AU2008202934B1 - Compositions for the treatment of a skin condition and methods for use therein - Google Patents

Description

Australian Patents Act 1990 Regulation 3.2 ORIGINAL COMPLETE SPECIFICATION STANDARD PATENT Invention Title "Compositions for the treatment of a skin condition and methods for use therein" The following statement is a full description of this invention, including the best method of performing it known to me/us:- Q:\OPER\TDOU0575099 Bozo filing doc 2/7/08 P.\0?ER\TOO\?CT.Co.,,c\3575O Piuisd-2/07WOB 00 -1- COMPOSITIONS FOR THE TREATMENT OF A SKIN CONDITION AND METHODS FOR USE THEREIN Cc FIELD OF THE INVENTION N~ C The present invention relates generally to compositions for use in treating skin conditions 00 Scharacterised by pathogen infection and/or inflammation and methods for use therein.

C More particularly, the present invention provides a tonic, cleansing lotion and moisturising cream for use in treating these skin conditions via their topical administration. Also provided are methods for the therapeutic and prophylactic treatment of these conditions, in particular psoriasis, eczema, acne and rashes.

BACKGROUND OF THE INVENTION Psoriasis is a chronic, inflammatory skin condition characterised by patches of thick, silvery scales that flake off. The condition is uncomfortable, itchy and often unsightly.

The severity of psoriasis varies from mild (a few scattered patches) through to severe (covering large areas of the body). The degree of discomfort will vary according to the degree of severity. Psoriasis can appear for the first time at any age however it most commonly appears between the ages of 10 and 40 years, and often during puberty. It affects both males and females equally and runs in families. Although the exact cause of psoriasis is unknown, it is known that it does not result from poor hygiene, as frequently believed, and it is not contagious.

The actual cause of psoriasis is not known. However, it has been observed that some individuals are born with a predisposition to psoriasis and, further, that there are some factors that may trigger the initial and subsequent outbreaks. These include skin injury, sore throat, chest infection, some drug treatments, sunburn and stress.

Psoriasis is currently believed to be the result of an overproduction of skin cells.

Specifically, people with psoriasis produce skin cells nine times faster than normal. This ?:IOPERTDO\PCTs.Cpctc\3575099 Pwin4 doc-2/O07/20 00 -2means they have a huge excess of skin to shed. Because the skin cells are producing so Srapidly they do not form properly hence silvery scales appear.

Cc Although psoriasis may be almost unnoticeable in its early stages it develops a very N 5 distinctive appearance as it progresses. Typically it starts with small red bumps on the skin N and then progresses to bigger scaly patches that become itchy and uncomfortable. As the 00 Scondition develops the scaly patches develop into deep red plaques with crusty silvery Sscales on the skin surface. If the scales are removed raw skin will be revealed which may bleed.

Research into the causes of psoriasis is ongoing. However, it is generally understood to result from an overproduction of skin cells, with research focussing on the cause of this overproduction.

To understand psoriasis, and where the psoriatic cell has become defective, it is first necessary to understand the mechanism of formation of the normal skin cell. The initial cell formation of the skin starts in the basal layer or at the base of the skin. Once formed the cell makes its way to the epidermis or skin surface where it sloughs off and is replaced by new skin cells forming below. In the normal cell this entire process from production, growth and gradual hardening to shedding takes approximately one month.

The psoriatic cell on the other hand progresses through this entire process in less than four days. So from developing in the skin's basal layer to being shed on the skin's epidermis it has insufficient time to form properly, or pass through the normal process of skin maturation and keratinization. Keratinization is the process by which the insoluble, fibrous structure of the skin is formed. This produces a build up of dead cells on the surface of the skin commonly known as the scales of psoriasis. The end result is the formation of thick scaly plaques which do not provide the skin with its usual protective layers. If the silvery scales are scraped away the dark red base of the lesion is exposed resulting in multiple bleeding points.

P.0PER\TDO\MTZ-C.pI.\iO375099 P-ii doc.2/07008 3- Although the underlying cause is unknown, it is known to be genetically inherited. Initial O lesions tend to form in areas of skin trauma sunburn or streptococcal infection).

These areas are believed to be "trigger" points in people with a genetic predisposition.

C N, Psoriasis is characterised by very distinctive signs and symptoms. The most distinctive of 00 these being the psoriatic lesion, which is sharply defined against the normal skin.

C Characteristically it is a discrete, bright red patch covered with thick, silvery scales. There may be one lesion or there may be many. The silvery scales correspond to the many immature cells which have formed and if scraped away the dark red base of the lesion is exposed.

Other symptoms of psoriasis include dry skin and inflammation. Although some individuals may say their psoriasis does not itch, the condition is usually very itchy, especially when the patches are spread over a large area of skin. Another very distinctive symptom of psoriasis is the involvement of the nails. One quarter to one half of people with psoriasis develop pitting and discolouration of the nails and crumbling beneath the free edges. The nail plate may actually separate.

To date, psoriasis has been unsuccessfully treated with strong medications, (many based on antiinflammatory drugs such as cortisone), UV light, laser and an endless number of other products. At best, these treatments have given temporary relief and upon ceasing their use, the psoriasis has reoccurred.

In work leading up to the present invention, the cause of psoriasis has been determined to be linked to a pathogen which is directed only to the cells of the dermal and epidermal layers. This infection leads to the onset of the symptoms characteristic of psoriasis, these being hyperproduction of skin cells, flaking, cracking, bleeding, itchiness and the like.

Also commonly affected are blood circulation, nerve endings, hair growth, pigmentation and the sweat glands.

P OPER\TDO\?CTSC4opkeaCs30575O99 Pswinis dm2/O71208 00

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0 -4- SIn addition to having identified the pathogen-based cause of psoriasis, there has been 0 developed composition for topical application which acts to treat this pathogenic cause and thereby provide a long lasting treatment directed to the cause of the psoriasis, rather than a Cc treatment directed to relieving its symptoms. These compositions, by virtue of their anti- CN 5 pathogenic and skin condition qualities have also been determined to be useful for the Cl treatment of other skin conditions characterised by pathogen infection and/or inflammation 00 0 such as eczema, acne or rashes.

0, P.'OPER\TDO\Ts-ComplIcta\30575099 Pswi.6 doJO7120 SSUMMARY OF THE INVENTION

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Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", C 5 will be understood to imply the inclusion of a stated integer or step or group of integers or C steps but not the exclusion of any other integer or step or group of integers or steps.

