JP2021195323A - External composition - Google Patents

Abstract

To provide an external composition effective for improving dermatitis in the ears and around the ears.SOLUTION: The external composition comprises (A) ufenamate, (B) glycyrrhetinic acid, a derivative of glycyrrhetinic acid, and/or salts thereof, and (C) diphenhydramine and/or a salt thereof. The external composition is effective in improving dermatitis in the ears and around the ears.SELECTED DRAWING: None

Description

The present invention relates to an external composition used for improving dermatitis of the ear and around the ear.

The skin of the ears and around the ears has unique characteristics that are different from the skin of other parts. Specific structural features include a thin point compared to the skin of other parts, a high density of sebaceous glands, and the like. In addition, specific environmental features include the fact that the complex structure makes it easy for cleaning and hair styling products to accumulate, making them susceptible to chemical stimuli, and the fact that they are susceptible to physical stimuli from eyeglasses and masks. Be done.

The ears and the skin around the ears are prone to inflammation due to the superposition of environmental features on these structural features. Examples of symptoms of inflammation include redness, rashes, roughness, cuts, scales, itching and the like.

The above symptoms are seen, for example, in seborrheic dermatitis. Seborrheic dermatitis occurs in a site with a high density of sebaceous glands, for example, in the posterior part of the auricle, and is accompanied by cracks and scales in the site (Non-Patent Document 1). Seborrheic dermatitis is also known to occur in areas with high friction, and may be accompanied by itching, redness, dryness and the like. External use of corticosteroids and antifungal agents is selected for the treatment of seborrheic dermatitis (Non-Patent Document 1).

In addition, the above-mentioned symptoms may be caused by contact dermatitis caused by chemical or physical irritation. For the treatment of contact dermatitis, external application of antipruritics and corticosteroids, and avoidance of causes that cause contact irritation are selected (Non-Patent Document 2).

In addition, the above symptoms may be triggered by excessive dryness due to the thin skin. External use of moisturizers is selected for the treatment of dry skin.

MSD Manual Professional Edition / 14. Skin Diseases / Dermatitis / Seborrheic Dermatitis MSD Manual Professional Edition / 14. Skin Diseases / Dermatitis / Contact Dermatitis

Generally, the above-mentioned treatments are selected for seborrheic dermatitis, contact dermatitis, and dryness, but these treatments are suitable for skin in other parts of the body. , The skin around the ears and the ears is not suitable in view of the characteristics peculiar to the site. For example, the use of steroids causes the skin to atrophy and thin, so it is not suitable for the ear and the area around the ear where the skin is thin, and its effect is not sufficient. In addition, the use of a moisturizer is also not suitable for the ear and the area around the ear where the layer that retains the moisturizing component is thin.

An object of the present invention is to provide an external composition effective for improving dermatitis of the ear and around the ear.

As a result of diligent studies, the present inventors have found that an external composition containing ufenamate, diphenhydramines, and glycyrrhetinic acid has an excellent effect in improving dermatitis in the ear and around the ear. The present invention has been completed by further studies based on this finding.

That is, the present invention provides the inventions of the following aspects.
Item 1. It contains (A) ufenamate, (B) glycyrrhetinic acid, a derivative of glycyrrhetinic acid, and / or a salt thereof, and (C) diphenhydramine and / or a salt thereof, and is used for improving dermatitis in the ear and around the ear. External composition.
Item 2. (D) The external composition according to Item 1, further containing tocopherol and / or a derivative thereof.
Item 3. (E) The external composition according to Item 1 or 2, further containing an antibacterial or bactericidal agent.
Item 4. Item 6. The external composition according to any one of Items 1 to 3, which is used for dry dermatitis, seborrheic dermatitis and / or contact dermatitis.
Item 5. Item 6. The external composition according to any one of Items 1 to 4, which is used for auricle.
Item 6. Item 6. The external composition according to any one of Items 1 to 5, which is used for redness, itchiness, and / or cracks.

INDUSTRIAL APPLICABILITY According to the present invention, an external composition effective for improving dermatitis of the ear and around the ear is provided.

The external composition of the present invention comprises (A) ufenamate (hereinafter, also referred to as "(A) component"), (B) glycyrrhetinic acid, a derivative of glycyrrhetinic acid, and / or a salt thereof (hereinafter, "" (B) component "or" glycyrrhetinic acid ") and (C) diphenhydramine and / or a salt thereof (hereinafter, also referred to as" (C) component "or" diphenhydramines ") are contained in the ear. And it is characterized by being used to improve dermatitis around the ears. Further, the external composition of the present invention further comprises (D) tocopherol and / or a derivative thereof (hereinafter, also referred to as "(D) component" or "tocopherols") and / or (E) quaternary ammonium. It may contain a system antibacterial agent (hereinafter, also referred to as “component (E)”). Hereinafter, the external composition of the present invention will be described in detail.

