WO2025179357A1 - Complexe cosmétique modulateur du microbiote, composition cosmétique, utilisation du complexe cosmétique modulateur du microbiote et méthode de traitement cosmétique - Google Patents

Complexe cosmétique modulateur du microbiote, composition cosmétique, utilisation du complexe cosmétique modulateur du microbiote et méthode de traitement cosmétique

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Publication number
WO2025179357A1
WO2025179357A1 PCT/BR2024/050072 BR2024050072W WO2025179357A1 WO 2025179357 A1 WO2025179357 A1 WO 2025179357A1 BR 2024050072 W BR2024050072 W BR 2024050072W WO 2025179357 A1 WO2025179357 A1 WO 2025179357A1
Authority
WO
WIPO (PCT)
Prior art keywords
cosmetic
microbiota
scalp
modulating
skin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/BR2024/050072
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English (en)
Portuguese (pt)
Inventor
Carla Maria SANCHES SCANAVEZ DE PAULA
Joice PANZARIN SAVIETTO
Brenda SANTOS DIAS FRACHONI
Amaro Emiliano TRINDADE SILVA
Luciana De Miranda Chaves Vasquez Pinto
Leonardo RODRIGUES DE PAULA
Guilherme BRUSSOLO BIDOIA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Natura Cosmeticos SA
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Natura Cosmeticos SA
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Publication date
Application filed by Natura Cosmeticos SA filed Critical Natura Cosmeticos SA
Priority to PCT/BR2024/050072 priority Critical patent/WO2025179357A1/fr
Publication of WO2025179357A1 publication Critical patent/WO2025179357A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin

