BR102018005599A2 - HAZARDOUS, HYDRATING, MOISTURIZING AND EMOLIENT COMPOSITION FOR TOPIC ADMINISTRATION IN INTERTRIGO SKIN INJURIES, SKIN INJURY AND FECAL INJURY AND OTHER RELATED INJURY. - Google Patents

Abstract

This invention relates to a medicament resulting from a combination of substances for treating intertrigo skin lesions, urinary and fecal incontinence skin lesions and other related lesions. acts by contributing to tissue restoration and wound healing. The present invention relates to a solution having in its composition vitamin a, d and e; clotrimazole, zinc oxide and linoleic fatty acid associated with capric and caprylic acids.

Description

Descriptive report of the invention patent for HEALING, HYDRATING, MOISTURING AND EMOLIENT COMPOSITION FOR TOPICAL ADMINISTRATION IN INTERTRIGO SKIN INJURIES, SKIN INJURIES FOR URINARY AND FECAL INCONTINENCE AND OTHER RELATED INJURIES. ”

TECHNICAL FIELD [001] The following specification refers to the invention of a composition resulting from a combination of substances that act synergistically in the treatment of intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other related lesions.

STATE OF THE ART [002] The man's skin is the covering mantle of the organism, indispensable to life and which isolates the organic components from the external environment, corresponding to 15% of his body weight. It presents constant changes, being endowed with great capacity for renovation, repair and a certain degree of impermeability.

[003] The skin can be easily damaged mechanically, chemically, biologically and by radiation. The skin's greatest functions are: protecting the body from chemical and physical damage and preventing the loss of water and other substances by the body.

[004] The skin is a complex tissue, composed of multilayers that can be divided into three main layers, the epidermis, the dermis and the hypodermis. The epidermis is formed by stratified keratinized epithelial tissue, with significant structural and functional variations depending on its anatomical site.

[005] The skin consists of: keratinocytic system, composed of epithelial cells called keratinocytes, responsible for the body of the epidermis and its attachments (hair, nails and glands); melanic system, formed by melanocytes; Langerhans cells, with immune function; Merkel cells, integrated into the nervous system, and dendritic cells

Petition 870190034328, of 4/10/2019, p. 9/40

2/30 undetermined.

[006] DMDM Hydantoin and Sludgepropinyl Butylcarbamate (IPBC) are bactericidal and fungicidal. It inhibits the growth of gram-positive and gram-negative bacteria, yeasts and mold.

[007] Clotrimazole is a topical antimycotic acting on the spot where it is applied on dermatophytes, yeasts, fungi, etc. Its main function is fungistatic or fungicidal, depending on the concentration in the infection. It is effective against Trichomonas vaginalis, gram-positive microorganisms (streptococci / staphylococci) and gram-negative microorganisms (Bacteroides / Gardnerella vaginalis).

[008] Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity belonging to the group of azo derivatives. It acts on fungi by inhibiting ergosterol synthesis, causing structural and functional damage to the cytoplasmic membrane. The broad spectrum of clotrimazole activity in vitro and in vivo includes dermatophytes, yeasts, fungi, etc.

[009] Variants of primary resistance of susceptible fungus species are very rare, having been observed, under therapeutic conditions, only very isolated cases of development of secondary resistance by sensitive fungi.

[010] Studies have shown that, after dermatological and vaginal application, only small amounts of clotrimazole (<2% and 3 - 10% of the dose, respectively) were absorbed. The peak plasma concentration of clotrimazole was <10 ng / mL, below the detection limit and did not cause measurable systemic effects or adverse effects.

[011] Vitamin A is related to the protective action on the skin and mucosa, participates in the strengthening of the immune system, participates in the development and maintenance of epithelial tissue, synthesizing mucus, keeping the skin intact and humidified.

[012] Hypovitaminosis A, that is, the lack of this vitamin, causes xerosis of the skin and increased keratinization, dry and flaking skin.

Petition 870190034328, of 4/10/2019, p. 10/40

3/30 [013] Vitamin A is also known as retinol, which belongs to the class of retinoids, due to the fact that it generates pigments necessary for the retina to function.

[014] Vitamin A has antioxidant power helping to regenerate the skin.

[015] Retinol helps the skin retain water and recover, looking better.

[016] Vitamin A penetrates the skin and normalizes the keratinization process, leaving the skin smooth and soft, reduces the thickening of the epidermis and normalizes dry skin.

[017] The mechanism of action of retinol may be linked to a product of its metabolism, transretinoic acid. This acid binds to receptors in the cell's nucleus and interacts with certain DNA sequences, regulating the production of certain proteins and enzymes, reducing the signals resulting from damage to the skin. It also undergoes oxidation before the essential structures for homeostasis, hence its antioxidant action.

[018] Vitamin A is found in food in two forms:

[019] Preformed vitamin A, which can be obtained from animal products in the form of retinoids, such as fish, meat, poultry and dairy products.

[020] Pro-vitamin A, present in foods of plant origin in the form of carotenoids, such as some fruits and vegetables. The most common type of this is beta-carotene, it is a precursor of Vitamin A.

[021] In the human organism vitamin A can be found in three forms, retinol, retinal and retinoic acid, the latter being the main and most abundant intracellular metabolite in mammals.

[022] There are five forms of vitamin A, the most important of which is retinol in the form of TRANS and CIS.

[023] Retinol esters are vitamin A linked to a fatty acid, being the form in which vitamin A is ingested through food of animal origin. THE

Petition 870190034328, of 4/10/2019, p. 11/40

4/30 oxidized form of this vitamin is called retinal or retinaldehyde. And Retinoic Acid, is the acid of vitamin A, when it oxidizes.

[024] Vitamin A accumulates in the liver.

[025] Cod liver oil, in the case of external application, is important because it is rich in vitamins A and D, being beneficial for tissue metabolism, controlling inflammatory reactions and acting in synergy with zinc oxide, helps in skin protection.

[026] Topical retinoids inhibit the accumulation of polymorphonuclear leukocytes (PMN), a fundamental characteristic of inflammatory dermatoses, in addition to reducing several other inflammatory and non-inflammatory lesions.

[027] Vitamin A (Retinol Palmitate) is used for cell nutrition and collagen replacement.

[028] Vitamin D is a group of fat-soluble prohormones, the two main forms of which are vitamin D2, ergo-calciferol (ergocalciferol) and vitamin D3.

[029] Vitamin D3 is produced by the human body through exposure to the sun, specifically to ultraviolet B radiation acting on an element (7dehydrocholesterol) present in the epidermis, being the best natural source of vitamin D. It is soluble in fat and can be stored in fat cells.

