AU711191B2 - Preparations for use in cosmetics and dermatology - Google Patents

Description

WO 97/30719 PCT/HU97/00007

PREPARATIONS

FOR USE IN COSMETICS AND DERMATOLOGY SUBSTITUTE SHEET (RULE 26) WO 97/30719 PCT/HU97/00007 The invention is related to cosmetic and dermatological preparations, to processes for their preparation and to their method of use. These preparations are specifically useful in treatment of cutaneous lesions attributable to seborrhoea, in purification of pustulous, fatty skin, treatment of acne, symptoms of seborrhoea, comedo, psoriasis, in prevention of related inflammatory and other symptoms.

There are numerous products known in this field both as dermatological preparations and cosmetics. The use of products of purely vegetal origin has a considerable tradition. These can be raw plants, or dried plants or parts of the same or extracts of these.

It is known that the sebaceous gland is placed in the upper third part of the corium, in the corner limited by the pilorum (muscle) and the hair follicle. As a consequence of division of the basal cells there are cells producing sebum formed which are situated in the connective tissue surrounding the gland.

Following cell division the new cells are moved deeper whilst they are progressively undergoing fatty degeneration. Within the sebaceous gland there are cells present which are filled with sebum. It takes about a week after division until the cell arrives into the interior of gland and discharge appears. Thus sebum comprises a mixture of cell fragments and cytoplasm which underwent fatty degeneration containing numerous glycerol esters, some fatty alcohols, free fatty acids and cholesterol (see Dr.

Hajdu I: Cosmetic Manual, edited by Miszaki K6nyvkiad6, Budapest 1990, pages 56 60). Seborrhoea is a functional disturbance of the sebaceous glands marked by the occurrence of excessive discharge of sebum from the glands forming white or yellowish greasy scales or cheesy plugs on the body. The irregularities based on seborrhoea are the consequences of the above. The comedo ("mitesser") represents a staphylome or retention blocking the exit opening of the sebaceous gland. It iscaused by increased production of suet and increased keratinization and other fac- SUBSTITUTE SHEET (RULE 26) WO 97/30719 PCT/HU97/00007 3 tors. Once the comedo is already present the acne is formed. The acne vulgaris is a chronic inflammatory disease of the sebaceous glands, occurring most frequently on the face, back and chest.

The inflamed glands form either small, pink papules, which sometimes surround comedones so as to have black centers, or else pustules or hypertrophied nodes. Because the ester cleaving enzyme of the Propionibacterium acne is cleaving the suet within the gland and on the course of hydrolysis fatty acids are formed together with glycerol. The fatty acids are irritating the ambient corium. Inflammations appear around the sebaceous gland, painful nods of violet to red colour are formed, a sanguineous or seropurulent discharge appears. In serious cases (and when there is an inclination for celoid formation) deforming scars remain on the skin after healing.

For the treatment of acne, pustulous facial skin etc. different kinds of "shaked mixtures", "face-washes" were suggested the task of which was the removal of the contaminated fatty layer. The compositions were completed with various plant extracts e.g. with extracts of nettle and Gramineae or extracts of ground camomile and peppermint Hungarian Patent specifications N° 210708 and N° 209484). Synthetic ingredients or antibiotics were also proposed for use e.g. for treatment of acne gel preparations containing tetracycline or keratolytic products e.g.

salicylic acid derivatives (Hungarian patent publications N° T54082 and N° T73041) For the treatment of fatty, pustulous skin also different skin-erasers and desquamative compositions were applied. One well known drug in this field is "acnomel": an ointment containing resorcinol, sulphur and alcohol. However the results are not satisfactory.

The aim of various known preparations relies in enhancing skin metabolism and it is the aim of the components of the preparations to help better absorption and incorporation of the active ingredients into the skin. However a number of valuable extracts is only active on the surface because entering into the deeper SUBSTITUTE SHEET (RULE 26) WO 97/30719 PCT/HU97/00007 4 spheres is inhibited by "fat plugs" which are blocking the pores and the hair follicles thereby limiting the activity of the active ingredients specifically in the fatty, inflamed skin. Also skin erasers and desquamative products are only serving elimination of the surface horny layer of the skin they do not treat the deeper inflamed regions.

