EP4444418A1 - Préparation pour application topique pour améliorer l'état de la peau - Google Patents

Préparation pour application topique pour améliorer l'état de la peau

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Publication number
EP4444418A1
EP4444418A1 EP22835218.3A EP22835218A EP4444418A1 EP 4444418 A1 EP4444418 A1 EP 4444418A1 EP 22835218 A EP22835218 A EP 22835218A EP 4444418 A1 EP4444418 A1 EP 4444418A1
Authority
EP
European Patent Office
Prior art keywords
weight
range
skin
preparation
hyaluronic acid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP22835218.3A
Other languages
German (de)
English (en)
Inventor
Sascha Baumann
Christoph Ernst
Andreas Firyn
Thomas Blatt
Denise KUSCHEL
Michael Kuhn
Gerlinde PAPPA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Beiersdorf AG
Original Assignee
Beiersdorf AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE102022202547.4A external-priority patent/DE102022202547A1/de
Application filed by Beiersdorf AG filed Critical Beiersdorf AG
Publication of EP4444418A1 publication Critical patent/EP4444418A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484—Glycyrrhiza (licorice)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/345—Alcohols containing more than one hydroxy group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
    • A61K8/365—Hydroxycarboxylic acids; Ketocarboxylic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A61K8/735—Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/10—Anti-acne agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/007—Preparations for dry skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/20—Chemical, physico-chemical or functional or structural properties of the composition as a whole
    • A61K2800/30—Characterized by the absence of a particular group of ingredients

Definitions

  • the present invention relates to topically applicable, in particular cosmetic or dermatological preparations comprising a substance combination of hyaluronic acid and/or hyaluronic acid salt, one or more fruit acids, one or more skin moisturizing agents and one or more alcohols.
  • the preparation does not include emollients and lipids.
  • the present invention relates to the use of the preparations for skin care, in particular for the care, prophylaxis and treatment of skin damaged by atopic dermatitis.
  • WO 2008/009956 A1 discloses mouthwash solutions and sprays that contain hyaluronic acid and fruit acids for taste.
  • CN 111671708 discloses a preparation comprising a base composition comprising ethanol, glycerin, water, citric acid and 0.1-0.3% allantoin, an emollient, and a hyaluronic acid composition.
  • US 2014/0088040 A1 discloses a cosmetic preparation that can be used mixed with water. It contains e.g. glycerin, citric acid and hyaluronic acid, but no ethanol.
  • hyaluronic acid a glycosaminoglycan
  • WO 2008072905 A1 describes compositions for the prevention and/or treatment of atopic dermatitis, comprising hyaluronic acid and/or a hyaluronic acid salt. and resveratrol.
  • US 2019209606 A1 describes in situ gelling compositions comprising an anti-inflammatory polysaccharide and a gelling polymer, the composition being a liquid prior to administration to a patient but converting to a gel upon administration to the patient.
  • Hyaluronic acid (also according to the nomenclature hyaluronan, abbreviation HA, CAS: 9004-61-9) is a glycosaminoglycan that is an important component of connective tissue.
  • the HA is characterized by a disaccharide repeat unit according to the structure below.
  • HA is a linear, acidic polysaccharide consisting of a large number of alternating dissaccharide units of 1,3-glycosidically linked N-acetyl-ß-D-glucosamine (GlcNAc) and ß-D-glucuronic acid (GlcA) molecules.
  • GlcNAc N-acetyl-ß-D-glucosamine
  • GlcA ß-D-glucuronic acid
  • Each of the basic disaccharide units is linked to the next by a ⁇ (1-4) bond.
  • the number of basic units can reach more than 10,000 with a molar mass of 4 million Daltons. Due to its hydrophilic acid groups and the hydroxy groups, HA has the ability to form a large number of hydrogen bonds through which hydrations can be added and it is therefore homogeneously miscible with water.
  • HA In an aqueous solution, HA is able to bind more and more water while increasing the average chain distance, since the negative charges cause repulsion of the closely spaced chain sections. Under physiological conditions, the carboxy groups of the HA are practically completely dissociated and represent a polyanionic compound.
