NZ751394A - Compositions that assist skin healing and/or maintain skin health - Google Patents
Compositions that assist skin healing and/or maintain skin health Download PDFInfo
- Publication number
- NZ751394A NZ751394A NZ751394A NZ75139414A NZ751394A NZ 751394 A NZ751394 A NZ 751394A NZ 751394 A NZ751394 A NZ 751394A NZ 75139414 A NZ75139414 A NZ 75139414A NZ 751394 A NZ751394 A NZ 751394A
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- NZ
- New Zealand
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- tarranl
- annotation
- composition
- use according
- skin
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- 239000000203 mixture Substances 0.000 title claims abstract description 107
- 230000036559 skin health Effects 0.000 title claims abstract description 7
- 230000035876 healing Effects 0.000 title abstract description 7
- 206010015150 Erythema Diseases 0.000 claims abstract description 46
- 231100000321 erythema Toxicity 0.000 claims abstract description 45
- 102000008186 Collagen Human genes 0.000 claims abstract description 42
- 108010035532 Collagen Proteins 0.000 claims abstract description 42
- 229920001436 collagen Polymers 0.000 claims abstract description 42
- -1 disodium lauriminodipropionate tocopheryl phosphates Chemical class 0.000 claims abstract description 27
- 229910019142 PO4 Inorganic materials 0.000 claims abstract description 26
- 235000021317 phosphate Nutrition 0.000 claims abstract description 26
- 238000000034 method Methods 0.000 claims abstract description 14
- 229940088594 vitamin Drugs 0.000 claims abstract description 11
- 229930003231 vitamin Natural products 0.000 claims abstract description 11
- 235000013343 vitamin Nutrition 0.000 claims abstract description 11
- 239000011782 vitamin Substances 0.000 claims abstract description 11
- 238000011282 treatment Methods 0.000 claims description 27
- 239000000284 extract Substances 0.000 claims description 24
- DFPAKSUCGFBDDF-UHFFFAOYSA-N Nicotinamide Chemical compound NC(=O)C1=CC=CN=C1 DFPAKSUCGFBDDF-UHFFFAOYSA-N 0.000 claims description 22
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 20
- 235000007319 Avena orientalis Nutrition 0.000 claims description 19
- 230000002265 prevention Effects 0.000 claims description 13
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 claims description 12
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims description 12
- 229940041616 menthol Drugs 0.000 claims description 12
- 239000003995 emulsifying agent Substances 0.000 claims description 11
- 238000004519 manufacturing process Methods 0.000 claims description 11
- 235000005152 nicotinamide Nutrition 0.000 claims description 11
- 239000011570 nicotinamide Substances 0.000 claims description 11
- 229960003966 nicotinamide Drugs 0.000 claims description 11
- 230000000699 topical effect Effects 0.000 claims description 11
- 239000003814 drug Substances 0.000 claims description 10
- 239000003974 emollient agent Substances 0.000 claims description 10
- 239000000126 substance Substances 0.000 claims description 9
- SNPLKNRPJHDVJA-ZETCQYMHSA-N D-panthenol Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCCO SNPLKNRPJHDVJA-ZETCQYMHSA-N 0.000 claims description 8
- 239000003906 humectant Substances 0.000 claims description 7
- 150000003722 vitamin derivatives Chemical class 0.000 claims description 7
- 239000003755 preservative agent Substances 0.000 claims description 6
- 239000006071 cream Substances 0.000 claims description 5
- POYIQRAKQJCAJV-TXSQEWSBSA-L disodium;3-[2-carboxylatoethyl(dodecyl)amino]propanoate;[(2r)-2,5,7,8-tetramethyl-2-[(4r,8r)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-yl] dihydrogen phosphate Chemical compound [Na+].[Na+].CCCCCCCCCCCCN(CCC([O-])=O)CCC([O-])=O.OP(=O)(O)OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C POYIQRAKQJCAJV-TXSQEWSBSA-L 0.000 claims description 5
- 229940101267 panthenol Drugs 0.000 claims description 5
- 239000011619 pantothenol Substances 0.000 claims description 5
- 235000020957 pantothenol Nutrition 0.000 claims description 5
- 239000011703 D-panthenol Substances 0.000 claims description 4
- 229960003949 dexpanthenol Drugs 0.000 claims description 4
- 210000002950 fibroblast Anatomy 0.000 claims description 4
- 239000002562 thickening agent Substances 0.000 claims description 4
- 102000012422 Collagen Type I Human genes 0.000 claims description 3
- 108010022452 Collagen Type I Proteins 0.000 claims description 3
- 235000004866 D-panthenol Nutrition 0.000 claims description 3
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 3
- 239000004480 active ingredient Substances 0.000 claims description 3
- KSDGSKVLUHKDAL-UHFFFAOYSA-L disodium;3-[2-carboxylatoethyl(dodecyl)amino]propanoate Chemical compound [Na+].[Na+].CCCCCCCCCCCCN(CCC([O-])=O)CCC([O-])=O KSDGSKVLUHKDAL-UHFFFAOYSA-L 0.000 claims description 3
- 239000000499 gel Substances 0.000 claims description 3
- 230000007794 irritation Effects 0.000 claims description 3
- 239000006210 lotion Substances 0.000 claims description 3
- 238000012423 maintenance Methods 0.000 claims description 3
- 229910052751 metal Inorganic materials 0.000 claims description 3
- 239000002184 metal Substances 0.000 claims description 3
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 3
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 3
- XZIIFPSPUDAGJM-UHFFFAOYSA-N 6-chloro-2-n,2-n-diethylpyrimidine-2,4-diamine Chemical class CCN(CC)C1=NC(N)=CC(Cl)=N1 XZIIFPSPUDAGJM-UHFFFAOYSA-N 0.000 claims description 2
- 241001465185 Drechslera avenae Species 0.000 claims description 2
- 241000196324 Embryophyta Species 0.000 claims description 2
- 239000004067 bulking agent Substances 0.000 claims description 2
- 229940073669 ceteareth 20 Drugs 0.000 claims description 2
- 229940081733 cetearyl alcohol Drugs 0.000 claims description 2
- 238000004040 coloring Methods 0.000 claims description 2
- 150000001875 compounds Chemical class 0.000 claims description 2
- 239000008387 emulsifying waxe Substances 0.000 claims description 2
- 150000002191 fatty alcohols Chemical class 0.000 claims description 2
- 239000003607 modifier Substances 0.000 claims description 2
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 claims description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 2
- 239000010452 phosphate Substances 0.000 claims description 2
- 229940068977 polysorbate 20 Drugs 0.000 claims description 2
- 238000002360 preparation method Methods 0.000 claims description 2
- 239000004094 surface-active agent Substances 0.000 claims description 2
- 241000209763 Avena sativa Species 0.000 claims 3
- DFPAKSUCGFBDDF-ZQBYOMGUSA-N [14c]-nicotinamide Chemical compound N[14C](=O)C1=CC=CN=C1 DFPAKSUCGFBDDF-ZQBYOMGUSA-N 0.000 claims 1
- 239000000839 emulsion Substances 0.000 claims 1
- 238000011161 development Methods 0.000 abstract description 6
- 239000002085 irritant Substances 0.000 abstract description 6
