WO2011069184A1 - Composition destinée au traitement des lésions cutanées - Google Patents

Composition destinée au traitement des lésions cutanées Download PDF

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Publication number
WO2011069184A1
WO2011069184A1 PCT/AU2010/001581 AU2010001581W WO2011069184A1 WO 2011069184 A1 WO2011069184 A1 WO 2011069184A1 AU 2010001581 W AU2010001581 W AU 2010001581W WO 2011069184 A1 WO2011069184 A1 WO 2011069184A1
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Prior art keywords
copper
formulation
skin
composition according
composition
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Ceased
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PCT/AU2010/001581
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English (en)
Inventor
John Spurge
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DYNAMICLEAR Pty Ltd
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DYNAMICLEAR Pty Ltd
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Priority claimed from US12/633,599 external-priority patent/US20110064826A1/en
Application filed by DYNAMICLEAR Pty Ltd filed Critical DYNAMICLEAR Pty Ltd
Priority to CA2783612A priority Critical patent/CA2783612A1/fr
Publication of WO2011069184A1 publication Critical patent/WO2011069184A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/34—Copper; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/38—Clusiaceae, Hypericaceae or Guttiferae (Hypericum or Mangosteen family), e.g. common St. Johnswort
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A61P31/22—Antivirals for DNA viruses for herpes viruses

Definitions

  • the present invention relates to a composition for the treatment of skin lesions and use of the composition.
  • the invention relates to compositions for treatment of skin lesions associated with viral infections, such as Herpes simplex.
  • Herpes is a sexually transmitted disease (STD) caused by the herpes simplex virus (HSV).
  • HSV herpes simplex virus
  • HSV1 Herpes Simplex 1
  • HSV2 Herpes Simplex 2
  • HSV1 or mouth herpes is commonly in the form of cold sores on and around the mouth.
  • HSV2 or genital herpes is a much more intense strain commonly found on the genitals. However both types can be found on the mouth or genital areas. It is possible to be infected by both HSV1 and HSV2. Being infected by one particular strain does not make you immune to another.
  • the stages are easily identifiable and include prodrome, vesicles, Ulceration, crust and healing.
  • Prodrome is generally a short period of tingling, itching, numbness or burning with no visible sig of an outbreak.
  • Vesicles are the formation of one or more fluid- filled blisters, often in a cluster and usually surrounded by sore, red skin.
  • the ulceration stage is when the blisters operi to form painful ulcers or open sores. At the edge of the sore, a soft or hard yellow crust begins to appear. Ulcers and painful, sore, red skin persist through this stage. At the crust stage, weeping sores or ulcers become completely covered by a crust or scab. No ulcers or blisters are present.
  • the healing process is manifested by disappearance of the crust, swelling, pain and itching.
  • Skin eruptions due to viral infection especially Herpes viruses, generally have a normal infective course that lasts from 10 to 60 days depending on the exact causative species and anatomical location of the infection.
  • the virus After the initial outbreak, the virus usually lies dormant in the skin or in nerve tissue (latent state) until something triggers another eruption or site infection. When the virus reactivates, it characteristically causes a sore at the site where it first entered the body. Often the trigger is unknown, but in some people overexposure to sunlight, fever, physical or emotional stress, hormonal changes such as pregnancy or menstruation, or certain foods and drugs seem to reactivate the virus.
  • Genital herpes on the other hand is generally considered to be sexually transmitted. An estimated 40 million people of the world population have genital herpes which makes it a chronic viral infection. About 500,000 people get new symptomatic herpes each year and there are even more people without symptoms. It has been estimated that about 20% of the world population have genital herpes and 90% have oral herpes (cold sores).
  • the present invention generally provides topical preparations and methods for treatment of skin and mucosal membrane lesions associated with microbial infections such as Herpes simplex.
  • a formulation e.g., an aqueous herbal formulation, comprising an amount of copper effective for topical treatment of one or more skin and mucosal membrane lesions in a subject.
