FIELD OF THE INVENTION The present invention relates to topical compositions for application to the skin of humans and other animals, and to their use in improving the condition and appearance of skin. The present compositions may also be used in therapeutic indications for the skin, and also tissues beneath the upper layers of the skin such as the subdermis. BACKGROUND TO THE INVENTION

There is a constant need for improved or alternative compositions for the treatment of skin conditions. The cosmetic market, for example, is replete with topical compositions directed to the treatment of aesthetic conditions such as cellulite, wrinkles, skin laxity, skin discolouration, blemishes, pimples, flaking skin, dry skin, and the like.

Many prior art compositions also claim efficacy in the treatment of conditions which are metabolic in nature such as excess adipose tissue about the skin, fluid retention, toxin deposition and the like. Such problems may also present an aesthetic issue (such as cellulite).

It is the generally held in the art that many skin conditions are treatable by the application of topical compositions having a substantially aqueous solvent base. Often, oily components are added to the base (typically with an emulsifier) to provide the very well known oil-in- water emulsions used as bases for many topical skincare compositions. It is generally accepted that such compositions do not lead to any alteration in the cellular functions of skin, and act more so to hydrate the upper layers skin. Sufficient hydration can lead to the skin becoming more firm, smooth and having a generally more youthful appearance. The prior art further teaches the addition of biologically active ingredients such as minerals, vitamins (such as A and C), vitamin derivatives (such as retinoids), amino acids, coenzymes, peptides, larger proteins (such as collagen), polysaccharides, alkaloids and the like to base compositions. It is proposed in the art that the active ingredient crosses the horny epidermis and into the dermis (or even into the subdermis) to exert a functional effect on viable cells of the skin. To be properly absorbed through the skin, an active must pass through the stratum corneum, which is the outermost layer of the epidermis and the rate-limiting barrier in absorption of a many actives. There remains significant controversy as to how well any particular active is capable of crossing the significant barrier formed by the stratum corneum, and indeed even underlying structures such as the stratum germinativum, and adipose layers. Accordingly, many different formulations have been provided for any given active in order improve transport of the active across the skin. For example, penetration of vitamin C is thought to be minimal without the addition of a divalent cation (such as Zinc) in combination with a phenyl-based amino acid (such as tyrosine).

Caffeine is an active ingredient that has been utilized in a range of topical formulations. It is thought that the topical application of caffeine may provide a number of aesthetic or therapeutic outcomes for a user. For example, caffeine is known to reduce blood flow by mild constriction of blood vessels. Caffeine has also demonstrated antioxidant and antiinflammatory activities which assist in the treatment of skin conditions. In vitro metabolism studies on fat cells have shown that caffeine may decrease the rate of lipogenesis while stimulating the lipolysis via the inhibition of phosphoesterase.

While caffeine is thought to have some ability to improve certain conditions of the skin or subdermis, there has been little study of the ability for caffeine to enter the skin to exert any biological effect. Some studies have shown that the sweat glands are an important portal of entry, while others show absorption via the hair follicles. A number of trials of topical caffeine containing skin compositions have shown disappointing results, and the possibility remains that less than optimal amounts of caffeine are deliverable to the dermis and subdermis.

It is an aspect of the present invention to overcome or alleviate a problem of the prior art by providing a topical caffeine composition useful in dermatological applications. The composition may provide for an improved rate or extent of delivery of caffeine to tissues of the skin. Alternatively, the composition may provide for ease of application of caffeine, or a more acceptable appearance or feel to the skin after application. The present compositions may be simply an alternative to topical caffeine compositions of the prior art.

The discussion of documents, acts, materials, devices, articles and the like is included in this specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all of these matters formed part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.

SUMMARY OF THE INVENTION

In a first aspect, but not necessarily the broadest aspect, the present invention provides a topical composition for use on the skin of an animal, the composition comprising caffeine in combination with one or more dermatologically-acceptable or pharmaceutically acceptable excipients, wherein the composition has a relatively low water content.

In one embodiment, the water content is less than about 10% (wt/wt), or less than about 1 % (wt/wt), or is trace, or is substantially 0% (wt/wt).

In one embodiment, the caffeine is an extract from a plant of the genus Coffea or Camellia.

