AU2006200823A1 - Soy depigmenting and skin care compositions - Google Patents

Description

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AUSTRALIA

t PATENTS ACT 1990 SCOMPLETE SPECIFICATION 00 oo SFOR A STANDARD PATENT

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o ORIGINAL Name of Applicant/s: Johnson Johnson Consumer Companies, Inc.

Actual Inventor/s: Miri Seiberg and Jue-Chen Liu and Stanley S Shapiro and John Kung and Rachel Grossman and Jonathan Miller Address for Service is: SHELSTON IP Margaret Street Telephone No: (02) 9777 1111 SYDNEY NSW 2000 Facsimile No. (02) 9241 4666 CCN: 3710000352 Attorney Code: SW Invention Title: SOY DEPIGMENTING AND SKIN CARE COMPOSITIONS Details of Original Application No. 14433/01 dated 30 Oct 2000 The following statement is a full description of this invention, including the best method of performing it known to me/us:- File: 32230AUP01 500810634 1.DOC/5844 la SOY DEPIGMENTING AND SKIN CARE COMPOSITIONS SThe present application is a divisional application of Australian Application No.

C 14433/01, which is incorporated in its entirety herein by reference.

C Field of the Invention 00 0 This invention relates to non denatured soy product-containing compositions that Ci can be used for depigmentation, evening out skin tone and skin texture, skin firming, and

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Scare of the skin. More particularly, this invention relates to the use of soybeancontaining compositions for depigmentation, producing skin of even tone and colour, increasing skin elasticity and reducing skin aging, increasing skin firming and promoting a younger look of the skin, for the prevention and treatment of sun-induced damage, for shine control, for the treatment and prevention of acne, treating cellulite and for inducing aesthetically pleasing skin feel.

Background of the Invention The understanding of the chemical and enzymatic basis of melanogenesis is heavily documented. Melanocytes migrate from the embryonal neural crest into the skin to produce secretory granules, melanosome, which produce melanin. Melanogenesis occurs within the melanosome, and the melanin is later distributed to keratinocytes via the melanocyte dendrites. The key enzyme in melanogenesis is tyrosinase, which initiates a cascade of reactions that convert tyrosine to the biopolimer melanin. Two tyrosinase-related proteins (TRPs) are known, TRP-1 and TRP-2. These proteins share with tyrosinase about 40% homology and have catalytic activities as well as regulatory roles in melanogenesis. TRP-1 is the most abundant glycoprotein in melanocytes.

Skin colouring has been of concern to human beings for many years. In particular, the ability to remove hyperpigmentation, such as found in age spots, freckles or ageing skin, is generally of interest to individuals who desire a uniform complexion. In certain areas of the world, general body whitening is desirable. There have been many methods proposed to accomplish depigmentation. For example, kojic acid, hydroquinone, retinoids and other chemical compounds have been used for depigmentation. Many of these previous solutions have not been found acceptable. There is often a distinct line of demarcation between the areas of skin to which such previous compositions have been applied. Therefore, precise application of all these compuds is necessary ini order to achiev Ih ~ic eut Miny of. hese coinpounds have also been found to be quite iritngothsknndheerr unidesirable for use. Post-inflammaty hyper-igeaio iafrqnt problem, representng..varidus- Cutaneous disordersas we' as therapeutic intervenitions. H4owever, the unqderlying mhechlanisms and the varability individuals show for developing post-infamtr hperpigmentatinare nt well understood ~Pisd~ r temens ate no6t effect ive forcompound' intrradermal, or ost-inflamtr igentato n r~o las 'I rabe Hydrojuiione and brod-& e rum s~L unsre~ r ut eWI uedafe therapeutic treatment, but they do not completely preent or eliminate the: h perpgetary tsos A ae fetv n fo-al ratmfetforposi-inflaxaroy hypr-fi~mntaionis higlydeired. Even moret desired is Ehe incorpo irat'f:sc treatment into a daily ski caepouwih wi~~ oahaltier d betterlokg Aging9 of the skin is a complex phen omnon rsulrIn frnihentrc f sgeeral intrinsic anid excrin ic tcor Sin changesassocaedwt aging often manifest as cotimeric disabilities. Due co its psychological impact,' aging of the skin has bedcome an issue of great socil sign ificance and concer n. With: baby boomers axging, 0h era of c6me 1, cosmhetic maintenanice and, rejuveu.ation gains incrteasedaw~rq''ids..Methods for'peetn n teatia sij agingareh hl deired. Intrinsiaggisa inevitable, genietically prrme process.Amrong extrinisic influences (wvind, eat, ;igarettei smoke, chemnicals;, uldraviolet radiationi appears to be the' sin'gle most important factor associated -with: aginig of the' skin. Photoaging is fiduced by'cumulative exposure to ultrayioIletradiationi (UJVR) *Increased recreational sun in~jcluding excessive suinbathing, the depletion of stratospheric ozone, and the use of UVR in the treatment of various skin diseases, have led to increased prevalence of pho-maging during the lasr decades. Photodamage can be prevented by sun avoidance and proper sun protection, and could be reversed4 by the use of topical retinoids, which could be irritating and expensive.: Overexposure to ultraviolet and visible radiation also causes sunbun. The use of aspirin and other nonsteroidal anti-iaflammatory drugs, cool baths and topical: sjeroids offer nly mild relief.

i t t is desird to have a single topical treatmenit that could prevent or reverse..

skin aging'and provide protection or relief from sunrn. It i mr esired o have 0 0 a sirle and affod~able topical tretmet for daily skin cre, which wil provide these.

f benes, with no irritation or niegative side effects, and which will further provie Sthe desired homogeneous skin cornple'ion, even out skin texture and tone, and induekin firmin ad a heathier, younger look.

indike: skiff heal' loo Acne is az inflammatory deiatologica disorder ich oc frequently in adolescence and-with some r ieg rty in older adults of thian species. The coadition:of acne can include skin lesions ranging f rm the d in a I: pilosebaceout follide, t6:more severe coo-inflarmairry syxnnom o such as us~ules, ppPulescsts and noidules. The condition is not only unomfortable for the vctimbu also embarrassing, and can resuti ifgrmn n crig he vitim ur.3 t i difigrerien .q dscatih Many different approaches to ameliorating this disorder have been tte pt in the past, withSme reatmeIts more effective than otherst- taks ranging from simle ~washing and cleansing to pharmeut!icals have been emply. d.

IE isdetired to have a single topicl reatment that could p r or rere acne, which does not require a pharmaceutical prescription. It is more'desired to have a single and affordable topical treatent fr ;'daily skin ce, hich ill provide theset benefits, with no irritation or negative side effects, and ih will further provide the desired homogeneous skin coplexion, even out skin- texture and tone, and induce skin firi ng and a healthier look.

