COMPOSITION FOR THE CARE OF SKIN, HAIR AND SCALP (Machine-translation by Google Translate, not legal

专利摘要:
Composition for the care of the skin, hair and scalp: The present invention relates to a pharmaceutical or cosmetic composition characterized in that it comprises: a) a component A comprising: an effective amount of a germinating extract of a plant of the genus Glycine; an effective amount of a germinating extract of a plant of the genus Triticum; and an effective amount of an extract of a plant of the genus Scutellaria; b) a component B comprising: an effective amount of a polysaccharide comprising a backbone of repeating structural units of formula (I) and c) one or more pharmaceutically or cosmetically acceptable excipients and/or carriers. The invention also relates to its pharmaceutical use for the treatment and/or prevention of diseases or disorders of the skin, hair and scalp; and its cosmetic use as an agent for the care of the skin, hair and scalp. (Machine-translation by Google Translate, not legally binding)
公开号:ES2698702A1
申请号:ES201731011
申请日:2017-08-04
公开日:2019-02-05
发明作者:Galar Maialen Elizari；Regueiro Susana Mezquita
申请人:Laboratorios Cinfa SA；
IPC主号:

专利说明:

[0001] Composition for the care of the skin, hair and scalp
[0002]
[0003] The present invention relates to the technical field of pharmacy and cosmetics, in particular it refers to a composition containing different active ingredients, as well as its use as a coadjuvant for a disease or disorder of the skin, hair and scalp; and its cosmetic use as an agent for the care of the skin, hair and scalp. The invention also relates to a composition that also contains one or more additional active compounds and their use for the treatment and / or prevention of a disease or disorder of the skin, hair and scalp.
[0004]
[0005] STATE OF THE ART
[0006]
[0007] Hair is a symbol of vitality and health, as well as being a fundamental characteristic of a person's identity and identity. The treatment of hair and scalp and, in particular, the treatment and prevention of hair loss, seborrhea, dandruff, dermatitis as well as the improvement of thickness or volume has been a frequent problem of consultation for many years. dermatologists, both for men and for women.
[0008]
[0009] The hair is a complex corneo annex that includes an external part, or capillary stem and an internal part, called hair follicle. Inside the follicle, different parts can be distinguished: the follicular matrix, where the hair will be made and the sebaceous gland that will lubricate the stem on its exit to the outside. Each hair follicle is subjected to capillary cycles in a more or less constant manner. These cycles consist of three distinct phases: a phase of rapid growth and formation of the capillary stem (called the anagen phase), followed by a regression phase based on cellular apoptosis of the matrix (called the catagen phase) and, finally, a period of rest of the hair follicle (called the telogen phase). In summary, the capillary cycle is divided into 3 phases: the anagen phase (or growth phase); the catagen phase (where growth stops and hair begins to separate from the dermal papilla); and the telogen phase (it is the phase of detachment in which the hair is expelled to the outside). At this time, the dermal papilla will receive the signal that will induce him to produce a new hair.
[0010] Hair loss is caused or induced by an alteration in hair growth cycles due to a multitude of factors such as the impact of androgens and their genetic receptors, skin alterations or stress among others. These alterations of the capillary cycle mainly involve a reduction in the number of hairs in the anagen phase and an increase in the number of hairs in the telogen phase; as well as a shortening of the anagen phase. The consequence of these modifications in its cycle is that the hair can not grow in a balanced way for the necessary time and is thinner at the same time that it falls prematurely.
[0011]
[0012] As described above, one of the most frequent causes of hair loss is the alteration of the skin or scalp, specifically sensitive skin (also called reactive skin). The sensitive skin is linked to an overexcitation of the nerve endings. In turn, this nervous excitement is related to the loss of cutaneous barrier function and also to inflammatory processes that cause the appearance of different manifestations such as itching, tightness, heat, burning sensation and alterations of the hair follicle cell cycle. These abnormal inflammatory processes also cause the appearance of malformations of the hair follicle, the accumulation of dead cells and the alteration of function of the sebaceous gland.
[0013]
[0014] Many compounds have been described in the state of the art for the treatment and / or prevention of diseases or alterations of the hair and the scalp, such as for example minoxidil. However, these compounds are used in treatments that are long and tedious. In addition, such treatments involve the appearance of many side effects associated with topical application such as burning, irritation, itching and redness of the area of the treated scalp, as well as the growth of unwanted hair anywhere in the body. Thus, it can be concluded that the low effectiveness and the secondary effects associated with the treatment are the main cause of the lack of compliance on the part of the patient, causing a high percentage of abandonment of the treatment.
[0015]
[0016] Therefore, from what is described in the state of the art, it follows that there is still a need to provide an effective composition with less or no effects secondary to the treatment or prevention of a disease or disorder of the skin, hair or scalp.
[0017]
[0018] EXPLANATION OF THE INVENTION
[0019]
[0020] The inventors have developed a composition comprising a combination of active ingredients with anti-inflammatory, soothing and activating properties of hair follicle stem cells, as well as a promoter action of glucose metabolism and protective against oxidative stress and senescence; which improves the general conditions of the skin, hair and scalp and, at the same time, reduces the reactions associated with nervous overexcitation by restoring the skin's barrier function and decreasing inflammatory reactions.
[0021]
[0022] In addition, the inventors have also found that the composition of the invention also improves the effectiveness of the additional active ingredients that are applied to the hair and scalp. This is due to the fact that the general conditions of the skin, hair and scalp on which the additional active ingredient is applied are also improved and the effects associated with nervous overexcitation are also reduced.
[0023]
[0024] Thus, the first aspect of the invention relates to a pharmaceutical or cosmetic composition characterized in that it comprises: a) a component A comprising: a therapeutically or cosmetically effective amount of a germinating extract of a plant of the genus Glycine; a therapeutically or cosmetically effective amount of a germinating extract of a plant of the genus Triticum; and a therapeutically or cosmetically effective amount of an extract of a plant of the genus Scutellaria; b) a component B comprising: a therapeutically or cosmetically effective amount of a polysaccharide of molecular weight comprised from 45,000 to 55,000 g / mol comprising a backbone of repeating structural units of formula (I) and c) one or more excipients and / or pharmaceutically or cosmetically acceptable vehicles.
[0025]
[0026] The term "therapeutically effective amount" refers to the amount of each ingredient of the invention which, when administered, is sufficient to prevent the development of, or alleviate to some extent, one or more of the symptoms of the disease or condition that The particular dose of each ingredient will be determined by the particular circumstances surrounding the case, including the compound administered, the route of administration, the particular condition to be treated and similar considerations.
[0027]
[0028] The term "cosmetically effective amount" refers to the amount of each ingredient of the invention which, when administered on the skin, hair or scalp, is sufficient to improve its appearance or beauty, preserve, condition, color or Protect the skin, hair and scalp.
[0029]
[0030] The term "extract" is used with its conventional meaning to refer to concentrated preparations of the plants of the genera Glycine, Tnticum and Scutellana obtained by extraction of the active ingredients by appropriate means.These active principles can be obtained from various parts of plants, such as leaves, roots, stems or sprouts, etc. Suitable means for extracting active ingredients include, for example, the use of organic solvents, microwaves or extraction with supercritical fluids.The active ingredients are sometimes incorporated directly in pharmaceutical or cosmetic compositions in a variety of forms, including as a pure or semi-pure component, as a solid or liquid extract, or as solid matter of the plant.The plant extracts contain not only one but several constituents, many of them assets. Often, the beneficial effect derives from the combination of many of these compounds or even in some cases the beneficial effect derives in particular from a compound that is primarily responsible for most of the activity.
[0031]
[0032] The terms "germinated", "sprout" and "sprout" have the same meaning and are used interchangeably.These terms refer to seeds that are germinated Germination is the process by which an embryo (seed) develops into In a plant, it is a procedure that is carried out when the embryo swells and the seed coat is broken.To achieve this, every new plant requires basic elements for its development as temperature and the presence of water, dioxide carbon and mineral salts The germination conditions of the seeds of each of the plants of the present invention are those described in the state of the art In particular, the germinates of the present invention were prepared using exclusively water for germination and the germination process stopped after 3 days.
[0033]
[0034] In one embodiment, the composition comprises a component A wherein the germinated extract of a plant of the genus Glycine is a germinated extract of Glycine soya. In one embodiment, the composition comprises a component A wherein the germinated extract of a plant of the Triticum genus is a germinated extract of Triticum vulgare. In one embodiment, the composition comprises a component A wherein the extract of a plant of the genus Scutellaria is a root extract of Scutellaria Baicalensis.
[0035]
[0036] In one embodiment, the germinated extracts of a plant of the genus Glycine, the genus Triticum and the genus Scutellaria are hydroglycolic extracts.
[0037]
[0038] In one embodiment, the composition comprises a component A comprising a germinated Glycine soybean extract, a germinated extract of Triticum vulgare and a root extract of Scutellaria Baicalensis.