Definitions

  • the present invention relates to a cosmetic microbiota modulating complex comprising the combination of the active ingredients: (a) recombinant silk protein, (b) xylitol phosphate ester and (c) caffeine, as well as cosmetic compositions containing the cosmetic microbiota modulating complex, its uses and method, aiming to promote the balance of the skin microbiota, and the health of the hair and scalp.
  • Microbiota is the set of microorganisms present in a given ecosystem, such as the skin, hair or scalp.
  • the skin microbiota is composed primarily of bacteria, but also includes viruses, fungi, and protozoa.
  • the microorganisms present in the skin microbiota are determined by environmental conditions such as anatomical location, humidity, sebum and sweat production, oxygen concentration, pH, among others, as well as biological factors such as hormonal fluctuations and the individual's age.
  • the hair or scalp microbiota is a community of microorganisms that develop on the scalp and may be present on the hair shaft due to its proximity to the scalp. It is composed of bacteria and fungi, which feed on sebum and keratinocytes (dead skin cells).
  • the microbiota is responsible for several physiological functions, such as the production of nutrients or defense peptides, modulation of the immune response and, in the case of the hair microbiota, it also has the function of protecting and maintaining healthy hair.
  • Biofilm forms a microenvironment with a different pH, oxygen concentration, nutrients, and metabolites than that of the skin. It also facilitates bacterial communication through quorum sensing and protects the microbiota from endogenous and exogenous antimicrobial agents and the individual's immune system.
  • hair loss is a cosmetic issue with a multifactorial etiology. Hair loss can occur due to breakage, telogen effluvium or temporary hair loss, diffuse alopecia, and even androgenic alopecia.
  • Hair loss due to breakage is non-pathological and occurs due to external damage to the hair. It usually results from continuous and/or acute physical and/or chemical aggressions that cause substantial mass loss in areas of the cortex and cuticle. The damage generated creates areas of greater fragility to breakage and, therefore, less physical stress. Hair breakage is observed anywhere along the length of the hair fiber. This condition can be easily recognized by phenomenological observation, in which hair loss resulting from breakage is observed when hands or tools that facilitate detangling and combing pass through it.
  • Diffuse alopecia also known as diffuse baldness, refers to unnatural and cyclical hair loss that affects both the hair and the scalp.
  • androgenic alopecia also called permanent baldness, also refers to unnatural but non-cyclical hair loss that affects both the hair and the scalp.
  • the superficial layers of the skin are constantly shedding, removing part of the microbiota.
  • the ability to adhere to viable skin cells ensures the persistence of microorganisms.
  • Bacteria bind to membrane receptors on cells, such as those of the toll-Hke family that recognize patterns associated with bacteria (TLR 1-10), mannose receptors, or NOD-//e receptors. These receptors trigger immune pathways that discriminate between pathogenic and beneficial bacteria, stimulating appropriate responses.
  • the composition of the microbiota teaches the immune system to more accurately discriminate between beneficial bacteria. modulating inflammatory responses and reducing the skin's sensitivity to external factors such as variations in temperature, humidity and exposure to UV radiation.
  • AMPs antimicrobial peptides
  • hBDs ⁇ and ⁇ -defensins
  • cathelicidins C-type lectins
  • dermicidins and others.
  • Most AMPs are composed of small peptides of approximately 2–15 kDa.
  • An imbalance (excess or lack) of AMPs in the skin is associated with pathologies such as atopic dermatitis, rosacea, and psoriasis.
  • AMPs are important for protecting the skin against pathogens, controlling the microbiota population, and limiting contact between keratinocytes and the microbiota. AMPs are generally broad-spectrum in their activity, affecting both Gram-positive and Gram-negative bacteria, and in some cases, fungi, protozoa, and viruses.
  • the microbiota also produces other substances, such as hyaluronic acid, produced by Streptococcus and some Lactobacillus, which is a constituent of the extracellular matrix that fills the dermis, giving shape to the skin and stimulating the production of [3-defensin 2 (hBD2).
  • hBD2 [3-defensin 2
  • Sphingomyelinase is produced by keratinocytes, Streptococcus and Lactobacillus, and is an enzyme that participates in the synthesis of ceramides that are essential for maintaining the skin barrier.
  • Lipoteichoic acid is the structural component of Gram-positive bacteria such as Staphylococcus, Lactobacillus, and Bifidobacteria, which stimulates the production of antimicrobial peptides such as ⁇ -defensins (hBD) and cathelicidins.
  • Peptidoglycans are structural components of the cell wall of Gram-positive bacteria, which modulate the individual's immune response, stimulating the production of IL-8 by keratinocytes and recruiting phagocytes to infected sites.
  • Lactic acid an alpha hydroxy acid, produced by Lactobacillus and Bifidobacteria, stimulates the skin's peeling process, weakening cell adhesions, stimulating the production of ceramides by keratinocytes, strengthening the skin barrier and composing the NMF, which retains skin moisture.
  • Acetic acid produced by Lactobacillus and Bifidobacteria, has antibacterial activity against S. aureus and P. aeruginosa.
  • the main representatives of the skin microbiota include Staphylococcus epidermidis, a major component of the skin, which is halotolerant and capable of growing in environments with low water activity. It is generally harmless to the skin but can cause nosocomial infections through colonization of foreign bodies such as catheters and implants in predisposed and immunocompromised individuals. These bacteria are extremely resistant to AMPs, do not attack keratinocytes, and produce AMPs (epidermin, Pep5, epilancin K7, and epicidin 280) that control the populations of S. aureus and Streptococcus.
  • Staphylococcus epidermidis a major component of the skin, which is halotolerant and capable of growing in environments with low water activity. It is generally harmless to the skin but can cause nosocomial infections through colonization of foreign bodies such as catheters and implants in predisposed and immunocompromised individuals. These bacteria are extremely resistant to AMPs, do not attack keratinocytes, and produce AMPs (epid
