GB2485483A - Botanic skin care compositions for the relief of psoriasis and eczema - Google Patents

Abstract

Botanic skin care compositions are disclosed: Eczema balm is produced by macerating 120g each of mangosteen fruit, comfrey root and Gotu leaves, 30g each of calendula flowers, liquorice root and chamomile into 2250g sunflower oil; 600 grams cocoa butter, 300 grams beeswax and 600 grams Shea butter are melted into 1125g of the macerated oil. 150g flax seed oil, 150g aloe vera oil, 75g borage and 30g vitamin E are added. After cooling for one hour 150 drops geranium oil added. Psoriasis balm is prepared by macerating 225g Oregon Grape root, 112.5g milk thistle seed powder, 56.25g Gotu leaves, 22.5g calendula flower, 112.5g liquorice root and 22.5g chamomile into 2756.25g sunflower oil. Subsequently, 700g cocoa butter, 400g beeswax and 800g Shea butter are melted into 1300g of the oil, then 400g flax seed oil, 480g Aloe Vera oil, 40g Borage oil and 200g cod liver oil are added.

Description

t V.' INTELLECTUAL ..* PROPERTY OFFICE Application No. GB 1119596.3 RTM Date:22 December 2011 The following terms are registered trademarks and should be read as such wherever they occur in this document: Aiphosyl Eumovate Betnovate Dovobet Halciderm Protopic Phenergan Benadryl Sebexol Epaderm Eucerin Diprobase Balneum Oilatum Milton Intellectual Properly Office is an operating name of the Patent Office www.ipo.gov.uk Improved Compositions

Field of the Invenfion

The present invenflon relates to a topical formulation for the treatment of various skin condiflons including but in no way limited to psoriasis or other skin disorders such as dry skin, eczema, itchy skin, red skin, itchy eczema, inflamed skin, and/or cracked skin. The invention includes topical formulations which include Garcinia mangostana (mangosteen) extracts and other natural extracts, processes for their preparation and methods of administering a therapeutically effective amount of the various formulations or compositions for the treatment of psoriasis, eczema and other skin disorders and conditions.

cMLcsllltIcLth?JnIQnliQn Psoriasis is a chronic skin disease which affects about 2-3% of the population in the UK and Ireland. Psoriasis is a condition in which cell proliferation of the skin and underlying capillaries is accelerated. Normally skin cells take about 21-28 days to replace themselves; in psoriasis this process is greatly accelerated, and skin cells can be replaced every 2-6 days.

This results in red patches of skin, covered with an accumulation of skin cells on the surface, in the form oF a psoriatic plaque. The psoria tic plaque is an accumulation oF skin cefls waiting to be shed, and:the redness is due to the increase in blood vessels required to support the increase in cell production.

There are different forms of psoriasis the most common of which is plaque psoriasis (psoriasis vulgaris), accounting for 80% of all cases, in which the plaques tend to appear most often on the elbows, knees, lower back and scalp, although any part of the body can be affected.

Areas of skin affected by psoriasis also frequently lose water significantly faster than normal healthy skin.

People affected by psoriasis suffer from discomfort, restricted joint movement and emotional distress.

Psoriasis can occur at any point in the lifespan, affecting children, teenagers, adults and older people. It affects males and females equafly.

There are three categories of treatment for psoria&s, nam&y topical therapies, phototherapy and systernc medication consisting of either tablets or injections.

Whatever treatment is used, it is vitafly important that a moistu riser is used to make the skin more comfortable.

The term eczema is apphed to a broad range of persistent skin conditions. These include dryness and recurring skin rashes that are charactedzed by one or more of these symptoms: redness, skin oedema (swefling), itching and dryness, crusting, flaking, bUstering, cracking, oozing, or bleeding. Areas of temporary skin discoloration may appear and are sometimes due to healed injuries. Scratching open a healing lesion niay result in scarring and may enlarge the rash.

Topical treatments for psoriasis or eczema are applied directly to the skin. They are avaUabie as creams, ofions, ointments, mousse and gels. Most people with psohass wifl use topical treatments to control the condition. In addition to any of the treatments used, emollients are recommended to keep the skin well moisturised.

The different categories of topical treatments are: Emollients Vitamin D analogues Coal tar preparations Topical steroids Dithranol Vitamin A analogues.

Emollients are used to moisturise dry or scaly skin. Emollients are short-lived and they need to be applied frequently. Sonic emolhents routinely prescribed by the NHS have been found to make the condition worse e.g. aqueous cream (a light, water-based emollient). Heavy greasy emollients containing white soft paraffin, which sit on the surface of the skin and act as a barrier.

Some emollients contain salicylic acid. Salicylic acid cannot be used on initated, broken or skin, which is common in psoriasis and other skin disorders. Side effects of using topical salicylic acid include stinging, irritation, excessive drying or burning of healthy skin and salicylic acid poisoning. Salicylic acid toxicity may occur particularly if applied on large areas of skin or on neonatal skin. Precautions include 1) avoidance of alcohol containing preparations. 2) Avoidance of any other medicated topical agents e.g. benzoyl peroxide, topical retinoids, calcipotriol. 3) Avoidance of abrasive soaps and cleansers. 4) Avoidance of cosmetics or soaps that dry the skin or are designed to peel/exfoliate. Salicylic acid preparadons can be absorbed through the mother's skin and so is of concern to pregnant or breast-feeding women.

Some emollients contain urea. Side effects may include stinging, itching, and skin rash.

Excipients in topical emollient preparations rarely known to cause sensitisation are: Benzyl alcohol Butylated hydroxyanisole Butylated hydroxytoluene Cetostearyl alcohol (including cetyl and stearyl alcohol) Chlorocresol Ethylene diamine tetra acetic acid (EDTA) Ethylenediamine Fragrances Hydroxybenzoates (parabens) imidurea Isopropyl palmitate N-(3-Chloroallyl)hexaminium chloride (Quaternium-1 5) Polysorbates Propylene glycol Sodium metabisulphite Sorbic acid Wool fat and related substances including lanolin Vitamin D derivatives or analogues, act by promoting normal skin cell growth and development and preventing the excessive growth rate of cells. Vitamin D and its analogues are used as first-line treatment for plaque psoriasis. Calcipotriol (Dovonex®), Tacaldtol (Curatoderm®) and Calcitriol (Silkis®) are analogues of vitamin D. Known adverse reactions consist of skin irritation, especiafly in folds of the skin, and vitamin D is not recommend for use on skin folds or on the face, where the skin is more sensitive. Furthermore, overuse can interfere with the body's absorption of calc!um.

A rare side effect is hypocalcaemia, which is an increase in the lev&s of calcium in the body.

Coal Tar: Coal tar has anti-inflammatory and anfiscaUng properties that are useful in chronic plaque psoriasis. Coal Tar is not suitable for use in sore, acute, or pustular psoriasis or in the presence of infection. Eyes, mucosa. genital or rectal areas, and broken or inflamed skin should also be avoided.

Coal tar can stain skin, clothing and linens and can have a strong odour. It can cause irritation and acne-like eruptions, contact aUergy and inflammation of hair follicles. Coal tar is a photosensitiser. After applying coal tar to the skin, it is important to be more careful than normal when exposing the same skin to sunlight or other UVB light sources. This photosensitivity can make tanning easier and burning more likely and skin damage can worsen psoriasis.

Dithranol is used to treat well-defined plaques of psoriasis and should he washed off after 1530 minutes. A local burning sensation and irritation can occur. Dehcate areas like the face, neck, underarm and groin should not be treated as they are more likely to become irritated. Dithranol stains skin, hair, and fabrics, is not suitable for blond hair as it stains this brown or purple.

Contra-indications include hypersensitivity; acute and pustular psoriasis.

Topical steroids, for example Alphosyl HC cream / Eumovate I Betnovate / Dovobet / Halciderm.

Steroids in the body regulate the amount of inflammation in an immune response.

Additional topically-applied steroids signal the immune system to reduce or shut down the inflammatory response. Psoriasis and eczema symptoms are reduced temporary. However, topicafly-applied steroids are also absorbed into the blood-stream where they can affect internal organs and can result in diseases related to disrupflon of the body's normal steroid balance.

ExternaUy, steroids can cause burning, itching, inflammation to the skin, atrophy (thinning) or striae (stretch marks).

Vitamin A derivatives Retinoids are a class of Vitamin-A derivatives for example Tazarotene (Zorac®), some of which show antipsoriatic activity. Retinoids can cause irritation, pruritus.

burning, erytherna, thinning of the skin, non-specific rash, contact dermatitis, and worsening of psoriasis; and rarely stinging and inflamed, dry or painful skin. Topical retinoids also cause sensitivity to the sunlight or other light sources. EmoHients or cosmetics must be avoided within 1 hour of application. Retinoids are to be avoided during pregnancy and breastfeeding.

The term eczema is broadly applied to a range of persistent skin conditions. These include dryness and recurring skin rashes that are characterized by one or more of these symptoms: redness, skin oedema (swelling), itching and dryness, crusting, flaking, blistering, cracking, oozing, or bleeding. Areas of temporary skin discoloration may appear and are sometimes due to healed injuries. Scratching open a healing lesion may result in scarring and may enlarge the rash. In practice the ten-n eczema refers to a set of clinical characteilstics. Classification of the underlying diseases has been haphazard and unsystematic, with many synonyms used to describe the same condition. A type of eczema may be described by location (e.g., hand eczema), by specific appearance (eczema craquele or discoid), or by possible cause (varicose eczema). Further adding to the confusion, many sources use the term eczema for the most common type of eczema (atopic eczema) interchangeably.

