RS58997B1 - Composition against aging of the intimate area skin - Google Patents

Abstract

The present invention relates to a cosmetic agent, an anti-aging composition of the skin of the intimate region, as well as to the use of that composition. The active ingredients of the composition are encapsulated in liposomes.

Description

Description of the invention

The present invention relates to a cosmetic product, an antiaging skin composition

intimate regions, as well as the use of that composition.

Technical problem

The technical problem solved by this invention is obtaining a composition intended for care

the skin of the intimate area and preventing aging, i.e. loss of elasticity. Subject invention

ensures a pH value of the intimate region of 3.8-4.5, ensures a reduction in the possibility of infection,

increasing the feeling of hydration of the skin, facilitating intimate relations, depigmentation.

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State of the art

European patent number EP2648739 relates to a multipurpose vaginal dryness gel with direct and

delayed effect. The said gel contains a colostrum fraction enriched with immunoglobulins,

growth factors, chemotactic factors and antimicrobial/antiviral factors. This gel

used in the treatment of vaginal dryness and no anti-aging effect is reported.

International patent application publication number WO 2017/069793 relates to compositions

vaginal gel and procedures for its use. The gel specified in this international application

solves the problem of vaginal dryness. The anti-aging effect is not attributed to the gel, it is only stated

as one of the effects of vitamin E. This application solves the problem of vaginal dryness with viscous

a pharmaceutical composition containing a water-soluble gel containing niacin and/or L-arginine.

L-arginine is listed as an ingredient or as an alternative ingredient in the gel.

In the state of the art, there are vaginal preparations that are used for the treatment of vaginal dryness, but

none of them deal with the problem of aging of the intimate area. Preparations from the state of the art

are applied vaginally, while the composition according to the subject application is applied to the skin

intimate area outside. For women, external treatment through application is more acceptable

compositions on the intimate region, rather than vaginal application. The composition in question prevents changes in the skin and thus contributes to improved circulation, reduced pigmentation, hydration of the skin, and via circulation also has effects in the vagina. The composition according to the subject application prevents thinning of the skin by stabilizing the DNA chain of skin cells and stimulating microcirculation with an antimicrobial effect and in conditions of a precisely defined pH value (pH 3.8-4.5). Also, none of the preparations known from the prior art contain this specific combination of ingredients. This composition ensures a pH value of the intimate region of 3.8-4.5, thereby reducing the possibility of infection, in addition, the feeling of hydration of the skin increases, intimate relations are facilitated, and depigmentation is achieved. In the part of the intimate region of women, the pH increases over time with aging, even up to pH 6. The composition in question affects the change in the pH of the skin of the intimate region by returning the pH to an optimal value - 3.8-4.5, preferably 4.0-4.4.

The composition can be used for showering (cleanses the skin, hydrates the skin...), instead of a lubricant, reduces scar tissue and has a hypoallergenic effect.

Various clinics around the world deal with anti-aging treatment of the intimate area, but they achieve this through surgical procedures or injections, for example. hyaluronic acid.

In the state of the art, there is no anti-aging treatment for the intimate area that would be non-invasive. Also, the less invasive the treatment is, the more acceptable it is for women. There are no defined preparations for the care of the skin of the intimate area on the market, and especially none with these active substances in liposomal form in one preparation with an arginine concentration of up to about 20%.

Another advantage of the present invention is that there is no effect of "leakage" of the composition, because the composition is not in the form of an aqueous solution, but inside a liposome.

Presentation of the essence of the invention

The term "intimate region/zone" means a woman's external genitalia and perineum, i.e. labia majora and minora, clitoris, vaginal opening and perineum.

The skin of the intimate part, which includes the external genital organs of a woman, has a number of specificities and special problems that are expressed only in this region. This part of the skin has its own specific pH of 3.8-4.5, which is lower than other parts of the skin, precisely to represent a defense against various infections. Also, in this part, the epithelium changes from squamous-layered with armature to squamous-layered, and the very border of the change of the epithelium represents a point of risk for the action of harmful agents, toxins and microbes. This area of the skin is highly exposed to mechanical lesions and damage to the surface parts of the skin. Every trip to the toilet, every sexual intercourse, creates small microlesions that disrupt the pH and structure of the skin, which loses its good properties, namely elasticity, hydration and compactness. Childbirth itself involves the creation of serious and unpleasant scars in this region, for which until now there has been no continuous treatment after the end of the healing phase. Change in the properties of the skin of this area, i.e. its aging, pH change and decrease in thickness and elasticity lead to a direct negative impact on reproductive and general health of women. With this care, it is achieved that the pH is optimal and serves as the first defense against infections, and the active ingredients that are incorporated into phospholipid liposomes lead to increased tissue blood flow, a large elimination of free radicals in the cells, stabilization of the DNA chain of cells and high hydration. These improvements in the metabolism of the skin of this region lead to the cessation of dryness, reduced infections, and easier and more pleasant sexual intercourse.