For the treatment of surface layers and deeper layers together a combination of preparations was suggested containing a first dispersion of lipide-vesicule comprising antibiotics, retinal and a second dispersion containing keratolytic products whereby the first dispersion is intended to treat the deeper layers while the second dispersion is intended to treat the surface layers of the skin (Hungarian patent publications Nos. T 71722 and T 71385) It is the intention of the invention to provide a new composition which is capable to purify the pores and keep them clean, which is acceptable for cosmetic and dermatology purposes and which optionally can be combined with adequate ingredients either to avoid or to cure inflammations. This would ensure transport of the active ingredients into the deeper regions of the fatty inflamed skin in a simple manner and in most cases would even make the use of active ingredients superfluous.

The basis of the present invention is the experience that in treatment of fatty skin with the dry or water-saturated powder of ground lentil seeds optionally peeled in the form of a pulp or after addition with a (preferably natural) carrier in the form of a creamy substance it was found that within short this product shows a "sucking action" on the treated skin binding thereby the fat blocking the pores and hair follicles of the skin. It is possible that the salts of the fatty acids present are formed which are dissolved in the preparation and are thus eliminated from the ambience of the sebaceous gland. Thus the product liberates the territory from the irritating fatty acids whereby free respiration of the skin is achieved and besides if SUBSTITUTE SHEET (RULE 26) still necessary it also gives free entrance for different active ingredients into the deeper regions of the skin whereby metabolism of the skin is already improved. The dry ground lentil seeds show also a water-absorbing activity and thus perform besides of treating the deeper regions of the skin also a peeling effect.

The object of the invention is a cosmetic or dermatology preparation specifically for the treatment of cutaneous lesions attributable to seborrhoea, for purification of pores of pustulous, fatty skin, for elimination of excess fatty acids, for treatment and prevention of acne, symptoms of seborrhoea, comedo, psoriasis, in prevention of inflammatory symptoms said preparation including a finely dispergated plant seed and optionally a carrier and whereby the plant seed may be dry or saturated with a liquid carrier the seeds being present as a fine dispersion of small particles having preferably a particle size <500p preferably <50t of a papilinaceous plant seed including a total of about 1000 mg of potassium and sodium (mostly in the form of ions) in 100 g of the dry seed mass while the mass ratio of potassium ions to sodium ions preferably amounts to 1 2.5 1 5 most preferably to 1 3 1 4 and the iron content in the seeds calculated on 100 g of the dry seed product amounts to a minimum value of between about 20 mg to 50 mg. It is preferable if ions containing phosphorus phosphates) are present besides of chlorides.

In preferred preparations according to the invention the finely dispersed seed is the seed of the lentil (Lens culinaris) which normally contains the necessary ions in a natural manner.

Further objects of the invention are preparations for use in cosmetics and dermatology characterized by containing seeds of lentil in finely dispergated form optionally with or without the chopped peelings of the seed.

In cases where the necessary ion quantity and ion ratio is not present in the natural seed the ions can be introduced into the preparation on the course of the process by way of addition into the seed mass, or into the composition on the course of its admixture or finishing. With appropriate adjustment of the ion content seeds of different papilinaceous plants can be used such as: vetch types (Vicia; V. villosa; V. sativa; sweat pea, hairy vetch), pea (Pisum sativum), beans (Phaseolus vulgaris, Faba alba) etc.

In the compositions according to the invention carriers are comprised which are acceptable in preparations for cosmetics and dermatology and in which the finely chopped seeds are readily disperged.

The papilinaceous plant seeds present in the compositions are in a state of saturation (swelling) of the seeds carried out before or after chopping or grinding. Suitable saturating agents include water, aqueous solutions, distilled water, solutions containing dissolved active ingredients or salt-solutions.

