WO2014030155A2 - Compositions topiques pour le traitement du psoriasis et de la séborrhée - Google Patents

Compositions topiques pour le traitement du psoriasis et de la séborrhée Download PDF

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WO2014030155A2
WO2014030155A2 PCT/IL2013/050696 IL2013050696W WO2014030155A2 WO 2014030155 A2 WO2014030155 A2 WO 2014030155A2 IL 2013050696 W IL2013050696 W IL 2013050696W WO 2014030155 A2 WO2014030155 A2 WO 2014030155A2
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extract
topical formulation
acid
formulation
topical
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PCT/IL2013/050696
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WO2014030155A3 (fr
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Sharon ROZENBLAT
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Kamedis Ltd
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    • 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)
    • A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/708—Rheum (rhubarb)
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/555—Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
    • 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)
    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • 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
    • 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)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/756—Phellodendron, e.g. corktree
    • 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)
    • A61K36/77—Sapindaceae (Soapberry family), e.g. lychee or soapberry
    • 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
    • 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
    • A61K8/368—Carboxylic acids; Salts or anhydrides thereof with carboxyl groups directly bound to carbon atoms of aromatic rings
    • 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
    • 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]
    • A61K8/9794—Liliopsida [monocotyledons]
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61P17/06—Antipsoriatics
    • 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
    • A61P17/08—Antiseborrheics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q5/00—Preparations for care of the hair
    • A61Q5/006—Antidandruff preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q5/00—Preparations for care of the hair
    • A61Q5/02—Preparations for cleaning the hair

Definitions

  • the invention is directed to topical formulations comprising plant extracts and additional ingredients.
  • the invention is further directed to use of the topical formulations for treating psoriasis and/or seborrhea.
  • Psoriasis is a chronic, immune-mediated inflammatory disease, affecting up to 2.5% of the world's population.
  • psoriasis vulgaris The most common form of psoriasis (psoriasis vulgaris) is characterized by the presence of red, raised scaly plaques that can cover any surface area of the body. Psoriasis is characterized by a disturbed proliferation (hyperproliferation) and differentiation of keratinocytes caused by increased Th-1 and Th-17 T cell activity. It has been shown that cytokines, such as TNF-a, IL-6, IL-8, IFN-gamma, IL-1 , and IL-17, have a significant role in the generation of proatheromatous abnormalities (dyslipidemia, insulin resistance, endothelial dysfunction, clotting system activation, and pro-oxidative stress).
  • stratum corneum consists of corneocytes and intracellular lipids, mainly ceramides, sterols, and free fatty acids, which form the barrier for diffusion of substances into the skin. Abnormal fat metabolism was considered to be an important factor in the etiopathogenesis of psoriasis.
  • Ceramides are a complex group of lipids that has gained much attention as cell signaling molecules and skin barrier constituents. There is a significant correlation between the ceramide level and the clinical severity in mild to moderate psoriasis.
  • Oxidative stress leads to oxidative damage of lipids and proteins contributing to barrier integrity, which is essential for healthy skin conditions.
  • SD Seborrehic Dermatitis
  • dandruff A milder variant of SD is dandruff, which is present in an estimated 15-20% of the population and is manifested by dry, flaking scales on the scalp. Some of the characteristic features of the dandruff condition include increased proliferation of the epidermis of dandruff scalp and in-complete keratinization.
  • the conventional treatment for adult SD of the scalp includes topical steroids or a calcineurin inhibitor.
  • Older treating modalities such as tar, salicylic acid, and zinc pyrithione shampoos, may have had keratolytic though do not display specific antifungal properties.
  • topical steroids rapidly reduce the severity of the disease by anti-inflammatory action, side effects associated with prolonged application and early relapse after discontinuation of treatment limit its wide usage.
  • Figures 1A, 1 B, 1 C and 1 D are bar graphs depicting the distribution of the people responses to the different parameters of the questionnaire following usage of the old formulation of the scalp lotion ( Figures 1A and 1 B) and the new formulation of the scalp lotion ( Figures 1 C and 1 D).
  • Figures 2A and 2B are bar graphs depicting the distribution of the people responses to the different parameters of the questionnaire following usage of the face cream new formulation.
  • Figures 3A, 3B, 3C and 3D are bar graphs depicting the distribution of the people responses to the different parameters of the questionnaire following usage of the old formulation of the body cream ( Figures 3A and 3B) and the new formulation of the body cream ( Figures 3C and 3D).
  • Figures 4A and 4B are bar graphs depicting the distribution of the people responses to the different parameters of the questionnaire following usage of an exemplary shampoo according to the embodiments of the invention.
  • Figure 5A shows mean percentage improvement in Psoriasis Scalp Severity Index (PSSI) scores over time following a combined treatment with scalp lotion (daily use) and shampoo (3 times a week).
  • Figure 5B shows proportion of patients with at least 50% (PSSI50), 75% (PSSI75) and 90% (PSSI90) improvement in PSSI at weeks 2, 4, 6; improvement of 50% in psoriasis severity (PSSI50) in 100% of patients and improvement of 90% in psoriasis severity (PSSI90) in 67% of patients are further observed following a combined treatment with scalp lotion (daily use) and shampoo (three times a week).
  • a topical formulation comprising at least two extracts or one extract and an active ingredient selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with one or more of a Dipotassium Glycyrrhizate, ceramide, phytosphingosine, cholesterol, free fatty acids, Butyrospermum Parkii (shea butter), panthenol (pro-vitamin B5), lanolin, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid, hyaluronic acid, zinc pyrithione, salicylic acid, climbazole and a cosmetic acceptable carrier.
