The present invention relates to a pharmaceutical and/or cosmetic composition for treating skin diseases, especially such as atopic dermatitis of various aetiologies, psoriasis, eczema, lichen, as well as for regeneration of skin damages, such as bites, wounds, frostbites, bums, including chemical and radiation burns, the process for preparing of pharmaceutical and/or cosmetic composition for treating skin diseases as well as for regeneration of skin damages, and also the use of pharmaceutical and/or cosmetic composition for treating skin diseases and regeneration of skin damages in humans and animals.

Skin diseases rank among the more and more common civilisation diseases. A large number of detergents used, inappropriate nutrition as well as environmental pollution, become the reason of the more and more frequently occurrmg skin lesions. There are also a lot of mechanical or chemical damages of the skin involving formation of wounds that are difficult in healing.

In the market, there are a lot of pharmaceutical preparations containing active substances manufactured using chemical or biotechnological methods. Unfortunately, a great deal of these preparations have low therapeutic efficacy or cause allergic reactions. There also exist a large number of cosmetic and pharmaceutical preparations in which the active substances are compounds of natural origin. Even though medicine and cosmetology have used natural resources for ages, and there are known a lot of applications of herbs, extracts and oils for treating various kinds of skin damages and diseases, the preparations developed do not always guarantee high efficacy or may cause occurrence of side effects, like the steroids.

Application of an ointment based on fir oil and aqueous extract of Siberian fir and cortisone for the treatment of skin diseases and purulent wounds is known from patent specification RF 2074730. However, the ointment dries the skin and causes irritations and frequent allergic reactions. This ointment only has a small anti-inflammatory effect, which restricts its application in skin diseases. Cortisone ointment has adverse side effects, such as skin ageing, reducing resistance to infection and causing haemorrhages and oedema. Thus, even though there are known a number of kinds of natural products applicable or potentially applicable in medical or cosmetic preparations, in order to create a high quality ointment with a wide therapeutic effect it is necessary to select appropriate quality composition of the preparation, to determine appropriate proportion of the ingredients and to develop appropriate manufacturing technology providing for retention of the precious properties of the preparation.

The objective of the present invention is to create a composition of selected ingredients that due to the synergy of action enable obtaining a high-quality composition with a wide therapeutic effect, having a high effectiveness of healing and a broad spectrum of therapeutic effect in treatment of skin diseases, such as atopic dermatitis of various aetiologies, psoriasis, eczema, lichen, wounds, as well as in regeneration of skin damages, such as frostbites, burns, etc. without at the same time causing side effects or allergic reactions.

The above objective has been achieved by creating a pharmaceutical and/or cosmetic composition comprising specially selected and mixed in ideal proportions plant ingredients that due to the synergy of action display a high efficacy in stimulating natural epidermal regeneration and treatment of diseases and skin damages of various aetiologies, and do not cause any side effects.

The present invention relates to a pharmaceutical and/or cosmetic composition for topical use in treatment of skin diseases and damages of various aetiologies, comprising a cosmetic base, pharmaceutically and cosmetically acceptable additives, as well as active substances, characterised in that as active ingredients it comprises: avocado oil (Persea gratissima), sea buckthorn oil (Hippophae rhamnoides), comfrey root macerate (Symphytum officinale L.), patchouli oil (Pogostemon cablin), neroli oil (Citrus aurantium), marigold oil (Calendula officinalis L.), vitamin B12 in the following proportions: a) any pharmaceutical and/or cosmetic base 30-95 wt %

b) avocado oil 1-30 wt %

c) sea buckthorn oil 1 -25 wt %

d) comfrey root macerate 0-30 wt %

e) patchouli oil 1 - 10 wt %

f) neroli oil 0.5-5 wt %

g) marigold oil 1 - 10 wt %

h) vitamin B12 0.1-10 wt % The pharmaceutical and/or cosmetic composition is preferably characterised in that it comprises a) any pharmaceutical and/or cosmetic base 62.9 wt %

b) avocado oil 16 wt %

c) sea buckthorn oil 7 wt %

d) comfrey root macerate 7 wt %

e) patchouli oil 2 wt %

f) neroli oil 1 wt %

g) marigold oil 4 wt %

h) vitamin B12 0,1 wt %

Also preferably, the pharmaceutical composition is characterised in that while maintaining the proportion of active ingredients, it contains pharmaceutical base in a quantity of over 62.9 wt % to 95wt %/ and active ingredients in a quantity of below 37.1 wt % to 5wt %.

