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WO2016005793A1 - Cosmetic method. - Google Patents

Cosmetic method. Download PDF

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Publication number
WO2016005793A1
WO2016005793A1 PCT/IB2014/062973 IB2014062973W WO2016005793A1 WO 2016005793 A1 WO2016005793 A1 WO 2016005793A1 IB 2014062973 W IB2014062973 W IB 2014062973W WO 2016005793 A1 WO2016005793 A1 WO 2016005793A1
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WIPO (PCT)
Prior art keywords
individual
vitamin
acid
defect
skin
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PCT/IB2014/062973
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French (fr)
Inventor
Maurizio Esposito
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Suisse Life Science S.A.
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Publication date
Application filed by Suisse Life Science S.A. filed Critical Suisse Life Science S.A.
Priority to PCT/IB2014/062973 priority Critical patent/WO2016005793A1/en
Priority to EP14761409.3A priority patent/EP3167074A1/en
Publication of WO2016005793A1 publication Critical patent/WO2016005793A1/en

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/106—Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/148—Screening for cosmetic compounds
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/156—Polymorphic or mutational markers

Definitions

  • the present invention relates to a cosmetic method for prevention and/or cosmetic improvement of aesthetic defects.
  • hard-to-treat defects are known, such as excess localized fat, tendency to overweight, achievement/maintenance of the ideal weight, cellulite defects, skin aging, skin sagging, hair aging and alopecia.
  • One object of the present invention is to provide a method for cosmetic prevention or treatment of defects affecting beauty, even when they are hardly removable, that provides long-lasting natural looking results.
  • One purpose of the present invention is to provide a method for prevention or cosmetic improvement of defects, that is easy to use and reliable.
  • Another object of the present invention is to provide a method for prevention or cosmetic improvement of defects that can be easily used by an individual who needs it.
  • a method of achieving cosmetic improvement and/or prevention of a defect in an individual which comprises the steps of:
  • SNP single-nucleotide polymorphism
  • step b) assigning a score to the result of each determination of step a);
  • step c) obtaining history information from the individual, concerning his/her current and past lifestyle, food habits and health, by submitting a set of standardized questions; d) assigning a score to the result of each determination of step c);
  • step e) assigning a total score to the individual, as determined from from the results of steps b) and d), using a genetic/lifestyle assessment algorithm, which relates the results of the genetic test to the effects of the lifestyle of the individual, and weights them; f) administering one or more substances for cosmetic improvement and/or prevention of the defect to the individual, with the type and amount of substance being determined according to the result of step e).
  • defects is intended to designate alterations of the normal state of the skin or anyway the exterior appearance of an individual, irrespective of his/her physiological condition and of any disease associated with such alterations.
  • Non-limiting examples of such defects are localized fat, tendency to overweight, androgenetic alopecia, cellulite, skin aging, skin sagging.
  • Active substance names as used herein are INCI (International Nomenclature of Cosmetic Ingredients) names, e.g. according to the Cosmetic Directive 76/768/EEC, the European Commission Decision 96/335/EC, the Regulation (EC) No. 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products and later updates.
  • INCI International Nomenclature of Cosmetic Ingredients
  • the present invention relates to a method of achieving cosmetic improvement and/or prevention of a defect in an individual, comprising the steps of: a) performing a genetic test on a biological sample taken from the individual to find any possible single-nucleotide polymorphism (S P);
  • step b) assigning a score to the result of each determination of step a);
  • step c) obtaining history information from the individual, concerning his/her current and past lifestyle, food habits and health, by submitting a set of standardized questions; d) assigning a score to the result of each determination of step c);
  • step e) assigning a total score to the individual, as determined from from the results of steps b) and d), using a genetic/lifestyle assessment algorithm, which relates the results of the genetic test to the effects of the lifestyle of the individual, and weights them; f) administering one or more substances for cosmetic improvement and/or prevention of the defect to the individual, with the type and amount of substance being determined according to the result of step e).
  • the present invention provides a highly customized predictive method, comprising predictive genetic analysis for cosmetic applications, which may be combined with nutritional/cosmetic treatments for an individualized treatment plan.
  • the purpose of the method is to allow predictive identification of defects, such as by a novel application of applied genetics or genomics, in combination with nutritional/cosmetic treatments, with a treatment and prevention plan tailored for each individual.
  • S P Single Nucleotide Polymorphism
  • Targeted reading of particular SNPs and their correlation, by the use of targeted substances allows determination of well-defined paths of customized medicine, possibly with a biomedical approach.
  • the method of the present invention includes:
  • This first step leads to the preparation of a report which provides the keys to address the defects, as determined by the interpretation of the genetic results according to the method of the invention.
  • Sequencing of the DNA sample allows quick identification of risk areas, which may affect visible and non-visible effects in the biological processes determined by the individual genetics.
  • Active substances are selected among naturally occurring substances, or substances that have already been tested in the medical/cosmetic field and have been proven to be safe for the patient, when used as known by the skilled person.
  • Each DNA analysis is provided with a total score, given with reference to the average score of the European/Caucasian population; the area that dominates the biological processes to be targeted to counteract the defects and the main areas are shown with customized scores, related to the population.
  • the genetic result is valid throughout the lifespan of the individual.
  • a set of rules and criteria is defined for quantification of the "level of well-being" of the individual with respect to the aesthetic defect under examination and the biological processes that cause or affect it.
  • the criteria are based on evidence and international literature, as well as non nutritional and lifestyle considerations.
  • the algorithm is also applied to the available genetic results and historical information about the individual.
  • the "level of well-being" of a person is determined by combining a number of genetic and non-genetic indicators (scores), which represent:
  • each possible genetic result is assigned one of 3 possible scores (step b)):
  • each SNP is assigned a weight number expressing:
  • a score is also determined from the history-taking questions (steps c) and d)).
  • the final score for each area is obtained as an average of the genetic score and the history score.
  • the genetic component is assigned a higher score (60/70%).
  • the scores of each area are averaged, according to their weights.
  • +1 designates a favorable overall predisposition (total score).
  • the total score of the panel is reprocessed on a scale from 0 to 100. This result may be considered as a percent "level of well-being" with respect to the defect under examination and the particular individual.
  • the new score is determined as follows:
  • the 0-100 score is the reference index of the method of the invention, which indicates the treatment level suggested by a proprietary algorithm, based on genetic guidance and correction of the interference of individual habits and on history self-assessment. According to the relevance of the area of the panel, the method of the invention indicates the area index as a reference for treatment or as a total index of the genetic panel.
  • the scale of the index ranges from 100 to 0.
  • the algorithm of the inventive method includes a selection of suggested products among potentially available cosmetic products and dietary supplements.
  • Selection is based on SNP scores, accoding to the following logic:
  • Table 1 shows an exemplary, non-limiting possibility of selection of suggested products.
  • the present invention affords customization of the therapy approach to each patient, based on his/her genetic predisposition to the particular defect to be addressed, using the biomedical approach of combination therapy.
  • the present invention provides an advanced form of customized medicine, which also provides pro-active prevention to also counteract, with time, non-genetic, environmental or lifestyle risk factors, using dietary supplements and phytocomplexes.
  • the method of the invention also comprises diet and lifestyle correction.
  • the assessment of step c) may be carried out before, at the same time as or after steps a) and b).
  • the defect is at least one of localized fat, tendency to overweight, androgenetic alopecia, cellulite, skin aging and skin sagging.
  • the method of the invention was surprisingly found to afford cosmetic improvement and/or prevention of an aesthetic defect in an individual through an unique relationship of the presence of a SNP or a combination of SNPs to the administration of one or more biologically active substances.
  • Such administration may be an oral or topical administration, using methods and appropriate formulations as known by the skilled person, such as suspensions, tablets, capsules, creams, ointments, lotions, spray, etc.
  • the administration is an oral administration.
