COSMETIC DERMATOLOGICAL COMPOSITION, EXCLUDING ITS THERAPEUTIC USE, FARNESOL-FREE, FOR THE TREATMENT AND / OR PREVENTION OF ATOPIC ECZEMA

Abstract

A dermatological composition for the treatment and / or prevention of atopic eczema, containing an active complex that inhibits and destroys the biofilm, regenerates the skin, and the dermatological form containing it, comprising: xylitol at a concentration of 3-10% by weight of the formulation; niacinamide at a concentration of 0.5-6% by weight of the formulation; glycerin at 2-15% by weight of the formulation; and sodium hyaluronate at 0.01-0.5% by weight of the formulation.

Description

DERMATOLOGICAL COMPOSITION FOR THE TREATMENT AND / OR PREVENTION OF ATOPIC ECZEMA TECHNICAL FIELD The present invention relates to a dermatological composition for the treatment and / or prevention of skin pathologies regulated by the formation of Staphycoccus Aureus biofilm when there is an alteration of the skin microbiome. SUMMARY OF THE INVENTION: Atopic dermatitis (AD) produces dysbiosis that affects the patient's innate and adaptive immunity. There is a significant increase in Staphylococcus aureus (SA) and a decrease in Staphylococcus epidermidis (SE) and the antimicrobial peptides (AMPs) generated by these bacteria. SA initiates and exacerbates inflammation in AD lesions by secreting several factors that modulate host immunity or compromise skin barrier function. SA secretes a large number of proteases, which are important virulence factors. These proteases degrade the skin barrier function and increase water loss, allowing greater exposure to external antigens. Furthermore, SA is a biofilm-producing strain, which, in dermatological lesions, contributes to the formation of these biofilms. IF-2019-79509238-APN-ANP#INPI1 Page 1 of 27. They offer some protection against the host's immune response and resistance to antibiotic action. It is for all these reasons that they cause serious health problems, as they are implicated in chronic, slow-growing, and treatment-resistant infections. The present invention contemplates a dermatological composition to prevent and synergize the treatment of pathologies regulated by the formation of biofilms colonized by SA; comprising an active complex formulated particularly with glycerin, xylitol, niacinamide and hyaluronic acid allowing an effective, rapid treatment without the need for the use of antibiotics or corticosteroids or other anti-inflammatories, which controls atopic eczema. STATE OF THE ART AND ITS ADVANTAGES Atopic eczema, also called atopic dermatitis (AD), is an increasingly common skin condition. It is an allergic disease that affects extremely dry skin. During flare-ups, the skin begins to itch and then ooze before blisters form. Atopic dermatitis is a common, chronic, and relapsing skin disease characterized by itching, dryness, and a predisposition to developing eczema (Weidinger S, et al. Atopic dermatitis. Lancet 2016; 387 (10023): 1109-22). It is the second most frequently diagnosed skin disease worldwide, with a higher prevalence in industrialized countries, ranging from 15-30%. IF-2019-795 0923 8-APN-ANP#INPI Page 2 of 27. Atopic dermatitis affects 2 to 10% of children and 2 to 10% of adults, although currently, a growing number of cases have also been observed in developing countries. 90% of patients experience the onset of the disease before the age of 5, and even 80% before the age of 2 (Bieber T. Atopic dermatitis. N Engl. J Med 2008; 358(14): 1483-94 - Biagini Myers JM et al. Eczema in early life: genetics, the skin barrier, and lessons learned from birth cohort studies. J Pediatr 2010; 157(5); 704-14). Because it is a chronic condition, prolonged treatment is required, which involves the use of antibiotics, corticosteroids, and / or anti-inflammatories for long periods of time, which is not recommended, especially in children. In this sense, our invention allows for the control of the disease for extended periods without resorting to the use of antibiotics, corticosteroids, or other drugs. Humans live with various