There are several treatments available, namely:-Corticosteroids They do not cure eczema, but are highly effective in controlling or suppressing symptoms in most cases. For mild-moderate eczema a weak steroid may be used (e.g. hydrocortisone or desonide), while more severe cases require a higher-potency steroid (e.g. clobetasol propionate, fluocinonideL Medium-potency corticosteroids such as clobetasone butyrate (Eumovate), Betamethasone Valerate (Betnovate) or triamcinolone are also available.

Prolonged use of topical corlicosteroids is thought to increase the risk of possible side efIcts, the most common of which is the skin becoming thin and fragile (atrophy). Because of this, if used on the face or other delicate skin, only a low-strength steroid should be used. Mditionally, high-strength steroids used over lame areas, or under occlusion, may be significantly absorbed into the body, causing hypothalamic-pituitary-adrenal axis suppression (HPA axis suppression). Finally by their immunosuppressive action they can, if used without antibiotics or antifungal drugs, lead to some skin infections (lüngal or bacterial). Care must be taken to avoid the eyes, as topical corticosteroids applied to the eye can cause glaucoma or cataracts. Furthermore, the eczema often returns to its previous level of severity once the medication is stopped.

Skin baffler emulsions Skin baffler emulsions made up of ceramides, free fatty acids and cholesterol can help to repair the damaged skin baffler of atopic skin. However, their long term effectiveness has yet to be established.

Immunomodulators Topical immunomodulators like pimecrolimus (Elidel and Douglan) and tacrolimus (Protopic) are claimed to suppress the immune system in the affected area, and appear to yield good results in some populations. There is a reported possible risk of lymph node or skin cancer from use of these products. In addition to cancer risk, there are other potential side effects with this class of drugs. Adverse reactions including severe flushing, headaches, flu-like syndrome, photosensitive reactivity and possible drug interactions with a variety of medications, alcohol and grapefruit, Antibiotics When the normal protective baffler of the skin is disrupted (dry and cracked), it allows easy entry for bacteria. Scratching by the patient both introduces infection and spreads it from one area to another. Any skin infection further irritates the skin and a rapid deLerioration in the condition may ensue, when the appropriate antibiotic should be given.

Im munosuppressants When eczema is severe and does not respond to other forms of treatment, immunosuppressant drugs are sometimes prescribed. These dampen the immune system and can result in dramatic improvements to the patient's eczema. However, immunosuppressants can cause side effects on the body. As such, patients must undergo regular blood tests and he dosely monitored by a doctor ftch rehef Anti-itch drugs, often anfihistamines, may reduce the itch during a flare up of eczema, and the reduced scratching in turn reduces damage and irritation to the skin (the itch cycle). However, in eczema, the itch relief is often due to the sedative side effects of these drugs, rather than their specific antihistamine effect. Hence, sedating antihistamines such as promethazine (Phenergan) or diphenhydramine (Benadryl) are more effective at relieving itch than the newer, non-sedating antihistamines.

Capsaicin applied to the skin acts as a counter irritant.

Hydrocortisone applied to the skin aids in temporary itch relief but the side effects referred to above must be considered Moistu risers Eczema can be exacerbated by dryness of the skin. Moisturizing is one of the most important self-care treatments for sufferers of eczema. Keeping the affected area moistened can promote skin healing and relief of symptoms. Moistening agents are called emollients'. In general, it is best to match thicker ointments to the driest, flakiest skin. Light emollients like aqueous cream may not have any effect on severely dry skin. Some common emollients for the relief of eczema include Oilatum, Balneum, Medi Oil, Diprobase, bath oils and aqueous cream. Sebexol, Epaderm ointment, Exederm and Eucerin lotion or cream may also be helpful with itching content, stay on the skin for longer and need fewer applications, hut they can be greasy and inconvenient. Steroids may also be mixed in with ointments.

However, as with psoriasis, some emollients used by the NHS can make the condition worse.

It wih be appreciated from the foregoing that there are shortcomings and drawbacks with the various known treatments for psoriasis and for eczema, and related skin conditions. It is an object of the present invenflon to provide improved topical skin care compositions that overcome or at least mitigate some or aU of the shortcomings outlined above.

Summary of Invention

According to a first aspect of the present invention there is provided a topical skin care composition for the treatment of eczema and related dry skin conditions said composition compdsing: at least one antiinflammatory component in an amount sufficient to reduce inflammation; at least one component which stimulates regeneration of skin cells and underlying connective tissue in an amount sufficient to heal damaged skin; at least one component that reduces itch/irritation in an amount sufficient to reduce itch/irritation; at least one component that softens, smoothes skin in an amount sufficient to soften, smooth and/or moisturise skin; at least one component that moisturises skin in an amount sufficient to moisturise skin.

The use of this combination of ac:tive components has proved to be particularly effective in the treatment or prophylaxis of eczema and related skin conditions. It will be appreciated that in the compositions that follow and that are described herein, certain natural ingredients have activity in more than one category.

Preferably the composition comprises:- at least one antknflammatory component selected from the group comprising:-Chamomile extract; Borage oil; Liquorice extract; Comfrey extract; Shea butter; Flax seed oil; Sunflower seed oil; Witch hazel (Hamamelis virginiana) extract; Evening primrose oil (Oenothera hiennis); Tea tree oil (Melaleuca alternifolia); Neem oil (Melia azadiracta); Amaranth seed oil (Amaranthus caudatus); Plantain (Flantago major) extract; jewelweed (Impatiens capensis) extract; horsetail(Equisetuni arvense) extract; burdock (Arctium lappa) extract; marshmallow (Althea officinelis) extract; at east one component which stimulates regeneration of skin ceHs selected from the group comprising:-Comfrey extract; Gotu kola extract; Calendula extract; Flax seed oil; Shea butter; Aloe Vera extract; Cod liver oil; Geranium extract; Vitamin E: Rosehip oil (Rosa rubginosa); Lavender oil (Lavandula); Marshmaflow (Althaea officinalis) extract; Horsetail (Equisetu arvense) extract; Burdock (Arctium Jappa) extract; Plantain (Plantago major) extract; St Johns wort (Hypericum perioratum) extract; at least one component that reduces itch/irritation selected from the group comprising:-Mangosteen extract; chamomile extract: Liquorice extract; Shea butter; Bees wax; Chickweed (Steflaria media) extract; Jewelweed (lmpatiens capensis) extract; Cayenne pepper (Capsicum annuum); urea; at least one component that softens, smoothes and/or moisturises skin selected from the group comprising:-Shea butter; Coca butter; Flax seed oil; White willow bark (Salix alba) extract; Urea; Lactic acid; Vitamin E; Shea butter; Cocoa butter; Aloe Vera extract; Bees wax; Sunflower oil; Apricot kernel oil (Prunus armeniaca); Jojoba oil (Simmodsia chinensis); Lactic acid; This:tle oil (carthamus tinctoria); olive oil (Olea europaea); soya oil (Glydne max); Grapeseed oil (Vitis vinifera); white lily (Lilium candidum) extract; Hemp seed oil.

These active components have been shown to be particularly effective in the treatment or prophylaxis of eczema and related dry skin conditions.

Preferably the composition further comprises Vitamin E. Hemp seed oil and Flax seed oil may be used interchangeably in these compositions generally. Flax seed oil is preferred but it is possible to substitute one for the other, or use mixtures of the two.

In a preferred embodiment the anti-inflammatory component comprises Borage oil, Shea butter, Conifrey extract or Liquorice extract or mixtures thereof In a further preferred embodiment the component which stimulates the regeneration of skin cells comprises Comfrey extract, Gotu Kola extract, Aloe Vera extract, Flax seed oil, Shea butter or mxtures thereof.

In a further preferred embodiment wherein the component that reduces itch/irritation comprises mangosteen extract, Liquorice extract or Shea butter or mixtures thereof.

In a further preferred embodiment the component that softens, smoothes and/or moisturises skin comprises Shea butter, Flax seed oil or Aloe Vera extract or mixtures thereof.