The ground and optionally saturated seeds and optionally Sdisperged in a carrier are already considered to represent a composition of the invention and they might be used in the sense of the treatments according to the invention.

9**99 The compositions according to the invention preferably may contain additional products along with the ground and optionally saturated seeds and disperged seeds, which additives are promoting application, spreading and acceptability of the preparation.

Optionally the composition might include further active ingredients and in these cases it is made possible to introduce into the deeper regions of the skin further active ingredients in addition of and favoured by the seed preparation namely active ingredients in addition to those which are naturally present in the papilionaceous plant seeds or which are added therein on the course of production of the composition.

Additive ingredients optionally present in the preparation according to the invention include cosmetically and dermatologically acceptable carriers, hydrating agents, gel forming addi- WO 97/30719 PCT/HU97/00007 7 tives, diluting agents, stabilisers, colorants, essences of perfume or other usual additives of skin preparations.

A preferable carrier is water (which also might serve as swelling material of the seeds before or after chopping) along with oils and fats mainly of plant origin. Thus the composition may contain sunflower oil, soy bean oil, olive oil, rape-seed oil, or other edible oils or other oils acceptable for use in cosmetics or dermatoligy. In the presence of oil as a carrier also the presence of a stabiliser against rancidity is advisable.

Stabilising agents such as antioxidants possibly of natural origin may be incorporated into the compositions. Colorants preferably of natural origin are optionally comprised into the preparation according to the invention. Such colorants have to meet the cosmetic and dermatological measures of the country of use of the product.

Along or after application of the composition according to the invention it is possible to bring further active ingredients on the surface of treatment and into the treated or already purified pores.

Thus the further object of the present invention are such compositions which include additional biologically preferable active ingredients above the finely dispersed seeds disclosed above.

According to a preferred form of the invention the preparation contains merely active ingredients used in the cosmetic or dermatological treatments which are of purely natural origin and which are suitable for mitigation, prevention or treatment of inflammation symptoms of the skin. Thus plants or parts of plants of the following group might be used as additional active ingredient: wild camomile, Gallium verum, Viola tricolor, Fumaria officinalis, Achillea millefolium, Equisetum arvense Salvia officinalis Salvia sclarea Calendula officinalis L., Centaurium minus, Centuarium uliginosum, Centaurium pulchellum, Arctium lappa Arctium minus, Arctium tomentosum Mill., Jug- SUBSTITUTE SHEET (RULE 26) 8 landis folia, H Prc herba, Euphrasiae herzba, Veron-icae herba, Urrcicae ffolimm etc. These are incorporated into the preparation in the form of the milling product, or suspensions or preferably in the form of extracts and they may be incorporated into the composition or can be formulated separately and can be used after the first treatment with the seed preparation as described in more details below.

The pH value of the composition according to the invention is within the range of 6 to 7.3 preferably around 6.4.

The products according to the invention may appear in any known form acceptable for cosmetic or dermatological use: suspensions, gels, creams, foaming products, powders, compressions, cosmetic sticks, plasters etc.

According to one object of the invention the composition according to t~he invention appears in at least two formulation forms which are physically separated from each other two jars, two tubes, two bottles etc.) In one formulation (in the examples the one marked the- formulation only contains the mixture containing the milled seeds. The second and optionally :further formulation (in the Examples the formulation marked comprise the additional active ingredients, plant extracts or suspensions, antipruritics etc. The preparations including two :or more formulations are preferably marketed together (e.g.

:packed into one common box etc.) The invention also includes the combination of such physically separated formulations.

A further object of the invention is the process for the preparation of the cosmetic and dermatological preparations according to the invention.

According to the process seeds of the selected Plants milled to an average particle size of <500pi preferably <50gi are mixed together optionally with further additives whereby the ground seeds are in dry state or in a swollen state using a liquid carrier.

WO 97/30719 PCT/HU97/00007 9 The process may be brought about by soaking the seeds of a papilionaceous plant (preferably lentils) in water or in water containing additives. Such additives are e.g. stabilisers, other water soluble additives, vitamins, trace elements andthe like.