00 C1 As used herein, the term "derived from" shall be taken to indicate that a particular integer or group of integers has originated from the species specified, but has not necessarily been obtained directly from the specified source. Further, as used herein the singular forms of "and" and "the" include plural referents unless the context clearly dictates otherwise.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

In one aspect the present invention provides a method for producing a herbal tonic, the method comprising the steps of: a) producing an extract from bark and flowers of tree of the genus Tilia by: i) contacting the bark and flowers of tree of the genus Tilia with water; ii) heating the mixture of bark and flowers of tree of the genus Tilia and water for a period of time between 10 and 60 minutes; b) producing an extract from flowers ofMatricaria recutita by: i) contacting the flowers ofMatricaria recutita with water; ii) heating the mixture of flowers ofMatricaria recutita and water for a period of time between 10 and 60 minutes; c) combining the extract of step a) with the extract of step b); wherein steps a) and b) may be performed in either order.

In one aspect the invention provides the herbal tonic produced according to the method described above.

P: OPER\TDO\PCTs-Cmpida 3Ocs\799 sorias.do-2/07fl008 00 -6- O In another aspect the invention provides a pharmaceutical composition for topical administration comprising the herbal tonic together with one or more pharmaceutically acceptable excipients and/or carriers.

N C, In yet another aspect the invention provides a moisturising cream for use in the 00 Sprophylaxis and/or treatment of psoriasis, the moisturising cream comprising: between about 9% and 11% stearic acid; (ii) between about 1 and 3% cetyl stearyl alcohol mixture; (iii) between about 1 and 3% cetyl alcohol; (iv) between about 9 and 11% liquid paraffin; between about 4 and 6% self-emulsifying wax (sodium lauryl ether in cetyl alcohol 98%); (vi) between about 0.8 and 1.0% magnesium sulfate; (vii) between about 0.2 and 0.4% disodium tetraborate; (viii) between about 4 and 6% glycerine; (ix) between about 0.1 and 0.2% methyl paraben; and between about 1 and 3% isopropyl myristate.

In another aspect there is provided a method for the therapeutic or prophylactic treatment of a skin lesion characterised by pathogen infection and/or inflammation, said method comprising contacting said lesion with an effective amount of the cleanser, tonic and, optionally, the moisturiser hereinbefore defined for a time and under conditions sufficient to ameliorate said pathogen infection and/or inflammation.

In yet another aspect there is provided a method for the therapeutic or prophylactic treatment of a psoriasis lesion, said method comprising contacting said lesion with an effective amount of the cleanser, tonic and, optionally, the moisturiser, hereinbefore defined, for a time and under conditions sufficient to ameliorate one or more of the symptoms characteristic of psoriasis.

P \OPER\TDMkPMTr-ppd.\3D37509 P-".dM2IfOOS 00 -7- In still another aspect, there is provided a method for the therapeutic treatment of a skin 0 lesion characterised by pathogen infection and/or inflammation, said method comprising: contacting said lesion with an effective amount of the cleanser hereinbefore Cc defined for a time sufficient for the skin of the lesion to soften; CN 5 (ii) removing said softened skin; 0 Cl (iii) contacting said lesion with an effective amount of the tonic hereinbefore 00 Sdefined; and CI (iv) contacting said lesion with an effective amount of a moisturiser; repeating step every 24 hours until the lesion has cleared.

P.\OPER\TDO\PCTsCompIpa's\3579 Psoriasidoc2107200 00 O-8 BRIEF DESCRIPTION OF THE DRAWINGS Figures 1-7 and 16 are a photographic representation of skin areas affected by psoriasis.

C< In the top panel of each figure is a photograph of the skin area prior to commencement of CI 5 treatment with the composition and methods of the invention. In the bottom panel of each CN figure is a photograph of the skin area, free from psoriasis, after treatment with the 00 O compositions and methods of the present invention.

Figures 8 and 9 are a photographic representation of a patient with psoriasis of the hands (top panel) and following treatment for 3 months and 19 days (bottom panel).

Figures 10-15 are a photographic representation depicting the treatment of a child who developed psoriasis at 2 years of age. The psoriasis was cleared with 5 months of treatment.

P: OPER\TDO\PCTCplctax3O7599 Po=s doc.1072700 00 o

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0 -9- DETAILED DESCRIPTION OF THE INVENTION The present invention is predicated, in part, on the determination that psoriasis is a aC pathogen induced disease condition which is treatable with the topical application of the CN 5 compositions herein disclosed. Accordingly, this finding has facilitated the development 0 N of methods of prophylactically and therapeutically treating psoriatic lesions, which 00 0 conditions have, to date, been treated with steroid based medications in order to provide C, transient relief of inflammatory symptomology. The present invention is also useful for the treatment of any other skin condition characterised by pathogen infection and/or inflammation, such as eczema, acne and rashes.

In one aspect of the present invention, it has been determined that a particularly potent herbal extract derived from the bark and flowers of trees of the genus Tilia and flowers of Matricaria recutita is effective in preventing and treating psoriatic lesions.

Trees of the genus Tilia are commonly referred to as Linden trees and are widely distributed throughout the world especially in North America, Europe and Asia. It has been determined that the particular species of the genus Tilia that is used in the manufacture of the herbal tonic for use in the methods of the present invention is not crucial, and bark and/or flowers of different species may be used interchangeably, or indeed combined. Whilst the bark and flowers of trees of the genus Tilia may be used in any particular ratio, it has been found that herbal extracts derived from mixtures of bark:flower in a ratio between approximately 1:9 and 2:8 (by weight) are most beneficial.

In some parts of the world (particularly Britain) trees of the genus Tilia may be referred to as Lime trees, and in other parts they may be referred to as Basswood.

Matricaria recutita (chamomile/camomile) is commonly known and widely distributed throughout Europe, Asia, North America and Australia.

Without wishing to be bound by theory, it is believed that the efficacy of the herbal extract derived from the bark and flowers of trees of the genus Tilia and flowers of Matricaria P: OPER\TDO\PCsCsn.pIea\3C575099 P- do.-2/0 7 /200 recutita in the prophylaxis and treatment of psoriatic lesions is dependent, in part, on the O method of extraction from the natural products (bark and flowers). In this respect it has been found that there is a relationship between the method of aqueous extraction (in Cc particular) from the natural products and the efficacy of the herbal extract. It has now been 5 determined that if the extraction occurs too rapidly then the potency of the herbal extract is N, substantially reduced, requiring more intensive and sustained application of the herbal 00 Stonic. Likewise if the extraction occurs too slowly then the potency is similarly reduced.

