenhagen: YearBook Medical Publishers, Inc; 1981. Chapter 10, Patch Testing; pages 71-81.

[0218] In this example, 16 compositions described in the following Table 3 were tested and compared based on their acute skin tolerance in single or multiple applications. The compositions tested were obtained according to the method described in Example 1 above. In particular, the dendrimers used were dendrimers commercially available from Colcom under the trade names DGL G2-TFA, DGL G2-acetate, DGL G3-TFA or DGL G3-acetate, respectively. These are polylysine dendrimers obtained and described in WO2006114528A1 or An Expeditious Multigram-Scale Synthesis of Lysine Dendrigraft (DGL) Polymers by Aqueous N-Carboxyanhydride Polycondensation. H. Collet and co-authors: Chem. Eur. J. 2010, 16, 2309-2316.

[0219] The compositions tested included vitamin C (also known as ascorbic acid) commercially available from Sigma-Aldrich laboratories, France.

[0220] According to strict ethical requirements, acute skin tolerance was evaluated by a 15-minute patch test in 12 healthy volunteers at least 18 years old. Among these 12 volunteers, 5 had sensitive skin regardless of any treatment (5 / 12). Macroscopic examinations were performed immediately 30 minutes and 24 hours after removing the product, including dermatological clinical examinations of the skin, including the evaluation of the examination parameters as mentioned above. Two volunteers applied these preparations every day for one week.

[0221] In Table 3, the percentages are given by mass relative to the total mass of the composition.

[0222] Table 3: Compositions used

[0223]

[0224]

[0225]

[0226] The results obtained were determined from twelve volunteers included in the study. The following Tables 4 and 5 show the different results obtained based on the compositions and the subjects. In Tables 4 and 5, the treatment site corresponds to the application of a patch (also referred to as a pad) comprising an exemplary composition according to the present invention to the skin of the shoulder blade, while the control site corresponds to the application of a patch (also referred to as a pad) not comprising a cosmetic or dermatological composition contralaterally to the skin of the shoulder blade.

[0227] All volunteers completed the study without any deviation from the protocol.

[0228] Table 4: Skin reaction / tolerance assessment results

[0229]

[0230]

[0231]

[0232] Table 5: Primary Irritation Index (PII) evaluation results

[0233]

[0234]

[0235] In Table 5 above, the PII mean value corresponds to the mean value of the PII values ​​measured in the 12 subjects.

[0236] As shown in Tables 4 and 5 above, the results obtained confirmed the absence of erythema, edema, papules, blisters and / or necrosis on the skin surface. As confirmed by the macroscopic examination results, all the tested compositions showed very good skin tolerance in volunteers with normal skin and volunteers with sensitive skin. In addition, no adverse events and / or side effects were observed.

[0237] Therefore, this example clearly demonstrates that the exemplary composition according to the present invention is a composition with high skin tolerance and does not cause possible side effects. This example also clearly demonstrates that the exemplary composition according to the present invention does not induce inflammatory or allergic reactions.

[0238] Example 3: Photocatalytic effect of an exemplary composition comprising poly-L-lysine dendrimers and at least one vitamin on the scalp Effects of keratosis pilaris

[0239] In this example, the compositions used were composition 1 and composition 2 as described above in Example 1. The compositions were applied to the scalp lesions of the actinic keratosis type by applying 1 cm 3 (1 mL) of the composition was applied to the scalp, extending one centimeter beyond the area to be treated, and gently massaged using inward-outward circular motions for 15 days, applying composition 1 in the morning and composition 2 in the evening. Before each application, the skin was rinsed with soapy water.

[0240] Figure 1 It shows that before the application of composition 1 and composition 2 ( Figure 1 A) and photographs of the scalp after application of composition 1 and composition 2 for 15 days.

[0241] From the first application of the compositions, itching and the urge to scratch were reduced. These results clearly demonstrate the rapid action of the compositions, especially in the treatment of scalp itching. Figure 1 As shown in B, after 15 days of application, the appearance of the scalp was normal, that is, the scalp no longer included scabs, lesions and scarring.

[0242] The results clearly demonstrate that the exemplary compositions according to the invention can be used to improve the appearance of the skin, in particular the scalp. The results also clearly demonstrate that the exemplary compositions according to the invention advantageously allow the treatment of skin diseases, such as actinic keratosis. The results also clearly demonstrate that the exemplary compositions according to the invention advantageously allow the treatment of skin lesions induced by UV rays and / or exposure to the sun.

[0243] Example 4: Example compositions comprising poly-L-lysine dendrimers and at least one vitamin are administered to a regular What happens after common skin warts

[0244] In this example, the compositions used were Composition 1 and Composition 2 as described above in Example 1. The compositions were applied to common warts by: applying 1 cm 3 (1 mL) of the composition was applied to the skin, extending one centimeter beyond the area to be treated (that is, including common warts), and gently massaged using inward-outward circular motions for 15 days, applying composition 1 in the morning and composition 2 in the evening. Before each application, the skin was rinsed with soapy water.

[0245] Figure 2 It shows that before the application of composition 1 and composition 2 ( Figure 2 A) and photographs of the anterior external surface of the right arm 7 days after application of Composition 1 and Composition 2.

[0246] like Figure 2 As shown in B, after 7 days of application, common warts were absent and the appearance of the skin was normal. In addition, no recurrence was observed after treatment.

[0247] The results clearly demonstrate that the exemplary compositions according to the invention can be used to improve the appearance of the skin. In addition, this example clearly demonstrates that the exemplary compositions according to the invention advantageously allow the treatment of skin diseases, such as skin lesions of the common wart type (B07 viral warts), which are included in the list of viral infections characterized by skin and mucous membrane lesions according to the International Classification of Diseases (B07, ICD10, Chapter 1).

[0248] Example 5: Example compositions comprising poly-L-lysine dendrimers and at least one vitamin applied to the skin Effects after seborrheic eyelid warts

[0249] In this example, the compositions used were composition 1 and composition 2 as described above in Example 1. The compositions were applied to seborrheic warts located on the eyelids by applying 1 cm 3 (1 mL) of the composition was applied to the skin, extending one centimeter beyond the area to be treated (that is, including the seborrheic warts), and gently massaged using inward-outward circular motions for 7 days, applying composition 1 in the morning and composition 2 in the evening. Before each application, the skin was rinsed with soapy water.