  • Hyaluronic acid is generally spoken of, regardless of whether HA itself or the salts are meant. Due to its viscoelastic properties and its biocompatibility, HA is of therapeutic importance as an injection solution in ophthalmology, orthopedics and cosmetic surgery.
  • Hyaluronic acid is a natural component of the skin. Two forms of hyaluronic acid are used in cosmetic products, a short-chain and a long-chain form.
  • the short-chain hyaluronic acid penetrates the upper layer of the skin and influences the inner moisture balance.
  • the long-chain hyaluronic acid is said to have a plumping effect on the skin. It effectively binds moisture in the upper skin layer. Its moisture-binding effect results from the fact that it only gradually releases its hydration layer and in this way acts on the skin over a long period of time.
  • Other tasks of the HA are the supply of connective tissue and skin with moisture and nutrients.
  • the sodium salt of hyaluronic acid is also used, among other things, as a moisturizer for the manufacture of cosmetic products (Römpp online lexicon version 2.5, 2004).
  • Hyaluronic acid is commercially available in the crosslinked state (e.g. Hylaform®, a crosslinked hyaluronic acid from Biomatrix, NJ, USA; for the production cf. also US Pat. Nos. 4,713,448, US Pat. Nos. 4,605,691, APC® from Fidia, lncert@ from Anika Therapeutics, interge) from LifeCore or Restylane@ from Q-Med).
  • Hylaform® a crosslinked hyaluronic acid from Biomatrix, NJ, USA
  • Hyaluronic acid is commercially available in the crosslinked state (e.g. Hylaform®, a crosslinked hyaluronic acid from Biomatrix, NJ, USA; for the production cf. also US Pat. Nos. 4,713,448, US Pat. Nos. 4,605,691, APC® from Fidia, lncert@ from Anika Therapeutics, interge) from LifeCore or Restylane@ from Q-Med).
  • skin care In addition to treating skin diseases such as atopic dermatitis, skin care is an essential prophylactic approach.
  • consumers are offered a large number of cosmetic preparations for skin care, mostly in the form of creams and lotions, i.e. as an emulsion.
  • Products that temporarily or permanently delay or eliminate the signs of aging on the skin, negative environmental influences and skin diseases are becoming increasingly important.
  • water for moisturizing the skin and oils and lipids for moisturizing the skin such skin care products contain a large number of active substances and additives.
  • moisturizers alone can already cause a significant therapeutic effect, which can sometimes be stronger than that of added active ingredients (Vehicles for atopic dermatitis therapes: more than just a placebo, Journal of Dermatological Treatment, DOI: 10.1080/09546634.2020.1789050).
  • these humectants are characterized by the content of emollients and occlusive substances, which are essential for an effect.
  • many of the active substances cannot be incorporated stably and storably in topically applicable preparations without problems.
  • the invention is a water-containing, topically applicable, in particular cosmetic or dermatological preparation comprising a substance combination of hyaluronic acid and/or hyaluronic acid salt, one or more fruit acids, one or more skin moisturizing agents and one or more alcohols.
  • the preparation does not comprise any emollients.
  • the present invention relates to the non-therapeutic, in particular cosmetic, use of the preparation to promote the development, stabilization or displacement of an existing skin microbiome.
  • the non-therapeutic use of the preparation according to the invention for the treatment of inflammatory skin diseases and/or indications, in particular acne, rosacea and atopic dermatitis, is advantageous.
  • the preparation according to the invention can also advantageously be used for skin care, in particular for the care, prophylaxis and treatment of skin damaged by atopic dermatitis.
  • the preparation according to the invention can also be used advantageously in the treatment of atopic dermatitis and/or allergic contact dermatitis.
  • the preparation according to the invention can also be used advantageously in wound healing and for the care of hypersensitive skin.
  • the object is therefore to provide a preparation that can be applied topically, which in particular leads to a reduction in S. aureus and at the same time balancing of the skin microbiome and thereby leads to an improvement, in particular in atopic dermatitis.
  • the preparations according to the invention comprise a substance combination of hyaluronic acid and/or hyaluronic acid salt, one or more fruit acids, one or more skin moisturizing agents and one or more alcohols.