(A) Ufenamart The external composition of the present invention contains Ufenamart as a component (A). Ufenamate, also called butyl flufenamic acid, is a known drug as a fat-soluble non-steroidal anti-inflammatory drug. The component (A) has almost no effect of improving dermatitis around the ears and ears by itself, but the external composition of the present invention can exert an excellent effect of improving dermatitis around the ears and ears. Is.

In the external composition of the present invention, the content of the component (A) is appropriately set according to the medicinal effect to be exerted, and examples thereof include 1 to 20% by weight. From the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears, the content of the component (A) in the external composition of the present invention is preferably 3 to 6% by weight, more preferably 4.5 to 5%. .5% by weight is mentioned.

(B) Glycyrrhetinic acid The external composition of the present invention contains glycyrrhetinic acid, a derivative thereof, and / or a salt thereof as the component (B).

Glycyrrhetinic acid is a known drug known to have an anti-inflammatory action, an antiallergic action and the like. The component (B) has almost no effect of improving dermatitis around the ears and ears by itself, but the external composition of the present invention can exert an excellent effect of improving dermatitis around the ears and ears. Is.

The derivative of glycyrrhetinic acid is not particularly limited as long as it is pharmaceutically acceptable, and specific examples thereof include pyridoxine glycyrrhetinate, stearyl glycyrrhetinate, glyceryl glycyrrhetinate, and monoglucuronide glycyrrhetinate. These derivatives of glycyrrhetinic acid may be used alone or in combination of two or more.

The salt of glycyrrhetinic acid and / or a derivative thereof is not particularly limited as long as it is pharmaceutically acceptable, and specific examples thereof include alkali metal salts such as sodium salt and potassium salt; ammonium salts and the like. These salts may be used alone or in combination of two or more.

The external composition of the present invention may be used by selecting one from glycyrrhetinic acid, a salt of glycyrrhetinic acid, a derivative of glycyrrhetinic acid, and a salt of a derivative of glycyrrhetinic acid as the component (B). You may use a combination of seeds or more.

Among these components (B), glycyrrhetinic acid is preferably mentioned from the viewpoint of further improving the effect of improving dermatitis in the ear and around the ear.

In the external composition of the present invention, the content of the component (B) is not particularly limited and may be appropriately set according to the medicinal effect to be imparted. For example, the total amount of the component (B) is 0. 05 to 5% by weight is mentioned, and from the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears, preferably 0.1 to 1% by weight, more preferably 0.2 to 0.5% by weight. Can be mentioned.

In the external composition of the present invention, the ratio of the component (B) to the component (A) is determined according to the contents of the component (A) and the component (B), and is, for example, 1 part by weight of the component (A). The total amount of the component (B) is 0.01 to 0.9 parts by weight. From the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears, the total amount of the component (B) per 1 part by weight of the component (A) is preferably 0.03 to 0.5 parts by weight, more preferably. Examples include 0.05 to 0.1 parts by weight.

(C) Diphenhydramines The external composition of the present invention contains diphenhydramine and / or a salt thereof as the component (C). Diphenhydramine is a known drug known to have antihistamine activity. The component (C) has almost no effect of improving dermatitis around the ears and ears by itself, but the external composition of the present invention can exert an excellent effect of improving dermatitis around the ears and ears. Is.

The salt of diphenhydramine is not particularly limited as long as it is pharmaceutically acceptable, but specifically, hydrochloride, citrate, succinate, tartrate, fumarate, maleate, salicylate. , Diphenyldisulfonate, tannate, lauryl sulfate, sulfate and other acid addition salts. These salts may be used alone or in combination of two or more.

The external composition of the present invention may be used by selecting one of diphenhydramine and a salt thereof as the component (C), or may be used in combination of two or more.

Among these components (C), diphenhydramine is preferably mentioned from the viewpoint of further improving the effect of improving dermatitis in the ear and around the ear.

In the external composition of the present invention, the content of the component (C) is not particularly limited, and for example, the total amount of the component (C) may be 0.1 to 5% by weight. From the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears, the content of the component (C) in the external composition of the present invention is preferably 0.3 to 2% by weight, more preferably 0.5. ~ 1.5% by weight can be mentioned.