[0250] Figure 3 It shows that before the application of composition 1 and composition 2 ( Figure 3 A), 3 days after the application of Composition 1 and Composition 2 ( Figure 3 B) and 7 days after application ( Figure 3 C) Photograph of the right eyelid.

[0251] like Figure 3 As shown in C, after 7 days of application, seborrheic warts were absent and the appearance of the skin was normal. In addition, no recurrence was observed after treatment. The results clearly demonstrate that the exemplary composition according to the invention can be used to improve the appearance of the skin. In addition, this example clearly demonstrates that the exemplary composition according to the invention advantageously allows the treatment of skin diseases, such as skin lesions of the seborrheic wart type ((L82) seborrheic keratosis), which form part of the list of diseases of the skin and subcutaneous cell tissue according to the International Classification of Diseases (L82, ICD10, Chapter XII).

[0252] Example 6: Example compositions comprising poly-L-lysine dendrimers and at least one vitamin applied to the skin Effects after skin eczema

[0253] In this example, the compositions used were Composition 1 and Composition 2 as described in Example 1 above. The compositions were applied to the eczema on the palms by applying 2 cm 3(2 mL) of the composition was applied to the skin, extending one centimeter beyond the area to be treated (that is, including the eczematous skin lesions), and gently massaged using inward-outward circular motions for 7 days, applying composition 1 in the morning and composition 2 in the evening. Before each application, the skin was rinsed with soapy water.

[0254] Figure 4 It shows that before the application of composition 1 and composition 2 ( Figure 4 A), 3 days after the application of Composition 1 and Composition 2 ( Figure 4 B) and 7 days after application ( Figure 4 C) Photo of the palm of the hand.

[0255] The results showed that after the first application, the itching affecting the skin lesions disappeared, followed by desquamation on the third day, and these lesions disappeared on the seventh day.

[0256] like Figure 4 As shown in C, after 7 days of application, the skin had a normal appearance.

[0257] The results clearly demonstrate that the exemplary composition according to the invention can be used to improve the appearance of the skin. In addition, this example clearly demonstrates that the exemplary composition according to the invention advantageously allows the treatment of skin diseases, such as skin lesions of the eczema type ((L20-L30) dermatitis and eczema (syndrome)), which are part of the list of diseases of the skin and subcutaneous cell tissue according to the International Classification of Diseases (L20-L30, ICD10, Chapter XII).

[0258] Example 7: Example compositions comprising poly-L-lysine dendrimers and at least one vitamin are administered to Effects after Ernay's cyst

[0259] In this example, the compositions used were Composition 1 and Composition 2 as described in Example 1 above. The composition was applied to the sudden cyst located in the groin by: applying 1 cm 3 (1 mL) of the composition was applied to the skin, extending one centimeter beyond the area to be treated (that is, including the cyst), and gently massaged using inward-outward circular motions for 5 days, applying composition 1 in the morning and composition 2 in the evening. Before each application, the skin was rinsed with soapy water.

[0260] Figure 5 It shows that before the application of composition 1 and composition 2 ( Figure 5 A), 4 days after the application of Composition 1 and Composition 2 ( Figure 5 B) 5 days after application ( Figure 5 C) and 21 days after administration ( Figure 5 D) Photograph of the groin.

[0261] like Figure 5 By the third day, movement toward localized inflammatory lesions was observed, as shown and observed in B. Subsequently, the inflammatory lesions could be easily removed and healed without complications and in the absence of antibiotics.

[0262] The results clearly demonstrate that the exemplary compositions according to the invention can be used to improve the appearance of the skin. In addition, this example clearly demonstrates that the exemplary compositions according to the invention can be used to treat skin diseases, such as skin lesions of the Verneuil type ((L73.2) hidradenitis suppurativa), which are part of the list of diseases of the skin and subcutaneous tissue according to the International Classification of Diseases (L73.2, ICD10, Chapter XII).

[0263] Example 8: Example compositions comprising poly-L-lysine dendrimers and at least one vitamin applied to the skin Effects after skin burns

[0264] In this example, the compositions used were Composition 1 and Composition 2 as described above in Example 1. Application of the compositions to skin burns on the back surface of the hand after spraying caustic soda was performed by applying 3 cm 3 (3 mL) of the composition was applied to the skin, extending one centimeter beyond the area to be treated (that is, including the burn area), and gently massaged using inward-outward circular motions for 3 days, applying composition 1 in the morning and composition 2 in the evening. Before each application, the skin was rinsed with soapy water.

[0265] Figure 6 It shows that before the application of composition 1 and composition 2 ( Figure 6 A and Figure 6 B) and after 3 days of application of Composition 1 and Composition 2 ( Figure 6 C and Figure 6 D) Photo of hands.

[0266] From the first application of the composition, pain relief was observed. Figure 6 C and Figure 6 As shown in D, on the third day of application, the skin had a normal appearance with no lesions.

[0267] The results clearly demonstrate that the exemplary compositions according to the present invention can be used to improve the appearance of the skin. In addition, this example clearly demonstrates that the exemplary compositions according to the present invention can be used to treat skin burns, such as caustic chemical burns ((T23) Burns and corrosions of the wrist and hand), which are part of the list of burns and corrosions according to the International Classification of Diseases (T23, ICD10, Chapter XIX).

[0268] Example 9: Example compositions comprising poly-L-lysine dendrimers and at least one vitamin applied to the lips Effects after herpes

[0269] In this example, the compositions used were Composition 1 and Composition 2 as described above in Example 1. The compositions were applied to herpes labialis by: applying 1 cm 3 (1 mL) of the composition was applied to the skin, extending one centimeter beyond the area to be treated (that is, including the herpes lesion), and gently massaged using inward-outward circular motions for 3 days, applying composition 1 in the morning and composition 2 in the evening. Before each application, the skin was rinsed with soapy water.

