KR101383217B1 - Composition for preventing hair loss and promoting hair growth - Google Patents

Abstract

The present invention relates to the composition of hair products, such as shampoos and hair tonic products having hair loss prevention and hair growth promoting effect, in particular, sarcoma extract (Cistanche tubulosa), niacin (called Niacin and includes Nicotinamide or Nicotinic Acid), seaweed It contains extract (Tashima and Wakame spore leaf fucoidan), sprout extract (colorful, safflower, pea sprout) or mixtures thereof to prevent hair loss and promote hair growth, and wash it with hair tonic in the form of a product or shampoo The present invention relates to hair loss prevention and hair growth promoting hair composition used in products and the like.
The present invention is compared to 100% by weight of the total component (Cistanche tubulosa), niacin (called Niacin and contains Nicotinamide or Nicotinic Acid), seaweed extract (Tashima and Wakame spore leaf fucoidan) and sprout extract (poly, safflower, pea sprout ) 0.01 wt% to 10 wt%.

Description

Hair Loss Prevention and Hair Growth Hair Composition {COMPOSITION FOR PREVENTING HAIR LOSS AND PROMOTING HAIR GROWTH}

The present invention relates to a hair product composition, and more particularly, to a hair loss prevention and hair growth promoting hair composition such as a shampoo having a hair loss prevention and hair growth promoting effect, a product in the form of a hair tonic and the like.

In modern man, about one third of males have alopecia due to excessively westernized eating habits, stress, and lifestyle, and about one fifth of men who suffer from considerable hair loss. According to the data provided by the National Health Insurance Corporation, the hair loss population of males in their 20s and 30s increased more than 30% from about 60,000 in 2001 to about 81,000 in 20008. Women also suffer from male pattern baldness (MPB), up to 1/5 of men. In particular, women also suffer from alopecia caused by pregnancy and childbirth. The female hair loss population soared by more than 40% over the same period. Gynecologic hair loss is heavily influenced by stress and androgen androgen. Initially, the scalp becomes dry or pulled, dandruff occurs, itching, etc., and thinning starts from the crown to thinning of the entire head.

In particular, female hair loss that appears in young women is mainly caused by stress, when toxins accumulated in the body are damaged due to long-term mental stimulation, resulting in hair loss.

Cortisol hormone, which is secreted when stressed, is a major cause of hair loss and 'menopausal female hair loss' with aging after 50s is a major cause of male hormones.

After menopause, the release of female hormones (estrogens) decreases, and the release of male hormones (androgens) increases, resulting in thinning hair and thinning hair. Hair loss in women does not progress to baldness like male baldness.

However, if left unchecked, it can be serious enough to show the scalp on the crown. Hair loss with severe damage to hair follicles and pores is difficult to treat and can be an external complex, so it is beneficial to treat hair loss early.

In addition, alopecia patients account for about 1-3% of all patients who visit the dermatologist. Androgenetic alopecia, or male pattern baldness, accounts for about 50% of white men and women, and Korean men. 14.1%, 5.6% of women (Paik JH, Yoon JB, Sim WY, Kim BS, Kim NI.The prevalence and types of androgenetic alopecia in Korean men and women.Br J Dermatol 2001; 145: 95- 99). This is a disease common enough to be regarded as a process of normal aging (Olsen EA.Pattern hair loss in men and women.In: Olsen EA, editors.Disorders of hair growth. 2 ^nd ed. -362) Age, genetic predisposition, and male hormones are thought to be important factors (Olsen EA, Messenger AG, Shapiro J, Bergfeld WF, Hordinsky MK, Robert JL, et al. Evaluation and treatment of male and female pattern hair loss.J Am Acad Dermatol 2005; 52: 301-311, Hoffmann R. Male androgenetic alopecia.Clin Exp Dermatol 2002; 27: 373-382). Hair loss in androgenetic alopecia is mainly known as DHT (dihydrotestosterone) produced by the action of 5α-reductase from testosterone. Gradual miniaturization leads to an increase in the proportion of resting hair and a decrease in the growth period.

In addition, it is known that a bald scalp is more vulnerable to sunburn, physical shock, and damage caused by ultraviolet rays, and mentally, androgen alopecia may negatively affect self and social life.

The direction of treatment for androgen alopecia is changing towards a tendency to actively treat hair loss at the early stages of hair loss.

Products that treat or prevent alopecia include oral finasterides (Drake L, Hordinsky M, Fieldler V, Swinehart J, Unger WP, Cotterill PC, et al.) That are approved and used by the US Food and Drug Administration. The effects of finasteride on scalp skin and serum androgen levels in men with androgenetic alopecia.J Am Acad Dermatol 1999; 41: 550-554) and minoxidil applicators (Olsen EA, Dunlap FE, Funicella T, Koperski JA, Swinehart JM, Tschen. EH, et al. A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men.J Am Acad Dermatol 2002; 47: 377-385). Formulations, Glyceryl pantadecanoate preparations, Cytopurine preparations, Hinokitiol preparations, etc.Cosmetic products include hair tonics containing blood circulation accelerators and topical stimulants as main ingredients, and shampoo formulations containing various herbal extracts. .