types of microorganisms, maintaining a symbiotic relationship. The skin's own flora, called the skin microbiota, has a density of up to 10⁷ microorganisms per cm². Although its biological role is still largely unknown, it is known that this flora maintains the skin and prevents the transient invasion of pathogenic bacteria (Fredricks DN. Microbial ecology of human skin in health and disease. J Investig Dermatol Symp Proc 2001; 6: 167-9. In Tomas ChL et al. The microbiome and atopic eczema: More than skin deep. Australian Journal of Dermatology 2017; 58: 18-24. - Masako K, et al. A novel method to control the balance of skin microflora. Part 1. Attack on biofilm of IF-2019-795 0923 8-APN-ANP#INPI Page 3 of 27 Staphylococcus aureus without antibiotics. Journal of Dermatological Science 2005; 38: 197—205). Staphylococcus epidermidis (SE) is a bacterial species of the genus Staphylococcus that is part of the normal flora of the body's surface, where it survives thanks to its lipases. This differs from Staphylococcus aureus (SA), which is commonly found in the nasopharynx and moist areas such as the groin and armpits. SE's role is to prevent the attachment of pathogenic microorganisms, but when this balance is disrupted, the skin is in an unnatural state, facilitating the entry of pathogens and leading to skin diseases. Atopic dermatitis (AD) is a multifactorial inflammatory disease that includes genetic susceptibility and dysbiosis of the skin microbiota. Genetic predisposition involves the expression of genes for proteins that contribute to the skin's barrier function, such as the structural protein filaggrin. In addition to genetic predisposition, the importance of the skin microbiome's role in the development of the disease has been recognized for over 20 years. Ninety percent of patients with AD are colonized by Staphylococcus aureus (SA), with a higher colonization rate observed in severe eczema, whereas only 5 to 10% of healthy individuals are typically colonized (Kobayashi T, et al. Dysbiosis and Staphylococcus aureus colonization drives inflammation in atopic dermatitis. Immunity 2015; 42(4): 756-66. - Otto M. Staphylococcus colonization of the skin and IF-2019-79509238-APN-ANP#INPI . Página 4 de 27 antimicrobial peptides. Expert Rev Dermatol 2010; 5(2): 183-95. En González T et al. Staphylococcal Biofilms in Atopic Dermatitis. Curr Allergy Asthma Rep 2017; 17:81). The SA initiates and exacerbates inflammation in atopic dermatitis lesions by secreting a number of factors that modulate host immunity or compromise skin barrier functions. In addition, the SA secretes a large number of proteases that are important virulence factors. These proteases degrade the skin barrier function and increase water loss, allowing greater exposure to external antigens (Amagai M, et al. Toxin in bullous impetigo and staphylococcal scalded-skin syndrome targets desmoglein 1. Nat Med 2000; 6(11):1275-7. In González T et al. Staphylococcal Biofilms in Atopic Dermatitis. Curr Allergy Asthma Rep 2017; 17:81). It has also been shown that 80% of SA isolates in patients with AD secrete superantigens, which lead to significant inflammation and atopy, also inducing resistance to certain drugs (Hauk PJ, et al. Induction of corticosteroid insensitivity in human PBMCs by microbial superantigens).J Allergy Clin Immunol 2000; 105(4): 782-7.53). More recently, the presence of biofilms has been described in the lesions of these patients, contributing to increased severity in many diseases (Archer NK, et al. Staphylococcus aureus b of m: Properties, regulation and roles in human disease. Virulence 2011; 2(5): 445-59). Such biofilms, commonly known as “biofilms,” are a highly dynamic sessile community of IF-2019-79509238-APN-ANP#INPI5 Page 5 of 27 microorganisms, characterized by cells irreversibly attached to a substrate or interface or to each other, embedded in an extracellular matrix of polymerized substances produced by them, and exhibiting an altered phenotype with respect to the growth rate and gene transcription (Sutherland I. Biofilmexopolysaccharides: a strong and sticky framework. Microbiology 2001; 147: 3-9). In general, biofilms are life forms adapted to survive in hostile environments. They occur on both smooth and rough surfaces, are highly viscoelastic, resistant to tension, and difficult to detach. They can be visualized with scanning electron microscopy and confocal laser scanning microscopy (Jefferson K, et al. Use of Confocal Microscopy to analyze the rate of Vancomycin Penetration through Staphylococcus aureus). BiofilmsAntimicrobAgentsChemother 2005; 49(6): 2467-2473). This ability to adhere to and form biofilms provides protection against antimicrobial or biological agents by forming bacterial aggregates within the biofilm, facilitating the efficient exchange of nutrients, metabolites, and genetic material due to the proximity between microorganisms. Thus, these biofilms provide bacteria with some protection against the host's immune response and resistance to antibiotic action. It is for this reason that they cause serious health problems, as they are implicated in chronic, slow-growing, and treatment-resistant infections. The main ones IF-2019-79509238-APN-ANP#INPI θ Page 6 of 27 Microorganisms involved in this type of complication are Staphylococcus Aureus, Pseudomonas Aeruginosa, Candida and other opportunists. US 6,328,984 (B1) - 2001 - SELECTIVE ANTIBACTERIAL COMPOSITION describes an external preparation for the treatment of atopic dermatitis, which can also be formulated as a nasal and ear drop. It is formulated with an antibacterial agent that is harmless to Streptococcus pneumoniae (SE) to avoid an adverse effect that would facilitate the gradual entry of other harmful bacilli into the skin. The formulation contains xylitol from 0.01 to 30% by weight and farnesol from 0.001 to 10% by weight, which inhibits the growth of Staphylococcus aureus (SA) without affecting the growth of SE. The difference with the composition being claimed is that it does not contain farnesol, which has some allergenic potential in the general population (Schnuch A et al., “Contactal allergy to farnesol in 2021 consecutively patch-tested patients.Results of the IVDK”, Contact Dermatitis 2004: 50: 117–121) and is formulated with an active complex that inhibits and destroys the biofilm formed by SA. The remaining components give the dermatological composition an anti-inflammatory effect, promote cell renewal and hydration, restore the barrier function of the epidermis, reduce itching, re-epithelialize, and heal. Furthermore, the composition being claimed prevents and synergizes the treatment of pathologies regulated by the formation of biofilms colonized by SA, regulating their formation and / or allowing any antimicrobial agent to enter and act. IF-2019-79509238-APN-ANP#INPIγ Page 7 of 27 The prior art of US patent 9,387,189(B2)Glasnapp - July 12, 2016, ANTIBIOTIC COMPOSITION COMPRISING A CHEMOTACTIC AGENT AND A NUTRIENT DISPERSION, describes compositions and methods for treating infectious diseases caused by biofilms. More specifically, this disclosure relates to a pharmaceutical composition that can be used to treat biofilm-forming infections, specifically those caused by bacteria such as Pseudomonas, E. coli, Klebsiella, and other human pathogens. The compositions may include a nutrient dispersion such as sodium citrate, succinic acid, xylitol, glutamic acid, and ethylenediaminetetraacetic acid (EDTA), among others. Additionally, it may include antibiotics such as ciprofloxacin, amikacin, tobramycin, colistin metate, or polymyxin, among others.In the patent referenced, Glassnappen, its composition employs N-formyl-methionyl-leucyl-phenylalanine as an anti-biofilm agent, which does not destroy the biofilm but only inhibits its formation. The importance of destroying the biofilm once it has formed allows for synergistic clinical treatments, as it facilitates the absorption of antibiotics, corticosteroids, and other active ingredients. Consequently, treatments are more effective, the response is faster, and lower doses of antibiotics, corticosteroids, anti-inflammatories, and