  • Hyaluronic acid and/or hyaluronic acid salt is preferably used in a proportion in the range from 0.05 to 3% by weight, in particular in the range from 0.5 to 1.5% by weight, preferably in the range from 0.7 to 1.2% by weight. %, based on the total mass of the preparation.
  • One or more fruit acids are preferably used in a proportion in the range from 0.005 to 2% by weight, in particular in the range from 0.01 to 1% by weight, preferably in the range from 0.02 to 0.5% by weight, based on the Total mass of the preparation used.
  • Alpha-hydroxy acids and in particular glycolic acid, lactic acid, malic acid, citric acid and/or tartaric acid are advantageously used as fruit acids.
  • Citric acid is preferably used.
  • fruit acid does not include the salts of fruit acids, such as sodium citrate, which is known as a food additive.
  • One or more skin moisturizers are preferably used in a proportion in the range from 0.1 to 15% by weight, in particular in the range from 0.5 to 10% by weight, preferably in the range from 1 to 7% by weight, based on the total mass of the Preparation used.
  • Humectants also known as moisturizers, are substances or mixtures of substances that give cosmetic or dermatological preparations the property of reducing and reducing the moisture release of the horny layer (also called transepidermal water loss (TEWL)) after application or distribution on the skin surface /or to positively influence the hydration of the stratum corneum.
  • TEWL transepidermal water loss
  • moisturizers for the purposes of the present invention are, for example, glycerin, caprylyl glycol, butylene glycol, propylene carbonate, urea, propylene glycol, hexanediols, aloe vera
  • glycerol and caprylyl glycol is particularly advantageous to choose as the skin moisturizing agent according to the invention.
  • One or more alcohols are preferably used in a proportion in the range from 0.05 to 15% by weight, in particular in the range from 1 to 10% by weight, preferably in the range from 2 to 8% by weight, based on the total mass of the preparation .
  • alcohols are n-alkanols with n in the range from 1 to 4.
  • Ethanol is advantageously used as the alcohol.
  • Sodium bicarbonate (soda) is advantageously added to the preparation according to the invention, in particular in a proportion by weight in the range from 0.5 to 10% by weight, in particular in the range from 1 to 9% by weight, based on the total mass of the preparation.
  • At least one representative of each group of substances is contained, which differs from the others, so that two different substances are contained even if a representative has possible double properties.
  • hyaluronic acid is also considered a hood moisturizer.
  • another skin moisturizing agent is therefore included in addition to hyaluronic acid.
  • emollients are dispensed with.
  • Emollients are agents intended to soften (soften) the skin. Emollients are substances that reduce skin roughness and make the skin appear softer and smoother. They work by "filling in” the spaces between the scabbing corneocytes, increase cohesion between the corneocytes and "smooth" the raised corners of the individual corneocytes. Examples of commonly used emollients are oils and fats such as lanolin, mineral oil and petroleum jelly. Some emollients include vegetable oils, synthetic and semi-synthetic oils such as cetyl ethyl hexanoate, isopropyl myristate, ethyl hexyl palmitate, caprylic/caric triglyceride and some silicones.
  • emollients are dispensed with according to the invention, so that their proportion in the preparation is at most 0.1% by weight.
  • the literature generally recommends treating it with an adapted and graduated therapy, according to the symptoms.
  • An essential component of the non-drug therapy is the daily treatment with moisturizing agents, so-called moisturizers, emollients, i.e lipophilic ingredients to smooth and soften the skin, occlusive substances, i.e. substances that prevent water loss and protect against external irritation, and humectants, i.e. substances that are supposed to moisturize the skin through active water binding and retention (Nicol NH, Rippke F. , Weber TM, Hebert AA, The Journal for Nurse Practitioners 2021 , 17, 920-925).
  • moisturizing agents so-called moisturizers, emollients, i.e lipophilic ingredients to smooth and soften the skin
  • occlusive substances i.e. substances that prevent water loss and protect against external irritation
  • humectants i.e. substances that are supposed to moisturize the skin through active water binding and retention
  • the use of emollients is dispensed with and only the combination of substances according to the invention is sufficient to fulfill the stated tasks.
  • the absence of emollients means that the proportion of emollients in the preparation is less than 0.1% by weight, so that possible minor proportions, for example due to impurities or entrainment with emollients, are still according to the invention.