[030] Vitamin D influences the production of hormones in the body, improving certain skin conditions, such as psoriasis, vitiligo and scleroderma, in addition to controlling mood.

[031] Topical application of vitamin D has been linked to increased expression of the antimicrobial peptide LL-37 in human skin. LL-37 is an antimicrobial peptide predominantly expressed by keratinocytes that performs several functions in skin health, including controlling microbial flora in intact and damaged skin, attracting cells from the immune system, promoting epithelial repair, and increasing angiogenesis

Petition 870190034328, of 4/10/2019, p. 12/40

5/30 required for skin healing.

[032] Decreased expression of various antimicrobial peptides has been reported in certain skin conditions, such as atopic dermatitis and chronic leg ulcers.

[033] Zinc oxide is a chemical compound whose chemical formula is ZnO. Zinc oxide is presented in the form of powder insoluble in water, but very soluble in acidic solutions.

[034] It is used as a fundamental component in creams for newborns and young children because of its powerful action against all types of itching and skin irritation.

[035] It is also a component of cosmetics for adults and, mainly, in sunscreens because, due to its presence in the cream, a very effective protective layer is formed. Its action is decisive in blocking ultraviolet rays.

[036] This powder, transformed into a cream when mixed with some moisturizing or oily base, has anti-inflammatory, anti-itchy, antiseptic and healing action. It is suitable in case of burns or as a preventive of these, in cases of diaper rash, decubitus bedsores and all types of skin irritation.

[037] The healing action of preparations with zinc oxide results from the total coverage that this powder gives to the skin, creating a favorable environment that encourages cell recovery.

[038] Along with the antiseptic action of zinc oxide - which prevents the proliferation of microorganisms on injured skin - this substance also has an astringent action and its use is very suitable due to antisepsis combined with the drying of the lesions.

[039] Another benefit of the dermatological use of zinc oxide is the reduction of skin redness, as a secondary symptom of inflammatory processes.

[040] A widely used function of zinc oxide has to do with its ability to inhibit the growth of fungi.

Petition 870190034328, of 4/10/2019, p. 13/40

6/30 [041] In medicine, zinc oxide enters treatments for dermatological problems such as eczema, various dermatitis, psoriasis, redness of the skin, acne and burns.

[042] It is used in creams and ointments in concentrations ranging from 10 to 15% (in some specific cases, this concentration can reach 50%).

[043] As a filter and sunscreen, the cream with zinc oxide has proven effectiveness. Not only does it act as a physical filter, preventing the sun's rays directly reaching the skin to be protected, it also has an effective action in blocking UVA and UVB radiation because its particles reflect this radiation preventing it from reaching the organism.

[044] In treatments for skin blemishes it is one of the most efficient products to allow the skin, little by little, to regain its texture and color.

[045] Among the symptoms of zinc deficiency in our body we have a deficiency in skin healing.

[046] Zinc oxide acts as a skin protector, antiseptic and astringent, exerting a healing and protective action on the skin in conditions that present superficial rashes.

[047] Several studies indicate the application of an ointment or paste containing zinc oxide in its composition.

[048] A study carried out to assess subclinical changes in the functions of the corneal layer of the skin with dermatitis, during treatment with zinc oxide paste and petroleum jelly, demonstrated that preparation based on zinc oxide reduced the risk of fungal infection.

[049] There are no reports of drug interactions between Retinol Palmitate, Colecalciferol and Zinc Oxide.

[050] Vitamin E is a fat-soluble (fat-soluble) vitamin.

[051] Vitamin E is actually made up of eight different molecules, between four tocopherols and four tocotrienols, with the α, β, γ or δ structures being determined according to the position of the methyl group

Petition 870190034328, of 4/10/2019, p. 14/40

7/30 (CH3). The alpha-tocopherol form is what is considered “vitamin E” [052] It acts as a lubricant, moisturizer and regenerator of the skin that has suffered the action of time, sun, pollution and oxidative stress, mainly for protecting membranes against lipoperoxidation. As it is a collagen stimulant, it also increases the firmness and elasticity of the skin.

[053] Therefore, vitamin E is widely used in topical products for the prevention of diseases or photoaging. After topical application, it is easily absorbed by the skin. Vitamin E is a highly desirable ingredient in formulations to rejuvenate and protect skin tissues, because it has antioxidant capacity in vivo offering protection against free radicals, reducing oxidative cell damage, which can affect the integrity of the tissues that form our body. .

[054] Vitamin E is widely used in after-sun products because it reduces the damage induced by UV rays, decreases erythema and skin sensitivity after exposure to UV light.

[055] It prevents cell damage by inhibiting the formation of free radicals, improving blood circulation and aiding tissue regeneration.

[056] It is present in baby rash creams, aftershaves and moisturizers for hands and feet due to its anti-inflammatory, calming and healing properties.

[057] Very high doses of vitamin E (active substance) reduce the absorption of vitamins A.

[058] Vitamin E participates in the formation of all tissues of mesodermal origin (fundamental substance, collagen and elastic fibers of the connective tissue, smooth and striated musculature, vessels) and in the maintenance of their functions. In the cell it participates in the metabolism of nucleic acids, as well as in the respiratory chain.

[059] Vitamin E is a biological antioxidant that prevents spontaneous oxidation of polyunsaturated compounds, responsible for the formation of harmful free radicals, thus preventing the formation of nitrosamines

Petition 870190034328, of 4/10/2019, p. 15/40

8/30 carcinogenic, protecting the skin from UV rays and the early appearance of wrinkles. It is no accident that many creams and beauty products are fortified with this vitamin. Sometimes, a deficiency can be evidenced with skin problems that can appear with various imperfections such as dryness, flaking, etc.

[060] Due to its lipophilic properties, vitamin E accumulates in cell membranes, protecting them from the functional aspect, mainly regarding the inhibition it exerts in the lipid peroxidation. Vitamin E contributes especially to the stabilization of lysosomal, mitochondrial and capillary membranes and, consequently, to the maintenance of normal erythrocyte resistance. Still based on this action, vitamin E promotes an increase in phagocytic activity.

[061] Deficiency of this vitamin leads, through the peroxidation of lipids, to the accumulation of lipofucsin or tissue wear pigment.

[062] Vitamin E intervenes in different stages of arachidonic acid synthesis and therefore acts on the metabolism of prostaglandins. Studies show that the platelet incorporation of vitamin E, obtained through oral supplementation, is associated with an inhibition of platelet aggregation. In premature infants placed in an incubator, vitamin E prevents the formation of retrolenticular fibroplasia and bronchopulmonary dysplasia.

[063] Vitamin E (Tocopherol Acetate) is used for anti-inflammatory and antioxidant action.