  • an active ingredient selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis
  • the formulation further comprises tocopheryl acetate.
  • a topical formulation comprising Indigofera tinctoria extract (Indigo naturalis) together with Dipotassium Glycyrrhizate, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid, hyaluronic acid and a cosmetic acceptable carrier.
  • a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract; and climbazole, panthenol (pro-vitamin B5) and Butyrospermum Parkii (shea butter) and a cosmetic acceptable carrier.
  • a topical formulation comprising Sapindus mukurossi fruit extract and zinc pyrithione together with ammonium laureth sulfate and/ or Ammonium Lauryl Sulfate and a cosmetic acceptable carrier.
  • a method for treating or preventing psoriasis comprising the steps of administering simultaneously or separately a scalp lotion topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with panthenol (pro-vitamin B5) and Butyrospermum Parkii (shea butter) and an acceptable cosmetic carrier in combination with a topical formulation in the form of a shampoo comprising Sapindus mukorossi fruit extract, zinc pyrithione, optionally salicylic acid and a cosmetic acceptable carrier.
  • a scalp lotion topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca olerace
  • the topical formulations of this invention can be used for manufacturing a scalp lotion, a shampoo, a face cream or a body cream according to the embodiments described herein for treating or preventing psoriasis, seborrhea, cradle cap and dandruff or any combination thereof.
  • a topical formulation comprising at least two extracts or one extract and an active ingredient selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with one or more of a Dipotassium Glycyrrhizate, ceramide, phytosphingosine, cholesterol, free fatty acids, Butyrospermum Parkii (shea butter), panthenol, lanolin, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid, hyaluronic acid, zinc pyrithione, salicylic acid, climbazole and a cosmetic acceptable carrier.
  • an active ingredient selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amur
  • a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with Dipotassium Glycyrrhizate , a ceramide, such as, ceramide 3, ceramide 611, ceramide 1 , phytosphingosine, cholesterol, free fatty acids, hyaluronic acid and a cosmetic acceptable carrier.
  • a method of treating or preventing psoriasis in a subject comprising the step of contacting the skin or the scalp of the subject with a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with Dipotassium Glycyrrhizate, a ceramide such as ceramide 3, ceramide 611, ceramide 1 , phytosphingosine, cholesterol, free fatty acids, hyaluronic acid and a cosmetic acceptable carrier.
  • a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis
  • a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with Dipotassium Glycyrrhizate, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid, hyaluronic acid and a cosmetic acceptable carrier.
  • Rheum palmatum root extract Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with Dipotassium Glycyrrhizate, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propa
  • a method of treating or preventing seborrhea in a subject comprising the step of contacting the scalp or the skin of the subject with a topical formulation comprising at one extract and one active ingredients selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with Dipotassium Glycyrrhizate, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid, hyaluronic acid and a cosmetic acceptable carrier.
  • a topical formulation comprising at one extract and one active ingredients selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract
  • a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with, panthenol (pro-vitamin B5), climbazole and a cosmetic acceptable carrier.
  • a method of treating or preventing psoriasis, seborrhea, or both psoriasis and seborrhea in a subject comprising the step of contacting the skin or the scalp of the subject with a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with panthenol (pro-vitamin B5), climbazole and a cosmetic acceptable carrier.
  • a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with pantheno
  • a method of treating or preventing psoriasis, seborrhea, or both psoriasis and seborrhea in a subject comprising the step of contacting the skin or the scalp of the subject with a topical formulation comprising at least one extract and one active ingredient selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with zinc pyrithione or salicylic acid or a combination thereof and a cosmetic acceptable carrier.
  • a topical formulation comprising at least one extract and one active ingredient selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract
  • a topical formulation comprising Sapindus mukurossi fruit extract, zinc pyrithione, ammonium laureth sulfate and/or salicylic acid and a cosmetic acceptable carrier.
  • a method for treating or preventing seborrhea (including dandruff), psoriasis or a combination thereof in a subject comprising the step of contacting the skin or the scalp of the subject with a topical formulation comprising Sapindus mukurossi fruit extract and zinc pyrithione together with ammonium laureth sulfate and/or salicylic acid and a cosmetic acceptable carrier.
  • One embodiment of the invention is a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with one or more of dipotassium glycyrrhizate, a ceramide, phytosphingosine, cholesterol, free fatty acids, Butyrospermum Parkii (shea butter), panthenol, lanolin, glycerin, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid, hyaluronic acid, zinc pyrithione, salicylic acid and a cosmetic acceptable carrier.
  • the invention provides a topical formulation comprising Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), and hyaluronic acid together with one or more of a ceramide, phytosphingosine, cholesterol, free fatty acids and a cosmetic acceptable carrier.
  • the topical formulation further comprises Dipotassium Glycyrrhizate.
  • the formulation comprises between about 0.01 -0.06% lanolin.
  • the amount of the lanolin is about 0.03%.
  • the formulation comprises between about 1 .8-3% of salicylic acid.
  • the topical formulation comprises Butyrospermum Parkii (shea butter).
  • the formulation may be in any form.
  • the formulation is in a form of a body cream.
  • an exemplary formulation according to the embodiments described herein was shown to be suitable for treating or preventing psoriasis.