other active ingredients are required. For example, US9,597,276 (B2) - 2017 - COMPOSITION FOR THE PROPHYLAXIS OF CANDIDIASIS - describes a method for prophylactic treatment in patients who are exposed to an increased risk of infection by IF-2019-79509238-APN-ANP#INPIo EITHER Page 8 of 27. For fungal infections caused by Candida albicans, the method involves applying a composition to the patient's mucosal surface. This composition includes xylitol in an amount effective to inhibit the infection, as well as alginate in an amount suitable to enhance the antifungal effect. Xylitol is used in this formulation to prevent the growth of Candida albicans fungi. Wolcott Randall et al. describe in EP2.815.754 (B1) - 2016 - COMPOSITION FOR TREATING BIOFILM-BASED INFECTIONS - compositions and methods for wound care, especially for the treatment of chronic or acute wounds, that inhibit biofilm reconstitution or prevent its expansion. The composition consists of a combination of a milk-derived protein product, lactoferrin, and xylitol for use in the treatment of sinus infections, rectal infections, infections associated with permanent devices such as catheters, and intestinal conditions associated with biofilms or increased biofilm formation. Wolcott Randall et al. describe lactoferrin and xylitol as inhibitors of the growth of biofilms formed in wounds. The following patent incorporated herein by reference, CN107.625.721 (A) 2018-01-26 - SKIN-REFRESHING ESSENCE FOR PERSON STAYING UP LATE AND PREPARATION METHOD THEREOF - from Hainan JingrunPearl BiotechHolding Co ltd. which describes a refreshing and rejuvenating skin composition and its preparation method characterized by containing, in phase A: Glycerin 2 to 8%, IF-2019-79509238-APN-ANP#INPIQ Page 9 of 27. Sodium hyaluronate 0.1 to 0.01%, Shea butter 0.2-5%, among others in phase B: cyclopentapolydimethylsiloxane 1 to 10%, polydimethylsiloxane crosslinked polymer 0.5 to 2%, cyclohexasiloxane 0.5 to 5%, among others; and in phase D-mycotinamide 0.2 to 5% and xylitol 0.01-3%, among others. While Hainan Jingrun Pearl Biotech Holding Co., Ltd. uses, among other ingredients, the components that make up the active complex of the composition being claimed, it is not formulated for the treatment and / or prevention of pathologies regulated by biofilm formation. Furthermore, it does not act in the prevention, destruction, or restoration of the area damaged by pathologies regulated by biofilm formation. DETAILED DESCRIPTION OF THE INVENTION The problem to be solved by the invention consists of developing a dermatological composition for the treatment and / or prevention of skin conditions regulated by the formation of atopic dermatitis (AD) biofilm, using readily available and safe components, and which can be recommended for the prevention and / or treatment of atopic eczema. The composition claimed herein has unexpectedly proven effective in the treatment of atopic dermatitis without the need for antibiotics, corticosteroids, or other anti-inflammatory drugs. While the components have the following known effects in the prior art, namely: IF-2019-795O9238-APN-ANP#INPI1θ Page 10 of 27 The xylitol component prevents biofilm formation by SA Glycerin moisturizes and soothes irritated skin Niacinamide restores barrier function, reduces itching, positively regulates ceramide synthesis and intercellular lipid production, and also promotes the biosynthesis of proteins involved in the keratinocyte differentiation process Sodium hyaluronate re-epithelializes and heals. The unexpected aspect is that our invention achieves in vitro the destruction of biofilms already formed and adhered to the skin of children with atopic dermatitis. Furthermore, this complex can be formulated in creams and emulsions, which control the inflammation, scaling, and itching caused by the established SA biofilm (see example 1). This implies that the composition of the invention is capable of destroying the already formed SA biofilm, which is the cause of these symptoms, in a relatively short time. In other