[064] Fatty acids are monocarboxylic acids obtained from oils and fats. They have important functions in the human body.

[065] Fatty acids are organic substances found at room temperature in the solid and liquid and semi-solid phases. They belong to the group of carboxylic acids, compounds that have carboxyl, carbon bound to an oxygen and a hydroxyl.

[066] In general, fatty acids have saturated (only single bonds) or unsaturated (

Petition 870190034328, of 4/10/2019, p. 16/40

9/30 or more pi bonds between carbons), in which the number of carbons (R) can vary between 4 and 22 atoms.

[067] Fatty acids are monocarboxylic acids, that is, they have only one carboxyl group.

[068] Stearic acid is a saturated fatty acid also called octadecanoic acid, as it has eighteen carbon atoms in its structure. It belongs to a class of compounds called carboxylic acids, which are characterized by having the carboxyl functional group COOH. At room temperature it is solid, looking like a microgranulated wax. It is used in the production of various cosmetics and drugs.

[069] Obtained from the fractionation of fatty acid through the hydrolysis of tallow of animal origin. White to slightly yellow powder or granules, has a slight characteristic odor and is well used as a consistency agent (for its unique properties). Biodegradable, it is not flammable, toxic or polluting.

[070] Stearic Acid consists of a mixture of solid fatty acids and fatty substances and consists mainly of stearic acid and palmitic acid.

[071] As a fatty acid, stearic acid can be saponified and is widely used in cosmetic formulations for shaving creams, soaps, evanescent creams and creamy lotions. Due to its high solidification point, it is used mainly as a viscosity and consistency donating agent in creams and deodorant creams.

[072] Linoleic acid is a polyunsaturated fatty acid also called octadec-9,13-dienoic acid, as it has eighteen carbon atoms and two double bonds (in carbons 9 and 13) in its structure.

[073] Essential fatty acids (those that the body cannot synthesize) are found mainly in the composition of plant cells, their presence being essential in the diet, especially when it comes to linoleic and linolenic acids.

Petition 870190034328, of 4/10/2019, p. 17/40

10/30 [074] Omega-6 and omega-3 acids are two families of polyunsaturated fatty acids, each represented by an essential acid: linoleic acid (omega-6) and α-linolenic acid (omega-3) , which in turn give rise to other longer chain essential acids, called long chain polyunsaturated fatty acids.

[075] Omega-3 acid is anti-inflammatory, antithrombotic, antiarrhythmic and reduces blood lipids, having vasodilating properties. These beneficial effects have been demonstrated in the prevention of heart disease, hypertension, type 2 diabetes, rheumatoid arthritis among others.

[076] Sources of saturated fatty acids are obtained by consuming various chocolates, red meat (beef, pork, etc.), eggs, whole milk and dairy products, animal fat, etc.

[077] Sources of polyunsaturated fatty acids are obtained by consuming oils extracted from vegetables (corn, sunflower, soy, chestnuts, almonds etc.), fish etc.

[078] In general, fatty acids are called essential because they are not produced by the body.

[079] Fatty acids play several roles for the body, including:

[080] They help, in general, in the control of inflammations, infections and injuries;

[081] They favor adequate blood clotting;

[082] They favor the production of hormones and [083] They favor the production of antibodies.

[084] Some fats are part of a group of lipids, also called glycerides, which are compounds formed by the union of a glycerol molecule, which is a molecule of tri-alcohol glycerin (propanotriol) and three fatty acids (long-chain carboxylic acids) , usually with 4 to 22 carbon atoms in even number, with only one carboxyl group), therefore, glycerides are also called triglycerides.

Petition 870190034328, of 4/10/2019, p. 18/40

11/30 [085] Linoleic acid stimulates the inflammatory process, angiogenesis, cell migration and proliferation and increases skin resistance.

[086] Triacylglycerol, also known as triglycerides, is the generic name of any triester derived from the combination of glycerol (a tri-alcohol) with acids, especially fatty acids (long-chain alkyl carboxylic acids), in which the three hydroxyls (of the glycerol) have undergone carboxylic condensation with acids, which need not necessarily be the same. Triacylglycerols are readily recognized as oils or fats.

[087] In a simplified way, a triacylglycerol is formed by the union of three fatty acids to a glycerol molecule, whose three hydroxyls (-OH groups) bind to the carboxylic radicals of the fatty acids.

[088] The triglycerides of capric and caprylic acid are medium chain triglycerides (TCM) consisting mainly of esters of caprylic (C8) and capric (C10) acids.

[089] Due to the size of the chain, the triglycerides of capric and caprylic acid have excellent solubility in alcohol and hence their importance in applicability in pharmaceutical products. These compounds are considered toxicologically and dermatologically innocuous and are classified as GRAS (Generally Recognized As Safe) by the FDA.

[090] Fully saturated emollient triester, recommended as an alternative to mineral or vegetable oil in various products for personal and pharmaceutical care, due to its structural composition, to be lubricating and emollient, to give thin and soft emollience leaving a non-occlusive film on the skin surface, be a good spreading agent, be an excellent vehicle or thinner for active ingredients in topical preparations, be a good solvent for chemical sunscreens, have an excellent dermatological behavior, non-toxic, have a low turbidity point, be inert and be oxidation stable.

[091] Capric triglyceride is a combined triester, a mixture of capric and caprylic acids. It is also known as coconut oil

Petition 870190034328, of 4/10/2019, p. 19/40

12/30 fractional. Its most popular use is as an emollient (to soften the skin), due to its ability to quickly penetrate. This compound is a very popular ingredient in many skin products and soaps.

[092] Some benefits of capric triglyceride include the fact that it is not oily, in addition to having a very light texture. It is also quickly absorbed, being highly compatible with the skin.

[093] The capric triglyceride is derived from coconut. Before the oil is even processed, it has high levels of saturated fat, with a content of about 90%. In its purest form, it has a milky color, although after refinement, the oil becomes transparent (and liquid at room temperature).

[094] Essential fatty acids increase skin resistance.

[095] Long chain polyunsaturated fatty acids play important cellular functions such as maintaining the integrity and fluidity of membranes, activities of membrane enzymes and synthesis of eicosanoids, such as prostaglandins, leukotrienes and thromboxanes. These, in turn, have the ability to modify inflammatory and immunological reactions, altering leukocyte functions and accelerating the tissue granulation process.

[096] The application of these products protect the integrity of the skin and increase its hydration. For this purpose, creams based on essential fatty acids are used, such as linoleic acid, caprylic acid, capric acid, vitamin A, vitamin E and soy lecithin.

[097] Among the essential fatty acids are linoleic and linolenic acids.

[098] Chemotaxis promotes the migration of neutrophils to the wound through a chemical stimulus. Neutrophils are the first cells to reach the wound.