  • S. epidermidis synthesize proteases, keratinases, lipases, and nucleases that participate in the physiological turnover of the skin. They synthesize soluble phenolic modulins (PSMs), proteins with surfactant and antibacterial properties selective for S. aureus and Streptococcus, by dissolving the biofilm formed by these pathogenic bacteria.
  • PSMs soluble phenolic modulins
  • Staphylococcus aureus is found on healthy skin. It is the main pathogen of human skin, responsible for folliculitis, boils, subcutaneous abscesses, meningitis, endocarditis, and septicemia. Conditions such as atopic dermatitis, viruses (Herpes simplex type I or Papillomavirus), and opportunistic fungi (Trichophyton rubrum) predispose the skin to S. aureus infections.
  • Corynebacteria jeikeium and Corynebacteria striatum are found on healthy skin, being the most common microorganisms after S. epidermidis. They are found in the axillary, inguinal, and perineal regions due to their high tolerance to salt concentrations. They adhere to keratinocytes at an estimated rate of 25 bacteria per cell through fibronectin receptors. They produce bacteriocins such as lacticidin Q, which is responsible for the synthesis of dermicidin and cathelicidin present in sweat, providing skin defense.
  • C. acnes present in healthy microbiota in areas such as the face and back, is a saprophytic, anaerobic microorganism found primarily in sebaceous glands and associated with manifestations such as folliculitis and acne vulgaris. Its main energy source is the lipids and fatty acids present in sebum. The presence of porphyrin makes C. acnes highly sensitive to UV radiation and stimulates the production of IL-8 and IL-12 by keratinocytes, creating a pro-inflammatory microenvironment. [33] Studies indicate that C. acnes is involved in the process of hypercorneification of the pilosebaceous duct, exacerbating inflammatory processes.
  • acetic acid and propionic acid synthesizes acetic acid and propionic acid, as well as lipases and proteases. It also synthesizes several bacteriocins such as propionicin PLG-1, jensenin G, propionicin SM1, SM2, T1, and acnein, with activity against several lactic acid bacteria, Gram-negative bacteria, fungi, and molds.
  • bacteriocins such as propionicin PLG-1, jensenin G, propionicin SM1, SM2, T1, and acnein
  • Malassezia furfur is a fastidious fungus present in healthy microbiota in areas such as the scalp and back, primarily responsible for opportunistic infections such as seborrheic dermatitis, dandruff, and tinea versicolor (or pityriasis). Its main source of carbon is free fatty acids. Furthermore, it synthesizes an enzyme capable of degrading the cell walls of microorganisms, contributing to skin protection against pathogens.
  • microbiota modulates the skin's inflammatory response, reducing sensitivity to factors such as temperature variations, humidity and exposure to UV radiation.
  • the microbiota produces lactic acid, which helps maintain a more acidic skin pH, antimicrobial peptides (AMPs) that protect the skin from pathogens and whose imbalance is related to pathologies such as dermatitis, rosacea and psoriasis, help regulate the production of vitamin D and are involved in the production of extracellular matrix proteins such as hyaluronic acid and enzymes important for maintaining the skin barrier such as sphingomyelinase.
  • AMPs antimicrobial peptides
  • Staphyloccocus epidermidis is the majority microorganism in the skin microbiota and remains so even during aging. S. epidermidis is harmless to keratinocytes and produces AMPs (epidermin, Pep5, epilancin K7, soluble phenolic modulins -PSMs- and epicidin 280) that control the populations of S. aureus and Streptococcus, protecting the skin.
  • AMPs epidermin, Pep5, epilancin K7, soluble phenolic modulins -PSMs- and epicidin 280
  • S. epidermidis synthesizes proteases, keratinases, lipases and nucleases that contribute to the physiological turnover of the skin and play a role in maintaining skin health, protecting it from harmful opportunistic microorganisms and promoting physiological mechanisms of skin renewal.
  • the bacterial population is predominantly composed of bacteria from the phyla Actinobacteria, Firmicutes, and Proteobacteria, with organisms of the genus Cutibacterium spp. (mainly Cutibacterium acnes) and the genus Staphylococcus spp.
  • Prebiotics are ingredients that promote beneficial bacteria.
  • Probiotics are microorganisms that interact with the skin's natural microbiota and stimulate it to produce its own defenses. Probiotics can also act as selective antibacterials, producing substances that control the proliferation of harmful bacteria.
  • prebiotic agents can selectively favor beneficial bacteria and, consequently, are candidates for use in cosmetic compositions for this purpose.
  • screening and suggesting possible prebiotic ingredients the prior art is limited in providing effective prebiotic ingredients with proven in vitro efficacy and an elucidated mechanism of action, particularly for topical administration, and, for this reason, still requires research.
  • Figure 1 illustrates the results of combating hair loss and improving hair density and thickness after using the anti-hair loss lotion of the present invention.
  • Figures 2A and 2B show the results obtained in relation to the diversity and abundance of fungi on the scalp after using the anti-hair loss lotion of the invention.
  • Figures 3A and 3B show the results obtained in relation to the bacterial profile, diversity and abundance of bacteria on the scalp after using the anti-hair loss lotion of the invention.
  • Figures 3C, 3D, and 3E show the ratios between bacterial genera on the scalp after treatment with an anti-hair loss lotion from invention.
  • Figures 4A, 4B and 5 show the impact on the lipid composition of the scalp after using the anti-hair loss lotion of the invention.
  • Figure 4A demonstrates that the lipid profile changes with treatment.
  • Figure 4B demonstrates the variation in lipid concentration.
  • Figure 5 illustrates the correlation between microorganisms, lipids and clinical data (Spearman correlation with FDR adjustment).
  • the present invention relates to a cosmetic microbiota modulating complex comprising the combination of the active ingredients: (a) recombinant silk protein, (b) xylitol phosphate ester and (c) caffeine.
  • microbiota-modulating cosmetic complex of the invention surprisingly promotes the balance of the microbiota of the skin, hair and scalp, as well as the health of the hair and scalp.
  • the present invention reveals a new approach associating the microbiota and scalp lipid profiles in hair loss.
  • a healthy scalp has certain characteristics such as no hair loss, a natural hair growth cycle (on average 1 cm every 28 days), few inflammatory cells, microcirculation of the scalp feeding the follicle and a balance of the microbiota and fungal species.