- 210000003491 skin Anatomy 0.000 description 52
- 210000004027 cell Anatomy 0.000 description 23
- 244000075850 Avena orientalis Species 0.000 description 15
- QXNVGIXVLWOKEQ-UHFFFAOYSA-N Disodium Chemical compound [Na][Na] QXNVGIXVLWOKEQ-UHFFFAOYSA-N 0.000 description 14
- 241001303601 Rosacea Species 0.000 description 11
- 201000004700 rosacea Diseases 0.000 description 11
- 239000003963 antioxidant agent Substances 0.000 description 10
- 235000006708 antioxidants Nutrition 0.000 description 10
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 9
- 239000003795 chemical substances by application Substances 0.000 description 9
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 9
- 239000002953 phosphate buffered saline Substances 0.000 description 9
- 239000000243 solution Substances 0.000 description 9
- 230000000694 effects Effects 0.000 description 8
- 239000002253 acid Substances 0.000 description 7
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 150000002500 ions Chemical class 0.000 description 6
- 238000002156 mixing Methods 0.000 description 6
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 description 5
- JUIUXBHZFNHITF-IEOSBIPESA-N [(2r)-2,5,7,8-tetramethyl-2-[(4r,8r)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-yl] dihydrogen phosphate Chemical compound OP(=O)(O)OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C JUIUXBHZFNHITF-IEOSBIPESA-N 0.000 description 5
- 230000003712 anti-aging effect Effects 0.000 description 5
- 230000018109 developmental process Effects 0.000 description 5
- 238000009472 formulation Methods 0.000 description 5
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 4
- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 description 4
- 230000008859 change Effects 0.000 description 4
- 235000011187 glycerol Nutrition 0.000 description 4
- JYGXADMDTFJGBT-VWUMJDOOSA-N hydrocortisone Chemical compound O=C1CC[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 JYGXADMDTFJGBT-VWUMJDOOSA-N 0.000 description 4
- 239000004615 ingredient Substances 0.000 description 4
- WYWIFABBXFUGLM-UHFFFAOYSA-N oxymetazoline Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C)=C1CC1=NCCN1 WYWIFABBXFUGLM-UHFFFAOYSA-N 0.000 description 4
- 150000003013 phosphoric acid derivatives Chemical class 0.000 description 4
- 239000000047 product Substances 0.000 description 4
- 239000012679 serum free medium Substances 0.000 description 4
- 150000003431 steroids Chemical class 0.000 description 4
- 230000000475 sunscreen effect Effects 0.000 description 4
- 239000000516 sunscreening agent Substances 0.000 description 4
- 238000011200 topical administration Methods 0.000 description 4
- FDCJDKXCCYFOCV-UHFFFAOYSA-N 1-hexadecoxyhexadecane Chemical compound CCCCCCCCCCCCCCCCOCCCCCCCCCCCCCCCC FDCJDKXCCYFOCV-UHFFFAOYSA-N 0.000 description 3
- FPIPGXGPPPQFEQ-UHFFFAOYSA-N 13-cis retinol Natural products OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-UHFFFAOYSA-N 0.000 description 3
- 201000004624 Dermatitis Diseases 0.000 description 3
- 241000208680 Hamamelis mollis Species 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- ZAKOWWREFLAJOT-ADUHFSDSSA-N [2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-yl] acetate Chemical group CC(=O)OC1=C(C)C(C)=C2OC(CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C ZAKOWWREFLAJOT-ADUHFSDSSA-N 0.000 description 3
- 239000013543 active substance Substances 0.000 description 3
- 230000032683 aging Effects 0.000 description 3
- FKIQSOGFDBALHA-UHFFFAOYSA-L aluminum trimagnesium potassium dioxido(oxo)silane oxygen(2-) difluoride Chemical compound [O--].[F-].[F-].[Mg++].[Mg++].[Mg++].[Al+3].[K+].[O-][Si]([O-])=O.[O-][Si]([O-])=O.[O-][Si]([O-])=O FKIQSOGFDBALHA-UHFFFAOYSA-L 0.000 description 3
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- 229940118846 witch hazel Drugs 0.000 description 3
- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 description 2
- LQIAZOCLNBBZQK-UHFFFAOYSA-N 1-(1,2-Diphosphanylethyl)pyrrolidin-2-one Chemical compound PCC(P)N1CCCC1=O LQIAZOCLNBBZQK-UHFFFAOYSA-N 0.000 description 2
- IQXJCCZJOIKIAD-UHFFFAOYSA-N 1-(2-methoxyethoxy)hexadecane Chemical compound CCCCCCCCCCCCCCCCOCCOC IQXJCCZJOIKIAD-UHFFFAOYSA-N 0.000 description 2
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- QFOHBWFCKVYLES-UHFFFAOYSA-N Butylparaben Chemical compound CCCCOC(=O)C1=CC=C(O)C=C1 QFOHBWFCKVYLES-UHFFFAOYSA-N 0.000 description 2
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- SHGAZHPCJJPHSC-NUEINMDLSA-N Isotretinoin Chemical compound OC(=O)C=C(C)/C=C/C=C(C)C=CC1=C(C)CCCC1(C)C SHGAZHPCJJPHSC-NUEINMDLSA-N 0.000 description 2
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- 150000007513 acids Chemical class 0.000 description 2
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- DDJSWKLBKSLAAZ-UHFFFAOYSA-N cyclotetrasiloxane Chemical compound O1[SiH2]O[SiH2]O[SiH2]O[SiH2]1 DDJSWKLBKSLAAZ-UHFFFAOYSA-N 0.000 description 2
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- HIPQTCQUXOFTFI-UHFFFAOYSA-N 2-methoxy-1,3-diphenylpropane-1,3-dione Chemical compound C=1C=CC=CC=1C(=O)C(OC)C(=O)C1=CC=CC=C1 HIPQTCQUXOFTFI-UHFFFAOYSA-N 0.000 description 1
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- DWYHDSLIWMUSOO-UHFFFAOYSA-N 2-phenyl-1h-benzimidazole Chemical compound C1=CC=CC=C1C1=NC2=CC=CC=C2N1 DWYHDSLIWMUSOO-UHFFFAOYSA-N 0.000 description 1
- MCSXGCZMEPXKIW-UHFFFAOYSA-N 3-hydroxy-4-[(4-methyl-2-nitrophenyl)diazenyl]-N-(3-nitrophenyl)naphthalene-2-carboxamide Chemical compound Cc1ccc(N=Nc2c(O)c(cc3ccccc23)C(=O)Nc2cccc(c2)[N+]([O-])=O)c(c1)[N+]([O-])=O MCSXGCZMEPXKIW-UHFFFAOYSA-N 0.000 description 1
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- 239000002076 α-tocopherol Substances 0.000 description 1
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
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
- A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
- A61K31/355—Tocopherols, e.g. vitamin E
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/164—Amides, e.g. hydroxamic acids of a carboxylic acid with an aminoalcohol, e.g. ceramides
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
-
- 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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K8/678—Tocopherol, i.e. vitamin E
-
- 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
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
- A61Q19/08—Anti-ageing preparations
Abstract
The present invention relates to compositions that assist skin healing and/or maintain skin health. The invention also relates to methods for increasing collagen in the skin and methods for treating or preventing the development or recurrence of erythema. The compositions according to the present invention comprise disodium lauriminodipropionate tocopheryl phosphates and, preferably, one or more anti-irritants and one or more vitamins.