Preferably, the pharmaceutical and/or cosmetic composition is characterised in that it is presented in particular in the form of cream, salve, lipstick, gel, aerosol, medicinal, suspension, spray, ointment and foam.

Preferably, the described pharmaceutical and/or cosmetic composition is characterised in that it has therapeutic applications and/or can be used prophylactically after completion of the therapy.

The invention also relates to the process for preparing of the above described pharmaceutical and/or cosmetic composition, characterised in that any freely chosen pharmaceutical and/or cosmetic base is placed in a furnace pre-heated to 35-40°C until it liquefies, and while constantly stirred the other ingredients are added until homogeneity is achieved.

The invention also relates to the use of the above described pharmaceutical and/or cosmetic composition for manufacturing a pharmaceutical and/or cosmetic preparation for treatment of skin lesions and damages, such as: atopic dermatitis of various aetiologies, psoriasis, eczema, acne, lichen, as well as for regeneration of skin damages, such as bites, wounds, swelling, frostbites, burns, including chemical and radiation burns. This objective is achieved by the synergy of action of the active ingredients comprising: avocado oil (Persea Gratissima), sea buckthorn oil (Hippophae rhamnoides), comfrey root macerate (Symphytum officinale L.), patchouli oil (Pogostemon cablin), neroli oil (Citrus aurantium), marigold oil (Calendula officinalis L.), vitamin B12.

Avocado oil (Persea Gratissima)

Due to the harmonious combination with vitamins F, A, E, C, B (Bl , B2, B3, B9), chlorophyll, squalene, phytosteroids and magnesium, it has the following properties useful for the human skin: it prevents age spots and premature skin ageing; it absorbs well and penetrates deep into the skin, moisturises it and actively protects it from excessive dryness and peeling; it increases topical resistance of the skin and protects it from the adverse effect of external factors, in particular UV radiation; it stimulates the production of collagen in the body and accelerates regeneration of skin cells.

Sea buckthorn oil (Hippophae rhamnoides)

This is the only oil that contains in its composition fat-soluble vitamins K, E, F, provitamin A, pectins, carotenoids; ascorbic acid, vitamins P, PP; B vitamins; fatty acids (linoleic acid, oleic acid, palmitic acid and stearic acid), flavonoids; macro- and micro-elements (iron, manganese, magnesium, aluminium, sodium, calcium, silicon, titanium); phospholipids; tannins. Present in coumarin oil, they sfrengthen vessels and improve blood flow. Sea buckthorn oil has regenerative effect on the skin and mucous membranes, accelerates granulation of wounds and healing of epithelium; it has overall strengthening, antiinflammatory and cytoprotective properties, and acts as an antioxidant; it reduces free radicals and protects cell membranes against damage.

Comfrey root macerate (Symphytum officinale L.)

Comfrey root macerate was used already in the Middle Ages to treat bone fractures, bruises and contusions. Allantoin present in the extract ensures that the stock has a soothing and regenerating effect. Comfrey root contains allantoin, ca 1 ,5%, tannins, ca 6%, mucus, 10-15%, starch, sugar compounds, polyphenols acids, amino acids, alkaloids and mineral salts: a relatively large fraction of silicon compounds. Comfrey root has strong anti-inflammatory and keratolytic properties; it stimulates repair of tissues and cell growth, accelerates healing of wounds. Patchouli oil (Pogostemon cablin)

It stimulates regeneration of the skin, heals cracks and ulcerations, removes erythemas and oedemas, and reduces symptoms of allergy, kills fungi and reduces dandruff, reduces skin peeling, providing the effect of skin lifting, and has a positive effect on skin problems.