In addition, many hair loss prevention and prevention agents or hair growth agents have been developed.

However, the results of using these products are not always satisfactory and require continuous research and development for the development of new therapeutics.

The effects on the treatment and prevention of alopecia of various products that have been commercialized so far have been shown to be effective during the continuous use of the product.However, the hair loss proceeds as it is when it is stopped and applied to the scalp. In the case of quasi-drugs, there is a slight effect, but these products also have a disadvantage in that the hair loss proceeds rapidly and is inconvenient to use if the products are discontinued.

The non-medicinal products in the form of shampoo that claim to prevent and prevent hair loss have the advantage of being convenient for daily use, but the effect of preventing hair loss is very weak or the effect is mostly the treatment and relief of dandruff itching.

In addition, cosmetics, shampoos and products that claim to prevent hair loss and hair growth negatively are very ineffective.

The present invention has been made to solve the conventional problems as described above, the main object of the present invention is a product in the form of a shampoo or hair tonic simply applied to the scalp and easy to use daily while containing natural products as the main ingredient and hair loss prevention and The purpose is to provide a hair loss prevention and hair growth promoting hair composition to maximize the hair growth effect.

In order to achieve the above object, the hair loss prevention and hair growth promoting hair composition of the present invention, compared to 100% by weight of the total components of the breeding (Cistanche tubulosa) extract, niacin (called Niacin and includes Nicotinamide or Nicotinic Acid), seaweed Extract (Tashima and Wakame spores Fucoidan) and sprout extract (poly, safflower, pea sprout) is characterized in that it comprises 0.01% to 10% by weight, respectively.

According to the present invention as described above, by using a hair product composition such as shampoo or hair tonic products applied to the scalp, it is possible to obtain the effect of preventing hair loss and promoting hair growth.

1 is a view showing the extraction powder preparation method for breeding according to one embodiment of the hair loss prevention and hair growth promoting hair composition according to the present invention,
Figure 2 is a graph showing the effect of increasing the hair growth rate in the C3H mouse of Canca extract according to one embodiment of the hair loss prevention and hair growth promoting hair composition according to the present invention,
Figure 3 is applied to the breeding extract according to one embodiment of the hair loss prevention and hair growth promoting hair composition according to the present invention 14 days, a substitute photograph showing the image of the dorsal portion of the C3H mouse,
Figure 4 is a graph showing the average number of hair loss after 16 weeks of topical coating agent according to an embodiment of the hair loss prevention and hair growth promoting hair composition according to the present invention,
5 is a graph showing the average number of hair loss after 16 weeks of shampoo form product according to an embodiment of the hair loss prevention and hair growth promoting hair composition according to the present invention,
Figure 6 is a graph showing the increase in the average number of hair after 16 weeks of topical coating agent according to an embodiment of the hair loss prevention and hair growth promoting hair composition according to the present invention,
7 is a graph showing the average hair thickness increase after 16 weeks of topical application according to an embodiment of the hair loss prevention and hair growth promoting hair composition according to the present invention,
8 is a graph showing the average number of hair growth after 16 weeks of topical application according to an embodiment of the hair loss prevention and hair growth promoting hair composition according to the present invention,
9 is a graph showing the average number of hair after 16 weeks of shampoo form product according to an embodiment of the hair loss prevention and hair growth promoting hair composition according to the present invention,
10 is a graph showing the average hair thickness increase after using 16 weeks of shampoo form product according to an embodiment of the hair loss prevention and hair growth promoting hair composition according to the present invention,
11 is a graph showing the average number of hair raising after 16 weeks of shampoo form product according to an embodiment of the hair loss prevention and hair growth promoting hair composition according to the present invention.

While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of example in the drawings and will herein be described in detail.

It should be understood, however, that the invention is not intended to be limited to the particular embodiments, but includes all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. Like reference numerals are used for like elements in describing each drawing.

The terminology used in this application is used only to describe a specific embodiment and is not intended to limit the invention. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this application, the terms "comprise" or "having" are intended to indicate that there is a feature, number, step, operation, component, part, or combination thereof described in the specification, and one or more other features. It is to be understood that the present invention does not exclude the possibility of the presence or the addition of numbers, steps, operations, components, components, or a combination thereof.

Unless defined otherwise, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Terms such as those defined in commonly used dictionaries are to be interpreted as having a meaning consistent with the contextual meaning of the related art and are to be interpreted as either ideal or overly formal in the sense of the present application Do not.

Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings.

The components used in the present invention to prevent hair loss and promote hair growth are as follows.

• Contains Cistanche tubulosa extracts that promote blood circulation and dilate blood vessels.

Cistanche tubulosa extract is obtained as follows.

The breeding extract of the present invention (Cistanche tubulosa Extract) is a powder obtained by extracting the plant with the heat sugar sugar (Cistanche tubulosa) with brine ethanol. The extraction process is as shown in FIG.