words, the action of xylitol, along with the other components, is not only preventive against biofilm formation to prevent eczema, as is already known in the prior art, but through their combined synergistic action, it is capable of reversing this condition, which can only be explained by the destruction of the biofilm causing it. This unexpected effect justifies the efficacy achieved in a relatively short period, which IF-2019-79509238-APNANP#INP] ¡1 Page 11 of 27 cannot be explained by the individual action of each component according to previous art. Moreover, the unexpected nature of the finding is reinforced by the fact that the formation of Staphylococcus aureus (SA) biofilms is one of the possible explanations for the lack of or poor response to topical treatments and antibiotics. It is precisely the imbalance of estrogen (SE) and the increase in SA in the affected areas that causes inflammation, redness, dryness, and swelling of the skin—effects that our invention manages to reverse without the use of antibiotics or corticosteroids. In current routine clinical practice, during outbreaks, dermatologists prescribe creams or ointments containing corticosteroids, called dermocorticoids. Other available treatments include antihistamines, which control itching and promote sleep, and antibiotics specifically for SA. The composition we intend to claim contains none of these drugs and manages to reverse the situation and restore the skin's condition to normal. Current treatments for atopic dermatitis (AD) are often prescribed for extended periods due to their poor response, leading to prolonged use of antibiotics, antihistamines, and corticosteroids. Prolonged use of these active ingredients is not advisable, especially in vulnerable populations such as children, who are significantly affected by this condition. The proposed formulation can be applied over a prolonged period, as it is safe and improves skin texture where the formulation does not IF-2019-79509238-APNAN P#IN PI]2 Page 12 of 27 not only prevents outbreaks but when symptoms appear, this composition acts against this disease even without the use of drugs. The dermatological composition that is intended to be claimed is formulated by an active complex characterized by containing glycerin, xylitol, niacinamide and sodium hyaluronate. While the components exhibit certain known effects in art such as: Glycerin moisturizes and soothes irritated skin Xylitol acts on the SA Niacinamide restores barrier function, reduces itching, positively regulates ceramide synthesis and intercellular lipid production, and also promotes the biosynthesis of proteins involved in the keratinocyte differentiation process Sodium hyaluronate re-epithelializes and heals. The composition achieves unexpected results in terms of the rapid destruction of the SA biofilm, beyond what has been taught in art to date. Cream and emulsion formulations with this complex may contain, in addition to common ingredients in the art, crimson butter, which has an anti-inflammatory effect and promotes cell renewal. IF-2019-795 0923 8-APN-ANP#INPI Page 13 of 27 In general, the formulations of the complex contain: Xylitol at a concentration of 3-10% by total weight of the formulation. Niacinamide at a concentration of 0.5 - 6% by total weight of the formulation. Glycerin 2-15% of the total weight of the formulation. Sodium hyaluronate 0.01 - 0.5% by total weight of the formulation. As well as other proprietary components, these can be adjusted to the desired cosmetic or pharmaceutical form for treating and controlling atopic dermatitis (AD) within a range that a practitioner can appropriately define according to the delivery vehicle. The formulations are free of farnesol and other fragrances and can be formulated paraben-free, as shown in the examples. The formulation can be adapted to different cosmetic or pharmaceutical forms such as cream, emulsion, foam, lotion, gel, ointment, body oil, cleansing solution, cleansing foam, soap, and spray. The formulation can be of the O / W or W / O emulsion type. EXAMPLES