Composition based on acmella oppositifolia and matricaria chamomilla

Abstract

The present invention relates to an ethanol extract of phytotherapeutic origin, from the Spilanthes americana (Acmella oppositifolia) plant and the Matricaria chamomilla plant, which acts directly on mouth ulcers, cold sores and shingles. The extract is for medical or odontological use, is composed of an ethanol extract with a vehicle to provide a cream dosage form, and works topically in the form of a rinse or cream, producing an antiviral effect in the prodrome, thereby preventing the onset of symptoms and the development of vesicles, pain and sores caused by viral herpes infection. If vesicles are present, the progression time is significantly reduced, enabling swift recovery.

Description

[0001] COMPOSITION BASED ON ACMELLA OPPOSITIFOLIA AND MATRICARIA CHAMOMILLA

[0002] FIELD OF INVENTION

[0003] The present invention relates to an ethanolic extract of phytotherapeutic origin, derived from the plants Spinlanthes americanus and Spinlanthes amehicus (Acmella oppositifolia) and the plant Matricaria chamomilla, which has a direct effect on canker sores, cold sores, and herpes zoster. Its application is medical or dental. It consists of an ethanolic extract with a vehicle to form a cream. It functions topically as a rinse or cream, producing an antiviral effect during the prodrome, preventing the appearance of symptoms, vesicles, pain, and sores characteristic of herpes viral infection. If vesicles are present, it dramatically reduces the duration of the infection, leading to a faster recovery.

[0004] BACKGROUND OF THE INVENTION

[0005] Cold sores, also known as fever blisters, oral herpes, and oral herpes, are a type of infection caused by the herpes simplex virus that primarily affects the lips. Symptoms generally include pain or a burning sensation on the lips, followed by the formation of blisters or sores. An outbreak may be accompanied by fever, sore throat, and swollen lymph nodes. The rash usually heals within a few days, but the virus remains dormant in the body and can reactivate periodically, causing another outbreak of sores on the mouth or lips. The cause is usually herpes simplex virus type 1 (HSV-1) and occasionally herpes simplex virus type 2 (HSV-2). The infection is typically transmitted between people through direct, non-sexual contact.The difference between Herpes HSV 1 and HSV 2 is the location of the outbreak; HSV1 is found from the waist up and HSV2 from the waist down, with the latter being transmitted through sexual contact.

[0006] Attacks or outbreaks can be triggered by sunlight, fever, psychological stress, or menstruation; prevention includes avoiding kissing or using personal items of an infected person.

[0007] Cold sores spread across the entire circumference of the lips, and when symptoms appear, they usually resolve within two weeks. Recurrent oral infections are more common with HSV-1 than with HSV-2, and symptoms typically progress through a series of well-defined stages. The first stage is known as the latent phase, which corresponds to a period of remission in which, after the initial infection, the viruses migrate to the sensory nerve ganglia where they reside as dormant viruses for life. In the second stage, called the prodromal phase, symptoms usually begin with tingling, itching, and reddening of the skin around the infected site. This can last from a few days to a few hours before the physical manifestation of an infection and is the best time to begin treatment.In the third stage, known as inflammation, the virus begins to replicate and infect the cells at the nerve endings, leading to invasion with swelling and redness of the area, which are symptoms of infection. In the fourth stage, or pre-pain stage, small, hard, inflamed papules and vesicles appear. These may itch and are painfully sensitive to the touch. These fluid-filled blisters cluster on the lip tissue, the area between the lip and the skin, and can also appear on the nose, chin, and cheeks. The next stage is when the small vesicles rupture and merge to create a large, open, oozing ulcer. The fluid slowly drains from the blood vessels and inflamed tissue, becoming a highly contagious secretion.In the sixth stage, a yellowish or brown scab forms. This scab is not made of active virus but of blood serum containing useful proteins such as immunoglobulins. However, if it breaks open due to friction or rubbing, it can release contaminating fluid. In the seventh stage, known as the healing stage, new skin begins to form beneath the scab as the virus enters a latent state. This results in the appearance of a series of scabs over the sore, causing symptoms such as irritation, itching, and some pain. Finally, a reddish area may remain at the site of the viral infection as the destroyed cells regenerate.