C Without wishing to be bound by theory, it is believed that exposing the natural products to heat over prolonged periods leads to degradation of not only the active components but also leads to contamination of the herbal extract with undesired components of the bark and flowers. Accordingly it has been found that a period of extraction at maximum temperature of between 10 minutes and 60 minutes, preferably about 30 minutes, is optimal for the aqueous extraction of the desired components. Preferably the bark and/or flowers are extracted by heating the water to, or near, its boiling point and maintaining that temperature for between about 10 and 60 minutes. For example, the bark and flowers of a tree of the genus Tilia may be contacted with water and the water brought to a boil for a period of about 30 minutes. Likewise flowers of Matricaria recutita may be contacted with water and the water brought to a boil for a period of about 30 minutes.

Furthermore, in one embodiment the extraction from the bark and flowers of trees of the genus Tilia takes place separately to the extraction from the flower ofMatricaria recutita.

That is, the extraction from each natural product takes place in separate steps.

Accordingly, in one aspect the present invention provides a method for producing a herbal tonic, the method comprising the steps of: a) producing an extract from bark and flowers of tree of the genus Tiia by: i) contacting the bark and flowers of tree of the genus Tilia with water; ii) heating the mixture of bark and flowers of tree of the genus Tilia and water for a period of time between 10 and 60 minutes; b) producing an extract from flowers ofMatricaria recutita by: i) contacting the flowers ofMatricaria recutita with water; P:\OPERkTDOs-Cpldac3O37599 Psorisis doc-2/07fl008 00 0 -11ii) heating the mixture of flowers ofMatricaria recutita and water for a 0 period of time between 10 and 60 minutes; c) combining the extract of step a) with the extract of step b); wherein steps a) and b) may be performed in either order.

N C, In embodiments of the method for producing a herbal tonic, the extract of step a) and the 00 Sextract of step b) are each filtered prior to being combined.

(N

It will be understood that the skilled worker may employ standard techniques to aid in the aqueous extraction from the bark and/or flowers. In this respect, it is preferable that the bark and/or flowers be comminuted and/or ground prior to the step of being contacted with water. Each mixture may also be stirred during each heating step.

The ratio of bark and/or flowers to water in the method for producing a herbal tonic is not crucial, although a substantial excess of water is preferable. In some embodiments the ratio of bark and flowers of trees of the genus Tilia to water is between about 1:10 and 1:90 (by weight). Preferably the ratio is between about 1:35 and 1:45 (by weight), or more preferably about 1:40 (by weight). Similarly, in some embodiments the ratio of flowers of Matricaria recutita to water is between about 1:10 and 1:90 (by weight). Preferably the ratio is between about 1:35 and 1:45 (by weight), or more preferably about 1:40 (by weight).

Furthermore, and without wishing to be bound by theory, it is believed that the extract of bark and flowers of trees of the genus Tilia and the extract of flowers of Matricaria recutita are approximately equally potent in the prophylactic and therapeutic methods of the present invention. Accordingly, in preferred embodiments, approximately the same weight of each natural product is used in the production of the herbal tonic.

The herbal tonic may also comprise other agents which are suitable for topical administration. In this respect the herbal tonic may comprise ethanol. Without wishing to be bound by theory it is believed that ethanol is an effective solvent and/or co-solvent and, PAOPE\TDO\PCTr.Copk.\3075O99 P. riasisdod.2/OWflO 00

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D -12owing in part to its boiling point, is particularly useful in promoting surface coverage O during topical administration. In some embodiments, the herbal tonic comprises approximately 50% of ethanol.

NC 5 In a further aspect the invention provides the herbal tonic produced by the method 0 CN described above.

00 C This herbal tonic is herein also referred to as the "tonic".

In still another aspect, the present invention provides a pharmaceutical composition for topical administration for the prophylaxis and/or treatment of psoriasis comprising the herbal tonic together with one or more pharmaceutically acceptable excipients and/or carriers. It should be understood that the compositions of the present invention are designed for topical administration to the skin and may take any suitable form in this regard. Techniques for formulation and administration may be found in "Remington's Pharmaceutical Sciences", Mack Publishing Co., Easton PA., 16th edition, 1980, Ed. By Arthur Osol. Thus, for local or topical administration, the subject compositions may be formulated in any suitable manner, including, but not limited to, lotions, pastes, creams, gels, oils, ointments, solutions, suspensions, powders, mists or aerosols. For transmucosal administration, penetrants appropriate to the barrier to be permeated are used in the formulation. Such penetrants are generally known in the art and include, but are not restricted to, benzalkonium chloride, digitonin, dihydrocytochalasin B5 and capric acid.

The compositions of the subject invention in the form of lotions, creams or gels may contain acceptable diluents or carriers to impart the desired texture, consistency, viscosity and appearance. Acceptable diluents and carriers are familiar to those skilled in the art and include, but are not restricted to, ethoxylated and non-ethoxylated surfactants, fatty alcohols, fatty acids, hydrocarbon oils (such as palm oil, coconut oil, and mineral oil), cocoa butter waxes, silicon oils, buffering agents, cellulose derivatives, emulsifying agents such as non-ionic organic and inorganic bases, preserving agents, wax esters, steroid alcohols, triglyceride esters, phospholipids such as lecithin and cephalin, polyhydric P:OPERXTDO\PCT.-C-placa\3O575099 P-i.u doc-2/07/2008 00

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O -13alcohol esters, fatty alcohol esters, hydrophilic lanolin derivatives, and hydrophilic O beeswax derivatives. Specific examples of pharmaceutically acceptable excipients and/or carriers include: cetyl alcohol, sodium lauryl ether sulfate, stearyl alcohol, stearic acid, C benzyl alcohol and water. Without wishing to be bound by theory it is believed that these NC 5 pharmaceutical excipients and/or carriers may aid in promoting penetration and/or CN spreading of one or more components of the herbal tonic into the layers of the skin.

oO cI Accordingly, in another aspect, the invention provides a lotion for the prophylaxis and/or treatment of psoriasis, wherein the lotion comprises the herbal tonic produced according to the method described above together with cetyl alcohol, stearyl alcohol, sodium lauryl ether sulfate, stearic acid, benzyl alcohol and water.

In one embodiment of the pharmaceutical composition, the lotion comprises: between about 3.7 and 4.15% cetyl alcohol; (ii) between about 0.075 and 0.085% sodium lauryl ether sulfate; (iii) between about 1.50 and 1.70% cetyl stearyl alcohol; (iv) between about 0.25 and 0.35% stearic acid; between about 0.50 and 1.50% of the herbal tonic produced according to the method described above; (vi) between about 0.15 and 0.25% benzyl alcohol.