  • the invention provides a topical formulation comprising Rheum palmatum root extract in an amount of 0.2-5% w/w, Indigofera tinctoria extract (Indigo naturalis) in an amount of about 0.1-1 % w/w, and hyaluronic acid in an amount of about 0.02-2 % w/w together with one or more of a ceramide, phytosphingosine, cholesterol, free fatty acids in a total amount of about 0.01 -5 % w/w and a cosmetic acceptable carrier.
  • the topical formulation further comprises Dipotassium Glycyrrhizate in an amount of about 0.5-5 % w/w.
  • the formulation comprises between 0.001-0.6% lanolin. According to some embodiments of the invention, the formulation comprises between 0.2- 10% of salicylic acid. In some embodiments, the topical formulation comprises Butyrospermum Parkii (shea butter) in an amount of 0.5-10 % w/w. According to some embodiments of the invention, the formulation further comprises tocopheryl acetate. In some embodiments, the amount of the tocopheryl acetate is about 0.05-5 % w/w.
  • the formulation may be in any form. According to some of the embodiments, the formulation is in a form of a body cream.
  • the invention provides a topical formulation comprising Rheum palmatum root extract in an amount of about 2% w/w, Indigofera tinctoria extract (Indigo naturalis) in an amount of about 1 % w/w, and hyaluronic acid in an amount of about 0.2% w/w together with one or more of a ceramide, phytosphingosine, cholesterol, free fatty acids in a total amount of about 0.05-1 % w/w and a cosmetic acceptable carrier.
  • a topical formulation comprising Rheum palmatum root extract in an amount of about 2% w/w, Indigofera tinctoria extract (Indigo naturalis) in an amount of about 1 % w/w, and hyaluronic acid in an amount of about 0.2% w/w together with one or more of a ceramide, phytosphingosine, cholesterol, free fatty acids in a total amount of about 0.05-1 % w/w and a cosmetic acceptable carrier.
  • the topical formulation further comprises Dipotassium Glycyrrhizate in an amount of about 1 % w/w. According to some embodiments of the invention, the formulation comprises between about 0.01-0.06% lanolin. According to some embodiments of the invention, the formulation comprises between about 1 .8-3% of salicylic acid. In some embodiments, the topical formulation comprises Butyrospermum Parkii (shea butter) in an amount of about 5% w/w. According to some embodiments of the invention, the formulation further comprises tocopheryl acetate. In some embodiments, the amount of the tocopheryl acetate is about 0.5% w/w. The formulation may be in any form.
  • the formulation is in a form of a body cream.
  • an exemplary formulation according to the embodiments described herein was shown to be suitable for treating or preventing psoriasis.
  • One embodiment of the invention is a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with one ore more of Dipotassium Glycyrrhizate, climbazol, panthenol (Pro-Vitamin B5), Butyrospermum Parkii (shea butter) and a cosmetic acceptable carrier.
  • the formulation comprises between 0.1-0.25% of zinc pyrithione.
  • the formulation may be in any form.
  • the formulation is in a form of a scalp lotion.
  • an exemplary formulation according to the embodiment described herein is suitable for treating or preventing psoriasis or seborrehic dermatitis (including dandruff).
  • a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with one ore more of Dipotassium Glycyrrhizate, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid, Butyrospermum Parkii (shea butter), hyaluronic acid and a cosmetic acceptable carrier.
  • the formulation may be in any form. According to some of the embodiments, the formulation is in a form of a face cream.
  • an exemplary formulation according to the embodiment described herein is suitable for treating or seborrehic dermatitis.
  • a topical formulation comprising Sapindus mukurossi fruit extract and zinc pyrithione together with ammonium laureth sulfate and an acceptable cosmetic carrier.
  • the formulation further comprises ammonium lauryl sulfate.
  • the formulation is in a form of a shampoo.
  • the topical formulation further comprises salicylic acid. According to further embodiments, the topical formulation further comprises at least 0.3% w/w salicylic acid. According to further embodiments, the topical formulation further comprises at least 0.4% w/w salicylic acid. According to further embodiments, the topical formulation further comprises at least 0.5% w/w salicylic acid. According to further embodiments, the topical formulation further comprises salicylic acid in the range of 0.3-0.6% w/w. According to further embodiments, the topical formulation further comprises salicylic acid in the range of 0.45-0.55% w/w.
  • a topical formulation comprising Sapindus mukurossi fruit extract in an amount of 1-4% w/w and zinc pyrithione in an amount of 0.5-2% w/w together with ammonium laureth sulfate in an amount of 20-60% w/w and other cosmetic carrier.
  • the formulation further comprises ammonium lauryl sulfate in an amount of 5-25% w/w.
  • the formulation is in a form of a shampoo.
  • Some embodiments of the invention are directed to a topical rinse off formulation or a shampoo comprising Sapindus mukurossi fruit extract, and zinc pyrithione together with ammonium laureth sulfate for use in treating and/or preventing seborrhea and/or psoriasis of the scalp.
  • the topical formulation further comprises salicylic acid.
  • the topical formulation further comprises at least 0.3% w/w salicylic acid.
  • the topical formulation further comprises at least 0.4% w/w salicylic acid.
  • the topical formulation further comprises at least 0.5%.
  • a topical formulation comprising Sapindus mukurossi fruit extract in an amount of 2% w/w and zinc pyrithione in an amount of 1 % w/w together with ammonium laureth sulfate in an amount of 45% w/w and other cosmetic carrier.
  • the formulation further comprises ammonium lauryl sulfate in an amount of 15% w/w.