[0039]
[0040] The term "percentage (%) by weight" refers to the percentage of each of the ingredients of the composition of the invention in relation to the total weight thereof or the total weight of component A.
[0041] In one embodiment, the composition comprises from 0.5% to 4% by weight of component A with respect to the total weight of the composition.
[0042]
[0043] In one embodiment, the composition is a pharmaceutical composition that is selected from the group consisting of a medicament and a sanitary product.
[0044]
[0045] For the purposes of the invention, the term "medicament" refers to a pharmaceutical composition that acts through a biochemical, immunological, and / or enzymatic mechanism, i.e. a pharmacological mechanism. And, the term "medical device" refers to any instrument, device, equipment, computer program, material or other article, used alone or in combination, including computer programs intended by its manufacturer for specific purposes of diagnosis and / or therapy and that intervene in its proper functioning, intended by the manufacturer to be used in humans for the following purposes: 1 ° Diagnosis, prevention, control, treatment or alleviation of a disease; 2nd diagnosis, control, treatment, relief or compensation of an injury or a deficiency; 3rd investigation, replacement or modification of the anatomy or a physiological process; 4th regulation of conception; and that does not exert the main action that is desired to obtain inside or on the surface of the human body by pharmacological, immunological, or metabolic means, but to whose function such means can contribute.
[0046]
[0047] In one embodiment, the composition is a pharmaceutical composition comprising from 2.5% to 4% by weight of component A with respect to the total weight of the composition. In one embodiment, the composition is a pharmaceutical composition comprising from 2.8% to 3.5% by weight of component A with respect to the total weight of the composition. In a particular embodiment, the composition is a pharmaceutical composition comprising 3% by weight of component A with respect to the total weight of the composition.
[0048]
[0049] In one embodiment, the composition is a cosmetic composition comprising from 0.5% to 2.4% by weight of component A with respect to the total weight of the composition. In one embodiment, the composition is a cosmetic composition comprising 0.8% to 2% by weight of component A with respect to the total weight of the composition. In a particular embodiment, the composition is a cosmetic composition comprising 1% by weight of component A with respect to the total weight of the composition.
[0050]
[0051] In one embodiment, when the composition is in the form of a shampoo, then the composition comprises from 0.5% to 2% by weight of component A with respect to the total weight of the composition; preferably comprised from 1% to 2% by weight of component A with respect to the total weight of the composition. In one embodiment, when the composition is in the form of a lotion, then the composition comprises from 2.5% to 4% by weight of component A with respect to the total weight of the composition; preferably comprised from 2.8% to 3.5% by weight of component A with respect to the total weight of the composition; particularly 3% by weight of component A with respect to the total weight of the composition.
[0052]
[0053] In one embodiment, the composition of the invention is characterized in that component A comprises: from 1% to 5% by weight of the germinated extract of the plant of the genus Glycine with respect to the total weight of component A; from 1% to 5% by weight of the germinated extract of the plant of the Triticum genus with respect to the total weight of component A; and from 0.45% up to 0.75% by weight of the root extract of the plant of the genus Scutellaria with respect to the total weight of the component A. In one embodiment, the composition of the invention characterized in that the component A comprises: from 1% to 5% in weight of the germinated extract of the plant of the genus Glycine soybean with respect to the total weight of component A; from 1% to 5% by weight of the germinated extract of the plant of the genus Triticum vulgare with respect to the total weight of component A; and from 0.45% to 0.75% by weight of the root extract of the plant of the genus Scutellaria Baicalensis with respect to the total weight of component A.
[0054]
[0055] The germinated extracts of the plant of the genus Glycine, of the genus Triticum, of the genus Scutellaria used in the present invention are commercially available. In one embodiment, component A of the composition of the invention is commercially available and comprises:
[0056]
[0057] from 1% to 5% by weight of Glycine soya germinated extract ;
[0058] from 1% to 5% by weight of germinated extract of Triticum vulgare; from 0.45% to 0.75% by weight of root extract of Scutellaria Baicalensis; from 35% to 55% by weight of propanediol;
[0059] from 35% to 55% by weight of water;
[0060] from 6% to 10% by weight of arginine;
[0061] from 5% to 10% by weight of lactic acid;
[0062] from 0.2% to 0.3% by weight of sodium benzoate:
[0063] from 0.7% to 0.8% of gluconolactone; Y
[0064] from 0.008% to 0.012% calcium gluconate,
[0065] where the sum of all the ingredients is 100% by weight.
[0066]
[0067] The polysaccharide of component B of the present invention has a molecular weight of from 45,000 to 55,000 g / mol. The term "molecular weight" refers to the weight-average molecular weight (Mw) .The said molecular weight can be calculated by methods well known in the state of the art.Some of these methods that can be used are for example viscometry, ultrafiltration, pressure of Steam and exclusion chromatography (GPC) In particular, the molecular weight of the polysaccharide of the present invention can be calculated by GPC using polystyrene standards In one embodiment, the composition of the invention is that wherein component B comprises a polysaccharide having In one embodiment, the composition of the invention is one in which component B comprises a polysaccharide comprising a backbone of repeating structural units of formula (I) having a molecular weight of 49,000. up to 51000 g / mol In one embodiment, the composition of the invention is that where component B comprises a polysaccharide comprising a backbone of repeating structural units of formula (I) has a molecular weight of 50000 g / mol.
[0068]
[0069] In one embodiment, the composition of the invention comprises from 0.1% to 5% by weight of component B with respect to the total weight of the composition.
[0070]
[0071] In one embodiment, the composition is a pharmaceutical composition comprising from 2% to 5% by weight of component B with respect to the total weight of the composition. In one embodiment, the composition is a pharmaceutical composition that comprises from 2.5% to 4% by weight of component B with respect to the total weight of the composition. In a particular embodiment, the composition is a pharmaceutical composition comprising 3% by weight of component B with respect to the total weight of the composition.
[0072]
[0073] In one embodiment, the composition is a cosmetic composition comprising from 0.1% to 1.9% by weight of component B relative to the total weight of the composition. In one embodiment, the composition is a cosmetic composition comprising 0.15% up to 1% by weight of component B with respect to the total weight of the composition. In a particular embodiment, the composition is a cosmetic composition comprising 0.2% by weight of component B with respect to the total weight of the composition.
[0074]
[0075] In one embodiment, when the composition is in the form of a shampoo, then the composition comprises from 0.1% to 1.9% of component B relative to the total weight of the composition. In one embodiment, when the composition is in the form of a lotion, then the composition comprises from 2% to 5% of component B with respect to the total weight of the composition.
[0076]
[0077] In one embodiment, the composition of the invention is characterized in that component B comprises from 2% to 3% of the polysaccharide of molecular weight comprised from 45,000 to 55,000 g / mol comprising a backbone of repeating structural units of formula (I) .
[0078]
[0079] Component B comprising a polysaccharide of molecular weight comprised from 45,000 to 55,000 g / mol comprising a backbone of repeating structural units of formula (I) is commercially available. In one embodiment, component B of the composition of the invention is commercially available and comprises:
[0080]
[0081] from 1% to 2% by weight of phenoxyethanol; Y
[0082] enough water to reach 100% by weight.
[0083] In one embodiment, the composition of the invention is characterized in that it comprises from 0.5% to 2% by weight of component A with respect to the total weight of the composition; and from 0.1% to 5% by weight of component B with respect to the total weight of the composition.
[0084]
[0085] In one embodiment, the composition is a pharmaceutical composition comprising from 2.5% to 4% by weight of component A with respect to the total weight of the composition; and from 2% to 5% by weight of component B with respect to the total weight of the composition. In one embodiment, the composition is a pharmaceutical composition comprising from 2.8% to 3.5% by weight of component A with respect to the total weight of the composition; and from 2.5% to 4% by weight of component B with respect to the total weight of the composition. In a particular embodiment, the composition is a pharmaceutical composition comprising 3% by weight of component A with respect to the total weight of the composition; and 3% by weight of component B with respect to the total weight of the composition.
[0086]
[0087] In one embodiment, the composition is a cosmetic composition comprising from 0.5% to 2.4% by weight of component A with respect to the total weight of the composition; and from 0.1% to 1.9% by weight of component B with respect to the total weight of the composition.
[0088]
[0089] In one embodiment, the composition is a cosmetic composition comprising from 0.8% to 2% by weight of component A with respect to the total weight of the composition; from 0.15% to 1% by weight of component B with respect to the total weight of the composition. In one embodiment, the composition is a cosmetic composition comprising 1% by weight of component A with respect to the total weight of the composition and 0.2% by weight of component B with respect to the total weight of the composition.
[0090]
[0091] In one embodiment, when the composition is in the form of a shampoo, then the composition comprises from 0.5% to 2% by weight of component A with respect to the total weight of the composition; and from 0.1% to 1.9% of component B with respect to the total weight of the composition. In one embodiment, when the composition is in the form of a lotion, then the composition comprises from 2.5% to 4% by weight of the component A with respect to the total weight of the composition; and from 2% to 5% of component B with respect to the total weight of the composition.