  • the proportion of emollients is preferably below 0.01% by weight, in particular below 0.001% by weight, advantageously 0% by weight, based on the total mass of the preparation.
  • Lipids such as fats, oils and waxes are therefore contained in the preparation at most below 0.1% by weight, so that possible minor impurities or entrainments with lipids are still in accordance with the invention.
  • the proportion of lipids is preferably below 0.01% by weight, in particular below 0.001% by weight, advantageously 0% by weight, based on the total mass of the preparation.
  • emulsifiers can also advantageously be dispensed with, so that their proportion in the preparation is preferably below 0.1% by weight.
  • the proportion of emulsifiers is preferably below 0.01% by weight, in particular below 0.001% by weight, advantageously 0% by weight, based on the total mass of the preparation.
  • the preparation according to the invention can be applied topically, i.e. it is applied to the skin and not to the mucous membrane, oral or nasal mucosa.
  • Cosmetic preparations are used in a variety of forms, such as cream, paste, lotion or gel.
  • the preparation according to the invention is advantageously provided as a hydrogel.
  • An essential object of the present invention is to alleviate atopic dermatitis (AD) with acute to subacute eczema, ie acute inflammation.
  • AD atopic dermatitis
  • the hydrophilic preparation according to the invention is characterized above all by water-binding components (HA, glycerol), as well as easily evaporating components (water, ethanol), which can contribute to the cooling of the acute inflammation.
  • the preparations according to the invention are stored at cool temperatures, for example in a refrigerator, ideally at 4° C., and are thus applied in a cooled state in order to additionally support the cooling effect.
  • the preparation is therefore also a method for applying the preparation according to the invention to the skin, characterized in that the preparation is provided in a first step and/or is produced by mixing the ingredients, in a second step at a temperature between 1°C and 10°C , preferably between 2 ° C and 8 ° C and particularly preferably between 3 ° C and 6 ° C (cooled), and in a third step, the temperature-controlled preparation is transferred to the human skin.
  • the invention could be further improved.
  • the preparations according to the invention do justice to all the tasks set.
  • the preparations according to the invention also show that the healthy skin microbiome is promoted and stabilized.
  • the preparations according to the invention can thus be used to promote the development, stabilization or displacement of an existing skin microbiome.
  • the preparations according to the invention therefore promote the development, stabilization and/or shifting of an existing skin microbiome towards a healthy state.
  • preparations according to the invention are therefore also suitable for cosmetic, ie non-therapeutic, skin care.
  • the non-therapeutic use of the preparations according to the invention for the treatment of inflammatory skin diseases and/or indications, in particular acne, rosacea, atopic dermatitis and also for the care, prophylaxis and treatment of atopic dermatitis and also for wound healing or care of hypersensitive skin is therefore also preferred.
  • the preparation listed in Example 1 was used twice a day over a period of three weeks.
  • the preparation used was:
  • Diagnostic criteria for neurodermatitis a local SCORAD of at least 6, preferably >10 with at least 2 comparable lesions on comparable body areas, with a minimum size of 2x2cm, preferably on the inner forearms, the crook of the arm or the hollow of the knee.
  • a cohort of 16 volunteers was asked to apply 0.6 ml of preparation (Example 1) twice a day to a 100 cm 2 large area of skin over a period of 3 weeks, which in the middle had a lesion typical of neurodermatitis of at least 2 ⁇ 2 cm, had to contain.
  • the distance from the lesion to the edge of the area should be at least 2 cm.
  • the preparation was spread over the area with circular movements over a period of 30 seconds
  • the treated area was air-dried for at least 15 minutes after application of the preparation until no more liquid could be seen. The application quantity should not be exceeded.
  • SCORAD (SCORing Atopy Dermatitis) is a clinical evaluation system that is used to determine the severity of atopic eczema in patients as objectively as possible.