[099] Essential fatty acids are necessary to maintain the integrity of the skin, due to its ability to function as a water barrier. These acids act by promoting chemotaxis and angiogenesis, maintaining the

Petition 870190034328, of 4/10/2019, p. 20/40

13/30 medium humid and, thus, accelerate the process of tissue granulation.

[100] In addition to the prevention and treatment of pressure ulcers, they can also prevent and treat dermatitis, venous and neutrophic ulcers, open ulcers with or without infection.

[101] Linoleic acid is a mediator that accumulates macrophages and leukocytes and accelerates the healing process.

[102] Medium Chain Triglycerides (TCM) - capric acid, caprylic acid, caprylic acid and lauric acid are used as a vehicle and emollient.

[103] The lanolin present in moisturizing creams, soaps and shampoos is a material made up of several types of substances, obtained from sheep's wool.

[104] Lanolin consists of several compounds, including esters and polyesters of long-chain alcohols and fatty acids, with a predominance of unsaturated ones, represented by a high proportion of eicosapentaenoic (EPA), linoleic and docosahexaenoic acids.

[105] It is obtained as a by-product of cleaning sheep's wool. Lanolin is a yellowish grease and is excreted by the sebaceous glands of these animals.

[106] Lanolin as a skin moisturizer manages to prevent water loss through the skin, keeping it hydrated, as its long chains have polar ends that bind to the water molecules on the skin.

[107] This moisturizing action makes it a moisturizing or emollient substance (softener), also increasing skin hydration and elasticity. As a result, many breastfeeding mothers use this moisturizer on their breasts to prevent cracking and pain.

[108] For the healing process, some wound and healing medications contain lanolin as an ingredient.

DETAILS OF THE INVENTION [109] Wounds can be defined as any alteration of the anatomical integrity of the skin, generating an injury to the skin, resulting from any type of trauma.

Petition 870190034328, of 4/10/2019, p. 21/40

14/30 [110] The classification of wounds is an important form of systematization, necessary for the evaluation and registration process. Thus, wounds can be classified, according to the time of tissue repair, into acute and chronic. Acute wounds originate from surgery or trauma and the repair takes place in a timely manner, without complications. Chronic wounds are those that are not repaired in the expected time and have complications. Risk factors associated with chronic wounds include: high blood pressure, diabetes mellitus, poor circulation, immunodeficiency and infection. Among the most common chronic wounds are venous ulcers, arterial ulcers, neuropathic ulcers and pressure ulcers.

[111] Chronic wounds are related to the increased cost of hospital care and to various infectious complications, local infection, cellulitis of neighboring tissues, contiguous osteomyelitis and bacteria / sepsis.

[112] The treatment of these skin lesions, wounds, involves systemic and local aspects. The local treatment is called dressing, and consists of the procedure for cleaning and covering a skin lesion, with the aim of helping to restore tissue integrity or prevent colonization of invasive device insertion sites, for diagnosis or therapeutics (for example: catheters and drains).

[113] The term “pharmaceutical composition” refers to a mixture of two or more active ingredients with your vehicle in order to make it possible to be applied to an organism.

[114] Financial expenses for wound care are high due, in particular, to the lack of an efficient medication.

[115] Topical treatment of intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other related lesions is difficult to treat, and is therefore a long, expensive treatment and causes great suffering to those with injuries.

[116] The compound object of this patent application solves these problems, as it has all the necessary properties for the optimization of

Petition 870190034328, of 4/10/2019, p. 22/40

15/30 cure of these skin lesions:

[117] - It acts contributing to the healing of lesions. It is presented as a cream with vitamin A, D and E in its composition; clotrimazole, zinc oxide and linoleic fatty acid associated with capric and caprylic acids.

[118] - Presents bacterial, antifungal and therapeutic action. Promotes faster healing of wounds through more effective wound healing.

[119] - Treat injuries contributing to better healing, reduced treatment time and decreased chance of infection, as it creates a barrier and a more efficient physiological response against infectious microorganisms.

[120] - It is a topical dermatological compound with therapeutic functions on the skin and mucosa that, due to its effectiveness in healing, accelerates this process with consequent cost reduction, treatment schedule and medical attention generating a global therapeutic gain.

[121] - It has an effective healing effect for the treatment of wounds unlike any other on the market. Those that are on the market are cosmetics that are not efficient in healing wounds due to their compositions, not being effective in the healing process, leaving, as a consequence: poor healing, longer treatment time and higher cost.

[122] - It is a therapeutic, non-toxic, restorative and healing dermatological medicine for the skin or mucous membranes, even preventing hypertrophic scarring. For this purpose, a composition of active ingredients is used that together have such a synergistic action that bring better results, not having a similar in the market capable of having the same effect, being, therefore, a novelty with non-toxic action and unparalleled therapeutic therapeutic effect. In its composition, the product proposed by the applicant has several active and supporting principles.

[123] - It has excellent spreadability and effects that contribute to the entire healing process since cleaning the wound due to

Petition 870190034328, of 4/10/2019, p. 23/40

16/30 autolytic and enzymatic debridement, re-epithelialization and maturation of new epidermal tissues and finally healing of the lesion.

[124] Linoleic acid, the main fatty acid of the omega-6 family associated with caprylic and capric acids, has a potent topical antiedematogenic action. It plays an important chemotactic role for macrophages, being fundamental in the expression of components of the fibrinolytic system (regulation of collagenase production); favors autolytic debridement in the wound bed by contributing to the production of metalloproteins, inducing granulation and being able to accelerate the healing process.

[125] It has been observed that linoleic acid is able to inhibit the growth of Staphylococcus aureus, altering the synthesis of proteins, cell wall, nucleic acids and cell membranes during division [126] Essential fatty acids and vitamins A and E show excellent results in the healing and restoration of the skin, having a fast and efficient response with the development of granulation tissue, intense angiogenesis and acceleration of the healing process in a few days, combined with the low cost and free of side effects.

[127] The Ministry of Health recognizes the importance of Essential Fatty Acids (AGEs), indicating it for the prevention and treatment of dermatitis, pressure ulcers, venous and neurotrophic; treatment of open ulcers with or without infection. (Manual of Conducts for Neurotrophic and Traumatic Ulcers - MS; pg 42; 2002) [128] The Brazilian Society of Dermatology also recognizes the importance of “Essential Fatty Acids (AGEs) and indicates saying that they can be used in all types of injuries , in the various stages of the healing process and as a preventive of injuries. ”[129] Associação Brasileira de Farmacêuticos states: One must consider the topical application of fatty acids in the treatment of wounds as an important therapeutic tool.