[0008] Studies focused on treatments or vaccines for the virus are scarce, and no highly effective treatments have been found. However, the human body's immune system and specific antibodies usually fight it off. Treatment options include topical creams, which may be antiviral or anesthetic, as well as oral antiviral medications. Other topical creams include zinc oxide and glycerin cream, which may cause itching and burning as side effects. Docosanol, a saturated fatty alcohol, is approved by the U.S. Food and Drug Administration (FDA) for cold sores in adults with healthy immune systems.

[0009] Antiviral creams include acyclovir and penciclovir, which can accelerate healing. Oral antivirals include acyclovir, valacyclovir, and famciclovir, which, taken in pill form, can be effective if applied in high doses in a single day and are more cost-effective and convenient than the traditional treatment of lower doses over 5 to 7 days. Anesthetic creams, including lidocaine and phlocaine, are also used and have been shown to reduce the duration of symptoms such as pain, burning, and rashes.

[0010] Treatment recommendations vary depending on the severity of symptoms and the chronicity of the infection. Treatment with oral antivirals such as acyclovir in children within 72 hours of illness onset has been shown to shorten the duration of fever, sore throat, and lesions, and reduce viral shedding. For patients with mild to moderate symptoms, a local anesthetic such as lidocaine for pain relief without antivirals is usually sufficient, although this does not stop any symptoms (vesicles, papules, sores, etc.), having an effect only on pain management.

[0011] Psoriasis, a non-contagious and long-lasting autoimmune disease, is characterized by areas of abnormal skin that turn red, pink, or purple, dry, itchy, and scaly. It is a rather bothersome condition for individuals, and its severity ranges from small, localized patches to full-body coverage. Plaque psoriasis, also known as psoriasis vulgaris, accounts for approximately 90% of cases, presenting as red patches with white scales on top in areas such as the backs of the forearms, shins, navel area, and scalp. Psoriasis is thought to be a genetic disease triggered by environmental factors. Symptoms often worsen during the winter and with certain medications, such as beta-blockers or NSAIDs.There is no known cure for psoriasis, but several treatments can help control symptoms, including pheromone creams, vitamin D3 cream, ultraviolet light, immunosuppressant drugs such as methotrexate, and biological therapies targeting specific immune pathways.

[0012] In general, to manage symptoms, the individual's skin should be kept moisturized and irritants such as harsh soaps or aggressive chemicals should be avoided. Some types of oral or injectable medications that affect the immune system to reduce inflammation and psoriasis symptoms are also indicated, including biologic therapies with drugs that target specific parts of the immune system related to psoriasis.

[0013] In the prior art, some herbal compositions are known, for example, for use in the treatment of herpes; for instance, US patent 11191795B2, which refers generally to herbal compositions for use in the treatment of herpes and methods for treating herpes. In some aspects, US patent 11191795B2 provides a herbal composition comprising a first plant material or preparation thereof, the first plant material being Jacaranda sp., and a second plant material or preparation thereof, the second plant material being Spilanthes sp. In some embodiments, the patent provides a herbal composition further comprising one or more agents selected from the group consisting of a wetting agent, a thickening agent, a pH-adjusting agent, and a preservative.In some respects, the patent provides a method for the topical treatment of herpes, wherein the method comprises administering the herbal composition described herein to a patient.

[0014] The claim is for an herbal composition comprising: a first plant material or preparation thereof, the first plant material being Jacaranda sp., where Jacaranda sp. is Jacaranda caucana Pittier; and a second plant material or preparation thereof, where the second plant material is Spilanthes sp. americana; the herbal composition being a cream, gel, emulgel, lotion, or ointment. The plant materials are in extract form. The herbal composition further comprises: (i) a wetting agent; (ii) a thickening agent; (iii) a pH adjusting agent; and (iv) a preservative. The herbal composition is in cream form, and the cream further comprises stearic acid, glyceryl stearate, lanolin, liquid paraffin, propylene glycol, sodium borate, water, carbomer, triethanolamine, methylparaben, and propylparaben.The herbal composition may be in the form of a gel, and thus the gel comprises propylene glycol, ethanol, water, carbomer, triethanolamine, sodium methylparaben, and propylparaben.

[0015] This patent does not claim a composition that uses a combined extract of Acmella Oppositifolia with Matricaria Chamomilla in specific proportions with an antiviral effect in the prodrome, reducing the appearance of symptoms, vesicles, and consequently the evolution time dramatically producing a prompt recovery.