Dimpling of the skia of the thighs and buttocks is a phenomenon commoly referred to as ellulite, which affects women much more frequently than men. The

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basic pathophysiology of cellulite has not been clearly identified. Theoretically, cellulire could reflect differences in adipose tissue biochemistry or connective tissue structure of affected versus unaffected individuals or regions within an individual.

Thre is noevidence of any primary role for adipose tissue physiology blood flo, S or biocheistry in the etiology of cellulite, although the connective tissue of the si aipoe isse: 00 le thigh is structured to accentuate differences ii sma eral adipose tisse depots Products aimedto cure cellulite Cellasene) have ben markete all over the world, but their efficacy is in doubt. Methods to treat celluilire like the solid- 'r d '6 t e r a c y t$ probe ultrasound-assisted lipoplasry technique or syringe liposcuiture resul in some body contouring but ae painful and expensive, and needed repeated trearmerits s desired' to have a topical affordable treatment that could prevenit or reverse cellulie in 1k 6h -skn n arid induce skiln firming, resulting in a halthiet, younger look ofthe skin, and provide aily skin care with no irritation or niegative side effects 1 In our previously filed PCT Parent Application WO 99/04752, the use of nonpasteurized soybeanderived extracts for the purpose of depigmenring skin was described. We have now found new stabilized and cosmetically superior compositions containing such soy products that contain less than 0.1% surfacants, have greaier skin dpigmenting activity d e less expensive to manufacture. We have unexpectedly foid that soybeahn-containing compositions have anti-aging activity, they better increase skin elasticity and firmness, and they are useful in the p tion and in the t nrearment of sun-induced damage and acne.

Summary of the Invcution The present invention features a skin care composition for the topical delivery of a soy product to a mniammal such as a human) comprising a soy product a: non-denatured soymilk or powder) and a stabilizing system, the stabilizing system comprising one or more members selected from the group consisting of an antioxidanr, a chelating agent, or a preservative. Preferably, the compositions of this invention do not contain more than about 0.1% of a suifactant. In one aspect, the composition 4 00 fturthercmrie on or" more other skin-related active agents such as, but notliiedao,%:I.-: to, depigmrnenting agets tikening agents, emollients,'antioaidants or0' cres The. present iniVention also featur-es a miethod of depigeTin the'skin. of a 51: mammal, said Method comprising the step of applying, to th kin the above corrpositionjs.

-Thepresnt nvenionalso describes a method to enhanceq the careothskn We unexpectedly found that'application of soymilk. or soyb~ean-derived compositions inreseskn irnesand elasiiy event tone and texcture, redce' skin agng and r sflIt preetion and in the teatment of sun-iniduced damkag An& acne. This.

inv*nion iprovids etamples of soy-derived comnpositions useful for ski ae Other features' and advantages of the present invention *ill be apparenE fromh 1B the detailed description of the invention and from the claims Bricf Descriptio ojte iiret: ligre shws hxe grphs deonsratng ha oymiulk cars inhibit trpiihibito' PAR- cleavge and inhibit kdratinocyte phagcts.

2ltinsard Figure 2 shows histological sections of swine skin treated. with soy form tos rd stained to demonstrate pigment deposition.

Figure 3 shows a picture of 'a flank of a dark skinned swine, treated with soyrnilk and DHLA formulations.

Figwte 4 shows histological sections of auce skins treated -with soyui.:ilk an~d'stained to document elastin Figure 5 shows pictures of an individual excessively exposed to, the'siufolowing treatment of a half of his face with soymilk.

Figre6shos amanification of the skcin of an individual excessivly exp osedtoih U1, olown trea tt f a haf of his fiace with s(?ymilk.

Figure7 sho~wsthe 'results of an acnegenicity andkirritancy study in graphcl o 1~iureB sowsa W bte bot of Soy formlations prolbefo ST (obea -Tr n Ig w ourorSi, Inhibitor).

Detailed Description 'of the- Preftered -Embodiments It'is believed that oie skilled in the art. Can, based upont te description heqreinj utilizet rh prsent inveion'to its full e etnt. The. follown specific embodirrents are to be construed as merely illutraive vndnd Iuiavefth di w s nd rwj f

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r emnaini der of he disclosure il ainy w hatoee Unless de e ore, all techncal and scieific terms used herein have the samre meaning as coimonly; nderstoodyo#e. f ordinary skill in the art to which' h ne all publi-Cation s, ptnaplcioptesndother' references'hmentioned' herein I~ Sl~~r fplicriohs pit s,:atent a n eo isfc it Arp iicorporited~h eri by reference.

the novel compositons of this invention. contain legume pro'ducts and prefeably soy products, that may be in, the for of a fluid soyirlk ra solid a soybean powder or. wonl pwer). Whati en y"o rdc"i s.bt~c deie rmtesyean, containing thigrdients naturally found in: soybeans, at the'relative Concenitrations as found in thie beans.t In one embodimet, the soy product is a non-denatue oypdut Dntaion" is define in the Bantam: *Medical Dictionary (1990 edition) as "the change in the physical ad t h pyiological .properties of a protein, that are brought about by heat,' X-rays or chemricals. These changes icllude loss of activity (in the case of enzymes) and loss (or alteration)0o antigeniciry (in the case of ant igens)". Wh atr- is meant by "noi-denatured soy product" Ls a soy product in which the processing for the derivation of such so product 6 the emperatue, extraction media) did ot eliminate its proease nhiitory activity In one embodietit, the nondenatured itare of the so product of this invention is F4 Oe em-~dpy ,th. r sin i: r T thi protein. 'i measured by the presence of an intact soybean trypsin hibitor (ST) protein.

In another embodiment, the soy product is soymilk. One way to make o soymilk is to soak the soybeans in deionized or purified watefor several hours, and Sg rii them after they were fully hydirated with the addition of small quantities of water. (he grinding process allows the soybean milk to be extracted). After collection, the soybean milk may be filtered to remove ary residualparts of the bean T husk. The soymilk used.in this inventio can be fresh soymilk as described ab6ve, or may be made from toybean powder and water. The soybean powder is Milked rom soybeans ad may also be lyopilied, spray dried, freezeried and the resulting soy ilk may or may not be filted. Such prepared soy nilk iny have from about 1 to ait90% weight r soybean powder. riother example is the use of soyiilk powder,' made from lyophilized spray dried o freee-dried soymilk, with the addition of water and finished with or without filtration or homogenization Other methods of soybean extraction could also be used to create the active ingredients used in this invention. or exampe, but not limited o the active igredients could be extracted from ground soybeans using ethaiol/water nilxtes followed by the removal of the ethanol from the extract, in such ways that the protease inhibitory activity,of the soybean will be retained.