  • the formulation is in a form of a shampoo.
  • the topical formulation further comprises salicylic acid.
  • the topical formulation further comprises at least 0.3% w/w salicylic acid.
  • the topical formulation further comprises at least 0.4% w/w salicylic acid.
  • the topical formulation further comprises at least 0.5% w/w salicylic acid.
  • the topical formulation further comprises salicylic acid in the range of 0.3-0.6% w/w.
  • the topical formulation further comprises salicylic acid in the range of 0.45-0.55% w/w.
  • Some embodiments include a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract , Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with Dipotassium Glycyrrhizate, climbazol, panthenol (Pro-Vitamin B5), nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid, ceramides, phytosphingosine, cholesterol, fatty acids or hyaluronic acid for use in treating and/or preventing psoriasis or seborrheic dermatitis.
  • a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense
  • Further embodiments include a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, and Indigofera tinctoria extract (Indigo naturalis) together with Dipotassium Glycyrrhizate, Climbazol, Panthenol (Pro-Vitamin B5), nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid, ceramides, phytosphingosine, cholesterol, or hyaluronic acid for use in treating and/or preventing psoriasis or seborrhea dermatitis.
  • Dipotassium Glycyrrhizate Climbazol
  • Panthenol Pro-Vitamin B5
  • nordihydroguaiaretic acid oleanolic acid
  • hydroxyphenyl propamidobenzoic acid ceramides
  • phytosphingosine cholesterol
  • hyaluronic acid for use in treating and/or
  • the pH of the topical formulation is in the range of 4.0-7.0. According to further embodiments, the pH of the topical formulation is in the range of 5.5-7.0. According to further embodiments, the pH of the topical formulation is in the range of 5.0-6.5.
  • One embodiment of the invention is a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with Dipotassium Glycyrrhizate, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid and hyaluronic acid.
  • Rheum palmatum root extract Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with Dipotassium Glycyrrhizate, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propa
  • a topical formulation comprising Indigofera tinctoria extract (Indigo naturalis) together with Dipotassium Glycyrrhizate, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid and hyaluronic acid.
  • the formulation further comprises Butyrospermum Parkii (shea butter).
  • the formulation is a face cream and is suitable for treating or preventing seborrhea.
  • a topical formulation comprising Indigofera tinctoria extract (Indigo naturalis) in an amount of 0.02-2 % w/w together with Dipotassium Glycyrrhizate in an amount of 0.5-4% w/w, nordihydroguaiaretic acid in an amount of 0.0001-0.001 % w/w, oleanolic acid in an amount of 0.0001 -0.001 % w/w, hydroxyphenyl propamidobenzoic acid in an amount of 0.0005-0.25% w/w and hyaluronic acid in an amount of 0.01-0.05 % w/w.
  • the formulation further comprises Butyrospermum Parkii (shea butter) in an amount of 0.1 -3% w/w.
  • the formulation is a face cream and is suitable for treating or preventing seborrhea.
  • a topical formulation comprising Indigofera tinctoria extract (Indigo naturalis) in an amount of about 0.2% w/w together with Dipotassium Glycyrrhizate in an amount of about 2% w/w, nordihydroguaiaretic acid in an amount of about 0.0009% w/w, oleanolic acid in an amount of about 0.000675% w/w, hydroxyphenyl propamidobenzoic acid in an amount of aboutO .005-0.025% w/w and hyaluronic acid in an amount of about 0.01 % w/w.
  • the formulation further comprises Butyrospermum Parkii (shea butter) in an amount of about 1 % w/w.
  • the formulation is a face cream and is suitable for treating or preventing seborrhea.
  • the topical formulation comprises Indigofera tinctoria extract (Indigo naturalis) together with, Dipotassium Glycyrrhizate, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid and hyaluronic acid.
  • Some embodiments include a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with Dipotassium Glycyrrhizate, nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid and hyaluronic acid for use in treating and/or preventing seborrhea.
  • Further embodiments include a topical formulation comprising Indigofera tinctoria extract (Indigo naturalis) together with Dipotassium Glycyrrhizate, Nordihydroguaiaretic acid, oleanolic acid, hydroxyphenyl propamidobenzoic acid and hyaluronic acid for use in treating and/or preventing seborrhea.
  • the pH of the topical formulation is in the range of 5.0-7.0. According to further embodiments, the pH of the topical formulation is in the range of 5.5-7.0. According to further embodiments, the pH of the topical formulation is in the range of 5.0-6.5.
  • One embodiment of the invention is a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit fxtract together with Dipotassium Glycyrrhizate, panthenol (pro-vitamin B5) and climbazole.
  • the topical formulation comprises Phellodendron amurense bark extract, Rheum palmatum root extract, Portulaca oleracea extract, Angelica polymorpha sinensis root rxtract, Indigofera tinctoria extract (Indigo naturalis) and Sapindus mukurossi fruit extract together with panthenol (pro-vitamin B5) and climbazole.
  • the formulation further comprises shea butter.
  • a topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with panthenol (pro-vitamin B5) and Butyrospermum Parkii (shea butter).
  • the formulation is a scalp lotion and is suitable for treating or preventing psoriasis, seborrhea and dandruff (including cradle cap) or any combination thereof.
  • the scalp lotion topical formulation further comprises zinc pyrithione at concentration of about 0.1-0.25 % w/w.