Further additives can be given to the mixture and thereafter the mass containing the soaked seed grains is subjected to chopping until a suspension is obtained the average particle size of which does not exceed 50 Practically the product appears in this stage in the form of a light, easily applicable, soft cream.

On the course of the process the optional additives are also incorporated into the cream using known methods of the cosmetic and pharmaceutical industry.

According to one preferred embodiment of the invention the preparations are filled into physically separated at least two distinct formulations. Thus the formulation (suspension, gel, cream) containing the seed preparation is separated from the formulation (suspension, gel, cream) containing other ingredients the application of which might be preferable or necessary for further treatment of the clean pores and skin.

The additives may be applied directly on the ground and/or swollen and chopped seeds or they can be added successively to the formulation on the course of its admixture. Additives which are soluble in the carrier fluid e.g. water, oil can be preferably dissolved in the carrier or in the soaking water to ensure maximal uniform distribution. Thus it is very simple to add natural active ingredients to the composition by using plant extracts e.g. aqueous extracts, teas) for soaking or dispergating of the whole or chopped seeds.

A further object of the invention consist in the application of cosmetic or dermatologic preparations for the treatment of patients in need of such treatment in cases of cutaneous lesions attributable to seborrhoea, for purification of pores of pustulous, fatty skin, for elimination of excess fatty acids, for treatment and prevention of acne, symptoms of seborrhoea, SUBSTITUTE SHEET (RULE 26) WO 97/30719 PCT/HU97/00007 comedo, psoriasis, in prevention of inflammatory symptoms said preparation comprising a finely dispergated plant seed and optionally a carrier and whereby the plant seed may be dry or saturated with a liquid carrier, ground into small particles of fine dispersion and preferably of a particle size <500k preferably t of a papilinaceous plant seed comprising a total of about 1000 mg of potassium and sodium (mostly in the form of ions) in g of the dry seed mass while the mass ratio of potassium ions to sodium ions preferably amounts to 1 2.5 1 5 most preferably to 1 3 1 4 and the iron content in the seeds calculated on 100 g of the dry seed product amounts to a minimum value of between about 20 mg to 50 mg. It is preferable if ions containing phosphorus phosphates) are present besides of chlorides. It is preferable to use the seed of lentils in the composition.

The method of treatment can be applied specifically well for regular treatment of fatty skin and to prevent and solve problems of acne of teenagers and those who are facing this problem practically through their lifetime.

The method of treatment may be carried out in the following way: The composition is adapted on the territory to be treated of the skin in a uniform manner so that the formulation (balsam, cream, liquid etc.) totally covers the territory where symptoms are to be seen or where the patient observes irregular symptoms itching, pain). If a preparation is used which comprises two or more separate formulations the first administration is accomplished with the formula containing the seed mixture (formula of the examples below) The preparation should be left on the skin until dry which takes about 10 to 30 minutes depending on the layer applied. Thereafter the surface is washed preferably with clean or distilled water or an aqueous solution which might already contain water soluble additives which are taken up by the freshly cleaned pores. If the formulation containing several (at least 2) physically separated formulations is SUBSTITUTE SHEET (RULE 26) WO 97/30719 PCT/IW97/00007 11 used the second formulation e.g. formula of the examples) is then applied on the skin. This layer can be dried and washed away or depending on the additives and carriers used it can be absorbed by the skin. If several formulae are used, the following layers can be applied thereafter.

It is preferable to apply 1-3 treatments per day until the symptoms disappear completely. Generally treatments between 1 week to 6 weeks are effective and in most cases e.g. when average severe cases of acne vulgaris are treated the treatment has to be continued for about 3 to 4 weeks.

The compositions according to the invention can be applied in the form of masks. This method is highly advantageous when preventive treatments are applied e.g. on fatty skin which is susceptible for acne formation. For this treatment the full skin surface to be treated is covered with the composition according to the invention such as the face, neck, shoulders etc. Creams, gels, liquids, pastes etc. can be used for this purpose. Again if the composition is used in the form of at least two distinct formulations the formulation containing the seeds is used first (formula of the examples below). The preparation should be left on the skin until dry which takes about 20 to 40 minutes.