  • the formulation may be any suitable pharmaceutical formulation capable of being administered by any route e.g., topically, parenterally, by inhalation, ingestion, by suppository, etc. subject to the proviso that such administration is capable of treating or preventing a skin or mucous membrane lesion.
  • the formulation may be a cream, lotion, liquid emulsion, gel, aqueous solution, tablet, or powder.
  • a herbal formulation shall be taken to mean a formulation that does not comprise a synthetic compound as an active agent in the treatment of a lesion of the skin and/or mucosa.
  • a herbal formulation may comprise an active agent type derived from a plant or part thereof or a fungus or a part thereof e.g., from the root, stem, leaf, flower, fruit, or seed of a plant.
  • a herbal formulation may comprise the active agent in a herbal base e.g., a plant-derived base comprising a cream, lotion, liquid emulsion, gel or aqueous solution.
  • amount of copper is meant a sufficient concentration of copper to ameliorate one or more visible symptoms of a skin lesion such as that associated with infection by a bacterium, fungus or virus such as a Herpes Simplex Virus e.g., HSV-1 or HSV-2, Herpes Zoster Virus, Polio virus, Shingles-associated viruses, Varicella Zoster Virus, Chicken pox-associated viruses or Human Immunodeficiency Virus (HIV-1) or any serotype thereof capable of infecting a human or causing a skin lesion in another animal species.
  • the copper is present in a trace amount, as an active trace metal.
  • topical treatment is meant that the formulation is suitable for treatment of a skin or mucous membrane lesion appearing on any one or more body surface(s) such as the skin, hair follicle, nail cuticle, mucous membrane, anus, throat including oral mucosa, eyes including cornea, conjuctiva or eyelid, lips, ears, or genitalia including vagina, labial tissue, penis, scrotum, etc.
  • body surface(s) such as the skin, hair follicle, nail cuticle, mucous membrane, anus, throat including oral mucosa, eyes including cornea, conjuctiva or eyelid, lips, ears, or genitalia including vagina, labial tissue, penis, scrotum, etc.
  • direct topical administration is clearly within the scope of the present invention.
  • lesion is meant any localized abnormal structural change in a body part such as produced by wounding, infection or other injury involving a cut or break in the skin or mucosa.
  • a lesion in the present context includes any disruption to the skin or mucosa associated with infection of a subject by a bacterium, fungus or virus.
  • lesions associated with virus infection may be apparent on the face and/or mouth (e.g., orofacial herpes), genitalia (e.g., genital herpes), or hands (e.g., herpes whitlow), eye (e.g., herpes keratitis).
  • the present invention provides a topical formulation comprising an amount of copper e.g., as an active trace metal, in an aqueous herbal base effective for treatment of skin and mucosal membrane lesions in a subject.
  • topical formulation is meant that the formulation is suitable for application direct to skin or a mucous membrane, such as directly on a lesion in the skin or mucous membrane.
  • a topical formulation is applied directly to one or more body surface(s) such as the skin, hair follicle, nail cuticle, mucous membrane, anus, throat including oral mucosa, eyes including cornea, conjuctiva or eyelid, lips, ears, or genitalia including vagina, labial tissue, penis, scrotum, etc.
  • Application may comprise direct contact with that part of the body surface e.g., that part of the body surface having the lesion/
  • composition base is meant that the composition base into which the active agent is introduced is derived substantially from a non-synthetic source such as a plant or part thereof or a fungus or a part thereof e.g., from the root, stem, leaf, flower, fruit, or seed of a plant.
  • the base may be a cream, lotion, liquid emulsion, gel or aqueous solution.
  • a composition of the present invention may comprising an effective amount of a copper compound in a herbal base comprising an extract selected from the group consisting of: Hypericum perforatum (St.