  • the substance administered in step f) is at least one substance selected from Bromelin 2500 GDU; Opuntia ficus indica extract (Nopal®); Triterpenes (Centella asiatica extract); Vitexin; Ruscogenin; Polyphenols; Tannins; Catechins EGCG - ECG; Chrome; L-Isoleucine; L-Taurine; L-Carnitine; L- Lysine; L-Valine; L-Arginine; L-Selenium methionine; Hydroxycitric acid; Synephrine; Vitamin B6; Ellagic acid; Biotin (vitamin H); Alpha lipoic acid; Superoxide dismutase 560 UI; Niacin (vitamin B3); Vitamin C; Vitamin D; Fatty acids (Serenoa repens); Iron; Copper; Chrome; Zinc; Potassium; Lignans; Silica; Melatonin; Fucoxanthine; L-Carnitine
  • the parameters under examination are those related to oxygenation, vasodilation, alteration of mucrocirculation, vascularization, homonal factors and presence of skin inflammations or alterations, which impart the typical orange peel look thereto.
  • the dominant area is oxygenation / vasodilation / alteration of the microcirculation / vascularization.
  • the genes under examination are:
  • HIFla it is a transcription factor whose alpha subunit is directly regulated by oxygen tension
  • HIFla assists the cell to reestablish oxygen homeostasis, associated with the homeostasis alteration, adipose tissue hypoxia slows down metabolic waste removal.
  • the resulting liquid stagnation and chronical inflammation leads to sclerosis, i.e. hardening, of fat.
  • water retention is intended to designate an accumulation of liquids in interstitial spaces (between cells), which causes abnormal swelling (edema), in certain areas of the body such as belly, thighs, buttocks and ankles. 30% of Italian women are affected by water retention, which may be caused by a salt-rich diet or by improper functioning of the venous and lymphatic systems or by hormone disequilibrium. It is associated with questions about:
  • Circulatory problems worsening of the circulatory state, with venous and lymphatic return insufficiency;
  • Smoking cigarettes finally leads to rigidity of arterial walls, with reduced oxygen delivery to the periphery and consequent tissue hypoxia and reduced lipolysis (fat breakdown); it also promotes the production of free radicals that can cause damage to small vessel walls.
  • Estrogen receptor associated with the cascade of events that lead to ovulation.
  • Estrogens may be the main hormones that initiate and worsen cellulite.
  • the hormone supply of women is richer in estrogens, which promote accumulation of excess weight on the lower part of the body, with water retention and circulatory stasis. It is associated with hormone disequilibrium. Increased levels of estrogens cause accumulation of excess weight on the lower part of the body, with water retention and circulatory stasis.
  • Cellulite mainly affects women, due to a hormonal factor (greater production of estrogens, which facilitate deposition of fat).
  • - ILIA It is a pro-inflammatory cytokine that has a major role in local and systemic inflammation.
  • the targets of these cytokines are not only the cells of the immune system, as these cytokines can adhere to endothelial cells and fibroblasts, thereby affecting replication of epithelial cells, endothelial cells and fibroblasts.
  • the latter stimulate collagen synthesis, which is important for the tightness of venous vessel walls, as it increases the resistance of blood vessel walls and reduces their permeability. This improves microcirculation and increases oxygen delivery to tissues. It is associated with an alteration of the local and systemic inflammatory response.
  • a hyperactivation of the immune system causes increased production of free radicals, which have a cell membrane disrupting function, and cause accumulation of liquids in the tissue.
  • Fat-rich diet it increases inflammatory processes
  • Smoke it increases inflammatory processes. Smoking cigarettes finally leads to rigidity of arterial walls, with reduced oxygen delivery to the periphery and consequent tissue hypoxia and reduced lipolysis (fat breakdown); it also promotes the production of free radicals that can cause damage to small vessel walls.
  • a diet with fish at least twice a week affords an adequate intake of Omega-3 which assist in counteracting inflammation.
  • Free radicals are dangerous because they have a destructive action on cells and the fats that form their membranes. It should be note that high levels of free radicals were also found in sedentary persons under psychophysical stress.
  • the aesthetic defect is cellulite and the SNP polymorphism determined in step a) is at least one of ACE, E S1, HIFla, ILIA, MTHFR and NOS3 and combinations thereof and, more preferably, in this case the substance administered in step f) is at least one substance selected from Bromelin 2500 GDU; Fucoxanthine, Opimtia ficus indica extract (Nopal®); Polyphenols, Ruscogenin, Tannins, Triterpenes (Centella asiatica extract), Vitexin and mixtures thereof.
  • the parameters under examination are those related to fat mass levels, body composition, sugar metabolism, fat distribution and lipid metabolism.
  • the dominant area (Area 1) relates to fat mass levels and body composition.
  • the genes under examination comprise:
  • - MC4R Optimal regulation of appetite and sense of fullness; normal fat mass levels; lower predisposition to type 2 diabetes and obesity. Decreased sense of fullmess and increased appetite stimulation. Increase of weight, namely of fat mass. Predisposition to obesity and hence to type 2 diabetes.
  • AREA 2 Sugar metabolism, fat distribution, include the assessment of the following genes:
  • ADRB2 It is a receptor involved in fat mobilization and maintenance of glucose levels in blood, and regulates removal of excess fat
  • - PPARG Transcription factor affecting glucose and insulin levels in blood, which is involved in adipocyte differentiation, and is associated with insulin sensitivity, metabolism and sugars. Influence of disequilibrium on insulin levels; predisposition to type 2 diabetes. Increased risk of obesity, metabolic syndrome and cardiovascular risk, the inventive method it is associated with questions about:
  • AREA 3 concerning lipid metabolism.
  • the associated genes comprise:
  • Lipoprotein lipase it hydrolyzes the triglycerides contained in the lipoproteins and has the purpose of collecting and carrying lipids, associated with an increased risk of cardiovascular diseases due to high levels of triglycerides and lower levels of HDL (good cholesterol)
  • PCSK9 it is the protein involved in the metabolism of LDL cholesterol (bad cholesterol), which is implied in familial hypercholesterolemia and induced lipid accumulation with localized adiposity. It is connected to an increased risk of coronary diseases.
  • the aesthetic defect is localized fat and the SNP polymorphism determined in step a) is at least one of ADRB2, FTO, ILIA, LPL, MC4R, MTHFR, PCSK9 and PPARG or combinations thereof and, more preferably, in this case, the substance administered to the individual in step f) is at least one of bromelain, caffeine, carnitine, Escine, isomerized linoelic acid (CLA), triethanolamine hydroiodide (TEA hydroiodide), peel of Citrus aurantium, sodium hyaluronate, theobromine, thioctic acid, tocopherol acetate and mixtures thereof.
  • the parameters under examination relate to genetic predisposition, presence of antioxidants and, based on genetic analysis only, a percent risk of developing alopecia at 30, 50 and 70 is further determined.
  • the dominant area is genetic predisposition.
  • the genes assessed in the inventive method are:
  • Androgen receptor that binds various steroid hormones and affects the development of secondary sexual characters
  • WNT10A Gene coding for signal molecules implied in cell regulation factors The strongest association signal was obtained for rs7349332 which is located in WNT10A. Studies on the expression in the human hair follicle indicate that WNT10A has a functional role in the etiology of AGA (androgenetic alopecia). These studies provide genetic evidence to support involvement of the W T signal in AGA development, which is associated with an increased predisposition to androgenetic alopecia.
  • (glutathione peroxidase) is an enzymatic antioxidant. It regulates the oxidoreductive cell equilibrium. It also counteracts the formation of free radicals also at skin level. Inefficiency of detoxification mechanisms with free radical accumulation. It is associated with alopecia aerata.
  • Alopecia aerata is a disease in which the abrupt fall of hair, or other body hairs, typically occurs in bald spots or areas (stage I- VII).
  • the aesthetic defect is androgenetic alopecia and the SNP polymorphism determined in step a) is at least one of AR, 20pl 1 , EDAR, GPX, MC4R and WNT 1 OA or combinations thereof or, more preferably, in this case, the substance administered to the individual in step f) is at least one of Bromelain, Caffeine, Carnitine, peel of Citrus aurantium, Escine, isomerized linoleic acid (CLA), Sodium hyaluronate, triethanolamine hydroiodide (TEA hydroiodide), Copper tripeptide-1 ; dextrane (e) acetyl tetrapeptide-3 (e) Trifolium pratense extact, Octapeptide-2, Serenoa serrulata extract; sh-Polypeptide-3; Sodium DNA, potassium glutathione, isomerized linoleate and mixtures thereof.