[0092]
[0093] In one embodiment, the composition of the invention comprises a weight ratio of the amount of the component A to the amount of the component B is from 7: 1 to 1: 3. The term "weight ratio" refers to the weight ratio of the amount of component A to the amount of component B comprising polysaccharide comprising repeat structural units of formula (I) that is needed to promote the improvement of the general condition of the hair and the scalp as mentioned in the present invention. In one embodiment, when the composition is in the form of a shampoo, then the weight ratio of the amount of component A to the amount of component B is from 6: 1 to 3: 1; preferably from 5: 1 to 4: 1. In one embodiment, when the composition is in the form of a lotion, then the composition of the invention comprises a weight ratio of the amount of the component A to the amount of the component B is from 4: 1 to 1: 2; preferably from 2: 1 to 1: 1.
[0094]
[0095] As mentioned, the composition of the invention comprises one or more pharmaceutically or cosmetically acceptable excipients and / or carriers. The term "pharmaceutically acceptable excipients and / or carriers" refers to excipients or carriers suitable for use in pharmaceutical technology for the preparation of compositions for medical use. In one embodiment, optionally in combination with one or more characteristics of the various embodiments described above or below, the pharmaceutical composition is selected from the group consisting of a medicament and a sanitary product. And, the term "cosmetically acceptable excipients and / or vehicles" or "dermatologically acceptable topical excipients and / or vehicles" which is used interchangeably herein refers to excipients or carriers suitable for use in contact with hair or hair. Scalp without toxicity, incompatibility, instability, and inappropriate allergic response, among others.
[0096]
[0097] The compositions of the present invention can be prepared by methods well known in the art. The excipients and / or carriers Suitable amounts, and their amounts, can be easily determined by the person skilled in the art according to the type of formulation to be prepared.
[0098]
[0099] In one embodiment, the composition of the invention is a topical pharmaceutical or cosmetic composition. For the purposes of the invention, the term "topical" refers to the local application on the skin, hair, scalp or mucosal surfaces of the body.
[0100]
[0101] The topical compositions defined above comprise excipients or carriers suitable for topical administration which may be pharmaceutical or cosmetic excipients and include, without limitation, moisturizing agents, stabilizing agents, emollients, emulsifiers, surfactants, thickeners, humectants, pH regulating agents. , antioxidants, preservatives, fillers, a vehicle or its mixtures. The excipients or carriers used have affinity for the skin, are well tolerated, stable, and are used in an appropriate amount to provide the desired consistency and ease of application.
[0102]
[0103] The term "emollient agent" refers to a material that softens and softens the skin to correct the dryness and desquamation of the skin, lubricating the surface of the skin, improving water retention of the skin, and altering the textures of the product .
[0104] Examples of suitable topical emollient agents include, without limitation, octyl hydroxystearate, lanolin, triglycerides of caprylic / capric acids, cetyl palmitate, octyl dodecanol, cetyl alcohol, isopropyl isostearate, glyceryl dilaurate, isopropyl myristate, palm alcohol, dimethicone, squalene, plukenetia volubilis seed oil, butyrospermum parkii butter (shea butter), sucrose cocoate, or mixtures thereof.
[0105] Preferably the emollient is selected from the group consisting of dimethicone, squalene, plukenetia volubilis seed oil, butyrospermum parkii butter, triglycerides of caprylic / capric acids, octyldodecanol, or mixtures thereof.
[0106]
[0107] The terms "emulsifying agent" or "emulsifier", which are used interchangeably herein, refer to a material that reduces surface tension, promoting the formation of intimate mixtures of immiscible liquids by altering the interfacial tension. The emulsifier stabilizes an emulsion by increasing its kinetic stability. Examples of suitable emulsifiers include, without limitation, glyceryl trioleate, glyceryl oleate, sucrose acetylate distearate, sorbitan trioleate, polyoxyethylene monostearate, glycerol monooleate, sucrose distearate, polyethylene glycol monostearate, octyl phenoxy poly (ethyleneoxy) ) ethanol, deacrylline penta-isostearate, sorbitan sesquioleate, hydroxylated lanolin, lecithin, lanolin, triglyceryl diisostearate, polyoxyethyleneleyl ether, sodium stearoyl 2-lactylate, lauroyl sodium lactylate, sodium stearoyl lactylate, sodium glucoside, cetearyl, methylglucoside sesquistearate, sorbitan monopalmitate, methoxy polyethylene glycol-22 / dodecyl glycol copolymer, polyethylene glycol-45 / dodecyl glycol copolymer, glyceryl stearate and polyethylene glycol distearate 400, polyglyceryl-3 esters of candelilla / jojoba / bran rice , cetyl phosphate, cetyl and potassium phosphate, or mixtures thereof. Preferably, the emulsifier is selected from the group consisting of glyceryl oleate, lecithin, lauroyl lactylate and sodium, stearoyl and sodium lactylate, glyceryl stearate, polyglyceryl-3 esters of candelilla / jojoba / bran rice and mixtures thereof.
[0108]
[0109] The term "surfactant" or "surfactant" refers to a material that decreases the surface tension of a liquid and the interfacial tension between two liquids, allowing them to spread more easily. Surfactants have a hydrophilic head that is attracted to water molecules and a hydrophobic tail that repels water and simultaneously binds to oil and grease from dirt. These opposing forces descaling the dirt and suspend it in the water, presenting the ability to remove it from surfaces, such as human skin, textiles and other solids, when the surfactant is dissolved in water. Examples of suitable surfactants include, without limitation, nonionic, ionic (both anionic and cationic) or zwitterionic (or amphoteric surfactants where the head of the surfactant contains two groups charged oppositely). Examples of anionic surfactants include, without limitation, those based on sulfate, sulfonate or carboxylate anions such as perfluorooctanoate (PFOA or PFO), alkylbenzene sulfonate, soaps, salts of fatty acids, or salts of alkyl sulfate, for example , perfluorooctanesulfonate (PFOS), sodium dodecylsulfate (SDS), sodium lauryl sulfate, or sodium lauryl ether sulfate (SLES). Examples of cationic surfactants include, without limitation, those based on quaternary ammonium cations such as for example alkyltrimethylammonium including cetyl trimethylammonium bromide (CTAB) aka, or hexadecyl trimethyl ammonium bromide, cetylpyridinium chloride (CPC), polyethoxyethylamine (POEA), benzalkonium chloride (BAC), or benzethonium chloride (BZT). Examples of zwitterionic surfactants include, without limitation, dodecyl betaine, cocamidopropyl betaine, or coconut ammoglycinate. Examples of non-ionic surfactants include, without limitation, alkyl polyethylene oxide, polyethylene oxide of alkylphenol, poly (ethylene oxide) copolymers, polypropylene oxide (commercially referred to as poloxamers) or Poloxamines), alkyl polyglucosides including alkyl glucoside and decyl maltoside, fatty acids including, cetyl alcohol and oleyl alcohol, cocamide MEA, cocamide DEA, or polysorbates including tween 20, tween 80, or dimethylamine dodecyl oxide. Preferably, the surfactant is suitable for skin and foaming, including polysorbate 20 or 40, coconut glucoside, lauryl glucoside, decyl glucoside, lauryl sulfates such as, for example, ammonium, sodium, magnesium, MEA, trimethylamine (TEA), or mipa lauryl sulfate, cocamidopropyl betaine, or sodium alkylsulfosuccinates.
[0110]
[0111] The term "wetting agent" refers to a hygroscopic material that attracts water molecules from the surrounding medium either by absorption or adsorption, preventing the skin from losing moisture Examples of suitable topical humectants include, without limitation, glycerin, diglycerin , ethylhexylglycerin, glucose, honey, lactic acid, polyethylene glycol, propylene glycol, sorbitol, sucrose, or trehalose.
[0112] Preferably, the humectant is selected from the group consisting of glycerin, diglycerin, ethylhexylglycerin, and mixtures thereof.
[0113]
[0114] The term "pH regulating agent" refers to acids or bases that can be used to adjust the pH of the finished product to the desired level without affecting the stability of the solution. Examples of topical pH regulating agents include, but are not limited to, acetic acid, lactic acid, citric acid, ethanolamine, formic acid, oxalic acid, potassium hydroxide, sodium hydroxide, triethanolamine, or mixtures thereof Preferably, the pH regulating agent is selected from the group consisting of triethanolamine, sodium hydroxide , lactic acid, and citric acid.
[0115]
[0116] The term "antioxidant" refers to a material that slows or prevents the oxidation of other molecules.Antioxidants include free radical scavengers and reducing agents. Examples of suitable antioxidants include, without limitation, free radical scavengers or reducing agents such as, for example, acetylcysteine, ascorbic acid, ascorbyl palmitate, butylated hydroxytoluene, green tea extract, caffeic acid, cysteine, tocopherol, ubiquinone, gallate propyl, butylated hydroxytoluene (BHT), and mixtures thereof. Preferably, the antioxidant agent is selected from the group consisting of ascorbyl palmitate and tocopherol.
