Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/67—Vitamins
  • A61K8/676—Ascorbic acid, i.e. vitamin C
• • 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
  • A61K8/35—Ketones, e.g. benzophenone
• • 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
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
  • A61K8/4973—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom
  • A61K8/498—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with oxygen as the only hetero atom having 6-membered rings or their condensed derivatives, e.g. coumarin
• • 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
  • A61K8/60—Sugars; Derivatives thereof
  • A61K8/602—Glycosides, e.g. rutin
• • 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
  • A61K8/63—Steroids; Derivatives 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
  • A61K8/67—Vitamins
  • A61K8/671—Vitamin A; Derivatives thereof, e.g. ester of vitamin A acid, ester of retinol, retinol, retinal
• • 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
  • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
  • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
  • A61K8/9783—Angiosperms [Magnoliophyta]
  • A61K8/9789—Magnoliopsida [dicotyledons]
• • 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
  • A61Q19/08—Anti-ageing preparations
• • 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
  • A61K2800/74—Biological properties of particular ingredients
  • A61K2800/78—Enzyme modulators, e.g. Enzyme agonists
  • A61K2800/782—Enzyme inhibitors; Enzyme antagonists

Definitions

• the present invention relates to topical compositions and methods of using same for improving overall dermatological health.
• the present invention also relates to compositions for reducing susceptibility to bruising and for decreasing the healing time for bruises that occur and to methods for using these compositions.
• the present invention further relates to topical compositions to alleviate dermatological symptoms associated with hormonal aging and methods for using same.
• Aging of the skin results from the synergistic effects of intrinsic aging (due to age and genetic factors), photoaging (due to exposure to ultraviolet radiation), and, for women, hormonal aging (due to estrogen deficiency in peri-menopausal and menopausal women.)
• Such dermatological aging manifests as skin wrinkles, pigmentation/age spots, sallow skin, sagging skin, thinning of skin, a decrease in skin's elasticity and resilience.
• One cause of the foregoing manifestations of dermatological aging is a net loss of collagen fibers in skin. This net loss of skin collagen fibers results in thinning of the dermis. Because the dermis acts to "cushion" the force of impact, this decrease in the thickness of the dermis can result in increased bruising.
• U.S. Patent No. 5,166,132 to Gordon provides topical compositions having an improved enzyme-modified casein solution that are useful for healing and relieving bruising.
• a “topical composition” as used herein refers to a composition intended to be directly applied or spread on the surface of skin.
• An “effective amount” means an amount of a compound or a composition sufficient to induce a positive change in the skin condition.
• physiologically acceptable vehicle or a “suitable topical vehicle” refers to a drug, cosmetic, medicament or inert ingredient that is suitable for use in direct contact with human tissues without undue toxicity. All percentages refer to weight percent, based on the total weight of the topical composition.
• the first principal component of the present compositions is a phytoextract.
• the phytoextract is preferably a phytoestrogen and, more preferably, either a (1) isoflavone, (2) steroidal, (3) sterol, (4) coumestan, (5) lignan, or (6) any mixture thereof.
• phytoextract encompasses all such compounds that occur naturally in plants regardless of whether the actual compound used in the present invention is extracted from plant sources or manmade. As stated above, it is preferred that the phytoextract is a phytoestrogen. Preferably, the phytoextract is derived from plant sources. In the more preferred embodiment, the phytoextract is a phytoestrogen that is naturally derived. Alternatively, the phytoextract may be synthetically derived. "Phytoestrogen” as used herein refers to compounds that are either (a) known to exhibit an estrogen-type effect or (b) specifically set forth herein as a phytoestrogen.
• the more preferred phytoextracts are phytoestrogens, such as daidzein, daidzin, acetyl daidzin, malonyl daidzin, glycitin, acetyl glycitin, malonyl glycitin, glycitein, genistin, acetyl genistin, malonyl genistin, genistein, equol, and any mixture thereof.