This lotion is herein also referred to as the "cleanser".

In a further embodiment of the pharmaceutical composition, the lotion consists of: 3.92% cetyl alcohol; (ii) 0.08% sodium lauryl ether sulfate; (iii) 1.60% cetyl stearyl alcohol; (iv) 0.30% stearic acid; 1.00% of the herbal tonic produced according to the method described above; (vi) 0.20% benzyl alcohol; P.\OPER\TDO\PCTs.C pcics\3O575099 Pw". d.-l2/07t2DS 00

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O -14- (vii) 92.90% water.

As described herein, the method of prophylaxis and/or treatment of psoriasis provided by ¢C the present invention benefits from the use of a moisturising cream. While it has been C 5 found that most commercially available moisturising creams are useful in performing this CI role, one newly developed formulation is believed to be particularly effective.

00 O Accordingly, in a further aspect the present invention provides a moisturising cream for the I treatment of psoriasis, wherein the cream comprises: stearic acid; stearyl alcohol; cetyl alcohol; liquid paraffin; sodium lauryl ether sulfate; magnesium sulfate; disodium tetraborate; glycerine; methyl paraben; isopropyl myristate; and water. Disodium tetraborate is otherwise known as sodium borate, or Borax.

Without wishing to be bound by theory, it is believed that some of the components of the moisturising cream may aid in maintaining skin moisture to assist with penetration of the pharmaceutical composition comprising the herbal tonic, or the herbal tonic itself, into the layers of the skin. In particular, it is believed that fatty alcohols (for example cetyl and stearyl alcohol), benzyl alcohol and isopropyl myristate may act as penetrants, whereas glycerine may act as a general skin moisturiser. Certain other components may perform different roles. For example, it is believed that methyl paraben performs the role of a preservative to prevent spoilage due to oxidation and/or microbial action. Sodium lauryl ether in cetyl alcohol 98%) acts as a self-emulsifying wax and may aid in the formation of a spreadable cream. Magnesium sulfate is hydrophilic and may assist with binding and subsequently releasing moisture to the skin.

In one embodiment, the moisturising cream comprises: between about 9% and 11% stearic acid; (ii) between about 1 and 3% cetyl stearyl alcohol mixture; (iii) between about 1 and 3% cetyl alcohol; (iv) between about 9 and 11% liquid paraffin; between about 4 and 6% self-emulsifying wax (sodium lauryl ether in cetyl alcohol 98%); P:WEPR\TD\PCrs.Cpmeta\30575M Po., doc-VO71flOS 00

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0 (vi) between about 0.8 and 1.0% magnesium sulfate; O (vii) between about 0.2 and 0.4% disodium tetraborate; (viii) between about 4 and 6% glycerine; (ix) between about 0.1 and 0.2% methyl paraben; and C 5 between about 1 and 3% isopropyl myristate.

0 SIn some embodiments the cream may further comprise a fragrance such as rose oil.

C1 Furthermore, the moisturising cream typically comprises water.

Accordingly, in another embodiment, the moisturising cream consists of: stearic acid; stearyl alcohol; cetyl alcohol; liquid paraffin; sodium lauryl ether sulfate; magnesium sulfate; disodium tetraborate; glycerine; methyl paraben; isopropyl myristate; rose oil; and water. Preferably these components are present in the following amounts: 10% stearic acid; (ii) 2% cetyl stearyl alcohol mixture; (iii) 2% cetyl alcohol; (iv) 10% liquid paraffin; 5% self-emulsifying wax (sodium lauryl ether in cetyl alcohol 98%); (vi) 0.9% magnesium sulfate; (vii) 0.3% disodium tetraborate; (viii) 5% glycerine; (ix) 0.15% methyl paraben; and 2% isopropyl myristate; (xi) 1% rose oil; and (xii) 61.65% water.

This moisturising cream is herein also referred to as the "moisturiser".

As detailed hereinbefore, the compositions of the present invention are useful in the prophylactic or therapeutic treatment of skin conditions characterised by pathogen P. OPER\TDO\?Crs-amplncs\3057" Pwaisidoc2J07/2008 00 -16infection and/or inflammation.

Accordingly, in another aspect there is provided a method for the therapeutic or Cc prophylactic treatment of a skin lesion characterised by pathogen infection and/or N, 5 inflammation, said method comprising contacting said lesion with an effective amount of the cleanser, tonic and, optionally, the moisturiser hereinbefore defined for a time and 00 Sunder conditions sufficient to ameliorate said pathogen infection and/or inflammation.

Reference to "skin lesion characterised by pathogen infection and/or inflammation" should be understood as a reference to any area of skin which is affected by a pathogen infection and/or inflammation. It would be understood by the person of skill in the art that in many cases, pathogen infection is associated with the onset of an inflammatory response.

However, this may not necessarily always be the case. It would also be appreciated that an inflammatory response on the skin, although quite commonly found to be associated with a pathogen infection may nevertheless occur independently of a pathogen infection. For example, eczema which is brought on by stress or allergy may not necessarily involve a pathogen infection but would nevertheless benefit from treatment with the compositions of the present invention which, in addition to their anti-pathogenic properties, provide more general skin conditioning properties which are useful in the context of treating skin inflammation.

Reference to a "lesion" should be understood as a reference to any area of skin which is affected by pathogen infection and/or inflammation. This includes, for example, the inflamed area itself, the skin area adjacent to this and any area of skin which is showing the changes which precede the development of a typical inflammation, such as areas of apparently intact but itchy skin.

Preferably, said lesion is psoriasis, eczema, acne or a rash.

In one embodiment there is provided a method for the therapeutic or prophylactic treatment of a psoriasis lesion, said method comprising contacting said lesion with an POPER\TDO\PC'IrCo.,,pI\30575179 Roi d-.2107/20 c -17effective amount of the cleanser, tonic and, optionally, the moisturiser, hereinbefore O defined, for a time and under conditions sufficient to ameliorate one or more of the symptoms characteristic of psoriasis.

CN 5 Reference to "psoriasis" should be understood as a reference to all forms of this disease CN condition and includes, for example, reference to: 00 S- Plaque psoriasis: The most common form of psoriasis, plaque psoriasis usually affects the scalp, elbows, knees, hands, feet and genitals. It features raised, thickened patches of red skin covered with silvery scales.

Pustular psoriasis: This form of psoriasis features pus like blisters.

Erythrodermic psoriasis: The affected area is intensely red and swollen and covers a large part of the skin surface.

Guttate psoriasis: The psoriasis appears as small drop like lesions.