[0117]
[0118] The term "preservative" refers to a material that prevents or reduces or slows microbial growth without affecting the stability of the solution. Examples of suitable preservatives include, but are not limited to, benzoic acid, butylparaben, ethylparaben, propylparaben, methylparaben, sorbic acid, potassium sorbate, sodium benzoate, phenoxyethanol, triclosan, or mixtures thereof. Preferably, the preservative is selected from the group consisting of potassium sorbate, sodium benzoate, and phenoxyethanol.
[0119]
[0120] The term "bulking agent" refers to a material that is in the solid state that allows to stabilize the active ingredients, specifically extracts, and facilitates their incorporation into the formulations. Examples of suitable fillers include, without limitation, silica, nylon powder, maltodextrins, talc or mixtures thereof.
[0121]
[0122] The term "chelating agent" refers to that compound that is capable of complexing one or more metal ions such as iron, copper and lead. Examples of suitable chelating agents include, without limitation, salts of edetic acid such as edetate disodium, calcium disodium edetate, tetrasodium edetate, trisodium edetate; Ethylenediaminetetraacetic acid; trisuccionato ethylene diamine or their mixtures; preferably, the chelating agent is ethylenediaminetetraacetic acid.
[0123]
[0124] The term "thickening agent" or "thickener" or "viscosity agent" or "viscosifying agent", which are used interchangeably herein, refers to a material that increases its viscosity without substantially modifying its other properties. Examples of suitable thickening agents include, without limitation, cellulose or its derivatives such as hydroxypropyl methylcellulose, polyethylene glycol, microcrystalline cellulose, cetearyl alcohol, alginates, branched polysaccharides, pyrogenic silica, xanthan gum, carbomer, and polyacrylates.
[0125]
[0126] The compositions mentioned above may also include a carrier (also referred to as a solvent or solubilizer). Examples of vehicle include, without limitation, water, propylene glycol, butylene glycol, ethanol, isopropanol or silicones.
[0127] Preferably, the vehicle is water or ethanol.
[0128]
[0129] The compositions of the present invention may contain other ingredients, such as, for example, fragrances, dyes, skin, hair or scalp conditioning agents and other components known in the state of the art concerning topical formulations. Additionally, the compositions of the present invention may contain other ingredients, such as, for example, vitamins, minerals, sunscreens, additional plant extracts and sugars.
[0130]
[0131] The topical compositions of the invention can be formulated in various ways including, without limitation, gel, cream, emulsion, lotion, ointment, ointment, solution, mousse, foams, sprays, paste, shampoo, conditioner, mask, toners, serums , tablets, capsules and dyes. In one embodiment, the composition of the invention is in the form of a shampoo or lotion.
[0132]
[0133] In one embodiment, the topical composition used is formulated in the form of an emulsion. The term "emulsion" refers to a dispersed system comprising at least two immiscible phases, one phase dispersed in the other in the form of droplets.The emulsifying agents mentioned above are included to improve stability.When the dispersed phase is water and the Oil is the medium of dispersion, the emulsion is called water-in-oil emulsion (w / o) When the oil is dispersed as drops in the aqueous phase, the emulsion is called oil in water (o / w). Other types of emulsions known in the state of the art are multiple emulsions, such as water-in-oil-in-water emulsions (w / o / w), GELTRAP emulsions, where the internal aqueous phase is gelled and is covered by the oil phase , and SWOP emulsions, also known as investment emulsions.
[0134] Preferably, the emulsions used are oil-in-water emulsions.
[0135] Preferably, the emulsions for use in the present invention are compatible with creams and lotions.
[0136] In one embodiment, the topical composition used is formulated in the form of surfactant base. The terms "surfactant base" or "surfactant system", which are used interchangeably herein, refer to a mixture of one or more surfactants, preferably anionic or amphoteric surfactants, which tend to form spherical micelles which are isotropic with low viscosity , or tend to form crystalline liquid phases of lamellar and hexagonal phases, which are anisotropic with higher viscosity. A surfactant base is a mixture of at least two surfactants. Surfactants are commonly used in cleaning products, removing dyes and keeping dirt in the aqueous solution to prevent re-deposition on the surface. The surfactants disperse the dirt that normally does not dissolve in water, allowing its dispersion in water, and its elimination with the washing water. The surfactants mentioned above are included to decrease the surface tension. Preferably, the surfactant bases for use in the present invention are compatible with rinse-off products (such as rinse-off) such as for example shampoos, shower gel and body or facial cleansers.
[0137]
[0138] In one embodiment, the topical composition used is formulated as a solution. The term "solution" refers to a chemically and physically homogeneous mixture of two or more substances.The solution may comprise a solid dispersed in a liquid, solid or semi-solid medium.Preferably, the solutions are compatible with products without rinsing (also called leave-on) as for example the hair lotions of the present invention.
[0139]
[0140] In one embodiment, the composition of the invention is a shampoo comprising the following excipients:
[0141]
[0142] From 0.2% to 5% by weight of one or more solvents;
[0143] From 10% to 25% by weight of one or more surfactants and / or emulsifiers;
[0144] From 0.05% to 2% by weight of one or more skin and hair conditioning agents
[0145] From 0.1% to 1% by weight of one or more preservatives;
[0146] From 0.08% to 0.4% by weight of one or more chelating agents;
[0147] From 1% to 4% by weight of one or more viscosity controlling agents; and from 0.4% to 1.5% by weight of one or more pH regulating agents.
[0148] In one embodiment, the composition of the invention is a lotion comprising the following excipients:
[0149]
[0150] From 0.2% to 3% by weight of one or more emollients;
[0151] From 15% to 32% by weight of one or more solvents;
[0152] From 0.03% to 1% by weight of one or more preservatives;
[0153] From 0.4% to 2% by weight of one or more skin conditioning agents and / or softeners; Y
[0154] From 0.1% to 1.5% by weight of one or more surfactants.
[0155]
[0156] The second aspect of the invention relates to a composition characterized in that it also comprises one or more additional active ingredients. In one embodiment, the composition characterized in that it further comprises one or more additional active ingredients selected from the group consisting of anti-dandruff agent, anti-fall agent, calming agent, anti-seborrhea agent, and mixture thereof.
[0157]
[0158] In one embodiment, the composition further comprises one or more antidandruff agents. The term "anti-dandruff agent" refers to one or several ingredients that act against the appearance of dandruff.Dandruff is a disorder of the skin characterized by massive desquamation of the stratum corneum.It is a common alteration in men and women of all ages. ages, which occurs equally in both sexes and often causes skin irritation and discomfort to those who suffer from it Examples of antidandruff agents suitable for the present invention include, without limitation, cytostatic agents that slow down the rate of cell division such as zinc pyrithione and selenium disulfide, antimicrobial agents with action against Malasezzia furfur such as pyroctone olamine and essential oil of tea tree.
[0159]
[0160] In one embodiment, the composition further comprises one or more anti-dropping agents. The term "anti-fall agent" refers to one or several ingredients that act against hair loss, which occurs when the loss of hair causes the reduction of hair population (capillary density) Examples of anti-fall agents suitable for the present invention include, without limitation, blood-boosting agents such as minoxidil and derivatives, menthol, caffeine, nutritional agents such as sulfur-containing amino acids, protein hydrolysates, vitamins; inhibitors of the enzyme 5-alpha-reductase as plant extracts of saw palmetto and hops; and mix them.
[0161]
[0162] In one embodiment, the composition further comprises one or more calming agents. The term "calming agent" refers to one or several ingredients that act to reduce irritation or inflammation, itching and discomfort of the sensitive scalp.The scalp, being a highly vascularized and innervated area, is more sensitive than the rest of the skin. When the scalp is irritated, the vascularity is altered and directly affects the health of the hair.The stratum corneum of the scalp is more disorganized than other areas of the body, due to this, cell renewal is faster and In some situations, it shows an increased sensitivity to some external or internal stimuli, and it responds with redness, itching and desquamations Examples of calming agents suitable for the present invention include, without limitation, ingredients that irritation like bisabolol, vegetable extracts of aloe, calendula and chamomile; edientes that prevent scaling and hydrate the scalp such as glycerin and panthenol; nutritive agents such as phospholipids, ceramides and vegetable oils; and mixtures thereof.
[0163]
[0164] In one embodiment, the composition further comprises one or more anti-seborrhea agents. The terms "anti-fat agent" or "anti-seborrhea agent" have the same meaning and are used interchangeably. They refer to one or several ingredients that act by decreasing the excess of sebaceous secretion. Seborrhea is an alteration of the sebum quantity and composition of the sebaceous glands. Examples of anti-seborrhea agents suitable for the present invention include, without limitation, ingredients that control excess fat secretion such as inhibitors of the enzyme 5-alpha-reductase such as plant extracts of saw palmetto, squash and hops; sulfur derivatives such as sulfur amino acids; antioxidant ingredients that prevent rancidity of excess sebum such as tocopherol acetate; astringent ingredients that reduce pore size such as zinc salts; and mixtures thereof.