[0016] The application filed in Colombia, identified as NC2020 / 0005349, provides herbal compositions with improved bioavailability formulated for oral administration. By providing improved bioavailability, the physiological benefits are enhanced, increasing the usefulness of these compounds. The herbal compositions described can create several administration benefits by providing therapeutically effective amounts in a variety of conditions. Examples of administration benefits include increased absorption, increased bioavailability, faster onset of action, higher peak concentrations, faster time to peak concentration, greater subjective therapeutic efficacy, and greater objective therapeutic efficacy.The best bioavailability of herbal compositions is created by including one or more A / -acylated fatty amino acids, absorption-enhancing agents, and / or various other beneficial carriers, such as surfactants, detergents, azones, pyrrolidones, glycols, and bile salts in an oral formulation.

[0017] The herbal compositions are described as being used to treat disorders such as herpes or psoriasis. A herbal composition is claimed to comprise:

[0018] or Mentha spp which may also contain chamomile; and (i) an A / -acylated fatty amino acid or salt.

[0019] In this application, Matricaria Chamomilla is shown as a secondary component within the herbal extract, but in no case is a composition mentioned or indicated in which chamomile is presented in mixture with Acmella Oppositifolia, much less with the presence of vitamin C combined with lidocaine as special components of a unique composition from a qualitative and quantitative point of view for the treatment of cold sores, psoriasis, rosacea or dermatitis.

[0020] However, based on the foregoing prior art, there is a clear need for herbal extract-based compositions that include ethanolic extracts of Acmella oppositifolia and Matricaria chamomilla in conjunction with vitamin C and lidocaine, which quickly eliminate inflammation, pain, and itching, and accelerate the healing process. Another advantage of the composition of the present invention is that it produces few or even no side effects when treating patients suffering from skin diseases such as herpes, psoriasis, dermatitis, and rosacea.

[0021] DETAILED DESCRIPTION OF THE INVENTION

[0022] More specifically, the present invention relates to an ethanolic extract of phytotherapeutic origin from the Spinlanthes amehcanus plant (Acmella oppositifolia), combined with an ethanolic extract of the Matricaria chamomilla plant. This combination of extracts has a direct effect on canker sores, cold sores, and herpes zoster. Its application is medical or dental. It consists of an ethanolic extract with a vehicle to provide a cream formulation. It functions topically as a rinse or cream, producing an antiviral effect during the prodrome, reducing the appearance of symptoms, preventing the development of vesicles, pain, and sores characteristic of herpes viral infection. If vesicles are present, the duration of the infection is dramatically reduced, leading to a faster recovery.

[0023] The present invention relates to compositions for treating, preventing, improving, and preventing the recurrence of skin disorders such as herpes in general, and specifically cold sores, psoriasis, dermatitis, and rosacea. More specifically, it relates to compositions comprising an N-alkylamide and a sesquiterpene for local administration. A further object of the present invention is to disclose a composition, as defined above, wherein said spilanthol is extracted from a plant selected from a group consisting of Acmella oleracea, Acmella spilanthes, Acmella dilate, Acmella oppositifolia, Acmella radicans, Acmella brachyglossa, Acmella paniculata, Acmella uliginosa, Welelia parviceps, Heliopsis longipes, and any combination thereof. The ethanolic extract of Matricaria Chamomilla contains mainly terpenoid compounds of the sesquiterpene type, phenolic acids and flavonoids.It is known that among the sesquiterpenes of *M. chamomilla*, alpha-bisabolol and beta-eudesmol are components present in 10 to 50% of the total content of the oil or ethanolic extract. Likewise, infusions of this plant material contain a large amount of phenolic acids such as hydroxybenzoic and hydroxycinnamic acids, and their glycosides such as apigenin, luteolin, and chamazulene. Quercetin has also been found to be one of the important flavonoid components. This combination of compounds offers effective activity in its application as an antiviral and anti-infective agent.

[0024] The sesquiterpene can be extracted from the selected plant family from the plant family known as Matricaria Chamomilla, which includes varieties such as Anthemis nobilis (Roman chamomile), Chamaemelum nobile (English chamomile or Spanish chamomile), Anthemis arvensis, Anthemis ti notoria, and Anthemis cotula.

[0025] Another very advantageous property of Matricaria Chamomilla is its ability to provide moisture to the composition and has a calming and astringent effect but without producing a sensation of dryness or burning when placed on the patient's skin or mucous membranes.