Inverse psoriasis: Smooth red lesions appear in the folds of the skin.

Psoriatic arthritis: This condition often occurs in conjunction with the skin related psoriasis. The joints become painful, stiff and swollen with decreased movement, morning stiffness and general tiredness. The condition is not dissimilar to rheumatoid arthritis in presentation.

Nail psoriasis: Nail involvement is common for people with psoriasis. If affected the nails become pitted and may lift off the nail bed.

Without limiting the present invention to any one theory or mode of action, psoriasis is a chronic inflammatory skin condition characterised by red scaly patches which develop and show on the skin. These areas are most common on the scalp, elbows and knees, but they P.0PER\TDOPCTCoopiCp.\3O7SO99 Psi.s do-2/7/200 00 -18can occur on any area of the body. Psoriasis is the result of an overproduction of skin O cells. More specifically, it is known that the skin in psoriasis patches is growing much quicker than normal skin. The epidermis grows continuously from its outer surface and usually a new layer is reformed each month. In psoriasis, the skin forms a complete layer C 5 of epidermis each 3-4 days, with the result that extra skin is shed in scales. This process is C' similar to healing of the epidermis after an injury except that normal skin cell growth rate 00 Sis ultimately reduced to normal levels while psoriasis skin cell growth rate does not.

Because the skin cells are producing so rapidly, they do not form properly leading to the occurrence of the silvery scales which are characteristic of psoriasis.

The method of the present invention is directed to the treatment of a mammal. The term "mammal" as used herein includes humans, primates, livestock animals (eg. horses, cattle, sheep, pigs, donkeys), laboratory test animals (eg. mice, rats, guinea pigs), companion animals (eg. dogs, cats) and captive wild animals (eg. kangaroos, deer, foxes). Preferably, the mammal is a human or a laboratory test animal. Even more preferably, the mammal is a human.

Without limiting the present invention to any one theory or mode of action, the cleanser acts to soften the surface skin of the lesion, thereby facilitating its sloughing off and exposure of the affected skin underneath. A particularly effective means of removing the skin treated with the cleanser is to run water over the skin. Some skin will be removed by the action of the water while the remainder can be removed with gentle abrasion such as with a face-washer or a towel. In the context of treating psoriasis, this cleansing step is particularly valuable due to the fact that psoriasis is characterised by a hard, scaly top layer which, without removal, prevents the treatment products from penetrating to the deeper skin layers underneath. Once the cleanser has been applied and then removed subsequently to softening of the top layer of skin, the tonic is applied to the lesion. Once the tonic is absorbed by the lesion, a moisturiser can optionally be applied. The moisturiser may be an any moisturiser which conditions the skin and prevents drying out of the skin. Preferably, the moisturiser is the moisturiser hereinbefore described.

P:O)PER\TDO\PCT-Cmptap 3 057509 9 Psoriasitdoc-2/07/2008 00 0-19- In another embodiment, there is provided a method for the therapeutic treatment of a skin O lesion characterised by pathogen infection and/or inflammation, said method comprising: contacting said lesion with an effective amount of the cleanser hereinbefore ¢C defined for a time sufficient for the skin of the lesion to soften; NC 5 (ii) removing said softened skin; CN (iii) contacting said lesion with an effective amount of the tonic hereinbefore 00 Sdefined; and CN (iv) contacting said lesion with an effective amount of a moisturiser; repeating step every 24 hours until the lesion has cleared.

More preferably, said moisturiser is the moisturiser hereinbefore defined.

Still more preferably, said lesion is psoriasis, eczema, acne or a rash.

Preferably, steps are repeated every 24 hours until 3-5 weeks after the lesion has cleared.

In general, the cleanser/tonic/moisturiser should be applied once every 24 hours.

However, since the cleanser is applied for the purpose of softening and enabling removal of the top layers of the skin lesion, the cleanser should be applied for such time as is required for this to be achieved. Typically, one could apply the cleanser in the evening and then remove the top layer of skin from the lesion the following morning, for example during showering. Thereafter the tonic and moisturiser are applied. The cleanser is then reapplied in the evening.

The treatment regime is required to be continued until the lesion has entirely cleared up.

Preferably, however, the treatment is continued for a further 3 to 5 weeks, most preferably for a further 30 days.

The method of the present invention is useful as a therapeutic or a prophylactic treatment.

By "prophylactic" treatment is envisaged the treatment of areas of skin which have not P:\OPER\TDO\PCTs-Compla\3O7599 Pwiasis doc2/07200 00 developed psoriasis, in order to prevent the onset in this regard. In the context of a O therapeutic treatment regime, the method of the present invention can reduce the extent and/or severity of psoriasis, although the method is preferably applied in order to achieve Cc elimination of the psoriasis lesion. Preferably, all lesions are simultaneously treated in C 5 order to entirely rid the mammal of psoriasis. However, treatment of selected lesions is N, nevertheless contemplated by the present invention.

00 Accordingly, reference herein to "treatment" and "prophylaxis" is to be considered in its broadest context. The term "treatment" does not necessarily imply that a subject is treated until total recovery. Similarly, "prophylaxis" does not necessarily mean that the subject will not develop some symptomology. However, the method of the present invention may slow or reduce the onset or degree of inflammation. The term "prophylaxis" may therefore be considered as reducing the severity or onset of a particular condition. "Treatment" may also reduce the severity of an existing condition.

The present invention is preferably achieved by administering to said mammal an effective amount of the compositions as hereinbefore defined. To this end, an "effective amount" means an amount necessary to at least partly attain the desired response, or to delay the onset or inhibit progression or halt altogether, the onset or progression of the particular condition being treated. The amount varies depending upon the health and physical condition of the individual to be treated, the taxonomic group of the individual to be treated, the degree of protection desired, the formulation of the composition, the assessment of the medical situation, and other relevant factors. It is expected that the amount will fall in a relatively broad range that can be determined through routine trials.

By way of guidance, the amount is preferably sufficient to cover the lesion and be absorbed into the skin such that an excess slimy layer of the composition does not remain on top. This may be, for example, 1 g per lesion.

In accordance with these methods, the composition defined in accordance with the present invention may be coadministered with one or more other compounds or molecules. By "coadministered" is meant simultaneous administration in the same formulation or in two P:OPERPTDO\ CT -CepIa\3O575099 Purni doc-2/O712003 00

O

O -21different formulations via the same or different routes or sequential administration by the O same or different routes. For example, the subject particles may be coadministered together with anti-inflammatory or other relevant drugs in the context of traditional ¢C treatments for relieving symptoms of psoriasis. By "sequential" administration is meant a NC 5 time difference of from seconds, minutes, hours or days between the administration of the CN two types of molecules, These molecules may be administered in any order.