Description
Compositions that assist skin healing and/or maintain skin health
This application is a divisional of NZ , all of which is hereby incorporated by
reference in its entirety.
Field of the invention
The t invention relates to compositions that assist skin healing and/or maintain
skin health, such as increasing collagen in the skin and/or treatment or prevention of the
development or ence of erythema. In addition, the present invention relates to a
method for assisting skin healing and/or maintaining skin health.
Background of the invention
There are many causes of damage to the skin and many of these results in erythema.
Erythema is a skin condition characterised by al redness of the skin. It is a
medical condition that is more significant than the normal flushed cheeks and/or nose in
the fair and sensitive skinned.
Erythema can occur in various skin conditions such as eczema, psoriasis and rosacea.
It is a condition associated with inflammation of the skin and can be caused by external
irritation of the skin, for example, by over exposure to the sun or t with irritating
substances such as plants (eg poison ivy), various chemicals and some metals (eg
nickel in jewellery). Erythema can also occur when the skin is d by piercing with
an object or following an insect bite. This damage can be unintentional or an intended
part of a procedure such as skin needling. Erythema may also occur following various
medical and ic procedures ing laser treatment, intense pulsed light (IPL)
treatment and microdermabrasion. Erythema may occur in response to an allergic
reaction or an infection. It is a common side effect of radiotherapy treatment and can be
a side effect of medication or an s. As a final example, erythema may occur as a
side effect of certain types of poisoning including vitamin A ty. Despite the
numerous known causes of erythema, in a significant proportion of cases the cause of
erythema is unknown.
Traditional treatments include antibiotics such as doxycycline. Alternative oral
treatments include vitamin A medications, such as isotretinoin, steroids and antifungal
medications. These treatments have significant side effects, for example isotretinoin has
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teratogenic side-effects. Antibiotics, antifungals and steroids can be administered
ally but have d efficacy and/or restrictions on use due to safety concerns.
Other topical treatments include metronidazoie, azelaic acid, retinoic acid/retinaldehyde,
and vitamin C.
There are also light therapies to treat erythema, particUlarIy erythema associated with
rosacea and laser treatments involving the ablation of blood vessels.
1% hydrocortisone as a topical cream is one of the common short-term l
treatments for ma. '
Therevare limitations to all ofrthe’current treatments either with efficacy or toxicity.
Erythema, ularly erythema ated with a, can be a persistent and
chronic condition involving repeated remission and bation. Many of the
treatments such as steroids or antibiotics are not riate for long term use. There is
a need for a non-prescription, non-steroid product that effectively assists the skin to heal
and, in particular, treats erythema. The minimisation of side-effects is particularly
important because some conditions ated with ma, such as rosacea, often
require lifelong symptomatic treatment. In addition. the subject’s skin may be so
sensitive that many topical products are irritating. If a treatment is not sufficiently mild, it
can exacerbate rather than improve the symptoms. A better treatment in these cases is
one that is effective, mild and can be used long term.
W0 2002/74290 describes treatment of rosacea with a non-steroidal anti-inflammatory
drug such as piroxiam, aspirin, ibufenac or naproxen in combination with nitroimidazole.
discloses itions for treating rosacea ning chitosan, a
chitosan derivative or a physiologically acceptable salt thereof and a short-medium
chain dicarboxylic acid amide.
.25- Brimonidine was reported asouseful in the topical treatment of erythema in WC
of oxymetazoline for
‘ treatin2011/fi77, disclosed cream compositionsmptoms of rosacea including erythema, and disclosed the,
topical treatment of rosacea with a combination of brimonidine and oxymetazoline.
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disclosed the topical treatment of rosacea with berberine or'a
biologically equivalent'analogue f. WO 2012/001053 disclosed treatment of
rosacea with metronidazole esters.
' The majority of the dermis of the skin is collagen. The collagen both supports the skin
structure and s moisture. en fibres in the skin are reduced by exposure to
iolet ion. a dry environment andloxidation. The amount of collagen in the skin
also reduces with age. Reduction of collagen is ated with reduced resilience and
”elasticity in the skin. Increased en production improves skin healing in patients
with erythema.‘ In addition, maintenance and/or increases in collagen levels in the skin
assist to maintain skin function and appearance. Overtime, this may prevent aging or
have an antiaging effect.
ids are known to increase en production. However, they' have high
photoreactivity and require protection from light for stable storage. Retinoids also have
- significant incidence of adverse reactions including photosensitisation of the skin, which
makes skin more susceptible to sunburn.
discloses the use of TGF-B and/or TGF—B degradation products in the
ion of collagen in the skin. WO 40363 discloses a composition 'for
ing collagen production comprising one or more. of D-aspartic acid, D-alanine
and derivatives and/or salts thereof. describes a compoSition for
promoting collagen productioncomprising one or more purine nucleic acid-related
substances.
Reference to any prior art in the specification is not, and should not be taken as, an
acknowledgment or any form of suggestion that this prior art forms part of the common
general knowledge in Australia or any Other jurisdiction or that this prior art could
‘25 reasonably be expected to be ascertained, understood and regarded as relevant by a
person skilled in the art.
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Summary of the invention
"The inventors of the present invention ped topical formulations intended as
soothing products for sensitive skin types, that is, to soothe sensitive but undamaged
skin. The formulations are intended to desensitise the skin by hydration and
moisturisation. Surprisingly, the inventors discovered that the formulations of the
invention have an additional and unexpected effect on healing damaged and inflamed
Skin with erythema. In addition, the formulations of the invention have been found to
increase the amount of collagen in the skin, which further assists with skin g. In
addition, the increase in collagen may protect the skin from degradation due to aging
' and/or provide an anti-ageing benefit.
in one aspect, the present invention provides a method of increasing collagen in the
skin‘of a subject sing topical administration of a physiologically effective amount
of a composition comprising disodium lauriminodipropionate tocopheryl phosphates. in
an alternate aspect, the present ion provides a method of increasing collagen in
the skin of a subject comprising topical administration of a logically ive
amount of a composition comprising hamemalis virginiana water. In a preferred
embodiment, the subject is identified as likely to benefit from increased collagen in the
skin. The benefit from the increased collagen may be improved g ing skin
, the prevention or reduction of skin damage from re to ultraviolet
radiation or during therapeutic or cosmetic procedures such as laser treatment,
prevention of aging, maintenance of skin health, or ing. The sed production
of collagen may occur in any skin cell type. It is‘particularly beneficial for'the increase in
collagen to occur in fibroblasts. Where the increased production of collagen occurs in
firbroblasts it may also occur in other skin cell types.