The compositions of the present invention minay contain froni about 1% to: about 99%, by wveight, of the yso product. Fr example, when a iquid so product soymilk) is used, the composition may contain from about 50% to about 99%. by' weight; from about 70% to about 99%) of the liquid soy product. For example, when a solid soy product soybean powder or soymilk powder) s used, the composition may contain from about 1% to about 50%, by weight (e.g.,fron about 2% to about 30%, by weight) of the solid soy product. Composition which comprises solid soy products may also comprise water distilled water or water contained tIhin ymilk) to form a liquid base to the composition to form.a cream, lotion, injectable solution or ge). Such composition may comprises from about 50% to about 986, by weight from aboit 70% to about 98%, by weight) of water. While no limited to these methods of administtation, the compositions of this nvention may be delivered topically, orally, or parenterally 00 The soy products useful in this invention imay be produced from all soybeia species, regardlesi of their geographic origin, sun exposure, harvest time and the like H -owever, specific strains, geographic origins or growth conditions mighi be preferred.

*o I Fp eample, but not limiting tosoybean strais or other leguie trains particularly ch in their typtin inhibitor (e.g STI; LTI, BBI) content or growvth conditibios that rest i trypsin inhibitor enrichment in the bean might be pr ied shodbe d that the legume products useful in the compositions of this invetin h ave a distinctive odoi, which mnay e tolerable in some cultures but is undesird in others if necessary, the odor of the cominpositions of this inventior may b reduced by using soybean products derived frm specific strains of soybeans known to produce reducedodor, including, but not limited to, lipoxygenase-2-deficient beins and those having A'cess to reduce oxy Ymodified sugar profile, and the like. A process to reduce oxygen levels in the Sformulation may also reduce the odor. Various masking agents or fgragrnces may also 0 be used to mask the odor.

In one embodiment, the compositios of this invention contain one or more preservatives. Due to the fact that the compositions of this invention are nondenatured compositions in which the protease inhibitory activity is retained), they may be more favorable as a medium for microbial growth. Preservatives are useful for substantially preventing microbial decomposition. Examples of preservatives include phenoxyethanol and parabens such as methyl-paraben, ethylparaben, and propyl-p araben Other examples of preservatives are listed on pages 16555 of the International Cosmetic Ingredient Dictionary and Handbook, eds. Wenningei and McEwen (CTA, ed., 1997), hereinafter referred to as the "Cosmetic Handbook." The composition may comprise from about 0.01% to about 20%, by weight (more.

preferably,- from about 0.5% to about by wreighi) of preservative. Microbial contai ntion an ~-4s be eliminated bga airadiatio ormcrofiltration, -or by brief hear treatments that do not result in rheelimination of prorease inhibitory r~l acti vity.

Antixidts and/o chdIatn agnsmy also be used to increaeseflf n stAility of hecmotirs. Arioxidants ma be added both for formaiox stblzation ad for biologikcal iefficcy Antixidnt corn di and thideiave incl~ude,: but ae not limted to, water-soluble'antiodat :uhas sulfhy drd compound n heir dejrivatives s sdium merabisulfite and N:aey-yti) lipoi1c acid and dihyd~rolipoic acid, reseratrol, aceyl-cysteine (I~frn~ rlactoferrn', and'asco rbi 'acid and ascrbicacid'deifivaives,(e g.,ascorbyl palmitate anid--ascorby-l polypeptid) Ooube antioidant sI U itabe for use in the compositions of thi invention include, but are rnot limie to buylate hyrXytounriods(g.

reinalI and reiy palimae) ocophe-ols Tocopherol acetate)tooieosan ujbiquiho6 Natural etat cotiig antioiclats- suitable'for- use in te comip sitions of this invention, include, but not limited to, exracts containing 4lyonod and. isaonoids, and their derivative genistein ;pnd diadz6in), extracts c~ntainine resycratrol and the like. Eamrrples of such natural extracts include gripe: ~0 sedgree te, pine bark prpls and legurhe extracts:. Oteexplso anroxians my e fun onpaes 61-13 of the Cosmetic Handbook. :Th~e copstions of tepsent invention may comprises the antioxidant in an ouint of from, about 0. 001% toE about 20%, by weight from about 0.01% to about 10% Oby' weight) of the compbsition..

Chel-ating agents are Also uieful in assisting the stabilizatio of 'the compositions of this invention. Examples of chelating agents include EDTA and derivatives thereof (egdisodiun EDtA, and dipotasium EDTA), 1xifeine 0, lactoferin ani cticacd Other exaaples of chelating agents are listed on page 1626 of the Cse i i ad6' Th opstoso h resent invention mpay comrprise the chelatinig agent In an 9 i ii i

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amount of from about 0.001% to about 20%, by weight from about 0.01% to about 10% biy weight) of the composition.

i i Thickening gets thickeners or viscosity enhancing agents) m-ay be S ied in the compositions of this invention td alter their viscosity. The desired viSosidty of the composition wil depend upo' the intended use e.g a bath product, cra oion, or gel) For ex2mpe, in applications such bath or wash products the viscosity of the com osition should be relatively low,similar to an aqueous solution.

A 'pplication, as a crem, lotion, or gel will have slighly higher viscosity between abit 100 cps aiid 100,000 cps).

Thickening agents that can be added to the copositions of this invention to al scosy includ polyers such as pyara te polyacrylamide). Other alE: polymers y ami exImples ofviscosity modifyiig agents are isedon pages 1692-97 o the Cosmetic Handbook. To achieve the approprie viscosity, compositions of th presen invention may comprise from about 0.01% to about 20%, by wieight (e.g from about 0.1% to about by weight) of a thickening agent.

The compositions of this invention may also contain other depigmenting agents: in addition to the soy product. Examples of such depigneting agents includ, but are not limiked to, lipoic acid, dihydrolipoic acid, resveratrol, ascorbic acid kojic a Id, hydroqu one, isoflavones, reianoids rinol, rerinoic acid, and retinylpalmitate), tyosinase inhibitors, mnelanosome transfer inhibitors, and selective cyrooxic agents for ielanocytes, or natural extracts containing these activities. The amount of the depigmenting agent iused will depend on the activity of the compound, and will typically range from about 0.001% to about 20%, by weight from about 0.01% to about 10%, by weight) of the composition.

The composition of the present invention may also contain compounds that enhance the feel of the composition on the skin of the user. Examples of such compounds include, but are not limited to, oils, silicones siloxane polymers such

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.4 KIas diihicone) anfd skin-conditioning agents such as emnollients, aind humeccants Eaple$ of such skin conditioning agents may be found of pages 1656-1670 of the Cos .Pmetic Handbook.

