AU2006200131A1 - Topical composition - Google Patents

Description

P/00/011 Regulation 3.2

AUSTRALIA

Patents Act 1990 COMPLETE

SPECIFICATION

STANDARD

PATENT

Invention Title: Applicant: TOPICAL COMPOSITION SKINFIX PTY LTD The following statement is a full description of this invention, including the best method of performing it known to me: -2- TOPICAL COMPOSITION Field of the Invention The present invention relates to topical compositions for the treatment of skin, musculo-skeletal, immune and circulatory system disorders or disturbances.

The invention also relates to methods of treating skin, musculo-skeletal, immune and circulatory system disorders or disturbances.

Background of the Invention Disorders and ailments of the skin, musculo-skeletal, immune and circulatory systems are common in humans and animals. For example, during everyday activity the skin is subjected to harsh conditions such as ultraviolet radiation, temperature extremes, irritants and physical trauma such as cuts, abrasions and burns. In addition to skin disorders resulting from external factors, other determinants such as viral, bacterial and fungal infections can lead to skin disorders such as rashes. Muscular disorders such as aches and soreness are also common in everyday life.

Many preparations for the treatment of skin disorders, muscular ailments or disorders, infections and the like have been developed. For example, a number of topical compositions for the treatment of the skin in order to treat or prevent conditions resulting from trauma, such as burns, cuts, abrasions and wounds are available. In each case, these compositions contain one or more active ingredients and a suitable carrier that allows the composition to be applied topically and delivers the active ingredient(s) to the affected site. However, compositions that are efficacious against a broad spectrum of disorders, diseases and ailments and that are suitable for administration without medical intervention are not very common. Accordingly, there is a need for a composition that can be applied topically that provides for minimal side effects and which provides relief from a range of ailments, disorders and diseases in animals.

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Summary of the Invention The present invention provides a general purpose composition suitable for topical application to the skin of an animal to ameliorate one or more ailments or disorders, the composition including an effective amount of: at least one plant extract having anti-inflammatory activity; at least one at least one at least one at least one at least one at least one at least one at least one at least one at least one plant extract having anti-bacterial activity; plant extract having anti-fungal activity; plant extract having diuretic activity; plant extract having antibiotic activity; plant extract having antiseptic activity; plant extract having expectorant activity; plant extract having immunostimulant activity; plant extract having diaphoretic activity; plant extract having astringent activity; plant extract having blood purifying activity; and a pharmaceutically acceptable carrier.

The present invention also provides a topical composition inclduing: an effective amount of a therapeutically active extract from the following plant species: Amica montana; Calendula officinalis; Echinacea angustifolia; Hydrastis canadensis; Ruta graveolens; Thuya occidentalis and Urtica dioica; and a pharmaceutically acceptable carrier.

The present invention has arisen from the inventors extensive studies of combinations of plant extracts that, in combination, are able to provide relief from a wide range of ailments or disorders.

The composition of the present invention may also contain an effective amount of an extract from a number of other plant species in addition to the seven core extracts. In one preferred form of the present invention, the composition contains an effective amount of a therapeutically active extract from each of the WAdocumentslDo Not Delete\Spedflcoons Compete\TOPCAL COMPOSITIONdoc -4following plant species: Arnica montana; Arctium lappa; Calendula officinalis; Galium aparine; Echinacea angustifolia; Hydrastis canadensis; Trifolium pretense; Ruta graveolens; Hypericum perfoliatum; Thuya occidentalis; Urtica dioica and Hamamelis virginica.

The present invention also provides a method for the treatment of disorders of the skin, musculo-skeletal, immune or circulatory system of an animal in need of such treatment, the method including applying a composition of the present invention to the skin in an affected area in order to ameliorate the symptoms of said disorder.

Detailed Description of the Invention Before proceeding with an explanation of at least one embodiment of the invention in detail it is to be understood that the invention is not limited to the details of the components provided in the following description. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting. Indeed, various terms used throughout the specification have meanings that will be well understood by a skilled addressee in the area.

Nevertheless, for ease of reference, some of these terms will now be defined.

The term "composition" as used throughout the specification is to be understood to mean a product containing the specified ingredients in the specified amounts, as well as any product which results, directly or indirectly, from combination of the specified ingredients in the specified amounts.