[0270] Figure 7 It shows that before the application of composition 1 and composition 2 ( Figure 7 A) and after 3 days of application of Composition 1 and Composition 2 ( Figure 7 B) Photo of lips.

[0271] From the first application of the composition, pain relief was observed. Figure 7 As shown in B, on the third day of application, the skin had a normal appearance with no lesions.

[0272] The results clearly demonstrate that the exemplary compositions according to the present invention can be used to improve the appearance of the skin. In addition, this example clearly demonstrates that the exemplary compositions according to the present invention can be used to treat skin lesions of the herpes type ((L13.0) dermatitis herpetiformis), which are included in the list of diseases of the skin and subcutaneous tissue according to the International Classification of Diseases (L13.0, ICD10, Chapter XII).

[0273] Example 10: Exemplary cosmetic and / or dermatological compositions

[0274] The compositions are in the form of gels and contain vitamin A (also known as retinol and derivatives) and / or vitamin C (also known as ascorbic acid and derivatives). The poly-L-lysine dendrimers used are DGL G2-TFA and DGL G3-acetate poly-L-lysine dendrimers commercially available from COLCOM. These are poly-L-lysine dendrimers obtained according to the method described in document WO2006114528A1 or An Expeditious Multigram-Scale Synthesis of Lysine Dendrigraft (DGL) Polymers by Aqueous N-Carboxyanhydride Polycondensation. H. Collet and co-authors: Chem. Eur. J. 2010, 16, 2309-2316 [2].

[0275] The vitamins used were vitamin C (also known as ascorbic acid) or vitamin A (also known as retinyl acetate), respectively, commercially available from Sigma-Aldrich, France.

[0276] Each composition was prepared according to a method comprising the following steps: in a beaker containing a mixture of water, glycerol and sodium polyacrylate, mechanically stirred at 600 rpm with a chopping disk and heated to 70°C ± 5°C, a hot mixture of sweet almond oil, isopropyl palmitate and tropolone (70°C ± 2°C) was added thereto. The solution was continuously stirred at 3000 rpm and at 70°C ± 2°C for 15 minutes. The solution was then brought to a temperature of 40°C ± 5°C while stirring at 600 rpm, and then the fragrance and the mixture of poly-L-lysine dendrimers and vitamins previously homogenized by ultrasound were added. The resulting emulsion was continuously stirred at 40°C ± 5°C for 15 minutes at 600 rpm. The samples were stored in a refrigerator at 2°C-6°C.

[0277] The exemplary compositions obtained are described below in Tables 6 and 7. In these tables, the percentages are given by mass relative to the total mass of the composition.

[0278] Table 6: Examples of polylysine dendrimers (especially polylysine dendrimers of generation G3) and vitamin A Composition (Composition I)

[0279] Name (INCI), mixed CAS Mass % relative to the total mass of the composition AQUA 7732-18-5 84.6 Isopropyl Palmitate 142-91-6 5.0 Prunus Amygdalus Dulcis (Sweet Almond) Oil 8007-69-0 4.0 glycerin 56-81-5 3.0 Sodium polyacrylate 25549-84-2 1.3 Denatured alcohol 64-17-5 1 spices / 0.5 Polylysine (DGL G3-acetate) 25104-18-1 0.05 Retinol 68-26-8 0.05 Tropolone 533-75-5 0.5 total 100.0

[0280] Table 7: Examples of polylysine dendrimers (especially polylysine dendrimers of generation G2) and vitamin C Composition (Composition H)

[0281] Name(INCI),Mixed CAS INCI% AQUA(Water) 7732-18-5 85.38 Isopropyl Palmitate 142-91-6 5.0 Prunus Amygdalus Dulcis (Sweet Almond) Oil 8007-69-0 4.0 glycerin 56-81-5 3.C Sodium polyacrylate 25549-84-2 1.6 ascorbic acid 50-81-7 0.5 Flavors (spices) / 0.5 Poly-L-lysine(DGL G2-TFA) 25104-18-1 0.02 total 100.C

[0282] Example 11: Stability test of cosmetic and / or dermatological compositions

[0283] In this example, the stability of Composition 5 described in Table 6 (Composition I) and Table 7 (Composition II) was evaluated.

[0284] The conditions under which the evaluation was performed are described in Table 8 below:

[0285] Table 8: Protocol for evaluating composition stability

[0286]

[0287] The results are shown in Tables 9 and 10.

[0288] If the appearance, color and odor remain unchanged and the measured parameters, especially pH and viscosity, do not deviate from their original values ​​by more than 20%, the composition is considered to be compliant (Knowlton, John L., and Steven EMPearce. Handbook of Cosmetic Science & Technology. Elsevier, 2013

[11] .

[0289] The appearance of the composition was evaluated by daylight inspection in the presence of flocculation, sedimentation and creaming, looking for significant changes in color, flow and texture according to the procedures described in the European Cosmetics Association. "Cosmetics Europe: Guidelines on stability testing of cosmetic products. Guide Stab Test Cosmet Prod [Internet], Cosmetics Europe; 2004 Mar." and Romanowski, Perry and Randy Schueller. "Stability testing of cosmetic products." Novel Cosmetic Delivery Systems 6 (2023): 115-129

[12] .

[0290] Table 9: Stability results of composition 1

[0291]

[0292] Fig. 9A Composition 1 is shown after a) 1 month at 25°C, b) 1 month at 4°C, and c) 90 hours at 45°C.

[0293] The results obtained show that the accelerated ageing test (3 months at 45° C.) of composition 1 showed stability in the five organoleptic characteristics (appearance, odor, color), that is, the composition had not significantly degraded.

[0294] In addition, the results show that under normal use and storage conditions (storage at room temperature: 15°C-25°C, away from light, heat, moisture and in a sealed condition), the estimated shelf life of Composition 1 is greater than 30 months.

[0295] Table 10: Stability results of composition 2

[0296]

[0297]

[0298] Fig. 9B Composition 2 is shown after a) 1 month at 25°C, b) 1 month at 4°C, and c) 90 hours at 45°C.