  • John's wort Aloe barbadensis extract
  • Melaleuca alternifolia tea tree
  • Melissa officinalis leafmon balm
  • Prunella vulgaris selfheal extract
  • a herbal extract or herbal base may contribute to efficacy of copper in a formulation of the present invention.
  • the copper formulations of the present invention will generally comprise a pharmaceutically acceptable copper salt wherein the transition metal cation has a charge of +2 or +3 such as a copper (II) complex or copper (III) complex, and the salt has low toxicity in humans.
  • a pharmaceutically acceptable copper salt are described e.g., Remington's Pharmaceutical Sciences, 18th ed., Mack Publishing, Easton Pa. (1990) and include copper acetate, copper sulphate, copper chloride, copper salicylate, copper nitrate, copper (Il)-aspirinate, copper (II) salsalate, a mixed carboxylate copper (II) complex and a caffeine, a copper (II) carboxylate-caffeine complex, and combinations thereof.
  • a solvate of a copper salt may be employed.
  • a formulation according to any example hereof comprises copper in the form of copper sulphate e.g., Cu(II)S0 4 or a solvate thereof.
  • the copper is provided as Cu(H)SC>4:7H 2 0.
  • a formulation according to any example hereof may comprise copper as an active trace metal.
  • the copper ion may be present in the formulation at a concentration in the range of about 1% (w/w) to about 5% (w/w), including about 2% (w/w) or about 3% (w/w) or about 4% (w/w) or about 5% (w/w) or 5.5% (w/w).
  • the copper compound is present in the range of between about 5% (w/w) of the formulation and about 9% (w/w) of the formulation, including about 7.0% (w/w) or about 7.1% (w/w) or about 7.2% (w/w) or about 7.3% (w/w) or about 7.4% (w/w) or about 7.5% (w/w) or about 7.6% (w/w) or about 7.7% (w/w) or about 7.8% (w/w) or about 7.9% (w/w) or about 8.0% (w/w) of the formulation.
  • Concentrations of copper ions that are permissible when applied topically may be higher than those concentrations considered toxic when copper is provided to isolated and cultured cells in vitro or by injection.
  • compositions should be acceptable for human or veterinary applications.
  • Such carriers, excipients and/or diluents are well-known to those skilled in the art.
  • Carriers and/or diluents suitable for use include any and all solvents, dispersion media, aqueous solutions, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents, and the like. Except insofar as any conventional media or agent is incompatible with the active ingredient, use thereof in the composition is contemplated. Supplementary active ingredients can also be incorporated into the compositions.
  • a herbal extract e.g., selected from the group consisting of: ,
  • Hypericum perforatum (St. John's wort) extract, Aloe barbadensis extract, Melaleuca alternifolia (tea tree) extract, Melissa officinalis (lemon balm) extract, Prunella vulgaris (selfheal) extract, and combinations thereof, is present at a concentration of about 0.05% (v/v) of an aqueous formulation to about 2% (v/v) of an aqueous formulation, including about 0.05% (v/v) of an aqueous formulation or about 0.1% (v/v) of an aqueous formulation or about 0.15% (v/v) of an aqueous formulation or about 0.2% (v/v) of an aqueous formulation or 0.5% (v/v) of an aqueous formulation or 1.0% (v/v) of an aqueous formulation or 1.5% (v/v) of an aqueous formulation or 2% (v/v) of an aqueous formulation.
  • a herbal extract such as that of Hypericum
  • One or more skin protectants e.g., glycerin may also be included in the formulation e.g., at a concentration of about 1% (w/w) to about 5% (w/w).
  • One or more preservatives, osmotic regulators, thickeners, flavors, fragrances, emollients, humectants, colorants, pigments and combinations thereof may also be included in the composition of the present invention.
  • composition according to any example hereof may further comprise sodium ascorbate e.g., at a concentration of about 3-10% (w/w) and/or hydrogen peroxide e.g., at a concentration of about 3-10% (w/w).