In one embodiment, the caffeine is present in the form of a seed oil. In one embodiment, the caffeine containing extract is present in an amount of up to about 10% (wt/wt), or up to about 1 % (wt/wt), or up to about 0.1 % (wt/wt).

In one embodiment of the composition, the dermatologically acceptable excipient(s) and/or pharmaceutically acceptable excipients is/are substantially non-polar and/or hydrophobic and/or lipophilic, or are predominantly substantially non-polar and/or hydrophobic and/or lipophilic.

In one embodiment, the dermatologically-acceptable excipient(s) and/or pharmaceutically acceptable excipients is/are plant-derived.

In one embodiment, the dermatologically-acceptable excipient(s) and/or pharmaceutically acceptable excipients is/are extracted from a plant seed.

In a further aspect, the present invention provides a method of producing a topical composition for use on the skin of an animal, the method comprising the steps of: providing a caffeine-containing extract from a tissue of a plant, and combining the caffeine containing extract with a dermatologically or pharmaceutically acceptable excipient. In a further aspect, the present invention provides a method of treating or preventing a condition relating to the epidermis, dermis or subdermis, the method comprising the steps of: providing the composition as described herein, and contacting the composition with the epidermis of animal in need thereof with a dermatologically or therapeutically effective amount of the composition under conditions allowing for the transport of the caffeine present in the caffeine-containing extract into or across the epidermis.

In one embodiment, the condition relating to the epidermis, dermis or subdermis relates to the function of an adipocyte and/or a fibroblast.

In one embodiment, the condition relating to the epidermis, dermis or subdermis selected from the group consisting of cellulite, excess adipose tissue, a rhytide, cutis laxa, thin skin, discoloured skin, dry skin, abnormal or impaired vascularity, the presence of a toxin, skin swelling, and lyphodema.

DETAILED DESCRIPTION OF THE INVENTION

After considering this description it will be apparent to one skilled in the art how the invention is implemented in various alternative embodiments and alternative applications. However, although various embodiments of the present invention will be described herein, it is understood that these embodiments are presented by way of example only, and not limitation. As such, this description of various alternative embodiments should not be construed to limit the scope or breadth of the present invention. Furthermore, statements of advantages or other aspects apply to specific exemplary embodiments, and not necessarily to all embodiments covered by the claims. Throughout the description and the claims of this specification the word "comprise" and variations of the word, such as "comprising" and "comprises" is not intended to exclude other additives, components, integers or steps.

Reference throughout this specification to "one embodiment" or "an embodiment" or "some embodiments" means that a particular feature, structure or characteristic described in connection with the embodiment are included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" or "in some embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment, but may.

The present invention is predicated at least in part on Applicant's finding that decreasing water content in topical caffeine formulations provides aesthetic and functional improvements in the skin, and also tissues beneath the skin. Accordingly, in a first aspect, the present invention provides a topical composition for use on the skin of an animal, the composition comprising caffeine in combination with one or more dermatologically- acceptable or pharmaceutically acceptable excipients, wherein the composition has a relatively low water content. It has been found that caffeine containing topical compositions are preferred by consumers where the water content of the composition is relatively low.

In the context of the present invention the term "animal" is intended to include without limitation any mammal such as a human, primate, domestic animal, beast of burden, zoo animal, agriculturally or economically significant animal. As will be appreciated, given the aesthetic and functional advantages of the present compositions as disclosed herein it is the primary intention that the compositions are formulated so as to be useful in application to humans. As used herein, the term "dermatologically acceptable excipient" includes without limitation any adjuvant, carrier, excipient, glidant, sweetening agent, diluent, preservative, dye/colorant, flavor enhancer, surfactant, wetting agent, dispersing agent, suspending agent, stabilizer, isotonic agent, solvent, or emulsifier, including those approved by the United States Food and Drug Administration as being acceptable for dermatological use on humans, or which are known, or are suitable for use in dermatological compositions.

As used herein, the term "pharmaceutically acceptable excipient" includes without limitation any adjuvant, carrier, excipient, glidant, sweetening agent, diluent, preservative, dye/colorant, flavor enhancer, surfactant, wetting agent, dispersing agent, suspending agent, stabilizer, isotonic agent, solvent, or emulsifier which has been approved by the United States Food and Drug Administration.