Thereafter the surface is washed preferably with clean water or distilled water or an aqueous solution which might already contain water soluble additives which are taken up by the freshly cleaned pores. If the formulation containing several (at least 2) physically separated formulations is used the second formulation e.g. formula of the examples) is then applied on the skin.

This layer can be dried and washed away or depending on the additives and carriers used it can be absorbed by the skin. If several formulae are used, the following layers can be applied thereafter.

In moderate cases where the skin is only fatty or shiny the preparations can be used for prevention. When double formulations are applied then it is only the first formulation which is SUBSTITUTE SHEET (RULE 26) WO 97/30719 PCT/HU97/00007 12 used for this treatment. The cream is left on the skin until dry which takes about 15 30 minutes. Thereafter the dry composition is eliminated by washing with water and the skin is dried. Treatments twice a week are advisable and there is no need to use the second formulation.

According to the invention preferred treatments are those where only natural active ingredients, originating from plants are used for the treatments.

There might be cases where treatment with other ingredients e.g. with disinfectants, antipruritics, antibiotics, sulphonamides is desired. In these cases the formulation containing only the seed compounds is used first and the treatment is then followed by the desired treatment with other active ingredients.

Finally the treatment for about 3-4 weeks is continued using only the natural based active ingredients after purification with the formula containing the seed preparation.

SUBSTITUTE SHEET (RULE 26) WO 97/30719 PCT/HU97/00007 13 o Details of the invention are illustrated in the following examples without the intention of limitation.

EXAMPLES

I. PROCESS Example I.1 1 kG of dried lentil (Lens culinaris) seeds milled to an average particle size of <50 pt are admixed with 4 kG of sunflower oil containing a minimum 70 mg/100 ml of natural tocopherol. A uniform cream is obtained which can be used for treatment of the skin.

Example 1.2 1 kG of dried lentil (Lens culinaris) seeds milled to an average particle size of <50 nt are mixed with 2 1 of distilled water and soaked for 12 hours. The pulp obtained can be used for treatment of the skin optionally after addition of a stabiliser.

Example 1.3 1 kG of dried lentil (Lens culinaris) seeds are mixed with 3 1 of distilled water and soaked for 24 hours. After separating the peels of the seeds from the surface layer the mixture is decanted leaving the swollen, wet seeds behind. Boric acid is added to the mixture obtained and the mixture is subjected to turbomixing technology until a uniform average particle size of tL is reached. The pulp obtained is mixed with 0.5 kG of sunflower oil containing a minimum 70 mg/100 ml natural tocopherol using a mixer equipment. The cream obtained is filled into tubes or jars.

Example 1.4 kG of dried lentil (Lens culinaris) seeds, 3 kG of boric acid, 0.3 kG of bronidox L and 70 kG of distilled water are filled into a vessel which is closed and the mixture is left alone for 12 hours. The seeds absorb the liquid. 0.18 kG of vitamin E are added to the mixture which is then chopped using a turbomix technology until an average particle size of <50 Lt is SUBSTITUTE SHEET (RULE 26) WO 97/30719 PCT/IlU97/00007 14 reached. A soft cream is obtained which is free of lumps. 0.09 kG of a colorant, 0.9 kG of menthol and 1.18 kG of hydroxyl-ethyl cellulose are added.

A cream of slight menthol odour is obtained which is filled into 60 ml tubes in a tube-filler apparatus. The tubes are closed by welding.