The term "tincture" as used throughout the specification is to be understood to mean a plant extract that is produced by steeping parts of the plant in alcohol for several weeks. Tinctures are often available commercially and are usually taken in drops.

MN\documents\Do Not Delete\Spedflcatons\Complete\TOPICAL COMPOSITIONdoc The term "plant extract" as used throughout the specification is to be understood to mean any plant material and includes any or all parts of a plant such as, without limitation, seeds, flowers, leaves and stems. The plant extract may be prepared from a single part of the plant, or from two or more parts of the plant.

The term "therapeutically effective amount" or "therapeutic amount" as used throughout the specification is to be understood to mean an amount sufficient to effect beneficial or desired clinical results. An effective amount can be administered in one or more administrations. An effective amount is typically sufficient to palliate, ameliorate, stabilise, reverse, slow or delay the progression of a disease state or disorder.

The term "therapeutically active" as used throughout the specification is to be understood to mean that the subject is able to palliate, ameliorate, stabilise, reverse, slow or delay the progression of a disease state or disorder.

The term "animal" as used throughout the specification is to be understood to mean any entire animal subject for which therapy or treatment is desired. The animal may be mammalian, including (but not limited to) humans, cattle, dogs, guinea pigs, rabbits, pigs, horses, or chickens. Most preferably, the animal is a human.

The present invention provides a general purpose composition suitable for topical application to the skin of an animal to ameliorate one or more ailments or disorders, the composition including: an effective amount of a therapeutically active extract from the following plant species: Arnica montana; Calendula officinalis; Echinacea angustifolia; Hydrastis canadensis; Ruta graveolens; Thuya occidentalis and Urtica dioica; and a pharmaceutically acceptable carrier.

Wdocuments\Do Not Delete\Spocflcaions\Comptet\TOPICAL COMPOSITIONdoc Preferably, the composition contains an effective amount of a therapeutically active extract from each of the following plant species: Arnica montana; Arctium lappa; Calendula officinalis; Galium aparine; Echinacea angustifolia; Hydrastis canadensis; Trifolium pretense; Ruta graveolens; Hypericum perfoliatum; Thuya occidentalis; Urtica dioica and Hamamelis virginica.

The composition is most suitable for topical application to the skin of an animal.

Preferably, the animal is a human; however, the composition may also be applied topically to domesticated animals, such as but not limited to, dogs, cats, horses and the like.

The composition of the present invention may be applied topically primarily as a first aid cream for the treatment of skin and muscular disorders and ailments including (but not limited to): bruising; broken skin including bleeding; sprains; sports injuries; skin infections; burns; animal and insect bites, including bee, wasp and ant stings and spider bites; burns and scalds, including sunburn; acne; ringworm; eczema; nappy rash.

The composition may also be used for the treatment of more chronic ailments, including discomfort and other symptoms associated with osteo, degenerative and rheumatoid arthritis; fibromyalgia; neuropathy; sciatica; lower back pain; knee, hip, shoulder and hand pain; musculoskeletal injuries; post surgery pain; shingles; sinus and migraine headaches; and other like conditions or injuries that cause a subject discomfort.

The composition of the present invention includes an effective amount of at least one plant extract having anti-inflammatory activity. Suitable extracts include extracts from Arnica montana (otherwise referred to as "arnica" or "leopard's bane"), Arctium lappa (otherwise referred to as "burdock root"), Galium aparine (otherwise referred to as "cleavers" or "goose grass"), Hypericum perfoliatum (otherwise referred to as "St John's wort" or "hypericum") and Hamamelis virginica (otherwise referred to as "witchhazel").

W:\documents\Do Not Delete\SpedfimcaonstCompite\TOPICAL COMPOSITIONdoc -7- The composition of the present invention also includes an effective amount of at least one plant extract having anti-bacterial activity. Suitable extracts include extracts from Arica montana (otherwise referred to as "arnica" or "leopard's bane"), Arctium lappa (otherwise referred to as "burdock root") and Hydrastis Canadensis (otherwise referred to as "hydrastis" or "goldenseal").