  • the substance administered to the individual in step f)
  • the parameters under examination are related to the texture, elasticity, tissue remodeling, skin type, detoxification and oxidative stress, vascularization and oxigenatin and inflammation.
  • the dominant area is texture/elasticity/tissue remodeling.
  • the following genes are assessed, without limitation:
  • - FLG It is an aggregation protein and the main component of keratohyalin granules in human epidermis. It has the purpose of holding the epidermis cells together and maintaining the horny layer hydrated, and is also a key protein for epidermal differentiation. It may be also associated with incomplete adhesion of keratinocytes with an alteration of the epidermal barrier protection function, which causes increased exposure damaging caused by external agents. It also predisposes the skin to intense dryness-related problems.
  • MMP3 The metalloproteinases are a group of enzymes implied in extracellular matrix degradation and in various tissue remodeling-related processes.
  • MMP3 or stromelisine is a proteoglycan strictly associated with the collagen mainly secreted by cells of the connective tissue and by basal keratinocytes. Its purpose is degrading extracellular matrix components such as laminin, fibronecting and type IV collagen. For this reason it is involved in tissue remodeling processes.
  • MMP3 is induced by inflammatory cytokines, and all stimulations that cause inflammation are caused by early skin aging.
  • - ELN It is the main constituent (70-90%) of elastic fibers and its strictly structural role is to impart elasticity and resistance to tissues.
  • An unfavorable variant thereof is associated with decreased skin extension, elasticity, compactness, softness, which facilitates skin aging. It is connected to decreased skin extension, elasticity, compactness and softness. Aging.
  • AREA 2 Skin type.
  • the genes assessed in the inventive method comprise:
  • - PPARG cell receptor acting on glucose and insulin levels in blood. Increase of adipose tissue. Alterations in the regulation of the lipid film with increased presence of subcutaneous fat, a typical symptom of oily skin and acne. It is associated with questions about:
  • AREA 3 Detoxification and oxidative stress.
  • the genes assessed in the method of the present invention comprise:
  • - SOD it is an antioxidant enzyme that can neutralize the superoxide, which is a dangerous free radical of oxygen. Its role is to protect cells from the oxidative stress induced by free radicals, which are among the most important photoaging factors. It is connected with free radical accumulation and oxidative stress, and consequently with photoaging.
  • - GSTT/GSTM they are part of the class of detoxifying enzymes, that can reduce the toxicity and reactiveness of dangerous compounds, through conjugation with glutathione. They are thought to be related to decreased removal of toxic substances from the body and to increased oxidative stress.
  • a further investigation area in the field of skin aging is vascularization and oxygenation.
  • the genes assessed in the inventive method comprise:
  • - NOS3 it is one of the most important molecules of the cardiovascular system, and is involved in the processes of vasodilation and regulation of blood flow. Also, it is involved in tissue repair processes after injury. A skin having an adequate nitric oxide intake is less compact and reactive and has a lower ability of defense and regeneration upon exogenous stimuli.
  • AREA 5 Inflammation
  • the genes assessed in the inventive method comprise:
  • - T F it is a pro-inflammatory cytokine, of both acute and chronic phases. Unfavorable variants may facilitate the occurrence of phlogistic phenomena and increase cardiovascular diseases. Excessive phologosis promotes cardiovascular diseases. An increased production of this cytokine is connected to a higher risk of phlogistic phenomena and skin aging. Photoaging processes are often associated with a loss of subcutaneou s fat at the face, and with the consequent occurrence of wrinkles and skin folds
  • the aesthetic defect is skin aging and the SNP polymorphism determined in step a) is at least one of ELN, FLG, GSTT/GSTM, MMP3, NOS3, SOD and TNF and more preferably, in this case, the substance administered to the individual in step f) is at least one of Acetyl decapeptide-3, Acetyl tetrapeptide-5, low and medium molecular weight hyaluronic acid, Dextrane palmytol hexapeptide-19, Dioscorrea villosa extract, Dipeptide diaminobutyrol benzylamide diacetate, Hydrolized rice protein, glycine soja protein, superoxide dismutase, Hydrolyzed verbascum thapsus flower, soybean isoflavones, Palmytol tripeptide-5, sh- Oligopeptide-1, Sodium hyaluronate crosspolymer, Superoxide dismutase,
  • the parameters under examination are related to texture and elasticity, resistance and elasticity, presence of antioxidants and hydration.
  • the dominant area is texture/elasticity.
  • the genes assessed in the inventive method in this area comprise: - COL3A1 : Collagen is the main protein of the connective tissue. Type 3 collagen is the most important constituent of extracellular matrix. It is important because it holds the cell elements together and initiates tissue and organ formation processes. It is the main fibrous element of skin, tenons, cartilages and vessels. It is also responsible for the mechanical protection of the body provided by the skin, for the skin state, for maintenance of texture quality and prevention of skin dehydration, for maintenance of elasticity and tone and finally for wrinkle minimization. It is connected to skin tone loss, with decrease of skin elasticity and increase of sagging. Skin appears more dehydrated, dry and with wrinkles and age effects
  • - EMILIN1 it helps to maintain a good quality of elastic fibers and consolidates dermal architecture by ensuring the bond between elastic fibers and collagen fibers. It is connected to alterations of elastic fibers, lower dermal compactness with sagging that may result in unaesthetic surface wrinkles, stretch marks or expression lines. It is associated with questions about:
  • AREA 2 Resistance/elasticity [additional dominant area].
  • the genes assessed in the inventive method in this area comprise:
  • Hyaluronic acid synthase is one of the basic constituents of the connective tissue in man, and imparts resistance properties and form maintenance to skin, due to its hydrating and antioxidant properties. Its concentration in tissues tends to decrease with age. It also has cicatrizing and anti-inflammatory properties. It is connected to skin resistance weakening with loss of tone and wrinkle and defect formation.
  • Skin type e.g. dry skin
  • AREA 3 Antioxidants.
  • the genes assessed in the inventive method in this area comprise:
  • Hyaluronic acid synthase it is one of the basic constituents of the connective tissue in man, and imparts resistance properties and form maintenance to skin, due to its hydrating and antioxidant properties. Its concentration in tissues tends to decrease with age. It also has cicatrizing and anti-inflammatory properties. It is connected to deficiencies of antioxidant and anti-inflammatory mechanisms, and resulting oxidative stress. Skin weakening with formation of wrinkles and defects.
  • (glutathione peroxidase) is an enzymatic antioxidant. It regulates the oxidoreductive cell equilibrium. It also counteracts the formation of free radicals also at skin level.
  • An optimal antioxidant barrier protects the skin from photoaging damages caused by UVA radiation, and can counteract free radical production and the resulting oxidative stress associated with environmental pollution, smoke, wrong diet. It is connected to inefficiencies of detoxification mechanisms with free radical accumulation. The resulting oxidative stress promotes photoaging processes, and chronic skin damages caused by the damaging action of ultraviolet radiation.
  • Menopause the lack of estrogens following the menopause causes skin atrophy and accelerated skin aging.
  • AREA 4 Hydration [additional dominant area]: The genes assessed in the inventive method in this area comprise:
  • Hyaluronic acid synthase it is one of the basic constituents of the connective tissue in man, and imparts resistance properties and form maintenance to skin, due to its hydrating and antioxidant properties. Its concentration in tissues tends to decrease with age. Therefore, as it lacks, the skin becomes weaker with formation of wrinkles and defects. It also has cicatrizing and anti-inflammatory properties. It is connected to a decrease of hydration, with loss of tone and wrinkle and defect formation.
  • the aesthetic defect is skin sagging and the SNP polymorphism detennined in step a) is at least one of COL3A1, EMILINl, GPX and HAS1 and more preferably, in this case, the substance administered to the individual in step f) is at least one of low and medium molecular weight hyaluronic acid, Ceramide-3, Glycine soybean protein, soybean isoflavones, sh-Oligopeptide-1, Sodium hyaluronate crosspolymer, Superoxide dismutase, thioctic acid.
  • the invention provides a combination therapy, with a treatment plan as described above, which modulates powerful active agents correlated to the identified biological processes, during an active biomedical therapy stage, followed by a follow-up stage.
  • a treatment plan as described above, which modulates powerful active agents correlated to the identified biological processes, during an active biomedical therapy stage, followed by a follow-up stage.