In the external composition of the present invention, the ratio of the component (C) to the component (A) is determined according to the contents of the component (A) and the component (C), and is, for example, 1 part by weight of the component (A). The total amount of the component (C) is 0.01 to 1.2 parts by weight. From the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears, the total amount of the component (C) per 1 part by weight of the component (A) is preferably 0.05 to 0.8 parts by weight, more preferably. 0.1 to 0.5 parts by weight may be mentioned.

In the external composition of the present invention, the ratio of the component (C) to the component (B) is determined according to the contents of the component (B) and the component (C). For example, the total amount of the component (B) is 1. The total amount of the component (C) is 0.1 to 12 parts by weight per part by weight. From the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears, the total amount of the component (C) is preferably 0.5 to 8 parts by weight, more preferably 0.5 parts by weight, per 1 part by weight of the total amount of the component (B). Examples include 1 to 5 parts by weight.

(D) Tocopherols The external composition of the present invention can further contain tocopherol and / or a derivative thereof as the component (D) from the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears.

Tocopherol is a known compound known as Vitamin E. The tocopherol may be any of d-form, l-form, and dl-form, but dl-form is preferable. Further, the tocopherol may be any of α-form, β-form, γ-form, and δ-form, but α-form is preferable.

The derivative of tocopherol is not particularly limited as long as it is pharmaceutically acceptable, and examples thereof include an ester form with a carboxylic acid such as acetic acid, nicotinic acid, and succinic acid, and a diester form with phosphoric acid. Among these tocopherol derivatives, an ester form with a carboxylic acid is preferable, and tocopherol acetate is more preferable, from the viewpoint of further improving the effect of improving dermatitis in the ear and around the ear.

The derivative of tocopherol may be d-form, l-form, or dl-form, but dl-form is preferable. Further, the derivative of tocopherol may be any of α-form, β-form, γ-form, and δ-form, but α-form is preferable.

In the external composition of the present invention, as the component (D), one of tocopherol and its derivative may be selected and used alone, or two or more thereof may be used in combination. Among the components (D), from the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears, a derivative of tocopherol, more preferably an ester of tocopherol with a carboxylic acid, still more preferably tocopherol acetate, particularly. Preferred examples thereof include d-α-tocopherol acetate, l-α-tocopherol acetate, and dl-α-tocopherol acetate.

The content of the component (D) when the external composition of the present invention contains the component (D) is not particularly limited, but from the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears (D). ) The total amount of the components is, for example, 0.05 to 2% by weight, preferably 0.1 to 1.3% by weight, and more preferably 0.3 to 0.8% by weight.

Further, when the external composition of the present invention contains the component (D), the ratio of the component (D) to the component (A) is determined based on the range of the content of each component, but the ear and the ear circumference. From the viewpoint of further improving the effect of improving dermatitis, the total amount of the component (D) is 0.01 to 1 part by weight, preferably 0.03 to 0.5 part by weight, per 1 part by weight of the component (A). More preferably, 0.05 to 0.3 parts by weight is mentioned.

(E) Antibacterial or bactericidal agent The external composition of the present invention may further contain an antibacterial or bactericidal agent as the component (E) from the viewpoint of further improving the effect of improving dermatitis around the ears and ears. The external composition of the present invention preferably contains the component (E) together with the component (D) from the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears.

The antibacterial or bactericidal agent is not particularly limited as long as it is pharmaceutically or cosmetically acceptable. Examples thereof include quaternary ammonium antibacterial agents, isopropylmethylphenol, hinokitiol, chlorhexidine hydrochloride, chlorhexidine gluconate, triclosan, lysozyme chloride, sulfadine and the like. Specific examples of the quaternary ammonium antibacterial agent include cetylpyridinium chloride, benzethonium chloride, benzalkonium chloride, decalinium chloride, alkyldimethylammonium chloride, alkyltrimethylammonium chloride, methylbenzethonium chloride, and lauroylcolaminoformylmethyl chloride. Examples include pyridinium.

These antibacterial or bactericidal agents may be used alone or in combination of two or more.

Among these antibacterial or bactericidal agents, quaternary ammonium antibacterial agents are preferably mentioned, and benzethonium chloride and benza chloride are more preferable, from the viewpoint of further improving the effect of improving dermatitis around the ears and ears. Examples thereof include luconium and cetylpyridinium chloride, and more preferably benzethonium chloride.