The composition of the present invention also includes an effective amount of at least one plant extract having anti-fungal activity. Suitable extracts include extracts from Arctium lappa (otherwise referred to as "burdock root") and Calendula officinalis (otherwise referred to as "calendula" or "pot marigold").

The composition of the present invention also includes an effective amount of at least one plant extract having diuretic activity. Suitable extracts include extracts from Arctium lappa (otherwise referred to as "burdock root"), Galium aparine (otherwise referred to as "cleavers" or "goose grass"), Hydrastis Canadensis (otherwise referred to as "hydrastis" or "goldenseal"), Urtica dioica (otherwise referred to as "hydrastis" or "goldenseal") and Thuya occidentalis (otherwise referred to as "urtica" or "stinging nettle").

The composition of the present invention also includes an effective amount of at least one plant extract having antibiotic activity. Suitable extracts include extracts from Echinacea angustifolia (otherwise referred to as "echinacea").

The composition of the present invention also includes an effective amount of at least one plant extract having antiseptic activity. Suitable extracts include extracts from Hydrastis Canadensis (otherwise referred to as "hydrastis" or "goldenseal") and Hypericum perfoliatum (otherwise referred to as "St John's wort" or "hypericum").

The composition of the present invention also includes an effective amount of at least one plant extract having expectorant activity. Suitable extracts include extracts from Ruta graveolens (otherwise referred to as "rue" or "ruta bitterwort") and Thuya occidentalis (otherwise referred to as "thuya" or "white cedar").

W:documentskDo Not DeletetSpoaficabonCompetetTOPICAL COMPOSITION.doc -8- The composition of the present invention also includes an effective amount of at least one plant extract having immunostimulant activity. Suitable extracts include extracts from Ruta graveolens (otherwise referred to as "rue" or "ruta bitterwort").

The composition of the present invention also includes an effective amount of at least one plant extract having diaphoretic activity. Suitable extracts include extracts from Arctium lappa (otherwise referred to as "burdock root").

The composition of the present invention also includes an effective amount of at least one plant extract having astringent activity. Suitable extracts include extracts from Galium aparine (otherwise referred to as "cleavers" or "goose grass"), Hydrastis Canadensis (otherwise referred to as "hydrastis" or "goldenseal") and Hypericum perfoliatum (otherwise referred to as "St John's wort" or "hypericum").

The composition of the present invention also includes an effective amount of at least one plant extract having blood purifying activity. Suitable extracts include extracts from Arctium lappa (otherwise referred to as "burdock root"), Echinacea angustifolia (otherwise referred to as "echinacea") and Trifolium pretense (otherwise referred to as "red clover" or "cow grass").

In one embodiment of the present invention, the composition includes arnica extract. Arnica extract has been used for the treatment of aches and bruises following injury as well as for rheumatism and gout. Externally, arnica extract has been used for the treatment of arthritis, burns, ulcers, eczema and acne. It also has anti-bacterial and anti-inflammatory properties that can reduce pain and swelling and improve wound healing.

The composition of the present invention may also include burdock root.

Burdock root is understood to have antioxidant, anti-inflammatory, anti-bacterial, anti-fungal, diuretic, diaphoretic, hepato-protective, blood purifying and tonic properties. Burdock root has been used for the treatment of skin ailments such as psoriasis, dry skin, acne and dandruff. It has also been used for the W:ocuments'fo Not Delete\SpedficationsComplete\TOPICAL COMPOSITIONdoc

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treatment or to provide relief from the symptoms of arthritis and rheumatism, as well as to improve liver function.

The composition of the present invention may further include calendula.

Calendula has been used as a wound healing agent, both internally and externally. Internally, calendula has been used for the treatment of gastric and duodenal ulcers. Externally, calendula has been used in the treatment of skin problems such as bites and stings, sprains, wounds, sore eyes and varicose veins. Calendula has also been used as an antiseptic and an astringent for the skin.

The composition of the present invention may further include cleavers. Cleavers has been used as a diuretic, alterative, anti-inflammatory agent, tonic, astringent and lymphatic cleanser. It has also been used for the treatment of skin conditions such as psoriasis, burns, grazes and other skin inflammations.

The composition of the present invention may further include echinacea.