A physiologically effective amount of disodium laurimin’Odipropionate tocopheryl
phosphates may be provided in the form of a topical formulation comprising 0.4 to 2%
wlw um lauriminodipropionate tocopheryl ates.
In a preferred embodiment, administration of the composition increases production of
Collagal by about 10% or more, for example, when measured by fluorescent antibody
binding. In a» preferred embodiment, administration of the composition increases
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collagen III by about 20% or more and in a most preferred embodiment, administration
of the composition increases collagen III by about 40%.
Further, in a preferred embodiment, administration of the composition increases
production of collagen l by about 5% or more, for example, when measured by
ent antibody binding. In a particularly preferred embodiment, administration of the
composition increases collagen l by about 15%. atively, the composition
administered to the subject is a composition that if administered to human foreskin
fibroblasts results in about a 40% increase in collagen Ill and/or about a 15% increase
in collagen | after)r about 60 hours of incubation with the composition.
'10 "In all alternative embodiments of the invention the subject can be a human subject.
In a second aspect, the present ion provides a method of treatment, prevention
or prevention of recurrence of erythema comprising topical administration of a
physiologically effective amount of a
. composition comprising disodium
lauriminodipropionate tocopheryl phosphates. in a preferred aspect, the method is a
.method of treatment. In one embodiment, the subject is identified as having erythema.
In an alternate embodiment, the tis fied as being at risk of developing
erythema. In another alternate embodiment, the subject is identified as being at risk of
ence of erythema. The erythema may be caused by any of the known causes
sed above. The cause of the erythema may be unknown. In one embodiment, the
'20 treatment of the erythema is post laser skin treatments, chemical peels,
microdemiabrasion or skin needling. In another embodiment, the erythema treated is
» assoCiated with rosacea, psoriasis or eczema. In another embodiment, the method is to
prevent recurrence of rosacea. \
in a preferred embodiment, the administration of the composition reduced the Standard»
\25 Scalar Rating for the erythema by 75% or more by 7 days after use. It is preferred if the
Standard Scalar Rating is d by 80% or more by 7 days after use. In an ative
preferred embodiment, the administration of the composition d the Standard
Scalar fling for the erythema by 3.0 or more by 7 days after use. It is preferred if the
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Standard Scalar Rating is reduced by 3.3 or more by 7 days after use. The Standard
Scalar Rating is explained below.
In an alternative preferred embodiment, the administration of the composition resulted in
a magenta to blue shift, ie a* as measured by a Minolta Spectrometer Model CM-2600,
of -2.5 or a greater ve by 48 hours after use. it is preferred if the magenta to blue
shift is -2.8 or a greater negative by 48 hours after use. In an alternative preferred
embodiment, the magenta to blue shift is -4 or a greater negative by7 days after use. 'It
is preferred if the magenta to blue shift is -4.6 or a greater negative by 7 days after use.
In an alternative preferred embodiment, the administration of the composition results in
a AE. ie (AE) = «1(AL2 + Aa2 + Abz) as measured by a Minolta Spectrometer, of 3.5 or
more by 48 hours after use. It is preferred if the AE is 3.7 or more by 48 hours after use.
In an alternative preferred embodiment, the AE is 5 or more by 7 days after use. It is
preferred if the AE~ is 5.7 or more by 7 days after use.
in a preferred embodiment, the composition of the present invention comprises
'15 disodium Iauriminodipropionate tooopheryl phosphates, at least one vitamin andrat least
one anti-irritant. The anti-irritant can be an emollient, a vitamin, an antioxidant or a
herbal extract. Vitamin E, liquid paraffin, aloe vera and avena sativa kernel extract are
suitable. Avena sativa kernel extract is red. The at least one vitamin is preferably
nicotinamide. in a particularly preferred embodiment, the composition includes the two
.20 vitamins nicotinamide and panthenol. -
In. a particularly preferred embodiment, the composition of the present invention
comprises disodium inodipropionate eryl phosphates, at least one vitamin,
at least one anti-irritant and hamemalis virginiana water.
In one embodiment, the composition r includes menthol for a cooling effect. In a
particularly preferred embodiment, the composition es the anti-irritant avena
sative kernel extract, the two vitamins nicotinamide and panthenol. and menthol.
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The composition of the present invention optionally further includes one or more
emulsifiers, emollients, ners, humectants. preservatives, body builders, zing
agents, bulking agents, pH adjusters, feel modifiers, colouring agents and/or fragrances.
The composition of the invention can be a cream, lotion or gel.
In one aspect, the cOmposition of the invention comprises:
a. disodium Iauriminodipropionate tocopheryl phosphate in an amount
lent to 1 to 5 percent (wlw) of a 40% active composition;
b. in combination with one or more of hamemalis virginiana water 0.5 to 10
percent (wlw);
c. nicotinamide 0.5 to 5 percent (wlw);
d. avena sativa kernel t in an amount equivalent to 0.5 to 5 percent
(wlw) of a 100 ppm solution; and
e. menthol 0.01 to 0.1 percent (wlw).
Where the disodium Iauriminodipropionate tocopheryl phosphate in the above
composition is in a form comprising 40% (wlw) active ingredient, that form is 1, 2, 3, 4 or
percent (wlw) of the composition. More preferably, the disodium Iauriminodipropionate
tecopheryl ate in the above composition is in a form comprising 40% active
ingredient and that form is 3 percent (wlw) of the composition. Where the disodium
Iauriminodipropionate eryl phosphate is not in a form comprising 40% active, the
active is preferably 1.2% (wlw) of the above composition.
The. avena sativa _kemel extract may be a 100 ppm solution. When in a 100 ppm
solution it is preferred that solution is 0.5 to 5 percent (wlw) of the composition and most
preferred that the solution is 1 percent (wlw) of the composition. Where the avena sativa
‘ kernel extract is in another form it is red that the active inthe extract is in an
amount equivalent to the amounts stated above.
In one embodiment, the disOdium Iauriminodipropionate tocopheryl phosphate is in
embocombifin with both the avena sativa kernel extract and the menthol. In an alternativent, the disodium, Iauriminodipropionate tocopheryl phosphate is in
ation with both the avena sativa kernel extract and the nicotinamide. In an
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alternative embodiment, the disodium lauriminodipropionate tocopheryl phosphate is in
combination with both the avena sativa kernel extract and the hamemalis virginiana
water. In a red embodiment, the disodium lauriminodipropionate tocopheryl
phosphate is in combination with the avena sativa kernel extract, the menthol and the
hamemalis virginiana water.