[0299] The results obtained confirm that the accelerated aging test (3 months at 45°C) of composition 2 shows stability in the 5 organoleptic characteristics (appearance, odor, color), that is, the composition has not significantly degraded.

[0300] In addition, the results show that under normal use and storage conditions (storage at room temperature: 15°C-25°C, away from light, heat, moisture and in a sealed condition), the estimated shelf life of Composition 2 is greater than 30 months.

[0301] Example 11: Hydration of a cosmetic or dermatological composition after a single application

[0302] In this example, the evaluation of skin hydration by the compositions described in Table 6 (Composition 1) and Table 7 (Composition 2) was performed by applying the compositions to the skin of the leg (treatment site), and a control site (untreated) was located on the contralateral leg and did not include any composition application.

[0303] Eleven adult female volunteers aged between 40 and 70 years (mean age 65 years) with dry skin on the legs (stratum corneum measurement less than or equal to 50 A.U.) were included in the study.

[0304] In this study, 0.07 mL of pure product, Composition 1 or Composition 2, was applied to the leg 35 cm 2 200 skin areas were treated and efficacy was assessed three hours later by stratum corneum measurement. The same person performed the measurements throughout the study.

[0305] Hydration is measured by measuring the electrical capacitance of the stratum corneum to determine the hydration level of the upper layers of the epidermis. A very low intensity electric field is generated on the surface of the skin by the keratometer probe. The capacitance is then measured and is proportional to the hydration level of the stratum corneum. CM 825 probe (Courage+Khazaka Electronic GmbH, Cologne, Germany) at 49 mm 2 The capacitance values ​​of the stratum corneum are given in arbitrary units on a scale of 0 A.U. to 130 A.U.

[0306] For each volunteer and each measurement time, only the mean of 3 repeated measurements was considered. This mean formed the basis for the individual data.

[0307] Based on the individual data, for each measurement time, the following descriptive statistics are given:

[0308] Mean value and standard deviation;

[0309] Percent change:

[0310] The gross change percentage (not taking into account the change in the control area) is calculated as follows:

[0311] Gross change % = (PTX-PTO) / PTO

[0312] Where: PTX = the average value of the TX value on the treatment area, PT0 = the average value of the T0 value on the treatment area

[0313] The relative change in % (taking into account the change recorded on the control area) is calculated as follows:

[0314] Relative change % = (((PTX-PTO)×100) / PTO)-(((CTX-CTO)×100) / CTO)) Where: PTX = the average of the values ​​at TX on the treated area, PT0 = the average of the values ​​at T0 on the treated area, CTX = the average of the values ​​at TX on the control area, CTO = the average of the values ​​at T0 on the control area

[0315] Table 11 shows the mean values ​​and standard deviations of the hydration of the sites (skin parts) to which Composition 1 and the control were applied, and the results of statistical analysis.

[0316] Table 11: Hydration means and standard deviations

[0317]

[0318] In Table 11, S represents significant difference (p≤0.05), NS represents non-significant difference (p>0.05), and AU represents arbitrary unit: value measured by a keratometer.

[0319] Table 12 shows the percent change in hydration level after Composition 1 application.

[0320] Table 12: Percent Change in Hydration Level

[0321] Time after application of the composition T1h T2h T3h % Change in Treatment Site 46.8％ 69.0％ 75.7％ % change in control site 5.8％ 3.1％ 9.5％ % change from treatment site to control site 41.0％ 65.9％ 66.2％

[0322] As shown, statistical analysis using the Wilcoxon test for paired data between Tx and T0 for Composition 1 revealed a statistically significant increase in hydration level of 41.0% at T1h, a statistically significant increase in hydration level of 65.9% at T2h, and a statistically significant increase in hydration level of 66.2% at T3h.

[0323] Table 13 shows the mean values ​​and standard deviations of the hydration of the sites (skin parts) to which Composition 2 and the control were applied, and the results of statistical analysis.

[0324] Table 13: Hydration means and standard deviations

[0325]

[0326] In Table 13, S represents significant difference (p≤0.05), NS represents non-significant difference (p>0.05), and AU represents arbitrary unit: value measured by a keratometer.

[0327] Table 14 shows the percent change in hydration level after Composition 2 application.

[0328] Table 14: Percent Change in Hydration Level

[0329] Time after application of the composition T1h T2h T3h % change in site after composition application 44.0％ 64.6％ 61.5％ % change in control site 5.8％ 3.1％ 9.5％ % change from the site where the composition was used to the control site 38.2％ 61.5％ 52.0％

[0330] As shown, statistical analysis using the Wilcoxon test for paired data between Tx and T0 for Composition 2 revealed a statistically significant increase in hydration level of 38.2% at T1h, a statistically significant increase in hydration level of 61.5% at T2h, and a statistically significant increase in hydration level of 52% at T3h.

[0331] Thus, the results demonstrate that the use of a composition comprising a substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g. vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier advantageously allows hydration of the skin, in particular of the superficial layers of the epidermis, in a statistically significant manner at each of the measured times.

[0332] Thus, this example clearly demonstrates that the use of an exemplary composition according to the invention or a composition comprising a substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g., vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier can significantly increase skin hydration in a very short period of time. This example also demonstrates that the use of a composition comprising a substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g., vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier can significantly increase the hydration of dry skin.

[0333] Example 12: Evaluation of clinical and dermatological tolerability and efficacy after use and use testing

[0334] In this example, exemplary compositions comprising substituted or unsubstituted polylysine dendrimers, at least one vitamin (e.g., vitamin A or vitamin C), and at least one cosmetically and / or dermatologically acceptable carrier, namely, Composition 1 and Composition 2 described above, were evaluated for clinical and dermatological tolerability and acceptability.

[0335] The composition was applied twice daily to clean, dry skin on the face and hands, and once daily to dry areas of the body (forearms, elbows and legs) over a 28-day period. Skin evaluation was performed before and 28 days after application of the composition.