The extract powder for sarcoma contains more than 25.0% of echinacea, 9.0% of acteosides, and 50.0% of phenylethanoid glycosides. This extract powder is water-soluble and its specifications are shown in Table 1 below.

Appearance It is a tea-light green powder with a slight peculiar smell. Echinacoside content 25.0% or more HPLC Acteoside content 9.0% or more HPLC Phenylethanoid Glycosides 50.0% or more UV Dry weight loss 10.0% or less Hygiene test method, 1g, 105 ℃, 2 hours Purity test - (1) heavy metal Not more than 10ppm (2) arsenic 1ppm or less General viable count 1 × 0 ³ pcs / g or less Hygiene test method, standard agar medium Fungus number 1 × 0 ² pcs / g or less Hygiene test method, Potato dextrose agar medium, Chloramphenicol added Escherichia coli voice Hygiene test method, BGLB medium Furtherance Ingredients (extracts for breeding) Content (100%)

The extract for breeding of the present invention may be included in an amount of 0.01 to 10% by weight, preferably 0.1 _to 3% by weight, based on the total weight of hair loss prevention and hair growth promoting composition.

● Niacin is called Niacin and contains Nicotinamide or Nicotinic Acid for the suppression of dandruff and itching or for the blood circulation of the scalp, which is essential for hair growth or hair growth. ).

The technique of the present invention can be seen in the effects of the following examples with significantly enhanced anti-dandruff and anti-itch effects compared to the technique of the previous invention (Korea Patent Publication No. 10-0242858, Kang Gil-sung, etc.), which used only niacin as an active ingredient. As shown, it shows a significant level of hair loss prevention and hair growth promoting effect.

In the present invention, niacin may be included in an amount of 0.01 to 10% by weight, preferably 0.1 _to 2% by weight, based on the total weight of hair loss prevention and hair growth promoting composition.

● Enhance the immune mechanisms of the scalp and hair roots, and contain seaweed extract (Tashima and Wakame spore leaf fucoidan) for the maintenance and production of healthy hair.

Currently, fucoidan extracted from kelp or seaweed spore leaf (reproductive system) among brown algae has been found to have all the main physiological active functions, and fucoidan extracted from seaweed and seaweed spore leaf was adopted.

In the present invention, 27% of fucoidan and 85% or more of fucoidan are used, in which the content of sulfuric acid group, which is the most important component of fucoidan, far exceeds the Japanese standard of 13%.

The characteristics of seaweed extract (Tashima and Wakame spore leaf fucoidan) used in the present invention are shown in Table 2 below.

[Table 2] shows the characteristics and contents of seaweed extracts (Tashima and Wakame spore leaf fucoidan).

Characteristics Characteristic of raw material It is light gray powder and has no odor except the slight flavor of seaweed.
It is water soluble and no material deformation after 12 months storage at PH505 ~ 6.0, 4 ~ 50 ℃ safety Fucoidan is extracted from seaweed, and has been used as a food for a long time, and stability has already been confirmed by animal experiments. Usage and application Nutritional supplements, health-oriented foods, pharmaceuticals, and basic raw material research samples, functional COSMRTIC product raw materials Display Kelp Extract (Fuco-Ⅰ), Seaweed Spore Leaf Extract (Advanced Fuco-Ⅱ, Intermediate Fuco-Ⅲ) Packing 500g, 1kg (500g / 2) HDPE Film / Bag Content analysis Item standard Test Methods Appearance Light gray powder, already slightly salty, no odor Visual and sensory tests moisture Less than 5% Atmospheric drying method Ash 26.3% or less
Dry painting protein 2.7 or less Lowry Act Total More than 80% Fucoidan 60.3%
Sulfuric acid group 27.9% (Dodgson algorithm) Uronic acid 8.9% Japanese raw materials include uronic acid in Fucoidan Sugar composition Rhamnose 0.7
Fueose 18.7
Xylose 0.3
Mannose 1.0
Galactose 16.5 GC method

In the present invention, kelp fucoidan is a hair loss prevention and hair growth promoting composition may be included in an amount of 0.01 to 10% by weight, preferably 0.1 _to 2% by weight based on the total weight.

• Sprout extracts (poly, safflower, pea sprouts) are used to activate the nutritional supply of scalp cells.

In the present invention, the "sprout" refers to the sprouts that are sown in a plant factory after germinating alpha waves, greens, and peas for three days, and harvested on the seventh day.

In the present invention, the origin of the sprout seed is not particularly limited, but preferably, the domestic sprout seed is used.

Sprout extract of the present invention may be included in the content of 0.01 to 10% by weight, preferably 0.1 _to 10% by weight based on the total weight of hair loss prevention and hair growth promoting composition.

In the future Hair Loss Prevention and Hair Growth Promoting Hair Product Compositions Comparative Examples (reference compositions) and examples are shown.

Cistanche tubulosa extract, niacin (called Niacin and include Nicotinamide or Nicotinic Acid), which is characteristically contained in the present invention, seaweed extract (Tashima and Wakame spore follicle fucoidan), sprout extract (polygon, safflower, pea sprout) or It was confirmed by the mixture of these that hair loss prevention and hair growth promoting effect is remarkable.