  • the nature of the defects to be corrected suggests administration of active agents and/or biomedical interventions that may be repeated with time, for achievement of results and durability thereof.
  • the present invention comprises a biologically active substances for use in treatment and/or prevention of a disorder that leads to an aesthetic defect, in which said use comprises the steps of:
  • SNP single-nucleotide polymorphism
  • step b) assigning a score to the result of each determination of step a);
  • step c) obtaining history information from the individual, concerning his/her current and past lifestyle, food habits and health, by submitting a set of standardized questions; d) assigning a score to the result of each determination of step c);
  • step e) assigning a total score to the individual, as determined from from the results of steps b) and d), using a genetic/lifestyle assessment algorithm, which relates the results of the genetic test to the effects of the lifestyle of the individual, and weights them; f) administering one or more substances for cosmetic improvement and/or prevention of the defect to the individual, with the type and amount of substance being determined according to the result of step e).

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Abstract

The present invention relates to prevention and/or treatment of aesthetic defects.

Description

"Cosmetic method" DESCRIPTION
The present invention relates to a cosmetic method for prevention and/or cosmetic improvement of aesthetic defects.
In the field of cosmetics, hard-to-treat defects are known, such as excess localized fat, tendency to overweight, achievement/maintenance of the ideal weight, cellulite defects, skin aging, skin sagging, hair aging and alopecia.
In the prior art, these defects are addressed using products, professional treatments and therapies that produce instable results.
In the rare cases in which results are achieved, these do not look natural and are not long-lasting.
The main reason of these drawbacks is that these defects are only addressed as surface defects, even when they are the visible effect of aging on the biological processes of the individual, and not as alterations of biological processes from normal physiology. Aesthetic medicine is a very good solution to counteract the effects of aging on the body, at an aesthetic level. Nevertheless, the less invasive the method, the higher the risk of not achieving long-lasting appreciable results.
One object of the present invention is to provide a method for cosmetic prevention or treatment of defects affecting beauty, even when they are hardly removable, that provides long-lasting natural looking results.
One purpose of the present invention is to provide a method for prevention or cosmetic improvement of defects, that is easy to use and reliable.
Another object of the present invention is to provide a method for prevention or cosmetic improvement of defects that can be easily used by an individual who needs it.
According to the present, these and other objects, as better illustrated hereinafter, are fulfilled by a method of achieving cosmetic improvement and/or prevention of a defect in an individual, which comprises the steps of:
a) performing a genetic test on a biological sample taken from the individual to find any possible single-nucleotide polymorphism (SNP);
b) assigning a score to the result of each determination of step a);
c) obtaining history information from the individual, concerning his/her current and past lifestyle, food habits and health, by submitting a set of standardized questions; d) assigning a score to the result of each determination of step c);
e) assigning a total score to the individual, as determined from from the results of steps b) and d), using a genetic/lifestyle assessment algorithm, which relates the results of the genetic test to the effects of the lifestyle of the individual, and weights them; f) administering one or more substances for cosmetic improvement and/or prevention of the defect to the individual, with the type and amount of substance being determined according to the result of step e).
As used herein, the term "defects" is intended to designate alterations of the normal state of the skin or anyway the exterior appearance of an individual, irrespective of his/her physiological condition and of any disease associated with such alterations. Non-limiting examples of such defects are localized fat, tendency to overweight, androgenetic alopecia, cellulite, skin aging, skin sagging.
Active substance names as used herein are INCI (International Nomenclature of Cosmetic Ingredients) names, e.g. according to the Cosmetic Directive 76/768/EEC, the European Commission Decision 96/335/EC, the Regulation (EC) No. 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products and later updates.
Unless otherwise stated, as used herein the percentages are intended to relate to the weight of one component based on the total weight of the composition.
In one aspect, the present invention relates to a method of achieving cosmetic improvement and/or prevention of a defect in an individual, comprising the steps of: a) performing a genetic test on a biological sample taken from the individual to find any possible single-nucleotide polymorphism (S P);
b) assigning a score to the result of each determination of step a);
c) obtaining history information from the individual, concerning his/her current and past lifestyle, food habits and health, by submitting a set of standardized questions; d) assigning a score to the result of each determination of step c);
e) assigning a total score to the individual, as determined from from the results of steps b) and d), using a genetic/lifestyle assessment algorithm, which relates the results of the genetic test to the effects of the lifestyle of the individual, and weights them; f) administering one or more substances for cosmetic improvement and/or prevention of the defect to the individual, with the type and amount of substance being determined according to the result of step e).
The present invention provides a highly customized predictive method, comprising predictive genetic analysis for cosmetic applications, which may be combined with nutritional/cosmetic treatments for an individualized treatment plan.
The purpose of the method is to allow predictive identification of defects, such as by a novel application of applied genetics or genomics, in combination with nutritional/cosmetic treatments, with a treatment and prevention plan tailored for each individual.
All human beings are similar from the genetic point of view, although minor variations may be found in each gene, leading to important differences. The most common type of variation is known as S P (Single Nucleotide Polymorphism). The presence of even one SNP may lead to a change toward improvement or worsening of the efficiency in the functions of the bases of a biological process. The presence of two or more SNPs may lead to possibly unpredictable synergistic effects. The combination of these minor differences defines how exposure to multiple environmental factors affects the body, the health and the presence or formation of aesthetic defects.
Targeted reading of particular SNPs and their correlation, by the use of targeted substances allows determination of well-defined paths of customized medicine, possibly with a biomedical approach.
The method of the present invention includes:
1. Performing genetic analysis using a novel combination of genetic panels targeted to each aesthetic defect;
2. Filling a history/self-assessment form for each genetic area, by the individual; 3. Applying a special genetic/lifestyle assessment algorithm, which relates the results of the genetic analysis to the effects of the lifestyle of the individual, and weights them.
This first step leads to the preparation of a report which provides the keys to address the defects, as determined by the interpretation of the genetic results according to the method of the invention.
Sequencing of the DNA sample allows quick identification of risk areas, which may affect visible and non-visible effects in the biological processes determined by the individual genetics.
Active substances are selected among naturally occurring substances, or substances that have already been tested in the medical/cosmetic field and have been proven to be safe for the patient, when used as known by the skilled person.
The application of genetic analysis is calibrated again upon history self-assessment for individual optimization, to define the effects of environmental factors.
Each DNA analysis is provided with a total score, given with reference to the average score of the European/Caucasian population; the area that dominates the biological processes to be targeted to counteract the defects and the main areas are shown with customized scores, related to the population.
The genetic result is valid throughout the lifespan of the individual.
As a non-limiting exemplary embodiment of the invention, a set of rules and criteria is defined for quantification of the "level of well-being" of the individual with respect to the aesthetic defect under examination and the biological processes that cause or affect it.
The criteria are based on evidence and international literature, as well as non nutritional and lifestyle considerations.
The algorithm is also applied to the available genetic results and historical information about the individual.
The "level of well-being" of a person is determined by combining a number of genetic and non-genetic indicators (scores), which represent:
• genetic data of each individual polymorphism;
· grouping of polymorphisms by areas (biological process/area of interest); determination of the weight of the polymorphisms of an area;
determination of the weight in each area of the panel;
assignation of history-taking questions to the areas of the defect of interest; determination of the weight of history-taking questions.
Also considering the reference scientific literature as known to the skilled person, each possible genetic result is assigned one of 3 possible scores (step b)):
-1 designates an unfavorable effect
0 designates a neutral effect
+1 designates a favorable effect.
Then each SNP is assigned a weight number expressing:
• Its occurrence in scientific literature
• Its scientific robustness
• Its degree of importance in the biological process of interest, based on the information as known to the skilled person.
For each area the scores of the SNPs are averaged, according to their weights.
This will provide a total score for each area, which may be one of the 3 following scores:
-1 designates an unfavorable predisposition
0 designates a neutral predisposition
+1 designates a favorable predisposition.
A score is also determined from the history-taking questions (steps c) and d)).
The final score for each area is obtained as an average of the genetic score and the history score. The genetic component is assigned a higher score (60/70%).
The scores of each area are averaged, according to their weights.
This will provide a total score for the whole panel, which may be one of the 3 following scores:
-1 designates an unfavorable overall predisposition (total score)
0 designates a neutral overall predisposition (total score)
+1 designates a favorable overall predisposition (total score).