  • Some embodiments include a topical formulation comprising at least two extracts selected from Rheum palmatum root extract in an amount of 1 -4% w/w, Indigofera tinctoria extract (Indigo naturalis) in an amount of 0.01 -1 % w/w, Phellodendron amurense bark extract in an amount of o.1-5 % w/w, Portulaca oleracea extract in an amount of 0.5-3 % w/w, Angelica polymorpha sinensis root extract in an amount of 0.5-3 % w/w and Sapindus mukurossi fruit extract in an amount of 0.1-1 % w/w together with panthenol (pro-vitamin B5) in an amount of 0.1 -1 % w/w and climbazole in an amount of 0.1-1 % w/w and other cosmetic carrier for use in treating and/or preventing seborrhea and/or psoriasis.
  • Indigofera tinctoria extract (In
  • the formulation further comprises glycerin in an amount of 0.3-3 % w/w. According to some embodiments, the formulation further comprising tocopheryl acetate in an amount of 0.1-1 % w/w. According to some embodiments, the formulation is in a form of a scalp lotion.
  • Some embodiments include a topical formulation comprising at least two extracts selected from Rheum palmatum root extract in an amount of about 2.4% w/w, Indigofera tinctoria extract (Indigo naturalis) in an amount of about 0.1 % w/w, Phellodendron amurense bark extract in an amount of about 1.2% w/w, Portulaca oleracea extract in an amount of about 1.2% w/w, Angelica polymorpha sinensis root extract in an amount of about 1 .2% w/w and Sapindus mukurossi fruit extract in an amount of about 0.5% w/w together with panthenol (pro-vitamin B5) in an amount of about 0.5% w/w and climbazole in an amount of 0.5% w/w and other cosmetic carrier for use in treating and/or preventing seborrhea and/or psoriasis.
  • Indigofera tinctoria extract Indigo naturalis
  • Phellodendron amurense bark extract in an
  • the formulation further comprises glycerin in an amount of about 1 .0 % w/w. According to some embodiments, the formulation further comprises tocopheryl acetate in an amount of about 0.5% w/w. According to some embodiments, the formulation is in a form of a scalp lotion.
  • the pH of the topical formulation is in the range of 5.0-7.0. According to further embodiments, the pH of the topical formulation is in the range of 5.5-7.0. According to further embodiments, the pH of the topical formulation is in the range of 5.0-6.5. According to some embodiments the pH of the formulation is between 5-5-.7.
  • the topical formulation includes anti-inflammatory ingredients, ingredients that regulate sebum secretion by inhibition of 5-alpha reductase, ingredients that modulate keratinocyte proliferation and differentiation, anti-itch ingredients, anti-hystaminic ingredients, skin hydration ingredients, anti oxidants, anti fungal ingredients, T-lymphocyte inhibitors, skin barrier function enhancers, or ingredients that induce cell apoptosis, and any combination thereof.
  • the active ingredients in the topical formulation provide a synergistic effect in treating and/or preventing psoriasis and/or seborrhea.
  • the combination of at least one of the active ingredients with at least one of the other components in the formulation provides a synergistic effect in treating and/or preventing psoriasis and/or seborrhea.
  • the synergistic effect may be direct, in treating/preventing the condition, indirect, e.g., by enhancing the penetration of the formulation/active ingredients into the skin or by lowering skin irritation, or both direct and indirect.
  • ceramides The level of ceramides is reduced significantly in lessional epidermis with psoriasis. There is a significant correlation between the ceramide level and the clinical severity in mild to moderate psoriasis. Except for their role in skin barrier integrity, ceramides induce the activation of apoptotic cell-signaling molecules, such as PKC- and JNK. Hence, the decreased ceramide levels in psoriasis lead to downregulation of the apoptotic pathway, resulting in proliferative characteristics of psoriatic epidermis. Indigofera tinctoria (Indigo naturalis) modulate the keratinocytes proliferation and differentiation. Dipotassium Glycyrrhizate shown to induce apoptosis in several cell lines, therefore both active ingredients act synergistically to prevent/ treat psoriasis.
  • a combination of Ceramides with Indigofera tinctoria (Indigo naturalis) and Dipotassium Glycyrrhizate is a multi-factor treatment to modulate psoriasis skin proliferation.
  • Oxidative stress leads to oxidative damage of lipids and proteins contributing to barrier integrity, which is essential for healthy skin conditions.
  • the lipid peroxidation markers were found significantly higher in the patients with severe or active psoriasis than in the patients with mild or inactive psoriasis.
  • the increased peroxidation of lipid bilayer caused by a decrease of antioxidant enzyme activities may be the essential mechanism of the membrane fluidity decrease observed in association with the exacerbation of the disease.
  • hyaluronic acid a potent anti-oxidant by its free-radical scavenging properties in combination with tocopheryl acetate with anti-oxidative herbal extracts, such as Indigofera tinctoria, Rheum palmatum, Dipotassium Glycyrrhizate act synergistically to protect the skin barrier of psoriasis and/or seborrhea patients.
  • Salicylic acid works as a keratolytic agent by causing the cells of the epidermis to shed more readily.
  • Combination of the herbal extracts Rheum palmatum root extract and Indigofera tinctoria extract (Indigo naturalis) with Dipotassium Glycyrrhizate and with salicylic acid (1 .8-3%) enable better penetration of the actives into the skin.
  • the ability of Indigofera tinctoria (Indigo naturalis) to modulate the keratinocytes proliferation and differentiation acts synergistically with salicylic acid to restore the skin barrier of psoriasis patients.