As used herein, the term "low" with respect to water content is intended to mean that the composition has a water content which is lower than oil-in-water or water-in-oil emulsions which are well know bases in the cosmetics formulation arts. For example, skin lotions of the prior art may have a water content of up to about 90%, with the remainder of the composition including ingredients such as oils, emulsifiers, fragrances, preservatives, actives and the like. The present invention is a significant departure from prior art lotions by providing caffeine in a low water topical composition.

Applicant has recognised a problem with prior art compositions in that caffeine is only sparingly soluble in water at ambient temperature, and so tends to precipitate out of relatively high water content compositions such as lotions and creams. It has been found that precipitation of caffeine may be reduced (or even avoided) where the water content of a caffeine-containing compositions is decreased. Thus, even a slight decrease in water content will result in a low propensity for caffeine to precipitate out of the composition.

Water content may be reduced by formulating the composition using an anhydrous form of caffeine. As is well known to the skilled person, caffeine may be isolated by water extraction methods whereby coffee beans are first soaked in water. The water is then passed through activated charcoal, which adsorbs the caffeine. The caffeine is reclaimed from the charcoal and dried to provide a substantially anhydrous form of caffeine.

Another method is by supercritical carbon dioxide extraction whereby carbon dioxide is forced through coffee beans at temperatures above 31 .1 °C and pressures above 73 atm. Under these conditions, carbon dioxide is in a "supercritical" state, and capable of dissolving 97-99% of the caffeine. The caffeine-laden gas is then sprayed with high pressure water to remove the caffeine. The caffeine can then be further isolated by charcoal adsorption (as above) or by distillation, recrystallization, or reverse osmosis.

A further method is by extraction using organic solvents such as ethyl acetate or dichloromethane. The extracted caffeine is then dried to a powdered form.

In one embodiment, the caffeine of the topical composition is used in the form of a caffeine- containing oil obtained from a tissue of a plant (such as a plant of the genus Coffea or Camellia). For example, triglyceride oils may be obtained from coffee beans (for example by cold pressing) with these oils being rich in caffeine. An advantage of this embodiment of the composition is that the caffeine is used in a naturally occurring form, having not been exposed to solvents or any other artificial compound or process. Thus, the caffeine is present amongst a matrix of non-caffeine compounds some of which are biologically active. As an example, chlorogenic acid (found in green coffee) is known to improve fat metabolism. Other actives include diterpenes, such as cafestol and kahweol which are thought to have anticarcinogenic properties.

Irrespective of the source of caffeine, the topical composition may have a water content of less than about 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 25%, 20%, 15%, 10%, or 5% (wt/wt).

It will be appreciated that caffeine preparations having some water content may be used as the source of caffeine for the present compositions. For example, water extracted caffeine which is still in aqueous solution may be used so long as the total water content of the composition is lower than that of a prior art lotion or cream. Thus, water within which the caffeine is dissolved (and added to form the composition) contributes toward the total water content of the topical composition. Similarly, the water content of any non-caffeine substantially aqueous component contributes toward the total water content of the topical composition.

In some embodiments the topical composition has a water content which is low (in an absolute sense) and may be less than about 5%, 4.5%, 4.0%, 3.5%, 3.0%, 2.5%, 2.0%, 1 .5%, 1 .0%, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.2%, or 0.1 % (wt/wt). In some embodiments, the composition is substantially free of water (i.e. about 0% (wt/wt)).

In addition or alternatively to the advantages of a relatively low or absolutely low water content composition discussed supra, there is a further advantage for some embodiments that the caffeine is delivered to the skin in a substantially non-aqueous (or substantially oily) vehicle. In this form, the caffeine is carried in a substantially lipophilic vehicle and therefore has a greater propensity to cross the stratum corneum (at least) and therefore contact the viable underlying cells of the dermis and/or subdermis.

In addition or alternatively to the advantages of a relatively low or absolutely low water content composition discussed supra, there is a further advantage for some embodiments that the composition remains for a longer period on the skin surface (or within the stratum corneum) given the lower amounts of water (which may be considered a volatile solvent in prior art lotions and creams). The longer residence time in or on the skin may provide a depot effect whereby caffeine enters the underlying tissues over a period of time, this avoiding a sharp peaking caffeine dosage being provided shortly after application. In addition or alternatively to the advantages of a relatively low or absolutely low water content composition discussed supra, there is a further advantage for some embodiments that the composition provides an improved immediate cosmetic effect for the user's skin. Higher oil content compositions may provide an aesthetically desirable shine or a glow to the skin surface.