For better customization of results, the total score of the panel is reprocessed on a scale from 0 to 100. This result may be considered as a percent "level of well-being" with respect to the defect under examination and the particular individual.
The new score is determined as follows:
• Each SNP and each question are assigned a score from 0 to 5 (0=worst condition, 5=best condition)
• Genetic scores are averaged according to the previously assigned weights. The 0-100 score is the reference index of the method of the invention, which indicates the treatment level suggested by a proprietary algorithm, based on genetic guidance and correction of the interference of individual habits and on history self-assessment. According to the relevance of the area of the panel, the method of the invention indicates the area index as a reference for treatment or as a total index of the genetic panel.
The scale of the index ranges from 100 to 0.
100 = BEST CONDITION + +. Basic FOLLOW UP - - is suggested.
0 = MAXIMUM RISK - -. MAXIMUM SUPPORT + + is suggested.
The algorithm of the inventive method includes a selection of suggested products among potentially available cosmetic products and dietary supplements.
Selection is based on SNP scores, accoding to the following logic:
• score -1 : associated products, maximum dose
· score 0: associated products, minimum dose
• score 1 : no product suggested.
If the history of the patient is not completely positive, then the result suggests some changes to his/her lifestyle to improve his/her well-being.
As an exception, based on the assessment of a skilled operator, irrespective of the genetic result for each SNP, in areas having a negative total score for both genetics and history, all possible products associated with the area may be selected.
Table 1 shows an exemplary, non-limiting possibility of selection of suggested products.
Table 1
Figure imgf000009_0001
The present invention affords customization of the therapy approach to each patient, based on his/her genetic predisposition to the particular defect to be addressed, using the biomedical approach of combination therapy. The present invention provides an advanced form of customized medicine, which also provides pro-active prevention to also counteract, with time, non-genetic, environmental or lifestyle risk factors, using dietary supplements and phytocomplexes.
Preferably, the method of the invention also comprises diet and lifestyle correction. The assessment of step c) may be carried out before, at the same time as or after steps a) and b).
Preferably, in the method of the invention, the defect is at least one of localized fat, tendency to overweight, androgenetic alopecia, cellulite, skin aging and skin sagging. The method of the invention was surprisingly found to afford cosmetic improvement and/or prevention of an aesthetic defect in an individual through an unique relationship of the presence of a SNP or a combination of SNPs to the administration of one or more biologically active substances.
Such administration may be an oral or topical administration, using methods and appropriate formulations as known by the skilled person, such as suspensions, tablets, capsules, creams, ointments, lotions, spray, etc.
Preferably, the administration is an oral administration.
Preferably, in the inventive method, the substance administered in step f) is at least one substance selected from Bromelin 2500 GDU; Opuntia ficus indica extract (Nopal®); Triterpenes (Centella asiatica extract); Vitexin; Ruscogenin; Polyphenols; Tannins; Catechins EGCG - ECG; Chrome; L-Isoleucine; L-Taurine; L-Carnitine; L- Lysine; L-Valine; L-Arginine; L-Selenium methionine; Hydroxycitric acid; Synephrine; Vitamin B6; Ellagic acid; Biotin (vitamin H); Alpha lipoic acid; Superoxide dismutase 560 UI; Niacin (vitamin B3); Vitamin C; Vitamin D; Fatty acids (Serenoa repens); Iron; Copper; Chrome; Zinc; Potassium; Lignans; Silica; Melatonin; Fucoxanthine; L-Carnitine; Ellagic acid; Biotin (Vitamin H); L-Arginine; Biotin (Vitamin H); Folic acid, Bromelain, Caffeine, Escine, Isomerized linoleic acid (CLA), triethanolamine hydroiodide (TEA hydroiodide), theobromine, Thioctic acid, tocopherol acetate, peel of Citrus aurantium, Escine, Sodium hyaluronate or mixtures thereof.
In the case of cellulite, the parameters under examination are those related to oxygenation, vasodilation, alteration of mucrocirculation, vascularization, homonal factors and presence of skin inflammations or alterations, which impart the typical orange peel look thereto.
In this case various areas are investigated. The dominant area (Area 1) is oxygenation / vasodilation / alteration of the microcirculation / vascularization.
The genes under examination are:
- ACE It is the angiotensin I converting factor, and acts on arterial pressure through regulation of sodium absorption and hence on water retention associated with vasoconstriction mechanisms,
Deficiency in sodium readsorption mechanisms, resulting in retention. It promotes edematous cellulite, with liquid stagnation in tissues perceivable to the touch and associated with heavy legs. Circulatory failure and increase of vasoconstriction.
- HIFla: it is a transcription factor whose alpha subunit is directly regulated by oxygen tension, HIFla assists the cell to reestablish oxygen homeostasis, associated with the homeostasis alteration, adipose tissue hypoxia slows down metabolic waste removal. The resulting liquid stagnation and chronical inflammation leads to sclerosis, i.e. hardening, of fat.
- NOS3: It regulates blood flow and arterial pressure and is associated with an alteration of arterial pressure and blood flow, the lower vasodilation causing damages to microcirculation in adipose tissue, which alterations of the microcirculation in adipose tissue have been suggested to have a key role in the formation of cellulite. In this respect, blood flow in cellulite-affected areas has been shown to be about 35% lower than that of unaffected areas. Local circulation alterations may be a cause and not a consequence of cellulite formation.
The term water retention is intended to designate an accumulation of liquids in interstitial spaces (between cells), which causes abnormal swelling (edema), in certain areas of the body such as belly, thighs, buttocks and ankles. 30% of Italian women are affected by water retention, which may be caused by a salt-rich diet or by improper functioning of the venous and lymphatic systems or by hormone disequilibrium. It is associated with questions about:
Age
• Circulatory problems: worsening of the circulatory state, with venous and lymphatic return insufficiency;
• Sedentary lifestyle: worsening of the circulatory state, with venous and lymphatic return insufficiency;
• High heels / tight jeans: worsening of the circulatory state, with venous and lymphatic return insufficiency;
• Sport: worsening of the circulatory state, with venous and lymphatic return insufficiency;
· Fat-rich nutrition: venous-lymphatic stasis;
• Smoke: venous-lymphatic stasis Smoking cigarettes finally leads to rigidity of arterial walls, with reduced oxygen delivery to the periphery and consequent tissue hypoxia and reduced lipolysis (fat breakdown); it also promotes the production of free radicals that can cause damage to small vessel walls.
· Alcohol: venous-lymphatic stasis • Constipation: venous-lymphatic stasis
• Fibers: they counteract constipation
• Fruit and vegetables: they counteract constipation
• Water retention
· Salt: water retention
• Water: water retention When the body is not adequately hydrated, it defends itself by retaining water, which will accumulate in extracellular spaces, thereby causing swelling.
• Menopause and hormonal alterations: unfavorable effect on adipose tissue and microcirculation
• Stress: unfavorable effect on adipose tissue and microcirculation
• Sedentary lifestyle: unfavorable effect on adipose tissue and microcirculation AREA 2: Hormonal factors
- ERSl : Estrogen receptor associated with the cascade of events that lead to ovulation. Estrogens may be the main hormones that initiate and worsen cellulite. The hormone supply of women is richer in estrogens, which promote accumulation of excess weight on the lower part of the body, with water retention and circulatory stasis. It is associated with hormone disequilibrium. Increased levels of estrogens cause accumulation of excess weight on the lower part of the body, with water retention and circulatory stasis.
Cellulite mainly affects women, due to a hormonal factor (greater production of estrogens, which facilitate deposition of fat).
It is associated with questions about:
Age
· Menopause • Stress-related hormone disequilibrium;
• Stress
- ILIA: It is a pro-inflammatory cytokine that has a major role in local and systemic inflammation. The targets of these cytokines are not only the cells of the immune system, as these cytokines can adhere to endothelial cells and fibroblasts, thereby affecting replication of epithelial cells, endothelial cells and fibroblasts. The latter stimulate collagen synthesis, which is important for the tightness of venous vessel walls, as it increases the resistance of blood vessel walls and reduces their permeability. This improves microcirculation and increases oxygen delivery to tissues. It is associated with an alteration of the local and systemic inflammatory response. A hyperactivation of the immune system causes increased production of free radicals, which have a cell membrane disrupting function, and cause accumulation of liquids in the tissue.