OF IMPLEMENTATION OF THE INVENTION IF-2019-795 0923 8-A PN-AN P# IN P^4 Page 14 of 27 The invention can be described by means of the following non-limiting examples. Example 1: A mixture that successfully destroys the biofilm formed by Staphylococcus aureus from skin samples of children with atopic dermatitis is tested for the first time. The mixture has the following composition: Component Quantity Glycerin 2.00 g Xylitol 3.00 g Niacinamide 0.50 g Hyaluronic Acid (sodium salt) 0.01 g Water qs 100 mL The study was conducted using the following experimental design 1) Swabs were taken from the lesions, which were cultured and studied by conventional microbiological techniques (Note: for this purpose 3 swabs per patient were soaked in sterile physiological solution to swab the lesions for IF-20 !9-79509238-APN-ANP#INPIl$ Page 15 of 27. Obtain damaged skin cells. The original sample was studied using conventional microbiological methods. 2) The swabs were rotated over three sterile glass wells 3) Two of them were placed in TSB culture broth and incubated at 36°C for 24 hours. Both were then stained with Gram and crystal violet techniques for microscopic observation of germs and biofilms and a score was assigned to each sample. 4) The third well was placed in TSB culture broth with the addition of the composition and was studied in the same way to determine the effect of the composition on biofilm adhesion. 5) Finally, the second control from point 3 was taken and cultured for 48 hours to see if the composition produced biofilm dispersion. At each step, to assess the presence of biofilms, photos of all preparations were taken with a digital camera (ΊOOOOOχ) which were classified, by an individual blind to the procedures, on a score from 0 to 5 (absence to maximum density). Images (see Image 7) of a sample with biofilm formation are shown here before and after treatment with the compound. In the treated sample, the biofilm has mostly disintegrated. IF-2019-795O9238-APN-ANP#INPI^ Page 16 of 27 Scatter test Biofilm in untreated sample Biofilm crumbled after treatment with the composition Image 1: Results of STAPHYLOCOCCUS biofilm dispersion AUREUS The results obtained are summarized as follows: 1) SA was cultivated in 88% of the children. 2) Of the 35 children who participated in the study, 24 had a score of 3 or more. 3) The median score for all children was 3.6 in the controls (without treatment) and 2 in those treated with the composition during the biofilm formation process in the adherence test (p<0.0001) 4) The median score for all children was 3.6 in the control group (no treatment) and 1.8 in the children treated with the composition during the process of IF-2019-795 0923 8-APN-ANP#INPI Page 17 of 27 Biofilm formation in the dispersion test of an already adhered biofilm (p<0.0001) 5) Taking samples from children per protocol who presented a biofilm score of 3 or more, 81% of them experienced a decrease in biofilm after only 48 hours of action of the composition. In conclusion: Most children with AD were colonized by SA, which were mostly found in the form of biofilms. The composition reduced the adherence of forming biofilms (result 3), as had already been observed by Katsuyama M et al. (Journal of Dermatological Science (2005) 38, 197–205), using only 5% xylitol, but on biofilms formed on plasma. In this case, skin from children with atopic dermatitis was used. Unexpectedly, the composition of the invention managed to destroy the biofilm already formed and adhered to skin cells in just 48 hours (results 4 and 5), whereas Katsuyama could only achieve this after 5 days with the addition of 0.02% Farnesol and 5% Xylitol. This constitutes a significant advantage because it allows for the treatment of children with atopic dermatitis, achieving faster biofilm dispersion and restoring the skin microbiome. IF-2019-795 0923 8-APN-ANP#INPI Page 18 of 27 excipients already widely used in cosmetic and pharmaceutical dermal products, without the use of antibiotics, corticosteroids and without resorting to potential allergens