. In a preferred embodiment, the hamemalis virginiana water is in combination with all of
the four ingredients listed in the paragraph directly above. In this embodiment, the -
proportions are desirably:
disodium lauriminodipropionate tocopheryl phosphates 3.00 percent (w/w)
in the form of a 40% active composition;
'hamemalis virginiana water 3 percent (w/w);
avena sativa kernel extract in a 100 ppm solution 1 percent (w/w);
nicotinamide 1 percent (w/w); and
menthol 0.03 percent (WM).
'15 Alternatively. the proportions are desirably:
disodium Iauriminodipropidnate tocopheryl phosphates 1.2 percent (wlw);
lis virginiana water 3 percent (w/w);
avena sativa kernel extract in an amount equivalent to 1 t (w/w) of a
100 ppm solution;
‘20 nicotinamide 1 t (w/w); and
menthol 0.031 t (w/w).
In a prfired embodiment, the'composition consists essentially of:
a. disodium lauriminodipropionate tocopheryl phosphates ‘1 .2 percent (w/w);
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b. hamemalis virginiana water 3 percent (w/w);
c. avena sativa kernel extract in an amount equivalent to 1 percent (w/w) of a
100 ppm solution;
d. nicotinamide 1 percent (w/w);
e. menthol 0.03 percent (w/w);
'f. one or more humectants, emollients, thickeners, emulsifiers,
preservatives, tants, pH adjusters, pearling, colouring or sent
agents; and
g. waterq.s..
1o In a further, aspect, the present invention provides the use of a physiologically effective
amount of a ition comprising disodium lauriminodipropionate tocopheryl
phOSphates in the preparation of a medicament for increasing collagen in the skin of a
subject. It is red, that the medicament is also for the topical treatment or
prevention of thedevelopment or recurrence of erythema.
. In a further aspect. the t invention provides a composition comprising a
physiologically ‘ effective amount of a
, composition comprising disodium
lauriminodipropionate tocopheryl phosphates when used to increase collagen in the skin
.of’a subject. It is preferred, that the itionxis also used in the topical ent or
prevention of the development or recurrence of erythema.
In a further aspect, the present invention provides the use of a composition comprising
a' physiologically effective '
amount of a composition sing disodium
lauriminodipropionate tocopheryl phosphates for sing collagen in the skin of a
t. It is preferred, that the use is also for the topical treatment or prevention of the
development or recurrence of erythema.
The exemplified composition may be ted in a container with a pump dispenser.
The amount dispensed from the pump can vary but is about 200 milligrams with a fixed
% of active as described abOVe. One pump may supply a physiciogically effective
amourm about 2.5 mg disodium lauriminodipropionate tocopheryl phosphates for
appli to the face. However, multiplepumps from the dispenser may also be
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applied, for~ example, 2, 5 or 10 pumps to provide a physiologically effective dose to a
greater area of skin or to se the amount of product used on the same area of skin.
.Without wishing to be bound by theory or mode of action, it is-considered that the
increase in the collagen in the skin in combination with the anti-inflammatory effect
caused by-to’pical stration of the compositions of the invention causes the
treatment or prevention of the development or recurrence of ma.
Detailed description of the embodiments
It will be understood that various terms employed in the specification, examples and
claims have meanings that will be tood by one of ordinary skill in the art.
However, certain terms are defined below.
As used herein, except where the context requires othewvise, the term ise" and
variations of the term, such as "comprising are» not
, comprises" and "comprised",
intended to exclude further additives, components, integers or steps.
The term “composition" as used throughout the specification is understood‘to mean a
'15 Composition comprising a therapeutically effective amount‘of at least one therapeutic
agent and at least one pharrnaceutically acceptable carrier, excipient,'diluent. additive
or vehicle consiStent with the intended form of topical administration and consistent with
I if
conventional pharmaceutical practices.
The term “disodium lauriminodipropionate tocopheryl phosphates” as used throughout
the specification is tood to mean a blend of tocopherol phosphates with disodium
lauriminodipropionate having the International lature of Cosmetic Ingredients
(INCI) name “disodium lauriminodipropionate tocopheryl phosphates”.
The term “hamemalis virgininiana water’" as used throughout the specification is
understood to mean a witch hazel distillate, in particular, the witch hazel distillate having
the lntemational Nomenclature of Cosmetic Ingredients (INCI) name Hamemalis
Virginia (Witch Hazel) Water;
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The term “therapeutic agent” or simply “agent” or “active" as used throughout the
specification are understood to mean any substance that is intended for the diagnosis,
cure, mitigation, treatment, prevention or modification of a state in a biological system.
The term “physiologically effective” as used throughout the specification relates to the
amount or dose of an active agent or a composition thereof that will lead to the deSired
physiological , in particular, the reduction or treatment of ma, prevention of
the development or recurrence of erythema or increase in collagen production in the
skin. A logically effective amount will vary according to s such as the,
severity of the condition, age, gender, and skin type of a subject, and the ability of the
'10 substance to elicit a desired response in the subject.
The term “Cetereth-ZO" as used hout the cation s to a polyethylene
glycol ether of cetyl alcohol. Its synonyms include Ceteareth-20, Cetomacrogol 1000;
PEG-20 cetyl ether; PEG-20 hexadecyl ether; polyethylene glycol 1000 cetyl ether;
polyoxyethylene (20) cetyl ether.
The term “panthenol” as used throughout the specification includes “dexpanthenol”.
The term “prevention” as used’throughout the specification means to inhibit, minimise,
defer or delay the onset of a condition.
The ition according to the present invention comprises a physiologically
effective amount of disodium Iauriminodipropionate tocopheryl phosphates. In *
ment, the compositions according to the present invention comprise disodium
lauriminodipropiOnate tocopheryl phosphates (40% active) in an amount of about 0.5 to
t (MW). in' a preferred embodiment, the compositions according to the present
invention comprise disodium inodipropionate tocopheryl phosphates (40% active)
in an amount of about 1 to 5 percent (w/w) or comprise disodium Iauriminodipropionate
tocopheryl phosphates active in an amount of about 0.5 to 2 percent (w/w). in a
particularly preferred embodiment, the composition comprises about 3 percent (w/w)
disodiqlauriminodiprOpionate tocopheryl phosphates (40% active) or 1.2 percent
(wlw) acrve disodium Iauriminodipropionate.tocopheryl phosphates .
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The composition of the invention can be a cream, lotion or gel. In a preferred
embodiment, the composition according to the present invention r comprises at
least one emulsifier. Emulsifiers suitable for use in pharmaceutical compositions are
well known "to those of ordinary skill in the art and include, for example,
polyoxyethylene derivative of sorbitan monolaurate such as polysorbate 20, fatty
alcohols such as cetearyl alcohol, ceteareth compounds, and emulsifying waxes. A
preferred emulsifier is eth-20, which is cially available from Croda under
the brand name Cetomacrogol 1000.