Echinacea is a blood purifier and antibiotic. Echinacea has been used in the treatment of insect and snake bites, toothaches, sore throat, wounds as well as mumps, smallpox and measles. The antibacterial properties of Echinacea can be utilized to stimulate wound healing and are of benefit to skin conditions such as burns, insect bites, ulcers, psoriasis, acne and eczema.

The composition of the present invention may also include hydrastis. Hydrastis is known to have antibacterial, antiseptic, antispasmodic, astringent, diuretic, laxative, sedative and tonic properties. It has been used for the treatment of disorders of the digestive system and mucous membranes. It is used primarily in the treatment of disorders affecting the eyes, ears, throat, nose, stomach, intestines and vagina.

The composition of the present invention may further include red clover. Red clover is thought to purify the blood by promoting urine and mucous production, and stimulating the secretion of bile. As a respiratory agent, it has been used in the treatment of whooping cough, bronchitis and other lung conditions where WAdocumentsDio Not Delete\Spedficaflons\Complete\TOPICAL COMPOSITION.doc spasm is present. Red clover has also been used in the treatment of other conditions such as cancer, mastitis, joint disorders, jaundice, asthma and skin inflammations such as psoriasis and eczema.

The composition of the present invention may also include rue. The whole herb of Ruta graveolens has been shown to be anthelmintic, antispasmodic, carminative, emetic, emmenagogue, expectorant, haemostatic, rubifacient, stimulant, stomachic and uterotonic. The extract has been used in the treatment of earache and skeletal pain.

The composition of the present invention may further include St John's wort. St.

John wort has been used in the repair of nerve damage and also for the reduction of pain and inflammation. It has been used in the treatment of cuts, grazes, bruises, minor burns, sciatica, injured nerves, inflammations, ulcers, poisonous reptile bites, kidney and lung ailments, allergic reactions, anxiety and depression. St John's wort is also an astringent that promotes wound healing and it has antiviral properties. In addition, St. John wort is also a good source of antioxidants.

The composition of the present invention may also include thuya. Thuya is recommended as an expectorant, diuretic, stimulant and in the treatment of rheumatism. It has also been used externally to treat warts, freckles, acne, seborrhea, blotches, brown spots, herpetic eruptions, brittle or soft nails, ingrown toenails and dandruff. Thuya is also used for its antibacterial properties.

The composition of the present invention may further include nettle. Nettle extract has been used for treatment of arthritis and allergy symptoms, as well as for treatment of hay fever, coughs, tuberculosis, kidney stones and urinary tract infections. It has also been used as a counter-irritant in the treatment of eczema, itching blotches, acne, burns and scalds.

The composition of the present invention may further include witch hazel. Witch hazel extract is a strong astringent as well as an anti-inflammatory, and has W:\documentsDo Not Delete\SpecflcavonsCompdete\TOPtCAL COMPOSITION.doc

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-11 also been shown to strengthen veins. Witch hazel extract has been used to treat eczema, haemorrhoids, injuries and wounds, skin ulcers, painful tumors, insect bites and varicose veins.

In addition to the plant extracts discussed, the composition of the present invention may further include other herbal extracts. It is within the skill of a person of ordinary skill in the art to identify and determine an effective amount of one or more other herbal extracts that could be included in the composition of the present invention.