In addition or alternatively to the advantages of a relatively low or absolutely low water content composition discussed supra, there is a further advantage for some embodiments that the composition is more easily applied, or in more pleasurable to apply to the skin.

The caffeine in the present compositions may be present as a trace amount or even up to saturation amounts. The amount may vary according to the condition to be treated, a proposed dosage regime, the species of animal to be treated, the physiological state of the animal to be treated, and any other matter deemed pertinent by the skilled person. In some embodiments, the caffeine is present in the composition in an amount of up to about 10%. 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1 %, 0.9%, 0.8%, 0.7%, 0.6%, 0.5%, 0.4%, 0.3%, 0.3% or 0.1 %.

In some embodiments, the composition comprises non-caffeine containing oils, and particularly plant-derived oils. For examples, oils derived from grape seed, almond, orange peel oil, hemp seed oil, coconut oil, cocoa seed oil, and the like may separately, or in any combination, be useful in the present compositions.

In some embodiments, the topical composition is formulated as a body balm or butter, and may therefore comprise one or more oils, waxes, butters, fats and the like known to be useful in the manufacture of such products. Otherwise, the compositions may be formulated more so according to a lotion or a cream, although in any event having a lower water content than any prior art lotion or cream. As required, and with the benefit of the present specification the skilled person is enabled to decide whether or not any buffer or salt is required to provide a required pH of ionic strength for the composition. Acceptable salts include those salts which retain the biological effectiveness and properties of the free acids, which are not biologically or otherwise undesirable. These salts are prepared from addition of an inorganic base or an organic base to the free acid. Salts derived from inorganic bases include, but are not limited to, the sodium, potassium, lithium, ammonium, calcium, magnesium, iron, zinc, copper, manganese, aluminum salts and the like. Preferred inorganic salts are the ammonium, sodium, potassium, calcium, and magnesium salts. Salts derived from organic bases include, but are not limited to, salts of primary, secondary, and tertiary amines, substituted amines including naturally occurring substituted amines, cyclic amines and basic ion exchange resins, such as ammonia, isopropylamine, trimethylamine, diethylamine, triethylamine, tripropylamine, diethanolamine, ethanolamine, 2-dimethylaminoethanol, 2- diethylaminoethanol, dicyclohexylamine, lysine, arginine, histidine, caffeine, procaine, hydrabamine, choline, betaine, benethamine, benzathine, ethylenediamine, glucosamine, methylglucamine, theobromine, triethanolamine, tromethamine, purines, piperazine, piperidine, N-ethylpiperidine, polyamine resins and the like.

In another aspect, the present invention provides a method of producing a topical composition for use on the skin of an animal, the method comprising the steps of: providing caffeine, and combining the caffeine containing extract with a dermatologically or pharmaceutically acceptable excipient. Where an ingredient is solid (or at least very viscous) at ambient temperature, that ingredient (either alone or when already in a mixture) may be heated to improve the ability to combine with, mix with, or solubilise other components of the composition. In such a case, the composition may be dispensed into a container to form a vendible product before complete cooling and solidification of any component.

In a further aspect, the present invention provides a method of treating or preventing a condition relating to the epidermis, dermis or subdermis, the method comprising the steps of: providing the composition as described herein, and contacting the composition with the epidermis of animal in need thereof with a dermatologically or therapeutically effective amount of the composition under conditions allowing for the transport of the caffeine present in the caffeine-containing extract into or across the epidermis.

"Treating" or "treatment" as used herein covers the treatment of the disorder or condition of interest in a human having the disorder or condition of interest, and includes:

(i) preventing the condition from occurring in the animal, in particular, when such animal is predisposed to the condition but has not yet been diagnosed as having the condition or;

(ii) inhibiting the condition, i.e., arresting its development;

(iii) relieving the condition, i.e., causing regression of the condition; or

(iv) stabilizing the condition. "Dermatologically effective amount" refers to that amount of an active ingredient which, when administered dermatologically (i.e., topically) to an animal, is sufficient to effect the desired treatment, as defined below, of the condition of interest in the animal. The amount of an active ingredient which constitutes a "dermatologically effective amount" may vary depending on, the condition and its severity, and the age of the animal to be treated, but can be determined routinely by one of ordinary skill in the art having regard to his own knowledge and to this disclosure.

