External composition

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

[Technical field]

[0001] The present invention relates to a composition for external use used to improve dermatitis in the ear and around the ear. [Background technology]

[0002] The skin of the ears and around the ears has unique characteristics that are different from the skin of other parts of the body. Specific structural characteristics include that the skin is thinner than the skin of other parts of the body, that the density of sebaceous glands is high, etc. Specific environmental characteristics include that the skin of the ears and around the ears is susceptible to chemical irritation due to the tendency for residual cleansing products and hair styling products to accumulate due to its complex structure, and that the skin is susceptible to physical irritation from glasses and masks, etc.

[0003] These structural and environmental characteristics make the ear and the skin around the ear susceptible to inflammation. Examples of symptoms of inflammation include redness, rash, roughness, cracks, scaling, itching, etc.

[0004] The above symptoms are seen, for example, in seborrheic dermatitis. Seborrheic dermatitis occurs in areas with a high density of sebaceous glands, such as the area behind the ear, and is accompanied by cracks and scales in the area (Non-Patent Document 1). Seborrheic dermatitis is also known to occur in areas subject to a lot of friction, and may be accompanied by itching, redness, flaking, etc. For the treatment of seborrheic dermatitis, topical application of corticosteroids and antifungal drugs is selected (Non-Patent Document 1).

[0005] The above symptoms may also be caused by contact dermatitis due to chemical or physical irritation. Treatment of contact dermatitis involves topical application of antipruritics and corticosteroids, as well as avoidance of the cause of the contact irritation (Non-Patent Document 2).

[0006] In addition, the above symptoms may be triggered by excessive dryness due to thin skin. To treat dry skin, topical application of moisturizers is the treatment of choice. [Prior art documents] [Non-patent literature]

[0007] [Non-Patent Document 1] MSD Manual Professional Edition / Skin Disorders / Dermatitis / Seborrheic Dermatitis [Non-Patent Document 2] MSD Manual Professional Edition / Skin Disorders / Dermatitis / Contact Dermatitis Summary of the Invention [Problem to be solved by the invention]

[0008] Generally, the above-mentioned treatment methods are selected for seborrheic dermatitis, contact dermatitis, and dryness, but while these treatment methods are suitable for the skin of other parts, they are not suitable for the skin of the ear and around the ear, considering the specific characteristics of the skin of the ear and around the ear.For example, the use of steroids causes the skin to shrink and become thin, so it is not suitable for the ear and around the ear, which is originally thin skin, and its effect is not sufficient.In addition, the use of moisturizing agents is also not suitable for the ear and around the ear, which has a thin layer to retain moisturizing ingredients.

[0009] The present invention aims to provide a composition for external application that is effective in improving dermatitis in and around the ear. [Means for solving the problem]

[0010] As a result of intensive research, the present inventors have found that a composition for external use containing ufenamate, diphenhydramines, and glycyrrhetinic acids shows excellent effects in improving dermatitis in the ear and around the ear. Based on this finding, the present invention has been completed through further research.

[0011] That is, the present invention provides the following aspects. Item 1. A composition for external use used to improve dermatitis in and around the ear, comprising (A) ufenamate, (B) glycyrrhetinic acid, a derivative of glycyrrhetinic acid, and / or a salt thereof, and (C) diphenhydramine and / or a salt thereof. Item 2. The composition for external use according to Item 1, further comprising (D) tocopherol and / or a derivative thereof. Item 3. The composition for external use according to Item 1 or 2, further comprising (E) an antibacterial or bactericidal agent. Item 4. The composition for external use according to any one of Items 1 to 3, which is used for dry dermatitis, seborrheic dermatitis, and / or contact dermatitis. Item 5. The composition for external use according to any one of Items 1 to 4, which is applied to the auricle. Item 6. The composition for external use according to any one of Items 1 to 5, which is used for redness, itching, and / or cracking. Effect of the Invention

[0012] According to the present invention, there is provided a composition for external application that is effective in improving dermatitis in and around the ear. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The topical composition of the present invention contains (A) ufenamate (hereinafter also referred to as "(A) component"), (B) glycyrrhetinic acid, a derivative of glycyrrhetinic acid, and / or a salt thereof (hereinafter also referred to as "(B) component" or "glycyrrhetinic acids"), and (C) diphenhydramine and / or a salt thereof (hereinafter also referred to as "(C) component" or "diphenhydramines"), and is characterized in that it is used to improve dermatitis in the ear and around the ear. The topical composition of the present invention may further contain (D) tocopherol and / or a derivative thereof (hereinafter also referred to as "(D) component" or "tocopherols") and / or (E) a quaternary ammonium antibacterial agent (hereinafter also referred to as "(E) component"). The topical composition of the present invention will be described in detail below.

