Skincare compositions

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a US National Stage of International Application No. PCT/GB2010/051170, filed 19 Jul. 2010, which claims the benefit of GB 0912481.9, filed 17 Jul. 2009, both herein fully incorporated by reference.

FIELD OF THE INVENTION

This invention relates to skincare compositions, in particular compositions effective in the treatment of acne vulgaris, and to methods of treatment of the skin that involve the application of such compositions.

BACKGROUND OF THE INVENTION

Acne vulgaris (acne) is a chronic inflammatory condition of the pilosebaceous units of the skin, which is particularly prevalent in adolescents. The condition generally causes the formation, on the skin, of comedones, red papules, pustules and sometimes cysts. This is unsightly and furthermore, if untreated, acne can lead to scarring of the skin. The major causes of acne are thought to be an increase in sebum production, an increased presence of propionibacterium acne (P. acne), blockage of the pilosebaceus duct and the production of inflammation.

Salicylic acid is known to be effective in the treatment of acne. It is a topical keratolytic agent that works by dissolving the intercellular cement that holds epithelial cells together. Salicylic acid is used in a variety of over-the-counter acne remedies.

In order to improve the efficacy of topical acne treatments, it is desired to formulate salicylic acid with one or more control agents to regulate the inflammatory effects sometimes observed, such as local skin peeling and discomfort such as burning and skin reddening.

BRIEF SUMMARY OF THE INVENTION

Surprisingly, it has now been found that skincare compositions comprising salicylic acid and at least two or more chosen actives have improved therapeutic efficacy in the treatment of acne. Said skincare compositions have both the ability to treat acne and reduce the appearance of redness on the skin.

Thus, according to a first aspect of the invention there is provided a skincare composition suitable for topical application to the skin, the composition comprising salicylic acid or a salt thereof, combined with at least 2 actives selected from the group consisting of: lactic acid or a salt thereof; glycyrrhizinic acid or a salt or derivatives thereof; bisabolol; cetylhydroxyproline palmitamide; allantoin; niacinamide; and, Canadian Willowherb (epilobium angustifolium) extract.

It has been found that this treatment provides advantages over existing acne treatments, particularly in tolerance of the acne treatment by the skin. It may have an effect in reducing the severity of the acne and hence any associated marks or scarring that can occur; furthermore, cutaneous irritation may be reduced. Other measures indicating advantages are the reduction in inflammation in the affected skin and/or a soothing effect. A synergistic association between the chosen combination of ingredients may provide that a composition may have lesser amounts of each individual ingredient

Salicylic acid is preferably incorporated into the composition according to the invention as the free acid. However, the pH of the composition may, and generally will, be such that the salicylic acid exists in the composition in dissociated form. As the composition may well contain cationic counterions, the salicylic acid may then be thought of as being present in salt form. Alternatively, the salicylic acid may be incorporated into the composition already in salt form, eg as a salt with a Group I metal, such as sodium salicylate. As used herein, unless the context requires otherwise, any and all references to salicylic acid should be taken to encompass references to the acid and to dissociated forms and salts thereof.

The concentration of salicylic acid in the composition according to the invention is preferably at least 0.01 percent by weight, more preferably at least 0.1 percent, most preferably at least 0.5 percent and especially at least 1 percent by weight. The concentration of salicylic acid is preferably less than 10 percent, more preferably less than 5 percent, most preferably less than 4 percent and especially less than 3 percent by weight. The concentration of salicylic acid may therefore fall in the range 0.01 percent to 10 percent by weight, more preferably 0.1 percent to 5 percent, and most preferably 0.5 percent to 4 percent and especially 1 to 3 percent by weight. A particularly preferred concentration of salicylic acid is 2 percent by weight.

The concentration of lactic acid or salt thereof when present in the composition is at least 0.01 percent by weight, more preferably at least 0.1 percent by weight and most preferably at least 1 percent by weight; and is less than 10 percent by weight, more preferably less than 5 percent by weight, and most preferably less than 3 percent by weight.

The concentration of glycyrrhizinic acid or a salt or a derivative thereof when present in the composition is at least 0.01 percent by weight and is less than 2 percent by weight, more preferably less than 1 percent by weight, and most preferably less than 0.5 percent by weight.

The concentration of bisabolol when present in the composition is at least 0.001 percent by weight, more preferably at least 0.01 percent by weight and is less than 1 percent by weight, more preferably less than 0.5 percent by weight,

The concentration of cetylhydroxyproline palmitamide when present in the composition is at least 0.001 percent by weight, more preferably at least 0.01 percent by weight and is less than 1 percent by weight, more preferably less than 0.5 percent by weight.

The concentration of allantoin when present in the composition is at least 0.01 percent by weight, more preferably at least 0.1 percent by weight and most preferably at least 0.2 percent by weight, and is less than 5 percent by weight, more preferably less than 2 percent by weight, and most preferably less than 1 percent by weight.

The concentration of niacinamide when present in the composition is at least 0.01 percent by weight, more preferably at least 0.1 percent by weight and most preferably at least 0.5 percent by weight, and is less than 10 percent by weight, more preferably less than 5 percent by weight.

The concentration of epilobium angustifolium extract when present in the composition is at least 0.01 percent by weight, and is less than 5 percent by weight, more preferably less than 1 percent by weight, and most preferably less than 0.5 percent by weight.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

In a particularly preferred embodiment of the present invention, there is provided a skincare composition comprising 0.1 to 5 wt % salicylic acid, or a salt thereof, in combination with at least 2 actives selected from the group consisting of: 0.1 to 5 wt % lactic acid or a salt thereof; 0.01 to 1 wt % glycyrrhizinic acid or a salt or derivative; 0.001 to 1 wt % bisabolol; 0.001 to 1 wt % cetylhydroxyproline palmitamide 0.1 to 2 wt % allantoin; 0.1 to 5 wt % niacinamide; and, 0.001 to 1% epilobium angustifolium extract

In a further particularly preferred embodiment of the present invention, there is provided a skincare composition comprising 1 to 3 wt % salicylic acid or a salt thereof; in combination with at least 2 actives selected from the group consisting of: 1 to 3 wt % lactic acid or a salt thereof; 0.01 to 0.5 wt % glycyrrhizinic acid or a salt or derivative 0.02 to 0.5 wt % bisabolol; 0.01 to 0.5 wt % cetylhydroxyproline palmitamide 0.2 to 1 wt % allantoin; 0.5 to 5 wt % niacinamide; and, 0.01 to 0.5% epilobium angustifolium extract.