Unfavorable factors such as microlesions, difficult maintenance of the pH of the intimate region, exposure to infections, scars, all have an impact on the skin of the intimate region and lead to its faster aging.

This composition ensures a pH value of the intimate region of 3.8-4.5, thereby reducing the possibility of infection, in addition, the feeling of hydration of the skin increases, intimate relations are facilitated, and depigmentation is achieved. In the part of the intimate region in women, the pH increases over time with aging, even up to pH 6. The subject composition affects the change in the pH of the skin of the intimate region by returning the pH to an optimal value - 3.8-4.5, preferably 4.0-4.4.

The problem of the present invention is solved by a composition containing: L-arginine, turmeric, hyaluronic acid or its salt, lactic acid and vitamin E as active ingredients encapsulated in liposomes.

The subject composition may additionally contain lecithin, glycerol and/or one or more preservatives, eg, potassium sorbate and/or sodium benzoate.

The subject composition may additionally contain vitamin C, niacin and/or lysine.

Our product contains L-arginine, a derivative of white turmeric, hyaluronic acid or its salt, lactic acid and tocopherol (vitamin E).

The composition in question contains about 20% of arginine, which is made possible through the use of liposomes that contain the active substances of the composition in question. The use of liposomes allows the active ingredients to reach the corneum of the skin and not into the circulation.

In a preferred embodiment, the composition is in the form of a gel.

The effect of L-arginine in the skin has been confirmed by many scientific works and it has been found to stimulate circulation in the skin, stimulate the work of growth hormones, stimulate fibroblasts and prevent thinning of the skin. It also prevents the action of free radicals before they lead to damage to the DNA chain and thus prolongs the life of the cell. L-arginine also helps in wound healing and is used in some cosmetic preparations for facial skin care, but what makes our preparation unique is the L-arginine concentration of about 20%, which is not present in any known skin care preparation.

Turmeric is proven to prevent skin pigmentation, has a distinct antimicrobial effect and is one of the strongest antioxidants.

Hyaluronic acid is known and widely used in cosmetics as an important skin hydration factor and collagen stimulator.

Tocopherol is a very common ingredient in preparations that increases the activity of enzymes in skin cells, hydrates and has an antioxidant effect.

Lactic acid is very important in this preparation because it achieves the ideal pH, but it also has a positive effect on the exfoliation of dead skin layers, reduction of pigmentation and strengthening of skin texture.

All these ingredients were incorporated by the inventors of the present invention into phospholipid liposomes that are used as active substance carriers. Phospholipid liposomes have the same structure as the cell membrane, so they stick to it by themselves and have the effect of preventing the loss of water from the cells. Also, their structure enables the transport of active substances into the deeper layers of the skin, where they actually achieve their biological effect and allow even large molecules, such as hyaluronic acid, to be absorbed and transported through the cell membrane, which is otherwise impossible to achieve with other types of carriers.

As will be further described in the section with examples, the composition in question represents a combination of ingredients that gives a synergistic effect in relation to the individual ingredients in relation to the following biophysical parameters of the skin of the subject: EC-as a measure of skin moisture, TEGV-transepidermal water loss as a measure of skin barrier properties, surface lipid content, El-erythema index and MI-melanin index.

Detailed description of the invention

Example 1

A composition against aging of the skin of the intimate region was prepared in the form of an intimate liposomal gel with the following composition:

The ingredients from the table above are incorporated into liposomes. Liposomes were automatically formed by mixing phospholipids from lecithin with a solution of L-arginine in water. The system is formed using high speed mixing and high pressure manufacturing processes. (source: Liposomes, a practical approach, edited by Vladimir P. Torchilin et al, Oxford university press, second edition).

Example 2

The liposomal intimate gel described in Example 1 was administered to women aged 25 to 70 years. In the course of two years, 80 women tried this gel and in the younger group there was a marked improvement in the feeling of blood supply to the region and improved sensitivity during sexual intercourse, and in the older group there was a significant increase in hydration and the feeling of blood supply to the region. In women from the age group of 55 to 70 years, after regular use of the preparation, there was an improvement in the quality of the tissues and the possibility of sexual intercourse, which they could not achieve before due to dryness.

The examination was carried out between October 2016 and January 2018. 80 gynecologically healthy women, sexually active, of different ages were selected, who used the preparation daily for 30 days and were checked after use and filled out a questionnaire.

The pH of the skin of the intimate region was examined before and after 30 days from the start of using the preparation. pH was measured at the opening of the vagina (introitus) using the CarePlan VpH pH control glove manufactured by INVERNESS MEDICAL GMBH.