The pharmaceutically acceptable carrier may be any vehicle that is toxicologically and pharmaceutically acceptable. Typical pharmaceutically acceptable carriers that can be used in compositions of the present invention include water, ethanol, acetone, isopropyl alcohol, stearyl alcohol, freons, polyvinyl pyrrolidone, propylene glycol, polyethlyene glycol, fragrances, gelproducing materials, mineral oil, stearic acid, spermaceti, sorbitan, monoleate, polysorbates, "Tweens," sorbitol, methyl cellulose, petrolatum, a mineral oil (vaseline oil), which may be any petroleum based product; modified or unmodified vegetable oils such as peanut oil, wheatgerm oil, linseed oil, jojoba oil, apricot kernel oil, walnut oil, palm oil, pistachio oil, sesame oil, colza oil, cade oil, corn germ oil, peach kernel oil, poppyseed oil, pine oil, castor oil, soya oil, safflower oil, coconut oil, hazelnut oil, grapeseed oil, avocado oil, soy oil, sweet almond oil, calophyllum oil, castor oil, olive oil, sunflower oil, or animal oils such as whale oil, seal oil, menhaden oil, halibut liver oil, cod liver oil, cod, tuna, turtle tallow, horse's hoof, sheep's foot, mink, otter, marmot oil and the like; synthetic oils such as silicon oil such as dimethylpolysiloxane; alkyl and alkenyl esters of fatty acids, such as isopropyl esters of myristic, palmitic and stearic acids and fatty esters which are solid at room temperature; waxes such as lanolin wax, candelilla wax, spermaceti, cocoa butter, karite butter, silicon waxes, hydrogenated oils which are solid at room temperature, sucroglycerides, oleates, myristates, linoleates, stearates, paraffin, beeswax, carnauba wax, ozokerite, candelilla wax, microcrystalline wax; fatty alcohols such as lauryl, cetyl, myristyl, stearyl, palmityl and oleyl alcohols; polyoxyethylated fatty alcohols; and wax esters, lanolin and its derivatives, W:\documents\Do Not Delete\SpeficatonstComplteTOPCAL COMPOSITIONdoc -12perhydrosqualene and saturated esters, ethyl palmitate, isopropyl palmitate, alkyl myristates such as isopropyl myristate, butyl myristate and decyl myristate, hexyl stearate, triglyceride esters, triglycerides of octanoic and decanoic acid, cetyl ricinoleate, stearyl octanoate (Purcellin oil), fatty acids, polyhydric alcohols, polyether derivatives, fatty acid monoglycerides, polyethylene gylcol, propylene glycol, alkyl ethoxy ether sulfonates, ammonium alkyl sulfates, fatty acid soaps, and hydrogenated polyisobutene, and mixtures of waxes and oils.

Most preferably, the pharmaceutically acceptable carrier is a commercial carrier known as Vegesorb T M which is a vegetable based sorbolene cream that is available from the Pharmaceutical Plant Company Pty Ltd, Victoria, Australia.

Vegesorb T M is a mixture of purified water, vegetable glycerin, cetylstearyl alcohol, caprylic/capric triglyceride, coconut oil, cetomacroigol, phenoxyethanol (preservative) and methyl, ethyl, propyl and butyl parabens (preservative). The Vegesorb TM preparation also contains less than 0.1% preservative.

The composition of the invention may contain other additives, such as a solvent, a humectant, a preservative, a thickener, a fragrance, a colorant, a compounding agent, a surfactant, an emulsifier, an antioxidant, a stabiliser or a diluent.

Dosage forms for topical application of compositions of the present invention include solutions, lotions, creams, gels, sticks, sprays, pads, ointments, pastes, mousses, cosmetics, mouthwashes and aerosols. These product types may comprise several types of carrier systems including, but not limited to solutions, emulsions, gels and solids.

The dosage form can be made by adding tinctures of each of the plant extracts to the pharmaceutically acceptable carrier. Alternatively, solutions containing each of the herbal extracts may be added to the pharmaceutically acceptable carrier. In each case, the extract or tincture is preferably diluted between about 1:1 and about 1:5 in a suitable solvent, such as an alcohol solvent.

Commercially available tinctures containing each of the plant extracts may be used. For example, tinctures that are commercially available from the W:\documents\Do Not Delete\Spedficatons\Complete\TOPICAL COMPOSITION.doc -13- Pharmaceutical Plant Company Pty Ltd, Victoria, Australia have been found to be suitable.

A lotion can be made from solutions or tinctures containing each of the plant extracts. Lotions preferably comprise from about 20% to about 40%, more preferably from about 30% to about 35%, of the combined herbal extracts.

Another type of product that may be formulated from solutions or tinctures containing each of the plant extracts is a cream. A cream of the present invention would preferably comprise from about 20% to about 40%, more preferably from about 25% to about 35%, of the combined herbal extracts.

Yet another type of product that may be formulated from solutions or tinctures containing each of the plant extracts is an ointment. An ointment may comprise a simple base of animal or vegetable oils or semi-solid hydrocarbons.