[130] Medium chain triglycerides can have uses in the treatment and

Petition 870190034328, of 4/10/2019, p. 24/40

17/30 prevention of ammoniac dermatitis and pressure ulcers, forming a protective barrier for the skin, preventing maceration, besides being of importance in the processes of cellular inflammation, providing relief after the first application and local cellular nutrition, besides having a great tissue regeneration capacity.

[131] Clotrimazole is widely used in several medications for the treatment of eczema (skin damage) and inflammatory skin processes (dermatitis), especially those caused by fungi. These infections can occur in many parts of the body and often manifest themselves through redness, peeling or inflammation of the skin, often accompanied by burning, itching (itching) or a damp wound.

CONCLUSIONS:

[132] Based on what was exposed in this patent application, it is concluded that the product applied for the patent has a superior effect in the treatment of wounds, promoting their more effective healing, with less cost and in less time.

[133] The compound that is presented in this patent application document synergistically incorporates the benefits of several active and supporting ingredients that alone do not have the same effectiveness.

[134] There is no news of the joint use of the active and supporting ingredients of this formula and its synergistic effects. With that, this product presents itself with a novelty and that is why its patent is requested with the INPI.

[135] The best results in the regeneration of tissues, the shorter time of the healing process provided by the product presented in this patent application bring, in addition to the cost reductions and gains in operating time, the reduction of the patient's suffering.

[136] The drugs found in the pharmaceutical market do not currently have the same efficiency as the one proposed for patent for several reasons, ranging from the undue amount of active components to the individualized use of components that alone do not contribute so

Petition 870190034328, of 4/10/2019, p. 25/40

18/30 effective in healing as the product now proposed for patent.

[137] It is concluded that the product whose patent is applied for is a novelty, meeting the requirements of patentability, as it confers inventive step, as provided in article 8 of Law 9,279 (Law of Patents, Trademarks and Related Rights), of 14 May 1996.

FORMULATION [138] In this stage of the document, technical information on the preparation of the proposed product for the treatment of wounds and the benefits resulting from its use in the treatment of regeneration of skin lesions will be exposed.

[139] The cream is a complex of active and supporting ingredients that synergistically produce a more effective effect on epithelial restoration in the case of chronic or acute lesions.

Table 1. Composition and concentrations of the solution.

Retinol 0.165 to 0.263 Cholecalciferol 0.0003 to 0.0008 vitamin E 0.158 to 1.03 Zinc oxide 3.06 to 6.02 Clotrimazole 0.02 to 0.463 triglyceride of capric and caprylic acids 15 to 33 linoleic acid (unsaturated fatty acid) 8.75 to 16.89 Lanolin 1.83 to 7.66 Disodium EDTA 0.002 to 0.0333 Butylene glycol 1.9 to 3.03 DMDM Hydantoin and Sludgepropinyl Butylcarbamate (IPBC) 0.07 to 0.13 Vanillin 0.005 to 0.0067 cod liver oil 1.87 to 3.53 butylated hydroxyanisole 0.002 to 0.01 Baby powder 0.54 to 4.16 mineral oil 0.050 to 1.66 Petrolato 3.017 to 10.86 polyethylene 2.8 to 5.7

Petition 870190034328, of 4/10/2019, p. 26/40

19/30

Lavender 0.001 to 0.003 benzilic alcohol 0.31 to 1.13 cetostearyl alcohol 1.6 to 4.9 sorbitan stearate 3.55 to 8.03 cetyl palmitate 0.867 to 2.2 Polysorbate 60 0.43 to 3.1 purified (deionized) water 21 to 36

[140] Clotrimazole is used as a topical antimycotic having its therapeutic effect in the region where it was applied acting on dermatophytes, yeasts, fungi, etc. Its main function is fungistatic or fungicidal.

[141] Clotrimazole inhibits ergosterol synthesis, causing structural and functional damage to the fungal cytoplasmic membrane.

[142] There are rare cases of primary and secondary resistance variants of susceptible fungus species. In therapeutic cases, there are only very few evolutions of secondary resistance by sensitive fungi.

[143] Studies show that few amounts of clotrimazole are absorbed, causing no measurable systemic effects or adverse effects.

[144] Clotrimazole is widely used in several medications for the treatment of eczema (skin damage) and inflammatory skin processes (dermatitis), especially those caused by fungi.

[145] Vitamin D is beneficial for the skin.

[146] Studies report the topical application of vitamin D and its link to increased expression of the antimicrobial peptide LL-37 in human skin. LL-37 is an antimicrobial peptide commonly expressed by keratinocytes that performs several functions in skin health, including the control of microbial flora in intact and damaged skin, attracting cells of the immune system, promoting epithelial repair, and increasing the angiogenesis necessary for the healing of the skin.

[147] Vitamin A has a protective action on the skin and mucosa, helps to strengthen the immune system, promotes the development and maintenance of epithelial tissue, synthesizing mucus, keeping the skin intact and humidified.

Petition 870190034328, of 4/10/2019, p. 27/40

20/30 [148] Xerosis of the skin and increased keratinization, dry and scaly skin are evidence of hypovitaminosis A.

[149] The antioxidant power of vitamin A helps with skin regeneration.

[150] Retinol contributes to the retention of water by the skin and to recover from it, leaving it with a better appearance.

[151] The keratinization process is solved because vitamin A enters the skin leaving it smooth and soft, reducing the thickening of the epidermis and renewing dry skin.

[152] The mechanism of action of retinol is linked to its oxidation before the essential structures for homeostasis.

[153] Vitamin A is found in food in two forms:

[154] Cod liver oil, administered externally, is beneficial for tissue metabolism due to its rich content of vitamins A and D, it controls inflammatory reactions and acts in synergy with zinc oxide, it helps to protect the skin.

[155] The accumulation of polymorphonuclear leukocytes (PMN) is inhibited by topical retinoids. This accumulation of inflammatory dermatoses. Retinoids reduce numerous inflammatory lesions.

[156] Vitamin A (Retinol Palmitate) is used for cell nutrition and collagen replacement.

[157] Zinc oxide is essential in creams for newborns and young children due to its powerful action against itching and skin irritations.

[158] It is used in cosmetics for adults, especially in sunscreens because it has a fundamental action in blocking ultraviolet rays.

[159] Creams with zinc oxide consisting of a hydrating or oily base, are excellent anti-inflammatory, antipruritic, antiseptic and healing agents. It is indicated for burns and all types of skin irritation.

[160] The healing action of zinc oxide preparations results from the

Petition 870190034328, of 4/10/2019, p. 28/40

21/30 full coverage that this powder gives to the skin, creating a favorable environment that encourages cell recovery.

[161] Zinc oxide has a drying action on injuries. Its antiseptic action prevents the proliferation of microorganisms in the injured skin.