It is associated with questions about:
· Fruit and vegetables: rich in antioxidants, which are important to counteract inflammatory processes
Fat-rich diet: it increases inflammatory processes
• Circulatory problems: formation of edemas associated with inflammation
• Coffee: it increases inflammatory processes
· Alcohol: it increases inflammatory processes
• Smoke: it increases inflammatory processes. Smoking cigarettes finally leads to rigidity of arterial walls, with reduced oxygen delivery to the periphery and consequent tissue hypoxia and reduced lipolysis (fat breakdown); it also promotes the production of free radicals that can cause damage to small vessel walls.
· Stress lifestyle: free radicals and oxidative stress • Sedentary lifestyle: free radicals and oxidative stress
• Physical activity: it counteracts stress, like a healthy diet
A diet with fish at least twice a week: affords an adequate intake of Omega-3 which assist in counteracting inflammation.
Free radicals are dangerous because they have a destructive action on cells and the fats that form their membranes. It should be note that high levels of free radicals were also found in sedentary persons under psychophysical stress.
Preferably, in the inventive method, the aesthetic defect is cellulite and the SNP polymorphism determined in step a) is at least one of ACE, E S1, HIFla, ILIA, MTHFR and NOS3 and combinations thereof and, more preferably, in this case the substance administered in step f) is at least one substance selected from Bromelin 2500 GDU; Fucoxanthine, Opimtia ficus indica extract (Nopal®); Polyphenols, Ruscogenin, Tannins, Triterpenes (Centella asiatica extract), Vitexin and mixtures thereof.
In the case of localized fat, the parameters under examination are those related to fat mass levels, body composition, sugar metabolism, fat distribution and lipid metabolism.
In this case various areas are investigated. The dominant area (Area 1) relates to fat mass levels and body composition. The genes under examination comprise:
- FTO: It is associated with the amount of fat mass and to the obesity risk and is expressed in appetite stimulating regions.
It predisposes to a decreased sense of fullness and facilitates the development of excess fat masses, that may have the form of localized adiposity.
- MC4R: Optimal regulation of appetite and sense of fullness; normal fat mass levels; lower predisposition to type 2 diabetes and obesity. Decreased sense of fullmess and increased appetite stimulation. Increase of weight, namely of fat mass. Predisposition to obesity and hence to type 2 diabetes.
It is associated with questions about:
BMI
· Weight girth
Age
• Exercise activity
Sedentary lifestyle
• Cardiovascular problems => FTO and hypertension were found to be directly related to BMI
• Fibers:
• Fat-rich diet
• Glycemia
AREA 2: Sugar metabolism, fat distribution, include the assessment of the following genes:
- ADRB2: It is a receptor involved in fat mobilization and maintenance of glucose levels in blood, and regulates removal of excess fat
Increased glucose levels in blood. Increased tendency to excess fat accumulation, caused by inefficient fat removal processes
- PPARG: Transcription factor affecting glucose and insulin levels in blood, which is involved in adipocyte differentiation, and is associated with insulin sensitivity, metabolism and sugars. Influence of disequilibrium on insulin levels; predisposition to type 2 diabetes. Increased risk of obesity, metabolic syndrome and cardiovascular risk, the inventive method it is associated with questions about:
· Glycemic levels Diet rich in refined carbohydrates (bread, pasta, rice, pizza, snacks, cookies, etc). Refined carbohydrates are fast-assimilating carbohydrates. They are complex sugars. · Diet of at least 1 month in the last 12 months: dysregulation of metabolism
· Anthropometric measurements, BMI
• Snacks between meals
Fibers
AREA 3: concerning lipid metabolism. The associated genes comprise:
- LPL: Lipoprotein lipase, it hydrolyzes the triglycerides contained in the lipoproteins and has the purpose of collecting and carrying lipids, associated with an increased risk of cardiovascular diseases due to high levels of triglycerides and lower levels of HDL (good cholesterol)
- PCSK9: it is the protein involved in the metabolism of LDL cholesterol (bad cholesterol), which is implied in familial hypercholesterolemia and induced lipid accumulation with localized adiposity. It is connected to an increased risk of coronary diseases.
In the inventive method it is associated with questions about:
• Triglycerides
• Cholesterol
· Fat-rich diet
• Exercise activity
• Lifestyle
• Cardiovascular problems
• Menopause: exercise activity and diets help to achieve favorable results in terms of cardiovascular profile and to decrease the risk of metabolic syndrome in post- menopausal women.
Preferably, in the method of the present invention the aesthetic defect is localized fat and the SNP polymorphism determined in step a) is at least one of ADRB2, FTO, ILIA, LPL, MC4R, MTHFR, PCSK9 and PPARG or combinations thereof and, more preferably, in this case, the substance administered to the individual in step f) is at least one of bromelain, caffeine, carnitine, Escine, isomerized linoelic acid (CLA), triethanolamine hydroiodide (TEA hydroiodide), peel of Citrus aurantium, sodium hyaluronate, theobromine, thioctic acid, tocopherol acetate and mixtures thereof. In the case of androgenetic alopecia, the parameters under examination relate to genetic predisposition, presence of antioxidants and, based on genetic analysis only, a percent risk of developing alopecia at 30, 50 and 70 is further determined.
In this case various areas are investigated. The dominant area (Area 1) is genetic predisposition.
The genes assessed in the inventive method are:
- AR: Androgen receptor that binds various steroid hormones and affects the development of secondary sexual characters
- EDAR: Involved in the development of ectodermal tissues, namely teeth, hair, nails and sweat glands
- 20pl l : The SNPs located in this chromosomal region are strongly associated with male baldness. This association was discovered through genomic studies, but its biochemical role still has to be clarified.
- WNT10A: Gene coding for signal molecules implied in cell regulation factors The strongest association signal was obtained for rs7349332 which is located in WNT10A. Studies on the expression in the human hair follicle indicate that WNT10A has a functional role in the etiology of AGA (androgenetic alopecia). These studies provide genetic evidence to support involvement of the W T signal in AGA development, which is associated with an increased predisposition to androgenetic alopecia.
Associated with questions about: genetic (familial) predisposition to alopecia.
AREA 2 related to androgenetic alopecia. Antioxidants. In the inventive method they are associated with the following genes:
- GPX: (glutathione peroxidase) is an enzymatic antioxidant. It regulates the oxidoreductive cell equilibrium. It also counteracts the formation of free radicals also at skin level. Inefficiency of detoxification mechanisms with free radical accumulation. It is associated with alopecia aerata.
Alopecia aerata is a disease in which the abrupt fall of hair, or other body hairs, typically occurs in bald spots or areas (stage I- VII).
Preferably, in the method of the present invention the aesthetic defect is androgenetic alopecia and the SNP polymorphism determined in step a) is at least one of AR, 20pl 1 , EDAR, GPX, MC4R and WNT 1 OA or combinations thereof or, more preferably, in this case, the substance administered to the individual in step f) is at least one of Bromelain, Caffeine, Carnitine, peel of Citrus aurantium, Escine, isomerized linoleic acid (CLA), Sodium hyaluronate, triethanolamine hydroiodide (TEA hydroiodide), Copper tripeptide-1 ; dextrane (e) acetyl tetrapeptide-3 (e) Trifolium pratense extact, Octapeptide-2, Serenoa serrulata extract; sh-Polypeptide-3; Sodium DNA, potassium glutathione, isomerized linoleate and mixtures thereof.
In the case of skin aging, the parameters under examination are related to the texture, elasticity, tissue remodeling, skin type, detoxification and oxidative stress, vascularization and oxigenatin and inflammation.
In this case various areas are investigated. The dominant area (Area 1) is texture/elasticity/tissue remodeling. In the method of the invention, the following genes are assessed, without limitation:
- FLG: It is an aggregation protein and the main component of keratohyalin granules in human epidermis. It has the purpose of holding the epidermis cells together and maintaining the horny layer hydrated, and is also a key protein for epidermal differentiation. It may be also associated with incomplete adhesion of keratinocytes with an alteration of the epidermal barrier protection function, which causes increased exposure damaging caused by external agents. It also predisposes the skin to intense dryness-related problems.