such as Farnesol (Schnuch A et al., “Contact allergy to farnesol in 2021 consecutively patch tested patients. Results of the IVDK”, Contact Dermatitis 2004: 50: 117-121). EXAMPLE 2 This example presents a formulation that was tested in children with atopic dermatitis with the following composition: Component Quantity Shea Butter 20.00 g Glycerin 15.00 g Xylitol 10.00 g Niacinamide 6.00 g Hyaluronic Acid (sodium salt) 0.5 g Glyceryl stearate and PEG 100 stearate 5.00 g Cetyl Alcohol 1.00 g Cyclohexasiloxane and Cyclopentasiloxane 1.00 g Polyacrylamide with C13-14 Isoparaffin and Laureth 7 1.00 g Dimethicone PEG7 Cocoate 0.10 g Caprylyl glycol 0.20 g Olive Oil 0.50 g IF-2019-795 0923 8-APN-ANP#INEJg Page 19 of 27 Sodium Benzoate 0.20 g Disodium EDTA 0.10 g Tocopheryl Acetate 0.20 g Butylhydroxytoluene 0.01 g Citric Acid q.s. to pH 5 - 6 Water q.s. to 100 g The study aimed to test the tolerance of the composition intended for children with atopic skin characteristics and a population of adults with a history of atopic skin and who currently have dry to extremely dry skin. The study protocol follows the standards of the American Society for Testing and Materials (ASTM) and the guidelines of the Scientific Committee on Consumer Safety (SCCS), in accordance with the requirements of the European Union (Directive 93 / 35 / EEC, Art. 7a, subsection 1 d). It also adheres to international standards for any study involving human subjects, specifically the International Council of Medical Colleges (ICH) Good Clinical Practices (GCP) and the World Medical Association Declaration of Helsinki (1964), as amended in Tokyo (1975), Venice (1983), Hong Kong (1989), and Seoul (2008). National regulations, specifically Resolution 1480-1, Article 6, repeal Resolution No. 1490 of November 14, 2007, issued by the Ministry of Health, which approved the Guide to Good Clinical Practices in Human Subjects. IF-2019-795 0923 8-APN-ANP#INP| θ Page 20 of 27 Volunteers: 20 volunteers were selected, of both sexes, whose ages ranged from 2 to 61 years. Inclusion criteria: Children with characteristics of atopic skin - Adults in good health but with characteristics of atopic or extremely dry skin. Study procedure: Study participants attended a visit during which a dermatologist and pediatrician evaluated and examined them to verify they met the selection criteria. Additionally, instrumental assessments were performed using bioengineering with a non-invasive methodology. pH, skin erythema, and transepidermal water loss were measured as baseline skin indicators. Adults and children applied the formulation daily for 21 days. Clinical aspects: a clinical observation scale of erythema, edema and desquamation was used according to Frosch & Kligman 1979. IF-2019-79509238-APN-ANP#INP^1 Page 21 of 27 Clinical observation Pitarais- Score (1 None 1 Mild — Moderate s Sea-ere· Score- Score Description IJ Ni nsuno 1 Mild — Moderate Λ Se'. rJ i? Score- Score Description o None PES'CBl-l CAJ.V 1 Mild — Moderate Sevei o Graph No. 1 represents the clinical response values ​​obtained after daily administration of the composition for 21 days. It was observed that in the tested population, redness or bacterial rash in the affected area decreased to normal levels by the end of the study. Another parameter evaluated was skin desquamation, since in atopic dermatitis (AD), the skin is primarily characterized by dryness, leading to scaling and irritation, and causing bothersome symptoms such as itching. These are dry skin types with low water and oil content, making them prone to scaling and irritation. Regarding this parameter, desquamation decreased during treatment. These results demonstrate that the composition being claimed is effective against AD, as it not only inhibits the development of biofilms IF-2019-79509238-APNANP#INP^2 Page 22 of 27 of SA, but destroys them. Once the biofilm is destroyed, daily use of this composition inhibits the appearance of symptoms caused by AD and the growth of the biofilm. In turn, the results demonstrated that this composition is effective