The amount of emulsifier added to the composition maybe readily determined by one of
ordinary skill in the art With a minimum of experimentation, and 'will depend upon factors
known to those skilled in the art, such as the properties of the emulsifier and the desired
properties of the pharmaceutical composition.
According to one ment of the present invention, the composition may include at
4 least one additional “skin active . Skin active agents may afford an improvement
715 in the appearance. tone or texture of the skin, and may include, but are not limited to,
eens, anti-wrinkling or anti-aging , antioxidants, vitamins, depigmentating
'or skin lightening , moisturizing , emollients, metal chelators, retinoids and
retinoid derivatives, agents intended'to reduce skin irritation. and alpha-hydroxy acids.
It will be recognised that the inclusion of skin active agents in the composition according
to the present invention will depend upon their physical, chemical and eutic
compatibility with the other components of the composition.
in one embodiment, the composition according to the present invention further
comprises an effective amount of at least one sunscreen. Examples of sunscreens
include, but are not limited to, octyl methoxycinnamate, oxybenzone and butyl
'methoxydibenzoylmethane. Some such sunscreens may- retain a more greasy feel but
the composition still provides a suitable ry vehicle for a therapeutic, such as
mometasone e. In another embodiment the sunscreen is phenylbenzimidazol
sulfoninid or disodium phenyl imidazole tetrasulfonate or similar.
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In one embodiment, the composition according to the present ion may include at
least one additional anti-wrinkling or anti-aging agent. Examples of rinkling or anti-
aging agents include, but are not limited to, retinoids (for e, ic acid, retinol,
retinal, l acetate, and retinyl palmitate), alpha hydroxy acids,\galactose' sugars (for
e, melibiose and lactose), lipoic acid and dihydrolipoic acid, lactoferrin, ascorbic
‘acid, and ascorbic acid derivatives '(for example ascorbyl palmitate and ascorbyl
polypeptide).
In another embodiment, the compositionaccording to'the present invention may include
at least one antioxidant or a natural extract that contains antioxidants. Antioxidants may
'10 be water or oil-soluble. Oil soluble antioxidants suitable for use in the composition of this
invention include, but areynot limited to, tocopherols and tocopherol derivatives (for
example, tocopheryl acetate, alpha-tocopherol), tocotrienols and ubiquinone. Natural
extracts containing antioxidants suitable for use in the composition of this invention,
include, but are not d to, extracts containing flavonoids, phenolic nds,
,15 flavones, flavanones, isoflavonoids, mono-, di- and tri-terpenes, sterols and their
derivatives. Examples of such natural extracts include grape seed, green tea, pine bark
extracts and legume extracts. Antioxidants may also minimize skin tion.
In another embodiment, the composition ing to the present invention may include
at least one agent intended to inhibit or minimise potential skin irritation, such as an
emollient (e.g., liquid n), a vitamin, an antioxidant (e.g., vitamin E) and a herbal
extract (e.g. ”aloe vera or avena sativa kernel extract). Avena sativa kernel extract is a
preferred [anti-irritant.
In another aspect according to the present invention, the composition comprises at least
one other ent intended to improve the appearance, stability or consumer appeal
of the composition; Such components include, but are not limited to: fragrances,
emollients, preservatives, vitamins and vitamin derivatives, antioxidants, colours,
humectants, plant extracts, surface active agents, and other ingredients to further
soothe and protect the skin.
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Again, it will be recognised that the inclusion of other ents intended to improve
the appeal or ity of the composition according to the present invention will depend
upon their physical, al and therapeutic compatibility with the other components of
the composition. I
According to the present invention the term ‘stability’ refers to a composition that does
not present any significant macroscopic change of appearance or microsCopic change
of appearance-(e9, precipitation of an ingredient) over time.
In one embodiment, the composition according to the present ion comprises at
least one humectant. Examples of humectants include, but are not limited to: glycerin,
glycerol, sodium PCA, panthenol/dexpanthenol, sorbitol, propylene glycol, 1,3—butylene
glycol, polypropylene glycol, xylitol, maititol, lactitoi, oat protein, allantoin, acetamine
MEA and hylauronicacid.
In another embodiment, the composition according to the present invention may
comprise at least one preservative. Examples of preservatives which may be used in
the composition of this invention include, but are not limited to, sodium salicylic acid,
chlorhexidine hydrochloride, phenoxyethanol, sodium benzoate, sodium methyl
ybenzoate, sodium propyl hydroxybenzoate, methyl para-hydroxybenzoate (i.e.,
methyl n), ethyl ydroxybenzoate, propyl para~hydroxybenzoate (i.e., propyl
,paraben) and butyl para-hydroxybenzoate.
' in another embodiment, the composition according to the present invention may
comprise one or more emollients. Parafflnum liquidum (liquid paraffin),
cyclotetrasiloxane and cylclopentasiloxane (Dow, Cylcomethicone 345) are suitable
emollients.
In another embodiment, the composition according to the present invention may
comprise one or more thickeners. Xantham gum and aristoflex AVC (ammonium
acryloyldimethyI-taurateNP copolymer) are suitable ners.
_ln anoB embodiment, the composition according to the present invention may
- comprise one or more body builders such as yl alcohol.
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In another embodiment, the composition ing to the present invention may
comprise one .or more zing agents such as synthetic fluorophlogopite (and)
titanium dioxide (and) tin oxide (Timiron Synwhite 40).
in another embodiment, the composition according to the present invention may
comprise one or more bulk agents such as water.
The formulations of the present invention are manufactured in a conventional manner
by thoroughly mixing the ingredients at t or elevated temperatures.
, Any pharmaceutically acceptable acid may be employed to adjust the pH of the
pharmaceutical composition of the present invention to a pH suitable for a topical
1O composition. The identity of such acids are known to those of ordinary skill in the art,
and include, but are not limited to those described in the lntemational Cosmetic
Ingredient Dictionary and Handbook 12m Edition, 2008, Volume'3, pp 3221-3222,
Preferred acids are lactic acid, citric acid, hydrochloric acid and ic acid. A
particularly preferred acid is citricvacid.
.15 The examples that follow are intended to illustrate but in no way limit the present
invention;
Example 1 — formulation of the ition
A composition suitable for use in the methods of the present invention can be prepared-
as follows:
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,—0.10
Sodium PCA
Cyclotetrasiloxane and
cyclopentasiloxane
Avena sativa kernel extract. 1.00
(100ppm solution) - .