[0165] The third aspect of the present invention relates to the pharmaceutical composition of the first aspect of the invention for use in the prevention and / or co-adjuvant treatment of a disease or condition of the skin, hair and scalp. The term "adjuvant treatment" as used herein refers to a treatment that contributes, assists or helps improve, cure or alleviate a disease or condition. In particular, the composition of the first aspect of the present invention improves the general condition of the skin, hair and scalp. This aspect can also be formulated as the use of the pharmaceutical composition as defined above for the preparation of a medicament for the prophylaxis and / or adjuvant treatment of a disease or condition of the skin, hair and scalp. It also relates to a method for the prophylaxis and / or adjuvant treatment of a disease or condition of the skin, hair and scalp where the method comprises administering an effective amount of the pharmaceutical composition of the present invention to a mammal that need such treatment.
[0166]
[0167] In one embodiment, the composition of the invention is an anti-hair loss shampoo comprising the following excipients and additional active ingredients:
[0168] From 0.2% to 5% by weight of one or more solvents;
[0169] From 10% to 25% by weight of one or more surfactants;
[0170] From 0.05% to 2% by weight of one or more skin and hair conditioning agents
[0171] From 0.1% to 1% by weight of one or more preservatives;
[0172] From 0.08% to 0.4% by weight of one or more chelating agents;
[0173] From 1% to 4% by weight of one or more viscosity controlling agents; From 0.4% to 1.5% by weight of one or more pH regulating agents;
[0174] From 0.003% to 0.1% by weight of hydrolelic root extract of Scutellana baicalensis; Y
[0175] From 0.05% to 2% by weight of diaminopyrimidine oxide (as an anti-fall agent).
[0176]
[0177] In one embodiment, the composition of the invention is an anti-drop lotion comprising the following excipients and additional active ingredients:
[0178] From 0.2% to 3% by weight of one or more emollients;
[0179] From 15% to 32% by weight of one or more solvents;
[0180] From 0.03% to 1% by weight of one or more preservatives;
[0181] From 0.4% to 2% by weight of one or more skin conditioning agents and / or softeners; Y
[0182] From 0.1% to 1.5% by weight of one or more surfactants;
[0183] From 0.001% to 0.1% by weight of one or more antioxidants;
[0184] From 0.2% to 2% by weight of diaminopyrimidine oxide (as anti-fall agent); Y
[0185] From 0.001% to 0.01% by weight of aqueous extract of Epilobium angustifolium (as anti-fall agent).
[0186]
[0187] The fourth aspect of the present invention relates to the pharmaceutical composition of the second aspect of the present invention for use in the treatment and / or prevention of a disease or condition of the skin, hair and scalp. This aspect can also be formulated as the use of the pharmaceutical composition as defined above for the preparation of a medicament for the prophylaxis and / or treatment of a disease or condition of the skin, hair and scalp. It also relates to a method for the prophylaxis and / or treatment of a disease or condition of the skin, hair and scalp where the method comprises administering an effective amount of the pharmaceutical composition of the present invention to a mammal in need. said treatment.
[0188]
[0189] In one embodiment, the disease or condition of the skin, hair and scalp are selected from the group consisting of dandruff, fat, hair loss, sensitive skin, dermatitis such as seborrhoeic dermatitis or contact dermatitis and allergies.
[0190]
[0191] This aspect can also be formulated as the use to treat dandruff, fat, hair loss, sensitive skin, dermatitis such as seborrheic dermatitis or contact dermatitis and allergies.
[0192]
[0193] The cosmetic composition of the first aspect of the present invention can be used for the care of the skin, hair and scalp. Thus, the fifth aspect of the present invention relates to the cosmetic use of the composition of the invention as a skin, hair and scalp care agent, where the care of the skin, hair and scalp comprises improving at least one of the following symptoms: roughness, peeling, dehydration, elasticity, flexibility, volume of the skin. hair, hair shine, redness and irritation. Therefore, the cosmetic compositions defined above are used for a non-medical application.
[0194]
[0195] Throughout the description and the claims the word "comprises" and its variants do not intend to exclude other technical characteristics, additives, components or steps. In addition, the word "comprises" includes the case "consists of". For those skilled in the art, other objects, advantages and characteristics of the invention will emerge partly from the description and partly from the practice of the invention. The following examples and drawings are provided by way of illustration, and are not intended to be limiting of the present invention. In addition, the present invention covers all possible combinations of particular and preferred embodiments indicated herein.
[0196]
[0197] DETAILED EXHIBITION OF REALIZATION MODES
[0198]
[0199] Although only certain embodiments and particular examples of the invention have been described here, the skilled person will understand that other alternative embodiments and / or uses of the invention are possible, as well as obvious modifications and equivalent elements.
[0200]
[0201] EXAMPLE 1. Coadjuvant composition
[0202]
[0203] 1.1. Hair lotion
[0204]
[0205] The composition of the hair lotion 1 of the present invention is that shown in Table 1, where the amounts of the ingredients are expressed as a percentage by weight with respect to the total weight of the composition:
[0206] Table 1
[0207]
[0208]
[0209]
[0210] c.s.p. it is the abbreviation of the sufficient quantity to reach 100% by weight.
[0211] Another composition of the present invention is the hair lotion 2 which is shown in Table 2, where the amounts of the ingredients are expressed as a percentage by weight with respect to the total weight of the composition:
[0212] Table 2
[0213]
[0214]
[0215]
[0216]
[0217] c.s.p. it is the abbreviation of the sufficient quantity to reach 100% by weight.
[0218]
[0219] 1.2. Preparation procedure
[0220]
[0221] In a container, equipped with paddle agitator (planetary) and turbine (homogenizer), the water was incorporated. The emollients and preservatives were then slowly added by gentle stirring at room temperature. The solvents were then slowly added with a planetary stirrer under agitation.
[0222]
[0223] The resulting mixture was homogenized for about 2 minutes under vacuum conditions (0.5-0.6 Atm). Subsequently, 3g of component B was added for 100g of capillary lotion comprising a polysaccharide comprising a backbone of repeating structural units of formula (I) (commercially available as defined above), and the resulting mixture was homogenized for about 2 minutes.
[0224]
[0225] Next, 3 g of component A was added for 100 g of hair lotion comprising the germinated extracts of Glycine soya, germinated germinated extract and the germinating extract of Scutellaria Baicalensis (which is commercially available as defined above) as well as the skin conditioning agents, softeners and humectants maintaining smooth agitation with planetary and turbine for approximately 2 min until total solubilization. All this process is carried out at room temperature.
[0226] EXAMPLE 2. Anti-fall composition
[0227]
[0228] 2.1. Hair loss lotion
[0229]
[0230] The composition of the anti hair loss hair lotion 1 of the present invention is that shown in Table 3, where the amounts of the ingredients are expressed as a percentage by weight with respect to the total weight of the composition:
[0231]
[0232] Table 3
[0233]
[0234]
[0235]
[0236] c.s.p. it is the abbreviation of the sufficient quantity to reach 100% by weight.
[0237]
[0238] Another composition of the present invention is the anti hair loss hair lotion 2 which is shown in Table 4, where the amounts of the ingredients are expressed as a percentage by weight with respect to the total weight of the composition:
[0239] Table 4
[0240]
[0241]
[0242] csp is the abbreviation of the sufficient amount to reach 100% by weight. The hair loss lotions described in the present invention are in the form of ampoules that were prepared by the following procedure:
[0243]
[0244] In a first container, equipped with paddle stirrer (planetary) and turbine (homogenizer), the water was incorporated. Subsequently, the hair conditioner, the emollients and the preservatives were incorporated with gentle agitation and at room temperature. The resulting mixture was homogenized for about 2 minutes under vacuum (0.5-0.6 Atm).
[0245]
[0246] In a second container, the pre-mix of the perfume was prepared with the solubilizers heated to a temperature between 38-40 ° C under gentle agitation until total homogenization. Then, this pre-mixture was incorporated into the solvent; and the resulting mixture was added to the first vessel by agitation (planetary and turbine) until complete homogenization.
[0247]
[0248] Subsequently, the planetary agitator was kept running and 3 g of component B was added to the reactor for 100 grams of anti-hair capillary lotion containing the polysaccharide (commercially available as described above), and then homogenized for about 2 minutes.
[0249]
[0250] Next, 3 g of component A were added for 100 grams of hair fall prevention lotion containing the germinated extracts of Glycine soya, germinated germinated extract and the germinating extract of Scutellaria Baicalensis (commercially available as described above) , as well as skin conditioning agents, softening and moisturizing agents, maintaining gentle agitation (planetary and turbine) for approximately 2 minutes until total solubilization.