[0014] (A) Ufenamart The topical composition of the present invention contains ufenamate as component (A). Ufenamate is also called butyl flufenamate and is a known drug as a fat-soluble nonsteroidal anti-inflammatory drug. Component (A) alone has almost no effect on improving dermatitis in the ear and around the ear, but the topical composition of the present invention can exhibit an excellent effect on improving dermatitis in the ear and around the ear.

[0015] In the topical composition of the present invention, the content of component (A) is appropriately set depending on the medicinal effect to be exerted, and may be, for example, 1 to 20% by weight. From the viewpoint of further improving the effect of improving dermatitis in and around the ear, the content of component (A) in the topical composition of the present invention is preferably 3 to 6% by weight, and more preferably 4.5 to 5.5% by weight.

[0016] (B) Glycyrrhetinic acid The topical composition of the present invention contains glycyrrhetinic acid, a derivative thereof, and / or a salt thereof as component (B).

[0017] Glycyrrhetinic acid is a known drug known to have anti-inflammatory and anti-allergic effects, etc. Component (B) alone has almost no effect on improving dermatitis in the ears and around the ears, but the topical composition of the present invention can exhibit an excellent effect on improving dermatitis in the ears and around the ears.

[0018] The derivatives of glycyrrhetinic acid are not particularly limited as long as they are pharma- ceutically acceptable, but specific examples include pyridoxine glycyrrhetinate, stearyl glycyrrhetinate, glyceryl glycyrrhetinate, monoglucuronide glycyrrhetinate, etc. These derivatives of glycyrrhetinic acid may be used alone or in combination of two or more.

[0019] The salt of glycyrrhetinic acid and / or its derivative is not particularly limited as long as it is pharma- ceutically acceptable, and specifically includes alkali metal salts such as sodium salts and potassium salts; ammonium salts, etc. These salts may be used alone or in combination of two or more.

[0020] In the topical composition of the present invention, one or more of glycyrrhetinic acid, salts of glycyrrhetinic acid, derivatives of glycyrrhetinic acid, and salts of derivatives of glycyrrhetinic acid may be selected as component (B) and used, or two or more may be used in combination.

[0021] Of these components (B), glycyrrhetinic acid is preferred from the viewpoint of further improving the effect of improving dermatitis in and around the ears.

[0022] In the topical composition of the present invention, the content of component (B) is not particularly limited and may be appropriately set depending on the medicinal effect to be imparted, and examples of the content include a total amount of component (B) of 0.05 to 5% by weight, and from the viewpoint of further improving the effect of improving dermatitis in and around the ear, the content is preferably 0.1 to 1% by weight, and more preferably 0.2 to 0.5% by weight.

[0023] In the topical composition of the present invention, the ratio of component (B) to component (A) is determined depending on the respective contents of components (A) and (B), but for example, the total amount of component (B) is 0.01 to 0.9 parts by weight per part by weight of component (A). From the viewpoint of further improving the effect of improving dermatitis in and around the ears, the total amount of component (B) is preferably 0.03 to 0.5 parts by weight, more preferably 0.05 to 0.1 parts by weight, per part by weight of component (A).

[0024] (C) Diphenhydramines The topical composition of the present invention contains diphenhydramine and / or a salt thereof as component (C). Diphenhydramine is a known drug known to have an antihistamine effect. Component (C) alone has almost no effect on improving dermatitis in the ear and around the ear, but the topical composition of the present invention can exert an excellent effect on improving dermatitis in the ear and around the ear.

[0025] The salt of diphenhydramine is not particularly limited as long as it is pharma- ceutically acceptable, and specific examples thereof include acid addition salts such as hydrochloride, citrate, succinate, tartrate, fumarate, maleate, salicylate, diphenyl disulfonate, tannate, lauryl sulfate, sulfate, etc. These salts may be used alone or in combination of two or more.

[0026] In the topical composition of the present invention, one type of diphenhydramine and its salts may be selected and used as component (C), or two or more types may be used in combination.

[0027] Among these components (C), diphenhydramine is preferred from the viewpoint of further improving the effect of improving dermatitis in and around the ears.