- MMP3: The metalloproteinases are a group of enzymes implied in extracellular matrix degradation and in various tissue remodeling-related processes. MMP3 or stromelisine is a proteoglycan strictly associated with the collagen mainly secreted by cells of the connective tissue and by basal keratinocytes. Its purpose is degrading extracellular matrix components such as laminin, fibronecting and type IV collagen. For this reason it is involved in tissue remodeling processes.
It promotes skin aging and decreases cell regeneration. MMP3 is induced by inflammatory cytokines, and all stimulations that cause inflammation are caused by early skin aging.
- ELN: It is the main constituent (70-90%) of elastic fibers and its strictly structural role is to impart elasticity and resistance to tissues. An unfavorable variant thereof is associated with decreased skin extension, elasticity, compactness, softness, which facilitates skin aging. It is connected to decreased skin extension, elasticity, compactness and softness. Aging.
It is associated with questions about:
Age
· Smoke • Skin type
• Phototype
• Sun exposure
• Hydration
AREA 2: Skin type. The genes assessed in the inventive method comprise:
- PPARG: cell receptor acting on glucose and insulin levels in blood. Increase of adipose tissue. Alterations in the regulation of the lipid film with increased presence of subcutaneous fat, a typical symptom of oily skin and acne. It is associated with questions about:
Age
• Fruit and vegetables
• Carbohydrates
• Oily skin
• Whole food
• Water
AREA 3 (further dominant area): Detoxification and oxidative stress. The genes assessed in the method of the present invention comprise:
- SOD: it is an antioxidant enzyme that can neutralize the superoxide, which is a dangerous free radical of oxygen. Its role is to protect cells from the oxidative stress induced by free radicals, which are among the most important photoaging factors. It is connected with free radical accumulation and oxidative stress, and consequently with photoaging.
- GSTT/GSTM: they are part of the class of detoxifying enzymes, that can reduce the toxicity and reactiveness of dangerous compounds, through conjugation with glutathione. They are thought to be related to decreased removal of toxic substances from the body and to increased oxidative stress.
It is associated with questions about:
Age
• Smoke
• Fruit and vegetables
• Coffee
Alcohol
A further investigation area in the field of skin aging is vascularization and oxygenation. The genes assessed in the inventive method comprise:
- NOS3: it is one of the most important molecules of the cardiovascular system, and is involved in the processes of vasodilation and regulation of blood flow. Also, it is involved in tissue repair processes after injury. A skin having an adequate nitric oxide intake is less compact and reactive and has a lower ability of defense and regeneration upon exogenous stimuli.
In the inventive method it is associated with questions about:
Age
• Smoke
• Hypersensitive skin
AREA 5: Inflammation The genes assessed in the inventive method comprise:
- T F: it is a pro-inflammatory cytokine, of both acute and chronic phases. Unfavorable variants may facilitate the occurrence of phlogistic phenomena and increase cardiovascular diseases. Excessive phologosis promotes cardiovascular diseases. An increased production of this cytokine is connected to a higher risk of phlogistic phenomena and skin aging. Photoaging processes are often associated with a loss of subcutaneou s fat at the face, and with the consequent occurrence of wrinkles and skin folds
It is associated with questions about:
Smoke
• Fruit and vegetables
· Sun/protections
• Menopause
• Stress lifestyle
Preferably, in the method of the invention, the aesthetic defect is skin aging and the SNP polymorphism determined in step a) is at least one of ELN, FLG, GSTT/GSTM, MMP3, NOS3, SOD and TNF and more preferably, in this case, the substance administered to the individual in step f) is at least one of Acetyl decapeptide-3, Acetyl tetrapeptide-5, low and medium molecular weight hyaluronic acid, Dextrane palmytol hexapeptide-19, Dioscorrea villosa extract, Dipeptide diaminobutyrol benzylamide diacetate, Hydrolized rice protein, glycine soja protein, superoxide dismutase, Hydrolyzed verbascum thapsus flower, soybean isoflavones, Palmytol tripeptide-5, sh- Oligopeptide-1, Sodium hyaluronate crosspolymer, Superoxide dismutase, alpha- lipoic acid , Ellagic acid, Biotin (vitamin H), L-Arginine, Niacin (vitamin B3), superoxide dismutase 560 UI, Vitamin C, Vitamin D and mixtures thereof.
In case of skin sagging, the parameters under examination are related to texture and elasticity, resistance and elasticity, presence of antioxidants and hydration.
In this case various areas are investigated. The dominant area (Area 1) is texture/elasticity. The genes assessed in the inventive method in this area comprise: - COL3A1 : Collagen is the main protein of the connective tissue. Type 3 collagen is the most important constituent of extracellular matrix. It is important because it holds the cell elements together and initiates tissue and organ formation processes. It is the main fibrous element of skin, tenons, cartilages and vessels. It is also responsible for the mechanical protection of the body provided by the skin, for the skin state, for maintenance of texture quality and prevention of skin dehydration, for maintenance of elasticity and tone and finally for wrinkle minimization. It is connected to skin tone loss, with decrease of skin elasticity and increase of sagging. Skin appears more dehydrated, dry and with wrinkles and age effects
- EMILIN1 : it helps to maintain a good quality of elastic fibers and consolidates dermal architecture by ensuring the bond between elastic fibers and collagen fibers. It is connected to alterations of elastic fibers, lower dermal compactness with sagging that may result in unaesthetic surface wrinkles, stretch marks or expression lines. It is associated with questions about:
Age
BMI
Exercise activity: it helps to prevent tone loss
· Lifestyle: it helps to prevent tone loss
Smoke: due to the formation of oxidant molecules, it reduces collagen synthesis to 40%
Menopause
AREA 2: Resistance/elasticity [additional dominant area]. The genes assessed in the inventive method in this area comprise:
- ELN: It is the main constituent (70-90%) of elastic fibers and its strictly structural role is to impart elasticity and resistance to tissues.
Decreased extension, elasticity and resistance, effects of aging
- HASl: Hyaluronic acid synthase, it is one of the basic constituents of the connective tissue in man, and imparts resistance properties and form maintenance to skin, due to its hydrating and antioxidant properties. Its concentration in tissues tends to decrease with age. It also has cicatrizing and anti-inflammatory properties. It is connected to skin resistance weakening with loss of tone and wrinkle and defect formation.
It is associated with questions about:
Age
BMI
• Exercise activity: it helps to prevent tone loss
Lifestyle: it helps to prevent tone loss
• Water
Skin type (e.g. dry skin)
AREA 3: Antioxidants. The genes assessed in the inventive method in this area comprise:
- HAS 1 : Hyaluronic acid synthase, it is one of the basic constituents of the connective tissue in man, and imparts resistance properties and form maintenance to skin, due to its hydrating and antioxidant properties. Its concentration in tissues tends to decrease with age. It also has cicatrizing and anti-inflammatory properties. It is connected to deficiencies of antioxidant and anti-inflammatory mechanisms, and resulting oxidative stress. Skin weakening with formation of wrinkles and defects.
- GPX: (glutathione peroxidase) is an enzymatic antioxidant. It regulates the oxidoreductive cell equilibrium. It also counteracts the formation of free radicals also at skin level. An optimal antioxidant barrier protects the skin from photoaging damages caused by UVA radiation, and can counteract free radical production and the resulting oxidative stress associated with environmental pollution, smoke, wrong diet. It is connected to inefficiencies of detoxification mechanisms with free radical accumulation. The resulting oxidative stress promotes photoaging processes, and chronic skin damages caused by the damaging action of ultraviolet radiation.
This area is associated with questions about:
Age
• Water: due to the gene Hasl . Skin tends to dehydration with age.
· Exposure to sun/sun lamps/use of protections: photoaging
• Skin color: a clear skin is more sensitive
Smoke: aging caused by external factors/lifestyle;
• Coffee: aging caused by external factors/lifestyle;
• Alcohol: aging caused by external factors/lifestyle;
· Fruit and vegetables: rich in antioxidants, they counteract free radicals;
• Menopause: the lack of estrogens following the menopause causes skin atrophy and accelerated skin aging.