[0026] The following description is provided, along with all the chapters of the present invention, to enable any person skilled in the art to make use of the invention and sets forth the best means contemplated by the inventor for carrying out this invention. However, various modifications are made so that they remain obvious to those skilled in the art, since the general principles of the present invention have been specifically defined to provide compositions for treating, ameliorating, preventing, and mitigating the recurrence of disorders such as herpes, cold sores, and symptoms of psoriasis, dermatitis, and rosacea. The term "local administration" or "local treatment," or "local therapy" or "local application" hereinafter refers to the application of a composition or compositions to a specific location; treatment that is directed to a specific organ or limited area of ​​the body.Examples of local therapy or administration include, but are not limited to, topical therapy (medicine in a lotion or cream applied to the skin) and mouth rinses.

[0027] The term topical administration, treatment, therapy, or application refers to the application of medications to body surfaces, such as the skin or mucous membranes, to treat ailments. This includes a wide range of products such as creams, foams, gels, lotions, and ointments. Many topical medications are epicutaneous, meaning they are applied directly to the skin. Topical routes of administration can also include inhalation, as with asthma medications, or application to the surface of tissues other than the skin, such as transmucosal, rectal, enteral, or vaginal administration, including vaginal or rectal mucus.

[0028] The term N-alkylamides or NAAs refers to a group of naturally occurring secondary metabolites. Plant-derived amides, found in various plant genera, primarily consist of a polyunsaturated aliphatic fatty acid chain and a shorter substituent on the amine side. Both may include cyclic systems and / or heteromolecules (nitrogen, sulfur, oxygen). At the core is the amide bond, which resembles the peptide bond -C(QO)NH- as found in polypeptides and proteins. Due to their resonance characteristics, amide bonds are planar and relatively stable, possessing partial double-bond characteristics and contributing to their large dipole moment.

[0029] Regarding chamomile and its active compounds of interest in this application, the following are present: (alpha)-bisabolol oxy-cyclic and beta-eudesmol; their corresponding IUPAC names are (2S)-6-methyl-2-[(1S)-4-methylcyclohex-3-en-1-yl]hept-5-en-2-ol and 2-[(2R,4añ,8aS)-4a-methyl-8-methylidene-1,2,3,4,5,6,7,8a-octahydronaphthalen-2-yl]propan-2-ol, respectively. These compounds belong to the class of compounds known as sesquiterpenes. Sesquiterpenes are a class of terpenoids characterized by having 15 carbon atoms and multiple isoprene units (C5H8 units).

[0030] The term extraction refers to a separation process that involves separating a substance from a matrix. This includes, among other things, liquid-liquid extraction based on solubility, solid-phase extraction based on different chemical and / or physical characteristics, supercritical fluid extraction, pressurized liquid extraction, chromatographs, hot water extraction under pressure, microwave-assisted extraction, subcritical CO2 extraction, membrane extraction, solvent-assisted extraction, solid-phase microextraction, and adsorption extraction with a stir bar. The distribution of a solute between two phases is an equilibrium condition described by partition theory. This is based precisely on how the analyte transitions from water to an organic layer.

[0031] Plant parts are extracted dry or wet using, among others, the following solvents: organic solvents, hydrophilic solvents, hydrophobic solvents, water, ethanol, petroleum ether, cold water extraction (CWE), methanol, chloroform, hexane, ethyl acetate, and methanol. Plant parts are extracted, in whole or in part, including, but not limited to, seeds, fruits, roots, flowers, stems, foliage, and leaves.

[0032] The terms Spilanthol or Affinin refer hereafter to a fatty acid amide, a very abundant and biologically potent NAA triene. The IUPAC name of Spilanthol is: (2E,6Z,8E)-N-isobutyl-2,6,8-decathenamide; isobutylamide of deca-2E,6Z,8E-trienoic acid.

[0033] The present invention is additionally useful for treating, improving, preventing and mitigating the recurrence and amelioration of dermal or genital skin disorders comprising, among others, herpes, cold sores, dermatitis (eczema), including: lichen simplex (dermatitis due to a localized itch, scratch, and itching response that produces oiling of the skin of the scrotum), atopic dermatitis (eczema), seborrheic dermatitis (generally also affecting the scalp), irritant contact dermatitis (from moisture, incontinence, vigorous cleansing), the most common cause of nonspecific balanitis (in men), intertrigo (in skin folds), and allergic contact dermatitis (most frequently due to fragrances, preservatives, or rubber).Dermatitis (eczema), including: lichen simplex (dermatitis due to a localized itch-scratch response that produces thickening of the skin of the labia majora), atopic dermatitis (eczema), seborrheic dermatitis (usually also affecting the scalp), irritant contact dermatitis (from moisture, incontinence, vigorous cleansing), the most common cause of vulvitis, intertrigo (in skin folds), allergic contact dermatitis (most often due to fragrances, preservatives, or rubber). Psoriasis (persistent, well-defined, red, scaly, or moist patches). Lichen sclerosus (patches with white scarring) and lichen planus.