  • the SCORAD system was developed in 1993 by the European Expert Group on Atopic Dermatitis
  • the local SCORAD was based on Angelova-Fischer et al. determined by
  • Table 1 Scale for assessing the various skin parameters by the subjects
  • the preparation was characterized by good and rapid absorption, low viscosity, a more pleasant texture (compared to creams with emollients) and a refreshing character. This resulted in some subjects using the formula on more areas of the body than those specified
  • the preparation according to the invention was able to significantly reduce the local SCORAD already after 5 days (t3), so the local SCORAD could be improved in general.
  • a reduction to 0 was achieved in 22 days (t8), which corresponds to freedom from symptoms.
  • Figure 1 and the table below show the results of the clinical/dermatological evaluation (median local SCORAD) of the preparation-treated areas over time.
  • Figure 1 shows the local SCORAD (median) over time (tO - t8)/(SCORAD 0 to 20)
  • Table 2 shows the clinical/dermatological assessment, local score and median of the differences from baseline (tO)
  • Figures 2 - 9 and Table 3 show the results of the test persons' questioning on the subjective parameters: skin sensitivity, itching, skin tightness, general well-being, skin reddening, general skin condition, skin smoothness and skin moisturization. These were rated on a 10-point scale (score 1 (poor) - 10 (good)). In general and surprisingly, every parameter starting at tO ⁇ 10 could be improved. The majority of the other parameters were given a moderately poor starting value of 4 on average at the start time tO. After 5 days (t3) a statistically significant improvement was observed for all parameters.
  • Figure 2 shows skin sensitivity
  • Figure 4 shows the assessment of skin tension.
  • a significant increase in the score compared to the initial condition ( improvement)*.
  • Table 3 Subjective evaluation by subjects, scores, mean of the differences from the initial value (tO)
  • Cosmetic preparations and their specific formulations can cause cumulative irritation and therefore irritant contact dermatitis in consumers cause.
  • the main pathological mechanisms of irritation involve disruption of the skin barrier, which can lead to a visible reaction, erythema.
  • allied and comparative epicutaneous plaster studies were carried out to determine the in vivo skin tolerance in healthy volunteers.
  • the skin compatibility of a face and body gel according to the invention was determined in vivo in test persons with sensitive skin and mild atopic eczema.
  • test product was applied twice daily to the body and face according to the physician's instructions and the participant information sheet for a total of two weeks. Other skin care products were not allowed to be used during the study.
  • Symptoms were graded on a 5-point scale (none to very severe). At the end of the study, the doctors also assessed the skin condition compared to the baseline value and the compatibility/tolerability of the test product.
  • the study showed that under the conditions used in this study, the hydrogel according to the invention proved to be very well tolerated by the skin of the participants with sensitive skin and neurodermatitis.
  • the hydrogel had a very positive effect on the overall skin condition of the body and face.
  • test products One application of the test products to the inside of the forearms by the test person, one test area remained untreated as a control.
  • Study population 35 female subjects aged 19 to 65 who were eligible for the study. Participate by demonstrating healthy skin based on a self-assessment, as well as by attending a preconditioning period.
  • the anti-irritative, anti-redness effectiveness of the preparations according to the invention was examined in comparison with an untreated control and a shaved untreated control on the forearm.
  • preparations according to the invention lead to an improvement in the condition of the skin after skin irritation (here shaving).
  • test product was applied to a shaved test site twice daily during these three days: immediately after the shave and in the evening. Another shaved test site was left untreated and used as a control.
  • the result of this study was that the irritated skin (skin redness induced by the shaving process) was significantly reduced after 3 days of treatment with the tested product compared to untreated and shaved skin. This was confirmed by chromameter measurements and by self-rating by the subjects. After 3 days of treatment with the test product, skin calming was significantly improved compared to untreated, shaved skin.
  • the study confirms that preparations according to the invention have an anti-irritant/anti-irritant effect, bring relief, reverse anti-redness and have a calming effect.
  • the preparations according to the invention are even suitable for irritated, sensitive skin.
  • the skin redness a* was tested with a chromameter after 3 days (on day 4, d4) for an untreated skin area (code 01), a shaved and untreated skin area (code 02) and a shaved and treated skin area (code 20) ( Figure 11 ).
  • the substance combination of hyaluronic acid and/or hyaluronic acid salt, one or more fruit acids, one or more skin moisturizing agents and one or more alcohols is provided as advantageous according to the invention in a preparation based on a hydrogel.