• the most preferred phytoextracts are daidzein, glycitein, genistein, equol and any mixture thereof.
• the topical composition preferably comprises from about 0.01 wt% to about 0.1 wt% phytoextract, more preferably from about 0.015 wt% to about 0.08 wt% phytoextract, and most preferably from about 0.02 wt% to 0.072 wt% phytoextract.
• Examples of preferred plant sources include soy, soy bean, red clover, pomegranate, saw palmetto, canola, and any mixture thereof.
• the present invention preferably includes a secondary component.
• the secondary component is selected from one or more of the following twelve groups.
• An estrogen synthetase stimulating compound examples include caffeine and/or derivatives thereof, and any mixture thereof.
• Caffeine is the more preferred of such compounds.
• a compound capable of inhibiting 5 alpha-reductase activity examples include linolenic acid, linoleic acid, finasteride, and any mixture thereof.
• An exfoliation promoting compound Suitable examples include alpha hydroxy acids; beta hydroxy acids; oxa acids as disclosed in U.S. Patent No. 5,847,003 (the disclosure of which is incorporated by reference herein); oxa diacids as disclosed in U.S. Patent No. 5,834,513 (the disclosure of which is incorporated by reference herein); mechanical exfoliation compounds, such as bamboo exfoliant extract; salicylic acid; benzoyl peroxide; alpha-keto acids, such as pyruvic acid, 2-oxopropanoic acid, 2-oxobutanoic acid, and 2-oxopentanoic acid; and any mixture thereof.
• the preferred exfoliation promoting compounds are lactic acid, glycolic acid, 3,6,9-trioxaundecanedioic acid, and any mixture thereof.
• the composition comprises about 1 wt% to 20 wt%, preferably 1 wt% to about 15 wt%, more preferably about 4 wt% to about 10 wt% acid, and most preferably about 4 wt% of the exfoliation promoting compound.
• An ultraviolet (UV) light protecting/sunscreen agent examples include organic and inorganic sunscreens, such as titanium dioxide, zinc oxide, methyl benzylidene camphor and/or its derivatives, octocrylene, anthranilates, benzophenones, butylmethoxydibenzoylmethane (avobenzone), naphtholsulphonates, benzoic acid derivatives, salicylates, cinnamic acid derivatives, and mixtures thereof.
• organic and inorganic sunscreens such as titanium dioxide, zinc oxide, methyl benzylidene camphor and/or its derivatives, octocrylene, anthranilates, benzophenones, butylmethoxydibenzoylmethane (avobenzone), naphtholsulphonates, benzoic acid derivatives, salicylates, cinnamic acid derivatives, and mixtures thereof.
• butylmethoxydibenzoylmethane PARSOL 1789
• octocrylene octylsalicylate
• octylmethoxycinnamate oxybenzone
• oxybenzone octylmethoxycinnamate
• genistein exhibits protective activity against ultraviolet induced skin photodamage and cancer.
• Co-formulation with an ultraviolet light protecting/sunscreen agent is particularly desirable when the present invention is prepared for consumers who engage in outdoor activities.
• suitable retinoids include retinol, retinoic acid, - retinyl palmitate, retinyl propionate, retinyl acetate, isotretinoin as well as synthetic retinoid mimics, and derivatives of the foregoing.
• Hirsutism inhibiting agents examples include ⁇ -linolenic acid, linoleic acid, and derivatives thereof.
• Barrier function enhancing agents examples include ceramides, essential fatty acids and their esters, especially glycerides, ⁇ -hydroxy fatty acids and their esters derived with alkanols through carboxylic hydroxyl or with other fatty acids at the omega-hydroxyl, the latter type being most preferred, with phospholipids, cholesterol and its esters, such as cholesteryl hemisuccinate and cholesteryl phosphate of which cholesterol phosphate and essential fatty acids are most preferred, cholestanol and its derivatives.