The composition is preferably prepared with a pH in the range 2.5 to 8.0, more preferably 3.0 to 7.0, and particularly a pH in the range 3.5 to 6.0, e.g. about pH 4.5 or pH 5.5.

A composition according to the invention may comprise one or more further topically active ingredients useful in skincare. Such active ingredients may include one or more of the following:

antimicrobial or antibacterial compounds, for example selected from the following: triclosan, neomycin, clindamycin, polymyxin, bacitracin, benzoyl peroxide, hydrogen peroxide, tetracylines such as doxycycline or minocycline, sulfa drugs such as sulfacetamide, penicillins, cephalosporins such as cephaiexin, and quinolones such as lomefloxacin, olfoxacin or trovafloxacin;

antiviral compounds, for example selected from acyclovir, tamvir, and penciclovir;

antifungal compounds, for example selected from the following: framesol, clotrimazole, ketoconazole, econazole, fluconazole, calcium or zinc undecylenate, undecylenic acid, butenafine hydrochloride, ciclopirox olaimine, miconazole nitrate, nystatin, sulconazole, and terbinafine hydrochloride; anti-inflammatory compounds, for example selected from the following: steroidal agents selected from hydrocortisone, fluocinolone acetonide, halcinonide, halobetasol propionate, clobetasol propionate, betamethasone dipropionate, betamethasone valerate, and triamcinolone acetonide, and non-steroidal anti-inflammatory agents selected from aspirin, ibuprofen, ketoprofen, naproxen, aloe vera gel, aloe vera, licorice extract, pilewort or zinc;

anthelmintic compounds, for example metronidazole.

The composition according to the invention may be formulated in numerous forms. However, the composition may often take the form of an aqueous or oily solution or surfactant wash or dispersion or emulsion or a gel. An emulsion may be an oil-in-water emulsion or a water-in-oil emulsion or microemulsion.

The oil phase of emulsions may comprise, but are not exclusive to: hydrocarbon oils such as paraffin or mineral oils; b) waxes such as beeswax or paraffin wax; c) natural oils such as sunflower oil, apricot kernel oil, shea butter or jojoba oil; d) silicone oils such as dimethicone, cyclomethicone or cetyldimethicone; e) fatty acid esters such as isopropyl palmitate, isopropyl myristate, dioctylmaleate, glyceryl oleate and cetostearyl isononanoate; f) fatty alcohols such as cetyl alcohol or stearyl alcohol and mixtures thereof (eg cetearyl alcohol); g) polypropylene glycol or polyethylene glycol ethers, eg PPG-14 butyl ether; or h) mixtures thereof, for example, the blend of waxes available commercially under the trade name Cutina (Henkel).

Emulsifiers used may be any emulsifiers known in the art for use in water-in-oil or oil-in-water emulsions or microemulsions. Known cosmetically acceptable emulsifiers may include: a) sesquioleates such as sorbitan sesquioleate, available commercially for example under the trade name Arlacel 83 (ICI), or polyglyceryl-2-sesquioleate; b) ethoxylated esters of derivatives of natural oils such as the polyethoxylated ester of hydrogenated castor oil available commercially for example under the trade name Arlacel 989 (ICI); c) silicone emulsifiers such as silicone polyols available commercially for example under the trade name ABIL WS08 (Th. Goldschmidt AG); d) anionic emulsifiers such as fatty acid soaps e.g. potassium stearate and fatty acid sulphates e.g. sodium cetostearyl sulphate available commercially under the trade name Dehydag (Henkel); e) ethoxylated fatty alcohols, for example the emulsifiers available commercially under the trade name Brij (ICI); f) sorbitan esters, for example the emulsifiers available commercially under the trade name Span (ICI); g) ethoxylated sorbitan esters, for example the emulsifiers available commercially under the trade name Tween (ICI); h) ethoxylated fatty acid esters such as ethoxylated stearates, glyceryl monostearates for example the emulsifiers available commercially under the trade name Myrj (ICI); i) ethoxylated mono-, di-, and tri-glycerides, for example the emulsifiers available commercially under the trade name Labrafil (Alfa Chem.); j) non-ionic self-emulsifying waxes, for example the wax available commercially under the trade name Polawax (Croda); k) ethoxylated fatty acids, for example, the emulsifiers available commercially under the trade name Tefose (Alfa Chem.)

l) methylglucose esters such as polyglycerol-3 methyl glucose distearate available commercially under the name Tegocare 450 (Degussa Goldschmidt); m) as well as polyacrylamide emulsifier systems for examples cream gel emulsifier under trade name Sepigel 305 (Seppic) or n) mixtures thereof.

Gels provided according to the invention may be aqueous or non-aqueous. Aqueous gels are preferred. The gel will contain a gelling agents in order to give sufficient viscosity to the gel. Suitable gelling agents may be hydroxypropyl guar or a copolymer of acryloyl dimethyl tauric acid (or a salt thereof), especially a copolymer of that monomer with another vinylic monomer. The salt may be a salt of a Group I alkali metal, but is more preferably an ammonium salt. Examples of suitable copolymer gelling agents are ammonium acryloyl dimethyl taurate/vinyl pyrrolidone copolymer, ammonium acryloyl dimethyl taurate/Beheneth-25 methacrylate copolymer, ammonium acryloyldimethyltaurate/vinyl formamide copolymer These materials are available from Clariant GmbH in the range of products under the trade name Aristoflex.

A variety of thickening agents may also be used according to the nature of the liquid carrier and the viscosity required. Thickeners that are water-soluble or hydrophilic are preferred, and examples include acrylic acid polymers, eg those available commercially under the trade name Carbopol (B.F. Goodrich), modified celluloses, eg hydroxypropylmethylcellulose or hydroxyethylcellulose available commercially under the trade name Natrosol (Hercules), alkylgalactomanans available under the trade name N-Hance, xanthan gum, cetyl alcohol and sodium chloride.