  • a hydrogel is a gel with a high water content. They consist primarily of hydrophilic polymers that can swell considerably in water while largely retaining their shape.
  • Hyaluronic acid is the water-binding substance in the hydrogel according to the invention.
  • emulsifiers can also be dispensed with.
  • Emulsifiers are also advantageously not used as the preferred hydrogel, so that their proportion in the preparation is preferably below 0.1% by weight.
  • the proportion of emulsifiers is preferably below 0.01% by weight, in particular below 0.001% by weight, advantageously 0% by weight, based on the total mass of the preparation.
  • the preparations according to the invention are preferably not emulsions.
  • a preferred preparation according to the invention consists only of hyaluronic acid and/or hyaluronic acid salt, one or more fruit acids, in particular citric acid, one or more skin moisturizing agents, in particular glycerol and/or caprylyl glycol and one or more alcohols, in particular ethanol, and water, as shown in particular in Table 8 below.
  • the preparations are used to promote the development or stabilization of a healthy skin microbiome.
  • preparations according to the invention can be used in a wide variety of application forms.
  • Preferred application forms are gels, sprays, sera, impregnation medium for impregnated patches, cloths or masks.
  • the sophisticated cosmetic compositions according to the invention can optionally include other customary auxiliaries and additives, such as bodying agents, fillers, perfume, dyes, active ingredients, vitamins, proteins, sunscreens, stabilizers, insect repellents, salts, EDTA, antimicrobial, proteolytic or keratolytic substances, etc. , unless they are excluded according to the invention.
  • bodying agents such as bodying agents, fillers, perfume, dyes, active ingredients, vitamins, proteins, sunscreens, stabilizers, insect repellents, salts, EDTA, antimicrobial, proteolytic or keratolytic substances, etc.
  • one or more active ingredients from the following groups are preferably added to the preparations in order to be able to ensure the broadest possible application forms and individual care and treatments.
  • Active ingredients can advantageously be added to the preparations or application forms according to the invention, such as preferably antibacterial active ingredients, antifungal active ingredients, sebum-reducing active ingredients, itching-alleviating active ingredients, anti-inflammatory, healing-stimulating, pain-relieving or antimicrobial active ingredients such as dexpanthenol, or natural additives, natural substances such as honey, chamomile or aloe vera.
  • additional active ingredients are vitamins such as vitamin A, C or E, growth factors such as PDGF, sugar or polysaccharides such as glucose, minerals such as zinc, amino acids and their derivatives such as arginine or creatine.
  • Also preferred according to the invention is the addition of active ingredients that address cell membranes, such as quats, octenidines or decanediol.
  • NRPS-derived ribosomal and non-ribosomal
  • PES-derived cyclic and non-cyclic polyketides
  • enzymes in particular cell wall hydrolytic enzymes such as endolysins, lysozyme, chitinases.
  • hydroxyacetophenone selected from the group consisting of hydroxyacetophenone, salicylic acid, glycyrrhiza inflata root extract, licochalcone A, Q10 and/or thiamidol, preferably hydroxyacetophenone, is particularly preferred.
  • quats in particular PQ16 Quat Excellence, octenidine, decanediol, quaternary amines, benzalkonium chloride and/or benzethonium chloride are advantageously added
  • Natural substances such as cyclic and non-cyclic peptides of ribosomal and non-ribosomal (NRPS-derived) origin, cyclic and non-cyclic polyketides (PKS-derived) and peptide/polyketide conjugates (NRPSVPKS-derived) can advantageously be added to the preparations according to the invention.
  • NRPS-derived ribosomal and non-ribosomal
  • PKS-derived cyclic and non-cyclic polyketides
  • NRPSVPKS-derived peptide/polyketide conjugates
  • enzymes especially cell wall hydrolytic enzymes such as endolysins, lysozyme, chitinases (fungus cell wall) is preferred.
  • Climbazole or Pirotone olamine are added from the group of antifungal agents.
  • additives can be selected from Ca, Mg, Al and/or Zn salts.