00 C, The present invention is further described by reference to the following non-limiting examples: P:%PER\TD\PaT&C-pJaw\357O99 P6WtaS-i2sidoc071200a 00 -22- EXAMPLE 1 O STUDY OF A DISEASE PSORIASIS Psoriasis is caused by a pathogen which can penetrate the membrane of the skin cell.

N, 5 When inside the cell, it can integrate with the intranuclear structure, in particular bind to I the gene and regulating the timing of the creation of new cells, causing accelerated creation 00 Sof cells and/or the genes regulating cell size, leading to production of smaller cells.

These disturbances are induced only when the pathogen interacts with the genes in the cells of the Stratum Basale, where the cells are created. In other layers of the skin, the pathogen can cause disturbances of the gene, without necessarily causing change in the timing of creation of cells or size of cells, largely because the cells already exist.

This pathogen is found in polluted and humid environments, in the air. About 3-5% of the population contract psoriasis. It is believed that this is due to the occurrence of the pathogen, the porosity of skin cells, and the mineral-chemical content of skin cells.

These factors are variable, and the disease can therefore exhibit a different appearance and intensity from one individual to another or even in terms of a single individual over a period of time.

It has been determined that resistance to pathogen infection is increased where there exists a strong physical barrier at the skin and/or a mineral-chemical content of the skin cells which is not hospitable to the pathogen.

Systemic immune system responsiveness to this pathogen has little influence on the contraction and development of the disease.

The occurrence of psoriasis across multiple members of a single family unit is thought to be linked to similarities in skin architecture within family units.

P:OPER\TDO\PCTI.Cwpiecs\3O575O99 Pwrisis d-2/07/2OOS -23- The contraction and spread of the psoriasis pathogen occurs horizontally and vertically.

Horizontal spreading The infection can infect 4 (four) upper layers of the skin. However, until the basic layer, Stratum Basale, is infected, there is no accelerated cell production. Changes on the infected skin are: itchiness and slight redness. It can affect large parts of the skin.

Vertical spreading .0 When the pathogen reaches the Stratum Basale, there occurs accelerated cell division and reduced cell size.

The human skin has 5 (five) layers.

1. Stratum Basale creation of new cells.

2. Stratum Spinosum the cells are polygonal.

3. Stratum Granulosum the cells are flat.

4. Stratum Lucidum with no visible boundaries.

Stratum corneum outer layer-dead cells.

The following is a graphic representation of human skin.

_L 4 I- t- -1 4_ 3 S0 c Blood vessels When the pathogen is present in the environment it can interact with one or few areas on the body. It needs to penetrate Stratum Corneum dead cells, and to reach Stratum P.NOPER\TDO\PCTs-0ploaes3057599 ftoriis *dc-20712008 00 O -24- Lucidum, which is alive. Then the infection starts. After this the pathogen can multiply, O migrate and infect surrounding cells. At the beginning of the infection that part looks like a small wart, a pimple. This is usually darker in colour from the normal skin. In a few C days time, the surrounding area is also infected, but the infection has still not reached the C 5 Stratum Basale. This is horizontal spreading. These small changes are often not 0 0 recognised, and the person infected neglects them.

C1 The next stage occurs when the pathogen invades all the layers of the skin, and infects them. The full effect of the pathogen is expressed when it enters the cells of the Stratum Basale, which regulate creation of skin cells, and which become accelerated by hyper production of smaller cells. The pathogen continues to infect other areas of the Stratum Basale, increasing the produced number of cells to far more than the normal number. The infected area starts to feel hard, itchy, red and starts to flake. This process continues, and after a short time of a few months the disease is well established with lesions. Infected areas of Stratum Basale can join; forming larger infected areas lesions. This is an advanced stage.

The following graphics represent the development of the disease psoriasis.

1. Beginning of the infection Not reaching Stratum Basale, "horizontal spreading".

2. Early stage Reaching Stratum Basale, "vertical spreading".

P OPER\TDO\? T.-C-pidt\307O99 fton .do.2/07/2003 25 Increased cell production starting.

3. Expanding a. Healthy cells b. Infected cells c. Increased cell production.

4. Established lesion Red edges active hyper cells production.

Advanced Progressing Increased number of cells Constant flaking of dead cells Hard, packed skin, easily cracks, itch and numbness P:NOPER\TDO)\PConCpI \3575099 Pwoiadoe2/072003 00 -26 Pressure on blood vessels, nerves, sweat and pigmentation glands, hair follicles.

The normal human skin cells have a cycle of 20 to 30 days. A skin cell infected and with Cc disturbances caused by genetic change begins a different cycle. For example, infected N 5 cells are produced in 5 (five) days, and their life span is 5 (five) days. In that case there N will be no build up of surplus cells. The time of creation of skin cells is accelerated, but 00 they are dying with the same speed, life span of 5 days. The number of cells in that area is Stherefore the same as the normal. If the size of the cells is affected, that area of the skin will be of lower level, ie. sunken.

The problems begin when the life span becomes longer than the time of creation. In this case, when a new cell is created, the old one is still alive, and the build up of surplus cells begins. The acceleration of creation of cells varies all the time. It can be from 3 to days. Life span of cells changes also from 4 to 21 days. This causes many different consequences.

Scale ofpossible disturbed timing Accelerated production time of cells, Life span of cells made on days Time of dying Increased build 3 to 4 4 to 5 to 6 Increased build up of surplus 3 6-7 cells 3 7-8 3 8-9 3 4 1 9-10 Largest build up of surplus cells.

Production creation of skin cells can vary, and sometimes can differ a little from the normal regular time. Then, the redness of the skin is present, size of the cells is affected, and intensive itchiness is present. There is not a build up of too many surplus cells.

P:)PER\TDO\PCTs mple \30575099 PRoaid-2/07/200 00 -27- The bigger the difference between the production time and the time of dying, the bigger O build up of surplus cells. They can building up hard, cracking, sometimes bleeding, and flaking yellow off white, painful layers. The smaller the time gap, the smaller the Snumber of surplus cells, with less severe consequences.

C, 0 Effects of the disease 00 C With surplus skin on the body, the affected area is exposed to a higher pressure than normal. That is transmitted to the blood vessels, nerve ends, hair follicles, and sweat and pigmentation glands. The blood does not circulate well, the nerves lose their sensitivity.