II. COMPOSITIONS Example II.1 Double formulation composition: Formulation Using the method of Example 1.4 the following composition is prepared: (mass 1. distilled water 69.44 2. bronidox L (10 :aqueous solution) 0.29 3. tocopherol 0.18 4. boric acid 2.72 ground lentil seed (<501) 26.09 6. menthol 0.09 7. colorant 0.009 8. hydroxyl ethyl cellulose 1.18 Formulation 1. plant infusion 95.56 2. bronidox L 0.20 3. tocopherol 0.20 4. carbopol 940 1.48 boric acid 0.99 6. menthol 0.09 7. sodium-hydroxide 30 aqueous sol.) 1.48 Composition of the plant infusion: 1. Galium verum 2. Equiseti herba 3. Salvia officinals 4. Calendula officinals Bardanae radix SUBSTITUTE SHEET (RULE 26) WO 97/30719 PCT/HU97/00007 6. Juglandis folium 7. Angelica 8. Hypericum perforatum The ground lentil seed comprises the following: Component t% Water 12.5 Protein 25.9 Fat 1.9 Carbohydrate 52.8 Fibre 3.9 Minerals 100 g of the milled lentil product comprises the following elements (mainly in the form of ions) Element mg K 900 Na 296 Ca 172 Mg P (mixed forms) 500 Cl 132 Fe 43 Process: The used quantity of the dry plants (whole or parts) is added to the boiling water. After boiling for about 1 minute the infusion is left alone for 5 minutes and is then filtered. Calculated on 100 g of the infusion 10 g of every plant is used with the exception of Galium verum which is used in a 50 g quantity.

The infusion is poured into a vessel and the compounds 2. 6. of the composition are added while stirring. The dispersion obtained is stirred until no foam or lumps are present whereupon the sodium hydroxide is added while stirring is continued. Bubbles of air are eliminated under vacuum.

SUBSTITUTE SHEET (RULE 26) WO 97/30719 PCT/HU97/00007 16 A transparent, stable gel is obtained (pH=6.4) which is filled into tubes of 60 ml using a tube filler machine and the tubes are closed by welding.

Example 11.2 Using the process of 1.4. the following composition is prepared: Composition mass 1. distilled water 69,44 2. bronidox L (10 aqueous solution) 0,29 3. tocopherol 0,18 4. boric acid 2,72 ground peeled lentil seed (<100) 26.09 6. menthol 0,09 7. colorant 0,009 8. hydroxyl ethyl cellulose 1.18 9. sunflower seed oil 10.00 cetylalcohol Example 11.3.

The process according to Example 1. is used however instead of lentil seeds the seeds of peas (Pusum sativum) or beans (Phaseolus vulgaris) are used. The seeds are treated as disclosed in Example II.1. with the difference that the soaking water is completed with the quantity of additional sodium and iron salts which are missing to achieve the ion relation according to the prescription of the invention.

It is also possible to dissolve the salts in water and add the solution to the formulation [in the case of double formulations to the formulation while stirring.

III. BIOLOGICAL EXAMPLES The objective of the experiment was to determine the efficacy of the preparation according to Example II.1 in the treatment of mild to moderately severe cases of Acne vulgaris.

Number of Patients: Length of treatment: 3 weeks (21 days) SUBSTITUTE SHEET (RULE 26) WO 97/30719 PCT/HU97/00007 17 Selection Criteria: -Prior written consent of all selected patients -Issue of instructions for use -Advance declaration of compliance by each patient.

Age of patients: 15 to 40 years; average age 27.3 years.

Patient gender: 14 women and 6 men.

Evaluation method: For the evaluation of the treatment an "acne load" numerical value was developed. Prior to treatment the symptoms of each patient were assessed and counted and an index applied: comedo papule pustule The acne patients selected for the tests have received treatment for years and presented a great number of clinical symptoms. As a rule, they were tired of the various treatments and had a negative opinion of themselves Method of treatment: The method of treatment was explained to each patient who was provided with components and of the product. The control examinations took place on the 4th, 7th, 14th and 21st days of treatment. At each visit, the acne load value was assessed. The medical evaluation of the tests was carried out on the basis of the acne load value as follows: Reduction of acne load by 90% or more: Cured Reduction of acne load by 60 89%: Marked improvement Reduction of acne load by 40 59%: Improved Reduction of acne load by 39%: No change.