AdTh compositions of this invention may also advanitageouisly cntain: other cellulre-cornbating aents including, but not limnited to, 'caffeine, retinol and'other retinoids'and the. like. Of course, other topical aents that may have activity on the skin incldn anti-ifammtr aenEs Such as corricosrEroids, atiprtc aets, opica: aalgesics, agents-wbich fight acne, ~such as benzoy peroxidle and'beta-h I'~c acid suh ssalcl acd iaging produicts iding retinoids,: retinol, alpha hyt~x aisc-enzyme-Q, adothers, niitc rc antimycot .ics and shinecontrol prout inlqn ioazolAe, eoconazole, elubiltacazlanth like, and -others'kno wn to those' of ordinaryskill'in the art, may beq cmbined lin h coMpositionst of thisinvention and used in the methods of this invention.

Coposion of, th peent invention may be prepae ymxn h eie ngedirqs Fo xmlsy k is nix'ed with the cheating agentq;, preservative, And/or antioxidant. Atbicke er is, then added to the systemn, arid the miu'=re is fur'ther- mi:xed until it rches homogeneity at the desired vriscosit. ;The compositions.

o thepresnivetoma be prepared uder an argon o r nitrgn(ooteier gasieous) blanket, inl order to enhance formulation stability 'and/ or to reduc oba odor. Th copsition of this, invention may be packa ged in a tube, a. sealed Packet, a ar, a pump, a bottle, A canalega oetaip or the like. -An airtight pack'g such as an alunun tube, aluminum pocket, pump, laminate rube, can also be used to* fuirther. enhance product stability.

The compositions of the present invention may be used to depigmient the skin of -a mammal aI un). What is meant by depigmentation is the lightenig of the' color of an area of skin, including but not liied to, the global lightening of the se' skin ione/coinplexion the face, hands, or whole body, which is uneven as a resuilt of aging skin, or darker tiian desired because of etLhnicity or pathology, and the like),I he evenig ofskin-color tone, orthe specific ghteg of age spots, frckles, or darker

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pig ented areas:such as, but nomited to, post-inflammatory hyper-pimentazy lesions.

We unexpectedly found that the composiion of this inventioni naybe use to rr 0.huran skin resulting inreduced skin oiliness and shine. The co0mpos iio16ns of ri invention, inldugi b not- limited to soy-conraining compositions, whic contain..

Sprote'ase inhibitory actvithen appli topically t the sn incldi use s a bath aditive, or in a w r educedhe oi'ly and shin ylookof facia kn. In one 0 pieferd embodiment, the cmpoSitin one aily ot log ias'ihe.:user tans the desired'effect.

o: :p s iq resent in be d o tt iat i e i Cj i omiposethis of th p re ivenion inay aso be ue to prevent or reat condii 6f ace. The compositions of this invenion m pplied, preferl twicer dy for a period'of time preferably at least about 45 davsi 6deons:rae an imroveent in the appearance of the skin and an ameliorioff tyte crdition.

Howeverit is ;hought hatapplication of the compositosr adlast a four wes should provide an amielioration or prevention of the condition, dependig" on the individual's sebaceous gland'activity.

n another .embodIment, we found that soy products, such as but not irmiting, to the compositions of this invention, which contain protease inhibitwy activity, when applied topically to the skin, incldig its useiaS a bath additive, or in a patch. assists in creating a soothing, coolg, and/or relaxing effect for the user, and an aesthetically pleaing skin feel. The amount of composiion administered afd the freeco administration will depend upon the concentration of the soy agent in the compoition the soymiik), the condition of the skin area being treated, and the desired effect and thus, willultimately be deterined by the user of the composition.- I'one embodimet, the composition is administered at least- once daily for as long as the user K wants the desired effect 12

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IMoreover, we unexpectedly found that soymilk treatment of humankin sn folloring aetessie exposureto the sun, relieved the pain and buring feelings and reduced the skin scaliness associated with sunburn. This invention provides a method for the soothing, cooling and pain reducing effects following sunburn or excessive sun ecpoure.i The method consists of daily topical treatment at least once per day for as long as the useir wants the desired effect, of soymilk containing compositions that contain protease inhibitory activity.

In anotirermbodimen wpe unexpectedly found that pre-treatent ofhuman l~p skin .ith yilk (e topical treatment, uise as bath additive) could protectfrom sun induced datage. Skin oer-exposedo he sun following sonilk reatment was not a ed, scaly, dy and painful, as the untreated skin of the same individual. This .ivention provides a mrethod for the prevention of skin scaling redness and pain foo wing excessive sun exsure. The method conists of daily topical treatment at least once per day for as lolg as the user wants the dsired effect, of soymilk conit'ing compositions that cointain protease inhibiry activity.

Thus, soymnilk and its derivatives can provide skin care properties, including elasticity, prevent scaliness/redness/pain of over exposure to the sun, after sun/sunburn, cooling sensation, bath, depigmenmation even tone and texture of the skin, post inflammatory hyperpigmentarion, acne and cellulite.

As evidenced by the examples herein, we have unexpectedly found that the topical ise of soyniilk results in an increase in the elastic properties of the treated skin.

Therefore, suitable topical use for legume extracts containing protease inhibitory activity, and in particular for soymilk and soybean formulations, is to incre e skin elasticity and firming, by affecting Elastin and collagen fibers and skin elastic properties. We unexpectedly found that the topical application of soy products, including but not limiting to the compositions of this invention and of our previous 3'30 invention (PCT Patent Application WO 99/04752), which contain protease inhibitory' activity, results in skin firming, increased skin elasticity, and anti-aging effects, and 00 induiced afl aesthetically' pleasing skin feel. This invention provides a metofo inlcreasi skin, firmiag and skin elasticiy and reducing signs of skini agng,.which is usful fr al oyparts, =nd preferably'for the face, upperbdado hsknf ',the thighs and buittocks. The method consists of. daily topical treatment At least once, 8 aily for as lonig as the uiser wants the desired effect, of. soymilk Containing,.

coftpositins that contain proteasd -inhibitory activity.

The following exam ples, illustrate severale em'bodimnents of the copsiin of thisinvetion Thy.should not be utilized to li mit or narrow The soeo h inveto in any way.

Exapl 1 Prpaatonof vmlkfo Soybean Powder 160g f syban ower(Sunilight Foods, Taipei, awn a de to about 1440 i nf dinze water~ The mixture was sirkred At romi tempetrature- forabout 1our. The M'itur Was rhen filtered'throug a ivehvighoe of diameter. The filtrate res'ulted in' about 1.1;kg of soymnilk.