Representative product formulations were tested for the effect of the present invention by using hair tonic type products (topical application) and shampoos as examples, but the technique of the present invention is not limited to the two types of products exemplified.

Hair Tonic Product (Topical)

The hair tonic composition according to the invention preferably contains the following components:

1. Scalp Protector and Scalp Activator

In the present invention, pantothenyl alcohol and its derivatives, tocopherol and its derivatives, photosensitizers, vitamin H and the like can be used as substances for this purpose.

2. Scalp Refreshers and Scalp Sodium Suppressants

In the present invention, L-menthol and its derivatives, vanylylalkyl ethers, red pepper extract and the like can be used.

3. Moisturizing agent

In the present invention, hyaluronic acid and derivatives thereof, glycerin, urea, pyrrolidone carboxylate and derivatives thereof, polyols such as propylene glycol, nuylene glycol, 1,5-pentanediol and 1,2-hexanediol, and dipropylene glycol Condensed or polymerized polyhydric alcohols such as diglycerin and the like can be used.

4. Solubilizer

In the present invention, castor oil-derived surfactants such as polyoxyethylene (60) hardened castor oil (POE (60) Hydrogenated Caster Oil) and various fatty acid sorbates can be used.

5. Spices

Contains various fragrances developed for skin care.

6. Stabilizer

For the purpose of containment of metal ions, various chelate compounds such as edeto acid and salts thereof, phosphate compounds and benzoic acid and salts thereof may be used for preservation purposes.

7. pH adjuster

Organic acids such as citric acid and pyrrolidone carboxylic acid are used.

8. Solvent

Use a mixture of ethanol and pure water.

Raw Material / Composition Standard composition Example 1 Example 2 Example 3 Example 4 Example 5 pure Up to 100 Up to 100 Up to 100 Up to 100 Up to 100 Up to 100 ethanol 40 40 40 40 40 40 glycerin 0.3 0.3 0.3 0.3 0.3 0.3 Polyoxyethylene (60) Cured Castor Oil 0.5 0.5 0.5 0.5 0.5 0.5 Sorbitan oleate 0.3 0.3 0.3 0.3 0.3 0.3 Tocopheryl acetate 0.5 0.5 0.5 0.5 0.5 0.5 l-menthol 0.15 0.15 0.15 0.15 0.15 0.15 Breeding extract - 1.0 - - - 1.0 Niacin - 0.5 - - 0.5 Seaweed Extract (Tashima and Wakame Spore Leaf Fucoidan) - 1.0 - 1.0 Sprout Extract - 1.0 1.0 d-Panthenol 0.2 0.2 0.2 0.2 0.2 0.2 antiseptic Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount Citric acid pH5.5 ~ 6.5 pH5.5 ~ 6.5 pH5.5 ~ 6.5 pH5.5 ~ 6.5 pH5.5 ~ 6.5 pH5.5 ~ 6.5 Spices Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount

[Table 3] shows the product of the hair tonic form, the product of the present invention has the appearance of a transparent or semi-transparent suspension state, the liquidity of pH 4.5 ~ 7.7 but preferably at pH 5.5 ~ 6.5 of 25 ℃ Adjust to weak acidity. In some cases, color may be expressed by using a dye.

Products in the form of shampoos

The shampoo composition according to the present invention preferably contains the following components.

1. Cleaning agent

In the present invention, most anionic surfactants can be used, but mainly alkyl sulfates, carboxylates, and protein-based or amino acid-based surfactants are used.

They have alkyl radicals of C8-C22 or when ethylene oxide (EO) is added, the added mole number is 1-12, and is mainly used in the form of sodium salt, ammonium salt and triethanol salt. The blending amount is 4 to 30%, particularly preferably 8 to 25%, based on the actual amount (based on the active amount) as a single or combination product.

Auxiliary cleaners or mild detergents are cationic surfactants, which include betaines such as cocamidopropyl betaine and lauamidopropyl betaine, imidazoles such as coco ampocarboxyglycinate, and alkylamine oxides such as lauamine oxide. It can be used, and surfactants, such as a salt system, such as cocamidopropyl celtan, are generally used.

The length of these carbon chains is also C8-C22 and is blended 1.5 to 10% in an actual amount as a single or a combination, and particularly preferably 2 to 6% is used.

In particular, the anti-irritant effect and the conditioning effect appear in a product when the compounding ratio with anion detergent is adjusted to a 2: 1 to 3: 1 ratio.

2. Increased and bubble stabilizer

Generally, alkylamine oxides or alkanolamides are used, but among the alkanolamides of C8-C24, monoethanolamide or diethanolamide are used. Especially, preferably lauric acid diethanolamide and coca are used. Middiethanolamide, lauroyl diethanolamide, or cocamide monoethanolamide is mix | blended in the quantity of 1 to 7% as a single piece or a combination.