• the barrier function enhancing agent can be added to a topical composition either as singular molecular entities or as a complex mixture of lipids derived from either synthetic, animal or plant sources.
• Collagen enhancing agents These agents prevent skin sagging by promoting a net increase in collagen, either by reducing collagen breakdown or by promoting collagen formation.
• examples of such inhibitors include Clara extract (Sophora augustifolia), ascorbyl-phoshoryl- cholesterol, ascorbic acid, ascorbic acid derivatives, and any mixtures thereof.
• Elastase inhibitors examples include Honeysuckle extract (Lonicera caprifolium). These inhibitors act to prevent sagging of the skin.
• Skin lightening agents examples include kojic acid, hydroquinone, licorice derivatives, ascorbic acid/ascorbic acid derivatives (e.g. magnesium ascorbyl phosphate), arbutin, bearberry (Arctostaphylos uva ursi), Glycyrrhiza glabra and its derivatives, Chlorella vulgaris extract, and- any mixture thereof.
• Antioxidants examples include compounds having phenolic hydroxy functions, such as ascorbic acid, ascorbic acid derivatives, gallic acid derivatives (e.g. propyl gallate); ferulic acid derivatives (e.g. ethyl ferulate, sodium ferulate); nitrones; N-tertbutyl-nitrone; I-(4-pyridyl-1-oxide)- N-tertbutyl-nitrone; curcumin, tetrahydrocurcumin; 6-hydroxy- 2,5,7,tetramethylchroman-2-carboxylic acid; uric acid; reductic acid; tannic acid; rosmarinic acid; tocopherol and its derivatives; catechins; and any mixtures thereof.
• phenolic hydroxy functions such as ascorbic acid, ascorbic acid derivatives, gallic acid derivatives (e.g. propyl gallate); ferulic acid derivatives (e.g. ethyl ferulate, sodium ferulate);
• antioxidants are those that have one or more thiol functions (-SH), in either reduced or non-reduced form, such as glutathione, lipoic acid, thioglycolic acid, and other sulfhydryl compounds.
• the antioxidant may be inorganic, such as sulfites, bisulfites, metabisulfite, or other inorganic salts and acids containing sulfur.
• Skin cooling compounds examples include menthol, menthyl glycerol, asymmetrical carbonates, thiocarbonates and urethanes, N-substituted carboxamides, ureas or phosphine oxides, menthyl lactate, menthone glycerine acetal, and any mixtures thereof. Since many women experience "hot flashes/flushes" during perimenopause, coformulation with skin cooling compounds is particularly desirable when providing topical compositions of the present invention for such women.
• compositions of the present invention include at least two secondary components with each secondary component being selected from a different group. Table 2, below, sets forth examples of such preferred combinations. TABLE 2
• compositions of the present invention can include other cosmetic and pharmaceutical actives and excipients.
• suitable cosmetic and pharmaceutical agents include, but are not limited to, antifungals, vitamins, anti-inflammatory agents, antimicrobials, analgesics, nitric oxide synthase inhibitors, insect repellents, self-tanning agents, surfactants, moisturizers, stabilizers, preservatives, antiseptics, thickeners, lubricants, humectants, chelating agents, skin penetration enhancers, emollients, fragrances and colorants.
• suitable thickening agents include xanthan gum, hydroxypropyl cellulose, hydroxyethyl cellulose, carbomer, gum acacia, Seppigel 305 (available from Seppic Co., France), and magnesium aluminum silicate.
• compositions of the present invention can include, and their utility can be enhanced by, humectants, such as urea, pyrrolidone carboxylic acid, amino acids, sodium hyaluronate, certain polyols and other compounds with hygroscopic properties.
• humectants such as urea, pyrrolidone carboxylic acid, amino acids, sodium hyaluronate, certain polyols and other compounds with hygroscopic properties.