[0336] Composition 1 included 22 volunteers, including 19 females and 3 males, with an average age of 63 years old, ranging from 34 to 70 years old. All volunteers had dry to very dry facial skin, and 11 volunteers reported facial skin sensitivity.

[0337] Composition 2 included 22 volunteers, including 21 females and 1 male, with an average age of 63 years, ranging from 47 to 70 years. All volunteers had dry to very dry facial skin, and 11 reported facial skin sensitivity.

[0338] Clinical and dermatological tolerance was assessed by clinical examination by dermatologists through inspection and skin palpation. The examination was performed under environmental conditions suitable for the study and was performed by the same assessor (investigator or clinical assistant in charge of the investigator) throughout the study. Each criterion was graded from 0 to 3 (0 = absent; 0.5 = very mild; 1 = mild; 2 = moderate; 3 = severe), with no clinical signs of intolerance or discomfort.

[0339] The exemplary compositions comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g., vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier, i.e., Composition 1 and Composition 2 described above, were evaluated for their efficacy in treating damaged skin, i.e., rough, cracked skin causing discomfort, tightness and itching, and for the nourishing effect of the compositions, in particular by evaluating the dryness and softness of the skin. The evaluation was performed by comparing the skin before application of the composition and after 28 days of application of the composition. The skin condition was evaluated on a scale of 0 to 10: damaged or undamaged, dryness and softness, i.e., damaged skin: 0 = undamaged skin; 10 = extremely damaged skin; dryness of skin: 0 = not dry skin; 10 = extremely dry skin; softness of skin: 0 = not soft skin; 10 = extremely soft skin. The evaluation was performed by a dermatologist performing a clinical examination by inspection and skin palpation.

[0340] Tables 15 and 16 show the mean, standard deviation, minimum and maximum values ​​and percentage change of damaged and non-damaged skin, skin dryness and softness, respectively, and the results of statistical analysis after application of Composition 1 or Composition 2.

[0341] Table 15: Results on the condition, dryness and softness of the skin with Composition 1

[0342]

[0343] Table 16: Results on the condition, dryness and softness of the skin with Composition 2

[0344]

[0345] In Tables 15 and 16, the statistical test was the Wilcoxon test for paired data, and S represents significant (p≤0.05).

[0346] As demonstrated, either Composition 1 or Composition 2 significantly improved skin condition, softness, and hydration over time.

[0347] Compositions comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g., vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier, i.e., Composition 1 and Composition 2 described above, were evaluated for skin tightness. The evaluation was performed by volunteers by comparing the skin before and 28 days after application of the composition. The tightness evaluation was performed by asking the subjects using a visual analog scale, using a score from 0 to 10, i.e.: 0 = no tightness; 10 = considerable tightness.

[0348] Tables 17 and 18 show the mean, standard deviation, minimum and maximum values, and percentage change of skin tightness after application of Composition 1 or Composition 2, respectively.

[0349] Table 17: Results on skin tightness with Composition 1

[0350]

[0351] Table 18: Results on skin tightness with Composition 2

[0352]

[0353] In Tables 17 and 18, the statistical test was the Wilcoxon test for paired data, and S represents significant (p≤0.05).

[0354] As demonstrated, application of a composition comprising a substituted or unsubstituted polylysine dendrimer, at least one vitamin (eg vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier to the skin results in a significant reduction in tautness.

[0355] Cosmetic acceptability evaluation was also conducted by volunteers after using Composition 1 or Composition 2 for 28 days. The results showed that the overall satisfaction was 95% and 91%, respectively, with more than 75% of the volunteers also verifying the following properties of the composition:

[0356] - Pleasant fragrance

[0357] - Pleasant texture

[0358] -The product is absorbed quickly

[0359] - Product is easy to apply

[0360] - The product does not make the skin sticky

[0361] -Soft skin

[0362] -Soft skin

[0363] - Products improve the overall appearance of the skin

[0364] - Products provide freshness

[0365] -The product leaves a protective film on the skin

[0366] -The product provides protection against external aggressors

[0367] - Products that respect the skin

[0368] -Skin is deeply nourished

[0369] -The skin regains its comfort

[0370] -Product hydrates the skin throughout the day

[0371] -Product reduces tightness

[0372] - Products suitable for your skin type

[0373] As demonstrated, the composition comprising a substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g., vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier has excellent cosmetic and dermatological tolerance for dry to very dry skin, in particular the face. In addition, the composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g., vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier does not induce any discomfort or reaction in volunteers who report having sensitive skin, thus clearly demonstrating that these compositions can be used for non-therapeutic cosmetic uses and / or the care and / or treatment of sensitive skin, such as sensitive facial skin. This example also clearly demonstrates that the composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g., vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier has a skin nourishing effect, such as advantageously helping to reduce dryness and improve skin softness. This example also clearly demonstrates that a composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g. vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier has a skin repairing effect, an anti-tightness effect and a very good cosmetic acceptability.

[0374] Example 13: A polylysine dendrimer comprising a substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g., vitamin Evaluation of the skin compatibility of a composition of vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier

[0375] The skin compatibility of compositions comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g. vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier was evaluated by patch testing on the anterolateral side of the arm for 48 hours.

[0376] An occlusive dressing (Finn or equivalent) applied to the anterolateral aspect of the arm for 48 hours.

[0377] The skin compatibility of the composition was assessed 48 hours after the initial application and between 30 and 40 minutes after removal of the dressing. Skin reactions (erythema and edema) were scored from 0 to 3 using the scale described in Table 19 below.

[0378] Table 19: Skin reaction scores

[0379]

[0380] Any other skin reactions (bullas, papules, blisters, dryness, scaling, roughness, soap effect, etc.) were also assessed and reported descriptively according to the following scale: 0: no reaction, 0.5: very mild, 1: mild, 2: moderate, and 3: marked.

[0381] The primary irritation index (PII) was calculated using the following formula:

[0382] 1.1.M. = (total skin reactions (E+OE+bullous+papules+vesicles)) / number of volunteers tested

[0383] The PII obtained was used to classify the tested compositions according to the scale shown in Table 20.