3. Polymer Conditioner

Polyquaternium-7, Polyquaternium-10, Polyquaternium-11, Polyquaternium-22 and Guahydroxypropyltrimonium chloride are available in the range of 0.1 to 1.5% as a single or combination, particularly preferably from 0.12 to It is compounded in 0.7% amount.

4. Moisturizer

Polyols such as 1,2-nucleic acid diol, glycerin, propylene glycol and hexylene glycol, sodium lactate and pyrrolidone carboxylate salt (PCA-Na) can be used as a single or a combination of 0.3 to 3.5%. Especially preferably, it mix | blends 0.5-2.0% content.

5. Emulsifiers or pearling agents

As the emulsifier, polyacrylate emulsions may be used as suspending agents, and glycol stearate is mainly used as a pearling agent, and the content is 0 to 3%.

6. Conditioner

An absolute amount of 0.1 to 3.0% is used as a single or a combination of alkyltrimethylammonium chloride, dialkyldimethylammonium chloride and trialkylmethylammonium chloride having C10-C22 carbon atoms.

7. Hair shine and sensation enhancer

Another lubricating agent and hair coating agent may be blended in an absolute amount of 0.1 to 4.5% as a single or a combination of dimethicone and amodimethicone, which are silicone compounds. The degree of polymerization of the dimethicone is expressed in viscosity up to 5,000 cps-Gum.

Fat alcohols are used to maintain the luster of hair and to give thixotropy in the product. Mainly 0.15 to 3.5% of cecyl alcohol, stearyl alcohol and behenyl alcohol can be used singly or in combination.

8. Other

Protein-based hair nutrients and animal and plant extracts that protect skin or hair can be mixed as needed.

The present invention is illustrated by the following examples. However, these examples should not be understood as limiting the present invention. The ratios described in these examples are based on the weight of the resulting composition.

Raw Material / Composition Standard composition Example 1 Example 2 Example 3 Example 4 Example 5 pure Up to 100 Up to 100 Up to 100 Up to 100 Up to 100 Up to 100 Sodium laureth sulfate 15.0 15.0 15.0 15.0 15.0 15.0 Comamidopropyl betaine 3.0 3.0 3.0 3.0 3.0 3.0 Coca-Am Dihey 3.0 3.0 3.0 3.0 3.0 3.0 Polyquaternium-10 0.3 0.3 0.3 0.3 0.3 0.3 Cation Hydrolyzed Protein 0.2 0.2 0.2 0.2 0.2 0.2 Propylene glycol 1.0 1.0 1.0 1.0 1.0 1.0 EDTA-2Na 0.05 0.05 0.05 0.05 0.05 0.05 Breeding extract - 1.0 - - - 1.0 Niacin - 0.5 - - 0.5 Seaweed Extract (Tashima and Wakame Spore Leaf Fucoidan) - 1.0 - 1.0 Sprout Extract - 1.0 1.0 antiseptic Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount Citric acid Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount Salt Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount Spices Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount Suitable amount

[Table 4] shows the product configuration of the shampoo form, the shampoo according to the technology of the present invention is a viscous transparent liquid or viscous pearlescent translucent liquid or viscous suspension or viscous pearlescent opacity Can be expressed as a liquid.

Although the liquidity of a product is obtained by pH 4.5-7.5, Preferably it adjusts to pH 5.5-7.0 at 25 degreeC.

The viscosity of the product does not affect the final potency, but is preferably adjusted to 3,000-10,000 mPa at 25 ° C.

Benefits of Breeding Extracts

The effects of wool, hair growth, and hair loss prevention of Cistanche tubulosa Extract were as follows using the skin on the back of C3H mice.

1. Method

An 8-week-old male C3H mouse was used to shave his back with an electric hair clipper and razor. After 2 days, 70% ethanol (control), 1% caca extract, and 2% of each sample (0.2 mL per animal) were applied to the dorsal skin once a day, 5 days a week, and 28 days.

On the 14th day after the start of the application, the skin of the back area was photographed with a camera, and the area of the hair-cutting part and the hair regrowth was measured by NIH image. The hair growth promoting effect was evaluated based on the hair growth rate (%) calculated by the following equation. On the 28th day after the start of application (test final day), hair on the back was collected and the length of the hair was measured.

* Hair growth promoting effect

[Hair growth rate (%)] = [area of hair growth] / [area of hair cutting] × 100

2. Results

The 1% and 2% groups for the sarcoma extract showed an increase in hair growth rate compared to the control group by application for 2 weeks.

Figure 2 shows the effect of increasing the hair growth rate (mean ± standard deviation, n = 4-5, *: p <0.05) in C3H mice of the Canca extract.

As shown in Figure 2, significant effects were recognized in the 2% application group for the sarcoma extract, which was also apparent in the photographed image.

In addition, as shown in Fig. 3, as a result of measuring the hair length on the last test day (28 days after the start of application), significant promoting action was recognized in the 2% application group for the extract for breeding.

As a result, the extract for sarcoma was recognized to induce an early growth phase, and the effect of wool, hair growth, and hair loss was confirmed.