The hair on the scalp and pubic region grow with less strength. The hair follicles on the body can be suppressed, and the hair growth can be stopped, interrupted. Sweat and pigmentation glands, can be stopped or interrupted also.

When the disease is present, it can cause severe negative psychological effects on the affected people.

Parts of the body affected The disease can start anywhere on the body. The treatment hereinafter described exhibits good results in respect of the nature of the area being treated.

The Head On the scalp the infection can start at one spot, but very quickly it can spread all over the scalp. The effects and the severity of the disease can be very high. The growth of the surplus skin can reach very high levels. A constant pressure is felt, tightness, itchiness, flaking etc. The hair growth may not be affected, but it is weakened. The hairline is also affected by excessive build up of surplus cells.

The face can be completely affected, but there is often less build up of surplus cells, P.%OPER\TDO\PCTsCpcNadS73099 Psioriasdez-.2/7/200S 00

O

O -28probably the influence ofUV light.

On the eyelids the development of surplus cells can "thicken" the eyelid and cause C constant, painful irritation with redness to the eye.

N 0 C Eyebrows and forehead can also be severely affected.

00 C Nose; an especially difficult area exists between the eye and the nose. Infection also occurs on the surface of nostrils and on the skin joining the face. the infection can spread inside the nose, causing bleeding.

Lips can be affected from the outside, causing pain, flaking, bleeding and also from the inside.

Ears; joining skin with the head can build up large surplus skin. Infects both sides and inside the ear canal.

Under the lower jaw; affected parts have surplus cells packed which pressure other tissues.

The neck and the body: Can be severely affected with the development of large lesions. Conditions for advancement of the disease are good: warmth and moisture (perspiration), and easy transmission by hands. the front and the back can be affected.

Arms, hands, palms and fingers: On the elbows there is a large skin surface which forms hard, packed surplus skin.

The armpits, and upper and lower arm can be severely affected. Hair growth can be stopped. The whole hand can be infected. Big and hard growth of surplus skin P.IOPER\TDOPT.Complac\3375099 Pnasis.dw.21O7/200 -29is observed on joints and on palms. The fingers can become swollen with "rotting" fingernails.

Legs: Can be affected on the knees, which exhibit large skin surface, and the front of the lower legs. The affected skin develops hard compacted lesions. The hair growth, sweat and pigmentation glands are also affected.

Feet can be affected on the top and on the bottom. The skin can build up surplus cells, can crack and bleed.

Toes are itchy, swollen, read, disfigured, rotting toenails.

Female intimate organ: Can be severely affected. Convenient conditions for development of the disease: large skin surface, moisture and warmth.

Male intimate organ: Regular skin and the spongy tissue. Convenient conditions: large skin surface, moisture and warmth.

The Treatment The treatment on average lasts 3-6 months. It is important from the beginning that the treatment covers all disease-affected parts.

Visible parts lesions; Surrounding skin; P.ROER\TDO\PCTi-lacs\3375099 Nmiasis doc-2O71208 00 3. Suspected parts* *The skin can have a "healthy" appearance, but an itch can be felt, slight redness, harder, Cc thicker, and less flexible from the surrounding skin.

CK, ,I The products of Example 2 are used for the treatment and are effective and selective in the 00 Sway they work. They eliminate the pathogen and the infected skin. At the same time they are conditioning the healthy skin. With their high conditioning properties, they can be used after the treatment for a good skin care and prophylactic treatment. The products are used topically. They do not interfere with any medication internally taken or with the diet.

All affected areas should be treated at the same time since untreated parts could serve as a source of repeated infection. When treated with the products, lesions and surrounding skin may appear to become worse. On suspected areas of psoriasis, lesions could develop, even if there was "nothing" there before the treatment. This occurs due to the fact that the product may reveal affected areas which were not yet visible to the patient. However, with ongoing application, the psoriasis is treated.

Effects of the treatment The infected skin is removed gradually. When the products neutralise the pathogen, the infected cells die. The dead cells are then removed and expose the next layer of infected skin cells and on which the products will work. The flaking intensifies with yellow off white flakes. Many layers of infected skin have to be removed. At the same time, Stratum Basale is still producing infected cells, with accelerated speed. The products enable the elimination of more bad skin than is produced. In this way, ultimately all cells are treated and the infection eliminated.

The flakes ultimately become clear white. This is an important part of the treatment since within a few days the skin cells begin to be created with a normal speed (20-30 days) and normal size. The areas of the Stratum basale which were affected are red. When the first P:\OPER\TDO\WCTs.CpIel\30575099 P=Wss do-2O7fl0 00

O

S-31new skin cells are created the spots disappear, but the skin still flakes. that will continue O until a regular thickness of 5 layers of skin is achieved, with all the functions normalised.

¢C The skin has to be treated and repaired gradually, taking care of the time factor and all the NC 5 functions (blood circulation, nerve sensitivity, hair growth, sweat and pigmentation glands, 0 CN regular cell growth and skin lines).

00 CI The repair recovery tine is individual.

It is recommended that the treatment continue for 30 days after the skin is repaired.

EXAMPLE 2 Herbal Tonic Method of extraction a) Dried and ground Linden tree bark and Linden tree flowers (bark:flowers 15:85, combined mass 50 g) were mixed with water (2 The mixture was heated to between and 100 °C and maintained between those temperatures for 30 minutes. The mixture was then removed from heat and filtered to remove particulate matter. The filtrate was allowed to cool to room temperature.

b) Dried and ground Camomile flowers (50 g) were mixed with water (2 The mixture was heated to between 90 and 100 °C and maintained between those temperatures for 30 minutes. The mixture was then removed from heat and filtered to remove particulate matter. The filtrate was allowed to cool to room temperature.

Formulation of the Tonic The filtrate obtained from step a) was combined with the filtrate obtained from step b).

P:IOPER\TDO\PCCoplcc\3O 75099 Poriis dc-2071200S 00

O

O -32- Ethanol 10L) was added to the combined filtrates, and the final volume made up to O 20 L using water.

SEXAMPLE 3 CN Cl Skin Cleansing Lotion 00 ri Part 1 1. emulsifying wax 4.00% (cetyl alcohol 98%, sodium lauryl ether sulfate 2%) 2. cetyl stearyl alcohol 1.60% 3. stearic acid 0.30% Part 2 4. Herbal tonic 1.00% benzyl alcohol 0.20% 6. purified water 92.90%.