The amount of gelling and/or thickening agent in the composition will each preferably lie in the range 0.1 to 5 percent w/w, more preferably 0.5 to 5 percent w/w. Typically, the amount of gelling and/or thickening agent will each be less than 3 percent w/w, eg about 1 percent w/w or about 2 percent w/w.

The composition according to the invention preferably has a viscosity of from about 10,000 mPas to about 200,000 mPas, Viscosity may be measured using a Brookfield RVT viscometer equipped with a T bar C rotating at 5 rpm for 1 minute.

In many instances, it is preferred that the composition should comprise a chelating or sequestering agent, or other agent capable of complexation or other interaction with metal ions present in the composition. Such agents may improve the stability of the composition, and in particular may inhibit or prevent degradation of several ingredients (eg fragrance). Examples of chelating or sequestering agents include ethylenediamine tetraacetic acid and its salts, notably the dipotassium and especially the disodium salt.

In the case of solutions or dispersions, and gels, the composition will generally contain a solvent system or other continuous liquid phase. Such a system is preferably aqueous. However, mixed solvent systems may often be used with advantage. Such a mixed solvent system most preferably comprises water, in admixture with a co-solvent, most preferably a lower (eg C.sub.1-6) alcohol, in particular ethanol and t-butyl alcohol.

Preferred aqueous systems comprise water in an amount of at least 25 percent by weight, more preferably at least 35 percent by weight, The upper limit of water will depend on the amounts of other ingredients incorporated in the composition so that the water may form the remainder of the composition up to 100 percent of the composition.

The composition may additionally comprise other components which will be well known to those skilled in the art. These include, for example:

a) Emollients--ingredients that help to maintain the soft, smooth and pliable appearance of skin. Such ingredients may function by their ability to remain on the surface of the skin or in the stratum corneum, and to act as lubricants, reducing or preventing flaking of the skin and improving the skin's appearance. Examples of emollients are isopropyl myristate, triglycerides of fatty acids eg lauric triglyceride or capric/caprylic triglyceride, such as the triglyceride available commercially under the trade name Miglyol 810 (Huls UK), and the polypropylene glycol ether of stearyl alcohol known as PPF-15 Stearyl Ether. Particularly preferred emollients are octyldodecanol and polysiloxane compounds, in particular those known as dimethicones.

b) Humectants or Moisturisers--ingredients intended to increase the water content of the top layers of the skin. Examples of such ingredients are glycerin, sorbitol, 1,3-butylene glycol and propylene glycol.

c) Surfactants--Surfactants may be used in compositions according to the invention as solubilisers, or as cleansing agents or foam boosters. Many different classes of surfactant may be suitable for inclusion in the composition according to the invention, and these will be readily apparent to those skilled in the art. Examples of suitable surfactants include anionic surfactants (eg sodium laureth sulphate, non ionic surfactants (eg cocoglucoside) cationic surfactants and/or amphoteric surfactants (eg cocoamidoproyl betaine). Polyethylene glycol ethers of alcohols such as isocetyl alcohol (eg Isoceteth-20), isostearyl alcohol (eg Isosteareth-20), cetyl alcohol (eg Ceteth-20), oleyl alcohol (eg Oleth-20) and cetearyl alcohol (eg Ceteareth-20).

d) Preservatives--ingredients which prevent or retard microbial growth and thus protect the composition from spoilage. Examples of preservatives include such as propylparaben, bronopol, sodium dehydroacetate, polyhexamethylenebiguanide hydrochloride, isothiazolone and diazolidinylurea.

e) Chelating agents or sequestering agents (sequestrants)--ingredients that have the ability to complex with and inactivate metallic ions in order to prevent their adverse effects on the stability or appearance of the composition, as described above. Examples of chelating agents are ethylenediamine tetraacetic acid and its salts, notably the dipotassium and especially the disodium or tetrasodium salt.

f) Abrasives--ingredients used to assist in the removal of unwanted tissue or foreign materials from the skin during application of the composition. Abrasives commonly comprise fine solid particles. Examples of suitable abrasives are polyethylene beads and aluminium oxide

g) opacifying agents such as clays (eg kaolin and bentonite) as well as titanium dioxide.

h) pH adjusters--Ingredients used to control the pH of the composition. Examples of pH adjusters are inorganic salts such as sodium hydroxide, and organic bases such as triethanolamine and arginine.

i) Conditioning agents, for example distearyldimonium chloride.

j) Perfumes and colourings.

The composition according to the invention may be applied and left on the skin to have the desired therapeutic effect or it may be applied and then rinsed off, for example with water for surfactant based formulations. The composition may be applied with the aid of a fibrous material, for example a pad or a wipe.

According to another aspect of the invention, there is provided an article comprising a fibrous substrate, for example a material in the form of a pad or a wipe, impregnated with a skincare composition comprising salicylic acid or a salt thereof and at least 2 actives selected from the group consisting of lactic acid or a salt thereof; glycyrrhizinic acid or a salt or derivative thereof; bisabolol; cetylhydroxyproline palmitamide; allantoin; niacinamide; and, and epilobium angustifolium extract.

The fibrous material may be used to apply the composition onto the skin.

Suitable fibrous materials include cellulose or cotton fibres or a mixture thereof. The fibrous material may be impregnated with the composition as a wet wipe which is arranged for immediate use to apply the skincare composition of the present invention to the skin of the user. Alternatively, the fibrous material may be impregnated with the skincare composition and dried to form a dry wipe which requires to be wetted, for example with water, before it can be used.

According to a further aspect of the invention, there is provided method for the prophylactic or remedial treatment of acne, which method comprises the topical application to the skin of a patient of a skincare composition comprising salicylic acid or a salt thereof and at least 2 of the list comprising lactic acid or a salt thereof; glycyrrhizinic acid or a salt and their derivatives, bisabolol; cetylhydroxyproline palmitamide, allantoin, niacinamide. and epilobium angustifolium extract.

It will be appreciated that the method according to this aspect of the invention may be a therapeutic method, but will often be a primarily cosmetic method, the objective of which is to reduce or eliminate externally visible, and often unsightly, symptoms of acne vulgaris.