In the example  Identified wool, hair growth, and hair loss prevention effect

In the developmental study of the present invention, breeding (Cistanche tubulosa) extract, niacin (referred to as Niacin and contains Nicotinamide or Nicotinic Acid), seaweed extract (Tashima and Wakame spore leaf fucoidan), sprout extract (poly, safflower, pea sprout) The effects of hair and hair loss prevention and adverse reactions of hair tonic type products (topical dispersant) and shampoo type products as main ingredients were confirmed, and the potential as a therapeutic or amelioration agent for new hair loss was confirmed.

A. Wool and Hair Loss Prevention Effect

In order to confirm the efficacy of the technology provided by the present invention in the process of evaluating the effect of the randomization, double blind (double blind), placebo-controlled (placebo-controlled) study was conducted an effect test.

1. Test subject

Patients with male alopecia from stage II to V by the Hamilton-Norwood classification who visited the hospital dermatology or with female alopecia with the Ludwig classification I or II, were aged between 19 and 55 years of age.

Patients with head and systemic diseases that could affect the results of the study were excluded and were treated with calpurium chloride, minoxidil, hair growth agents, corticosteroids, and UV treatment for alopecia treatment for at least 4 weeks prior to the start of the study. And patients who did not use other drugs such as immunosuppressants. Patients who participated in this study were fully informed about the clinical study and given informed consent.

2. Test Product

Test Product 1) The hair tonic type product (local coating agent),

Light yellow or light brown transparent liquid, the main components of which are Cistanche tubulosa extract, niacin (called Niacin and contain Nicotinamide or Nicotinic Acid), seaweed extract (Kashima and Wakame spore leaf fucoidan), sprout extract (poly, safflower, Pea sprouts) or a mixture thereof and water and ethanol were used as a solvent.

Test Product 2) The product in the form of shampoo,

Light yellow or light brown transparent and viscous liquid, the main ingredients of which are also Cistanche tubulosa extracts, niacin (called Niacin and contain Nicotinamide or Nicotinic Acid), seaweed extracts (soda and seaweed spore leaf fucoidan), sprout extract (Colorful, safflower, pea sprouts) or mixtures thereof, and water was used as a mixed medium together with a surfactant and a hair conditioning agent.

Except for the main components of the test product, a solvent having the same appearance and aroma was used as the reference composition (placebo).

The test product test and the reference composition product should be placed in the same shape container and used by volunteers in the test group and the control group, respectively.

Test Product 1) Hair tonic product (local application) was applied to the hair loss site twice a day for morning and evening for a total of 16 weeks.

Test Product 2) The shampoo type product is to wash the hair once every morning for a total of 16 weeks. Unlike the general shampoo, the product is foamed and massaged from the scalp without rinsing for more than 3 minutes.

3. Validation method

1) Hair loss at tricycle

Using the equipment provided to all volunteers, five times of every other day from -11 to -1 before each visit were collected on the 0th and 16th weeks of treatment to reduce the amount of hair loss at tril and the rate of hair loss at trib divided by baseline. Measured.

2) Evaluation by Phototrichogram

On the first visit, a black spot was tattooed on the hair loss site of the volunteer (the median part of the hair), and then a round was cut around the spot.

Three days later, the hair removal site was photographed with a digital camera to obtain a phototrigram image. In order to minimize light scattering, a drop of water was dropped on the hair loss site, and the camera was brought into close contact with the scalp, and the newly grown hair was photographed while lying horizontally.

The magnification and the distance between the lens and the scalp were always kept constant. At the 16th week of treatment, hair removal was performed in the same manner as above, and 3 days later, a phototriogram was taken.

After that, the phototricogram images were analyzed to obtain the following biological variables.

Total hair count (number / cm ² ) evaluated at the first visit and at 16 weeks of treatment: Number of hairs in 1 cm ² of the depilation plaque

Anagen hair count (number / cm ² ) evaluated at first visit and at 16 weeks of treatment: Number of growing hairs within 1 cm ² of the ablation nevus

-Mean hair diameter μm evaluated at the first visit and at 16 weeks of treatment: Hair thickness was defined as the average size of the hairs within 1 cm ² of the ablation plaque.

That is, after measuring the thickness of each hair, the hair having a thickness of 40 µm or more was regarded as hair growth, and the average of these hairs was defined as the average hair thickness at each visit.

3) Improvement of clinical symptoms evaluated by the present invention

Itching, scalp seizures, dandruff, and erythema at the start of treatment and at 8 and 16 weeks of treatment, according to the subject's subjective judgment, the degree of symptom change was assessed as 'exacerbation', 'no change', or 'improvement'. I did it.

4) Comparison of Participant Satisfaction with Test Participant

The formulation satisfaction of the topical application example 5 and the shampoo type product example 5 and the respective standard formulations was evaluated at the start of treatment and at the 8 and 16 weeks, The subject himself evaluateds it into five stages: no change, slightly effective, effective, and surely effective.

Of the five stages, 'slightly effective', 'effectively' and 'surely effective' are classified as 'effective', and as a result, the total number of subjects at each stage is classified into three stages. Confirmed and compared the two groups.