[0034] The formulation of the composition is prepared in the form of a liquid, solution, capsule, gel, dissolving capsule, capsule comprising a filter, infusion, cream, ointment, electroporation formulation, foam, suspension, emulsion, lotion, microspheres, microbeads, oil, paste, nanospheres, liposomes, powder, roller, soap, surfactant, aerosol, suppositories (anal or vaginal), washing or bathing preparations, tampons, patches, dressings, local injections, liniments, lotions, drops, injections, ointment, vaginal ring, vaginal douche, intrauterine device (IUD), extra-amniotic infusion, intravesical infusion, enema solution, hydrogel liposome balm, shampoo, dermal patch, transdermal patch, transdermal spray, jet injector, and any combination thereof.

[0035] The extraction products or N-alkyamides and oxycyclic (alpha)-bisabolol and / or beta eudesmol are formulated with vehicles, solvents, dispersing agents, surfactants, lubricants, fillers, thickening or viscosifying agents, diluting agents, local anesthetic agents, vitamins, antibiotics and antifungals that will be applied locally to treat, improve, prevent and prevent recurrence. More specifically, the detailed concentration of the composition of the present invention for treating, improving, preventing, and mitigating the recurrence of disorders such as herpes, cold sores, dermatitis, and psoriasis in a mammalian subject, wherein said composition is obtained by mixing the components of at least one N-alkylamide such as spilanthol in a proportion of between 25 to 70% (weight to weight percentages) and a sesquiterpene such as (alpha)-hydroxycyclic bisabolol and / or beta eudesmol in a proportion of between 3 to 20%.

[0036] In more detail, the components that accompany the active compounds are, for example, vehicle complexing and formulation agents such as lidocaine HCL in a proportion of 0.5 to 2%; xanthan gum from 1.5 to 3.5%; vitamin C from 1 to 3%, methylparaben from 0.2 to 1%; propylene glycol from 0.5 to 2% and sterile water from 50 to 65%.

[0037] The formulation / composition of the present invention is applied locally to the diseased area of ​​the mammalian subject, the routes of administration of this formulation / composition comprising, among others, topical, dermal, transmucosal (oral, vaginal and rectal), transdermal and any combination thereof.

[0038] Notwithstanding the foregoing, the composition is also provided in a selected form from a group consisting of liquid, solution, capsule, gel, dissolving capsule, capsule comprising a filter, infusion, cream, ointment, electroporation formulation, foam, suspension, emulsion, lotion, microspheres, microbeads, oil, paste, nanospheres, liposomes, powder, soap, surfactant, aerosol, suppositories (anal or vaginal), vaginal tablets, wash or bath preparations, tampons, patches, plasters, local injections, liniments, lotions, drops, injections, ointments (vaginal suppository), vaginal ring, vaginal douche, intrauterine device (IUD), extra-amniotic infusion, intravesical infusion, enema solution, hydrogel liposome balm, shampoo, dermal patch, transdermal patch, transdermal spray, jet injector, and any combination thereof. EXAMPLES WITH COMPARATIVE RESULTS ON THE THERAPEUTIC EFFICACY OF THE PRODUCT

[0039] Skin disease: Herpes type one on the lip and oropharyngeal mucous membranes and herpes zoster

[0040] Number of patients treated: 8

[0041] Maximum number of days to achieve results: 6

[0042] General achievements attained with the treatment: pain relief, disappearance of inflammation, disappearance of itching, inhibition of the appearance of vesicles or elimination of these, acceleration of healing with the appearance of eschars.

[0043] Phases: (i) The first phase refers to the Prodrome in which the patient identifies the appearance of symptoms characteristic of the beginning of the disease; in this phase the appearance of a sensation of itching, burning, inflammation begins, (ii) The second phase refers to the clinical stage, in which the disease is established with greater inflammation, intense pain and the appearance of vesicles.