[0251]
[0252] 2.2. Hair loss hair shampoo
[0253]
[0254] The hair loss hair shampoo composition 1 of the present invention is the one shown in Table 5, where the amounts of the ingredients are expressed as a percentage by weight with respect to the total weight of the composition:
[0255] Table 5
[0256]
[0257]
[0258] Another composition of the present invention is the hair loss hair shampoo 2_ which is shown in the following table:
[0259]
[0260]
[0261]
[0262] c.s.p. it is the abbreviation of the sufficient quantity to reach 100% by weight.
[0263]
[0264] The hair loss hair shampoo described in the present invention was prepared by the following procedure:
[0265]
[0266] In the main vessel, equipped with blade agitator (i.e. planetary agitator) and turbine (i.e. homogenizer), the surfactants were incorporated, which were mixed and homogenized at a smooth speed until the mixture remained homogeneous. To the resulting mixture, the perfume and water were slowly incorporated by shaking with the planetary stirrer and slow turbine until full incorporation. Subsequently, vacuum was applied and capillary conditioning agents, chelating agents, preservatives and diaminopyrimidine oxide were added, maintaining the planetary agitation and slow turbine during its addition until its total incorporation.
[0267]
[0268] Subsequently, approximately 80% of the thickeners and viscosity control agents were incorporated, maintaining the planetary agitation and slow turbine during its addition until its full incorporation. To the resulting mixture was added the polysaccharide comprising a main chain of repeated structural units of formula (I) maintaining the planetary and slow turbine agitation during its addition until its full incorporation.
[0269] Subsequently the pH was adjusted by the addition of the pH regulating agents by shaking with planetary and slow turbine until its full incorporation. In addition, the viscosity was adjusted with the other viscosity controllers (ie the remaining 20%) by shaking with planetary and slow turbine until full incorporation. Finally, the extracts of Scutellaria baicalensis, Glycine soya and Triticum vulgare were incorporated maintaining the agitation with planetary and slow turbine until its total incorporation to obtain the hair fall prevention shampoo of the present invention.
[0270]
[0271] 2.3. Oral fall prevention tablets
[0272]
[0273] The composition of the oral anti-hair loss tablets 1 of the present invention is that shown in Table 6, where the amounts of the ingredients are expressed as a percentage by weight with respect to the total weight of the composition:
[0274]
[0275] Table 6
[0276]
[0277]
[0278] Another composition of the present invention are the oral fall prevention tablets 2 shown in the following table:
[0279] Table 7
[0280]
[0281]
[0282]
[0283]
[0284] The oral fall prevention tablets described in the present invention were prepared by the following procedure:
[0285]
[0286] A) Preparation of tablet cores:
[0287] In a first phase, the active ingredients were weighed and sieved through a light mesh <1.0mm in the mixing vessel at a speed of 7 rpm and for 22 minutes. The stabilizers and anti-caking agents were then weighed and sieved and mixed at 7 rpm for 8 minutes.
[0288]
[0289] The resulting mixture was loaded into the hopper of the rotary compression machine, with the following compression parameters:
[0290] -Height: 6.8-7.2 mm
[0291] -Weight: 650 mg
[0292] -Hardness: 65-85 KN
[0293] -Speed rotating machine: 21 rpm
[0294]
[0295] The average weight of the cores of the tablets obtained is 650 mg.
[0296]
[0297] B) Coating of tablet cores
[0298]
[0299] Next, the cores of the tablets obtained in the previous step were coated with the homogeneous mixture resulting from mixing the coating agents, the stabilizers, the dyes, the anti-caking agents, and were added to the osmotized water until complete homogenization.
[0300]
[0301] The conditions for coating the cores of the tablets are carried out under the following conditions:
[0302]
[0303] -The drum is preheated to these conditions:
[0304] Entry temperature: 60 ° C
[0305] Output temperature: 45 ° C
[0306] Drum speed: 3 rpm
[0307] Peristaltic pump: 4.5 mm
[0308] Time: 10 min
[0309]
[0310] - After introducing the Cores to be coated and proceeding to the coating under the following conditions:
[0311]
[0312] Entry temperature: 70-80 ° C
[0313] Output temperature: 40-43 ° C
[0314] Product temperature: 35-38 ° C
[0315] ATOM air: 0.25 MPa
[0316] Air Pressure: 0.25 MPa
[0317] Peristaltic pump: 10 mm
[0318] Time: 50 min
[0319] Drum speed: 10 rpm
[0320] Quantity Coating 2%
[0321]
[0322] The initial average weight of the nuclei is 650 mg.
[0323] The final average weight of the coated tablets is 663 mg.
[0324]
[0325] - The coated tablets were cooled to a temperature ranging from 28 ° C to 33 ° C.
[0326]
[0327] EXAMPLE 3: In vivo efficacy studies of the adjuvant composition 2
[0328]
[0329] The objective of the present study is the evaluation of the improvement in the scalp and the increase of the density of the hair. Another objective of this study is also to evaluate the increase in hair strength, increase in vitality, reduction of hair loss, increase in the number of new hair, as well as problems related to organoleptic characteristics and tolerance of treatment.
[0330]
[0331] 3.1. Type of study
[0332] This study was carried out in a single center with a group of 20 volunteers with sensitive hair and scalp loss. The study was carried out in accordance with the standard operating procedure of the Capilar Technology Center, S.L. shown below and in compliance with the standards set out in the Guide for Research on Human Beings and the guidelines of the Scientific Committee on Consumer Safety ("International ethical guidelines for biomedical research involving human subjects." Council for International Organizations of Medical Sciences Available on the website of the "World Health Organization" http://www.who.int/ethics/research/en/ on July 25, 2017).
[0333]
[0334] 3.2. Duration of the study
[0335] The study was conducted for 90 days. During this period of time, various tests were carried out. The tests performed and the times are detailed below:
[0336] - At time zero (T0) and at 90 days (T90): General photograph of the hair.
[0337] TrichoScan®
[0338] Volunteer surveys
[0339] Dermatological control of volunteers - On time 45 days (T45): Volunteer surveys
[0340]
[0341] 3.3. Attributes under study
[0342] The following attributes were evaluated in this study:
[0343] - General appearance of the hair
[0344] - Increase / decrease in capillary density
[0345] - Volunteer surveys
[0346]
[0347] 3.4. Equipment and material
[0348] To carry out this study, the following equipment and materials were needed: Canon EOS 600D digital camera
[0349] -TrichoScan®, Tricholog GmbH, Germany
[0350] Digital microscope Dino-Lite Pro (micro camera), Naarden, The Netherlands
[0351] Light microscope
[0352] - Pean Clamp
[0353] - Disposable plastic layers
[0354] - Comb, towels and envelopes
[0355]
[0356] 3.5. Volunteers
[0357] The study was carried out with 20 volunteers (15 women and 5 men) aged between 18 and 60 years. The criteria for selecting such volunteers are summarized below:
[0358]
[0359] Inclusion criteria:
[0360] -18 to 60 years old
[0361] - Healthy volunteers with sensitive skin
[0362] - There is no evidence of systemic diseases (eg, heart disease or psychiatric)
[0363] - Relationship phase anagen / phase telogen (A / T) <4 (loss of hair for different reasons)
[0364] - Men: grades II-IV on the Hamilton Norwood scale (see Norwood OT. "Male pattern baldness: classification and incidence." South Med J. 1975, vol.68 (11), pp.1359-65); : grades I-II on the Ludwig scale (see Venning V et al.
[0365] "Patterned androgenetic alopecia in women." J. Am. Acad. Dermatol., 1988, vol.18 (5), pp. 1073-1077).
[0366] - Without treatment with anti-hair loss products in the last 6 months
[0367] - Commitment not to use topical, systemic or oral administration compositions with an effect similar to that of the products to be tested throughout the study period
[0368] - Do not change the daily routine
[0369] - Commitment to maintain the same length of hair in the various visits to the CTC.
[0370] - Have signed the written consent and be informed of the objective of the study. - Sufficient motivation and availability
[0371]
[0372] Criteria for non-inclusion / exclusion:
[0373] - Do not sign the written consent
[0374] - Allergy or hypersensitivity to any of the ingredients of the products tested
[0375] - Having diseases of the scalp such as psoriasis or dermatitis. - Be under medical treatment with an active substance that may cause alopecia, such as fluoxetine, anticoagulants and retinoids.
[0376] - Be using nutricosmetics to reduce hair loss.
[0377] - Modification of the normal diet such as hypocaloric diet or Atkins diet. - Pregnant volunteers.
[0378]
[0379] 3.6. Samples
[0380] The samples tested were the following:
[0381] - Adjuvant lot 2 of the present invention
[0382] - Hair fall prevention shampoo 2 of the present invention
[0383] 3.7. Protocol
[0384] A) Before the beginning of the study (T-2):
[0385] The volunteers did not wash their hair 48 hours before the first visit and did not comb 24 hours before this visit (T0).