In a yet further aspect of the invention, there is provided the use of salicylic acid and at least 2 actives selected from the group consisting of lactic acid (or salts thereof); glycyrrhizinic acid (or salts or derivatives thereof); bisabolol; cetylhydroxyproline palmitamide; allantoin; niacinamide and epilobium angustifolium in the manufacture of a composition for the prophylactic or remedial treatment of acne by topical application of the composition to the skin.

The invention will now be described in greater detail, by way of illustration only, with reference to the following Examples.

Example 1: Serum

Example 2: Clear gel scrub

Example 3: Pearlised Gel Scrub

Example 4: Wash/mask

Example 5: Wash/mask

Example 6: Hydro alcoholic gel

Example 7: Cream Scrub

Example 8: Foaming Cream Scrub

The composition of each of these examples is shown fully in the following Tables 1-8.

Example 1

TABLE-US-00001 % w/w in % w/w in Trade Name Formula Function EU INCI Name final formula Purified water QS 100 Solvent Aqua to100% Dissolvine Na2 0.05 Sequestrant Disodium EDTA 0.05000 Carbopol Ultrez 20 0.60 Thickener 0.60000 Veegum Ultra 0.25 Viscosity control Magnesium 0.24250 (Thickener) Aluminum Silicate CI 77891 0.00750 Keltrol RD 0.75 Emulsion Xanthan Gum 0.75000 stabilising/ Viscosity control Titanium dioxide 0.20 pigment CI 77891 0.20000 Ph Eur Eutanol G 4.50 Emollient Octyldodecanol 4.50000 Arlamol HD 1.50 Emollient Isohexadecane 1.50000 Silfar 100 2.00 Skin conditioning Dimethicone 2.00000 Salicylic acid 2.00 Keratolytic active Salicylic Acid 2.00000 DENATURED 4.80 Solvent Alcohol Denat. 4.79376 ETHANOL SDA- (Ethyl Alcohol) 40B 200 PROOF Denaturant Denatonium Benzoate 0.00003 Denaturant Tert-Butyl alcohol 0.00624 SEPIGEL 305 2.0000 Emulsion Aqua 0.71167 stabilising/ Polyacrylamide 0.80000 Viscosity control C13-14 lsoparaffin 0.37833 Laureth-7 0.11000 CLEARLY FRESH 0.2000 Fragrance Benzyl salicylate 0.01844 FRAGRANCE Limonene 0.00689 Parfum 0.20000 Sodium hydroxide 2.35 Buffering agent Aqua 1.64500 30% soln Sodium hydroxide 0.70500 Purasal S/HQ 60 3.33 moisturiser, skin Aqua 1.332 lightener, anti- Sodium Lactate 1.99800 inflammatory Symrepair 0.50 Anti-inflammatory, Hexyldecanol 0.42000 wound healing Bisabolol 0.02500 Cetylhydroxyproline 0.02500 Palmitamide Stearic Acid 0.02500 Brassica Campestris 0.00500 Sterols Nicotinamide 2.00 skin lightening, Niacinamide 2.00000 anti-inflammatory Dipotassium 0.10 anti-inflammatory/ Dipotassium 0.10000 Glycyrrhizate skin lightening Glycyrrhizate Allantoin 0.50 anti-inflammatory Allantoin 0.50000 Canadian 0.50 Anti-inflammatory Epilobium 0.0100 Willowherb angustifolium

Example 2

TABLE-US-00002 % w/w in % w/w in Trade Name Formula Function EU INCI Name final formula Purified Water To 100% Solvent Aqua to 100% Carbopol 1.3 Suspending Agent Acrylates/C10-30 Alkyl 1.3 Ultrez 20 Acrylate Crosspolymer Dissolvine Na2 0.1 Sequestring Agent Disodium EDTA 0.1 Glycerin 8 Humectant Glycerin 8 Sorbitol 2 Humectant Sorbitol 1.40 Aqua 0.60 Empicol ESB3/ 20 Surfactant Aqua 14.37 M6 Sodium Laureth Sulfate 5.40 Sodium Hydroxide 0.2 Salicylic Acid 2 Active Salicylic Acid 2 Cocoglucoside 4.8 Surfactant Aqua 2.352 Cocoglucoside 2.544 Tego Betaine 6.9 Surfactant Cocamidopropyl Betaine 2.553 Aqua 3.726 Sodium Chloride 0.5037 Perfume 0.25 Fragrance Parfum 0.25 Clearly Fresh Limonene 0.010329 Benzyl Salicylate 0.023055 Sodium 3 pH Adjuster Sodium Hydroxide 0.9 Hydroxide Aqua 2.1 Aluminium 1.2 Exfoliating Beads Alumina 1.2 Oxide Cotahylene 1 Exfoliating Beads Polyethylene 1 HO 1681 Gotalene 0.2 Exfoliating Beads Polyethylene + COLOUR 0.2 Green (TBD) Genamin PQ 43 1 Skin Conditioner Aqua 0.85 Polyquaternium 43 0.15 FD&C Yellow 6 0.001 Colourant CI 15985 0.001 FD & C Blue 1 0.002 Colourant CI 42090 0.002 Purasal S/HQ 3.33 Moisturiser, Skin Aqua 1.3320 60 lightener, Anti- Sodium Lactate 2.0000 inflammatory Nicotinamide 2.00 Skin lightening, Niacinamide 2.0000 Anti-inflammatory Dipotassium 0.10 Skin lightening, Dipotassium 0.1000 Glycyrrhizate Anti-inflammatory Glycyrrhizate SymRepair 0.50 Anri-inflammatory, Hexyldecanol 0.42000 Wound healing Bisabolol 0.02500 Cetylhydroxyproline 0.02500 Palmitamide Stearic Acid 0.02500 Brassica Campestris 0.00500 Sterols Allantoin 0.50 Anti-inflammatory Allantoin 0.5000 Canadian 0.50 Anti-inflammatory Epilobium 0.0100 Willowherb angustifolium