even without the use of antibiotics, antihistamines, corticosteroids, or any other active ingredient that may act against this type of pathology. Graph No. 1: Values ​​corresponding to the clinical skin response as a function of time. Graph No. 2: Values ​​corresponding to the response of skin pH as a function of time. IF-2019-795 0923 8-APN-ANP#INPI Page 23 of 27 * W I-fl lb Ha t= 71Ϡ Graph No. 3: Values ​​corresponding to skin erythema as a function of time. UMC'· '4 Hs - 210 Graph No. 4: Values ​​corresponding to transepidermal water loss as a function of time. IF-2019-7950923 8-APN-ANP#INP^ Page 24 of 27 Based on the results obtained from a three-week clinical dermatological and pediatric evaluation, as well as instrumental evaluation using non-invasive bioengineering, the composition proved effective in the treatment and / or prevention of atopic dermatitis (AD). The composition in question does not irritate or sensitize the skin, reduces the urge to scratch, and relieves itching. The dermatological composition being claimed, which consists of an active complex of xylitol, niacinamide, glycerin, and sodium hyaluronate, has proven effective against biofilm-regulated pathologies. It not only inhibits biofilm growth but also disrupts the biofilm structure, demonstrating its efficacy in these types of treatments. The composition may also contain active ingredients such as corticosteroids, antihistamines, antibiotics, anti-inflammatories, vitamin D, vitamin A, and vitamin E to facilitate and synergize their response in severe cases. IF-2019-7950923 8-APN-ANP#INP£5 Page 25 of 27 EXAMPLE 3: An emulsion lotion was formulated with the following composition: Component Quantity Shea Butter 5.00 g Glycerin 15.00 g Xylitol 3.00 g Niacinamide 2.00 g Glyceryl Stearate and PEG 100 Stearate 3.00 g Cetyl Alcohol 1.00 g Cyclohexasiloxane and Cyclopentasiloxane 1.00 g Polyacrylamide con 013-14 Isoparaffin and Laureth 7 0.30 g Dimethicone PEG7 Cocoate 0.10 g Caprylyl glycol 0.20 g Olive Oil 0.50 g Sodium Benzoate 0.20 g Disodium EDTA 0.10 g Tocopheryl Acetate 0.20 g Butylhydroxytoluene 0.01 g Hyaluronic Acid (sodium salt) 0.01 g Citric Acid csp pH 5-6 Water csp 100 g EXAMPLE IF-2019-795 0923 8-ΑΡΝ-ΑΝΡ#ΙΝΒ)θ Page 26 of The composition of a cleaning foam is given with the composition Component Quantity Disodium Cocoamphodiacetate 20.00 g Glycerin 15.00 g Xylitol 10.00 g Hyaluronic Acid (Sodium Salt) 0.50 g Niacinamide 0.50 g Polyquaternium 16 0.30 g Sodium Benzoate 0.50 g Disodium EDTA 0.10 g Caprylyl Glycol 0.20 g Citric Acid q.s. pH 5.0 - 6.0 Water q.s. 100 ml IF-2019-79509238 -APN-ANP#INP^7 Page 27 of 27 Argentine Republic - National Executive Branch 2019 - Year of Exports Additional Signature Sheet Graphic Report Number: IF-2019-795 0923 8-APN-ANP#INPI CITY OF BUENOS AIRES Monday, September 2, 2019 Reference: 20190100755 The document was imported by the GEDO system with a total of 27 page(s). Digitally signed by GESTION DOCUMENTAL ELECTRONICA - GDE DN: cn=ELECTRONIC DOCUMENTARY MANAGEMENT - GDE, c=AR, o=GOVERNMENT SECRETARY OF MODERNIZATION, ou=ADMINISTRATIVE MODERNIZATION SECRETARY, serialNumber=CUIT 30715117564 Date: 2019.09.02 20:20:45 -03'00' Marcelo Esteban Rubino Administrative Assistant National Patent Administration National Institute of Industrial Property Digitally signed by GESTION DOCUMENTAL ELECTRONICA GDE DN: cn=GEST10N ELECTRONIC DOCUMENTARY - GDE, c=AR, o=GOVERNMENT SECRETARY OF MODERNIZATION, ou=ADMINISTRATIVE MODERNIZATION SECRETARY, serialNumber=CUIT 30715117564 Date: 2019.09.02 20:20:45 -03'00'

Claims

1. A farnesol-free, cosmetic dermatological composition, excluding its therapeutic use, for the treatment and / or prevention of atopic eczema, said composition being characterized in that it comprises: - xylitol in a concentration of 3-10% by weight of the composition; - niacinamide in a concentration of 0.5-6% by weight of the composition; - glycerin in a concentration of 2-15% by weight of the composition; and - sodium hyaluronate in a concentration of 0.01-0.5% by weight of the composition. Four claims follow.