ExAMr'Ie 2: -Peparation Fof S milk Get from Soyil Tfollowing comnpositions of this invenition weepeae sfollows. The' weight per-centages of each ingredient in"the compositions: are indicated.blw n Table 1 Anid Table 2. First, the soymilk, as prep ared in exampple 1, was placed into a,, firt bake. Te pesevatvePhenonip" (a mture of the pre~servtv ehl paraben, propyl-paraben, e thyl-paraben, and phenoxy-ethanol- sold by NIPA, Wilmington, Delaware) or the preservative phenoxyethanol were added to the soyMilk. Next, the chelating agent Disodium EDTA and in some examples the humectant glycerin were added to the first beaker and mnixed with the soymilk.. It is.

ilsb pq~sSiblefto further add cyclome'Thicone. ortdimerhicone-radenarne-Dow- Corning 200 Fluid or PolySorbate 20, or Aluminum Starch Octvl'Succinate, or *Sucrose Cocoate, or PEG-6 Capric/Caprylic Triglycerides to the so'ymilk mixture at this step as required in some examxples in Table I and Table 2. A mixture of the' thickener polyacrylaiide, laureth-7, and C1.3-14 isoparaffins (sold by Seppic, Paris, 14 France undez, the Tradexim-ne Sepigal) was added to a second beaker along with the' anti-oxidant BHT. The ingredients in the second beaker were then added to the ingredients of the first beaker and mxed until homogenous. The anti-oxidants ascorbic acid, sodium ascorbyl phosphate, lactofer-in, or tocopherol were, then added to the beaaker and hcrnogeneously Mixed ro form the. resulting gel 00 Examole. 3: 'Prelgaatr.-pqf -SOYMIlk G3el. from Soan noWder.

The follotwing. coiiposiMIM&"of this invenio wee repared. as follo,ts. The eiht Orczrtage of each in dtzgn a~o the -prep arationis is; indicatedl below in: Table 2.~rs-c, zhe sovym'ilk powder PD ;noy F~Rans. CarrolliA) rte oba power Slih~ ood, Tipe~ aiwa)o h Soy bean Extracrand deonizedc water were placod into a istbAer and mied torconsitute, the so powder h prsrvtvePeunp n techltng aLgent Disodilumh EDTA were then a'dded to ihe 'first beaker 'ad mi'xed wirb' the soyil"k. A niixture of polyacrylarn.e laureth- 7, arnd C 13-14hioparaffins was acd to0a s-cid. beker aog with the-anti-oxidant DHIi. The ingredients in the seconid beaker, were then added to the inredients of the first beaiker'arnid utlhonosanous.

Table i 00 'C r; Soybean Essences .1 6 B 21* SYMilk-.

Cyclomethicone AlumrinuiM Starch OceM 4Succtnate Sucrose Coc Oate 87,42% 89.04% 96.09% I 0.73% 1'.00% 1.00%/ 96.05% 1.00% PE arprJCanr ki.TraIriides

'-I

2.50% 2.50% 2.000/ 0.75%: 1.00%/ 1.00% 3.00%, 0.10% 2.50% 2-.6% 0.10% Disodium. EDTA.

P olyaecry'am~ide/LAuret1-7/Ci 3 .d Isdoftarrain Ascorbic Acid Bulyated Hydroxytoluene.:....

!2olysorbRt

TOTAL*

2.90%6/.9 0.01% 0.05%/ 23 9 5.70% 1.00% 3.20%, o6 056/6 100% 050% 100% 100%- 100% .100%' 16 TabL-,2 24 26 27 8, 33. 3' milk 04.40% 92-40% 90-70% 94.70%: novrao n aa~s1.00% 1.00% 1;00/. .1.00% 1.600% t.00% 1700%'' wium EDTA". .0.05% 0.05% 0.05% 0.-05% 0.05% 6081/6 racrlamd~Iaureh-7~~~' Ispaifn3..50% 3-50% 3.20/ .%320% 3.20% 3.20 brbic Acid' 1.00% rialed Hy d'rdxxolu fl 0.05% 0.0% 0.5 0.05% .05 0.6%005%, mized ater.. 0.0 9.70% 85.,0 ~oferin '1.00% i Comiiq 200 Fiid 1.00% milk F'Okd~r 5 50% bKnE*t4act Using EthaoAatrlre .5 TOTAL to00%,:10%:00 00 100% 100% 100% Example 4: sovilk' inhiit5 tb!E PA R-2 PathMET Our parent, application WO 99/04752 describes the imotne othe PAR-2 paphWay in pigmentation, and shoiws that the soybean-derived protease ihibitor ST! jnhibits this:'paithwray and induces depigmrentation.: Our patent'application WO; 99/30729 fuirther describes the. role of PA-2 in inducn keratiaocyt -Ago.ytosis and its effect on melabosome transfer and pigmentation. To test the possibility that soyik induces depigrnEnarion by inhibiting' PAR-2 i~nduced* PhagocyxoSiS the.

following experinents, w ere performed. First, STI and soymnilk were shown to act1 AS serine protease inhibitors, by inhibiti" the tysiidce clavageo afloecn casein. peptide in a dose-dependent manner (Figure 1a), Total protease activity was measured using the EnzChekTM protecase assay kit, following maufacturrs struccuons (Molecular Prob6es). STI and soymailk were diuted inPB(iwfe Technologies) and incubated at 1: 1 with 1 00 units of trypsin, prepared in PBS.

Follow ing inicubafion with BOD1IPY fluorescent Casein substrate at room, tempe rature for one hour,. fluorescence was measured (e .xcitation 505/emision 51.5) on a SpectraMax' Gemini rnicroviter plate reader (Molecular De vices Corporation) using Softrnaxo Pro 3.0 software (Molecular Devices Corporation). Each experiment.

CIwsprform-ed insix replicat .es and was riee ated three ti=,es- The percent inhibition .Of try sin cleavage of the substrate by STI adsyikwscluae sn Micosot EceLandgraphed inlSigma Plot As shown in Figure Sa Y sorik can inhibit trypsin-induced cleavage in a dose response mannier.