  • Hydroxyphenyl Propamidobenzoic Acid, a synthetic avenanthramide, and Nordihydroguaiaretic acid enhance the anti-inflammatory activity of Indigofera tinctoria and anti-itch activity of Dipotassium Glycyrrhizate in a synergetic manner.
  • Nordihydroguaiaretic Acid reduces hyperkeratosis while Indigofera tinctoria extract (Indigo naturalis) modulates keratinocytes proliferation and differentiation.
  • Indigofera tinctoria extract Indigo naturalis modulates keratinocytes proliferation and differentiation. The combination of these two ingredients helps to restore the impaired barrier of seborrhea patients.
  • Zinc pyrithione has anti-fungal activity. Combination of zinc pyrithione with the antifungal activity of Phellodendron amurense bark extract, Sapindus mukurossi fruit extract and climbazole - enhances efficacy against Pityrosporum ovale which play an important role in the pathogenesis of seborrhea dermatitis and dandruff.
  • the formulations of the present invention may be formulated into a variety of preparations, depending on the intended use. These preparations include, but are not limited to, topical skin compositions for medical use, topical skin cosmetic compositions and scalp-treatment compositions.
  • topical skin compositions for medical use and topical skin cosmetic compositions many forms of gels, ointments, soaps, pastes, creams and lotions may be used.
  • the formulation may be applied in any suitable manner, i.e., by hand, spatula, spray or pad.
  • the formulation of the invention may be used as hand, facial, scalp and body cream.
  • the formulations of the invention show high dermal compatibility and low irritation behavior when applied to human skin.
  • compositions of the present invention are used as cosmetic compositions
  • cosmetic or dermatological acceptable ingredients may be optionally incorporated in arbitrary combinations as desired and determined in accordance by a person skilled in the art.
  • the compositions may include oils, fats, waxes, detergents, conditioners, pH modifiers, preservatives, solvents, viscosity modifiers, colorants, perfumes, dyestuffs and the like.
  • the composition may be in a form of oil-in-water, water-in-oil, water-in-oil-in-water, and oil-in-water-in-silicone emulsions, a cream, an ointment, an aqueous solution, a lotion, a soap, a paste, a foam, an emulsion, a gel, a salves, an oil, a wash, a shampoos, a conditioners or an aerosol.
  • compositions of the invention are administered once a day. According to other embodiments, the compositions are administered twice a day, or three times a day.
  • the composition is administered chronically.
  • the composition is administered for about 10 days or more, 20 days, 30 days, 60 days, 90, 120 days or more.
  • the composition further comprises cleaning agents or detergents that are typically anionic, cationic, non-ionic or amphoteric surfactants.
  • Typical anionic surfactants are carboxylates, sulfonates, sulfates or phosphates, e.g. fatty acid soaps, salts of lauryl sulfate and salts of lauryl ether sulfate.
  • Examples of cationic surfactants are aliphatic mono, di and polyamines derived from fatty and rosin acids, amine oxides, ethoxylated alkyl amines and imidazolines.
  • non-ionic surfactants are polyoxyethylene surfactants, alkylphenol ethoxylates, carboxylic acid esters, e.g., mono and diglycerides, polyoxyethylene esters and fatty acid diethanolamine condensates.
  • Amphoteric surfactants are those containing combinations of the anionic and cationic groups described above, particularly those containing both acid carboxyls and basic nitrogen groups.
  • Typical amphoteric surfactants are imidazolines and betaines, e.g., lauric and myristic imidazolines and betaines, and amidopropylbetaines.
  • the topical pharmaceutical compositions may also comprise a suitable emulsifier which refers to an agent that enhances or facilitates mixing and suspending oil-in-water or water-in-oil.
  • a suitable emulsifier which refers to an agent that enhances or facilitates mixing and suspending oil-in-water or water-in-oil.
  • the emulsifying agent used herein may consist of a single emulsifying agent or may be a nonionic, anionic, cationic or amphoteric surfactant or blend of two or more such surfactants; preferred for use herein are nonionic or anionic emulsifiers.
  • Such surface-active agents are described in "McCutcheon's Detergent and Emulsifiers", North American Edition, 1980 Annual published by the McCutcheon Division, MC Publishing Company, 175 Rock Road, Glen Rock, N.J. 07452, USA.
  • CTFA Cosmetic Ingredient Handbook Second Edition (1992) describes a wide variety of non-limiting cosmetic ingredients commonly used in the skin care industry, which are suitable for use in the compositions of the present invention.
  • these ingredient classes include: abrasives, absorbents, aesthetic components such as fragrances, pigments, colorings/colorants, essential oils, skin sensates, astringents, etc.
  • anti-acne agents e.g., clove oil, menthol, camphor, eucalyptus oil, eugenol, menthyl lactate, witch hazel distillate
  • anti-acne agents e.g., clove oil, menthol, camphor, eucalyptus oil, eugenol, menthyl lactate, witch hazel distillate
  • antimicrobial agents e.g., iodopropyl butylcarbamate
  • antioxidants e.g., iodopropyl butylcarbamate
  • binders biological additives, buffering agents, bulking agents, chelating agents, chemical additives, colorants, cosmetic astringents, cosmetic biocides, denaturants, drug astringents, external analgesics, film formers or materials, e.g., polymers, for aiding the film-forming properties and substantivity of the composition (e.g., copolymer of
  • skin care carrier means a carrier that is compatible with the skin, scalp, hair, nail and the like.