[162] Zinc oxide reduces skin redness, a secondary symptom of inflammatory processes.

[163] Zinc oxide inhibits the growth of fungi.

[164] Deficiency in skin healing is one of the symptoms of zinc deficiency.

[165] Zinc oxide acts as a skin protector, antiseptic and astringent, exerting a healing and protective action on the skin in conditions that present superficial rashes.

[166] Studies have concluded that zinc oxide preparations reduce the risk of yeast infection.

[167] There are no reports of drug interactions between Retinol Palmitate, Colecalciferol and Zinc Oxide.

[168] Vitamin E has a lubricating, moisturizing and regenerating effect on skin damaged by weather, sun, pollution and oxidative stress, especially by protecting against the lipoperoxidation given by the membranes. It increases the firmness and elasticity of the skin, as it stimulates collagen.

[169] In view of this, vitamin E is widely used in topical products to prevent diseases or photoaging, and is easily absorbed by the skin.

[170] Vitamin E is important in formulations to rejuvenate and protect skin tissues, due to its antioxidant capacity, providing protection against free radicals and reducing oxidative cell damage, which can affect the integrity of skin tissues.

[171] Vitamin E optimizes blood circulation and contributes to tissue regeneration.

[172] Because of its anti-inflammatory, soothing and

Petition 870190034328, of 4/10/2019, p. 29/40

22/30 healing, is used in baby rash creams, aftershaves and moisturizers for hands and feet.

[173] Vitamin E participates in the formation of all tissues of mesodermal origin (fundamental substance, collagen and elastic fibers of the connective tissue, smooth and striated musculature, vessels) and in the maintenance of their functions.

[174] Vitamin E deficiency can manifest itself via skin problems, in the form of various imperfections such as dryness, flaking, etc.

[175] Vitamin E has lipophilic properties, accumulating in cell membranes, this protects them in terms of functional aspects, especially in the inhibition of lipid peroxidation. Vitamin E is essential in stabilizing lysosomal, mitochondrial and capillary membranes and, therefore, in maintaining the normal resistance of erythrocytes. Vitamin E stimulates increased phagocytic activity.

[176] Its deficiency leads to the accumulation of lipofucsin or tissue wear pigment due to lipid peroxidation.

[177] Vitamin E acts on the metabolism of prostaglandins, as it acts on the synthesis of arachidonic acid. Vitamin E prevents the formation of retrolenticular fibroplasia and bronchopulmonary dysplasia in premature infants in an incubator.

[178] Vitamin E (Tocopherol Acetate) is used as an anti-inflammatory and antioxidant agent.

[179] Stearic acid is used in the production of various cosmetics and drugs.

[180] Due to its high solidification point, it is mainly used as a viscosity and consistency donating agent in creams and deodorant creams.

[181] Linoleic acid (omega-6) and α-linolenic acid (omega-3), which in turn, give rise to other longer chain essential acids,

Petition 870190034328, of 4/10/2019, p. 30/40

23/30 called long-chain polyunsaturated fatty acids.

[182] Omega-3 acid is anti-inflammatory, antithrombotic, antiarrhythmic and reduces blood lipids, having vasodilating properties.

[183] Linoleic acid contributes to collagen synthesis by promoting the accumulation of fibroblasts, due to its ability to attract macrophages, which stimulate PDGF (platelet-derived growth factor).

[184] In general, fatty acids are called essential because they are not produced by the body.

[185] Fatty acids play several roles for the body, including:

[186] They help, in general, in the control of inflammations, infections and injuries;

[187] They favor adequate blood clotting;

[188] They favor the production of hormones and [189] They favor the production of antibodies.

[190] Linoleic acid stimulates the anti-inflammatory process, angiogenesis, cell migration and proliferation and increases skin resistance.

[191] Hypertrophic scarring and the emergence of keloids in scarring cease to exist because the production of collagenase stimulated by macrophages balances the production of collagen.

[192] Growth factors promote the development of an organ, with the skin being the largest organ in our body. This skin growth occurs through mitogenic or mitogenic agents which stimulate cell division, triggering mitosis, mainly by relieving negative intracellular controls that block the progression of the cell cycle.

[193] Cell growth means increasing cell mass through the synthesis of proteins and other macromolecules.

[194] Before the cell divides it has to grow until it reaches an adequate and constant size, which depends, among other factors, on the

Petition 870190034328, of 4/10/2019, p. 31/40

24/30 availability of growth factors.

[195] Substances of a polypeptide nature are polypeptides and proteins. In general, polypeptides with 100 or more amino acids are called proteins, and those with more than 10 and less than 100 amino acids are called polypeptides.

[196] EGF (epidermal growth factor) is one of the main growth factors acting on epidermal, endothelial and fibroblast cells; stimulating angiogenesis (formation of new vessels), cell proliferation and collagen synthesis.

[197] Epidermal growth factor (EGF) is mitogenic for epithelial cells and fibroblasts. In the healing of skin wounds, EGF is produced by keratinocytes, macrophages and other inflammatory cells that migrate into the wound area, stimulating cell division. EGF is considered a polypeptide with potent mitogenic activity in different cell types.

[198] The product proposed in this patent application influences the growth factor by favoring it.

[199] Macrophages are the main cells involved in controlling the tissue repair process, degrading and removing components of damaged connective tissue, such as collagen, elastin and proteoglycans.

[200] Macrophages provide chemotactic factors which attract inflammatory cells to the wound region and produce prostaglandins, a dilating vessel that influences microvessel permeability. Macrophages produce several growth factors.

[201] The proposed product has a positive influence on bringing macrophages to the wound site.

[202] The healing process mainly involves three stages: inflammation, formation of granulation tissue and deposition of extracellular matrix and remodeling [203] Hypergranulation tissue is very important in the treatment of

Petition 870190034328, of 4/10/2019, p. 32/40

25/30 wounds, which can delay the healing process and develop a complex wound.

[204] The hypergranulation tissue appears as an excess of granulation tissue, forming beyond the level of the wound bed, creating tension at the edges, preventing the migration of basal epithelial cells and consequently healing.

[205] Linoleic acid together with vitamin E, present in the product proposed in this patent application, prevents hypergranulation.

[206] In order for healing to take place, cleaning and debridement of the wound is necessary. Cleaning consists of using fluids to remove bacteria, fragments, exudates, foreign bodies, residues of topical agents, whereas debridement refers to the removal of adhered necrotic tissues or foreign bodies and particles in the wound, using mechanical, surgical or chemical.

[207] Linoleic acid contributes to the production of MMP-1 (collagenase) and MMP-3 (stromelysin).