In a particularly preferred embodiment the composition comprises: Butyrospermum (Shea Butter) 10 to 50% by weight; Theobroma cocoa (Cocoa Butter) 0 to 50% by weight; Cera alba (Bees wax) 0 to 30% by weight; Linum usitatissinium (Flax) seed oil 5 to 50% by weight; Borage officinalis (Borage) Seed oil I to 40% by weight; Centella asiatica (Gotu Kola) extract 5 to 50% by weight; Calendula officianalis (Calendula) extract 0 to 50% by weight; Aloe barbadensis (Aloe Vera) extract 5 to 50% by weight; Glycyrrhiza glabra (Liquorice) extract 5 to 50% by weight; Garcinia mangostana (niangosteen) extract 5 to 50% by weight; Symphytum officinale (Comfrey) extract 5 to 50% by weight; Tocopherol (Vitamin E) 0 to 5% by weight; Pelargoniuni graveolens (Geranium) essential oil up to 2% by weight; Matricaria chamomilla (Chamomile) extract 0 to 50% by weight; and more preferably comprises:-Butyrospermum (Shea Butter) 20% by weight; Theobromna cocoa (Cocoa Butter) 20% by weight; Cera alba (Bees wax) 10% by weight; Linum usitafissimum (Flax) seed oil 10 to I 5% by weight; Borage officinalis (Borage) Seed oil 12.5% by weight; Centella asiatica (Gotu Kola) extract 2.5-10% by weight; Calendula officianalis (Calendula) extract 2.5% by weight; Aloe barbadensis (Aloe Vera) extract 5-10% by weight; &ycyrrhiza glabra (Liquorice) extract 2.5-5% by weight; Garcin mangostana (mangosteen) extract 10% by weight; Symphytum offidna (Comfrey) extract 10% by weight; Tocopherol (Vitamin E) 1% by weight; Pelargonium graveolens (Geranium) essenflal oil up to I % by weight; Matricaria chamomifla (Chamomile) extract up to 2.5% by weight.

The present invenflon extends to cover use of a topical skin care composition according to any preceding daim for the treatment of eczema.

According to a further aspect of the present invention there is provided a topical skin care composition for the treatment of psoriasis and related dry skin conditions said composition comprising:-at least one antknflammatory component in an amount sufficient to reduce inflammation; at least one component which stimulates regeneration of skin ceUs and underlying connective tissue in an amount sufficient to heal damaged skin; at least one component that reduces itch/irritation in an amount sufficient to reduce itch/irritation; at least once component that softens, smoothes and/or moisturises skin in an amount sufficient to saften. smooth and/or moisturise skin; at least one component that slows abnormal cell turnover in an amount suffident to slow abnormal cell turnover.

Preferably the composition comprises:- at least one anti-inflammatory component selected from the group comprising:-Chamomile extract; Borage oil; Liquorice extract; Comfrey extract; Shea butter; Flax seed oil; Sunflower seed oil; Witch hazel (Harnamelis virginiana) extract; Evening primrose oil (Oenothera biennis); Tea tree oil (Melaleuca alternifolia); Neem oil (Melia azadiracta); Amaranth seed oil (Amnaranthus caudatus); Plantain (Plantago major) extract; jewelweed (lmnpatiens capensis) extract; horsetail (Equisetum arvense) extract; burdock (Arctium lappa) extract; marshmallow (Althea officinalis) extract; Oregon grape extract: at least one component which stimulates regeneration of skin cells selected from the group comprising:-Comfrey extract; Gotu kola extract; calendula extract; Flax seed oil; Shea buffer; Aloe Vera extract; Cod liver oil; Vitamin E; Rosehip oil (Rosa rubginosa); Lavender oil (Lavandula); Marshmallow (Althaea officinalis) extract; Horsetail (Equisetum arvense) extract; Burdock (Arctium lappa) extract; Plantain (Plantago major) extract: St Johns wod (Hypericum perloratum) extract; at least one component that reduces itch/initation selected from the group comprising:-Mangosteen extract; chamomile extract; Liquorice extract; Shea butter Bees wax; Chickweed (Stellaria media) extract; Jewelweed (Impatiens capensis) extract; Cayenne pepper (Capsicum annuum); urea; at least one component that softens, smoothes and/or moisturises skin selected from the group comprising:-Shea buffer; Coca butter; Flax seed oil; Milk thistle seed extract; White willow bark (Salix alba) extract; Urea; Lactic acid; Cod liver oil; Vitamin E; Aloe Vera extract; Bees wax; Sunflower oil; Apricot kernel oil (Prunus armeniaca); Jojoba oil (Simmodsia chinensis); Thistle oil (carthamus tinctoria); olive oil (Olea europaea); soya oil (Glycine max); Grapeseed oil (Vitls vintlera); white lily (Lilium candidum) extract; hemp seed oil.

at least one component that slows abnormal cell growth selected from the group comprising:-Oregon Grape extract; Milk Thistle extract; Cod Liver Oil (vitamins A and D); Psoralea (Coriifolia linn) extract; Goldenseal (Hydrastis canadensis) extract.

These active components have been shown to be particularly effective in the treatment or prophylaxis of psoriasis and related dry skin conditions.

Preferably the composition further comprises Vitamin E. Preferably the anti-inflammatory component comprises Borage oil, Shea butter, Liquorice extract, flax seed oil or mixtures thereof.

Preferably the component which stimulates the regeneration of skin ceMs comprises Gotu Kola extract, Aloe Vera extract, Flax seed oil, Shea butter, Cod Liver oU or mixtures thereof. b

Preferably the component that reduces itch/irritation comprises Liquorice extract or Shea butter or mixtures thereof.

Preferably the component that softens, smoothes and/or moisturises skin comprises Shea butter, Flax seed oil, Cod Liver oil, or Aloe Vera extract or mixtures thereof.

Preferably the component that slows abnormal cell growth comprises Oregon Grape extract, Milk Thistle extract. Cod Liver oil or mixtures thereof In a particularly preferred embodiment the composition comprises:-Butyrospermum (Shea Butter) 10 to 50% by weight; Theobroma cocoa (Cocoa Butter) 10 to 50% by weight; Cera alba (Bees wax) 0 to 30% by weight; Borage officinalis (Borage) Seed oil I to 40% by weight; Centella asiatica (Gotu Kola) extract I to 50% by weight; Calendula alficianalis (Calendula) extract 0 to 40% by weight; Aloe barbadensis (Aloe Vera) extract 5 to 50% by weight; Glycyrrhiza glabra (Liquorice) extract 25 to 50% by weight; Mahonia aquifolium (Oregon Grape) extract 5 to 50%by weight; Silybum marianum (Milk Thistle) extract 5 to 50% by weight; Cod liver oil I to 40% by weight; Matricaria chamomilla (Chamomile) extract 0 to 40% by weight; Linum usitatissimum (Flax) seed oil 5 to 50% by weight; and more preferably Butyrospermum (Shea Butter) 20% by weight; Theobroma cocoa (Cocoa Butter) 20% by weight; Cera alba (Bees wax) 10% by weight; Borage officinalis (Borage) Seed oil 1-2.5% by weight; Centella asiatica (Gotu Kola) extract 2.5-10% by weight; Calendula officianalis (Calendula) extract 2.5% by weight; Aloe barbadensis (Aloe Vera) extract 5-10% by weight; Glycyrrhiza glabra (Liquorice) extract 2.5-5% by weight; Mahonia aquifolium (Oregon Grape) extract 10% by weight; Silybum marianum (Milk Thistle) extract 10% by weight; Cod liver oil 1% by weight; Matricaria chamomilla (Chamomile) extract 2.5% by weight; Linum usitatissimum (Flax) seed oil 5-10% by weight The present invention extends to the use of a topical skin care composition as described herein for the treatment of psoriasis.

According to a further aspect of the present invention them is provided a topical skin care composition for the treatment of eczema and related dry skin conditions said composition comprising at least one component from the group comprising:-Garcinia Mangostana (Mangosteen) extract; Stellaria media (Chickweed) extract; and at least two of the following:-Centella asiatica (Gotu Kola) extract; Aloe barbadensis (Aloe Vera) extract; Glycyrrhiza glabra (Liquorice) extract; Symphytum officinale (Comfrey) extract.

The use as a skin care formulation of mangosteen extract in combination with these other herbal extracts makes for a particularly effective composition for treating a variety of skin conditions, including and especially eczema.

Preferably the composition further comprises one or more components from the group comprising:-Calendula officianalis (Calendula) extract; Matricaria chamomilla (Chamomile) extract; Tocopherol (Vitamin E); Pelargonium graveolens (Geranium) essential oil.

These preferred optional extracts, vitamins and essential oils increase the efficacy of the skin care composition by including compositions which heal damaged skin, reduce itching and moisturise skin.

A further preferred embodiment of the composition further comprises one or more components from the group comprising: Theobroma cocoa (Cocoa Butter); Cern Aiba (Bees wax); Flax seed oil; Borage officinalis (Borage) Seed oil; and optionally Butyrospermum (Shea Butter).

These components form a particularly effective balm base and, because of their moistuilsing and emollient properties, play an active part in the healing effects shown by these skin care compositions.

Preferably the components listed below are present in the following relative proportions by weight of the total weight of the composition:-Centella asiatica (Gotu Kola) extract 0 to 10%; Aloe barbadensis (Aloe Vera) extract 0 to 10%; Glycyrrhiza glabra (Liquorice) extract 0 to 5%; Garcinia mangostana (Mangosteen) extract 0.05 to 10%; Symphytum officinale (Comfrey) extract 0 to 10%.

The relative proportions of these active ingredients are important to the overall effectiveness of the skin care composition. It is preferred that some of each extract is present but this is not essential. Details of relative percentages and preferred essentiallpreferable and optional components are shown in Tables 2 and 3 below.

Preferably the components listed below are present in the following relative proportions by weight of the total weight of the composition:-Calendula officianalis (Calendula) extract 0 to 2.5%; Matricaria chamomilla (Chamomile) extract 0 to 2.5%; Tocopherol (Vitamin E) 0 to 2%; Pelargonium graveolens (Geranium) essential oil 0 to 1%.