Vegesorb TM is one example of a suitable vegetable oil base. An ointment may also comprise from about 0.1% to about 2% of a thickening agent. A more complete disclosure of useful thickening agents can be found in Segarin, Cosmetics, Science and Technology, 2nd Edition, Vol. 1, pp. 72-73 (1972).

Alternatively, the composition may be formulated as an emulsion having from about 1% to about 10%, preferably from about 2% to about of an emulsifier.

Emulsifiers may be nonionic, anionic or cationic. Suitable emulsifiers are disclosed in, for example, U.S. Patent Nos. 3,755,560 and 4,421,769, and McCutcheon's Detergents and Emulsifiers, North American Edition, pages 317- 324 (1986). Preferred emulsifiers are anionic or nonionic, although the other types may also be used.

If the compositions of the present invention are formulated as a gel or a cosmetic stick, a suitable amount of a thickening agent is preferably added to a cream or lotion formulation.

The present invention also provides a method for the treatment of disorders of the skin, musculo-skeletal, immune or circulatory system of an animal in need of W.documentsDo Not DeleteNSpeificabon\Compete\TOPICAL COMPOSITIONdoc -14such treatment, the method including applying a composition of the present invention to the skin in an affected area in order to ameliorate the symptoms of said disorder.

The amount of the composition, and thus of the cosmetic agents to be administered, will be an effective amount for the desired result expected therefrom. This may be readily ascertained by the person skilled in the art utilising his ordinary skill and without undue experimentation.

Examples of Preferred Embodiments of the Invention The following discussion describes ranges, preferred concentrations and optimum concentrations for preferred compositions according to one embodiment of the present invention. However, it is to be understood that the present invention is not limited to the particular embodiment that is described, and other embodiments based on the disclosure presented herein will be readily apparent to one of ordinary skill in the art.

Example 1 Preparation of a cream Table 1 lists the ingredients of a composition constructed in accordance with the present invention. The amount of each of the ingredients present in each composition is listed as weight percent of the composition. Each of the compositions is prepared as described herein below.

To prepare the composition of Table 1, the tinctures containing each of the ingredients listed in Table 1 are combined and mixed together, and then the mixture is combined with the base material (Vegesorb T M and the phases are mixed together until the resulting composition is uniform. Each of the tinctures listed in Table 1 and the Vegesorb T M were purchased from Pharmaceutical Plant Company Pty Ltd, Unit 2, 24 London Drive, Bayswater 3153, Victoria, Australia.

W:document\Do Not Dele etSpeoficetionskComplete\TOPICAL COMPOSITION.doc Table 1 Tincture or Extract Plant extract Dilution Arnica (Arnica Montana) Calendula (Calendula officinalis) Ech in acea (Echinacea angustifolia) Hidrastis (Hydrastis Canadensis) Rue (Ruta graveolens) Thuya (Thuya occidentalis) Nettle (Urtica diolca) Equal volumes of each of the seven tinctures in liquid form are added to Vegesorb

TM

in a proportion of about 30% (by weight).

Example 2 Preparation of a cream A cream was prepared as in Example 1 using the tinctures shown in Table 2.

W.Adocumerift\o Not Delee\SpecificatonsCompleteTOPICAL COMPOSITlONdoc 16- Table 2 Tincture or Extract Plant extract Dilution Arnica (Arnica Montana) Burdock (Arctium lappa) Calendula (Calendula officinalis) Cleaver (Galium aparine) Echinacea (Echinacea angustifolia) Hidrastis (Hydrastis Canadensis) Rue (Ruta graveolens) Red Clover (Trifolium pretense) St John's Wort (Hypericum perfolia turn) Thuya (Thuya occidentalis) Nettle (Urtica dioica) Witch Hazel (Ham amelis virginica) W:NdocumentM'fo Not Delete\SpedflcabonsComplete\TOPICAL COMPOSITIONdoc -17- Equal volumes of each of the twelve tinctures in liquid form are added to Vegesorb TM in a proportion of about 30% (by weight).

Example 3 Treatment of Ailments The composition prepared according to Example 1 or Example 2 is topically applied to a subject's skin for relief from a variety of symptoms caused by medical conditions or physical injuries. Symptoms include pain, soreness, swelling and inflammation.