  • preventing refers to keeping a disease, disorder or condition from occurring in a subject. In some cases the subject may be at risk for developing the disease, but has not yet been diagnosed as having the disease. In some instances, the term “preventing” refers to preventing the next cycle of the disease from occurring.
  • the plant extracts used herein may be purified by the use of a polar solvent (i.e. polar extract) such as, ethyl alcohol (ethanol), butyl alcohol (butanol), methanol, water or proanol propylene glycol and glycerin.
  • a polar solvent i.e. polar extract
  • ethanol ethyl alcohol
  • butyl alcohol butanol
  • methanol ethyl alcohol
  • water or proanol propylene glycol and glycerin ethyl alcohol
  • the polar extracts of the present invention may comprise any percentage of a polar solvent.
  • a non-polar solvent i.e. non-polar extract
  • the non-polar extracts of the present invention may comprise any percentage of non-polar solvents.
  • hydrophobic molecules tend to be non-polar and thus non-polar solvents are used.
  • Hydrophilic molecules tend to be polar and dissolve by water and/or other polar substances.
  • the active ingredients can be concentrated in the extract via affinity chromatography, mass chromatography and the like.
  • the plant extract of the present invention is an aqueous extract.
  • the aqueous plant extract is typically further purified using a resin chromatography such as a macroporous resin or other chromatography methods.
  • a method of preparing a composition comprising concentrated herbal extracts for treating and/or preventing seborrhea and/or psoriasis comprising: (a) subjecting a plant to x1-10 volumes of water to produce an extract of the plant; and (b) reducing the amount of organic salts and/or heavy metals and/or starch in the plant extract using a macroporous resin which results in an elevated content of the active ingredients present in the plant extract.
  • the formulation comprises any additional ingredients, including solvents, emollients, moisturizers, conditioners, viscosity builders, skin calmers, emulsifiers, pH adjusters, preservatives, antioxidants, viscosity increasing agents, perfumes, humectants, anti-acne agents, stabilizers and detergents.
  • solvents including solvents, emollients, moisturizers, conditioners, viscosity builders, skin calmers, emulsifiers, pH adjusters, preservatives, antioxidants, viscosity increasing agents, perfumes, humectants, anti-acne agents, stabilizers and detergents.
  • the preservative or antioxidant is tocopheryl acetate.
  • the amount of tocopheryl acetate in the formulation is about 0.5% w/w.
  • a combined method for treating or preventing psoriasis comprising the steps of administering a scalp lotion topical formulation comprising at least two extracts selected from Rheum palmatum root extract, Indigofera tinctoria extract (Indigo naturalis), Phellodendron amurense bark extract, Portulaca oleracea extract, Angelica polymorpha sinensis root extract and Sapindus mukurossi fruit extract together with panthenol (pro-vitamin B5) and Butyrospermum Parkii (shea butter) in combination with the topical formulation in the form of a shampoo comprising Sapindus mukorossi fruit extract, zinc pyrithione, optionally salicylic acid and a cosmetic acceptable carrier.
  • the shampoo may be used daily.
  • the shampoo may be used once, twice or three times a week or more.
  • the scalp lotion may be used daily.
  • the treatment may last a week, two weeks, three weeks, four weeks, five weeks, six weeks or more.
  • New products in a form of a scalp lotion, face cream, body cream and shampoo were designed to treat psoriasis and Seborrheic dermatitis (including dandruff and cradle cap).
  • the effects of the improved formulations were compared in some of the examples to previous formulations.
  • Evaluation questionnaire for the products included the following questions:
  • Example 1 formulation for treating/preventing seborrhea and/or psoriasis (scalp lotion)
  • Table 1 exemplary new and previous scalp lotion formulations for treating/preventing seborrhea and/or psoriasis:
  • Panthenol (Pro- 0.5 Natural Carbomer Gel Former Vitamin B5) Moisturizer
  • Methylchloroisothiaz Preservative Methyl isothiazolipne Preservative olinone & mixture
  • Both previous and new scalp lotion formulations include the same herbal extracts: Rheum palmatum extract, Portulaca oleracea extract, Phellodendron amurense bark extract, Angelica polymorpha sinensis root extract, Sapindus mukurossi fruit extract and Indigofera tinctoria extract.
  • Figures 1 A to 1 D demonstrate the distribution of the people's responses following the usage of the Scalp Lotion previous formulation (1 A and 1 B) and new formulation (1 C and 1 D).
  • the new scalp lotion was found more effective than the previous formulation in all examined parameters. Therefore, the active ingredients in the formulation act synergistically to treat and/or prevent seborrehic dermatitis or psoriasis.
  • Example 2 - exemplary face cream formulation for treating/preventing seborrhea
  • the formulation includes Indigofera tinctoria extract and Dipotassium Glycyrrhizate.
  • the formulation's pH is 5-6.5. Five people suffering from seborrhea of the face at the ages of 44.8 ⁇ 10.3 years applied the cream twice a day on their faces for seven days.
  • FIGS 2A and 2B demonstrate the distribution of the people's responses following the usage of the new formulation. As can be seen, the new formulation face cream was found effective in all parameters.
  • Example 3 - exemplary body cream formulation for treating/preventing psoriasis
  • the new formulation contains a mixture of cholesterol, ceramides mix and fatty acids instead of cholesterol alone in the previous formulations.
  • Laminaria ochroleuca extract used in the previous formulations to hydrate the skin was replaced with hyaluronic Acid.