a) Medical Evaluation: (Table i.) Cured 6 patients Significantly improved 11 patients Improved 3 patients Total 20 patients b) Change of the average acne load during treatment (Table 2): SUBSTITUTE SHEET (RULE 26) WO 97/30719 PCT/HU97/00007 18 Average acne load at start of treatment: 93.5% Average acne load at end of treatment: 20.0% Average decrease in absolute terms: 73.5% Average decrease in percentage terms: 78.5% On completion of treatment it was particularly observed that the number of severe symptoms (pustules) had reduced: they had either decreased or had completely disappeared. The peeling effect of the preparation had very favourably influenced the quality of the skin surface and through this the quality of the "barrier" function. Hyperkeratosis and scaling ceased and the development of comedos was considerably reduced. No allergic reaction has been observed. No inflammatory symptoms were observed.

The development of pustules was considerably inhibited. The reduction of abnormal keratinisation (scaling), a phenomenon that had a beneficial effect on the development of comedos, could be evaluated as early as the 7th day of the treatment. No patients suffered a worsening or stagnation of their condition by day 21 of the treatment. Every patient showed an improvement of condition.

SUBSTITUTE SHEET (RULE 26) Table 1 PaietAcne load Acne load Difference/ Difference/ Patient No: Ptet Gender prior to after Reduction Reduction Status of Patient after Age treatment treatment of Acne of Acne treatment load load as 1 *16 1 M 132 20 112 I85% 1Marked improvement 2 24 F 77 30 47 I61% 1Marked improvement 3 26 M i127 I43 I 84 66% IMarked improvement 4 25 F I96 I16 80 830% Marked improvement 123 M I131 16 115 88% Marked improvement 6 f26 F J95 15 80 84% Marked improvement 7 122 F j97 41 56 158% j Improved 8 j33 M I144 I83 61 42% j' Improved 9 135 M T62 f 12 1 50 81% I Improved 36 F r 9831 79% Marked improvement 36 F 1 3 30 I 63 68% J.Marked improvement 121 _26 F j43 118 1 25 58% Improved 13 29 M 72 5 I 67 93% J Cured 14 33 F 55 I 2 53~ 96% I Cured 36 F 163 136 83% Marked improvement 16 19 M 62 0 62 100% j Cured 17 28 M 97 0 97 100% j Cured 18 21 M 87[ 3 84 97% Cured 19 31 M 97~ 21 76 78% jMarked improvement 22 M 102 10 92 90% Cured Average: 27.3 93.5 1 20 I 73.4 1 78.5 Table 2 180 Acne load prior to start of treatment Acne load at end of treatment 160 140 120 S100 0 0 0 U 2 0 I I I I I 1 I

I

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Ave Serial no. of the patients

Claims (23)

1. Preparation for use in cosmetics and dermatology specifically for treatment and prevention of cutaneous lesions attributable to seborrhoea, symptoms of seborrhoea, comedo, psoriasis, for purification of pores of pustulous, fatty skin, for elimination of excess fatty acids, for treatment and prevention of acne, for prevention of inflammatory symptoms of the skin said preparation including small particles of fine dispersion of a papilinaceous plant seed including potassium and sodium (mostly in the form of ions) and the iron content in the seeds calculated on 100 g of the dry seed product amounts to a minium value of 20 mg whereby the plant seed may be dry or saturated with a liquid carrier.

2. The preparation according to claim 1 wherein the particle size is less than 500 j,.

3. The preparation according to claim 2 wherein the particle size is less than o

4. The preparation of any one of claims 1 to 3 wherein the potassium and sodium are present in the amount of 1000 mg in 100 g of the dry seed mass. The preparation of any one of claims 1 to 4 wherein the mass ratio of potassium ions to sodium ions is 1:2.5 20 6. The preparation of claim 5 wherein the mass ratio of potassium ions to be sodium ions is 1:3 1:4.