The optimal pH of the skin of the intimate region is 4.0-4.4.

The number of test subjects by age group who had an optimal pH at the beginning of the test, expressed as a percentage:

At the beginning of the study, out of all 80 subjects, 30 had a normal pH of the skin of the intimate region (4.0-4.4), which represents 37.5% of the total number. After 30 days of daily use of the preparation, 82.5% of all test subjects had a normal pH of the skin of the intimate region. This result shows a statistically significant change in achieving a normal pH with the use of the preparation. The most pronounced effect is achieved in older age groups, where due to the loss of estrogen, the biggest problem with the optimal pH value occurs. The feeling of better hydration of the skin of the intimate region after 30 days of daily use of the preparation in the descriptive rating of "slight" and "significant" was determined in 63 subjects, i.e. 79% of the subjects, of which 33 subjects, i.e. 41%, had a "significant" improvement. This shows great statistical significance. The examination of the improvement in the quality of intimate relations after 30 days of daily use of the preparation showed that in 64 subjects there was a "small" and "significant" improvement in the quality of intimate relationships, which accounts for 80% of the total number of respondents, and of those, 26 respondents, or 32.5%, had a "significant" improvement. And this result indicates great statistical significance.

This study showed that the use of this preparation brings significant positive qualitative changes for a woman's intimate health and improvement of the general quality of life.

Example 3

Examination of the effectiveness of the preparation on the healthy skin of subjects-volunteers

Efficacy was tested after application of the preparation on the healthy skin of test subjects-volunteers.

A long-term study of the effectiveness of the preparation on healthy skin was conducted (4 weeks of application).

In vivo efficacy testing on healthy skin

In vivo testing of the effectiveness of the samples was performed in a long-term, double-blind study by measuring the biophysical parameters of the subjects' skin (EC-as a measure of skin moisture, TEGV-transepidermal water loss as a measure of skin barrier properties, surface lipid content, El-erythema index and MI-melanin index).

Test protocol

Healthy subjects participated in the study. The study was conducted in August and September 2018. The subjects were instructed not to use any skin care products in the examined area (the skin of the inner forearm) during the study period, as well as for one week before the start of the study. The tested preparation was applied as well as the preparation containing individual active principles in the concentration in which they are present in the tested product.

After the initial measurement (before the start of the study, basal values) the volunteers were given instructions to apply the preparation at home once a day, in the evening, after showering in the area of the marked skin surface for 4 weeks. Measurements were performed before the start of the application (basal values) as well as after 1, 2 and 4 weeks of application. Also, measurements were taken 4 days after the application was stopped

In accordance with the obtained results, we conclude that the tested preparation statistically significantly increases the moisture of the skin after 7 days of application (compared to the basal value) and the level of hydration is maintained at a statistically significant level throughout the test (4 weeks of application). Throughout the test, the preparation has a statistically significant effect on TEGV in terms of its reduction compared to the basal value, which indicates a positive effect on the barrier properties of the skin. The content of surface lipids increases on the skin treated with the tested preparation from the 7th day of application, during the entire application period, which indicates the formation of a thin phospholipid film on the skin surface as a result of liposome application to the skin. The increase in MI and EI indicates the anti-irritant effect of the tested preparation. All measured parameters were statistically significantly better with the tested preparation compared to preparations containing individual active principles, significantly better than the simple sum of the effects of individual preparations, which indicates a synergistic effect of the selected active principles.

Claims (12)

Patent claims 1. A composition characterized by containing L-arginine, turmeric, hyaluronic acid or its salt, lactic acid and vitamin E encapsulated in liposomes. 2. Composition according to patent claim 1, characterized in that it additionally contains lecithin, glycerol and/or one or more preservatives. 3. Composition according to claim 2, characterized in that the preservatives are potassium sorbate and/or sodium benzoate. 4. A composition according to any of the preceding claims, characterized in that it contains about 20% L-arginine. 5. A composition according to any of the preceding claims, characterized in that it contains the following ingredients incorporated into liposomes: 6. A composition according to any of the preceding patent claims, characterized in that it additionally contains vitamin C, niacin and/or lysine. 7. The composition according to any of the preceding claims, characterized in that it is in the form of a gel. 8. Non-therapeutic cosmetic use of the composition according to any of the preceding patent claims for antiaging treatment of the skin of the intimate region. 9. Non-therapeutic cosmetic use of the composition according to patent claim 8 for achieving pH 3.8-4.5 of the intimate region. 10. Non-therapeutic cosmetic use of the composition according to claim 9 for achieving pH 4.0-4.4 of the intimate region. 11. Non-therapeutic cosmetic use of the composition according to patent claim 8 against pigmentation of the skin of the intimate region. 12. Non-therapeutic cosmetic use of the composition according to claim 8 as a lubricant for the intimate region.