[0044] When the product is first applied in phase I, a rapid decrease in the sensation of itching and inflammation is observed within a day, as well as complete remission of the initial symptoms by the third day.

[0045] When the product is first applied to the blisters in phase II, a gradual decrease in inflammation and pain is observed, and within three to four days, the blisters dissolve and the healing process is accelerated with the appearance of a scab or eschar from the sixth day onwards.

[0046] Patient one

[0047] Within six days of medication application, the patient showed noticeable and rapid positive effects, beginning with pain relief on the first night of application, followed by a reduction in inflammation starting on the second day, and by the third day, an almost complete recovery with the disappearance of pain, redness, and swelling. By the sixth day, the patient was in excellent condition with excellent healing. Patient two

[0048] After four days of applying the medication, a noticeable improvement was evident. The first two days showed no change, but from the third day onward, the lesion stopped growing and there was no more pain. On the fourth day, a scab began to form, indicating good healing, and the itching disappeared.

[0049] Patient three

[0050] In four days of applying the medication, the patient showed a marked improvement with the disappearance of the itching, which she described as intense on the first day; disappearance of the inflammation and total healing.

[0051] Patient four

[0052] The patient, who began applying the medication to treat herpetic stomatitis with intense pain, inflammation, itching, and multiple blisters, reported a marked improvement after three days of repeated applications three times a day, after which she reported the disappearance of intense symptoms and complete healing.

[0053] Patient five

[0054] The patient, who began the first day of application of the medication with moderate itching and inflammation but with intense pain, reported after three days of application with permanent moisturizing, that the itching, pain and inflammation disappeared, and there was total healing with scabs.

[0055] Patient six

[0056] The patient presented with a lesion containing vesicles. After the first application, she experienced burning and dryness. She kept the area moisturized with the product, and after two days, the vesicles, inflammation, and pain disappeared, and the healing process began. On the fifth day, a scab formed, and the lesion disappeared after two days. The patient reported experiencing prodromal symptoms (the onset of new symptoms with itching and inflammation). She began applying the product again, and despite the dryness, she experienced a decrease in itching and inflammation, and this time, no vesicles appeared. Three days later, the symptoms disappeared. Three months after this initial report, the patient reported no recurrence (whereas in her case, cold sores occurred at least once a month).

[0057] Patient seven

[0058] The patient, who began applying the medication to treat shingles on her back, with intense pain, inflammation, and multiple blisters, applied the product with gauze to the lesions and reported relief from the burning pain and a cooling sensation after the second day of application. After six days of application, the lesions disappeared, and there was no post-herpetic pain. She reported a marked improvement with complete healing.

[0059] Patient eight

[0060] The patient presented with moderate inflammation and pain, intense itching, and the appearance of blisters. The product was started, and by the sixth day of application, scabs appeared and the pain, inflammation, and itching disappeared.

[0061] Two months later, the itching, pain, and inflammation recurred, and on the second day after applying the product, the symptoms disappeared without the appearance of blisters.

[0062] Common differences found by patients who have used antiretrovirals in similar previous events:

[0063] The most significant difference with this product is the faster disappearance of inflammatory symptoms, pain, and itching, in a shorter period than with antiretroviral therapy. The second key difference is that it reduces the frequency of disease outbreaks, and when they do occur, the symptoms are milder, the remission period is shorter, and the appearance of vesicles is virtually prevented. Additional differences compared to previous antiretroviral treatments administered to patient six when the disease first appeared include:

[0064] Unlike previous episodes where the patient had used antiretrovirals, with this product she experienced no recurrence of the disease for a period of six months, during which she has not experienced any further symptoms. It is worth noting that this patient typically experienced monthly recurrences of the disease on her lip. Furthermore, even before using antiretrovirals, vesicles appeared when the disease manifested; however, with this product, they did not appear during the immediate recurrence she experienced while using it.

[0065] Additional differences with previous antiretroviral treatments applied by patient eight when the disease appeared:

[0066] This patient experienced monthly recurrences of the disease, which became less frequent over time. During the second recurrence, after applying this product, no vesicles appeared, and the positive effects of the application were experienced more quickly than with the first application. These are the differences compared to the antiretroviral treatments the patient had used previously. During the third recurrence of the disease, six months after the first application of this product, the patient experienced a complete disappearance of itching, inflammation, and burning symptoms within a single day of application, and no vesicles appeared.