[0028] In the topical composition of the present invention, the content of component (C) is not particularly limited, but may be, for example, 0.1 to 5% by weight in terms of the total amount of component (C). From the viewpoint of further improving the effect of improving dermatitis in and around the ear, the content of component (C) in the topical composition of the present invention is preferably 0.3 to 2% by weight, more preferably 0.5 to 1.5% by weight.

[0029] In the topical composition of the present invention, the ratio of component (C) to component (A) is determined depending on the respective contents of components (A) and (C), but for example, the total amount of component (C) is 0.01 to 1.2 parts by weight per part by weight of component (A). From the viewpoint of further improving the effect of improving dermatitis in and around the ears, the total amount of component (C) is preferably 0.05 to 0.8 parts by weight, more preferably 0.1 to 0.5 parts by weight, per part by weight of component (A).

[0030] In the topical composition of the present invention, the ratio of component (C) to component (B) is determined depending on the respective contents of components (B) and (C), but may be, for example, 0.1 to 12 parts by weight of component (C) per part by weight of component (B). From the viewpoint of further improving the effect of improving dermatitis in and around the ears, the total amount of component (C) is preferably 0.5 to 8 parts by weight, more preferably 1 to 5 parts by weight, per part by weight of component (B).

[0031] (D) Tocopherols The topical composition of the present invention may further contain tocopherol and / or a derivative thereof as component (D) in order to further improve the effect of improving dermatitis in and around the ears.

[0032] Tocopherol is a known compound known as vitamin E. Tocopherol may be any of d-, l-, and dl-forms, with dl-form being preferred. Tocopherol may be any of α-, β-, γ-, and δ-forms, with α-form being preferred.

[0033] The tocopherol derivative is not particularly limited as long as it is pharma- ceutically acceptable, and examples thereof include esters with carboxylic acids such as acetic acid, nicotinic acid, succinic acid, and diesters with phosphoric acid, etc. Among these tocopherol derivatives, from the viewpoint of further improving the effect of improving dermatitis in and around the ears, preferred are esters with carboxylic acids, and more preferred is tocopherol acetate.

[0034] The tocopherol derivative may be any of d-, l-, or dl-forms, with the dl-form being preferred.The tocopherol derivative may be any of α-, β-, γ-, or δ-forms, with the α-form being preferred.

[0035] In the topical composition of the present invention, one of tocopherol and its derivatives may be selected as component (D) and used alone, or two or more may be used in combination. Among the components (D), from the viewpoint of further improving the effect of improving dermatitis in and around the ears, preferred are tocopherol derivatives, more preferred are tocopherol esters with carboxylic acids, even more preferred are tocopherol acetate, and particularly preferred are d-α-tocopherol acetate, l-α-tocopherol acetate, and dl-α-tocopherol acetate.

[0036] When the topical composition of the present invention contains component (D), the content of component (D) is not particularly limited. From the viewpoint of further improving the effect of improving dermatitis in and around the ears, the total amount of component (D) 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.

[0037] Furthermore, when the topical composition of the present invention contains component (D), the ratio of component (D) to component (A) is determined based on the above-mentioned content ranges of each component. From the viewpoint of further improving the effect of improving dermatitis in and around the ears, the total amount of component (D) per part by weight of component (A) is 0.01 to 1 part by weight, preferably 0.03 to 0.5 parts by weight, and more preferably 0.05 to 0.3 parts by weight.

[0038] (E) Antibacterial or disinfectant The topical composition of the present invention may further contain an antibacterial or bactericidal agent as component (E) from the viewpoint of further improving the effect of improving dermatitis in the ear and around the ear. The topical composition of the present invention preferably contains component (E) together with component (D) from the viewpoint of further improving the effect of improving dermatitis in the ear and around the ear.

[0039] The antibacterial or bactericidal agent is not particularly limited, as long as it is pharmaceutically or cosmetically acceptable.For example, quaternary ammonium antibacterial agents, isopropylmethylphenol, hinokitiol, chlorhexidine hydrochloride, chlorhexidine gluconate, triclosan, lysozyme chloride, sulfazine, etc. are included.Specific examples of quaternary ammonium antibacterial agents include cetylpyridinium chloride, benzethonium chloride, benzalkonium chloride, dequalinium chloride, alkyldimethylammonium chloride, alkyltrimethylammonium chloride, methylbenzethonium chloride, lauroylcollaminoformylmethylpyridinium chloride, etc.

[0040] These antibacterial or bactericidal agents may be used alone or in combination of two or more.