A particularly preferred embodiment consists of a topical skin care composition comprising:-Butyrospermum (Shea Butter) 20% by weight; Theobroma cocoa (Cocoa Butter) 20% by weight; Cern Alba (Bees wax) 10% by weight; Flax seed oil 2.5-10% by weight; Borage officinalis (Borage) Seed oil 1-2.5% by weight; Centella asiatica (Gotu Kola) extract 2.5-10% by weight; Calendula officianalis (Calendula) extract 2.5% by weight; Aloe barbadensis (Aloe Vera) extract 5-10% by weight; Glycyrrhiza glabra (Liquorice) extract 2.5-5% by weight; Garcinia mangostana (mangosteen) extract 10% by weight; Symphytum officinale (Comfrey) extract 10% by weight; Tocopherol (Vitamin E) 1% by weight; Pelargonium graveolens (Geranium) essential oil up to 1% by weight; Matricarla chamomilla (Chamomile) extract 2.5% by weight.

In a further aspect of the present invention there is provided use of a topical skin care composition according to the above aspect of the present invention for the treatment of eczema and related dry sin conditions.

AccordIng to a further aspect of the present invention there is provided a topical skin composition for the treatment of psoriasis and related dry skin conditions said composition comprising at least one component from the group comprising:-Mahonia aquifolium (Oregon grape) extract; Silybum marianum (Mild Thistle) extract; and At least two of the following:-Centella asiatica (Gotu Kola) extract; Aloe bardadensis (Aloe Vera) extract; Glycyrrhiza glabra (Liquorice) extract; Cod liver oil.

The use as a skin care composition containing this particular combination of herbal extracts and, optionally, cod liver oil makes for a particularly effective composition for the treatment of a variety of skin conditions, including and especially psoriasis.

Preferably the skin care composition further comprises one or more components from the group comprising: Calendula officianahs (Calendula) extract; Matnicaria chamomifla (Chamome) extract; Lftium usitafissimum (flax) seed oH.

These preferred optional extract and essentia' oils increase the efficacy of the skin care composition by including components which reduce inflammation, and heal damaged skin.

In a further preferred embocflment the composition comprises one or more components from the group comprising:-Theobroma cocoa (Cocoa Butter); Cera Alba (Bees wax); Linum usitatissimum (flax) seed oH; Borage officinahs (Borage) Seed oH; and optionafly Butyrosperrnurn (Shea Butter).

These components form a particularly effective balm base and, because of their moisturising and emollient properties, play an active part in the healing effects shown by these skin care compositions.

Preferably the components isted below are present in the following relative proporfions by weight of the total weight of the composition:-CenteHa asiatica (C3otu Kola) extract 0 to 10%; Aloe barbadensis (Aloe Vera) extract 0 to 10%; &ycyrrhiza glabra (Liquorice) extract 0 to 5%; Mahonia aquifolium (Oregon grape) extract 0 to 10%; Silybum marianum (Milk Thistle) extract 0 to 10%; Cod liver oil 0 tol %.

The relative proportions of these active ingredients are important to the overall effectiveness of the skin care composition. It is preferred that some of each extract or oil is present, but this is not essential.

Preferably the components Usted below are present in the foHowing relative proportions by w&ght of the total weight of the composWon:-Calendula officnaUs (Calendula) extract from 0 to 2.5%; Mathcaria chamomifla (CharnornUe) extract from 0 to 2.5%; Lftiurn usitafissirnum (flax) seed oH from 0 to 10%.

A parficularly preferred embodiment consists of a topical skin care composition corn prisi ng Butyrosperrnurn (Shea Butter) 20% by weight; Theobroma cocoa (Cocoa Butter) 20% by weight; Cera Alba (Bees wax) 10% by weight; Borage officinalis (Borage) Seed oil 1-2.5% by weight; Centella asiatica (Gotu Kola) 2.5-10% by weight; Calendula officianalis (Calendula) 2.5% by weight; Aloe barbadensis (Aloe Vera) 5-10% by weight; Gycyrrhiza glabra (Liquorice) 2.5-5% by weight; Mahonia aquifoliurn (Oregon grape) 10% by weight; Silyhum marianuni (Milk Thistle) 10% by weight; Cod liver oil I % by weight; Matricaria chamornilla (Chamomile) 2.5% by weight; Linum usitatissirnurn (Flax) seed oil 10% by weight.

In a further aspect of the present invention there is provided use of a topical skin care composition according to the above aspect of the present invention for the treatment of psoriasis and related skin care composition.

The present invention also extends to methods for the preparation of skin care compositions and to methods for administering therapeutically effective amount of the compositions described for the treatment of psoriasis, eczema and other related skin disorders and conditions.

Pcr[ption of the Preferred EmbodJments Preferred embodiments will now be described, by way of example only. These embodiments represent the best ways known to the applicant of putting the invention into practice, hut they are not the only ways in which this can he done.

Embodiments of the present invention and their technical advantages may be better understood by referring to the following disclosure.

The term "Mangosteen extract" refers to an extract from the fruit of the Garcinia mangostana L. plant, including the rind. The whole of the fruit may be used in preparing this extract or, alternatively, just the rind or pericarp may be used.

The term "chickweed extract" refers to extracts from the plant Stellaria media.

Preferably the leaves of the Stellaria media plant are used in the preparation of this extract.

Extraction of active plant compounds A variety of processes can be used for the extraction of active ingredients. In relation to the extracts used in the present invention, extraction of active plant compounds is preferably by oil maceration, alcohol tincture, water decoction or cold-pressed extraction.

a) Oil maceration: Macerated extracts of botanicals are suspended in a plant oil (preferably Helianthum annuus-sunflower oil) whereby the dried botanical mixture comprises a certain weight of the total composition. Macerated extracts of botanicals in a plant oil (sunflower oil) are typically a minimum of 1 to 3 parts dry weight botanical to 5 parts by weight of sunflower oil. Maceration takes place either on a window sill for a minimum of I month or by gently simmering the mixture over a water bath for 3 hours to extract the active plant compounds.

b) Alcohol extraction. Extraction of plant compounds can also be achieved by alcohol extraction and/or water extraction using I to 3 parts dry weight botanical mixture to 5 parts water and/or alcohol.

c) Extraction of plant compounds can also be by cold-pressed extraction.

Without wishing to be held to any particular theory, the various components included in the various skin care compositions according to the invention may be categorised as set out in Table 1. The particular combination of components for various skin conditions described has been found to be particulariy effective.

Table 1: Possible therapeutic categories for skin care composition components and possib'e ahernatives Therapeutic Active component alternatives category Antkinflamrnatory/ Chamomile (contains Witch haz&(Harnamehs reduces swelhng! aluzene & gamma virgin iana) reduces redness inolenic acid) Evening prim rose oH * Borage (contains gamma (Oenothera biennis) linolenic acid) Tea tree oH (Melaleuca * Liquorice (contains altemnftoUa) glycyrrhizinic acid a Neem oil (M&ia sapoin & flavonoids) azadiracta) * Comfrey (also contains Amaranth seed rosmaric acid) ofl(Aniaranthus caudatus * Shea butter Plantain (Plantago major) * Flax seed oil (ALA) jewelweed (Impatiens * sunflower oH (68% linoleic capens) acid) horsetal (Eqwsetum arvense) Oregon grape burdock (Arctwrn lappa) calendula marshmaHow (Althea officinalis) Slowing abnormal Oregon Grape (Alkaloid Psoralea (Corlifolia linn) cell turnover in Berberine) psoriasis only Milk thistle (glycoside Goldenseal (Hydrastis silymarine) canadensis) * Cod liver oil (vitamin D) Healing damaged Conifrey (allantoin) Rosehip oil (Rosa skin (stimulates * Gotu kola (contains a ruhginosa) regeneration of triterpenoid saponin called skin cells and asiaticoside) Lavender oil (Lavanduia) underlying calendula (triterpenoid Marshmallow (Althaea connective tissue) esters, essential oils. officinalis) saponins, flavonoids and Horsetail (Equisetum alkaloids) arvense) * Flax seed oil (ALA) Burdock (Arctiurn lappa) * Shea butter Plantain (Plantago major) * cod liver oil (vit A) St Johns wort (Hypericum * Aloe Vera perloratum) * Geranium essential oil * vitamin E

Table I: Continued

Therapeutic Preferred Active component Alternatives category Redudng itching! Mangostene (antk Chickweed (SteHaria reducing histamine) media) rntaton/aritk a Chamomile (contains Jewelweed (lmpatlens aflergen aluzene. anti histamine) capensis) * Liquorice (contains glycyrrhizinic acid a Cayenne pepper sapoin & liavonoids) (Capsicum annuum) a Shea butter urea a bees wax Softening * Shea butter White wiflow bark (Safix smoothing and * Cocoa butter (to lesser alba) moisturising skin extent) Urea a Flax seed oil (ALA) Laclic acid a Milk Thistle Apricot kernel oil (Prunus a Cod liver oil (contains Vit armeniaca) A, D) Jojoba oil(Simmodsia a Vitamin E chinensis) a Shea butter Lactic acid Thistle oil (cartharnus a cocoa butter (contains fatty acids: Unoleic, paimic tiiictona) & oleic. Antioxidants,vit E) ohve oil (0/ca europaca) a Aloe Vera (contains soya ol (Glycine max) anthraquinones) Grapeseed oil (Vitis a beeswax (seals moisture vinfera) and p/ant extracts) a sunflower oil (moisture white lily (Lflium retention) candidum) a milk thistle Urea a Flax seed oil Hemp seed oil Many components listed in Table I and described herein benefit more than one therapeutic category and therefore are particularly useful in the compositions described.