"Therapeutically effective amount" refers to that amount of an active ingredient which, when administered orally to an animal, is sufficient to effect the desired treatment, as defined below, of the condition of interest in the animal. The amount of an active ingredient which constitutes a "therapeutically effective amount" may vary depending on, the condition and its severity, and the age of the animal to be treated, but can be determined routinely by one of ordinary skill in the art having regard to his own knowledge and to this disclosure.

The condition relating to the epidermis, dermis or subdermis may be selected from the group consisting of cellulite, excess adipose tissue, a rhytide, cutis laxa, thin skin, discoloured skin, dry skin, abnormal or impaired vascularity, the presence of a toxin, skin swelling, and lyphodema.

Caffeine has known biological activities with respect to a range of cell types. With reference to the present invention such biological activities may be directed against any cell of the epidermis, dermis or subdermis such as an adipocyte and/or a fibroblast. In accordance with the method, the composition is typically self-applied by the user, by placing an aliquot on the hand and smoothing the composition of the skin requiring treatment.

It will be appreciated that in the description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognize that other and further modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as fall within the scope of the invention. Steps may be added or deleted to methods described within the scope of the present invention.

Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.

The present invention will be more clearly described by reference to the following non- limiting examples.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

In embodiments using coffee seed oil, the oil was cold pressed and used as an essential oil without further modification. Roasted Coffea arabica beans were used for all pressings.

Suppliers for the remaining ingredients were as follows.

Beeswax Redox Pty Ltd, Australia

Cocoa Butter Bronson & Jacobs Pty Ltd, Australia

Shea Butter Aromatic Ingredients Pty Ltd, Australia

Grape Fruit Seed Extract N Essentials Pty Ltd, Australia

Candelilla wax Ingredients Plus Pty Ltd, Australia

Caprylic/Capric Natural Instinct Pty Ltd, Australia Triglyceride -

Vitamin E Ingredients Plus Pty Ltd, Australia

Sweet Orange Oil New Directions Pty Ltd, Australia

Hemp Seed Oil New Directions Pty Ltd, Australia

Preferred Composition 1. Substantially water-free body balm

(Orange) Peel Oil

Cannabis Sativa Seed Oil 0.1 - Hemp Seed Oil

METHOD OF MANUFACTURE:

· Add Cetearyl Alcohol, butters, candelilla wax, grapeseed, sweet almond and coconut oil into main mix tank.

• Heat to 80 degrees with stirring until all melted and uniform.

• Once tank is below 60 degrees; add remaining ingredients.

• Mix until all ingredients are evenly dispersed.

· Pour at 46- 50 degrees and allow to set.

Preferred Composition 2. Low water content composition with emulsifying agent - first embodiment

METHOD OF MANUFACTURE:

• Combine all ingredients into main mix tank. • Heat to 80 degrees with stirring until all dispersed and uniform.

• Pour at 46- 50 degrees and allow to cool.

Preferred Composition 3. Low water content composition with emulsifying agent - second embodiment

METHOD OF MANUFACTURE:

• Combine all ingredients into main mix tank.

• Heat to 80 degrees with stirring until all dispersed and uniform.

• Pour at 46- 50 degrees and allow to cool. Preferred Composition 4. Low water content composition with emulsifying agent - third embodiment

Ceteareth-20 10.0 68439-49-6 Ceteareth-20

Prunus Amygdalus Dulcis 12.6 8007-69-0 Sweet Almond Oil (Sweet Almond) Oil

Cocos Nucifera (Coconut) Oil 10.0 8001 -31 -8 Coconut Oil

Cetearyl Alcohol 5.5 67762-27-0 Cetearyl Alcohol (CSA)

Coffea Arabica (Coffee) Seed 3.0 Coffee Seed Oil

Oil

Tocopherol 0.5 1406-18-4 Vitamin E

METHOD OF MANUFACTURE:

• Combine all ingredients into main mix tank.

• Heat to 80 degrees with stirring until all dispersed and uniform.

• Pour at 46- 50 degrees and allow to cool.