[0067] EXAMPLES OF OTHER FINDINGS WITH INTERESTING RESULTS ON POSSIBLE THERAPEUTIC EFFICACY USES OF THE PRODUCT

[0068] Skin disease: dermatitis, psoriasis, and rosacea

[0069] Number of patients treated: 4 Based on the results obtained in these cases, and the surprising findings as a result of the treatment, we can infer that the product may have a positive effect on the regulation of TH2 (cellular and viral immune system).

[0070] Patient one

[0071] A case of dermatitis. The patient presented with an allergic reaction on his back and arms that had been ongoing for two months and had not resolved with previous treatments such as ointments or homeopathic creams. After applying the product, the patient reported a significant improvement in symptoms after two days (itching, inflammation, and redness disappeared).

[0072] It should be noted that this patient's allergy has been present for many years, with monthly episodes, and that despite trying various treatments previously, she had never achieved the results obtained with this product. No treating physician has yet identified the cause of this patient's allergy. She is a healthy, sixty-year-old woman.

[0073] Patient two

[0074] A case of dermatitis on the chest and back. The patient presented with dermatitis characterized by redness and itching. After applying the product, the patient reported relief of symptoms within two days, as they disappeared. This was an allergic dermatitis that occurred sporadically in the patient.

[0075] Patient three

[0076] A case of psoriasis. The patient presented with bleeding lesions on her elbow, consistent with a type of psoriasis. Upon application of the product, positive results were obtained within two days, with 80% epithelialization of the lesion, which disappeared completely within two more days. In a subsequent episode after applying the product, she presented with lesions on her elbow and nose, and obtained similar positive results. Patient four

[0077] A case of rosacea. The patient, who suffers from rosacea due to sun exposure, applied the product, keeping her skin moisturized with it for two days. After this period, the patient reported relief from the flare-up with a notable reduction in symptoms, redness, and flushing.

[0078] No side effects were detected in patients treated with the combined herbal formulation, including patients with diabetes, heart conditions, or high blood pressure. Furthermore, the use of the combined herbal formulation reduced or even eliminated the need for antiviral medication in 100% of patients.

[0079] Although the present invention has been described with the preferred embodiments shown, it is understood that modifications and variations that preserve the spirit and scope of this invention are understood to be within the scope of the attached claims; the examples included are some embodiments of the invention, but they should not be interpreted as limiting the invention.

Claims

CLAIMS 1. A local composition for treating, improving and preventing the recurrence of disorders such as herpes, cold sores, dermatitis, rosacea and psoriasis in a mammalian subject, wherein said composition comprises at least one N-alkylamide such as spilanthol in a proportion of between 25 to 70% (weight percent) and a sesquiterpene such as (alpha)-cyclooxybisabolol and / or beta eudesmol in a proportion of between 3 to 20%.

2. The composition of claim 1, wherein said composition further comprises, vehicle complexing and formulation agents such as solvents, dispersing agents, surfactants, lubricants, fillers, thickening or viscosifying agents, diluting agents, local anesthetic agents, vitamins, antibiotics and antifungals to be applied locally to treat, improve, prevent and prevent recurrence.

3. The composition of claim 1, wherein said composition further comprises, complexing and formulation agents such as lidocaine HCL in a proportion of 0.5 to 2%; xanthan gum from 1.5 to 3.5%; vitamin C from 1 to 3%, methylparaben from 0.2 to 1%; propylene glycol from 0.5 to 2% and sterile water from 50 to 65%.

4. The composition of claim 1, wherein said composition is provided in a form selected from a group consisting of liquid, solution, capsule, gel, dissolving capsule, capsule comprising a filter, infusion, cream, ointment, electroporation formulation, foam, suspension, emulsion, lotion, microspheres, microbeads, oil, paste, nanospheres, liposomes, powder, soap, surfactant, aerosol, suppositories (anal or vaginal), vaginal tablets, wash or bath preparations, tampons, patches, plasters, local injections, liniments, lotions, drops, injections, ointments (vaginal suppository), vaginal ring, vaginal douche, intrauterine device (IUD), extra-amniotic infusion, intravesical infusion, enema solution, hydrogel liposome balm, shampoo, dermal patch, transdermal patch, transdermal spray, jet injector and any combination thereof.

5. The composition of claim 1, wherein said composition is in a selected form of a pharmaceutical product or a cosmetic product or a medical device.

6. The composition of claim 1, wherein said mammalian subject is an animal or a human being.