00 In asecod exerimnt1 a similar assay was designed to test thep pssible sp ecfic ihibition of soymilk onl PAR-2 cleavage. Ini this assaasyte' ,c'fluorecn ptId comprising .th clavage site 0 ftehmnJAR-2

SKRLIG

similar ssay Is described in: Lourbakos A, Chinni Thompson P, Notempa J aci l ieRN laaeadactivation of proteinaseactivated- .rcpor-Lon hua nethilt by gingipain-R from:op ibipsgr FSLer435: 1, 45-8, Sep: 11, 1998), replaced: the casein peptid e as a substrate for trpin.'Th pde 6! was labeled with the fl:uorophre parEdans/D.by vne Boocpt, Montral Canada), and was used as a subsrt fo A- eiepoe I~atvtr;'lavag of this peptid with PAR-2 activators such as i u-pin could, be detected fluoresey 1 (excitation 3351/611sio1 55) The inhibition of tysn induced PAR-2 pepude cleaivage by STI or Soymilk was measured by incubating 100' nicromolar peptide with 10.units of trypsin (in 100mM TRIS (hydr6-xym edayllaininfomnethaine buffer, pH 8.0, Diee esilM) ihor withotr the test material, for one. hour at room temperature, protected from igh Flurecene asmeasured o n SpecraMaLx' Gerini microtirr platereader qqMlecI Ar Devices Corporatilon) using Softmax® Pro 3.0 software (Molecular Devices Corporation). Each experiment was pefr In sia elcte a repeated three times. The percent inhibition of trypsin cleavage was calculated using.

Micrsoft Excel ad graphed in Sigma Plot., As shown in Figure lb, the cleavageo this.PAR-2 peptide by trypsin was completely inhibited in the presence of STI.

Soril reandteaiiyt niit this trypsin-induced PAR-2 cleavge (Figur 2b), suggest that simrilar to STI, soybean extracts could inhibit PAR-2 activition.

To exa='ne the possibility that soyrnilk could inhibit PAR-2 induced keratinocyce phagocytcosis, we used the VybrantTlm Phagocy'cos*is Assay (Molecular Probes). HIaCaT keratinocytes were treated with SGRthe PAR-. activtg pveptide, and increas .ing concentrationis of Sfl or soymilk for'24 hours, followng by incubation with'100 rnicroliter of fluorescein-labeled Z, coli K-12 bioparricles for four, hours. hitracellular fluorescence, indcie of ngste L iprils a meas ured-aftertrypan. blue qu enching of the nion-internalied: fluoreec.

Fl~ecnc a easured(8 nm exci ltion/53 9nm emi ssio n) usinfg A Specr aMa Gemn ncrit late reae MoculrDevices Corporation, -Sunnyvale,'CA)..L Data waS. collected. Using Sofrrnaxa Pro 3.0 software (Molecular DevcesCororation), and *as Aayed: usingSgPot 5.0: (SPSS Scine 100~cg, it) and SigmaStat 9 2.0 (SPSS Science) software. MEach e'xperiment was 'perfmed. in si replicates: andwas repeated at last three times.' As shown in Figue SICR increased keratinoye phagcrss n T rvne hs~ inceae n dse deedn anr. Interestingly, freshly prepared syikwa~ ab to ihibit SLIL ,indu'ced phagocytosis in kerat.n..te toaw iiar degree Thee three experinent SLindct htsyii contains A protease inhibiry.

~acivc ha inibT AR- actvaion, which leads to reduced k'eratinocy-te phagocytosis. This data suggest thaX the depiginenting activity af the soy pro ducts is due, in part, to their PAR-2 inhibjtor' a1ctivity.

Ficamtele 5: The devi~mentiy atvt fnwsvikfnnaiisi esz~vor.

Our patent application WO 99/04752 documents the depigmenting activitry of soyxnil, and presents soyw' ilk-conraining formulations for the use of depigxnentaion.A xml ofuch formulation is Soy Essence I, as described in:.

S able 1 above. The pres-ent iventioni describes depg1etig copstos com sn a so prouctand a stabilizing system but with no more than 0.l1/6 tr~tn.A 0ex pof such formiulation iS oy Essence 23, as descrbdi al bv.T demonstrate that Soy Essence,23 -is superior to Essence 1 in its depigmeniting activity the following experiment was performed..

Dark skinned Yucatan microswine (Charle's River, Maie were housed in appropriately si2edcags.i an enviernmentally cotrolled room WJith a 12-hour ligh 12-hor drk potprdan suppied with food and water ad libitum. Anmlcrewsbsdo he"Gudefor the:Ca're and Use'oftLaboratory Animals", NIH Publication No. 85-23., Twenty microliter.of test compounds were.

applied topically, twice a day, five dalys/week, for eOight or nine; weeks, on, the- dorsumn of the swine. Treatments of in dividuaswn were; a]Wa .sarranged in 2 head to -tait'order on one' side, and in; a tail to head order- on the other side of the animal.*: BOopsies were tknung sandard techni ques.. All swine studies showed no, vi s ual irritation; and histological analyses revealed nmaker of irritation or other pathological signs.

Sections from biopsies were stained with Fonan-Masn(&) using standard Procedures (Sheenan and Hrapckak, 1980), F&Mv staiing identiifies silver M~rra Ee reducing: molecules. In Sk hs no-specifc st d idniis primaily meaIn At least thr'ee sections per biops weepoesd, Each experiment was repeated at: least three'tms Fiur 2s v hs691a ccsiE iw uheprienitfs. h ecii were stained with P&M, to mark the' melanin deposition in the treated site s. The top panel shows the control and the Soy Esseuce23 treated sites of one swine.: The lowevr paniel'shows the control and the Soy Essencel treated sites of another swine4 It is obvious from this figure That the both the relative ind the absolute reducti. on in pigme nt deposition induced by So y Essence 23'is superTior to' the level induced by Soy Essence 1.

Exam ble 6: the debi~-menting activity of soytmilk is, enhanced wh en. combined wt antioxidanrs: Orpaten appliatio WO 9/04.752 documents the deipigmnigatvt of soymrik. As we ,show here, this depigmtenting activity is due, in ,part, to the iniiion of PAR-2 induced keratinoct phagoc yosis. To test the h ypothesis that A1 mprove d depigrnientauion could be achieved by combining mon thaoe menchanismn That lead to depIgmeontation, we tested the depigrnenttig effect of0 .1.s ymlk ad';anti-oxidant combi-tos Swinew were treated'with. soymfilk or Soymilk Essence formhulations,. I% d'hydrolipoic acid (DHULA), and 16% Resiveratrol twice daily,.or. with' combination treatments of soymxilk once daily and D1lLA or Res once a day. Vistial sLkin lightening was 6bserved aft6 svn, or eight weeks of treatet. Anexmp' of such experimient is demonstrated in Figure showing a flank of a dark' skinne~d twie floIn eight weeks treatment with soyrnilk:Essence ad. DIMLA combination., The, left site(l) is treated wit SonjkEse12, orik formulation described above, The right site is5 treated with DH-LA, and the rniddle site is treated with both Soyrnilk Essence 23 and DIiLA. This figur clearly demonstrates increased depigmentation follow.ing the combination treatment of soyil esne 23 and DI-ILA, relative to treatmentswt each ingredient alone.