[208] Linoleic acid participates in the production of MMPs and, as a result, macrophages produce autolytic debridement and collagenases the enzyme helping in the formation of granulation tissue.

[209] Linoleic acid, through the action of elongase and desaturases, is transformed into prostaglandins and leukotrienes, which are immunomodulators.

[210] Triacylglycerol, also known as triglycerides, is the generic name for any triester derived from the combination of glycerol (a tri-alcohol) with acids, especially fatty acids (long-chain alkyl carboxylic acids), in which the three hydroxyls (of glycerol) have undergone carboxylic condensation with acids, which need not necessarily be the same. Triacylglycerols are readily recognized as oils or fats.

[211] In a simplified way, a triacylglycerol is formed by the union of three fatty acids to a glycerol molecule, whose three hydroxyls (-OH groups)

Petition 870190034328, of 4/10/2019, p. 33/40

26/30 bind to the carboxylic radicals of fatty acids.

[212] The triglycerides of capric and caprylic acid are medium chain triglycerides (TCM) consisting mainly of esters of caprylic (C8) and capric (C10) acids.

[213] Due to the size of the chain, the triglycerides of capric and caprylic acid have excellent solubility in alcohol and hence their importance in applicability in pharmaceutical products. These compounds are considered toxicologically and dermatologically innocuous and are classified as GRAS (Generally Recognized As Safe) by the FDA.

[214] Fully saturated emollient triester, recommended as an alternative to mineral or vegetable oil in various products for personal and pharmaceutical care, due to its structural composition, to be lubricating and emollient, giving thin and soft emollience leaving a non-occlusive film on the skin surface, be a good spreading agent, be an excellent vehicle or diluent for active ingredients in topical preparations, be a good solvent for chemical sunscreens, have an excellent dermatological behavior, non-toxic, have a low turbidity point, be inert and be oxidation stable.

[215] Capric triglyceride is a combined triester, a mixture of capric and caprylic acids. It is also known as fractionated coconut oil. Its most popular use is as an emollient (to soften the skin), due to its ability to quickly penetrate. This compound is a very popular ingredient in many skin products and soaps.

[216] Some benefits of capric triglyceride include the fact that it is non-greasy, in addition to having a very light texture. It is also quickly absorbed, being highly compatible with the skin.

[217] The capric triglyceride is derived from coconut. Before the oil is even processed, it has high levels of saturated fat, with a content of about 90%. In its purest form, it has a milky color, although after refinement, the oil becomes transparent (and liquid in

Petition 870190034328, of 4/10/2019, p. 34/40

27/30 room temperature, approximately 25 degrees celsius).

[218] Essential fatty acids increase skin resistance.

[219] Long-chain polyunsaturated fatty acids, including linoleic acid, perform important cellular functions such as maintaining the integrity and fluidity of membranes, activities of membrane enzymes and synthesis of eicosanoids, such as prostaglandins, leukotrienes and thromboxanes. These, in turn, have the ability to modify inflammatory reactions, stimulate platelet aggregation, promote the action of leukocytes in the lesion and immunology, altering leukocyte functions and accelerating the process of tissue granulation. All of this contributes to the process of epithelialization and epidermal maturation.

[220] The application of these products protect the integrity of the skin and increase its hydration. For this purpose, creams based on essential fatty acids are used, such as linoleic acid, caprylic acid, capric acid, vitamin A, vitamin E and soy lecithin.

[221] Essential fatty acids are necessary to maintain the integrity of the skin, due to its ability to function as a water barrier. These acids act by promoting chemotaxis and angiogenesis, keeping the environment moist and, thus, accelerate the process of tissue granulation.

[222] In addition to the prevention and treatment of pressure ulcers, they can also prevent and treat dermatitis, venous and neutrophic ulcers, open ulcers with or without infection.

[223] Medium Chain Triglycerides (TCM) - capric acid, caprylic acid, caprylic acid and lauric acid are used as a vehicle and emollient.

[224] The lanolin present in moisturizing creams, soaps and shampoos is a material made up of several types of substances, obtained from sheep's wool.

[225] Lanolin consists of several compounds, including esters and polyesters of long-chain alcohols and fatty acids, with a predominance of unsaturated, represented by a high proportion of eicosapentaenoic (EPA), linoleic and docosahexaenoic acids.

Petition 870190034328, of 4/10/2019, p. 35/40

28/30 [226] It is obtained as a by-product of cleaning sheep's wool. Lanolin is a yellowish grease and is excreted by the sebaceous glands of these animals.

[227] Lanolin as a skin moisturizer manages to prevent water loss through the skin, keeping it hydrated, as its long chains have polar ends that bind to the water molecules on the skin.

[228] This moisturizing action makes it a moisturizing or emollient substance (softener), also increasing skin hydration and elasticity. As a result, many breastfeeding mothers use this moisturizer on their breasts to prevent cracking and pain.

[229] For the healing process, some medications for wound care and healing contain lanolin as an ingredient. INFERENCES [230] Linoleic acid, the main fatty acid of the omega-6 family associated with caprylic and capric acids, has a potent topical antiedematogenic action. It plays an important chemotactic role for macrophages, being fundamental in the expression of components of the fibrinolytic system (regulation of collagenase production); favors autolytic debridement in the wound bed by contributing to the production of metalloproteins, inducing granulation and being able to accelerate the healing process.

[231] It has been observed that, in vitro, linoleic acids inhibit the growth of S. Aureus by acting as antimicrobial agents and can be used in the treatment of wounds.

[232] Inhibiting the growth of Staphylococcus aureus by linoleic acid, as it alters the synthesis of proteins, cell wall, nucleic acids and cell membranes during division [233] Essential fatty acids and vitamins A and E have excellent results in healing and restoration of the skin, having a fast and efficient response with the development of granulation tissue, intense angiogenesis and acceleration of the healing process in a few days, combined with the low cost and

Petition 870190034328, of 4/10/2019, p. 36/40

29/30 free of side effect.

[234] Studies have evaluated the influence of topical administration of linoleic acid (n-6) on the wound healing process in rats. It was observed that animals treated topically with linoleic acid showed a significant reduction in the wound area after the 5th day.

[235] The Ministry of Health recognizes the importance of Essential Fatty Acids (AGEs), indicating it for the prevention and treatment of dermatitis, pressure ulcers, venous and neurotrophic; treatment of open ulcers with or without infection. (Manual of Conducts for Neurotrophic and Traumatic Ulcers - MS; pg 42; 2002) [236] The Brazilian Society of Dermatology also recognizes the importance of “Essential Fatty Acids (AGEs) and indicates saying that they can be used in all types of injuries , in the various stages of the healing process and as a preventive of injuries. ”[237] Associação Brasileira de Farmacêuticos states: One must consider the topical application of fatty acids in the treatment of wounds as an important therapeutic tool.