  • Other preferred active ingredients can be selected from Magnolia, Arctiin, Bioxilift, Creatine, Isoflavones, Laminaria, NAHP, Phloridzin, Vitamin C, Lotus Extract, Myriceline, White Tea, AGR, Glycyrrhetinic Acid, Silymarin S, Tocopheryl, Carnitine, Garcinia Cambogia, Guarana C22, Butyloctanoic Acid, Dioic, Ethylhexylglycerol, Methyl Phenylbutanol, Polyglyceryl-2 Caprate, Polysaf 5600 Polymer, Silver Citrate, Zinc Citrate, Betaine, Sea Salt, Taurine, SymSave H, DHA, Rucinol, Panthenol/Dexpanthenol.
  • the proportion of one or more additionally added active ingredients can be less than 1% by weight, preferably less than 0.5% by weight, based on the total mass of the preparation.
  • Essential oils can also be added to the preparations. Menthol, camphor and their derivatives, but also other essential oils lower the stimulus threshold of the neuronal cold receptors and thus cause a feeling of cold. These active ingredients can also be used in a preferred embodiment. According to the invention, essential oils do not belong to the group of lipids or emollients.

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Abstract

Composition, en particulier cosmétique ou dermatologique, pour application topique, comprenant une combinaison de substances à base d'eau, d'acide hyaluronique et/ou de sel d'acide hyaluronique, d'un ou de plusieurs acides de fruits, d'un ou de plusieurs agents d'hydratation cutanée et d'un ou de plusieurs alcools, pouvant faire l'objet d'une utilisation efficace pour le soin de la peau, en particulier pour soigner, prévenir et traiter les lésions cutanées résultant d'une dermatite atopique, la composition ne contenant généralement ni émollient et ni lipide.
EP22835218.3A 2021-12-09 2022-12-07 Préparation pour application topique pour améliorer l'état de la peau Withdrawn EP4444418A1 (fr)

Applications Claiming Priority (3)

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DE102021214021 2021-12-09
DE102022202547.4A DE102022202547A1 (de) 2021-12-09 2022-03-15 Topisch applizierbare Zubereitung zur Verbesserung des Hautzustandes
PCT/EP2022/084692 WO2023104843A1 (fr) 2021-12-09 2022-12-07 Préparation pour application topique pour améliorer l'état de la peau

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EP4444418A1 true EP4444418A1 (fr) 2024-10-16

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CN116554122B (zh) * 2023-06-29 2023-09-19 南京桦冠生物技术有限公司 α-酮酸酰胺或取代草酸酰胺酯类化合物及其组合物

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US4605691A (en) 1984-12-06 1986-08-12 Biomatrix, Inc. Cross-linked gels of hyaluronic acid and products containing such gels
US4713448A (en) 1985-03-12 1987-12-15 Biomatrix, Inc. Chemically modified hyaluronic acid preparation and method of recovery thereof from animal tissues
DE102004002001A1 (de) 2004-01-14 2005-08-11 Reinmüller, Johannes, Dr.med. Mittel zur Behandlung von entzündlichen Erkrankungen
WO2007148831A1 (fr) * 2006-06-23 2007-12-27 Ajinomoto Co., Inc. Promoteur de synthèse du collagene contenant un sel de zinc en tant qu'ingrédient actif
GB0614353D0 (en) 2006-07-20 2006-08-30 Oraldent Ltd Oral compositions, their preparation and use
KR100927579B1 (ko) 2006-12-13 2009-11-23 주식회사 엘지생명과학 히아루론산 및/또는 그것의 염을 함유하는 아토피성피부염의 개선 및 치료를 위한 조성물
FR2940908B1 (fr) * 2009-01-12 2012-08-24 Oreal Association cosmetique d'un microorganisme et d'un derive phytosphingosine
JP5912397B2 (ja) 2011-05-10 2016-04-27 由香子 菅原 化粧液，化粧液の製造方法及び化粧方法
US11337994B2 (en) 2016-09-15 2022-05-24 University Of Utah Research Foundation In situ gelling compositions for the treatment or prevention of inflammation and tissue damage
CN111671708A (zh) 2020-07-27 2020-09-18 广东真丽斯化妆品有限公司 一种平衡修复肌肤用益生菌复合物化妆品及其制备方法

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