Preferred Composition 5. Low water content composition with emulsifying agent - fourth embodiment

METHOD OF MANUFACTURE:

• Combine all ingredients into main mix tank.

• Heat to 80 degrees with stirring until all dispersed and uniform.

Pour at 46- 50 degrees and allow to cool.

Preferred Composition 6. Substantially water-free body balm using anhydrous caffeine. Vitis Vinifera (Grape) Seed Oil 43.1 8024-22-4 Grapeseed Oil

Prunus Amygdalus Dulcis 30.0 8007-69-0 Sweet Almond Oil

(Sweet Almond) Oil

Cocos Nucifera (Coconut) Oil 10.0 8001 -31 -8 Coconut Oil

Cetearyl Alcohol 5.5 67762-27-0 Cetearyl Alcohol (CSA)

Beeswax (Cera Alba) 5.0 8012-89-3 Beeswax

Theobroma Cacao (Cocoa) 2.0 8002-31 -1 Cocoa Butter

Seed Butter ^*

Butyrospermum Parkii (Shea 2.0 194043-92- Shea Butter

Butter) 0

Caffeine (anhydrous) USP 0.094 58-08-2 Caffeine

Vitis Vinifera (Grape) Fruit 0.001 84929-27-1 Grape Fruit Seed Extract Extract

Euphorbia Cerifera (Candelilla) 0.5 8006-44-8 Candelilla wax

Wax

Caprylic/Capric Triglyceride 0.905 65381 -09-1 Caprylic/Capric

Triglyceride

Tocopherol 0.5 1406-18-4 Vitamin E

Citrus Aurantium Dulcis 0.3 8008-57-9 Sweet Orange Oil

(Orange) Peel Oil

Cannabis Sativa Seed Oil 0.1 - Hemp Seed Oil

METHOD OF MANUFACTURE:

· Add Cetearyl Alcohol, butters, candelilla wax, grapeseed, sweet almond and coconut oil into main mix tank.

• Heat to 80 degrees with stirring until all melted and uniform.

• Once tank is below 60 degrees; add remaining ingredients.

• Mix until all ingredients are evenly dispersed.

· Pour at 46- 50 degrees and allow to set. Preferred Method of Treatment 1 for Cellulite.

Preferred Composition 1 as detailed supra was used in a prospective cohort study of 10 women between the ages of 18 and 25 years. All participants demonstrated physical signs of cellulite on the thighs and buttocks.

A liberal amount of the composition was self-applied daily to the thighs and buttocks (typically after bathing) for a period of 4 weeks. All participants reported the composition was easy to apply and, and agreed with the proposition that the composition left an aesthetically pleasing shine to the skin.

At the conclusion of the test period, all participants reported a decrease in the appearance of cellulite upon self assessment. Some (but not all) participants reported a localized reduction in adipose tissue in the thigh and buttock region by self-assessment.

Preferred Method of Treatment 2 for Skin Laxity.

Preferred Composition 5 as detailed supra was used in a prospective cohort study of 12 women between the ages of 45 and 55 years. All participants demonstrated physical signs of skin laxity about the abdomen.

A liberal amount of the composition was self-applied daily to the abdomen (typically after bathing) for a period of 4 weeks. All participants reported the composition was easy to apply and, and agreed with the proposition that the composition left an aesthetically pleasing shine to the skin.

At the conclusion of the test period, most participants reported a tightening of the abdominal skin in the abdominal area upon self assessment. Most participants also reported an improvement in skin texture at the treatment site.

Preferred Method of Treatment 3 for the Physical Signs of Ageing Skin on the Face.

Preferred Composition 6 as detailed supra was used in a prospective cohort study of 25 women between the ages of 35 and 45 years. All participants demonstrated at least one physical sign of ageing about the face and neck including skin pigmentation/discolouration, skin laxity, redness/inflammation, dry skin, and wrinkles. A sparing amount of the composition was self-applied daily to the face and neck (typically before bed time) for a period of 12 weeks. All participants reported the composition was easy to apply and, and agreed with the proposition that the composition left an aesthetically pleasing shine to the skin.

At the conclusion of the test period, all participants reported a lessening of at least one sign of ageing on the face and neck by self-assessment. Skin laxity in particular was found to be improved by use of Preferred Composition 6.