• Topical compositions of the present invention can also include one or more of the following:
• vitamins such as any B vitamin; 1 , 25-di hydroxy vitamin D3; vitamin K; tocopherol and its derivatives; tocotrienols and their derivatives; nicotinic acid and its esters; pantothenic acid and it esters; panthenol; folic acid and its derivatives; phytic acid; ascorbic acid and its derivatives; vitamin A and its derivatives; and any mixtures thereof;
• antifungals such as tolnaftate and ketoconazole
• anti-microbial agents such as erythromycin and tetracycline
• topical analgesics such as lidocaine, benzocaine, butacaine, tetracaine, clove oil and eugenol;
• anti-inflammatory agents may be included in topical compositions of the present invention. These anti-inflammatory agents are used at concentrations from about 0.025 wt% to about 10 wt%, preferably, about 0.5 wt% to about 1 wt%, with the concentration of the anti- inflammatory adjusted upward or downward depending upon the potency- of the utilized agents. Examples include hydrocortisone, prednisone, prednisolone, aspirin, aspirin derivatives, aloe vera, willow bark, chamomile, and mixtures thereof;
• nitric oxide synthase inhibitors that reduce skin redness, vasodilation and inflammatory reactions, especially in response to electromagnetic and ionizing radiation or to the action of chemically or biochemically aggresive compounds can be included in the present invention.
• the nitric oxide synthase inhibitors are more preferably selected from the group including guanidine derivatives, especially monoaminoguanidine and methylguanidine, L-arginine derivatives, especially NG-nitro-L-arginine and its esters, NG-monomethyl-L-arginine, 2-iminopiperidines, asymmetric dimethyl arginine (ADMA), boronic acid analog of L-arginine (Boroarg-OH»2HCI), and other 2- iminoazaheterocycles;
• insect repellents such as aliphatic, cyclic or aromatic amides, citronella oil, terpineol, cineole, neem oil, terephthalic acid and its esters, ethyl butylacetylaminopropionate and N,N-diethyl-m-toluamide (DEET) may be included in the present invention.
• DEET N,N-diethyl-m-toluamide
• Coformulation with insect repellents can be particularly desirable when the present invention is used to prevent bruising. For those who engage in vigorous outdoor activities, such as hiking and other sports, having an insect repellent incorporated into the present invention provides a convenient two-in-one preventative measure.
• the vehicle can comprise most conventional emollients including mineral oil, petrolatum, paraffin, ceresin, ozokerite, microcrystraliine wax, perhydrosqualene dimethyl polysiloxanes, methylphenyl polysiloxanes, silicone-glycol copolymers, triglyceride esters, acetylated monoglycerides, ethoxylated glycerides, alkyl esters of fatty acids, fatty acids and alcohols, lanolin, lanolin derivatives, polyhydric alcohol esters, sterols, beeswax derivatives, polyhydric alcohols and polyethers, and amides of fatty acids.
• emollients including mineral oil, petrolatum, paraffin, ceresin, ozokerite, microcrystraliine wax, perhydrosqualene dimethyl polysiloxanes, methylphenyl polysiloxanes, silicone-glycol copolymers,
• the emulsifiers can be cationic, anionic, nonionic, amphoteric, or a combination thereof.
• Nonionic emulsifiers are preferred.
• Exemplary nonionic emulsifiers are commercially available sorbitans, alkoxylated fatty alcohols and alkyl polyglycosides.
• Anionic emulsifiers may include soaps, alkyl sulfates, monoalkyl and dialkyl phosphates, alkyl sulphonates and acyl isothionates.
• the preservatives suitable for use with the present compositions include alkanols, especially ethanol and benzyl alcohol, parabens, sorbates, benzoic acid/benzoates, urea derivatves, and isothiazolinones.
• the general activity and mildness to skin of the present topical compositions can also be enhanced by neutralization to pH about 3.5 to about 7.0, most preferably from pH about 3.7 to about 5.6, with one or more of ammonium hydroxide, potassium hydroxide, sodium hydroxide, arginine or other amino acids, and/or triethanolamine.