With regards to the components for a skin care composition useful for treating eczema and related dry skin conditions, these are set out in Table 2 below. It will be understood that the percentage of each component may be varied, but Table 2 sets out maximum and minimum percentages by weight, as well as a preferred percentage.

IiiP&2: Eczema Components kigredent EssenUaU Preferred % Mnmum % Maxrnurn % Preferable! OpUonal Mangosteen E 10 5 50 extract Comfrey extract E 10 5 50 Gotu koa extract E 10 5 50 Caendula extract P 2.5 0 50 Aloe Vera extract P 5 5 50 Uquoilce extract E 2.5 5 50 Chamomile extract P 25 0 50 Shea butter E 20 10 50 Cocoa butter 0 20 0 50 Beeswax 0 10 0 30 FlaxseedoH E 5 5 50 Borage oU E 25 40 \fltarnhiE 0 1 0 5 Geranium oil 0 1 0 2 With regards o the components [or a skin care composition useful for reatirig psoriasis, these are set out in Table 3 hebw. It wiU be understood that the percentage of each component may be varied, but Table 3 sets out maximum and minimum percentages, as wefl as preferred percentages by weight. b

TEc Psoria&s components Ingredient Essential! Preferred % Minimum % Maximum % Preferable! ___________________ Optional ____________ ____________ _____________ Oregon grape extract E 10 5 50 Milkthstleextract E 10 5 50 Gotu kola extract E 2.5 1 50 Calendula extract P 2.5 0 40 Aloe Vera extract E 10 5 50 Liquorice extract E 5 2.5 50 ChamomUe extract P 2.5 0 40 Shea butter E 20 10 50 Cocoa butter 0 20 10 50 Beeswax 0 10 0 30 Flax seed oil E 7.5 5 50 Borage oil E 1 1 40 Cod liveroil E 1 1 40 In a preferred method of preparing topical skin care compositions according to the present invention, this consists of mixing together an extraction of the plant materials, an extract of Aloe Vera if Aloe Vera is included in the composition. and a special balm mixture. These ingredients are blended together using as little heat as possible.

Examples of some typical formulations include mixtures of the following: a maccrated oil extract of: Ground whole dried mangosteen fruit and!or dried chickweed; Comfrey root powder; Crushed Gotu Kola leaves; Crushed Calendula flower; Liquorice root powder; Crushed Chamomile flower; a mace rated extract of Abe Vera; a balm base consisfing off: a) Butyrospermum (Shea Butter); b) Theobroma cocoa (Cocoa Butter); c) Cera aba (Bees wax); d) Linum usitatissimum (flax) seed; e) Borage officinaUs (Borage) seed oil; f) Tocopherol (Vitamin E); g) Pelargoniuni graveolens (Geranium) essential oil.

The resulting balm is particularly effective for the treatment and prophylaxis of eczema and related skin condffions.

It will be appredated by those skilled in this particular art that certain substituflons may he made without altering the effectiveness of the composition. For example, Shea butter and Cocoa butter may be used in combination or substituted one for the other. Mangosteen and Chickweed both reduce itch and can be used alone or in combination. Likewise, Flax seed oil and Borage seed oil can be used alone or in any suitable combination. In particular, Hemp seed oil and Flax seed oil can be used interchangeably although Flax seed oil is preferred.

A further typical formulation includes a mixture of the following:- a maccrated oil extract of:-Mahonia aquifolium (Oregon Grape) root powder and/or Silyhum marianum (Milk Thistle) seed; Crushed Matricaria chamomilla (Chamomile) flower; Crushed Gotu Kola leaves; Crushed Calendula flower; Liquorice root powder; a maccrated extract of Aloe Vera leaves; a baftn base consisting off: a) Butyrospermum (Shea Butter); b) Theobronia cocoa (Cocoa Butter); c) Cera alba (Bees wax); d) Linurn usitaUssimum (flax) seed oU; e) Borage officinalis (Borage) Seed oil; f) Tocopherol (Vitamin E); g) Pelargonium graveolens (Geranium) essential oi; h) Cod liver oiL The resufting balm is particularly effective for the treatment and prophylaxis of psoriasis. Once again, it wifi be appreciated that certain suhstdutons can be made.

For example, cod hver oil is a rich source oF vitamins A and D. Purified versions &1 these vitamins, either natural or synthetic, could he used in place of cod liver oil if desired.

The foflowing examples are included to demonstrate certain non-flmiting aspects of the invention. t should he appreciated by those of skill in the art that the techniques disclosed in the exampes which follow represent techniques discovered by the inventor to function well in the practice of the invention. However, those of skill in the art should, in light of the present disclosure, appreciate that many changes can he made in the specific embodiments which are disclosed and stiU obtain a like or similar result without departing from the spirit and scope of the invention.

The herbal components of the compositions described herein are readily available but, for completeness. sources of the various components are listed in Table 4 below.

Tabe 4 Suppilers ngredent descdpton suppher Butyrospermum (Shea Butter) Raw Shea Butter Organic AKOMA skincare Fairtrade http://www.akomaskincare.co uk Theobroma cocoa Raw Cocoa Butter -Organic AKOMAskincare (Cocoa Butter) Fairtrade http://wwwakomaskincare.co.uk Cera aba (Bees wax) Unprocessed. Buzzworks uribieached Hitchin Borage officinalis (Borage) Organic Borage oil NHR Organic Oils Seed ol wwwnhrorganicoils.co.uk Centella asiabca (Gotu Kola) Calendula officianalis (Calendula) ______________________ _________________________ Certified Organic Freeze Aloe Laboratories Aloe barbadensis (Aloe Vera) Dried Aloe Vera Powder A Harmony Green company (whole leaf) USA Glycyrrhiza giabra (Liquorice) Dried Liquorice powder New Loon Moon Supermarket Dragon & Phoenix Pa Gernard Street, London,

WID SPN

Mahonia aquifolium (Oregon Oregon Grape Root powder. Florida Herb House Inc. Grape) Wildharvested 1648 Taylor Rd., 363 Port Orange, FL 32128,

USA

www.sharpweblabs.com Silyhuni marianum (Milk Milk Thistle Seed Powder Florida Herb House Inc. Thistle) Organic Grown 1648 Taylor Rd., 363 Port Orange, FL 32128 USA Cod liver oil Seven Seas pure cod liver Sainsbury oil Matricaria chamomilla Organic Camomile petals http://www.neuteeiandde (Chamomile) GERMANY Linum usitatissinium Organic cold-pressed flax (Flax)seed od seed oil Garcinia rnangostana Dried LO-HAN-KUO New Loon Moon (Mangosteen) Dragon & Phoenix Supermarket Symphytum officinale (Comfrey) Tocopherol (Vitamin E) Cold-pressed pure Vitamin E NHR Organic Oils Oil (Tocopherol GM free) www.nhrorganicoilscouk Pelargonium graveolens (Geranum) essential oil Helianthum annuus (sunflower Organic Sunflower Oil *Sainshury's Brand oil)

EXAMPLE I Eczema Bam

I. PreparaUon of macerated oH for Eczema 1.1 Preparafion of Equipment \AJ[ 3kg glass botfie with warm soapy water, then drain.

FW hotfie with cod water Add one Milton sterifising tablet (Sodium Dichloroisocyanurate 800mg) Ensure sterUising tablet is dissolved.

Immerse weighing boat and plasfic spoon Ensure no air bubbles are trapped inside the hotUes/utensils Leave to sterflise for 15 minute Drain sterihsing solution and use to disinfect aH work area Rinse thoroughly with cooled boiled water and dry in warm oven.

Warning: Milton sterilising tablet: Harmful if swallowed. When in contact with an acid, releases a toxic gas. Keep the pack closed. Irritating to eyes and respiratory system. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice and show the packaging.

1.2 Weigh out dried plant material On digital weighing scales weigh out the foHowing and place directly into a dry 3kg glass botfie:-grams of Ground whole dried mangosteen fruit grams of organic comfrey root powder.

120 grams of crushed organic Gotu kola leaves.

grams of crushed organic calendula flower.

grams of organic liquorice root powder.

grams of German chamomUe NOTE: Record Batch numbers and supplier of ALL ingredients in BATCH Register.

1.3 Add plant oil.

Weigh out 2250 grams of organic sunflower oil and pour directly into glass jar with dried plant material. Label bottle with date and contents and leave on a windowsill for one month. Every day agitate contents of bottle by shaking the bottle. After maceration is complete, strain oH/plant mixture though a sieve foUowed by an unhleached coffee filter.

Approximat&y 1200 grams maccrated oH is produced. b

NOTE: Extraction of active plant compounds is by oH maceraflon. Macerallon takes place either on a windowsifl for I month or by gentle simmering in a double boiler "Bain Marie' for 5 hours.