(all percentages are w/w) Manufacturing Procedure 1. Heat Part 1 separately to 60-65 °C; 2. Heat Part 2 separately to 65-70 °C; 3. Remove both Part 1 and Part 2 from the heat; 4. Add Part 2 to Part 1 (water to oil) in small portions, with mixing at high speed for 20-30 min to emulsify and achieve a smooth and even consistency. Continue mixing until temperature drops below 45 OC to obtain the skin cleansing lotion as a smooth, white, viscous liquid with no observable aeration P OPER\TO\PCT..CpId.3O0759O9 doc.2/O7/208 O0

O

O

mc -33 EXAMPLE 4 Moisturising Cream Part 1 1.

2.

3.

4.

stearic acid cetyl stearyl alcohol cetyl alcohol liquid paraffin 68 emulsifying wax (cetyl alcohol 98%, sodium lauryl ether sulfate 2%) 1000 g 200 g 200 g 1000 g 500 g Part 2 6.

7.

8.

9.

11.

12.

MgSO 4 .7H 2 0 disodium tetraborate (Borax) glycerine methyl paraben isopropyl myristate rose oil water purified 90 g 30 g 500 g 200 g 100 g 6320 mL Part 3 Water to weight 380 mL Total 10,000 g NB: The water of part 3 is used to replace water lost due to evaporation to give a final mass of 10,000 g.

P.\OPER\TDO\PCTs-Cmplcrn'337O99 Pia.sis &-2/O7/20 00

O

O -34- Manufacturing Procedure

O

1. Heat Part 1 to 75-80 oC.

c 2. Heat Part 2 to 75 OC to dissolve solids well.

CN 5 3. Add Part 2 to Part 1 (water to oil) in small portions, with mixing at high speed for CN 30 min to emulsify. The water of Part 3 is added to maintain the mass of the 00 oO O product at 10,000 g. The speed of mixing is reduced to allow the mixture to cool to C below 40 °C to obtain the smooth, white and viscous moisturising cream which thickens over a few days.

Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. It is to be understood that the invention includes all such variations and modifications. The invention also includes all of the steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations of any two or more of said steps or features.

Claims (14)

1. A method for producing a herbal tonic, the method comprising the steps of: producing an extract from bark and flowers of tree of the genus Tilia by: contacting the bark and flowers of tree of the genus Tilia with water; (ii) heating the mixture of bark and flowers of tree of the genus Tilia 00 and water to, or near boiling point and maintaining this temperature Sfor a period of time between 10 and 60 minutes; producing an extract from flowers of Matricaria recutita by: contacting the flowers of Matricaria recutita with water; (ii) heating the mixture of flowers ofMatricaria recutita and water for a period of time between 10 and 60 minutes; combining the extract of step with the extract of step wherein steps and may be performed in either order.

2. The method according to claim 1 wherein the period of heating in each of steps and is 30 minutes.

3. The herbal tonic produced according to the method of claim 1 or claim 2.

4. The herbal tonic according to claim 3 further comprising 50% ethanol.

A pharmaceutical composition for topical administration for the prophylaxis and/or treatment of a skin lesion, said composition comprising the herbal tonic according to claim 3 or claim 4 together with one or more pharmaceutically acceptable excipients and/or carriers.

6. The pharmaceutical composition according to claim 5 comprising: between about 3.7 and 4.15% cetyl alcohol; (ii) between about 0.075 and 0.085% sodium lauryl ether sulfate; (iii) between about 1.50 and 1.70% cetyl stearyl alcohol; P.WOPER\TDO30575099 Qainmsdoc29/09/2008 00 -36- S(iv) between about 0.25 and 0.35% stearic acid; between about 0.50 and 1.50% of the herbal tonic according to claim 3 or claim 4; and (vi) between about 0.15 and 0.25% benzyl alcohol. Cc,

7. The pharmaceutical composition according to claim 6 consisting of: 0 0 3.92% cetyl alcohol; (ii) 0.08% sodium lauryl ether sulfate; (iii) 1.60% cetyl stearyl alcohol; (iv) 0.30% stearic acid; 1.00% of the herbal tonic according to claim 3 or claim 4; (vi) 0.20% benzyl alcohol; and (vii) 92.90% water.

8. A method for the therapeutic or prophylactic treatment of a skin lesion characterised by pathogen infection and/or inflammation, said method comprising contacting said lesion with an effective amount of the pharmaceutical composition of any one of claims 5-7, a tonic of any one of claims 3-4 and, optionally, a moisturiser for a time and under conditions sufficient to ameliorate said pathogen infection and/or inflammation.

9. The method according to claim 8 wherein said method comprises contacting said lesion with each of said pharmaceutical composition, tonic and moisturiser.

The method according to claim 8 wherein said moisturiser comprises: between about 9% and 11% stearic acid; (ii) between about 1 and 3% cetyl stearyl alcohol mixture; (iii) between about 1 and 3% cetyl alcohol; (iv) between about 9 and 11% liquid paraffin; between about 4 and 6% self-emulsifying wax (sodium lauryl ether in cetyl alcohol 98%); (vi) between about 0.8 and 1.0% magnesium sulfate; P:'OPER\TDO\30575099 Clains do-.29/09f2008 00 D -37- (vii) between about 0.2 and 0.4% disodium tetraborate; (viii) between about 4 and 6% glycerine; (ix) between about 0.1 and 0.2% methyl paraben; and between about 1 and 3% isopropyl myristate. tc,

11. The method according to claim 10 wherein said moisturiser comprises: 0 0 10% stearic acid; (ii) 2% cetyl stearyl alcohol; (iii) 2% cetyl alcohol; (iv) 10% liquid paraffin; 5% self-emulsifying wax (sodium lauryl ether in cetyl alcohol 98%); (vi) 0.9% magnesium sulfate; (vii) 0.3% disodium tetraborate; (viii) 5% glycerine; (ix) 0.15% methyl paraben; 2% isopropyl myristate; (xi) 1% rose oil; and (xii) 61.65% water.

12. The method according to claim 9 or 10, said method comprising: contacting said lesion with an effective amount of said pharmaceutical composition for a time sufficient for the skin of the lesion to soften; (ii) removing said softened skin; (iii) contacting said lesion with an effective amount of said tonic; and (iv) contacting said lesion with an effective amount of said moisturiser; repeating step every 24 hours until the lesion has cleared.

13. The method according to claim 12 wherein steps are repeated every 24 hours until 3-5 weeks after the lesion has cleared. P.OPER\TDOO30575099 aimsdoc-29/09R200S 00 O -38-

14. The method according to claim 13 wherein said 3-5 weeks is 30 days. The method according to any one of claims 8-15 wherein said skin lesion is psoriasis, eczema, acne or a rash. 00 0- 0"-