Neroli oil (Citrus aurantium)

Neroli oil facilitates regeneration of damaged epidermis and promotes active growth of new, healthy cells. It exhibits regenerative effect on tiredness, skin dryness, and also has rejuvenating and smoothing effect on wrinkles for each skin type. It increases elasticity, removes skin irritations and stress, acne rosacea and eliminates spider veins, has beneficial effect on the skin and is of essential importance in treating inflammation of the muscles, nerves and connective tissue. It also exhibits antiseptic and antineoplastic effect.

Marigold oil (Calendula officinalis L.),

Marigold flowers contain a mixture of triterpene saponines, oleanolic acid derivatives and triterpene alcohols. Another group of ingredients is comprised of a mixture of carotenoids (provitamin A), up to 3%, and further flavonoids, mucous substances, essential oil, phytosterols, organic acids (Including salicylic), phenol derivatives, mineral salts. Moreover, it contains a bitter principle, elements such as zinc, copper, molybdenum, selenium in trace amounts, has a strong bactericidal, antiseptic and anti-inflammatory effect, and it promotes healing of wounds and also exhibits repairing properties.

It is recommended as an auxiliary agent in curing cuts, abrasions, wounds, burns (scalds), eczemas, insect bites, skin inflammations, eruptions or cracking and frostbites. It is suitable for all, even very sensitive types of skin. It softens bumps on cracked skin, accelerates the process of healing, alleviates pain, strengthens blood vessels and improves microcirculation, stimulates regeneration and improves skin elasticity, eliminates itching and skin irritations, including such that are related to chlorinated water, freezing air and sunlight.

Vitamin B12

Vitamin B12 has blood-forming properties. In the organism (mainly in the liver) it is transformed into a coenzyme— adenosylcobalamin, which is an active form of vitamin B12 and is a part of many enzymes. It has a high biological activity. Cobalamin plays an important role in the transformation of proteins, carbohydrates and fats. It takes part in the process of formation of amino acids and lipids. It is responsible for the proper functioning of the nervous system and the liver. It is comprised in the composition of the layer protecting nerve cells, so- called myelin sheath. It takes place in the process of reproduction of the genetic code in the cell. It is responsible for the formation and functioning of all cells. Together with the other vitamins, it produces neurotransmitters, i.e. substances taking part in transferring information between nerve cells. It is necessary for proper haematopoiesis - promotes maturation of erythrocytes. It activates blood coagulation; reduces blood cholesterol concentration; increases the regenerative ability of tissues.

Even though the properties of the individual ingredients of the composition are known, the appropriately selected composition and proportions ensure the exceptional synergy of action of the claimed preparation prepared according to the claimed formula.

The above properties, due to the presence of the special combination of ointments of biologically active substances with z pronounced bacteriostatic and bactericidal properties, healing properties, actively influence topical regulatory processes, which leads to changes in the metabolism in the exposed area. Furthermore, this combination of active substances has a high permeability and ensures effective skin penetration of vitamins, trace elements and other active substances, creating an aseptic zone, and enhances nutrition of the exposed area. The proposed ointment can be applied in medical practice. The process for preparing the same is not complicated. The ointment is made from available raw materials of plant origin. The mechanism of action of the pharmaceutical composition with healing properties according to the present invention consists in regeneration of mechanically or pathologically damaged epidermis, in inhibiting skin inflammatory processes, in intensive facilitation of the healing of wounds and cracks. The mechanism of action is based on the synergic action of the individual ingredients of the preparation that enables multi-stage regeneration of the pathologically changed or damaged epidermis through absoiption of the preparation into the region of the damaged epidermis, and thereafter softening the same. This induces irritating effect on the receptors of the autonomic nervous system and causes activation of the protective mechanisms of the immune system. In the following stage, there takes place absorption of the healing substances and restoration of the natural metabolism in epidermal cells. It is particularly recommended for AD, psoriasis, dermatitis, eczema of various aetiologies, and herpes. The synergic effect achieved by mixing together the above listed compounds leads to a number of essential benefits. In order to achieve the same effect, it is possible to reduce the concentration of some of the active substances, resulting in reduced risk of intolerance to some of the ingredients in patients.