Example 3

TABLE-US-00003 % w/w in % w/w in final Trade Name Formula Function EU INCI Name formula Purified Water To 100% Solvent Aqua To 100% Carbopol Ultrez 1.4 Suspending Agent Acrylates/C10-30 Alkyl 1.4 20 Acrylate Crosspolymer Dissolvine Na2 0.1 Sequestring Agent Disodium EDTA 0.1 Glycerin 8 Humectant Glycerin 8 Polyquaternium 0.7 Conditioning Agent Polyquaternium 43 0.105 43 Aqua 0.595 Cocoglucoside 4.8 Surfactant Aqua 2.352 Cocoglucoside 2.544 Tego Betaine 6.9 Surfactant Cocamidopropyl Betaine 2.553 Aqua 3.726 Sodium Chloride 0.5037 Glycol 2.5 Pearlising Agent Aqua 1.625 Distearate Glycol Distearate 0.25 Laureth-4 0.25 Cocamidopropyl Betaine 0.25 Citric Acid 0.125 Empicol ESB3/ 26.7 Surfactant Aqua 19.18395 M6 Sodium Laureth Sulfate 7.209 Sodium Hydroxide 0.267 Salicylic Acid 2 Active Salicylic Acid 2 Sodium 3 pH Adjuster Sodium Hydroxide 0.9 Hydroxide Aqua 2.1 Perfume 0.2 Fragrance Parfum 0.2 Clearly Fresh Benzyl Salicylate 0.027666 Limonene 0.006886 Aluminium 2.2 Exfoliating Alumina 2.2 Oxide Coathylene 2 Exfoliating Polyethylene 2 HO1681 Gotalene 0.2 Exfoliating Polyethylene (+CI TBD) 0.2 Green FD & C Yellow 0.0015 Colour CI 15985 0.0015 No.6 Blue No.1 0.00225 Colour CI 42090 0.00225 FD&C Purasal S/HQ 3.33 Moisturiser, Skin Aqua 1.3320 60 lightener, Anti- Sodium Lactate 2.0000 inflammatory Nicotinamide 2.00 Skin lightening, Niacinamide 2.0000 Anti-inflammatory Dipotassium 0.10 Skin lightening, Dipotassium 0.1000 Glycyrrhizate Anti-inflammatory Glycyrrhizate SymRepair 0.50 Anri-inflammatory, Hexyldecanol 0.42000 Wound healing Bisabolol 0.02500 Cetylhydroxyproline 0.02500 Palmitamide Stearic Acid 0.02500 Brassica Campestris 0.00500 Sterols Allantoin 0.50 Anti-inflammatory Allantoin 0.5000 Canadian 0.50 Anti-inflammatory Epilobium 0.0100 Willowherb angustifolium

Example 4

TABLE-US-00004 % w/w in % w/w in Trade Name Formula Function EU INCI Name final formula Purified to 100% Solvent Aqua To 100% Water Dissolvine 0.01 Sequestring Agent Disodium EDTA 0.0100 Na2 Glycerin 8.00 Humectant Glycerin 8.0000 Sodium 1.25 pH Adjuster Aqua 0.8750 Hydroxide Sodium Hydroxide 0.3750 30% Solution Keltrol RD 0.20 Emulsion Stabiliser/ Xanthan Gum 0.20 Thickener Veegum 0.20 Emulsion Stabiliser/ Magnesium Aluminium 0.194 Ultra Thickener Silicate CI77891 0.006 Dehydol LS3 4.00 Emulsifier/Surfactant Laureth-3 4.0000 Lanette 1665 8.00 Emulsifier Cetearyl Alcohol 8.0000 Salicylic Acid 2.00 Active Salicylic Acid 2.0000 Hostopan 10.00 Surfactant Sodium Cocoyl 8.5000 SCI 85G Isethionate Emollient/Emulsifying/ Coconut Acid 1.0000 Surfactant Antistatic/Hair Sodium Isethionate 0.4000 conditioning/Cleansing Solvent Aqua 0.0010 Empicol 4.00 Surfactant Aqua 2.8740 ESB3/M6 Sodium Laureth Sulfate 1.080 Sodium Hydroxide 0.040 Tego 3.50 Non-ionic surfactant Sodium cocoamphoacetate 1.05000 glycinate Aqua 2.17000 818M Kaolin 6.00 Clay Hydrated Aluminium 6.0000 Silicate Dry Flo PC 2.00 Oil Absorber Aluminum Starch 2.0000 Octenylsuccinate Titanium 2.00 Opacifier CI77891 2.0000 Dioxide Ph Eur Perfume 0.30 Fragrance Parfum 0.3000 Clearly Benzyl Salicylate 0.0277 Fresh Limonene 0.0103 Phenonip 0.30 Preservative Phenoxyethanol 0.2178 Ethyl paraben 0.045 Propyl paraben 0.012 Isobutyl paraben 0.012 Butyl Paraben 0.006 Methyl Paraben 0.006 Bentonite 3.00 Sebum Absorber Bentonite 3.0000 Purasal 3.33 Moisturiser, Skin lightener, Aqua 1.3320 S/HQ 60 Anti-inflammatory Sodium Lactate 2.0000 Nicotinamide 2.00 Skin lightening, Niacinamide 2.0000 Anti-inflammatory Dipotassium 0.10 Skin lightening, Dipotassium 0.1000 Glycyrrhizate Anti-inflammatory Glycyrrhizate SymRepair 0.50 Anri-inflammatory, Hexyldecanol 0.42000 Wound healing Bisabolol 0.02500 Cetylhydroxyproline 0.02500 Palmitamide Stearic Acid 0.02500 Brassica Campestris 0.00500 Sterols Allantoin 0.50 Anti-inflammatory Allantoin 0.5000 Canadian 0.50 Anti-inflammatory Epilobium 0.0100 Willowherb angustifolium