[0041] Among these antibacterial or bactericidal agents, from the viewpoint of further improving the effect of improving dermatitis in and around the ears, preferably, quaternary ammonium antibacterial agents are used, more preferably, benzethonium chloride, benzalkonium chloride, and cetylpyridinium chloride are used, and even more preferably, benzethonium chloride is used.

[0042] When the topical composition of the present invention contains component (E), the content of component (E) may be appropriately set depending on the type of antibacterial or bactericidal agent used, and may be, for example, 0.01 to 1% by weight. From the viewpoint of further improving the effect of improving dermatitis in and around the ears, the content of component (B) is preferably 0.03 to 0.5% by weight, and more preferably 0.05 to 0.3% by weight.

[0043] When the topical composition of the present invention contains component (E), the ratio of component (A) to component (E) is determined according to the respective contents of these two components described above, but for example, the ratio may be 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 of component (E) per 1 part by weight of component (A).

[0044] Other Ingredients In addition to the above-mentioned components, the composition for external use of the present invention may contain other pharmacological ingredients as necessary. Examples of such pharmacological ingredients include antihistamines (chlorpheniramine maleate, etc.), local anesthetics (lidocaine, dibucaine, procaine, tetracaine, bupivacaine, mepivacaine, chloroprocaine, proparacaine, meprylcaine, or salts thereof), alkyl benzoates (e.g., ethyl aminobenzoate, diethylaminoethyl p-butylaminobenzoate hydrochloride), orthocaine, oxethazaine, oxypolyethyleneoxydecane, Scopolia extract, percaminpase, tesitdesitin, etc.), anti-inflammatory agents (alanine, benzoic acid ... These include but are not limited to, salicylic acid, glycol salicylate, methyl salicylate, indomethacin, felbinac, diclofenac sodium, and loxoprofen sodium), antipruritic agents (crotamiton, thianthol, etc.), skin protectants (collodion, castor oil, etc.), blood circulation promoting ingredients (vanillyl nonyl amide, nicotinic acid benzyl ester, capsaicin, chili pepper extract, etc.), cooling agents (menthol, camphor, etc.), vitamins (vitamins A, B, C, D, etc.), and mucopolysaccharides (sodium chondroitin sulfate, hyaluronic acid, etc.).

[0045] In addition to the above-mentioned components, other bases and additives that are usually used in skin external preparations and the like may be included as necessary. Such bases and additives are not particularly limited as long as they are pharma- ceutically acceptable, and examples of such bases and additives include aqueous bases such as water, lower alcohols (e.g., isopropanol), and polyhydric alcohols (glycerin, propylene glycol, dipropylene glycol, 1,3-butylene glycol, etc.); oils (olive oil, safflower oil, soybean oil, camellia oil, corn oil, rapeseed oil, sunflower oil, cottonseed oil, peanut oil, lard, squalane, fish oil, etc.), mineral oils (liquid paraffin, paraffin, gelling hydrocarbon, petrolatum, etc.), waxes (beeswax, carnauba wax, candelilla wax, ceresin, rice wax, microcrystalline wax, etc.), ester oils (isopropyl myristate, adipine, etc.), and the like. oily bases such as isopropyl acetate, 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, glyceryl tri-2-ethylhexanoate, cetyl 2-ethylhexanoate, silicone oils (dimethylpolysiloxane, cyclic silicone, etc.);Polyoxyethylene alkyl ethers such as POE (10-50 mol) phytosterol ether, POE (10-50 mol) dihydrocholesterol ether, POE (10-50 mol) 2-octyldodecyl ether, POE (10-50 mol) decyltetradecyl ether, POE (10-50 mol) oleyl ether, POE (2-50 mol) cetyl ether (cetomacrogol 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 ether, phosphoric acid salts thereof (e.g. sodium POE cetyl ether phosphate), POE (20-60 mol) sorbitan monooleate, POE (10-60 mol) sorbitan mono Surfactants such as isostearate, POE (10-80 mol) glyceryl monoisostearate, POE (10-30 mol) glyceryl monostearate, POE (20-100 mol)·polyoxypropylene modified silicone, POE·alkyl modified silicone, polyethylene glycol monolaurate, polyethylene glycol monopalmitate, polyethylene glycol monostearate, polyethylene glycol dilaurate, polyethylene glycol dipalmitate, polyethylene glycol distearate, polyethylene glycol dioleate, polyethylene glycol diricinoleate, polyoxyethylene hydrogenated castor oil (5-100), polysorbate (20-85), glycerin fatty acid ester (glycerin monostearate, etc.), hydrogenated soybean phospholipid, hydrogenated lanolin alcohol, etc.;Cooling agents (menthol, camphor, borneol, peppermint water, peppermint oil, etc.), preservatives (methylparaben, propylparaben, benzoic acid, sodium benzoate, sorbic acid, etc.), flavoring agents (citral, 1,8-thioneol, citronellal, farnesol, etc.), coloring agents (tar dyes (brown No. 201, blue No. 201, yellow No. 4, yellow No. 403, etc.), cacao dyes, chlorophyll, aluminum oxide, etc.), thickeners (carboxyvinyl polymer, hypromellose, polyvinylpyrrolidone, sodium alginate, ethyl cellulose, hydroxyethyl cellulose, sodium carboxymethylcellulose, xanthan gum, carrageenan, etc.), pH adjusters (phosphoric acid, hydrochloric acid, citric acid, chlosyl ester, ethyl cellulose ... Examples of additives include additives such as sodium enoate, succinic acid, tartaric acid, sodium hydroxide, potassium hydroxide, triethanolamine, triisopropanolamine, etc.), wetting agents (sodium dl-pyrrolidone carboxylate solution, D-sorbitol solution, macrogol, etc.), stabilizers (dibutylhydroxytoluene, butylhydroxyanisole, sodium edetate, sodium metaphosphate, L-arginine, L-aspartic acid, DL-alanine, glycine, sodium erythorbate, propyl gallate, sodium sulfite, sulfur dioxide, chlorogenic acid, catechin, rosemary extract, etc.), antioxidants, ultraviolet absorbers, chelating agents, adhesives, buffers, dissolution aids, solubilizers, and preservatives.