Compositions according to the present invention exhibit very good tolerability. They do not contain allergic substances originating from animal sources (such as lanolin, beeswax, animal fat), preservatives (such as parabens, isothiazolinones, derivatives of phenols, etc.) that are commonly accountable for allergic contact dermatitis.

Thanks to the above characteristic features, compositions according to the present invention are useful in treating existent skin allergic reactions, in preventing recurrent forms, and as auxiliary agents in treating chronic diseases, such as atopic dermatitis of various aetiologies, allergic contact dermatitis, seborrhoic dermatitis, radiation dermatitis, psoriasis, eczema, lichen, and for regeneration of skin damages, such as bites, wounds, frostbites, burns, including chemical and radiation burns.

Compositions according to the present invention are particularly useful in treating conditions such as irritative and eczematous dermatitis, as wetting agents and alleviating agents for sensitive and delicate skin, in allergic irritations due to the use of medicinal agents, detergents and solvents, in erythema resulting from excessive exposure to solar radiation, in frostbites, insect stings, oedemas and erythemas of various origins, irritations caused by shaving, bums, cutaneous hypersensitivity, as normalising agents after cosmetic treatments such as laser therapy. Perfect tolerability of the composition according to the present invention makes them useful in paediatrics, too.

The solution accordmg to the present invention comprises an active composition in conjunction with any (selected) cosmetic and/or pharmaceutical base. Cosmetic and therapeutic activity of the present claimed solution/invention results directly from the combination of active substances comprised in the described composition.

Pharmaceutical and/or cosmetic agents may further contain preservatives, solubilisers, stabilisers, wetting agents, emulsifiers, colouring agents, fragrances, salt used to change the osmotic pressure, buffers, masking agents or antioxidants. They may also contain other therapeutically valuable substances, vitamins, mineral substances, solar filters, other plant extracts and the like. For topical use, the above listed compounds can be conveniently used in the form of pharmaceutical and/or cosmetic preparations or agents that additionally contain an acceptable carrier material. Depending on the dosage form used, they may contain higher or lower concentrations. Agents for topical use according to the present invention can be used in quantities and with frequency adapted appropriately to the patient's needs.

The term "topical use" as used herein relates to the use of the above listed active substances, formulated together with an appropriate carrier material and applied to the skin or mucous membrane in such manner that they should exert topical action. Therefore, the topical forms embrace pharmaceutical and/or cosmetic dosage forms which are suitable for external use, so that a direct contact with the skin results. The topical dosage forms embrace gels, creams, lipsticks, lotions, salves, powders, aerosols and other known forms which are suitable for the direct application of products on the skin or mucous membrane.

These dosage forms can be manufactured by mixing the above listed compounds with any carrier materials that are suitable for topical use.

Salves and creams contain oily, absorbent, water-soluble and/or emulsifying carrier materials such as Vaseline, paraffin oil, propylene glycol, cetylalcohol, glycerol monostearate, alkyl- branched fatty acids and the like.

Lotions are liquid preparations and can vary from simple solutions to aqueous or aqueous/alcoholic preparations which contain the substances in finely divided form. The preparations contain suspended or dispersing substances such as, for example, sodium carboxymethylcellulose, which suspends or disperses the active substance in a carrier prepared from water, alcohol, glycerine and the like.

Gels are semi-solid preparations obtained by gelling a solution or suspension of the active substance in a carrier material. The carrier materials, which can be hydrophilic or hydrophobic, are gelled using a gelling agent in the form of polymers of biological, natural or synthetic origin.

Aerosols are solutions or suspensions of the active substance in a carrier material which are applied using spray generators. Usually used carriers include for example, trichloromonofluoromethane, trichlorodifluoromethane, volatile silicones, nitrogen, etc. Spays are solutions suspensions or powders of the active substance in a carrier material which are applied using mechanical pumps.

The compositions according to the present invention are used by applying an amount of the active compounds sufficient to provide a therapeutic and/or cosmetic effect to the skin to be treated. This application can be effected in the usual manner by rubbing, spraying or by a plaster, etc.