[0386]
[0387] B) Time zero (T0):
[0388] During the first visit, a specialist performed the following tests: General photograph of the hair; Trichoscan®; survey of volunteers and dermatological control.
[0389]
[0390] C) During the treatment in the homes of the volunteers:
[0391] The volunteers applied the treatment according to the following guidelines and with the following frequency:
[0392] i) Adjuvant lotion 2 of the present invention: Daily the first two months, 3 times a week the rest of the treatment. The lotion was applied as follows: apply the lotion (5 ml) daily, preferably at night; massage gently with the fingertips to help absorption and not rinse; Y
[0393]
[0394] ii) Washing with hair fall prevention shampoo 2 of the present invention three times a week. The shampoo was applied as follows: Wet the hair with plenty of water; apply 5 g of shampoo in the hand and spread with both hands; massage gently with the fingertips; and rinse with plenty of water.
[0395]
[0396] D) Time 45 days (T45)
[0397] The volunteers did not wash their hair 48 hours before the visit, and did not comb their hair 24 hours before this visit. During the visit, a specialist conducted the following test: volunteer survey.
[0398]
[0399] E) Time 90 days (T90)
[0400] The volunteers did not wash their hair 48 hours before the visit, and did not comb their hair 24 hours before this visit. During the visit, a specialist carried out the following test: General photograph of the hair; Trichoscan®; Volunteer survey and dermatological control
[0401]
[0402] 3.8. Tests carried out
[0403] - General photograph of the hair: In T0 and T90 several photographs of the upper part of the scalp were taken. The images show the temporal and vertex (crown) areas of all the volunteers. The objective was to see if the study treatment visually improves the quality and appearance of the hair.
[0404]
[0405] -Density of hair: hair density is defined as the number of hair present in a unit area (usually cm2). The hair density was calculated from the images of the scalp taken with the TrichoScan® micro camera on T0 and T90. For this, the computer program associated with TrichoScan® was used, allowing the manual count of the number of hair present in an area equal to 0.25 cm2 of scalp. For the comparison between the number of hairs present at the end and at the beginning of the study, the increase in the number of hairs in that area was established and the capillary density could be calculated at the end of the study. -Study of the volunteers: In T0, T45 and T90 the volunteers evaluated the general appearance of their hair.
[0406]
[0407] -Control dermatological: In T0 and T90 the dermatologist evaluated the status of the scalp of the volunteer
[0408]
[0409] 3.9. Results
[0410]
[0411] After 90 days of treatment, an increase in hair density of 6.40% was observed and 74% of the volunteers noticed a reduction in hair loss. The increase in hair density at the end of the study is a proof of the effectiveness of the regeneration treatment.
[0412]
[0413] Likewise, around 67% of the volunteers noticed an improvement in the shine and volume of their hair and 78% of the volunteers considered their hair stronger and more vital.
[0414]
[0415] Additionally, the volunteers also noticed a reduction of the fat aspect and dandruff on the scalp by 69% and 79% respectively at the end of the treatment. A reduction in redness of the scalp was also detected in 35% of the cases evaluated and an improvement in the vascularity of the scalp in the 10% of the volunteers at the end of the treatment.
[0416]
[0417] Finally, the treatment of the present invention has a stabilizing effect on the scalp with a tendency to flake off. Specifically, 80% of the volunteers showed less scales at the end of the treatment and a reduction in sensitivity in 79% of the volunteers and a reduction in the scalp itch in 74% of the volunteers.
[0418]
[0419] In conclusion, 64% of the volunteers are satisfied with the treatment and 74% believe that their hair looks brighter, healthier and has more volume.
[0420]
[0421] EXAMPLE 4: In vivo efficacy studies of an anti-hair loss treatment of the present invention
[0422]
[0423] The objective of the present study is to evaluate the reduction of hair loss as well as the regeneration, hair growth and volume. Another objective of the present study is also to evaluate the number of hairs that are in the anagen phase before and after treatment.
[0424]
[0425] This study was also completed with the evaluation of the treatment by self-perception of the volunteer of the different aspects: increase of hair strength, increase of vitality, reduction of hair loss, increase of the number of new hair, as well as related problems with the organoleptic characteristics and tolerance of the treatment.
[0426]
[0427] Specifically, in this study, to facilitate the understanding of volunteers, the thermal peel resembles dandruff. Therefore, when we talk about dandruff we are defining peeling processes due, for example, to the typical dehydration of the sensitive scalp with the barrier function of the damaged skin.
[0428]
[0429] 4.1. Type of study
[0430]
[0431] This study was carried out in a single center with a group of 40 volunteers with hair loss. The study was conducted according to the operating procedure standard of the Capilar Technology Center, SL shown below and in compliance with the standards established in the Guide for research on human beings and the guidelines of the Scientific Committee on Consumer Safety ("International ethical guidelines for biomedical research involving human subjects" Council for International Organizations of Medical Sciences, available on the website of the "World Health Organization" http://www.who.int/ethics/research/en/ on July 25, 2017).
[0432]
[0433] 4.2. Duration of the study
[0434] The study was conducted for 150 days. During this period of time, various tests were carried out. The tests performed and the times are detailed below:
[0435] - At zero time (T0) and at 150 days (T150): General photograph of TrichoScan® hair
[0436] Washing test
[0437] Hairstyle test
[0438] Trichogram
[0439] Volunteer surveys
[0440] Dermatological control of volunteers - On time 45 days (T45): General hair photography Washing test
[0441] Hairstyle test
[0442] Volunteer surveys
[0443] 4.3. Attributes under study
[0444] The following attributes were evaluated in this study:
[0445] - General appearance of the hair
[0446] - Anagen / telogen relationship (Trichogram)
[0447] - number of hairs extracted during the combing test
[0448] - number of hairs extracted during the washing test
[0449] - Volunteer surveys
[0450] - Dermatological control of volunteers
[0451]
[0452] 4.4. Equipment and material
[0453] To carry out this study, the same equipment and materials described were needed in section 3.4.
[0454]
[0455] 4.5. Volunteers
[0456] The study was carried out with 40 volunteers (28 women and 12 men) aged between 18 and 60 years. The inclusion and non-inclusion criteria are the same as those described in section 3.5.
[0457]
[0458] 4.6. Samples
[0459] The samples tested were the following:
[0460] - Anti hair loss hair shampoo 1 of the present invention
[0461] - Anti hair loss hair lotion 2 of the present invention
[0462] - Oral fall prevention tablets 2 of the present invention
[0463]
[0464] 4.7. Protocol
[0465] A) Before the beginning of the study (T-2):
[0466] The volunteers did not wash their hair 48 hours before the first visit and did not comb 24 hours before this visit (T0).
[0467]
[0468] B) Time zero (T0):
[0469] During the first visit, a specialist performed the following tests: General photograph of the hair; Trichoscan®; Trichogram hairstyle test; wash test; survey of volunteers; and dermatological control.
[0470]
[0471] C) During the treatment in the homes of the volunteers:
[0472] The volunteers applied the treatment according to the following guidelines and with the following frequency:
[0473] i) The anti-hair shampoo was applied as follows: Wet the hair with plenty of water; apply 5 g of shampoo in the hand and spread with both hands; massage gently with the fingertips; and rinse with plenty of water.
[0474] ii) The anti-hair lotion was applied daily (5ml), preferably at night; massage with the fingertips to help absorption and not rinse; and iii) Take one tablet a day, preferably after the meal.
[0475]
[0476] D) Time 45 days (T45)
[0477] The volunteers did not wash their hair 48 hours before the visit, and did not comb their hair 24 hours before this visit. During the visit, a specialist carried out the following test: General photograph of the hair; hairstyle test; wash test and survey of volunteers.
[0478]
[0479] E) Time 150 days (T150)
[0480] The volunteers did not wash their hair 48 hours before the visit, and did not comb their hair 24 hours before this visit. During the visit, a specialist carried out the following test: General photograph of the hair; Trichoscan®; Trichogram hairstyle test; wash test; survey of volunteers; and dermatological control.
[0481]
[0482] 4.8. Tests carried out
[0483] - General photograph of the hair: In T0, T45 and T150 several photographs of the upper part of the scalp were taken. The images show the temporal and vertex (crown) areas of all the volunteers. The objective was to see if the study treatment visually improves the quality and appearance of the hair.
[0484]
[0485] -Tricogram Cosmetic: The Trichogram involved the extraction of between 15 and 25 hairs by hair removal of the scalp in order to determine in which phase of the hair growth cycle they were, as well as the initial and final appearance of the hair bulbs. Immediately after the depilation, the hair bulbs were mounted on glass plates for microscopic study. In general, the trichogram is useful to study the physiology and growth phase of the hair roots before treatment to compare it with the end of the study to see if growth phases have increased. In particular, the trichogram is a "snapshot" of the condition of the roots of the hair or bulbs, and therefore, of the scalp at a certain time. Depending on the results, it shows whether the treatment has had a positive effect on the hair bulbs.