[0046] Properties, formulation, etc. The properties of the topical composition of the present invention are not particularly limited, and include aqueous liquid compositions, aqueous gel compositions, oily gel compositions, emulsion compositions, etc. Among these, from the viewpoint of further improving the effect of improving dermatitis on the ears and around the ears, the emulsion composition is preferably used. The emulsion state of the emulsion composition may be either oil-in-water type or water-in-oil type, but from the viewpoint of further improving the effect of improving dermatitis on the ears and around the ears, the oil-in-water type is preferably used.

[0047] The formulation of the topical composition of the present invention is not particularly limited, and examples thereof include lotions, emulsions, ointments, creams, etc. Among these, from the viewpoint of further improving the effect of improving dermatitis in and around the ears and from the viewpoint of ease of application, emulsions and creams are preferred.

[0048] Specific examples of the composition for external use of the present invention include medicines, quasi-drugs, cosmetics, etc. Among these preparation forms, medicines are preferred.

[0049] Purpose The topical composition of the present invention is used to improve dermatitis in the ear and around the ear. The ear refers to the auricle and the ear canal. The area around the ear refers to the skin around the auricle, which is subject to chemical irritation caused by residual cleansing agents and hair styling agents that tend to accumulate, and / or physical irritation caused by glasses and masks, and areas with a relatively high density of sebaceous glands (behind the auricle).

[0050] Specific examples of dermatitis in and around the ear include seborrheic dermatitis, contact dermatitis, and dry dermatitis. Seborrheic dermatitis occurs in areas with high sebaceous gland density or areas prone to friction, specifically in the ear and around the ear, more specifically in the pinna, ear canal, and post-auricular area. Contact dermatitis occurs in areas subject to chemical irritation due to residual detergent or hair styling products that tend to accumulate, and / or physical irritation due to glasses or masks, specifically in the ear, more specifically in the upper part of the pinna, and post-auricular area. Dry dermatitis occurs when excessive dryness occurs due to excess oil caused by seborrheic dermatitis, or when excessive dryness occurs due to thin skin, specifically in areas where seborrheic dermatitis occurs, such as the earlobe, edge of the pinna, and pre-auricular area, where the skin is thin and / or the surface temperature is low. These dermatitis may occur alone, or multiple dermatitis may occur in combination.

[0051] Examples of symptoms of dermatitis in the ear and around the ear include redness, rash, roughness, cuts (cracks), scales, itching, pain, etc. The topical composition of the present invention is highly effective in improving redness, itching, and / or cuts (cracks) among these symptoms, and is particularly effective in improving cuts (cracks).

[0052] The topical composition of the present invention can be applied to the area where dermatitis occurs in the ear or around the ear by applying it 1 to 6 times a day. In order to more effectively improve dermatitis in the ear or around the ear, the topical composition of the present invention is preferably applied for, for example, 5 days or more, preferably 1 week or more. EXAMPLES

[0053] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples.