Thus, in the process for preparing of the object of the above invention, the claimed solution can be applied in combination with any known cosmetic base, depending on the customer's preferences, the condition, the type of the customer's skin and with special consideration given to the fact whether the person using the preparation according to the present invention is a child, an adult or an animal. The choice of the cosmetic base may be determined by many factors. It is worth noticing that the thickness of the epidermis in animals significantly differs from the thickness of epidermis in a human adult, and even more so in a child. The particular species differ with regard to, inter alia, the pH of the skin. The appropriate base has an essential influence on the absorption and distribution of the active substance.

Examples

Described below is an use of the composition according to the invention in combination with one of the possible cosmetic bases that are suitable for application. The below examples and the bases used do not in any way restrict the scope of the claimed invention.

The pharmaceutical and/or cosmetic composition used has the following formulation: a) DAC base 62.9 wt %

containing, based on 100.0 g base:

• glycerol monostearate, 60-4.0 g

• cetylalcohol, 6.0 g

• medium-chain triglycerides (MCTs), 7.5 g

• white Vaseline, 25.5 g

• macrogol 20 glycerol monostearate, 7.0 g

• propylene glycol, 10.0 g

• purified water, 40.0 g

b) avocado oil 16 wt % c) sea buckthorn oil 7 wt %

d) comfrey root macerate 7 wt %

e) patchouli oil 2 wt %

f) neroli oil 1 wt %

g) marigold oil 4 wt %

h) vitamin B12 0.1 wt %

Examples of application of the ointment

1. Man, aged 45 - medically diagnosed with psoriasis; affected for several years;

a. location: dorsal surface of the hands and between the fingers, elbows;

b. application of the preparation: twice daily for three weeks; two weeks break and application of the preparation for another three weeks;

c. at present: complete regression of symptoms; no recurrence.

2. Man, aged 30; medically diagnosed with psoriasis; affected for 10 years; hospitalised every year without any signs of improvement;

a. location: entire body from neck to ankles; pustular form;

b. application of the preparation: twice daily for 2 months until remission of the symptoms at the places of application.

3. Man, aged 50, diagnosed with psoriasis; affected for over a dozen years; various treatments without result;

a. location: elbows;

b. application of the preparation— irregular for a month until complete remission of the symptoms.

4. Lichen, zoogenous, the preparation was smeared on the affected area in an irregular manner, i.e. occasionally. The condition, that had been troublesome for over twenty years, remitted.

5. Lichen planus. Regular smearing, in the morning and evening, in this case, the (female) patient was very persevering. The condition remitted partially after 8 weeks. Treatment of juvenile acne by smearing the preparation; the observed changes consist in drying out the of the pimples: upon pressing they are dry inside (no purulent substance). Additional information: the preparation caused a smoothing of the skin. Woman, aged 16; juvenile acne;

a. application of the preparation - face and back, twice daily for two weeks;

b. final effect - remission of the symptoms (purulent pimples) without any traces left. Woman, aged 40. Atopic dermatitis on hands for 15 years. Ointment applied twice daily - in the morning and evening. After 3 weeks the skin lesions disappeared. After 2 years, minor recurrence, healed in the same manner. After regression of the symptoms, the ointment is being applied prophylactically after contact with detergents, in 5% concentration of the active ingredients and 95% base. Man, aged 65. Allergic reaction to cement occurred on the hands. Ointment was applied for about 5 weeks until remission of the symptoms. Man, aged 50. Atopic dermatitis, especially in the right hand, with deeps cracks of the cornified skin layer. Other treatments during 10 years were not successful. Ointment was applied for 4 weeks until remission of the symptoms. Woman, aged 34. Affected with AD for over 8 years. Ointment was applied for about 4 weeks. Cutaneous symptoms of the condition disappeared. Burns / scalds: positive effect of the ointment has been observed in skin burnt by hot oil, boiling water, hot objects like a hot brick, stone of metal. After smearing the ointment on the burnt area it was cooled and then the preparation was applied for several days by smearing the burnt area. Similar therapeutic effect has been observed in treating animals; in 2 dogs and 1 cat originating from the same from the same breeding site fungal skin lesions were observed. For 3 weeks, once daily a small amount of the ointment was applied on the affected areas. The application of the ointment resulted initially in the softening of the scabs followed by full cicatrisation and healing of the wounds.