• compositions can also be enhanced by certain chelating agents incorporated into the composition at levels from about 0.01% to about 25% by weight, more preferably from about 0.5% to 10%, and most preferably from about 1% to about 5%.
• Suitable examples of chelating agents include those that have a high affinity for zinc, calcium, magnesium, iron and/or copper ions, such as ethylene-diamine-tetra-acetic acid.
• topical compositions of the present invention can be further formulated according to procedures known in the art to provide cosmetic compositions such as emulsions, gels, creams, lotions, ointments, pastes, sticks, cakes, pencils, essences and serums as well as other topical cosmetic vehicles. It is also contemplated that topical compositions of the- present invention can be incorporated into delivery systems such as liposomes and topical patches, tapes, and sprays.
• compositions of the present invention are useful to improve the aesthetic appearance of skin by any one of the following methods:
• the present invention also includes methods by which these compounds can be used to address the aforementioned skin conditions. Such methods include topically applying an effective amount of the composition of the present invention to areas of the skin, typically once or twice daily.
• the preferred areas of application include the face and neck areas.
• preferred areas of application include hands, arms (particularly, forearms), legs (particularly, lower leg areas), hips and any other areas subject to impact.
• EXAMPLE 1 Thirty-seven women participated in a twelve week clinical study to evaluate the efficacy of a topical composition, Sample A, in increasing the thickness of the skin. The women treated one forearm with a test product for twelve weeks. The arm to be treated (right or left) was assigned randomly as the test area. Treatment was once every morning and sample A was applied to the test area.
• the skin was then assessed visually at four weeks and at eight weeks. Visual improvements of the treated arm were very evident. At four weeks, the skin looked and felt smoother. The skin also appeared brighter. At eight weeks, pigment discolorations looked lighter, and the skin had a much better overall appearance. If the treated skin was laterally compressed, the treated skin was far more resistant to compression. Untreated skin compressed easily, resulting in visible crinkling.
• the test utilized Sample A set forth above. Fifteen of the thirty- seven women who participated in the test discussed in Example 1 , above, agreed to have their arms bruised at the twelve-week time point. All of these women were post-menopausal.
• volar forearm was bruised using a pinch method.
• the skin was given a calibrated pinch using Lange Skinfold Calipers.
• Both treated and untreated volar forearms were pinched approximately two inches from the elbow flex region.
• Minolta chromameter L-a-b measurements an objective measurement of skin color
• Each woman also completed a self- assessment questionnaire on the evaluation days.
• Chromameter measurements done in the L-a-b mode assessed three color components of the bruise color.
• the "L” value is an assessment of light/dark.
• the “a” value is an assessment of red/green.
• the “b” value is an assessment of yellow/blue. The following are the average change from baseline (normal skin color) values obtained for "L", "a" and "b".
• the “a” value increases with greater redness. Untreated bruises were redder than treated bruises.
• the yellow component of the bruise, the "b” value is more yellow with a greater number.
• the "b” value can also be a blue measurement, however, most of the values obtained were in the yellow range (positive) of the scale.
• the average "b” value for untreated skin was greater for untreated skin than treated skin.
• a method for reducing susceptibility to, severity or duration of bruising comprising applying a topical composition comprising a phytoextract and a vehicle.
• phytoestrogen is selected from the group consisting of: isoflavones, steroidals, sterols, coumestans, lignans, and any mixture thereof.
• the phytoextract is selected from the group consisting of: daidzein, daidzin, acetyl daidzin, malonyl daidzin, glycitin, acetyl glycitin, malonyl glycitin, glycitein, genistin, acetyl genistin, malonyl genistin, genistein, equol, and any mixture thereof.
• topical composition further comprises a secondary component selected from the group consisting of:

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• 1999
  • 1999-09-10 WO PCT/US1999/020854 patent/WO2000013661A1/en active Application Filing
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