Example 5

TABLE-US-00005 % w/w in % w/w in Trade Name Formula Function EU INCI Name final formula Purified Water To 100% Solvent Aqua To 100% Dissolvine Na2 0.05 Sequestring Agent Disodium EDTA 0.05 Glycerin 7 Humectant Glycerin 7.00 Polyquaternium 0.3 Conditioning Agent Polyquaternium 43 0.045 43 Aqua 0.255 Keltrol RD 0.3 Emulsion Stabiliser/ Xanthan Gum 0.30 Thickener Veegum Ultra 0.3 Emulsion Stabiliser/ Magnesium Aluminium 0.291 Thickener Silicate CI77891 0.009 Butylene Glycol 3 Humectant Butylene Glycol 3.00 Salicylic Acid 2 Active Salicylic Acid 2.00 Empicol ESB3/ 13.3 Surfactant Aqua 9.5561 M6 Sodium Laureth Sulfate 3.591 Sodium Hydroxide 0.133 Cocoglucoside 3.2 Surfactant Aqua 1.568 50% Cocoglucoside 1.696 Tego Betaine 4.6 Surfactant Cocamidopropyl Betaine 1.702 Aqua 2.484 Sodium Chloride 0.3358 Phenonip 0.3 Preservative Phenoxyethanol 0.2178 Ethyl paraben 0.045 Propyl paraben 0.012 Isobutyl paraben 0.012 Butyl Paraben 0.006 Methyl Paraben 0.006 Sodium 1.25 pH Adjuster Sodium Hydroxide 0.38 Hydroxide Aqua 0.88 Kaolin 8 Clay Hydrated 8.00 Aluminium Silicate Bentonite 4 Sebum Absorber Bentonite 4.0000 Titanium Dioxide 2 Opacifier CI77891 2.0000 Fragrance 0.2 Fragrance Parfum 0.2000 Clearly Fresh Benzyl Salicylate 0.0277 Limonene 0.0069 Structure XL 2 Thickener/foam Hydroxypropyl Starch 2.0000 boosrter Phosphate Structure Plus 0.4 Thickener Acrylates/ 0.0800 Aminoacrylates/C10-30 Alkyl PEG-20 Itaconate Copolymer Aqua 0.3160 Phenoxyethanol 0.00288 Methyl Paraben 0.00064 Ethyl Paraben 0.00016 Propyl Paraben 0.00008 Butyl Paraben 0.00016 Isobutyl Paraben 0.00008 Blue No. 1 FD&C 0.0018 Colour CI 42090 0.0018 Purasal S/HQ 60 3.33 Moisturiser, Aqua 1.332 Skin lightener, Sodium Lactate 1.998 Anti-inflammatory Nicotinamide 2 Skin lightening, Niacinamide 2.000 Anti-inflammatory Dipotassium 0.1 Skin lightening, Dipotassium 0.100 Glycyrrhizate Anti-inflammatory Glycyrrhizate SymRepair 0.5 Anri-inflammatory, Hexyldecanol 0.420 Wound healing Bisabolol 0.025 Cetylhydroxyproline 0.025 Palmitamide Stearic Acid 0.025 Brassica Campestris 0.005 Sterols Allantoin 0.5 Anti-inflammatory Allantoin 0.5 Canadian 0.50 Anti-inflammatory Epilobium 0.0100 Willowherb angustifolium

Example 6

TABLE-US-00006 % w/w in % w/w in Trade Name Formula Function EU INCI Name final formula Purified water Qs 100 Solvent Aqua To 100% Jaguar HP 105 1.20 Thickener Hydroxypropyl Guar 1.12680 Aqua 0.10800 Proteins 0.01200 Ashes 0.01920 Timiron Silk 0.20 pearlising agent CI77891 0.14200 Green Mica 0.07400 Tin oxide 0.00200 Salicylic acid 2.00 Keratolytic active Salicylic Acid 2.00000 Tween 20 2.50 surfactant Polysorbate 20 2.50000 DENATURED 27.00 Solvent Alcohol Denat. 26.96490 ETHANOL (Ethyl Alcohol) SDA-40B 200 Denaturant Denatonium Benzoate 0.00016 PROOF Denaturant Tert-Butyl alcohol 0.03510 Sodium hydroxide 2.00 Buffering agent Aqua 1.40000 30% soln Sodium hydroxide 0.60000 CLEARLY 0.2000 Fragrance Benzyl salicylate 0.01844 FRESH Limonene 0.00689 FRAGRANCE Parfum 0.00000 Purasal S/HQ 60 3.33 moisturiser, skin Aqua 1.332 lightener, anti- Sodium Lactate 1.99800 inflammatory Symrepair 0.50 Anti- Hexyldecanol 0.42000 inflammatory, Bisabolol 0.02500 wound healing Cetylhydroxyproline 0.02500 Palmitamide Stearic Acid 0.02500 Brassica Campestris 0.00500 Sterols Nicotinamide 2.00 skin lightening, Niacinamide 2.00000 anti-inflammatory Dipotassium 0.10 anti-inflammatory/ Dipotassium 0.10000 Glycyrrhizate skin lightening Glycyrrhizate Allantoin 0.50 anti-inflammatory Allantoin 0.50000 Canadian 0.50 Anti-inflammatory Epilobium 0.0100 Willowherb angustifolium

Example 7

TABLE-US-00007 % w/w in % w/w in Trade Name Formula Function EU INCI Name final formula None To 100% Solvent Aqua To 100% DISSOLVINE 0.01000 Sequestrant Disodium EDTA 0.01000 NA2 Veegum ultra 0.25000 Emulsion stabiliser/ Magensium 0.24250 Thickener Aluminium Silicate CI77891 0.00750 Keltrol RD 0.50000 Emulsion stabiliser/ Xanthan Gum 0.25 Thickener Glycerin 99.7% 3.00000 Humectant Glycerin 3.00000 USP Arlamole E 2.00000 Emollient PPG-15 Stearyl Ether 2.00000 Stearyl Alcohol 3 SALICYLIC 2.00000 Keratolytic Salicylic Acid 2.00000 ACID USP Varisoft TA 100 1.50000 Skin Conditioning Distearyldimonium 1.44000 Chloride Aqua 0.06000 Sodium Chloride 0.00225 Tego Alkanol 16 1.00000 Emollient Myristyl Alcohol 0.02500 Cetyl Alcohol 1.00000 Birj 721 0.50000 Emulsifier Steareth-21 0.49000 Aqua 0.01000 Stearyl Alcohol 0.03360 Arachidyl Alcohol 0.08400 Behenyl Alcohol 0.33600 Tego Alkanol S2 0.25000 Emilsifier Steareth-2 0.25000 Stepanol-WA 3.57000 Surfactant Aqua 2.53470 extra PCA (SLS) Sodium Lauryl Sulfate 1.07100 Lauryl Alcohol 0.04641 Sodium Sulfate 0.02499 Tego Betain A 6.67000 Surfactant Aqua 3.60180 16 Cetyl Betaine 2.13440 Alcohol 0.66700 Sodium Chloride 0.46690 Clearly Fresh 0.35000 Fragrance Benzyl Salicylate 0.03228 E0525379 Limonene 0.01205 Parfum 0.35000 Aluminium oxide 8.00000 Abrasive agent Alumina 8.00000 F100 Purasal S/HQ 60 3.33 Moisturiser, skin Aqua 1.333 lightener, anti- Sodium Lactate 2.00000 inflammatory Sym Repair 0.50 Anti-inflammatory, Hexyldecanol 0.42000 wound healing Bisabolol 0.02500 Cetylhydroxyproline 0.02500 Palmitamide Stearic Acid 0.02500 Brassica Campestris 0.00500 Sterols Nicotinamide 2.00 Skin lightening, Niacinamide 2.00000 anti-inflammatory Dipotassium 0.10 Anti-inflammatory/ Dipotassium 0.10000 Glycyrrhizate skin lightening Glycyrrhizate Allantoin 0.50 anti-inflammatory Allantoin 0.50000 Canadian 0.50 Anti-inflammatory Epilobium 0.0100 Willowherb angustifolium