  • a diseased scalp presents temporary hair loss, thinning of the hair and increased hair loss, inflammation, impaired microcirculation, imbalance of the microbiota and fungal species and increased production of FFAs (free fatty acids) and oiliness.
  • the cosmetic complex comprising the combination of active ingredients: (a) recombinant silk protein, (b) xylitol phosphate ester and (c) caffeine, has the activity of modulating the microbiota, promoting the balance of the skin, hair and scalp, nourishing the beneficial microorganisms residing in the microbiota, strengthening the hair, reducing sensitivity and irritation with proven efficacy in vitro.
  • microbiota modulating cosmetic complex of the present invention acts as follows:
  • recombinant silk protein is used in a concentration of 0.01-1%, particularly around 0.33%, relative to the total weight of the composition.
  • the recombinant silk protein may be the recombinant ADF-4 protein which is known by the name Silkgel®.
  • xylitol phosphate ester is used in a concentration of 1-5%, particularly around 3%, relative to the total weight of the composition.
  • the xylitol phosphate ester used may be the ingredient Hygeaphos® obtained from the supplier Chemyunion.
  • caffeine is used in a concentration of 0.01-1%, particularly around 0.65%, in relation to the total weight of the composition.
  • caffeine can be obtained from the supplier Brenntag.
  • compositions according to the present invention may be in the form of emulsions, solutions, gels, powders, pastes, among others, also comprising cosmetically appropriate vehicles for the chosen cosmetic form.
  • compositions according to the present invention are intended for topical application.
  • the microbiota modulating effect provided by the cosmetic complex according to the present invention is not only efficient in reducing harmful bacteria and fungi on the skin, hair and scalp, favoring the beneficial bacteria in these regions, balancing their microbiota, but also provides balance and nutrition, providing advantageous cosmetic effects, combating hair breakage and loss and stimulating growth, increasing the density and thickness of the strands, without harming the microbiota of the skin and scalp.
  • microbiota-modulating topical cosmetic compositions according to the present invention may be made available in any cosmetic forms known to the person skilled in the art, suitable for application to the face, body, hair or scalp, for treatment or cleaning, including, without limitation, soaps, shampoos, elixirs, conditioners, sticks, tonics and lotions, among other forms.
  • Cosmetically acceptable excipients may be selected from compounds known in the art. Without limitation, the excipients may be selected from the group comprising emollients, antioxidants, humectants, emulsifiers, surfactants, sensory or viscosity modifiers, preservatives, chelators, stabilizers, lubricants, thickeners, dispersants, solubilizers, and their combinations, among other cosmetically acceptable vehicles.
  • the present invention also contemplates the use of a cosmetic microbiota modulating complex according to the present invention to reduce the diversity and abundance of fungi present on the scalp.
  • the present invention contemplates the use of a cosmetic microbiota modulating complex according to the present invention, for maintaining the diversity and modulating the abundance of bacteria present on the scalp.
  • An additional aspect of the present invention is a cosmetic treatment method that consists of applying to the skin, hair and/or scalp the microbiota modulating cosmetic complex or cosmetic composition defined in the present invention.
  • Hair growth kinetics and density were assessed by obtaining scalp microimages using a microcamera (i-Scope USB, Moritex, JP) with a 30x objective and polarized light at baseline and after 30, 60, 90, and 150 days of treatment.
  • Laser Doppler ultrasound was used to assess improvements in blood microcirculation at baseline and after 30, 60, 90, and 150 days of home use of the experimental product.
  • the method used to evaluate the scalp microbiota was metagenomics, which consists of analyzing fragments of the genome of microorganisms, where a preserved region is evaluated, in bacteria called 16S rRNA and in fungi ITS as a universal marker. It is used in phylogenetic reconstruction to define its taxa and thus allow the identification of each population in a given community with the aid of the lon chefs System and Ion S5 following the NGS (Next-Generation Sequencing) protocols.
  • the samples came from a swab rubbed on the scalp of individuals who used the product and analyzed the initial condition and after 30, 60, 90 and 150 days of treatment.
  • composition of the present invention provides a double-action treatment, combating breakage and stimulating hair growth, as shown in the results illustrated in Figure 1 and summarized in the Table below:
  • EXAMPLE 2 Assessment of the diversity and abundance of fungi on the scalp.
  • the relative abundance of fungi is characterized by the predominance of the phylum Basidiomycota, which contains the genus Malassezia, and a minority by the phylum Ascomycota. This abundance profile is maintained with treatment, with small variations in the composition of minority fungi.
  • the fungal diversity profile, calculated by the Shannon index, at 150 days of treatment remains close to the initial one, with significant changes occurring only between 30 and 90 days of treatment, observed by ANOVA + Tukey with Bonferroni adjustment (See Figures 2A and 2B).
  • Malassezia remains the main genus present at all times.
  • the bacterial profile in other words, the relative abundance of bacteria on the scalp, changes with treatment, with the phylum Actinobacteria increasing its predominance, with the genera Cutibacterium and Lawsonella being the main representatives observed in the samples.
  • the relative abundance of the phylum Proteobacteria decreases, and bacteria from the Burkholderia-Caballeronia-Paraburkholderia group are the main representatives of this phylum in the samples (See Figure 3A).
  • Treatment with the anti-hair loss lotion of the invention globally increases the lipids present in the scalp (see Figures 4A and 4B), demonstrating that the lipid profile changes with treatment.
  • the lipid profile correlates with the major genera of bacteria found and varies with the use of the anti-hair loss lotion (Figure 5). The hypothesis is that treatment with the anti-hair loss lotion modulates the lipid profile and disrupts the metabolism of enzymes necessary to maintain the population of Burkholderia spp.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
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Abstract