  • a formulation of the present invention may be administered without limitation in any subject susceptible to a lesion of the skin and or mucosa, especially subjects that are at risk of virus infection or have a pre-existing infection by one or more viruses.
  • the subject may be a sexually-active person, healthcare worker, or a subject having an immature or suppressed immune system e.g., a newborn, transplant recipient, HIV- 1 -infected subject or AIDS patient.
  • the formulations of the present invention are effective in ameliorating one or more visible symptoms of a skin lesion or lesion in the mucosa e.g., associated with infection.
  • the formulation will reduce duration and/or severity of a lesion and/or reduce pain and/or reduce inflammation and/or reduce itchiness and/or reduce virus shed.
  • a formulation of the present invention prevents or assists in preventing a lesion from increasing in size and/or decrease virus shed or spread during healing.
  • a formulation of the present invention prevents or reduces recurrence of a lesion or virus outbreak.
  • a formulation of the present invention may be applied at any stage during presentation of symptoms in a subject.
  • a formulation of the present invention provides a beneficial effect when applied early e.g., at first appearance of a lesion or with 24 hours or 48 hours or 72 hours of the first appearance of a lesion or before the lesion weeps.
  • the formulation may be applied to an active lesion.
  • the present invention is performed as a stand-alone therapy.
  • the present invention is performed as an adjunct therapy with other prophylactic or therapeutic treatment e.g., one or more of an antiviral agent, non- steroidal anti-infiammatory drug (NSAID), vaccine, dietary supplement, etc.
  • NSAID non- steroidal anti-infiammatory drug
  • acyclovir Zovirax
  • valaciclovir valaciclovir
  • famciclovir famciclovir
  • penciclovir docosanol
  • tromantadine zilactin
  • lipactin lipactin
  • tea tree oil cimetidine
  • probenecid aspirin
  • lidocain prilocaine
  • tetracaine petroleum jelly
  • Herpevac lysine
  • lactoferrin vitamin C
  • vitamin A vitamin E
  • zinc zinc
  • a method of treating or preventing one or more skin lesions comprising applying to the . lesion a therapeutically effective amount of a formulation according to any example hereof e.g., for a time and under conditions sufficient for ameliorate one or more visible symptoms of a skin lesion or lesion in the mucosa e.g., associated with infection.
  • the amelioration of one or more symptoms may comprise a reduced duration and or severity of a lesion and/or reduces pain and/or reduced inflammation and/or reduced itchiness and/or reduced virus shed and/or decrease in virus shed and/or decrease in virus spread.
  • a formulation of the present invention is applied for a time and under conditions sufficient to prevent or reduce recurrence and/or to prevent a lesion from increasing in size.
  • the therapeutic or prophylactic method of the present invention is particularly suited to the treatment and prevention of skin and/or mucosal lesions associated with infection by a bacterium, fungus or virus, including one or more of Herpes Simplex Virus e.g., HSV-1 or HSV-2, Herpes Zoster Virus, Polio virus, Shingles-associated viruses, Varicella Zoster Virus, Chicken pox-associated viruses, Human Immunodeficiency Virus (HIV-1), or any serotype thereof capable of infecting a human or causing a skin lesion in another animal species.
  • Herpes Simplex Virus e.g., HSV-1 or HSV-2
  • Herpes Zoster Virus Polio virus
  • Shingles-associated viruses Shingles-associated viruses
  • Varicella Zoster Virus Chicken pox-associated viruses
  • Human Immunodeficiency Virus (HIV-1) Human Immunodeficiency Virus
  • the present invention provides a method for the treatment and/or prevention of skin lesions associated with infection by a herpesvirus e.g., HSV-1 and/or HSV-2 or any serotype thereof capable of infecting a human or causing a skin lesion in another animal species.
  • a herpesvirus e.g., HSV-1 and/or HSV-2 or any serotype thereof capable of infecting a human or causing a skin lesion in another animal species.