7. The preparation of any one of claims 1 to 6 wherein the composition contains further additives.

8. The preparation of any one of claims 1 to 7 wherein the composition contains chopped peelings of the seed.

9. Preparations according to any one of claims 1 to 8 whereby the papilinaceous plant seed is the seed of the plant lentil (Lenus culinaris). Preparations for use in cosmetics and dermatology characterised by containing seeds of lentil in finely dispergated form.

11. Preparations of claim 10 containing chopped peelings of the seed.

12. Preparations according to any one of claims 1 to 11 whereby the papilinaceous plant seed is chopped to an average particle size of <50 i.

13. Preparations according to any one of claims 1 to 12 whereby the carrier or the soaking (saturating) material of the seeds is water.

14. Preparations according to any one of claims 1 to 13 whereby further a active ingredients are in the composition which are of plant origin and which are t; acceptable as cosmetics or dermatological products and which are anti- inflammatory, anti-itching, skin soothing and skin regenerating. 15 15. The preparation of claim 14 wherein the further active ingredients are in the form of milled or chopped solids or extracts of plants such as Galium verum, Equiseti herba, Salvia officinals, Calendula officinalis, Bardanae radix, Juglandis folium, Angelica, Hypericum perforatum and the like.

16. Preparations according to any one of claims 1 to 15 whereby the preparation appears in at least two separated formulations which are physically separated from each other (such as two jars, two tubs, two bottles) and whereby one formula includes only that part of the formula where the chopped plant seeds are incorporated while the other formula contains further additives. IIII1 23

17. Process for the preparation of cosmetic and dermatological preparations characterised by admixing seeds of selected papilionaceous plants of an average particle size of <50 g with a carrier whereby the ground seeds are in dry state or in a swollen state using a liquid carrier.

18. The process of claim 17 wherein the preparations include other dermatologically acceptable additives.

19. Application of cosmetic or dermatologic preparations for the treatment of patients in need of such treatment in cases of cutaneous lesions attributable to seborrhoea, for purification of pores of pustulous, fatty skin, for elimination of excess fatty acids, for treatment and prevention of acne, symptoms of seborrhoea, comedo, psoriasis, in prevention of inflammatory symptoms said .9 S. preparation including a finely dispergated plant seed and whereby the plant seed may be dry or saturated with a liquid carrier, ground into small particles of fine dispersion of papilinaceous plant seed including a total of about 1000 mg of .ooooi potassium and sodium (mostly in the form of ions) in 100 g of the dry seed mass. The application of claim 19 wherein the preparation contains a carrier.

21. The application of claims 19 or 20 wherein the plant seed particle size is less than 50 p,.

22. The application of any one of claims 19 to 21 wherein the mass ratio of potassium ions to sodium ions is between 1:2.5

23. The application of claim 22 wherein the mass ratio of potassium ions to sodium ions is between 1:3 1:4.

24. The application of any one of claims 19 23 wherein the preparation further includes ions containing phosphorus phosphates). The application according to any one of claims 19 to 24 characterised by covering the symptoms on the skin in a uniform manner with the preparation, waiting until the preparation is dry and eliminating the preparation from the skin by way of washing with water or an aqueous solution.

26. The application according to any one of claims 19 to 24 characterised by covering the symptoms on the skin in a uniform manner with only that formulated part of the preparation which contains the finely dispersed seeds, waiting until the preparation is dry, eliminating the preparation from the skin by way of washing with water or an aqueous solution preparation.

27. The application of claim 26 wherein the second part of the preparation containing further active ingredients and carriers is applied on the pre- treated, cleaned skin.

28. The application according to any one of claims 19 to 25 characterised by Sapplying daily 1-3 treatments for 1 to 6 weeks.

29. The application according to claim 28 wherein the treatments are carried out for 3 to 4 weeks. MARVEL INTERNATIONAL LTD DATED this 14th day of July, 1999 WATERMARK PATENT TRADEMARK ATTORNEYS 290 BURWOOD ROAD HAWTHORN VICTORIA 3122 AUSTRALIA