[0384] Table 20: Classification according to the composition of PII

[0385] PII≤0.20 No stimulation 0.20<PII≤0.50 Mild irritation 0.50<PII≤2 Moderate stimulation 2<PII≤3 Severe irritation

[0386] For Composition 1, the number of volunteers included was 11 individuals. The PII result obtained was 0, and no side effects were identified.

[0387] For Composition 2, the number of volunteers included was 11 individuals. The PII result obtained was 0, and no side effects were identified.

[0388] A test for evaluating the ocular irritation potential of composition 1 or composition 2 by studying the cytotoxicity after diffusion of agarose gel on the NCTC L929 cell line was also performed. This test is an in vitro method for evaluating the potential for ocular irritation. The principle is based on measuring the cytotoxicity of the test element, i.e., the composition, 24 hours after the composition is applied to the surface of the agarose gel in contact with the cell monolayer. Cell viability is assessed by the activity of mitochondrial succinate dehydrogenase in living cells. This enzyme converts MTT into blue formazan crystals. The range of cell lysis revealed by staining is related to the diffusion capacity of the test element through the agarose gel. The diameter measurement of the dissolution range is proportional to the cytotoxicity of the test element. This test is carried out according to the protocol published in the Official Journal of the French Republic (No. 302) on December 30, 1999. The cells used are NCTC L929 mouse lung fibroblasts (ATCC-CCLI); the cells do not contain mycoplasma. The culture medium used is:

[0389] -Complete medium: DMEM 1g / L glucose, 2mM L-glutamine or stabilized glutamine, 10% stripped FBS, 50IU / mL penicillin, 50μg / mL streptomycin, 1% non-essential amino acids -Store at 5°C ± 3°C

[0390] - Complete medium concentrated 2x: DMEM 2×, 4 mM L-glutamine or stabilized glutamine, 20% stripped FBS, 100 IU / mL penicillin, 100 μg / mL streptomycin - prepare extemporaneously and use on the same day

[0391] -CA-free 2+ and Mg 2+ Dulbecco's PBS - stored at room temperature - Trypsin EDTA IX (0.5 g / l porcine trypsin, 0.2 g / l EDTA) - stored at -20°C ± 5°C

[0392] -2% agarose ultrapure aqueous solution - stored at 8℃±3℃

[0393] - Staining solution: 0.5 mg / mL MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) solution in 1 g / L DMEM (unsupplemented) - prepared extemporaneously and used on the same day

[0394] The positive control was 3% SDS solution (CAS No.: 151-21-3), while the negative control was complete culture medium.

[0395] The test is performed as follows:

[0396] Cells are trypsinized and counted.4.5mL cell suspension was inoculated into culture dishes with 2.5 × 10 cells / mL in complete medium, and then cultured overnight (37 ° C, 5% CO ).At the end of incubation, the cell layer confluence was checked.2% agarose gel was melted by heating in a water bath of about 80 ° C, and mixed by volume with 2 × concentrated complete medium.After removing the culture medium by suction, 4.5mL 1% agarose complete medium (about 37 ° C of temperature) was poured into each culture dish.After solidifying at room temperature for a few minutes, culture dishes were placed at 37 ° C, 5% CO 30 minutes ± 10 minutes below to stabilize the reagent system.Filter paper disc (6mm in diameter) was placed in the center of each culture dish on the agarose gel surface.Then, 10 μL compositions 1 or compositions 2 (test elements) and reference elements (positive control or negative control) were carefully deposited on the disc.

[0397] The test system was exposed to Composition 1 or Composition 2 and to the reference element at 37° C., 5% CO 2 for 24 hours ± 1 hour.

[0398] At the end of the treatment time, carefully remove the agarose gel using a spatula without damaging the cell layer. Development is performed at 37°C, 5% CO2 by adding 2 mL of staining solution to each culture dish for 1 hour ± 30 minutes. The solution is then removed by inversion or aspiration. After cell staining, an unstained area (dissolved area) may appear in the center of the culture dish. To account for diffusion heterogeneity, measure the maximum and minimum diameters of this area with a piece of chart paper and calculate the mean diameter (MD). The cytotoxicity of the composition corresponds to the arithmetic mean of the mean diameters measured on four culture dishes. This value is expressed in centimeters to two decimal places.

[0399] The results obtained clearly demonstrate the absence of cytotoxicity and the absence of eye irritation and / or eye irritation potential of the compositions.

[0400] A test for evaluating the comedogenic effect of compositions comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g. vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier, in particular Composition 1 or Composition 2, was performed.

[0401] The composition was applied once daily to clean the facial skin over a period of 28 days. Skin assessment was performed before and 28 days after the composition was applied. A clinical dermatological examination was performed by a dermatologist, including sun examination and facial skin palpation. Scoring consisted of counting all skin lesions, i.e. comedones, microcysts, papules and pustules that might be present.

[0402] For Composition 1, the number of volunteers included was 21, where the average age was 35 years old, ranging from 19 to 45 years old. All volunteers had oily skin, prone to acne and blemishes, and 11 volunteers said that their facial skin was sensitive.

[0403] For Composition 2, the number of volunteers included was 24, of which the average age was 36 years old, ranging from 20 to 45 years old. All volunteers had oily skin on their faces, prone to acne and blemishes, and 12 volunteers said that their facial skin was sensitive.

[0404] Daily application of Formulation 1 and Formulation 2 consisted of applying a hazelnut-sized amount (approximately 2 mL) of one composition to the entire face, massaging gently using inward-outward circular motions.

[0405] All volunteers underwent clinical examination (examination site: face) and acne lesions were counted. Table 21 shows the corresponding results.

[0406] Table 21. Volunteer characteristics

[0407]

[0408] Tables 22 and 23 show the mean, standard deviation, minimum and maximum values ​​and percentages related to the presence of comedones and microcysts, papules, pustules or nodules and cysts, and the results of statistical analysis after the administration of Composition 1 or Composition 2, respectively.