Similar results were obtained using soymilk o omlessene cmiedit DIILA or Res. This example'dearly demonstrates' that. additives of different mechanism can improve the depigmenting effect of soyrnilk.

ExaMpe 7: Sovmilk affects sn elasticity Whie performning the soyrnilk studies described in our applications JBP-430, JBP-464 and JBP-467, we unexpeczedily noticed that the skin of soyxnfl treated mice,

\O

Supon palpation, felt more elastic. To test the possibility that soymilk has a positive effect on skin elasticity, we performed two sets of experiments: non-invasive cier se mn s (cutometer measurements) and staining of skin section for i ti fibers. Thes studies indicate that saymilk treatment increases Elastit fibers in skin, and the treated skin has increased elastic properties.

ci 00 SG3OH and 57B1/6 mice were either induced for a new hair cycle as described i *V our applications JBP430, JBP464 iand JBP467, or shaved. Mice were treated with a soymilk daily as described in the above applications. At the start 'of theex rixent S(dayj1 efore fist reatmen) nd at day 21, a cutometer measurement was performed to measure skin elasticity. We used a curometer available from Aaderm (Mernlo Park,;a Califoria), and employed the methods described in Couurautd ral., "Skin Bomechainical Pioperties: In Viv Evaluation of Influence of Age and Body Site by a Non-Iivasive Methdb 1 Skin Res. and Technol. 68-73 (195) and Eisner et a, 'Miehanical Properties of Human Forearm and Vulvar Skin:" 122 Br J. Dermatol.

607-614 (1990) which'are both incorporated herein by reference in their entirety: SSucionwas applied through a 2 mm aperture and the corresponding skin displacement and recovery after release of the negative piessure were measured. In human studies, an imprtovement in the roci of deforiation paramieters Ua/Uf (skin fatigue, or total, recover from the load), Ur/Uf(biological elasticity, or elastic recovery fter loading), Sand Utr/ e (firriress, or improvement in the deformation resistance of the skin) iidicates bercret onicity and elasticity of the skin. The defoimaion parameters Ue, UTf, Ua, and Ur are dependent, in part, on skin thickness. Consequently, ratios were used for evaluation as described in Baretl ei aL., "Suction Method for Measurement of Skin MechanicalProperties: The Cutorneter," Handbook of Non-Invasive Methods and the Skin 335-340 (1995) which is incorporated herein by reference in its entirety.

An ezample of one such experiment is shown in Table 3 demonstrating that soymilk treatment increases these parameters, which reflect improved skin elasticity.

While variations between animals were significant, the increase in cutomeric properties was consistent, reflecting the beneficial effect of soymilk to skin elasticity, 22

INO

Table 3:1Mechanical Properties of shaved soyrnik-treated CAI mnice'skini Bpysica Day 1Day 21 Parameter Unireaied Soyni'lk: Untreated Soymnilk C-U Cntrol Treated Control T reated* 0.6 0.815+! 0.839 4 0.904t+1 0.066: .0,154 0.068 0.043 -U r/Ue 0.964 0.607+/- 1.402 P- .7 A3 01. 0'846, tr/Uf 0.720 G1 077+- 0506 0.7+1 C]0,115: 0.168 0.136l 006 Tolfurt~her study this elasticity effect,,Skin bio6psies wieetaken hoghti this; eperimnt, ind sections weesand, for' Eirinacordance,wh Ithe methods set, forth in KIligman, L.H, Luria's Tch nique, A Beautifil: Stainfor Elastin "3(2 Th Ae. of Dermrahl.9920(91whcisicrpre herein by eeren+e n its entirety., As how.'n in Figure 4i Elatin fibers (staind dak bluie-purpe we re Incr2se, iii thickness and~dcnsit arunihe skin appedazes and the: upe deric o h soyinilk- treated C3H mice (right panel) when compared to the untreated.'controls, (let ane).This inicrease was deetable as early. As at the forth day ofteamitn was consistent throughout the study Samne results were also obtaie sn the+ G57BI/6 mnice. This example demonstrates: that the use of soymni~k and soymnilk formulations for skin care would inc rease, skinx elasticit y and reduce, skin. aging..

1n A separated experiment, the effect of soy powder on collagen synthesis was studied in yin-v. The effect of soy powder to enhance, the rate of collagen synthesis in' normal humran dermal fibroblasts was assessed by evaluating the incorporation of radioactive proline in qxrracellulaxr collagen after three days of treatmenat.; As shown ina Table 4, soy powder enhanced the rate of collagen synthesis in normal human.

dermal fibroblasrs aE I ig/tnl by 58%. At lower concenitrations, no significant stCimulation was, seen'with. soy powder.: Thus, The ski* appae ore fim, full and rhorq youthful.

Table 4: Effect of Soy powder on extra-cellular clage snthesis in Inormal human dermnal fibroblasts.

.0.01: 0.1A, Collagen snthei -11126 ±1i.62 15.0 *-1.46 I13.68+ !;51 1.8 ±.0 P N NS 00Q5 -NS; non sigrniiat Exam Die,&- Sqvnilk bretents sni4nduced daage O:ne hua individual was tre ted withaco oiinacrdgtohs invention containing soyilk on the'rgh" hl of his fac, e diyinmdately after.

Shaving. Afe cih weeks of synktram thiidvidua w sexesvl exposed to the sun,- dui^ngrecreational acivity, wit;hout the us f aunscreen Th individual's skin exhibited thre symptoms of "sun-burn":'his face turnd d a painful adslissWas developed by the seon ad thr ay afer sun exposure.

Uepectedly, the right, side of his face, havinig been prrate with asyrnl comriposition according to this invention, was not red, painful or scaly. Figuire 5 show thd two sides of the individual's face. The difference iAsi enn in tedge 2Q:. of sun, damage are obvious firmthis figure., Figure 6 shows 'ii-scp i age ofthe indvidal' skndemionstrating cbhe scaliness of the untretetd side and the smoothness of the treated side." This examl dmnstrae that the routine w6~s of soyrn. ik comtpositions accordingv.eto to this invni, could protec the skin from unexpected strong sun'exposure, and reduce redness, scaliness and pain associated with "sun The individual described in Exa mple 7 also used a soymilk composition. on a part on hos untreated s'ide, only at 24 and 48 hoUrs Post sun-exposure. The application of soymilk aflir sun exposure served not onilytonmoisturizeC the damaged skin:. It was found' o i'duce oling and soothing sensation, to relieve the pain asciate witte* excessive su epsre; and to reduce redness, an d'scaliness while leaving a "frs feelingj. This eapedemonstrates that topica ;application of soyrnilk or soymilk f~rtnmudationis could relieve the pain and reduce the'redness and scaliness. resulted fromk C ~cse sun exposure. The use; of so-ymilk on sun-exposed skin leids, to a cool and fresh sensation.