Comparison of the effects of 'local coating agent Examples 1-4' and 'local coating agent composition' and 'Shampoo-type product Examples 1-4' and 'shampoo composition product standard composition' containing each active ingredient are relatively few. The participants were evaluated as abbreviated for 8 weeks.

4. Statistical Analysis

In each group, the 0 and 16 week values of hair biological variables were compared using paired t-tests.

After treatment in each group, the change value of the variable (16-week value-0-week value) was obtained, and the change value of each variable was compared between groups by performing a t-test or chi-square test. P-value less than 0.05 was considered statistically significant.

B. Results

1. Subject Information

[Table 5] shows the evaluator characteristics (Characteristic of volunteers) of the hair tonic form (local coating agent) product, [Table 6] shows the evaluator characteristics of the shampoo form product.

As shown in [Table 5] and [Table 6], a total of 100 subjects (male: 74, female: 26) were selected for both types of test products, but 27 and 16, respectively, were dropped out for personal reasons. And 84 patients completed the study.

As a background factor, no significant differences were found between the test and control groups when comparing sex, age, systolic, diastolic blood pressure, pulse rate, pre-treatment of dandruff, itching, sebum and erythema.

Number of people age Topical Coating Example 5 Use Group 43 32.8 ± 10.9 Topical Use Base Composition 41 33.5 ± 5.5

Number of people age Shampoo Example 5 Use Group 33 38.8 ± 8.9 Shampoo Standard Composition 40 41.7 ± 8.9

2. Validity Evaluation

1) Decreased hair loss in tricycle

As shown in Figures 4 and 5, both types of test products were statistically significantly reduced in the number of hair loss when triturated in both the test and control group after 16 weeks of testing, respectively, showed a greater decrease in each test group.

However, there was no significant difference between test and control group.

2) Evaluation by Phototrigram

As shown in FIG. 6 (P = 0.0223) and FIG. 7 (P = 0.0362), after 16 weeks of testing in both types of test products, the total number of hairs in the test group was statistically significantly increased. It was a significant value. There was no significant increase in the number of growing hairs and the thickness of the hairs. In the control group, hair thickness increased significantly, but there was no significant difference between the groups. There was a significant increase in the total hair count and growth hair count.

In addition, FIG. 8 shows the average number of hair growth after 16 weeks of topical application (p = 0,0193), and FIG. 9 shows the average number of hairs increased after 16 weeks of shampoo form product (P = 0.0305). 10 shows an average increase in hair thickness after 16 weeks of shampoo form product, and FIG. 11 shows an average average number of hair growth after using 16 weeks of shampoo form product (p = 0,0188).

3) Evaluation of the improvement of clinical symptoms evaluated by the researcher

None of the subjects showed improvement in itch, scalp sebum, dandruff, and erythema in all of the two types of test products. The number decreased.

[Table 7] shows the results of the inventors and the like for the improvement effect in the topical coating efficacy test, [Table 8] shows the results of the inventors and the like for the improvement effect in the shampoo efficacy test.

As shown in Tables 7 and 8, there was no statistically significant difference in the comparison between the groups.

Topical Coating Example 5 Use Group Local coating standard composition use group p-value  (N = 43), N (%) (N = 41), N (%) 8 weeks Worse 2 (6.1) 1 (2.5) No change 31 (93.9) 39 (97.5) 0.4861 Dandruff Dandruff ) Improved 0 (0.0) 0 (0.0) 16 weeks Worse 2 (6.1) 1 (2.5) No change 31 (93.9) 39 (97.5) 0.3227 Improved 0 (0.0) 0 (0.0) 8 weeks Worse 8 (24.2) 4 (10.0) No change 25 (75.8) 35 (87.5) 0.1864 itch( Itching ) Improved 0 (0.0) 1 (2.5) 16 weeks Worse 4 (12.1) 1 (2.5) No change 29 (87.9) 39 (97.5) 0.1686 Improved 0 (0.0) 0 (0.0) 8 weeks Worse 7 (21.2) 12 (30.0) No change 26 (78.8) 28 (70.0) 0.3944 Sebum amount ( Sebum ) Improved 9 (0.0) 0 (0.0) 16 weeks Worse 5 (15.2) 6 (15.0) No change 28 (84.9) 34 (85.0) Improved 0 (0.0) 0 (0.0) 8 weeks Worse 0 (0.0) 0 (0.0) No change 33 (100.0) 40 (100.0) - eczema( Erythema ) Improved 0 (0.0) 0 (0.0) 16 weeks Worse 0 (0.0) 0 (0.0) No change 33 (100.0) 40 (100.0) - Improved 0 (0.0) 0 (0.0)

Shampoo Example 5 Use Group
(N = 33), N (%) Shampoo Standard Composition Use Group (N = 40), N (%) p-value



Dandruff Dandruff ) 8 Weeks
Worse
No change
Improved
16 Weeks
Worse
No change
Improved
2 (6.1)
31 (93.9)
0 (0.0)