An amount of the composition is applied liberally to an area of discomfort on the subject by rubbing cream into the skin. The composition should cover as much of the affected area as possible. Application of the composition to the skin is repeated as needed.

Case study 3.1 Treatment of dermatitis The cream prepared according to Example 1 was trialled on a human subject having painful dermatitis and relief from the symptoms occurred within 24 hours of application of the cream to the affected area.

Case study 3.2 Treatment of burns The cream prepared according to Example 1 was trialled on a human subject having a burn. The cream was applied three times a day and after a period of about three days the burn had healed.

Case study 3.3 Treatment of muscular soreness The cream prepared according to Example 1 was trialled on a human subject having muscular soreness and relief from the symptoms was found within minutes of application of the cream to the skin in the affected area.

Case study 3.4 Treatment of haemorrhoids WMdocuments\Do Not Delete\SpectfcationsComplteTOPICAL COMPOStTION.doc -18- The cream prepared according to Example 2 was trialled on a human subject having periodic haemorrhoid eruptions of up to three to four times a year. When treatment began, the haemorrhoids look like grapes and were painful. The subject could not sit on the chair and found walking difficult.

The subject was treated with the cream prepared according to Example 2 and it gave him instant relief. After 36 hours the haemorrhoids had totally regressed.

All other discomfort sensations were gone and the subject returned to his daily routine.

The subject did have treatment with "Anusol" before as prescribed by his doctor, but the treatment was not as effective as with the cream of the present invention.

Case study 3.5 Treatment of acne vulgaris The cream prepared according to Example 2 was trialled on a human subject having acne vulgaris. The subject had eruptions on the face, neck, shoulders, and upper back.

The subject had tried PROACTIV in the past but it did not produce any significant results and it was difficult to use. The subject started treatment with the cream prepared according to Example 2. Applications were made three times a day. There was a visible improvement after 48 hours. After 14 days sebaceous cysts (white points) and pustules were no longer present.

The application continued for another two weeks and the improvement after that time comedones with black centres did not form, the damage to the skin had healed, and the skin on the face, neck and upper shoulder had regained its natural look.

WMdocumen\Do Not DeleteSpeificafonskComplete\TOPICAL COMPOSITIONdOC 1 -19- Case study 3.6 Treatment of acne rosacea The cream prepared according to Example 2 was trialled on a human subject having acne rosacea. The subject showed acne rosacea on the nose, cheeks and forehead.

The subject showed signs of an allergic reaction to commercially available creams recommended by a physician. The allergy was manifested with increased itchiness on the affected area and increased contrast in coloration.

On the physician's recommendation, the subject had treatment with topical corticosteroids.

The subject started treatment with the cream prepared according to Example 2.

Applications were made AM and PM every day for two weeks. There was a visible improvement after 48 hours. After 14 days the coloration was reduced by 95%, the itchiness was occasional, and the burning feeling had subsided.

Case study 3.7 Treatment eczema The cream prepared according to Example 2 was trialled on a human subject having eczema. The subject was previously diagnosed with eczema and the eruption of eczema covered the subject's hands. It was a long lasting disorder lasting for a period of 11 years. During this period of time the subject had undergone numerous treatments, including ELOCON® (furoate cream, USP).

The ELOCON® cream 0.1% contains mometasone furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with antiinflammatory activity. The treatment did not bring the subject any relief. In the last five years the subject's condition has been aggravated and cracks on his palms appeared where the skin folds or on near the joints of the fingers. The cracks were bleeding; the subject wore cotton gloves and could not handle hand tools.

The subject started treatment with the cream prepared according to Example 2.

He continued application of the cream several times a day. After 14 days, the W:Wocuments'fo Not DeieteNSpeaficabonsCompete\TOPICAL COMPOSITION.doc subject's palms had healed. No cracks were present, and the skin had regained elasticity. No scars were visible.

It will be appreciated by a person skilled in the art that numerous variations and/or modifications may be made to the present invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are therefore, to be considered in all respects to be illustrative and not restrictive.