Example 8

TABLE-US-00008 % w/w in % w/w in final Trade Name Formula Function EU INCI Name formula None To 100% Solvent Aqua to 100% DISSOLVINE 0.05000 Sequestrant Disodium EDTA 0.05000 NA2 Carbopol ultrez 0.30000 thickener Acrylates/C10-30 0.30000 20 Alkyl Acrylate Crosspolymer Ethyl Acetate 0.00135 Cyclohexane 0.00135 Glycerin 99.7% 3.00000 Humectant Glycerin 3.00000 USP FD&C Blue 0.00045 Colorant CI 42090 0.00042 No. 1 Granules FD&C Yellow 6 0.00030 Colorant CI 15985 0.00030 Hostapon SCI 10.00000 Surfactant Sodium Cocoyl 8.50000 85G Isethionate Coconut Acid 1.00000 Sodium Isethionate 0.40000 Aqua 0.10000 Genapol LA030 3.00000 Emulsifying/ Laureth-3 3.00000 Surfactant Tego Alkanol 16 6.00000 Emollient Myristyl Alcohol 0.15000 Cetyl Alcohol 6.00000 SALICYLIC 2.00000 Keratolytic Salicylic Acid 2.00000 ACID USP Empicol 9.26000 Anionic Surfactant Sodium Laureth Sulfate 2.54650 ESB3/M6 Aqua 6.80610 Sodium 1.25000 Buffering agent Sodium hydroxide 0.37500 Hydroxide 30% Aqua 1.12500 Tego glycinate 6.13000 Non-ionic Sodium 1.83900 818M surfactant cocoamphoacetate Aqua 3.80060 Clearly Fresh 0.35000 Fragrance Benzyl Salicylate 0.03228 E0525379 Limonene 0.01205 Parfum 0.35000 Genamin PQ 43 0.10000 Conditioning agent Polyquaternium 43 0.08500 Aqua 0.01500 Aluminium 8.00000 Abrasive agent Alumina 8.00000 oxide F100 Parabeads 0.50000 Exfolliant Mycrocristalline wax 0.48995 green CI 77289 0.01000 Tocopherol 0.00005 (Processing aid) Purasal S/HQ 60 3.33 Moisturiser, skin Aqua 1.33300 lightener, anti- Sodium Lactate 2.00000 inflammatory SymRepair 0.50 Anti-inflammatory, Hexyldecanol 0.42000 wound healing Bisabolol 0.02500 Cetylhydroxyproline 0.02500 Palmitamide Stearic Acid 0.02500 Brassica Campestris 0.00500 Sterols Nicotinamide 2.00 Skin lightening, Niacinamide 2.00000 anti-inflammatory Dipotassium 0.10 Anti-inflammatory/ Dipotassium 0.10000 Glycyrrhizate skin lightening Glycyrrhizate Allantoin 0.50 anti-inflammatory Allantoin 0.50000 Canadian 0.50 Anti-inflammatory Epilobium 0.0100 Willowherb angustifolium

Example 9

TABLE-US-00009 % w/w % w/w % w/w Trade in in raw in final Supplier Name Formula Function EU INCI Name material formula Purified 73.12 Solvent Aqua 100 73.12 water Akzo Nobel Dissolvine 0.05 Sequestrant Disodium EDTA 100 0.05 Na2 Noveon Carbopol 0.60 Thickener Acrylates/C10-30 Alkyl 100 0.6 Ultrez 20 Acrylate crosspolymer RT Veegum 0.25 Viscosity Magnesium Aluminum 97 0.2425 Vanderbilt Ultra control Silicate Co (Thickener) Titanium Dioxide 3 0.0075 CP Kelco Keltrol RD 0.60 Emulsion Xanthan Gum 100 0.6 stabilising Viscosity control sensient Titanium 0.20 pigment Titanium Dioxide 100 0.2 dioxide Ph Eur Cognis Eutanol G 4.50 Emollient Octyldodecanol 100 4.5 Croda Arlamol HD 1.50 Emollient Isohexadecane 100 1.5 Wacker Silfar 100 2.00 Skin Dimethicone 100 2.0 conditioning Rhodia Salicylic 2.00 Keratolytic Salicylic Acid 100 2.0 acid active MGP Denatured 4.80 Solvent Alcohol Denat. 99.87 4.79376 Ingredientes Ethanol (Ethyl Alcohol) Seppic SEPIGEL 2.0 Emulsion Water 35.583 0.71167 305 stabilising/ Polyacrylamide 40 0.8 Viscosity C13-14 Isoparaffin 18.917 0.37833 control Laureth-7 5.5 0.11 Mane CLEARLY 0.20 Fragrance Benzyl salicylate 9.222 0.01844 FRESH Limonene 3.443 0.00689 FRAGRANCE Fragrance 100 0.2 Univar Sodium 2.35 Buffering Water 70 1.645 hydroxide agent Sodium hydroxide 30 0.705 30% soln Purac Purasal 3.33 moisturiser, Water 40 1.332 S/HQ 60 skin lightener, Sodium Lactate 60 1.998 anti- inflammatory Symrise Symrepair 0.50 Anti- Hexyldecanol 84 0.42 inflammatory, Bisabolol 5.0 0.025 wound healing Cetylhydroxyproline 5.0 0.025 Palmitamide Stearic Acid 5.0 0.025 Brassica Campestris 1.0 0.005 Sterols Rona Nicotinamide 2.00 skin lightening, Niacinamide 100 2.0 (S Black) anti- inflammatory Jan Dekkar Dipotassium 0.05 anti- Dipotassium 100 0.05 (Mauruzen) Glycyrrhizate inflammatory/ Glycyrrhizate skin lightening