2 (6.1)
31 (93.9)
0 (0.0)
1 (2.5)
39 (97.5)
0 (0.0)

1 (2.5)
39 (97.5)
0 (0.0)

0.5861



0.5861


itch( Itching ) 8 Weeks
Worse
No change
Improved
16 Weeks
Worse
No change
Improved
8 (24.2)
25 (75.8)
0 (0.0)

4 (12.1)
29 (87.9)
0 (0.0)
4 (10.0)
35 (87.5)
1 (2.5)

1 (2.5)
39 (97.5)
0 (0.0)

0.1864



0.1686


Sebum amount ( Sebum ) 8 Weeks
Worse
No change
Improved
16 Weeks
Worse
No change
Improved
7 (21.2)
26 (78.8)
9 (0.0)

5 (15.2)
28 (84.9)
0 (0.0)
12 (30.0)
28 (70.0)
0 (0.0)

6 (15.0)
34 (85.0)
0 (0.0)

0.3944



1.0000


eczema( Erythema ) 8 Weeks
Worse
No change
Improved
16 Weeks
Worse
No change
Improved
0 (0.0)
33 (100.0)
0 (0.0)

0 (0.0)
33 (100.0)
0 (0.0)
0 (0.0)
40 (100.0)
0 (0.0)

0 (0.0)
40 (100.0)
0 (0.0)

-



-

4) Comparative evaluation of the participant's satisfaction with the test subject (subject)

Comparing all the two types of test products with the reference composition product, the test results of the groups of test participants (test subjects) were as shown in Tables 9 and 10 below.

[Table 9] shows the results of evaluation of the improvement effect on the participants 'own hair condition in the topical application test, [Table 10] shows the results of the evaluation of the improvement effect on the participants' own hair condition in the shampoo efficacy test.

Each of the 'local application examples 1 to 4 use group' and 'the local application standard use group', 'the shampoo type product examples 1 to 4 use group' and 'the shampoo type product reference composition use group' containing each active ingredient The results of the short-term evaluations for eight weeks also showed that a certain amount of wool and hair loss prevention effects were realized.

Example 1 Use Group Example 2 Use Group Example 3 Use Group Example 4 Use Group Base composition use group (N = 10),
N (%) (N = 12),
N (%) (N = 12),
N (%) (N = 13),
N (%) (N = 11),
N (%) 8 weeks Worse 0 (0.0) 1 (8.3) 0 (0.0) 0 (0.0) 1 (2.4) No change 7 (70.0) 8 (66.7) 8 (66.7) 10 (76.9) 8 (72.7) Improved 3 (30.0) 3 (25.0) 4 (33.3) 3 (23.1) 2 (18.1)

Example 1
Use group Example 2
Use group Example 3
Use group Example 4
Use group Standard composition
Use group (N = 13),
N (%) (N = 11),
N (%) (N = 13),
N (%) (N = 11),
N (%) (N = 10),
N (%) 8 weeks Worse 0 (0.0) 0 (0.0) 1 (7.7) 1 (9.1) 0 (0.0) No change 10 (76.9) 9 (81.8) 9 (68.2) 8 (72.7) 9 (90.0) Improved 3 (23.1) 2 (18.2) 3 (23.1) 2 (81.8) 1 (10.0)

In addition, [Table 11] shows the results of the evaluation of the improvement effect on the subject's own hair condition in the topical application test, and [Table 12] shows the results of the evaluation of the improvement effect on the participants' own hair condition in the shampoo efficacy test. It is shown.

As shown in the following [Table 11] and [Table 12], the comparison between the 'local application agent 5 use group' and 'local coating agent standard composition use group', 'Shampoo form product example 5 use group' and 'shampoo Overall, the proportion of subjects who answered 'effective' in the two product groups in the evaluation of the 'formal product base composition use group' was higher than the placebo group.

In addition, there was no statistically significant difference between the groups.

Topical Coating Example 5 Use Group Topical Use Base Composition p-value  (N = 43), N (%) (N = 41), N (%) 8 weeks Worse 1 (2.3) 1 (2.4) No change 21 (48.8) 29 (70.7) 0.4373 Improved 21 (48.8) 11 (26.8) 16 weeks Worse 1 (2.3) 2 (48.8) No change 15 (34.9) 28 (68.6) 0.8214 Improved 27 (62.8) 11 (26.8)

CTP / PDG (N = 33) Control (N = 40) p-value N (%) N (%) 8 weeks Worse 2 (6.1) 3 (7.5) No change 20 (60.6) 27 (67.5) 0.4572 Improved 11 (33.3) 10 (25.0) 16 weeks Worse 3 (9.1) 2 (5.0) No change 20 (60.6) 27 (67.5) 0.9219 Improved 10 (30.3) 11 (27.5)

Claims (8)

It comprises 0.01 wt% to 10 wt% of Cistanche tubulosa extract, niacin containing nicotinamide and nicotinic acid, kelp and seaweed spores, and poly, safflower and pea sprout extracts, based on 100 wt% of the total constituents. Hair loss prevention and hair growth promoting hair composition.
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