Hamemaiis virginiana water
Part F: ner
um acryloyldimethyl-
taurateNP copolymer
—3-50 ,
Synthetic fluorophlogopite (and)
um dioxide (and) tin oxide
Disodium Iauriminodipropionate 3;00
tocopheryl phosphate (40%
active) '
Methofi formulationi -
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.1. Heat Part A water & citric acid to HBO-65°C
2. At 65 00 add Part-c and mix until dissolved
3. Add Part D with propeller . Homogenise for 1 minute.
4. Cool batch to 50 °C with propeller mixing.-
. Combine Part A Glycerin and-Dexpanthenol and add to batch
6. Add Part E & B with propeller mixing. Homogenise for ‘30 seconds
7. Combine Part F Glycerin, Xanthan gum and. Synthetic fluorophlogopite (and) titanium
- dioxide (and) tin oxide
8. Add ammonium'acryloyldimethyI—taurateNP copolymer then the rest of ‘Part F to the
‘10 Batch with propeller mixing
9. Cool batch to 45°C with propeller mixing.
. Add Part G with ler mixing
11. Homogenise for 2 minutes.
.15 e 2 - increase of collagen l and III in the skin
Experimental protocol:
1. Human in fibroblast (HFF) cells were seeded in a 96 well plate. 100p| of cells at
5X105 cells/ml was added per well in Dulbecco’s d eagle medium (DMEM) +
% fetal calf serum (FCS) + penicillin streptomycin (penstrep).
2. .The cells were incubated at 37°C in 5% C02 overnight
3. After 24 hrs the cells were transferred serum free media‘(SFM) for 6 hrs
4. The cell replated with SFM plus in 200;” of the composition formulated in Example 1.
SFM alone was used as a control.
. The cells were left at confluence for 60 hrs to allow collagen to build up
'6. Thulls were washed 3x with 100pl per well of phosphate buffered saline (PBS)
7. The cells were fixed and permeabilised in. ice cold MeOH (—20°C)
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8. The fixed cells were transferred to the freezer for 15 s
9. The fixed cells were aspirated and air dried briefly then washed 3x with 100pl per well
of PBS and treated with Tween 20 (0.5%) in PBS for 10 minutes.
. The cells were blocked in 50pl per well PBS Tween + 3% normal goat serum (N68)
and ted in '50pl per well. primary dy in PBS + 3% NGS. For the collagen l
experiment the primary antibody was 1:200 Collagen l rabbit polyclonal antibody
(Rockland - Cat# 600—401-103.05). For thecollagen III experiment the primary antibody
was 1:200 Collagen Ill rabbit polyclonal antibody (Rockland - Cat# BOO—401405.05).
11. The cells were stored at room temperature for 2 hours then washed 3x in 100pl per
Well PBSand incubated in mm per well Alexa conjugated secondary antibody in PBS.
The antibody used was 1:200 Alexa 488 goat anti-rabbit 'lgG (lnvitrogen - Cat# A
12. The cells were stored at room temperature for 1 hour then washed 3x in 100pl per
well PBS and .100pl PBS was added to each well.
Analysis:
Analysis was conducted on an Olympus IX81 fluorescence microscope, with Olympus
DP80 digital camera and CooILED light source. In both instances there was a 1.493
'20 second re and a 4x gain using the camera set to 0.6MP and with the light path
split between the ocular and camera. Images were captured and analysed using
cellSens Dimension software (Olympus). Measurements are mean grey scale values of
14 bit images.
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Results:
Table 1 - Collagen I
—w_l-Cellstreated with
exam . le 1
IEEIIIIIIIIIIIIIIIIIIIflfiflllllllliflZEIIIIIIIIIIIIIlifliilllllllllllllll
E_——_
IZEJBIIIIIIIIIIIIIIIIIIIII3§§IIIIIIlEBEEIIIIIIIIIIIIIIflliiallllllllllllllllll
IEEZIIIIIIIIIIIIIIIIIIlflilllllllIiIIEIIIIIIIIIIIIIIIEHEIIIIIIIIIIIIIIIII
IJZEIIIIIIIIIIIIIIIIIIIliiflllllllIiflalllllllllllllllliiflllllllllllllllll
IZEEIIIIIIIIIIIIIIIIIIIIZIIIIIIIIliEElIIIIIIIIIIIIIIIEEEIIIIIIIIIIIIIIIII
lIHIiIIIIIIIIIIIIIIIIIIIIIEIBIIIIIIIliilllllllllllllllllilBlIIIIIIIIIIIIIIII
008 _——
. lNfliflIIMiIIIIIIIIIIIIIIHIIHIBEEIIIIiZBilIIIIIIIIIIIIIIIBEZIIIIIIIIIIIIIIIII
————
[SEMIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIZIIIIIIIIIIIIIIIIIEIIIIIIIIIIIIIIIIII
—_——1
Mean OD percentage of- 100% ‘
SFM Mean OD ,
The s from Table‘ 1 are graphed in Figure 1. The graph shows a significant
difference in the collagen I levels in cells treated with serum free medium compared with
cells treated with the composition of example 1. The fluorescence for the cells d
with serum free medium was about 6,300, while the fluorescence for the cells treated
' with the composition of example 1was about 7,300. This represents a 15% increase in
collagen l.
10A Table 2 — Collagen lll
Cells treated with
composition of
exam . le 1
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, 2.0
Cells treated with
composition of
exam - le 1
797' 8122 '
- 10265
739125 7 7499.0 10275.8
e ,
Mean loo — blank 6759.9 9536.6
Est-I— 163.8 '
P Value v control 1.47E-08 ’
Mean OD 100% 141% ”
percentage of SFM ‘
Mean OD ,
The s from Table 2 are graphed in Figure 2. The graph shows a significant
difference in the collagen Ill levels in cells treated with serum free medium compared
with cells treated with the composition of example 1’: The fluorescence for the cells
treated with serum free medium] was about 6,800. while the fluorescence for the cells
treated with the composition of example 1 was about 9,500. This represents a 41%
increase in collagen lll.
' Example 3
— ion in erythema
Experimental protocol:
1. The baseline assessment for each test participant was determined a day befOre
exposure to the Solar Simulator at time = -1.
2. A Solar Simulator was used to induce mild ma on 7 designated areas of the
back of test subjects at time = 0.
l ‘
3. The composition of example 1 or a control of 1% hydrocortisone cream was topically
applied to the irradiated skin immediately after irradiation and again 4-5 hours later. The
{Composition or positive control was rubbed in Well upon each application. There was
also a negative control involving irradiation and assessment without topical application.
4. Test subjects returned for assessment at 24 hours (i=1), 2 days (i=2), 4 days (t=3)
and 7 «fl (t=4).
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. Assessment ed visual assessment and scoring of the ma. In addition,
colorometric measurements were taken using a Minolta Spectrophotometer Model CM,
2600 and the L*a*t)* colour space values recorded. The L Value es skin
ning, the a*b* values indicate change in tone against the background skin tone. _
Total colour change (AE) = \/(AL2 + Aa2 + Abz). ments at T=1 are compared with .
, =2, T=3 and T=4 to quantify the improvement in colour over time.