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Claims (21)

1. A topical composition including an effective amount of: at least one plant extract having anti-inflammatory activity; at least one plant extract having anti-bacterial activity; at least one plant extract having anti-fungal activity; at least one plant extract having diuretic activity; at least one plant extract having antibiotic activity; at least one plant extract having antiseptic activity; at least one plant extract having expectorant activity; at least one plant extract having immunostimulant activity; at least one plant extract having diaphoretic activity; at least one plant extract having astringent activity; at least one plant extract having blood purifying activity; and a pharmaceutically acceptable carrier.

2. A topical composition including: an effective amount of a therapeutically active extract from each of the following plant species: Arnica montana; Calendula officinalis; Echinacea angustifolia; Hydrastis canadensis; Ruta graveolens; Thuya occidentalis and Urtica dioica; and a pharmaceutically acceptable carrier.

3. A topical composition according to any one of the preceding claims, further including an effective amount of a therapeutically active extract from any one of the following plant species: Arnica montana; Arctium lappa; Calendula officinalis; Galium aparine; Echinacea angustifolia; Hydrastis canadensis; Trifolium pretense; Ruta graveolens; Hypericum perfoliatum; Thuya occidentalis; Urtica dioica, and Hamamelis virginica.

4. A topical composition according to any one of the preceding claims, wherein the composition contains an effective amount of a therapeutically active extract from each of the following plant species: Arnica montana; Arctium lappa; Calendula officinalis; Galium aparine; Echinacea angustifolia; Hydrastis W:documents\Da Not Delete\Specifcaons\Complete\TOPICAL COMPOSITION.doc -22- canadensis; Trifolium pretense; Ruta graveolens; Hypericum perfoliatum; Thuya occidentalis; Urtica dioica and Hamamelis virginica.

A topical composition according to any one of the preceding claims, wherein the pharmaceutically acceptable carrier is a vegetable based sorbolene cream.

6. A topical composition according to any one of claims 2 to 5, wherein the therapeutically active extract is diluted between about 1:1 and about 1:5 in a suitable solvent.

7. A topical composition according to claim 6, wherein the solvent is an alcohol solvent.

8. A topical composition according to either claim 6 or claim 7, wherein the composition is a lotion containing from about 20% to about 40% of the combined therapeutically active extracts.

9. A topical composition according to either claim 6 or claim 7, wherein the composition is a cream containing about 20% to about 40% of the combined herbal extracts.

A topical composition according to claim 9, wherein the composition contains from about 25% to about 35% of the combined herbal extracts.

11. A topical composition according to either claim 6 or claim 7, wherein the composition is an ointment.

12. A method for the treatment of disorders of the skin, musculo-skeletal, immune or circulatory system of an animal in need of such treatment, the method including applying a composition of any one of claims 1 to 11 to the skin in an affected area in order to ameliorate the symptoms of said disorder.

13. A method according to claim 12, wherein the animal is a human. Wdocuments\Do Not DeletelSpeaflcations\Complete\TOPICAL COMPOSITIONdoc -23-

14. A method according to either claim 12 or claim 13, wherein the disorder is one or more of bruising; broken skin; bleeding; sprains; sports injuries; skin infections; burns; animal and insect bites, including bee, wasp and ant stings and spider bites; burns and scalds, including sunburn; acne; ringworm; eczema; nappy rash; osteo, degenerative and rheumatoid arthritis; fibromyalgia; neuropathy; sciatica; lower back pain; knee, hip, shoulder and hand pain; musculoskeletal injuries; post surgery pain; shingles; menstrual cramps; sinus and migraine headaches.

A method according to claim 12, wherein the disorder is dermatitis.

16. A method according to claim 12, wherein the disorder is haemorrhoids.

17. A method according to claim 12, wherein the disorder is acne vulgaris.

18. A method according to claim 12, wherein the disorder is acne rosacea.

19. A method according to claim 12, wherein the disorder is eczema.

A topical composition according to claim 1 and substantially as hereinbefore described with respect to the accompanying examples.

21. A method according to claim 12 and substantially as hereinbefore described with respect to the accompanying examples. DATED: 12 January 2006 PHILLIPS ORMONDE FITZPATRICK Attorneys for: Skinfix Pty Ltd Av a W:documentsXDo Not DelateSpedficatons\CompeteTOPICAL COMPOSITIONdoc