[0409] Table 22: Regarding the presence of comedones and microcysts, papules, pustules or nodules and cysts after application of Composition 1 result

[0410]

[0411] Table 23: Regarding the presence of comedones and microcysts, papules, pustules or nodules and cysts after application of Composition 2 result

[0412]

[0413] In Tables 22 and 23, the statistical test was the Wilcoxon test for paired data, NS means not significant (p>0.05), and NA means not applicable.

[0414] As shown in Tables 22 and 23 above, the number of comedones and microcysts, papules, pustules or nodules and cysts did not increase after 28 days of administration.

[0415] The results in Tables 22 and 23 show that the negative change in the "comedones and microcyst counts" score was -0.8% or -12.2%, clearly demonstrating a reduction in the number of comedones and microcysts after application of Composition 1 or Composition 2 for 28 days.

[0416] As demonstrated, the composition comprising substituted or unsubstituted polylysine dendrimers, at least one vitamin (eg vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier has excellent cosmetic and dermatological tolerability for oily or combination-oily skin, in particular for the face.

[0417] As demonstrated, compositions comprising substituted or unsubstituted polylysine dendrimers, at least one vitamin (eg, vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier have no comedogenic potential.

[0418] In addition, the sebum regulating effect of the tested compositions was also studied. For this purpose, dermatologists observed and rated the "oily appearance" of the skin: 0.5: very slight; 1: slight; 2: moderate; 3: significant. For composition 1, the number of volunteers included was 21, of which the average age was 35 years old, ranging from 19 to 45 years old. The facial skin of all volunteers was oily. In particular, the comparative test of composition 1 or composition 2 consisted in applying a sufficient amount of the composition corresponding to hazelnuts (about 2 ml) to the entire face, gently massaging using an inward-outward circular motion.

[0419] Table 24 summarizes the results obtained.

[0420] Table 24: Skin Oiliness

[0421]

[0422] As shown in Table 24, use of a composition comprising a substituted or unsubstituted polylysine dendrimer, at least one vitamin (eg, vitamin A or vitamin C), and at least one cosmetically and / or dermatologically acceptable carrier advantageously helps reduce the oily appearance of the skin.

[0423] In addition, the anti-defect (i.e., comedones, microcysts, papules and pustules) effect of the tested composition was studied. Specifically, the improvement / anti-defect effect corresponds to a decrease in the total defect score: the number of comedones, microcysts, papules and pustules, and the absence of the effect corresponds to no decrease or increase in the total defect score. For this purpose, the skin was observed by a dermatologist, and the skin defects were scored at the beginning of the study (D1) and at the end of the study (D28). All volunteers had facial defects: (i) 21 subjects aged between 19 and 45 years old applied composition 1 to their facial skin every day, gently massaging with inward-outward circular motions, and (ii) 24 subjects aged between 20 and 35 years old applied composition 2 to their facial skin every day, gently massaging with inward-outward circular motions.

[0424] Table 25 summarizes the results obtained.

[0425] Table 25: Results on the anti-defect effect

[0426]

[0427] As shown in Table 25, the results obtained show that the skin appearance improved after daily application of each composition for 28 days in volunteers with skin imperfections. Specifically, after application of composition 1, improvement was observed in 24% of the volunteers, while after application of composition 2, improvement was observed in 75% of the volunteers.

[0428] Cosmetic acceptability evaluation was also conducted by volunteers after using Composition 1 or Composition 2 for 28 days. The results showed that the overall satisfaction rates were 81% and 92%, respectively, and more than 75% of the volunteers confirmed the following properties of the composition:

[0429] - Pleasant fragrance

[0430] - Pleasant texture

[0431] -The product is absorbed quickly

[0432] - Product is easy to apply

[0433] - The product does not make the skin sticky

[0434] -Soft skin

[0435] -Soft skin

[0436] - Products improve the overall appearance of the skin

[0437] - Products provide freshness

[0438] -The product leaves a protective film on the skin

[0439] -The product provides protection against external aggressors

[0440] - Products that respect the skin

[0441] -Products improve skin texture

[0442] -Products reduce skin shine

[0443] - Products to remove shine from the skin

[0444] -The product tightens pores

[0445] - Products suitable for your skin type

[0446] This example clearly demonstrates that a composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g., vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier does not cause side effects and is non-irritating after application to the skin. In other words, this example clearly demonstrates that a composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g., vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier has very good skin tolerance and compatibility.

[0447] Example 14: Comprising substituted or unsubstituted poly-lysine dendrimers, at least one vitamin (e.g. Stability / preservation of a composition comprising vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier Research

[0448] In this example, a study of the preservation of a composition in relation to a bacterial strain was performed. The compositions tested were Composition 1 and Composition 2 mentioned above. The evaluation was carried out according to the standard and according to the protocol of ISO 11930.

[0449] The tested composition was divided into sterile vials and each vial was inoculated with a suspension of a test strain. Incubation was carried out for 28 days in the dark at 22.5°C ± 2.5°C. Neutralization validation was performed for all strains. The neutralization phase that could be preserved was performed at the lowest dilution compatible with the validation. The microbial density obtained during the monitoring period for each test strain was counted and compared with the logarithmic reduction threshold adopted by the standard.

[0450] The strains used and experimental conditions are summarized in Table 26.

[0451] Table 26: Experimental conditions

[0452]

[0453] The enumeration method is performed by inclusion, with results given in CFU / g or mL.

[0454] The compliance criteria are summarized in Table 26 below.

[0455] Table 27: Qualification criteria according to ISO 11930

[0456]

[0457] In Table 27, NI means no increase in microbial count compared to the previous contact time.

[0458] The neutralizer was LT SUP medium containing 15 g / L casein tryptone, 5 g / L soy papain peptone, 0.7 g / L L-cystine, 4.0 g / L sodium chloride, 0.2 g / L sodium sulfite, 5.5 g / L glucose, 1.0 g / L egg lecithin, 15.0 g / L polysorbate 80, and 1.56 g / L sodium laureth sulfate.

[0459] Table 28 shows the results of the bacterial density in Composition 1 after inoculation (in CFU / g).