Example 10

TABLE-US-00010 % w/w in % w/w in Trade % w/w in raw final Supplier Name Formula Function EU INCI Name material formula -- Purified 56.55685 Solvent Aqua 100 56.55685 Water BASF Trilon BD 0.05 Sequestring Disodium EDTA 100 0.050 Agent P & G Glycerin 5.00 Humectant Glycerin 100 5.00 CP Kelco Keltrol RD 1.00 Emulsion Xanthan Gum 100 1.00 stabiliser/ Thickener Rhodia Salicylic 2.00 Active Salicylic Acid 100 2.00 Acid Huntsman Empicol 10.70 Surfactant Sodium Laureth 27.5 2.9425 ESB3/M6 Sulfate Aqua 73.5 7.8645 Cognis Cocoglucoside 1.00 Surfactant Aqua 49 0.490 50% Cocoglucoside 53 0.530 Evonik Tego 1.31 Surfactant Cocamidopropyl 37 0.485 Betaine Betaine Aqua 54 0.707 Sodium Chloride 7.3 0.0956 Brenntag Sodium 1.20 pH Adjuster Sodium 30 0.36 Hydroxide Hydroxide Aqua 70 0.840 Brenntag Kaolin 6.00 Clay Hydrated 100 6.00 Aluminium Silicate Brenntag Bentonite 6.00 Sebum Absorber Bentonite 100 6.00 Huntsman Titanium 3.00 Opacifier CI77891 100 3.00 Dioxide Mane Fragrance 0.30 Fragrance Benzyl Salicylate 9.222 0.03 Clearly Limonene 3.443 0.01 Fresh Parfum 100 0.30 Sun Chem Blue No. 1 0.0026 Colour CI 42090 100 0.00260 Sun Chem Yellow No.6 0.00055 Colour CI 15985 100 0.00055 Purac Purasal 3.33 Moisturiser, Skin Aqua 40 1.33 S/HQ 60 lightener, Anti- Sodium Lactate 60 2.00 inflammatory Rona Nicotinamide 2.00 Skin lightening, Niacinamide 100 2.00 (S Black) Anti-inflammatory Jan Dekkar Dipotassium 0.05 Skin lightening, Dipotassium 100 0.05 (Mauruzen) Glycyrrhizaet Anti-inflammatory Glycyrrhizate Symrise SymRepair 0.50 Anri- Hexyldecanol 84 0.42 inflammatory, Bisabolol 5 0.03 Wound healing Cetylhydroxyproline 5 0.03 Palmitamide Stearic Acid 5 0.03 Brassica Campestris 1 0.01 Sterols

Example 11--In Vitro Testing (Epiderm Skin Model)

TABLE-US-00011 IL-6 no IL-6 + TNF.alpha. TNF.alpha. + IL-8 no IL-8 no MTT < PMA PMA no PMA PMA PMA PMA Material 95% (pg/ml) (pg/ml) (pg/ml) (pg/ml) (pg/ml) (pg/ml) Negative Control value -0.371 63.64 996.8 Positive control -4.358 -0.378 48.5 (hydrocortisone) Nicotinamide (NA) 96.8 -4.294 -2.712 -0.171 40.202 47.54 1383.235 Dipotassium 93.7 -1.781 7.591 -0.636 78.48 44.413 995.622 glycyrrhizinate (GLYR) Sodium Lactate (SLA) 99.1 4.909 22.6 0.882 92.434 104.549 1368.319 Symrepair (SYM) 101.3 -4.231 1.512 -0.687 72.343 17.767 735.562 Salicylic acid (SCA) 103.2 -1.445 6.159 -0.068 12.265 72.757 362.253 SCA + NA 106.3 -4.231 -3.407 -0.481 5.535 38.963 392.411 GLYR + SCA + NA 105.6 -3.153 -0.877 -0.274 4.541 61.931 412.226 NA + GLYR +SLA 113.7 -2.837 1.955 -0.088 52.327 62.91 2513.021 Example 9 99.7 -1.192 1.267 -0.171 9.802 88.766 938.475 (NA + GLYR + SLA + SCA)

The purpose of the in vitro testing was to evaluate the potential anti-inflammatory action of compositions according to the present invention.

In vitro tests were carried out as follows: take an irritant treated EpiDerm.TM. skin model. Initial inflammation was measured by the cytokine release after exposure to a single dose of irritant. apply test compositions to the irritant treated EpiDerm skin anti-inflammatory potential was then measured by reduction in cytokine release specifically, the levels of cytokines TNF-.alpha., IL-6 and IL-8 were measured to give a picture of the performance of the product across the lifecycle of an acne event or related skin inflammation.

Experimental design follows standard procedures, using phorbol-12-myristate 13-acetate (PMA) as irritant. Test samples were applied by pipette as solutions to the Epiderm tissue, and each sample was tested in triplicate against positive and negative controls. Anti-inflammatory activity measured by relative decrease in cytokine release in irritant-treated tissue compared to non-irritant treated tissue.

The separate active components of an example according to the invention were tested, along with some combinations in pairs and one combination lacking the salicylic acid. Where these actives were applied, they were in the same w/w ratio as in the example composition, example 9. The data shown in the table are the cytokine release values in pg/ml, wherein a lower figure shows a lower release rate of cytokines i.e. a lower inflammation.

It will be seen that salicylic acid alone acts inter alia as an anti-inflammatory, but that unexpectedly it also acts with the combination of ingredients in the example according to the invention to reduce significantly the inflammatory behaviour of each of these ingredients. This synergistic behaviour is totally unexpected and permits the formulation of products according to the invention such as the one tested which have a broad range of active ingredients to deal with traumas arising from every stage in the lifecycle of a specific acne event or related skin inflammation.