2. Preparation of Moe Vera rnacerated oil.

2.1 Preparation of Equipment \A/ash 3kg glass bottle with warm soapy water, then drain.

Fill bottle with cold water Add one Milton sterilising tablet (Sodium Dichloroisocyanu rate 800mg) Ensure sterilising tablet is dissolved.

Immerse weighing boat and plastic spoon Ensure no air bubbles are trapped inside the bottles/utensils Leave to sterilise for 15 minute Drain sterilising solution and use to disinfect all work area Rinse thoroughly with cooled boiled water and dry in warm oven.

Warning: Milton sterilising tablet: Harmful if swallowed. When in contact with an acid, releases a toxic gas. Keep the pack closed. Irritating to eyes and respiratory system. In case of contact with eyes, ilnse immediately with plenty of water and seek medical advice and show the packaging.

2.2 On digital weighing scales weigh out the following and place directly into dry 3kg glass bottle 4 grams Aloe Vera to 400 grams organic sunflower oil. Label bottle with date and content and leave on a windowsill for one month (no heat). Every day agitate contents of bottle by shaking the bottle. Filtering maccrated oil. After maceration is complete, strain oil/plant mixture though a sieve followed by an unhleached coffee filter.

3. Mixing the balm ingredients Set up a double Bain Marie' to a gentle simmer, one pan inside another pan containing water.

Add 600 grams cocoa butter until melted; Add 300 grams beeswax untU meRed; Add 600 grams Shea butter until only just meRed; and sUr. (heat as httie as possibe).

Add 1125 grams macerated oH (from above); and sflr.

AHow to cool for 10 minutes. Add:-

grams flax seed oil (heat as little as possible); and stir.

150g abe Vera oil; grams Borage; 30 grams vitamin E (ALL heat as little as possihe); and stir.

Stir continuously whUe balm is cooling for about one hour until balm is the consistency of porridge.

Add 150 drops geranium essential oil and stir NOTE: faHure to stir continuously may lead to crystallising of the Shea butter.

4. Botthng 4.1 Pour balm mixture into wide mouthed jars.

4.2 Place jars in freezer (-2 to -4 degrees centigrade) for 1 hour.

4.3 Remove jars from freezer. Surface condensation wifl appear. Leave at room temperature u ntU condensation evaporates (about 2 hours).

4.4 Secure lid and label.

NOTE: Remember to include batch number.

EXAMPLE 2 Psorktsis BMrn 1. PreparaUon of macerated oil for psorasis 1.1 Preparation of Equipment \Alash 3kg glass bottle with warm soapy water, then drain.

Fill bottle with cold water Add one Milton sterilising tablet (Sodium Dichloroisocyanurate 800mg Ensure sterilising tablet is dissolved.

Immerse weighing boat and plastic spoon Ensure no air bubbles are trapped inside the bottles/utensils Leave to sterilise for 15 minute Drain sterilising solution and use to disinfect aH work area Rinse thoroughly with cooled hoUed water and dry in warm oven.

Warning: Milton sterihsing tablet: Harmful if swaflowed. When in contact with an acid, releases a toxic gas. Keep the pack closed. frritafing to eyes and respiratory system. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice and show the packaging.

1.2 Weigh out dried plant material On digital weighing scales weigh out the foHowing and place direcfly into a dry 5 kg glass bottle: 225 grams of organic Oregon Grape root powder.

112.5 grams of organic milk thistle seed powder.

5625 grams of crushed organic Gotu kola leaves.

225 grams of crushed organic calendula flower.

112.5 grams of organic liquorice root powder.

22.5 grams of crushed German chamomile flower.

NOTE: Record Batch numbers and supplier of ALL ingredients in BATCH Register.

1.3 Add plant oil \Neigh out 2756.25 grams of organic sunflower oil and pour directly into glass jar with dried plant. Label bottle with date and content and leave on a windowsill for one month. Every day agitate contents of bottle by shaking the bottle. After maceration is complete, strain oil/plant mixture though a sieve followed by an unbeached coffee filter. Approximately 1350 Grams maccrated oil is produced.

NOTE: Extraction of active plant compounds is by oil maceration. Maceration takes place either on a windowsill for I month or by gentle simmering in a double boiler Bain Marie" for S hours.

2. Preparation of Aloe Vera macerated oil.

2.1 Preparation of Equipment Wash 3kg glass bottle with warm soapy water, then drain.

Fill bottle with cold water Add one Milton sterilising tablet (Sodium Dichloroisocyanurate 800mg) Ensure sterilising tablet is dissolved.

Immerse weighing boat and plastic spoon Ensure no air bubbles are trapped inside the botfies/utensils Leave to sterUise for 15 minute Drain sterWsng soluton and use to disinfect aU work area Rinse thoroughly with cooled boiled water and dry in warm oven.

VVarning: MUton sterihsing tablet: Harmful if swaflowed. When in contact with an acid, releases a toxic gas. Keep the pack closed. k'ritating to eyes and respiratory system. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice and show the packaging.

2.2 On digital weighing scales weigh out the following and place directly into dry 3kg glass bottle 4.8 grams Aloe Vera to 480 grams organic sunflower oil. Label bottle with date and content and leave on a windowsill for one month (no heat). Every day agitate contents of bottle by shaking the bottle. Filtering macerated oil. After maceration is complete, strain oil/plant mixture though a sieve followed by an unhleached coffee filter.

3. Mixing the baIrn ingredients Set up a double Bain Marie" to a gentle simmer, one pan inside another pan containing water: 700 grams cocoa butter until melted; 400 grams beeswax until melted; 800 grams Shea butter until only just melted, stir. (heat as little as possible); 1300 grams maccrated oil (from number 1); and stir.

Allow to cool for 10 minutes, then add: 400 grams flax seed oil (heat as little as possible); and stir.

480 grams Aloe Vera maccrated oil; grams Borage oil (ALL heat as little as possible); and stir.

Finally add 200 grams cod liver oil (NO heat); and stir.

Stir continuously while balm is cooling for about one hour until balm is the consistency of porridge.

NOTE: failure to stir continuously may lead to crystallising of Shea butter.

4. Bottling 4.1 Pour balm mixture into wide mouthed jars.

4.2 Place jars in freezer (2 to 4 degrees centigrade) for 1 hour.

4.3 Remove jars from freezer. Surface condensation wiH appear. Leave at room temperature untU condensation evaporates (about 2 hours).

4.4 Secure hd and labeL NOTE: Remember to include batch number. b

In summary, the treatment regimes for chronic skin conditions, such as psoriasis and eczema and other dry skin conditions, may consist of a combination of therapeufic agents. A variety of different treatments attempt to treat, or prevent r&apse of the skin disease. Current topical treatments have generay not provided safisfactory or long term treatment of psoriasis or eczema, or related skin disorders for individuals.

The inventors have sought a Natural method of treating psoriasis, eczema and other dry skin conditions for a variety of patients which overcomes the drawbacks of current topical therapies by applying the skin treatment compositions according to the present invention and as set out in the Claims. The use of these compositions results in:-deep moisturisation; reduction of inflammation fredness; reduction of itching; reduction of skin plaques in psoriasis; softening of skin; increased thickening of skin; formation of fingerprints and life-lines if previously absent.

The efficacy of compositions according to the present invention were tested in the series of clinical stuthes described below, in which these compositions were compared with the efficacy of compositions which contained components selected from only some, but not all, of the therapeutic categories required according to the present invention.

Clinical Study Corn posilions AP LE3EczemaTraiCompostionAcomprisingcornponentsfrornthe fJHitIc cateqpries 3.1 Maccrated oU Using the procedure set out in Example I Stage I for the preparation of a maccrated oil, steps 1.1, 1.2, and 1.3 were foHowed using the following acUve ingredients:-grams of Ground whole dried mangosteen fruit 120 grams of organic comfrey root powder.

grams of crushed organic Gotu kola leaves.

grams of crushed organic calendula flower.

grams of organic liquorice root powder.

grams of German chamomile 2250 grams of organic sunflower oil (Approximately 1200 grams maccrated oil/s produced.) 3.2 Formulation mixed as descdbed and then botfled as described.

1125 grams maccrated oil (from above); 1.5g Aloe Vera dried leaf powder in I 50g organic sunflower oil; 525 grams cocoa butter; 300 grams beeswax; 600 grams Shea butter; grams Flax seed oil; 75 grams Borage; grams vitamin E; 7.5 grams geranium essential oil.

Composition A was tested on volunteers and compared with the efficacy of Composition B described below in Example 4.

EXAMPLE4-EczemaTriCornonBcornrngcornpofrornonl 30 grams of Ground whole dried mangosteen fruit 700 grams cocoa butter until melted; grams beeswax until melted; Ground maccrated mangosteen fruit was maccrated in liquid (warm) cocoa butter.

The resulting balm was whisked to make it softer but it was still much harder than composition A and took longer to melt onto skin.

fufl5tvpes of therapeutic cateqpries specified 5.1 Maccrated oU Using the procedure set out in Example 1 Stage I for the preparation of a macerated oiL steps 1.1, 1.2, and 1.3 were foUowed using the foUowing active ingredients- 225 grams of organic Oregon Grape root powder.