Zxamtle V9: Soycnan Corn positibnK Can.Redziceadne Lesions;, A ~clinical srudyawas conduicted inodrto study the effect" of aplInasy containing co .psition twice per day for fort,-five days upon sub jec havingml acne having greater hn1 no i-i a matriv an nfa maoy eins at the: start of the stdy an iuonsubjects having no acne; neaiatb fan lesion.

countsa assm t oe-yherna and a photographi asesent were mae SOy Essenice23 co ntain'ing; 0.005% isoflavione'wis applied to- both grous of Subje'cts.

In mild acne subject There was a highly significant: decreoase firm baseline in *the niumber of inflamtr papuIs (p 6--0.001), a 41.9% decreae. There was also a direCcional-r-rend toward a decrease in erythemal(pssO.06 3 from baseline In rno acne subjcs there Was nosgifcn incre .ase in comnedones apesopstles. This decreased number of papules is illustrated graphically in Figure. 7.

FxqcM'e Soym ilk-coniarni g Com Positions of This Ll!euenrion Contiain: intact.

The soMlk-containing comnpositions of this invention are non-denatured, and have protease-inhibitory activity. These cornpositions are unique because'tbey contain intact: porteains, and in parricilar intact STI, a *serine p-roteas inhibitor. To demonstrate this uniqueness, equal volumie of Essence 23, described above in E~Ame 3, and of a comnmercially available soy- .based produc (Helenak' Rbintin' FufureWhite: Essence, lai niun'g "soja proteins" in their ingredients),j were comared for their STI content using Western blos, a ccording to Bonifacinio J.S. (1999).

Imnmunofluoresence Staining. 'In Current. Protocols in Cell Biology on CD-Rom.

ohn Wie os n.(eo aaSses, Jackson, WY). Salples were lysedin RIPA buffer.11% nonider-P40 0.5% sodium deoxych olate, 0. 1% sodiumi docedyl: sulfate, and C omplete t Protease inhibitors (Boehringer Ma~tnheirn, Indianapolis, IN)] -in PBS, RIPA ly'sates (10 pgper lane) were eleciopoed i1 10% SDS-PAGE.

CI gl n prtin *ere anayzed by'enhanced chemlumninescence (ECLWeer 00 blotin (Aers~zn Arington Heights, 1Q). Antibodies to Sfl werefo Chrn~con ad were used at a 1;500 dilution.

0 As shown in:Figure 8, our soy formulation Essence 23 contains intact STI which is equa in size to anSTI miarker: (which is run in ai paralle lane). Incoirs neicheT, the placbo of Essence 23, or the com nrial soy-based prdutcnan ina ct STI.

It is uIInderstood chat while the inve&ntion: has been described in conjunction w::ith the derailed description cherepof, that the foregoing description is intenaded to.

ilustrat:e and, nr. limit the 'scope of the inention, wh ich is defindytescp ofthe- appended claims. Other aspects, advantages, and'tmodifilcations ;are within the ci AWms..

Claims (17)

1. Asin care comnpoition for, the topical deliveryb. ofasy produc comprising a non-denatured soy product and a stabilizin g system~, said stabIig;ng 5: system comprising g miember selected from the group consisting of a:antiox int, A'. ceaing agent, or a peraie

2. A composition' ccording to clam1 herin isaid compositiondoAes not ontain ihore. than about 01 fasratn

3. A *compositioni according to, claim 1, wheren, said psto complrises axn annioxidant. 2' 4. A composition of claimn 1,).whrerein said composition contirises a heating agent. A composition according to caim 1,i wvhereid cimpoS1 i. me11rse a p.reservative.

6. A composition accordingz to, claim 37 wherein said antioxidant niemer eleted romthegroup consistin fBT reiseleted fron the ou cosstn ofET Wn itivstee,

8. A compoiinocli ,whrisadperviv i paaen.

9. A cmpsiticon ao clim 1, ul w ,hereinn said tblzn tem orprse BHTq EDT or evtv th ereof 7 E and p raben. A comrpositiont of claimi I, w herein said non-denaturied so y prod uct is soy rn'uic

11. A composition of claimi I, wherein said nion-denatured soy product is soy bean powder.

12.- A composidw~ of claim 10,- wherein said comnpositon furthe-r comprises a thickening agent.

13. A skin care comnpositionx for Tile topical delivery of a soy produtt consisting 'sentially of a non-denatured soy product and a stabilizilng system, said stabilizing system consisting of one or more of the members selected from the group consisting of an antioxidant, a chelating agent, and a preservative.

14. A skin care composition for the topical delivery of a soy product consisting essentially of a non-denatured say product, a thickening agent, and a stabilii ng system, said stabilizing system consisting of one or more of the iimembers cted from the group consisting of an antioxidant, a chelatingagent, and a 00 preservative. A method of evening sin n tone of the skin of a mammal, said met od comprising the step of applying to the skin a compositnin of claim L?. I0' A method of treating or preventing acne in the skin of a mamm. ial, said method omprising the step of applyingto the skin a composition of claim L.

17.; A method of depigmenting the skin of a mamnal, said inethod cornprisi ng the stop of applying to the skin a composition of clai 1.

18. A method of evening the texture of the skin of a manrnal, said inethod comprising the step of plying to the skin a composition of claim 1.

19. A method of increasing the elasticity and firmness of the skin of M an a, saTid method comprising the step of applying to the skin a composition of claim 1 A method of reducing the-shine and oiliness of the skin of a mammal, 2 0 said method comprising the step of applying to the skin a composition of claim1.

21. A method of treating cellulite in the skin of a mammal; said method comprising the step of applying to the skin a composition of claim 1,

22. A method of treating and preventing sun burn on the skin of a mammal, said method coniprising the step of applying to the skin a compsition of clain*.

23. A composition according to claim 1 further comprising retinol.

24. A composition according to claim 1 further comprising retinol and caffeine A skin care composition for the topical delivery of a legume product comprising a non-denatured legume product and a stabilizing system, said stabilizing C-Isysem om risn~a me berselctd fom hegroup consisting of an antioxint, A.: chelaing agent; or, a' preservative. 00 DATED this 27h day of February 2006 Sh-eiston IP Attorneys for: Johnson Johnson consumer Companies, Inc. f~)