When the external composition of the present invention contains the component (E), the content of the component (E) may be appropriately set according to the type of antibacterial or bactericidal agent used, and is, for example, 0.01 to. 1% by weight is mentioned. From the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears, the content of the component (B) is preferably 0.03 to 0.5% by weight, more preferably 0.05 to 0.3% by weight. %.

When the external composition of the present invention contains the component (E), the ratio of the component (A) to the component (E) is determined according to the contents of both of these components described above, and is determined by, for example, (A). Examples of the component (E) are 0.001 to 0.5 parts by weight, preferably 0.005 to 0.1 parts by weight, and more preferably 0.01 to 0.05 parts by weight per 1 part by weight of the component.

Other Ingredients The external composition of the present invention may contain other pharmacological components in addition to the above-mentioned components, if necessary. Examples of such pharmacological components include antihistamines (chlorpheniramine maleate, etc.), local anesthetics (lidocaine, dibucaine, procaine, tetracaine, bupivacaine, mepivacaine, chloroprocine, propparacaine, meprilcaine or salts thereof), and scents. Acid alkyl esters (eg ethyl aminobenzoate, diethylaminoethyl parabutylaminobenzoate), orthokine, oxesazein, oxypolyentoxydecane, funnel extract, percaminpase, tesitdecitin, etc.), anti-inflammatory agents (alantin, salicylic acid, glycol salicylate, salicylic acid, etc.) Methyl, indomethacin, fervinac, diclofenac sodium, loxoprofen sodium, etc.), antipruritic agents (crotamiton, thiantoll, etc.), skin protective agents (corodion, castor oil, etc.), blood circulation promoting components (nonyl acid vanillylamide, nicotinic acid benzyl ester, capsaicin, pepper) Extracts, etc.), refreshing agents (menthol, camphor, etc.), vitamins (vitamins A, B, C, D, etc.), mucopolysaccharides (sodium chondroitin sulfate, hyaluronic acid, etc.) and the like.

In addition to the above-mentioned components, other bases and additives usually used for external skin preparations and the like may be contained, if necessary. Such base materials and additives are not particularly limited as long as they are pharmaceutically acceptable, but for example, water, lower alcohols (for example, isopropanol), polyhydric alcohols (glycerin, propylene glycol, dipropylene glycol). , 1,3-butylene glycol, etc.); oils (olive oil, saflower oil, soybean oil, camellia oil, corn oil, rapeseed oil, sunflower oil, cottonseed oil, peanut oil, lard, squalane, fish oil, etc.) , Mineral oil (liquid paraffin, paraffin, gelled hydrocarbon, vaseline, etc.), waxes / waxes (mitsurou, carnauba wax, candelilla wax, selecin, rice wax, microcrystallin wax, etc.), ester oil (isopropyl myristate, etc.) Isopropyl adipate, diethyl sebacate, isopropyl sebacate, isopropyl palmitate, cetyl palmitate, ethyl oleate, etc.), fatty acid alkyl esters, fatty acids (stearic acid, oleic acid, palmitic acid, behenic acid, linoleic acid, lanolin, etc.) , Fatty acid esters (cetyl palmitate, isopropyl palmitate, ethyl linoleate, etc.), higher alcohols (stearyl alcohol, cetanol, behenyl alcohol, myristyl alcohol, oleyl alcohol, hexadecyl alcohol, lanolin alcohol, etc.), cholesterol, tri2-ethylhexane Oily bases such as glyceryl acid, cetyl 2-ethylhexanoate, silicone oil (dimethylpolysiloxane, cyclic silicone, etc.); POE (10-50 mol) phytosterol ether, POE (10-50 mol) dihydrocholesterol ether, POE ( 10 to 50 mol) 2-octyldodecyl ether, POE (10 to 50 mol) decyltetradecyl ether, POE (10 to 50 mol) oleyl ether, POE (2 to 50 mol) cetyl ether (set macrogol 1000, etc.), POE (5-50 mol) behenyl ether, POE (5-30 mol) polyoxypropylene (5-30 mol) 2-decyltetradecyl ether, POE (10-50 mol) polyoxypropylene (2-30 mol) cetyl Polyoxyethylene alkyl ethers such as ethers, their phosphates and phosphates (POE cetyl ether sodium phosphate, etc.), POE (20-60 mol) sorbitan monoolate, POE (10-60 mol) sorbitan monoisosteer Rate, POE (10-80 mol) glyceryl monoisostearate, POE (10-30 mol) glyceryl monostearate, POE (20-100 mol) polyoxypropylene-modified silicone, POE-alkyl-modified silicone, polyethylene monolaurate Glycol, polyethylene glycol monopalmitate, polyethylene glycol monostearate, polyethylene glycol dilaurate, polyethylene glycol dipalmitate, polyethylene glycol distearate, polyethylene glycol dioleate, polyethylene glycol dilysinoleate, polyoxyethylene hydrogenated castor oil (5- 100), Polysolvate (20-85), glycerin fatty acid ester (glycerin monostearate, etc.), hydrogenated soybean phospholipid, hydrogenated lanolin alcohol, and other surfactants; Hakka oil, etc.), preservatives (methylparaben, propylparaben, benzoic acid, sodium benzoate, sorbic acid, etc.), flavoring agents (citral, 1,8-sionel, citronellal, farnesol, etc.), colorants (tar pigment (brown) 201, blue 201, yellow 4, yellow 403, etc.), cocoa pigment, chlorophyll, aluminum oxide, etc.), viscous agent (carboxyvinyl polymer, hypromellose, polyvinylpyrrolidone, sodium alginate, ethyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, etc.) Sodium, xanthan gum, carrageenan, etc.), pH adjuster (phosphate, hydrochloric acid, citric acid, sodium citrate, succinic acid, tartrate acid, sodium hydroxide, potassium hydroxide, triethanolamine, triisopropanolamine, etc.), wetting agent (wetting agent) dl-Pyrrolidone sodium carboxylate solution, D-sorbitol solution, macrogol, etc.), stabilizers (dibutylhydroxytoluene, butylhydroxyanisole, sodium edetate, sodium metaphosphate, L-arginine, L-aspartic acid, DL-alanine , Glycin, sodium erythorbate, propyl gallate, sodium sulfite, sulfur dioxide, chlorogenic acid, catechin, rosemary extract, etc.), antioxidants, UV absorbers, chelating agents, adhesives, buffers, solubilizers, Examples thereof include additives such as solubilizers and preservatives.