  • a formulation according to any example hereof may be applied once or more . times during an outbreak, such as prior to virus shed or weeping of the lesion or to a visible and/or mature lesion.
  • a lesion may be applied to the mouth area of a subject suffering from a cold sore, or around the genitalia of a subject suffering from genital herpes.
  • Another example ⁇ of the present invention provides for use of a formulation according to any example hereof in the manufacture of a medicament for the treatment or prevention of a virus-associated skin or mucosal membrane lesion e.g., wherein the virus is selected from the group consisting of Herpes Simplex Virus e.g., HSV-1 or HSV-2, Herpes Zoster Virus, Polio virus, Shingles-associated viruses, Varicella Zoster Virus, Chicken pox-associated viruses, Human Immunodeficiency Virus (HTV-1), or any serotype thereof capable of infecting a human or causing a skin lesion in another animal species, especially HSV-1 and/or HSV-2 or any serotype thereof capable of infecting a human or causing a skin lesion in another animal species.
  • Herpes Simplex Virus e.g., HSV-1 or HSV-2
  • Herpes Zoster Virus Polio virus
  • Shingles-associated viruses Shingles-associated viruses
  • a further example of the present invention provides a process of producing a composition for the treatment of viral associated skin and mucosal membrane lesions, the process comprising forming a copper solution from a copper compound, adding glycerin to the copper solution, adding a herbal extract to the copper solution, bringing the solution to a desired concentration using water, optionally adding a preservative; and optionally filtering to remove any sediment.
  • a composition comprising copper ions, such as in the form of copper sulphate pentahydrate and a herbal base such as Hypericum perforatum extract or Aloe barabensis extract is effective in dramatically reducing the healing time of lesions due to infection by herpesviruses, stopping the normal progression of the viral outbreak from the stage at which the initial outbreak occurred, and also in reducing recurrence of lesions.
  • the composition of the present invention is a copper-based solution with copper as the active trace metal in an aqueous herbal base.
  • compositions Whilst it is not intended that the present invention should be restricted in any way by a theoretical explanation of the mode of action of copper, it is believed that copper may exert an antiviral and healing effect by virtue of the composition being slightly acidic, which is corrosive to the virus. Accordingly, preferred compositions possess an acid group and sulfur molecule to assists in penetration of the composition through the protective capsule of a virus such as herpesvirus,' thereby allowing for direct contact with the virus and subsequent destruction of the virus.
  • a virus such as herpesvirus
  • compositions of the present invention are those recognised in the pharmaceutical arts as being suitable for topical application and include, without ' intended limitation, creams, lotions, liquid emulsions, gels, aqueous solutions and the like.
  • the present compositions preferably include copper sulphate pentahydrate in from about 5 to 9, preferably 7.8% by weight or copper ion from about 1 to 5%, (equivalent to about 3 to 7% copper sulphate) , preferably 5% by weight.
  • a skin protectant e.g., glycerin
  • a herbal extract is included from about 0.05 to 0.15%, preferably about 0.1 % by weight
  • the subject composition is also advantageous in that it is safe and has no known side-effects.
  • the composition can also be safely used for veterinary purposes.
  • a skin protectant forms a barrier over the skin surface to protect against irritation due to touching, rubbing etc.
  • the skin protectant also provides a protective barrier over the lesion, preventing loss of the active ingredient to the action of saliva.
  • the skin protectant is in the form of glycerin.
  • composition of the present invention may contain other ingredients such as are recognised by those skilled in the pharmaceutical industry as being typically. present in such formulations. These include, without limitation, one or more preservatives, osmotic regulators, thickeners, flavours, fragrances, emollients, humectants, colorants, pigments and the like. It would be clear to the skilled addressee that the compounding of the composition of the present invention will be carried out utilising some or all of these ingredients depending on the area of application and intended use. For example, for a preparation intended for application in or around the mouth, it may be necessary to add flavours to mask the taste of the essential ingredients.