  • the new formulation's pH is 4-6.5 as compared to the pH of 6.0-7.5 of the previous formulation.
  • Figures 3A to 3D show the distribution of the people's responses following the usage of the exemplary previous body formulation (3A and 3B) and the exemplary new formulation (3C and 3D).
  • the herbal mixture together with the additional selected ingredients improved the efficacy of the formulation.
  • the ingredients in all new formulations act synergistically in treating seborrehic dermatitis, dandruff and psoriasis treatment.
  • the improvement was shown on the spread of seborrhea and/or psoriasis, itching feeling, dryness or oiliness, redness appearance and dandruff scales.
  • the shampoo is designated to treat seborrheic dermatitis (including dandruff) and psoriasis of the scalp.
  • the shampoo showed major beneficial effects, eliminated the redness, the itchiness and improved the general condition of the scalp.
  • the texture and the feeling were evaluated as "OK" or above that.
  • PSSI Psoriasis Scalp Severity Index
  • PSSI50 stands for the proportion of patients with at least 50% improvement.
  • FIG. 5A which shows the mean percentage improvement in Psoriasis Scalp Severity Index (PSSI) scores over time, an improvement of 92% in severity of scalp psoriasis was observed after six weeks of treatment.
  • PSSI Psoriasis Scalp Severity Index
  • Example 5 The results of the experiment of Example 5 show that a combined usage of the exemplary shampoo formulation and the exemplary scalp lotion formulation according to embodiments of the invention is a safe and efficient treatment for scalp psoriasis.
  • the treatment is effective in both mild-moderate and severe scalp psoriasis.
  • An improvement of more than 75% (PSSI75) is observed after six weeks in more than 90% of the patients suffering from mild- moderate and severe scalp psoriasis.
  • the treatment reduces pruritus by 84%. According to patients evaluation both disease condition and quality of life were extremely improved. Almost all the patients (95%) were satisfied.

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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne des formulations topiques sous la forme d'une lotion pour cuir chevelu, d'un shampooing, d'une crème pour le visage ou d'une crème pour le corps pour traiter ou prévenir le psoriasis, la séborrhée, la calotte séborrhéïque et les pellicules ou toute combinaison de ceux-ci. La formulation topique comprend au moins deux extraits de racine ou un extrait et un ingrédient actif et un excipient cosmétique acceptable. Des échantillons prélevés sur des personnes souffrant de psoriasis ou de dermatite séborrhéique (y compris les pellicules) du cuir chevelu et du visage ou du corps par application de la lotion pour cuir chevelu, du shampooing, de la crème pour le visage ou de la crème pour le corps montrent des résultats efficaces en comparaison avec la formulation précédente dans les paramètres examinés.
PCT/IL2013/050696 2012-08-20 2013-08-18 Compositions topiques pour le traitement du psoriasis et de la séborrhée WO2014030155A2 (fr)

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US201261684851P 2012-08-20 2012-08-20
US201261684854P 2012-08-20 2012-08-20
US61/684,851 2012-08-20
US61/684,854 2012-08-20

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WO2014030155A2 true WO2014030155A2 (fr) 2014-02-27
WO2014030155A3 WO2014030155A3 (fr) 2014-11-06

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CN110035797A (zh) * 2016-11-13 2019-07-19 卡梅蒂丝有限公司 用于治疗痤疮的局部组合物
CN110545788A (zh) * 2017-04-20 2019-12-06 荷兰联合利华有限公司 抗微生物组合物
WO2023107659A1 (fr) * 2021-12-09 2023-06-15 Colgate-Palmolive Company Compositions de soins personnels

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CN105497089B (zh) * 2014-09-25 2020-10-23 伽蓝（集团）股份有限公司 含雪菊提取物的组合物及其用途和皮肤外用剂

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'Sebo Medis Dandruff-Cleansing Shampoo' KAMEDIS, [Online] 01 July 2010, pages 1 - 2 Retrieved from the Internet: <URL:http://www.forresthealth.com/sebo-medis-shampoo-200-ml.html> [retrieved on 2013-12-26] *
'Sebo Medis Face Cream' KAMEDIS, [Online] 28 June 2010, pages 1 - 5 Retrieved from the Internet: <URL:http://www.forresthealth.com/sebo-medis-face-cream-70-ml.html> [retrieved on 2013-12-26] *
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Cited By (7)

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Publication number Priority date Publication date Assignee Title
CN110035797A (zh) * 2016-11-13 2019-07-19 卡梅蒂丝有限公司 用于治疗痤疮的局部组合物
EP3538219A4 (fr) * 2016-11-13 2020-06-03 Kamedis Ltd. Compositions topiques destinées au traitement de l'acné
CN110035797B (zh) * 2016-11-13 2022-08-23 卡梅蒂丝有限公司 用于治疗痤疮的具有益生元特性的协同草药组合物
US11478522B2 (en) 2016-11-13 2022-10-25 Kamedis Ltd Synergistic herbal compositions with prebiotic properties for treatment of acne
CN110545788A (zh) * 2017-04-20 2019-12-06 荷兰联合利华有限公司 抗微生物组合物
CN110545788B (zh) * 2017-04-20 2022-10-21 联合利华知识产权控股有限公司 抗微生物组合物
WO2023107659A1 (fr) * 2021-12-09 2023-06-15 Colgate-Palmolive Company Compositions de soins personnels

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TW201412324A (zh) 2014-04-01

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