[238] Medium Chain Triglycerides may have uses in the treatment and prevention of ammoniac dermatitis and pressure ulcers, forming a protective barrier for the skin, preventing maceration, besides being of importance in the processes of cellular inflammation, providing relief after the first application and local cellular nutrition, in addition to having a great capacity for tissue regeneration.

[239] The proposed product is a safe, effective and inexpensive drug, being excellent for the treatment of skin wounds, as it collaborates effectively in healing and analgesia.

[240] In view of the foregoing, there is a patent right for the proposed product, a topical cream for healing chronic or acute cutaneous and mucosal lesions, as it meets the novelty requirement of the patent rules for inventions in accordance with the Intellectual Property Law. and Industrial in

Petition 870190034328, of 4/10/2019, p. 37/40

30/30 its article 8, novelty.

PREPARATION [241] 1. Heat polyethylene, petrolatum, butylated hydroxyanisol, benzyl alcohol, cetostearyl alcohol, mineral oil, sorbitan stearate, cetyl palmitate, polysorbate 60 and lanolin to a 75 ° C water bath;

[242] 2. Heat the water to 70 ° C and dissolve the disodium EDTA and butylene glycol;

[243] 3. Pour the components of item 4 into that of item 3, stirring moderately and maintaining the temperature for eight to ten minutes, until the formation of an emulsion, preventing the development of foam;

[244] 4. In a suitable container, crush the zinc oxide and talc;

[245] 5. Decrease the stirring speed and cool to 35 ° C and add under stirring zinc oxide, talc, cod liver oil, DMDM Hydantoin, sludge propyl butylcarbamate (IPBC), lavender, vanillin solubilized in qsp alcohol , unsaturated fatty acid and triglyceride of capric and caprylic acids;

[246] 6. Stir until the mixture is homogeneous;

[247] 7. Spray clotrimazole finely;

[248] 8. Wait 24 hours to add the active ingredients retinol, cholecalciferol, vitamin E and clotrimazole to this ointment base.

HOW TO USE [249] Wash the affected area with warm water and mild soap, rinse and dry the skin with soft, friction-free fabric.

[250] After cleaning, apply the product proposed in this patent application as a thin layer, rubbing it lightly over the affected area.

[251] Perform this process four times a day until the lesion has completely healed.

Claims (20)

Claiming framework 1- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions characterized by the synergistic action of the active ingredients clotrimazole, vitamin A, vitamin E, vitamin D, oxide zinc and linoleic acid associated with capric and caprylic acids and excipients, the healing composition being applied directly to the wound and affected adjacent areas. 2- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that the composition comprises about 0 , 02% to about 0.463% by weight of clotrimazole, from about 0.205% to about 0.263% by weight of retinol, from about 0.0003% to about 0.0008% by weight of cholecalciferol, from about 0.158% to about 1.03% by weight of vitamin E, from about 3.06% to about 6.02% by weight of zinc oxide, from about 15% to about 33% by weight of triglyceride of capric and caprylic acids, from about 8.75% to about 16.89% by weight of linoleic acid. 3- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that clotrimazole, linoleic acid, retinol and vitamin E act synergistically promoting healing. 4- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that autolytic debridement is optimized by acid linoleic accelerating tissue regeneration. 5- Healing, moisturizing, moisturizing and emollient composition for Petition 870190034328, of 4/10/2019, p. 4/40 2/5 topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other related lesions according to claim 1, characterized by the fact that linoleic acid and vitamins A, D and E contribute to the development granulation tissue and intense angiogenesis in order to accelerate the healing and restoration process of the skin. 6- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that clotrimazole is a highly effective antifungal efficiency. 7- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that the oily components of the cream have action bactericidal due to the presence of linoleic acid, which stimulates the inflammatory process, angiogenesis, cell migration and proliferation and increases skin resistance. 8- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that the healing composition optimizes the re-epithelialization of tissues. 9- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that the healing composition contains essential fatty acids , in particular linoleic acid, vitamin A, D and E, capric acid, capric acid, caprylic acid, lauric acid, sunflower oil and soy lecithin, which together have a potent antiedematogenic action Petition 870190034328, of 4/10/2019, p. 5/40 3/5 topical, favor autolytic debridement in the wound and induce granulation accelerating the healing process. 10- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that zinc oxide has astringent properties and antiseptic, acting as a healer and skin protector in conditions that present superficial eruptions. 11- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that zinc oxide forms a layer protective on the injured skin surface, preventing irritation by air and fixation of clothes on the skin, thus reducing burning and itching, creating an environment conducive to cell recovery, in addition to, given its drying effect, makes the environment unfavorable for bacterial growth. 12- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that zinc oxide reduces redness cutaneous, secondary symptom of inflammatory processes, being efficient in cases of diaper rash, bedsores and all types of skin irritation. 13- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that the topical application of vitamin D exerts control of microbial flora in damaged skin, attracting cells of the immune system, promoting epithelial repair and increasing the angiogenesis necessary for skin healing. Petition 870190034328, of 4/10/2019, p. 6/40 4/5 14- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that vitamin E has anti-inflammatory properties. inflammatory, calming and healing, promoting an increase in phagocytic activity allowing healing. 15- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other related lesions according to claim 1, characterized by the fact that the healing composition of wounds and disinfection and tissue restoration, has as supporting ingredients DMDM Hydantoin, cod liver oil and lanolin which contribute synergistically with the other substances in the composition for the healing of injuries. 16- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that vitamin A has antioxidant power helping in skin regeneration, participates in cell nutrition and collagen replacement, penetrates the skin and normalizes the keratinization process and its interaction with certain DNA sequences, regulates the production of certain proteins and enzymes, reducing the signs resulting from skin damage . 17- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 15, characterized by the fact that cod liver oil is rich in vitamins A and D, being beneficial for tissue metabolism, it controls inflammatory reactions and acts in synergy with zinc oxide, helps in skin protection. Petition 870190034328, of 4/10/2019, p. 7/40 5/5 18- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 15, characterized by the fact that DMDM Hydantoin and Butylcarbamate of Iodopropynil (IPBC) inhibits the growth of gram-positive and gram-negative bacteria, yeasts and mold. 19- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 15, characterized by the fact that lanolin has a moisturizing action making it a moisturizing or emollient substance, increasing skin hydration and elasticity, thus contributing to the healing process. 20- Healing, moisturizing, moisturizing and emollient composition for topical administration in intertrigo skin lesions, skin lesions caused by urinary and fecal incontinence and other similar lesions according to claim 1, characterized by the fact that it is a healing and restorative composition of skin.