[0054] Test Example 1 The topical composition shown in Table 1 was prepared as an oil-in-water emulsion composition (cream). The topical composition was applied to the affected area for one week (three times a day) to subjects (N=5) with dry ear and / or ear-around dermatitis (dry dermatitis). These subjects complained of redness, cracks, pain, and itching as symptoms of dry dermatitis. After one week, the degree of improvement of each item was scored using a five-level VAS (0 being no improvement, the upper limit being 4 being complete recovery), and the average score was calculated and the sum of these scores was used as the "overall score 1 for improvement of ear and ear-around dermatitis." The results are shown in Table 1.

[0055] [Table 1]

[0056] As shown in Table 1, the topical composition of Example 1 was found to have a significant effect of improving dermatitis (dry dermatitis) of the ears and / or around the ears. In particular, it was found to have a high effect of improving redness, itching, and cracks, and further, a particularly high effect of improving cracks.

[0057] Test Example 2 The topical composition shown in Table 2 was prepared as an oil-in-water emulsion composition (cream). The topical composition was applied to the affected area for one week (three times a day) to complainants (N=5) with ear and / or ear-around dermatitis (combined type of contact dermatitis and seborrheic dermatitis) caused by masks, glasses, and / or hair cleansers not rinsed off. These complainants complained of redness, cuts (cracks), pain, and itching as symptoms of dry dermatitis. After one week, the degree of improvement of each item was scored using a five-level VAS (0 being no improvement, the upper limit of 4 being complete recovery), the average was calculated, and the sum of these was taken as the "overall evaluation 1 of improvement of ear and ear-around dermatitis". The results are shown in Table 2.

[0058] [Table 2]

[0059] As shown in Table 2, the topical composition of Example 2 was found to have a significant effect of improving dermatitis of the ears and / or around the ears (a combination of contact dermatitis and seborrheic dermatitis). In particular, it was found to have a high effect of improving redness, itching, and cracking, an even higher effect of improving itching and cracking, and a particularly high effect of improving cracking.

[0060] Test Example 3 The topical composition shown in Table 3 was prepared as an oil-in-water emulsion composition (cream). The topical composition was applied to the affected area for one week (three times a day) to subjects (N=4) with ear and / or ear-around dermatitis (contact dermatitis) caused by masks, glasses, and / or hair cleanser residue. After one week, the degree of improvement of each item was scored using a 10-point VAS (0 being no improvement, the upper limit being 9 being complete recovery), and the total score was calculated and used as the "overall score 2 for improvement of ear and ear-around dermatitis." The results are shown in Table 3.

[0061] [Table 3]

[0062] As shown in Table 3, excellent improvement effects were observed for dermatitis (contact dermatitis) of the ears and / or around the ears with the topical compositions of Examples 3 to 5. Among them, the topical compositions of Examples 4 and 5 containing tocopherol acetate showed even more excellent improvement effects, and in particular, the topical composition of Example 5 containing tocopherol acetate and benzethonium chloride showed an extremely high improvement effect.

[0063] Prescription Examples The topical compositions shown in Tables 4 and 5 were prepared as oil-in-water emulsion compositions (creams). All topical compositions showed excellent improving effects on dermatitis of the ears and / or around the ears (dry dermatitis, contact dermatitis, seborrheic dermatitis).

[0064] [Table 4]

[0065] [Table 5]

Claims

1. A composition for external use containing (A) ufenamate, (B) glycyrrhetinic acid, pyridoxine glycyrrhetinate, stearyl glycyrrhetinate, glyceryl glycyrrhetinate, glyceryl glycyrrhetinate, glycyrrhetinic acid monoglucuronide, and / or salts thereof, and (C) diphenhydramine and / or salts thereof, for use in improving dermatitis on and around the human ears (but excluding the face).

2. The composition for external use according to claim 1 , further comprising (D) tocopherol, a carboxylic acid ester of tocopherol, and / or a phosphoric acid diester of tocopherol.

3. The topical composition according to claim 1 or 2, further comprising (E) an antibacterial or bactericidal agent.

4. The composition for external use according to any one of claims 1 to 3, which is used for dry dermatitis, seborrheic dermatitis and / or contact dermatitis.

5. The composition for external use according to any one of claims 1 to 4, which is applied to the auricle.

6. The composition for external use according to any one of claims 1 to 5, which is used against redness, itching, and / or cracking.

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