La présente invention concerne un complexe cosmétique modulateur du microbiote, comprenant la combinaison des principes actifs suivants : (A) protéine de soie recombinante, (b) ester de xylitol phosphate et(c) caféine. L'invention concerne également des compositions cosmétiques comprenant ledit complexe cosmétique modulateur du microbiote, leurs utilisations et une méthode cosmétique, dont l'objectif est de promouvoir l'équilibre du microbiote de la peau ainsi que la santé des cheveux et du cuir chevelu.
PCT/BR2024/050072 2024-02-29 2024-02-29 Complexe cosmétique modulateur du microbiote, composition cosmétique, utilisation du complexe cosmétique modulateur du microbiote et méthode de traitement cosmétique Pending WO2025179357A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/BR2024/050072 WO2025179357A1 (fr) 2024-02-29 2024-02-29 Complexe cosmétique modulateur du microbiote, composition cosmétique, utilisation du complexe cosmétique modulateur du microbiote et méthode de traitement cosmétique

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/BR2024/050072 WO2025179357A1 (fr) 2024-02-29 2024-02-29 Complexe cosmétique modulateur du microbiote, composition cosmétique, utilisation du complexe cosmétique modulateur du microbiote et méthode de traitement cosmétique

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WO2025179357A1 true WO2025179357A1 (fr) 2025-09-04

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PCT/BR2024/050072 Pending WO2025179357A1 (fr) 2024-02-29 2024-02-29 Complexe cosmétique modulateur du microbiote, composition cosmétique, utilisation du complexe cosmétique modulateur du microbiote et méthode de traitement cosmétique

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112016006898A2 (pt) * 2013-09-30 2017-08-01 Silk Therapeutics Inc composições de fragmentos de proteína de seda e seus artigos manufaturados

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112016006898A2 (pt) * 2013-09-30 2017-08-01 Silk Therapeutics Inc composições de fragmentos de proteína de seda e seus artigos manufaturados

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
MASAKO, K. YUSUKE, K. HIDEYUKI, I. ATSUKO, M. YOSHIKI, M. KAYOKO, M. MAKOTO, K.: "A novel method to control the balance of skin microflora", JOURNAL OF DERMATOLOGICAL SCIENCE, ELSEVIER, AMSTERDAM, NL, vol. 38, no. 3, 1 June 2005 (2005-06-01), AMSTERDAM, NL , pages 207 - 213, XP004914105, ISSN: 0923-1811, DOI: 10.1016/j.jdermsci.2005.01.003 *

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