112.5 grams of organic milk thisfie seed powder.

56.25 grams of crushed organic Gotu kola eaves.

22.5 grams of crushed organic calendula flower.

112.5 grams of organic liquorice root powder.

22.5 grams of crushed German chamomile flower.

2756.25 grams of organic sunflower oil çApproximate/y 1350 Grains maccrated oil is produced.) 5.1 Formula Using procedure set ou n ExampblStagç3the foowigkigredentswerernixed as described and then bottled as described.

1300 grams maccrated oil (from above); 4.8 grams Abe Vera in 480 granis organic sunflower oil.

700 grams cocoa butter; 400 grams beeswax; 800 grams Shea butter; 400 grams flax seed oil; grams Borage oil; 200 grams cod Uver oil; Composition C was tested on volunteers and compared with the efficacy of Composition D described below.

EXAMPLE6:PsoriasisT&CornposiUoflD compr[ng components from 45 grams of organic Oregon Grape root powder.

22.5 grams of organic milk thistle seed powder.

750 grams cocoa butter.

grams beeswax.

Organic grape root powder and organic milk thistle powder were maccrated in liquid (warm) cocoa butter. The resulting balm was whisked to make softer but was still much harder than composition C and took longer to melt onto skin.

A series of clinical stuthes were performed in order to determine the effectiveness of compositions according to the present invention. These were tested against compositions which contained components from ess than the fuU range of therapeutic categories. b

CUfflc& Stuthes Compositions A and B prepared as described in Example 3 and Example 4 above were tested in volunteers. The object of this investigation was to compare the effectiveness of the 2 types of formulation on itchy dry or scaly skin conditions such as eczema.

Compositions C and D prepared as described in Example 5 and Example 6 above were tested in volunteers. The object of this investigation was to compare the effectiveness of the 2 types of formulation on itchy dry or scaly skin conditions such as psoriasis.

Factors tested? The factors tested were as foflows: 1) ReductioninDrynessofaffectedskin a 2) Reduction in Scaliness of affected skin a 3) Reduction in Itchiness of affected skin a 4) Reduction in Redness of affected skin a 5) Reduction in Damage (cracked! broken of bleeding) of affected are.

Pre-tria requftements: a A before-trial photo was requested.

a Participants completed a pre-trial questionnaire and signed terms and conditions of participation.

A test sample of the appropriate composition or compositions were provided to patch test on a small area of skin for 24 hours to exclude aUergy to any of the ingredients. Any individual with an allergic reaction would have been discontinued immediately. Individuals applied the composition(s) 3 times a day for 4 weeks. At the end ofthe4weeks: a a post-trial photo was requested a a post-trial questionnaire was completed and analysed.

Pre-trial and post-trial photographs of target areas were independently assessed by two assessors, and also assessed by the investigator and patient.

Criteria for Participation in these Trizils Indusion Criteria: Patient with diagnosed plaque psoria&s with a diagnosis of stable, mild to moderate plaque psoriasis vulgaris with two to four plaques on extensor surfaces of limbs or with a diagnosis of stable mild to moderate eczema in 2- 4 areas AND less than 10% of the body surface area involved with psoriasis * Both left and right sides of body affected * Patient is between 18 years and older * Patient is capable of reading and understanding English quesfionnaires.

* Patient is capable of gMng informed consent.

Exclusion Criteria: * Patient is under 18 years old.

* Patient has presence of eythrodermic, pustular or guttate psoriasis.

* Patient has another non psoriatic arthropathy (such as osteoarthritis).

* Patient has another non psoriatic dermatosis.

* Patient has any other co-morbidity with a severity.

* Patient has had a significant flare-up of psoriasis or psoriatic arthritis within days of Day 0.

* Patient has received investigational drugs within four weeks prior to Day 0 * Patient has been treated with systemic anfi-psoriatic drugs such as steroids, retinoids, cyclosporine, PUVA therapy within the four weeks prior to Day 0.

* Methotrexate, sulphasalazine and lefiunomide are allowed during the study as long as patient has been on a stable dose within 90 days of Day 0.

* Patient has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0.

* Patient has used biologics (such as etanercept, adalimumab, infliximab, abatacept, ustekinumab) within 180 days of Day 0 * Patient is currently pregnant or lactating.

Resuhs Resuts of Eczema Tra 1) ReducBon n Dryness of affected skin Tra composffion A. Dryness. Rght säde. Pre4riffl __________ ________ Volunteer Skhi not dry Slightly dry Moderately dry Very dry Score Score =0 Score =1 Score =2 Score 3 Eczema I 1 2 Eczema 2 3 t) Trial compos it on & Dryness. Right side.

Volunteer Skin not dry Slightly dry Moderately dry Very dry Score Score =0 Score =1 Score =2 Score 3 Eczema 2 1 1 1 Volunteer Skin not dry Slightly dry Moderately dry Very dry Score Score =0 Score =1 Score =2 Score 3 Eczema 1 1 2 Eczema 2 3 Volunteer Skin not dry Slightly dry Moderately dry Very dry Score Score =0 Score =1 Score =2 Score 3 Eczema 1 1 2 Eczema 2 1 2 Category Reduction of Dryness No Reduction of Dryness Trial Composition A 2/2 0/2 Trial Composition B 1/2 1/2 Results of Reduction in Dryness of affected skin: AH partidpants experienced a reducUon of skki dryness with composffiori A, compared with only I out of the 2 participants with composifion B. It is Ukely that any oikhased appUcation afleviates dryness of skin to a limited degree. I of the 2 parUcipants using composition A experienced an improvement of skin dryness by as much as 2 scores.

2) Reduction in Scaliness of affected skin Trial composition A. Sea ne.Riht side. Pre4rial __________ ______ Volunteer Not scaly A little scaly Moderately scaly Very scaly Score Score =0 Score =1 Score =2 Score 3 Eczema I 2 Eczema 2 4 i Tria co wosition. Scaliness. Right Side. Post4rial Volunteer Not scaly A little scaly Moderately scaly Very scaly Score Score =0 Score =1 Score 2 Score 3 Eczema I 4 i Eczema 2 1 0

I

Volunteer Not scaly A little scale Moderately scaly Very scaly Score Score =0 Score =1 Score =2 Score 3 Eczema I 1 2 Eczema 2 f I Trial composition B. Scaliness. Left side. Post4rial Volunteer Not scaly A little scaly Moderately scaly Very scaly Score Score =0 Score =1 Score 2 Score 3 Eczema 1 i

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Category Reducflon of scaly skm No Reduction of scaly skin Tria! Composition A 2/2 0/2 Trial Composition B 1/2 1/2 Results of scaliness of affected skin: AU parficipants experienced a reduction of scahness of skin with composition A, compared with only I out of the 2 participants with composition B. It is likely that any oH-based application alleviates dryness of skin to a limited degree.

3) Reduction n tchness of affected skn Tra compoeffion A. Rchiness Rght eWe. Pre$da _____________ ______ V&unteer Never ftchy *SeWom kohy Often ftchy Always ftchy Score Score =0 Score =1 Score =2 Score =3 Eczema 1 4 3 Eczema 2 4 3 Tda composffion A. Rcfflness Rght eWe. Post4ra _____________ ______ Vohinteer Never ftchy Sekiom ftchy Often ftchy Aways ftchy Score Score =0 Score =1 Score =2 Score 3 Eczema I V I Eczema 2 4 2 Tra compoeffion B. Uchness Left eWe. Pre4ra Vohinteer Never ftchy Sekiom ftchy Often Rchy Aways ftchy Score Score =0 Score =1 Score =2 Score 3 Eczema I 4 3 Eczema 2 4 3

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Vohinteer Never Rchy Sekiom tchy Often Itchy Aways Itchy Score Score =0 Score =1 Score =2 Score =3 Eczema 1 4 2 Eczema 2 4 2

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Category Reduction of tchiness No Reduction of Itchiness Trial Composition A 2/2 0/2 Tri& Composftion B 2/2 0/2 Results of tchiness of affected skin: AM participants experienced a reduction in itchiness of skin with both composition A, and composition B. However, the reduction ai itchiness was greater with composition A. 4) Redness of affected skin Tra composfton A. Redness, Rght side. Pre4rai __________ ______ V&unteer Not Red A Utlie Red Moderat&y Red Very Red Score Score =0 Score =1 Score =2 Score 3 Eczema I 3 Eczema 2 2 Tda composffion A. Redness. Rght side. Post4ña _________ ______ Vohinteer Not Red A UtUe Red Moderat&y Red Very Red Score Score =0 Score =1 Score =2 Score 3 Eczema I 2 Eczema 2 -1 I Tra composition B. Redness. Left side. Pre$rkil Vohinteer Not Red A itfle Red Moderatily Red Very Red Score Score =0 Score =1 Score =2 Score 3 Eczema I 3 Eczema 2 2

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Vohinteer Not Red A Uttie Red Moderat&y Red Very Red Score Score =0 Score =1 Score =2 Score 3 Eczema I 2 Eczema 2 2