AREA 4: Hydration [additional dominant area]: The genes assessed in the inventive method in this area comprise:
- HAS 1 : Hyaluronic acid synthase, it is one of the basic constituents of the connective tissue in man, and imparts resistance properties and form maintenance to skin, due to its hydrating and antioxidant properties. Its concentration in tissues tends to decrease with age. Therefore, as it lacks, the skin becomes weaker with formation of wrinkles and defects. It also has cicatrizing and anti-inflammatory properties. It is connected to a decrease of hydration, with loss of tone and wrinkle and defect formation.
It is associated with questions about:
• Fruit and vegetables.
Preferably, in the method of the invention, the aesthetic defect is skin sagging and the SNP polymorphism detennined in step a) is at least one of COL3A1, EMILINl, GPX and HAS1 and more preferably, in this case, the substance administered to the individual in step f) is at least one of low and medium molecular weight hyaluronic acid, Ceramide-3, Glycine soybean protein, soybean isoflavones, sh-Oligopeptide-1, Sodium hyaluronate crosspolymer, Superoxide dismutase, thioctic acid.
In a preferred embodiment, the invention provides a combination therapy, with a treatment plan as described above, which modulates powerful active agents correlated to the identified biological processes, during an active biomedical therapy stage, followed by a follow-up stage. Preferably, the nature of the defects to be corrected suggests administration of active agents and/or biomedical interventions that may be repeated with time, for achievement of results and durability thereof.
In one embodiment, the present invention comprises a biologically active substances for use in treatment and/or prevention of a disorder that leads to an aesthetic defect, in which said use comprises the steps of:
a) performing a genetic test on a biological sample taken from the individual to find any possible single-nucleotide polymorphism (SNP);
b) assigning a score to the result of each determination of step a);
c) obtaining history information from the individual, concerning his/her current and past lifestyle, food habits and health, by submitting a set of standardized questions; d) assigning a score to the result of each determination of step c);
e) assigning a total score to the individual, as determined from from the results of steps b) and d), using a genetic/lifestyle assessment algorithm, which relates the results of the genetic test to the effects of the lifestyle of the individual, and weights them; f) administering one or more substances for cosmetic improvement and/or prevention of the defect to the individual, with the type and amount of substance being determined according to the result of step e).

Claims

1. A method of achieving cosmetic improvement and/or prevention of a defect in an individual, comprising the steps of:
a) performing a genetic test on a biological sample taken from the individual to find any possible single-nucleotide polymorphism (S P);
b) assigning a score to the result of each determination of step a);
c) obtaining history information from the individual, concerning his/her current and past lifestyle, food habits and health, by submitting a set of standardized questions; d) assigning a score to the result of each determination of step c);
e) assigning a total score to the individual, as determined from from the results of steps b) and d), using a genetic/lifestyle assessment algorithm, which relates the results of the genetic test to the effects of the lifestyle of the individual, and weights them; f) administering one or more substances for cosmetic improvement and/or prevention of the defect to the individual, with the type and amount of substance being determined according to the result of step e).
2. A method as claimed in claim 1 , wherein the defect is at least one of localized fat, tendency to overweight, androgenetic alopecia, cellulite, skin aging and skin sagging.
3. A method as claimed in any of the preceding claims, wherein the substance administered in step f) is at least one substance selected from Bromelin 2500 GDU; Op ntia ficus indica extract (Nopal®); Triterpenes (Centella asiatica extract); Dioscorrea villosa extract; Vitexin; Ruscogenin; Polyphenols; Tannins; Catechins EGCG - ECG; Chrome; L-Isoleucine; L-Taurine; L-Carnitine; L-Lysine; L-Valine; L- Arginine; L-Selenium methionine; Hydroxycitric acid; Synephrine; Vitamin B6; Ellagic acid; Biotin (vitamin H); Alpha lipoic acid; Superoxide dismutase 560 UI; Niacin (vitamin B3); Vitamin C; Vitamin D; Fatty acids (Serenoa repens); Iron; Copper; Chrome; Zinc; Potassium; Lignans; Silica; Melatonin; Fucoxanthine; Glycine soybean protein, Soybean isoflavones, L-Carnitine; Ellagic acid; Biotin (Vitamin H); L-Arginine; Biotin (Vitamin H); Folic acid, Bromelain, Caffeine, Escine, Isomerized linoleic acid (CLA), triethanolamine hydroiodide (TEA hydroiodide), theobromine, Thioctic acid, tocopherol acetate, peel of Citrus aurantium, Escine, Sodium hyaluronate; Dipeptide diaminobutyrol benzylamide diacetate; Hydrolized rice protein; sh-Oligopeptide- 1; Sodium hyaluronate crosspolymer; Superoxide dismutase; Ceramide-3; Glycine soybean protein; Hydrolyzed verbascum thapsus flower; Palmytol tripeptide-5, or mixtures thereof.
4. A method as claimed in any of the preceding claims, wherein the defect is cellulite and the SNP polymorphism determined in step a) is at least one of ACE, ERS 1 , HIF 1 a, ILIA, MTHFR and NOS3.
5. A method as claimed in claim 4, wherein the substance administered to the individual in step f) is at least one of Bromelin 2500 GDU, Fucoxantin, Opuntia ficus Indica estract (Nopal®), Polyphenols, Ruscogenin, Tannins, Triterpenes (Centella asiatica), Vitexin and mixtures thereof.
6. A method as claimed in any of claims 1 to 4, wherein the defect is localized fat and the SNP polymorphism determined in step a) is at least one of ADRB2, FTO, ILIA, LPL, MC4R, MTHFR, PCSK9 and PPARG.
7. A method as claimed in claim 6, wherein the substance administered to the individual in step f) is at least one of bromelain, caffeine, carnitine, Escine, isomerized linoleic acid (CLA), triethanolamine hydroiodide (TEA hydroiodide), peel of Citrus aurantium, sodium hyaluronate, theobromine, thioctic acid, tocopherol acetate and mixtures thereof.
8. A method as claimed in any of claims 1 to 4, wherein the defect is androgenetic lopecia and the SNP polymorphism determined in step a) is at least one of AR, EDAR, GPX, MC4R, 20pl 1 and WNT10A.
9. A method as claimed in claim 8, wherein the substance administered to the individual in step f) is at least one of Bromelain, Caffeine, Carnitine, peel of Citrus aurantium, Escine, isomerized linoleic acid (CLA), Sodium hyaluronate, triethanolamine hydroiodide (TEA hydroiodide), Copper tripeptide-1; dextrane (e) acetyl tetrapeptide-3 (e) Trifolium pratense extact, Octapeptide-2, Serenoa serrulata extract; sh-Polypeptide-3; Sodium DNA, potassium glutathione, isomerized linoleate and mixtures thereof.
10. A method as claimed in any of claims 1 to 4, wherein the defect is skin aging and the SNP polymorphism determined in step a) is at least one of ELN, FLG, GSTT/GSTM, MMP3, NOS3, SOD, PPAR and TNF.
11. The method as claimed in claim 10, wherein the substance administered to the individual in step f) is at least one of Acetyl decapeptide-3, Acetyl tetrapeptide-5, low and medium molecular weight hyaluronic acid, Dextrane palmytol hexapeptide-19, Dioscorrea villosa extract, Dipeptide diaminobutyrol benzylamide diacetate, Hydrolized rice protein, glycine soja protein, superoxide dismutase, Hydrolyzed verbascum thapsus flower, soybean isoflavones, Palmytol tripeptide-5, sh- Oligopeptide-1, Sodium hyaluronate crosspolymer, Superoxide dismutase, alpha- lipoic acid , Ellagic acid, Biotin (vitamin H), L-Arginine, Niacin (vitamin B3), superoxide dismutase 560 UI, Vitamin C, Vitamin D and mixtures thereof.
12. A method as claimed in any of claims 1 to 4, wherein the defect is skin sagging and the SNP polymorphism determined in step a) is at least one of COL3A1, ELN, EMILINl, GPX and HAS1.
13. A method as claimed in claim 12, wherein the substance administered to the individual in step f) is at least one of low and medium molecular weight hyaluronic acid, Ceramide-3, Glycine soybean protein, soybean isoflavones, sh-Oligopeptide-1, Sodium hyaluronate crosspolymer, Superoxide dismutase, thioctic acid.
PCT/IB2014/062973 2014-07-09 2014-07-09 Cosmetic method. WO2016005793A1 (en)

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