[0486]
[0487] 4.9. Results
[0488]
[0489] A) expression of the results:
[0490]
[0491] The following parameters were calculated:
[0492] A0 Number of hairs in anagen phase at T0 (before treatment)
[0493] T0 Number of hair in telogen phase at T0 (before treatment)% A0 Percent of hair in anagen phase at T0 (before treatment)
[0494] % T0 Percentage of hair in telogen phase at T0 (before treatment)
[0495] A0 / T0 Relationship between hair in anagen phase and telogen phase at T0 A150 Number of hair in anagen phase at T150 (after 150 days of treatment)
[0496] T150 Number of hair in telogen phase at T150 (after 150 days of treatment)
[0497] % A150 Percentage of hair in anagen phase at T150 (after 150 days of treatment)
[0498] % T150 Percentage of hair in telogen phase at T150 (after 150 days of treatment)
[0499] A150 / T150 Relationship between hair in anagen phase and telogen phase in T150.
[0500]
[0501] B) Criteria to evaluate the results
[0502]
[0503] To evaluate the results obtained in the study, the trichogram values considered "normal" were used as described in the state of the art (see Camacho F. et al., "Trichology, Diseases of the pilosebaceous follicle." Medical Classroom. 1996): anagen 86% hair; catagen 1% hair and telogen 13% hair. These values provide an anagen / telogen ratio of approximately 6.
[0504]
[0505] However, it is very possible that these values will be revised. In fact, as confirmed in recent conferences of dermatology and through our experience, today it is not common to find such a high proportion of hairs in the anagen phase. Currently, the most common trichromas show a definite increase in hair in the telogen phase and a slight increase in hair in the catagen phase, so the anagen / telogen ratio is usually less than 6. This observation is already applying in effectiveness studies of cosmetic products for hair loss. For example, the effectiveness study of Prodhyhair concentrated active of the Laboratoires Prod'Hyg accepts a value of anagen / telogen ratio greater than or equal to 4 as "normal". Consequently, this study will consider the normal anagen / telogen ratio if the anagen / telogen ratio is equal to or greater than 4 (ie A / T> 4).
[0506] Hair density was calculated as mentioned in section 3.8. to T0 and T150.
[0507]
[0508] The photograph of the hair bulbs for the trichogram was made at the beginning and at the end of the treatment, using the Zeiss Primo Star optical microscope adapted to an AxioVision camera.
[0509]
[0510] The combing test: It was carried out in T0, T45 and T150. As a precondition, the volunteers went to the visit without washing their hair at least 48 hours before and without having combed their hair at least 24 hours before, in order to maintain the hair that is near the end of the telogen phase and avoid reduction artificial hair percentage in telogen phase. The technician combed the hair of each volunteer. The falling hair - in the comb and in the coat - was collected for the later count.
[0511]
[0512] The washing test: It was carried out in T0, T45 and T150. As a precondition, the volunteers went to the visit without washing their hair at least 48 hours before and without having combed their hair at least 24 hours before. The technician washed the hair of each volunteer. Falling hair was collected for later counting
[0513]
[0514] C) Conclusion
[0515]
[0516] After 150 days of treatment, it was observed that the application of an anti-fall treatment comprising the application of at least one composition comprising a component A containing a Glycine soybean germinated extract, a germinated extract of Triticum vulgare and a root extract of Scutellaria Baicalensis, in combination with a component B containing the polysaccharide mentioned in the present invention allows to increase the ratio of anagen / telogen phase by 33%. That is, the application of the anti-hair loss composition of the present invention makes it possible to increase the number of hairs in the anagen phase. This translates into a maximum reduction of hair loss at the end of the treatment of 89%.
[0517]
[0518] In addition, the composition of the present invention has a good capillary hydrating capacity that allows to improve the resistance of the hair to the tear and avoids the rupture (or breakage) of the hair as it is demonstrated in the reduction of the hair. broken hair observed at the end of the treatment at 150 days. In relation to the capillary density of the study carried out, a positive average increase in capillary density of 11.93% is revealed. This capillary density along with the dimensions of the scalp, this increase in hair density would be equivalent to an increase of about 13,000 hairs.
[0519]
[0520] In conclusion, at the end of the treatment, 95% of the volunteers observed that their hair is stronger and had more vitality.
[0521]
[0522] LIST OF APPOINTMENTS
[0523]
[0524] 1. "International ethical guidelines for biomedical research involving human subjects". Council for International Organizations of Medical Sciences. Available on the website of the "World Health Organization" http://www.who.int/ethics/research/en/ on July 25, 2017.
[0525]
[0526] 2. Norwood OT. "Male pattern baldness: classification and incidence". South Med J.
[0527] 1975, vol. 68 (11), pp.1359-65.
[0528]
[0529] 3. Venning V et al. "Patterned androgenetic alopecia in women". J. Am. Acad.
[0530] Dermatol 1988, vol. 18 (5), pp. 1073-1077
[0531]
[0532] 4. Camacho F. et al. "Trichology. Diseases of the pilosebaceous follicle ". Medical Classroom Madrid. nineteen ninety six

权利要求:
Claims (15)
[1]
A pharmaceutical or cosmetic composition characterized in that it comprises:
a) a component A comprising:
a therapeutically or cosmetically effective amount of a germinating extract of a plant of the genus Glycine ;
a therapeutically or cosmetically effective amount of a germinating extract of a plant of the genus Triticum; Y
a therapeutically or cosmetically effective amount of an extract of a plant of the genus Scutellaria;
b) a component B comprising:
a therapeutically or cosmetically effective amount of a polysaccharide of molecular weight comprised from 45,000 to 55,000 g / mol comprising a backbone of repeating structural units of formula (I)

[2]
2. Composition according to claim 1, characterized in that the germinated extract of a plant of the genus Glycine is a germinated extract of Glycine soya.
[3]
Composition according to any one of claims 1-2, characterized in that the germinated extract of a plant of the Triticum genus is a germinated extract of Triticum vulgare.
[4]
4. Composition according to any of claims 1-3, characterized in that the extract of a plant of the genus Scutellaria is an extract of the root of Scutellaria Baicalensis.
[5]
5. Composition according to any of claims 1-4, characterized in that it comprises:
from 0.5% to 4% by weight of component A with respect to the total weight of the composition; Y
from 0.1% to 5% by weight of component B with respect to the total weight of the composition.
[6]
6. Composition according to any of claims 1-5, characterized in that the proportion by weight of the amount of component A with respect to the amount of component B is from 7: 1 to 1: 3.
[7]
Composition according to claim 6, characterized in that the proportion by weight of the amount of component A with respect to the amount of component B is 1: 1.
[8]
8. Composition according to any of claims 1-7, characterized in that component A comprises:
from 1% to 5% by weight of the germinated extract of the plant of the genus Glycine with respect to the total weight of component A;
from 1% to 5% by weight of the germinated extract of the plant of the genus Triticum with respect to the total weight of component A; Y
from 0.45% to 0.75% by weight of the extract of the plant of the genus Scutellaria with respect to the total weight of component A.
[9]
9. Composition according to any of claims 1-8, characterized in that component B comprises: from 2% to 3% of the molecular weight polysaccharide comprised from 45,000 to 55,000 g / mol comprising a backbone of repeating structural units of formula (I).
[10]
10. Composition according to any of claims 1-9, characterized in that it also comprises one or more additional active ingredients.
[11]
11. Composition according to claim 10, wherein the additional active ingredient is selected from the group consisting of anti-dandruff agent, anti-fall agent, calming agent, anti-seborrhea agent, and mixture thereof.
[12]
12. Composition according to any of claims 1-9, for use in the prevention and / or co-adjuvant treatment of a disease or condition of the skin, hair and scalp.
[13]
13. Composition according to any of claims 10-11, for use in the treatment and / or prevention of a disease or condition of the skin, hair and scalp.
[14]
Composition for use according to any of claims 12-13, wherein the disease or condition of the skin, hair and scalp is selected from the group consisting of dandruff, fat, hair loss, sensitive skin, dermatitis and allergy.
[15]
15. Cosmetic use of the composition according to any of claims 1-9, as a skin, hair and scalp care agent, where the care of the skin, hair and scalp comprises improving at least one of The following symptoms: roughness, peeling, dehydration, elasticity, flexibility, hair volume, hair shine, redness and irritation.

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US20150132401A1|2007-12-20|2015-05-14|Elc Management, Llc|Methods and Compositions for Treating Skin|

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US20100015072A1|2008-06-30|2010-01-21|Christopher Polla|Topical Compositions Comprising Isonicotinamide|

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US20100233110A1|2009-03-13|2010-09-16|Kenneth Cohen|Powder Compositions Containing Edible Grains|

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