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Category Reduction in Redness No Reduction in Redness Tria Composition A 2/2 0/2 Tri& Composition B 1/2 1/2 Resufts of redness of affected skin: All participants experienced a reduction of redness of skin with composition A, compared with I out of 2 with composition B. 5) Reduction in Damage (cracked! broken of beeding) of affected area Tria composition A. Reduction in Damage of affected area. Right side. Pre trial ________ ______________ _______________ ___________ ______ Volunteer Never Seldom Often Always Score Score =0 Score =1 Score =2 Score 3 Eczema I 3 Eczema 2 3 Trial composition A. Reduction in Damage of affected area. Right side. Post trial ________ _____________ _______________ __________ ______ Volunteer Never Seldom Often Always Score Score =0 Score =1 Score =2 Score 3 Eczema 1 -Eczema 2 0 1 Volunteer Never Seldom Often Always Score Score =0 Score =1 Score =2 Score 3 Eczema I -j 3 Eczema 2 3

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Volunteer Never Seldom Often Always Score Score =0 Score =1 Score =2 Score 3 Eczema 1 -3 Eczema 2 3 Summary of results. Reduction in Damage (cracked! broken of bleeding) of affected area Category Reduction in Damage No Reduction in Damage Tri& Composition A 2/2 0/2 Trial Composition B 012 2/2 Results of Reduction in Damage (cracked! broken of bleeding) of affected area: afl parflcipants experienced a reduction in damage of skin with composition A, compared with none with composition B. 1 of the 2 parUcipants using composition A experienced a reduction in damaged skin by as much as 2 scores and the other a reduction in damaged skin by as much as 3 scores.

Concksion As can he seen from the above trial results, it is clear that the prod uct in accordance with the present invenflon, Composition A, is abe to effectively aHeviate and treat the symptoms associated with dry itchy skin such as eczema in a particularh effective manner, and is significanfly more effective in this regard than Composition B. Psoriasis Tria Resufts Reduction in Dryness of affected skin

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Vokinteer Skin not dry ghty dry Moderat&y dry Very dry Score Score =0 Score =1 Score =2 Score =3 Psohas is I 3 Psodasis 2 3 Psohasis3 1 2 Tria composition C. Dryness. Right side. Post4ria __________ ______ V&unteer Skin not dry SHghUy dry Moderat&y dry Very dry Score Score =0 Scorel Score =2 Score Psoriasis I I Psoria&s 2 2 Psoriasis 3 J 0 Vokinteer Skin not dry SUghUy dry Moderat&y dry Very dry Score Score =0 Score =1 Score =2 Score 3 Psonasis 1 1 2 Psonasis 2 -J 3 Psorlasis 3 1 2

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Vokinteer Skin not dry SHghUy dry ModeratSy dry Very dry Score Score =0 Score =1 Score =2 Score 3 Psoriasis I i Psorasis 2 2 Psoriasis 3 2 a Category Reducflon of Dryness No Reduction of Dryness TriS Composition C 3/3 0/3 Td& Compo&tion D 2/3 1/3 Resuts of Reduction in Dryness of affected skin: AU participants experienced a reduction of skin dryness with composition C, compared with on'y 2 out of the 3 participants with composiflon ft R is Ukey that any oUbased apphcation afleviates dryness of skin to a Umited degree. 2 of the 3 participants using composition C experienced an improvement of skin dryness by as much as 2 scores.

Reduction in Scahness of affected skin V&unteer Not scay A Utfie scay Moderat&y scay Very scay Score Score =0 Score =1 Score =2 Score 3 Psonasis I 3 Psorlasis 2 2 Psor;asis 3 I

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Vounteer Not scaHy A UtUe sc&y ModerateHy scaHy Very scay Score Score =0 Score =1 Score =2 Score 3 Psorasis I I Psoriasis 2 Psoriasis 3 i 0 Tria composition D. ScaUness. Left side, Pre4ria Vounteer Not scaHy A Utfie scay Moderat&y sc&y Very scay Score Score =0 Score =1 Score =2 Score 3 Psoriasis I 3 Psoriasis2 2 Psor!asis3 I TriaH composition D. Scafiness. Left side. Post4ria VoHunteer Not scaHy A Htte sc&y ModerateHy scaHy Very scay Score Score =0 Score =1 Score =2 Score 3 Psoriasis I 2 Psoriasis 2 2 Psoriasis 3 1

Summary of results. Reduction in scaliness of skin

Category Reduction of scaly skin No Reduction of scaly skin Trial Compo&tion C 3/3 0/3 TriS Composidon D 1/3 2/3 Results of scaliness of affected skin: AU participants experienced a reduction of scahness of skin with composiflon C, compared with only I out of the 3 participants with composition D. It is likely that any oikbased application afleviates dryness of skin to a limited degree. I of the 3 participants using composition C experienced an improvement of scaliness in as much as 2 scores.

Reduction in Itchiness of affected skin Trial composition C. Itchiness Right side. Pre$rial Volunteer Never Itchy Seldom Itchy Often Itchy Always Itchy Score Score =0 Score =1 Score =2 Score =3 Psodasis 1 4 3 Psohasis 2 4 2 Psodasis3 1 2 Trial composition C. Itchiness Right side. Post4rial Volunteer Never Itchy Seldom Itchy Often Itchy Always Itchy Score Score 0 Score =1 Score =2 Score 3 Psodasis I I I Psoriasis 2.1 0 Psoriasis 3 4 1 Trial composition D. Itchiness Left side. Pre4rial Volunteer Never Itchy Seldom Itchy Often Itchy Always Itchy Score Score =0 Score =1 Score =2 Score =3 Psonasis I 4 Psonasis2 4 2 Psorasis 3 4 2 Trial composition 0. Itchiness Left side. Posttrial Volunteer Never Itchy Seldom Itchy Often Itchy Always Itchy Score Score =0 Score =1 Score =2 Score =3 Psoriasis I 3 Psodasis 2 2 Psoriasis 3 2

Summary of resultt Reduction in Itchiness

Category Reduction of Itchiness No Reduction of Itchiness Trial Composition C 3/3 0/3 Trial Composition D 0/3 3/3 Results of itchiness of affected skin: AU participants experienced a reducdon in itchiness of skin with composition C, compared with none with composition D. Redness of affected skin Trial composition C. Redness. Right side. Pre4rial Volunteer Not Red A little Red Moderately Red Very Red Score Score =0 Score =1 Score =2 Score =3 Psonasis I 3 Psoriasis 2 2 Psoriasis 3 V 3 Trial composition C. Redness. Right side. Post4rial Volunteer Not Red A little Red Moderately Red Very Red Score Score =0 Score =1 Score =2 Score =3 Psonasis I 2 Psohasis 2 1 Psoriasis 3 1 Trial composition 0. Redness. Left side. Pre4rial

___________ ________ __________ _______________ ______________ _______

Volunteer Not Red A little Red Moderately Red Very Red Score Score =0 Score =1 Score =2 Score =3 Psoriasis I 3 Psonasis2 I Psonasis Trlzil composiflon 0. Redness. Left side. Post4ria V&unteer Not Red A Uttle Red Moderat&y Red Very Red Score Score =0 Score =1 Score =2 Score =3 Psoriass I 4 3 Psohass 2 2 Psohass 3 1 3

Summary of resufts. Reduction in Redness.

Category Reduction in Redness No Reduction in Redness Trial ComposiUon C 3/3 0/3 Trk Composiflon 0 0/3 3/3 Results of redness of affected skin: AU parficipants experienced a reducflon of redness of skin with composition C, compared with none with composition D. I of the 3 participants using composition C experienced a reducfion of redness by as much as 2 scores.

Reduction in Damage (cracked/ broken or bleeding) of affected area Trial composition C. Reduction in Damaged skin of affected area. Right side.

Pre-trial Volunteer Never Seldom Often Always Score Score =0 Score =1 Score =2 Score Psoriasis I 2 Psohasis 2 1 Psoriasis 3 4 3 Trial composition C. Reduction in Damaged skin of affected area. Right side, Post4rial Volunteer Never Seldom Often Always Score Score =0 Score =1 Score 2 Score 3 Psodasis 1 4 Psonasis 2 1 Psonasis 3 1 I Trial composition 0. Reduction in Damaged skin of affected area. Left side.

Pre4rial Volunteer Never Seldom Often Always Score Score 0 Score =1 Score =2 Score 3 Psoriasis I 2 Psonasis2 I Psonasis 3 3 Trial composition 0. Reduction in Damaged skin of affected area. Left side.

Post4rial Volunteer Never Seldom Often Always Score Score =0 Score =1 Score =2 Score 3 Psonasis I 2 Psonasis 2 Psonasis I Summary of Results. Reduction n Damaged skin (cracked! broken of bleeding) of affected area Category Reduction in Damage No Reduction in Damage Trial Composition C 2/3 1/3 Trial Composition 0 0/3 3/3 Results of Reduction in Damage (cracked! broken of bleeding) of affected area: 2 out of 3 participants experienced a reduction in damage of skin with composition C. compared with none vvith composition ft I of the 3 participants using composition C experienced a reduction of redness by as much as 2 scores.

Conclusion:

As can be seen from the above trial results, it is clear that the product in accordance with the present invention, Composition C, is able to effectively alleviate and treat the symptoms associated with dry itchy skin such as psoriasis, and is significantly more effective in this regard than Composition ft