[0460] Table 28: Bacterial density in composition 1

[0461]

[0462] Table 29 shows the interpretation of the results obtained for composition 1 using the ISO 11930 standard

[0463] Table 29: Bacterial density in composition 1 using ISO 11930 standard 5

[0464]

[0465] Table 30 shows the results of the bacterial density in Composition 2 after inoculation (in CFU / g).

[0466] Table 30: Bacterial density in composition 2

[0467]

[0468]

[0469] Table 31 shows the interpretation of the results obtained for composition 2 using the ISO 11930 standard

[0470] Table 31: Bacterial density in composition 2 using ISO 11930 standard

[0471]

[0472] As demonstrated in this example, a composition comprising a substituted or unsubstituted polylysine dendrimer, at least one vitamin (e.g., vitamin A or vitamin C) and at least one cosmetically and / or dermatologically acceptable carrier is stable over time and does not allow bacterial growth after inoculation of the composition. This example clearly demonstrates the effectiveness of an antimicrobial preservative.

[0473] References

[0474] 1. WO2006114528A1

[0475] 2. An Expeditious Multigram-Scale Synthesis of Lysine Dendrigraft (DGL) Polymers by Aqueous N-Carboxyanhydride Polycondensation. H. Collet and collaborators: Chem. Eur. J. 2010, 16, 2309-2316.

[0476] 3. Fregert S. Manual of Contact Dermatitis. 2nd ed. Munksgaard, Copenhagen: Year Book Medical Publishers, Inc; 1981. Chapter 10, Patch Testing; pp. 71-81.

[0477] 4. International Classification of Diseases (B07, ICD10, Chapter I),

[0478] 5. International Classification of Diseases (L82, ICD10, Chapter XII),

[0479] 6. International Classification of Diseases (L20-L30, ICD10, Chapter XII),

[0480] 7. International Classification of Diseases (L73.2, ICD10, Chapter XII),

[0481] 8. International Classification of Diseases (T23, ICD10, Chapter XIX),

[0482] 9. International Classification of Diseases (L13.0, ICD10, Chapter XII),

[0483] 10.Scholl, Markus et al. "The thermal polymerization of amino acids revisited; Synthesis and structural characterization of hyperbranched polymers from l-lysine." Journal of Polymer Science Part A: Polymer Chemistry 45.23 (2007): 5494-5508

[0484] 11.Knowlton et Pearce[Knowlton, John L. and Steven EM Pearce.]Handbook ofCosmetic Science&Technology.Elsevier, 2013

[0485] 12. European Cosmetics Association. "Cosmetics Europe: Guidelines onstability testing of cosmetic products. Guidel Stab Test Cosmet Prod [Intemet]. Cosmetics Europe; 2004 Mar." and Romanowski, Perry, and Randy Schueller. "Stability testing of cosmetic products." Novel Cosmetic Delivery Systems 6 (2023): 115-129.

Claims

1. A non-therapeutic cosmetic use of a cosmetic composition comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one cosmetically acceptable carrier.

2. The non-therapeutic cosmetic use according to claim 1, wherein the at least one substituted or unsubstituted polylysine dendrimer is a substituted or unsubstituted polylysine dendrimer of the 2nd (G2) to 10th (G10) generation.

3. The non-therapeutic cosmetic use according to claim 1 or 2, wherein the at least one vitamin is selected from the group consisting of water-soluble vitamins and fat-soluble vitamins.

4. The non-therapeutic cosmetic use according to any one of claims 1 to 3, wherein the polylysine dendrimer is substituted with at least one group selected from aspartate, succinate, guanidino, acetate or fluorine.

5. The non-therapeutic cosmetic use according to any one of the preceding claims, wherein the cosmetic composition comprises from 0.01% to 10% by weight of said at least one vitamin relative to the total weight of the composition.

6. The non-therapeutic cosmetic use according to any one of the preceding claims, wherein the cosmetic composition comprises from 0.01% to 10% by weight of said at least one substituted or unsubstituted polylysine dendrimer relative to the total weight of the composition.

7. The non-therapeutic cosmetic use according to any one of the preceding claims, wherein the at least one vitamin is selected from the group comprising vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B8, vitamin B9, vitamin B12, vitamin C, vitamin A, vitamin D, vitamin E, vitamin K1 and vitamin K2, preferably from the group comprising vitamin C and vitamin A.

8. The non-therapeutic cosmetic use according to any one of the preceding claims, wherein the composition is in a form selected from gels, ointments, creams, oils, milks, salves, powders, soaking pads, solutions, serums, balms, butters, lotions, suspensions, soaps and emulsions.

9. A non-therapeutic cosmetic care method comprising applying a cosmetic composition according to any one of claims 1 to 8 to the skin or mucous membrane.

10. The method according to claim 9, wherein the cosmetic treatment is selected from hydration, improvement of appearance and soothing of the skin and / or its appendages and / or the mucous membranes.

11. A dermatological composition for use in the treatment of skin diseases, comprising at least one substituted or unsubstituted polylysine dendrimer, at least one vitamin and at least one dermatologically acceptable carrier.

12. The composition for use according to claim 11, wherein the skin disease is selected from the group comprising skin inflammation and / or skin infection.

13. The composition for use according to claim 11 or 12, wherein the at least one substituted or unsubstituted polylysine dendrimer is a substituted or unsubstituted polylysine dendrimer of the 2nd (G2) to 10th (G10) generation.

14. The composition for use according to any one of claims 11 to 13, wherein the at least one vitamin is selected from the group comprising water-soluble vitamins and fat-soluble vitamins.

15. A composition for use according to any one of claims 11 to 14, wherein the skin disease is selected from the group comprising the following: actinic keratosis, impetigo, pemphigus, dermatitis herpetiformis, (L20) atopic dermatitis, seborrheic dermatitis, allergic contact dermatitis, irritant contact dermatitis, chronic simple lichen and prurigo, pruritus, psoriasis, lichen planus, urticaria, sunburn, radiation dermatitis, alopecia areata, onycholysis, alopecia, vitiligo, seborrheic keratosis, pressure sores, seborrheic warts, eczema, herpes, skin burns.

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