Properties, formulation form, etc. The properties of the external composition of the present invention are not particularly limited, and examples thereof include an aqueous liquid composition, an aqueous gel composition, an oil gel composition, and an emulsified composition. Among these, an emulsified composition is preferably mentioned from the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears. The emulsified state of the emulsified composition may be either an oil-in-water type or a water-in-oil type, but the oil-in-water type is preferable from the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears. Can be mentioned.

The pharmaceutical form of the external composition of the present invention is not particularly limited, and examples thereof include lotions, emulsions, ointments, and creams. Among these, emulsions and creams are preferable from the viewpoint of further improving the effect of improving dermatitis in the ears and around the ears and from the viewpoint of ease of application.

Specific examples of the external composition of the present invention include pharmaceuticals, quasi-drugs, cosmetics and the like. Among these pharmaceutical forms, pharmaceutical products are preferable.

Applications The external composition of the present invention is used for improving dermatitis in the ears and around the ears. The ear refers to the pinna and the ear canal. The area around the ear is the skin around the auricle, which is a site that receives chemical irritation due to the tendency of the rinse residue of cleaning agents and hairdressing agents to accumulate, and / or the site that receives physical irritation with eyeglasses or masks, and the sebaceous glands. Examples include sites where the density is relatively high (rear part of the auricle).

Specific examples of dermatitis in and around the ears include seborrheic dermatitis, contact dermatitis, and dry dermatitis. Seborrheic dermatitis occurs in areas where the sebaceous glands are dense or more prone to friction, specifically in the ears and around the ears, more specifically in the auricle, ear canal, posterior auricle, etc. .. Contact dermatitis occurs in areas that are subject to chemical irritation due to the tendency of the rinse residue of cleaning agents and hair styling products to accumulate, and / or to physical irritation caused by glasses or masks, specifically around the ears, more specifically. Occurs in the upper part of the auricle, the posterior part of the auricle, etc. Dry dermatitis is excessive dryness due to excess oil due to seborrheic dermatitis, or excessive dryness due to thin skin, and specifically, seborrheic dermatitis. It occurs in areas where dermatitis occurs, where the skin is thin and / or the surface temperature is low, the auricle, the edge of the pinna, the anterior part of the pinna, etc. These dermatitis may occur alone, or multiple dermatitis may occur in combination.

Examples of symptoms of dermatitis in and around the ears include redness, rashes, roughness, cuts (cracks), scales, itching, pain and the like. Among these symptoms, the external composition of the present invention has a high effect of improving redness, itchiness, and / or cuts (cracks), and further has a particularly high effect of improving cuts (cracks).