  • compositions Although best long term results are achieved by applying the composition to a visible and mature lesion, patients have reported great success in preventing outbreaks by applying the composition in the early stages. This can include applying the composition topically to the affected area as the first sign of symptoms such as itching, tingling, redness or inflammation.
  • Each solution was prepared by filling a suitable vessel with about 60% distilled water. Copper compound was added to water with continuous stirring. Mixing of a solution continued for 10 minutes or until the copper was fully dissolved. Glycerin was added to a solution and mixed for a few minutes. Hypericum perforatum was gradually added with continuous mixing. Each solution was then brought to final weight by the slow addition of the required amount of water with continuous blending for about 10 minutes. Preservative Germall Plus was added and a solution was then allowed to stand for 12 to 15 hours to stabilise. Each solution was then filtered to remove the sediment and packaged.
  • Example 1 A solution prepared in Example 1 was tested for its effectiveness against Herpes virus. To determine efficacy of the composition in reducing the healing time of lesions associated with Herpes virus infection and/or reducing the recurrence of the lesions, 51 patients were observed.
  • Subjects were randomized into two groups (A and B). Subjects in Group A topically applied a composition as defined in Example 1, transferring 2-4 drops of aqueous copper formulation (depending upon the affected area) to a wet cotton swab (enough to saturate it) on the affected part only once at clinic. Subjects in Group B topically applied 0.5 - 1.5 grams of the comparator article (acyclovir 5% cream) twice daily (once in the morning and once at night) to cover affected areas for 7 days. Treatments were initiated on Day 1, pending the results of laboratory investigations. Patients in Group A presented for efficacy & safety assessments on Day 2, Day 3, Day 8 and Day 14. Group B patients presented on Day 3 and Day 8 for efficacy evaluation and on Day 14 for follow up. Patients also recorded their self-assessment of symptoms in a patient diary from Day 1 to Day 14.
  • Efficacy endpoint assessments determine time to achieve greater than about 50% crusting/scabbing or healed ulcer. Cutaneous assessments are performed to detennine disappearance of erythema, crust/scab formation in ulcers, disappearance of pain and disappearance of itching and burning sensation.
  • Cutaneous efficacy assessments are performed at each visit on Day 2, Day 3 and .

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Abstract

La présente invention concerne une composition destinée au traitement topique des lésions de la peau et des muqueuses, ladite composition comprenant une combinaison synergique d'un composé de cuivre et d'un extrait de Hypericum perforatum.
PCT/AU2010/001581 2009-12-08 2010-11-25 Composition destinée au traitement des lésions cutanées Ceased WO2011069184A1 (fr)

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US11000545B2 (en) 2013-03-15 2021-05-11 Cda Research Group, Inc. Copper ion compositions and methods of treatment for conditions caused by coronavirus and influenza
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US11318089B2 (en) 2013-03-15 2022-05-03 Cda Research Group, Inc. Topical copper ion treatments and methods of making topical copper ion treatments for use in various anatomical areas of the body
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US12318406B2 (en) 2013-03-15 2025-06-03 Cda Research Group, Inc. Methods of treatment using topical copper ion formulations
US11717535B2 (en) 2013-03-15 2023-08-08 Cda Research Group, Inc. Copper ion compositions and methods of treatment for conditions caused by coronavirus and influenza
US11857514B2 (en) 2013-03-15 2024-01-02 Cda Research Group, Inc. Topical copper ion treatments and methods of treatment using topical copper ion treatments in the dermatological areas of the body
US12171867B2 (en) 2013-03-15 2024-12-24 Cda Research Group, Inc. Topical copper ion treatments and methods of making topical copper ion treatments for use in various anatomical areas of the body
US11459638B2 (en) 2019-02-22 2022-10-04 Cda Research Group, Inc. System for use in producing a metal ion suspension and process of using same
US11193184B2 (en) 2019-02-22 2021-12-07 Cda Research Group, Inc. System for use in producing a metal ion suspension and process of using same

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