6. Visual assessment scoring was madeaccording to the Standard Scalar Ratings:
0 = no erythema present
1 = minimal faint (light pink), uniform or spotty erythema
2 = mild erythema, pink uniform erythema covering most of contact site
3 = moderate erythema, pink/red erythema visibly. m in entire contact area »
'4 = marked bright red erythema
= severe deep red erythema
Results:
'15 Table 5 - AE
U-V only, negative
control
Positive control
Composition of
exam . le 1
Table 6 - magenta to blue shift (a* at the relevant time point minus the initial a*
D value)
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_T=2 — T=1 T=3 — T=1 ‘
1:4 ._ 1:1
control
Positive l
I1 -
exam - lo 1
'Table 7 - Visual assessment scoring
---—--reduction0
UV only, 3.8 1.6 76.30
. negafive
control '
‘-----ucontrol
-ofexam- le 1
ltwill be understood that the invention disclosed and defined in this specification
s to all alternative combinations of two or more of the individual features
mentioned or evident from the text. All of these different combinations constitute various
alternative aspects of the invention.
Claims (24)
1. Use of a physiologically effective amount of a composition comprising disodium lauriminodipropionate eryl phosphate, avena sativa kernel extract, nicotinamide, hamemalis virginiana water, and menthol in the preparation of a medicament formulated for the topical treatment, tion or prevention of recurrence of erythema caused by external irritation of the skin of a subject, wherein the external irritation of the skin is selected from over exposure to the sun and contact with an irritating substance.
2. The use of claim 1, wherein the irritating substance is a plant or a metal.
3. The use according to claim 1 or claim 2, wherein the use reduces the Standard Scalar Rating for the erythema by either (i) 77% or more; or (ii) 3.0 or more after 7 days.
4. The use according to any one of claims 1-3, wherein the use s in (i) a magenta to blue shift (a*) of -2.5 or a greater negative; and/or (ii) a ΔE of 3.5 or more by 48 hours after use as measured by a Minolta Spectrometer; or the method results in (i) a magenta to blue shift of -4 or a r negative and/or (ii) a ΔE of 5 or more by 7 days after use as measured by a Minolta Spectrometer.
5. The use ing to any one of claims 1-4, wherein the medicament is for the maintenance of skin health.
6. The use according to any one of claims 1-5, wherein the medicament also increases the collagen in the skin of the subject.
7. The use according to claim 6, wherein the sed collagen ses increased production of collagen in fibroblasts in the skin. 1003244951
8. The use according to claim 6 or claim 7, wherein the use increases production of collagen III by about 10% or more and/or increases production of collagen I by about 5% or more.
9. The use according to claim 8, n the use increases production of collagen III by about 40% and/or ses production of en I by about 15%.
10. The use according to any one of claims 1-9, wherein the composition is a cream, lotion or gel.
11. The use according to any one of claims 1-10, wherein the composition further includes the vitamin panthenol or dexpanthenol.
12. The use according to any one of claims 1-11, n the ition is an emulsion.
13. The use of any one of claims 1-12, wherein the composition further includes one or more emulsifiers, emollients, thickeners, humectants, preservatives, body builders, bulking agents, pH adjusters, and/or feel modifiers.
14. The use according to claim 13, n the ition further comprises at least one emulsifier selected from the group consisting of yethylene derivative of sorbitan monolaurate such as polysorbate 20, fatty alcohols such as cetearyl alcohol, ceteareth compounds, and emulsifying waxes.
15. The use according to claim 14, wherein the emulsifier is ceteareth-20.
16. The use according to any one of claims 1-15, wherein the disodium lauriminodipropionate tocopheryl phosphate is in a form comprising 40% active ingredient and that form is 3 % (w/w) of the composition.
17. The use according to any one of claims 1-16, wherein the disodium lauriminodipropionate tocopheryl phosphate active is 1.2% (w/w) of the composition. 1003244951
18. The use according to any one of claims 1-17, wherein the composition ses: a. hamemalis virginiana water 0.5 to 10 % (w/w); b. disodium lauriminodipropionate tocopheryl phosphate in an amount equivalent to 1 to 5 % (w/w) of a 40% active composition; c. nicotinamide 0.5 to 5 % (w/w); d. avena sativa kernel t in an amount equivalent to 0.5 to 5 % (w/w) of a 100 ppm solution; and e. menthol 0.01 to 0.1 % (w/w).
19. The use according to claim 18, wherein the composition ses: a. disodium lauriminodipropionate tocopheryl phosphates 1.2 % (w/w); b. hamemalis virginiana water 3 % (w/w); c. avena sativa kernel extract in an amount equivalent to 1 % (w/w) of a 100 ppm solution; d. nicotinamide 1 % (w/w); and e. menthol 0.03 % (w/w).
20. The use according to claim 19, wherein the composition consists essentially a. disodium lauriminodipropionate tocopheryl ates in an amount equivalent to 1.2 percent (w/w); b. hamemalis virginiana water 3 percent (w/w); c. avena sativa kernel extract in an amount equivalent to 1 percent (w/w) of a 100 ppm solution; d. nicotinamide 1 percent (w/w); e. menthol 0.03 percent (w/w); f. one or more humectants, emollients, thickeners, emulsifiers, vatives; surfactants, pH adjusters and pearling, colouring or scent ; and g. water q.s. 1003244951
21. The use according to any one of claims 1-20, n the physiologically effective amount is about 2.5mg disodium lauriminodipropionate tocopheryl ate applied to the face.
22. The use according to any one of claims 1-21, wherein the composition is in a container with a pump dispenser.
23. The use according to claim 22, wherein the pump dispenses about 200 milligrams.
24. The use according to claim 22 or claim 23, wherein one pump supplies about 2.5 mg disodium lauriminodipropionate tocopheryl phosphates. 1003244951 [Annotation] tarranl None set by tarranl [Annotation] tarranl MigrationNone set by tarranl [Annotation] tarranl Unmarked set by tarranl [Annotation] tarranl None set by l [Annotation] tarranl MigrationNone set by tarranl [Annotation] tarranl ed set by tarranl
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
NZ751394A NZ751394B2 (en) | 2014-03-12 | Compositions that assist skin healing and/or maintain skin health |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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NZ721641A NZ721641A (en) | 2014-03-12 | 2014-03-12 | Compositions that assist skin healing and/or maintain skin health |
PCT/AU2014/000241 WO2015135016A1 (en) | 2014-03-12 | 2014-03-12 | Compositions that assist skin healing and/or maintain skin health |
NZ751394A NZ751394B2 (en) | 2014-03-12 | Compositions that assist skin healing and/or maintain skin health |
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NZ751394A true NZ751394A (en) | 2020-11-27 |
NZ751394B2 NZ751394B2 (en) | 2021-03-02 |
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WO2015135016A1 (en) | 2015-09-17 |
NZ721641A (en) | 2020-08-28 |
AU2014386711A1 (en) | 2016-07-14 |
AU2014386711B2 (en) | 2020-04-30 |
AU2020204232A1 (en) | 2020-07-16 |
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