The external composition of the present invention can be applied to a site where dermatitis occurs in the ear and around the ear by applying it 1 to 6 times a day. In addition, the external composition of the present invention is preferably applied for, for example, for 5 days or more, preferably for 1 week or more, in order to more effectively obtain the effect of improving dermatitis in the ears and around the ears.

Hereinafter, the present invention will be specifically described with reference to Examples, but the present invention is not limited to these Examples.

Test Example 1
The external composition having the composition shown in Table 1 was prepared as an oil-in-water emulsified composition (cream preparation). The prepared external composition was applied to the affected area for one week (three times a day) to a complainant (N = 5) of dermatitis (dry dermatitis) in the ears and / or around the ears due to dryness. These complainants complained of redness, cuts (cracks), pain and itching as symptoms of dry dermatitis. One week later, the degree of improvement of each item was scored on a 5-point VAS (0 is no improvement, and the upper limit is 4 for complete cure), the average value was calculated, and the total was calculated as "ear and around the ear". Comprehensive evaluation of dermatitis improvement 1 ". The results are shown in Table 1.

As shown in Table 1, the external composition of Example 1 showed a remarkable improving effect on dermatitis (dry dermatitis) around the ears and / or ears. Among them, it was found that the improvement effect on redness, itchiness and cracks was high, and the improvement effect on cracks was particularly high.

Test Example 2
The external composition having the composition shown in Table 2 was prepared as an oil-in-water emulsified composition (cream preparation). For complainants (N = 5) of dermatitis (combination of contact dermatitis and seborrheic dermatitis) of the ears and / or around the ears due to unrinsed masks, glasses and / or hair cleaning agents. The prepared external composition was applied to the affected area for one week (three times a day). These complainants complained of redness, cuts (cracks), pain and itching as symptoms of dry dermatitis. One week later, the degree of improvement of each item was scored on a 5-point VAS (0 is no improvement and the upper limit is 4), the average value was calculated, and the total was calculated as "ear and around the ear". Comprehensive evaluation of dermatitis improvement 1 ". The results are shown in Table 2.

As shown in Table 2, the external composition of Example 2 showed a remarkable improving effect on dermatitis of the ear and / or around the ear (composite type of contact dermatitis and seborrheic dermatitis). .. Among them, it was found that the effect of improving redness, itchiness and cracks was high, the effect of improving itchiness and cracks was even higher, and the effect of improving cracks was particularly high.

Test Example 3
The external composition having the composition shown in Table 3 was prepared as an oil-in-water emulsified composition (cream preparation). For a complainant (N = 4) of dermatitis (contact dermatitis) around the ears and / or ears due to unrinsed masks, eyeglasses and / or hair cleansers, the prepared external composition was applied to the affected area for 1 week. It was applied (three times a day). One week later, the degree of improvement of each item was scored on a 10-point VAS (0 is no improvement, and the upper limit is 9 for complete cure), and the total value was calculated. Comprehensive evaluation 2 ". The results are shown in Table 3.

As shown in Table 3, the external composition of Examples 3 to 5 showed an excellent improving effect on dermatitis (contact dermatitis) in the ears and / or around the ears. Among them, the external composition of Examples 4 and 5 containing tocopherol acetate was found to have a more excellent improving effect, and in particular, the external composition of Example 5 containing tocopherol acetate and benzethonium chloride had an extremely high improving effect. Was recognized.

Formulation Examples The external composition shown in Tables 4 and 5 was prepared as an oil-in-water emulsified composition (cream). Both external compositions showed excellent ameliorating effects on dermatitis around the ears and / or ears (dry dermatitis, contact dermatitis, seborrheic dermatitis).

Claims (6)

It contains (A) ufenamate, (B) glycyrrhetinic acid, a derivative of glycyrrhetinic acid, and / or a salt thereof, and (C) diphenhydramine and / or a salt thereof, and is used for improving dermatitis in the ear and around the ear. External composition. (D) The external composition according to claim 1, further containing tocopherol and / or a derivative thereof. (E) The external composition according to claim 1 or 2, further containing an antibacterial or bactericidal agent. The external composition according to any one of claims 1 to 3, which is used for dry dermatitis, seborrheic dermatitis and / or contact dermatitis. The external composition according to any one of claims 1 to 4, which is used for auricle. The external composition according to any one of claims 1 to 5, which is used for redness, itchiness, and / or cracks.