External composition

Abstract

To provide an external composition used for improving urinary rash.SOLUTION: The external composition comprises (A) ufenamate and (B) lidocaine. The external composition is effective in improving urinary rash.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a composition for external use used to improve urinary rash. [Background technology]

[0002] Urinary incontinence is a complaint of involuntary leakage of urine, and the number of people with this condition increases sharply from the age of 40 onwards, and tends to increase further with age. In response to this, an increasing number of people are using sanitary products such as urinary incontinence pads and urinary incontinence sheets in an effort to live a comfortable daily life. However, the use of such sanitary products is actually promoting urinary rash, and there is data showing that approximately 80% of people who use urinary pads suffer from painful skin problems (Non-Patent Document 1).

[0003] The lower urinary tract is the part that is most different in structure between men and women, and due to the characteristics of the urinary continence mechanism due to anatomical differences, urinary leakage is particularly common in women (Non-Patent Document 2). In addition, since estrogen receptors are abundant in the urethra, bladder, and the anterior vaginal wall that supports them, atrophy of the urethra and vagina due to a decrease in estrogen after menopause reduces urethral pressure and causes urinary incontinence. During menopause, estrogen is reduced, and urinary incontinence in women increases rapidly after menopause (Non-Patent Document 3). In addition, the fact that the pelvic floor muscles are more likely to loosen than men also contributes to the rapid increase in urinary incontinence in women. For this reason, urinary rash in women after menopause is accompanied by a unique difficulty in treating it. Furthermore, in many cases, circumstances unique to women, such as the presence of vaginal discharge, pressure irritation from underwear such as pantyhose, and friction irritation from the use of toilet paper, further exacerbate the difficulty in treating urinary rash that is unique to women. [Prior art documents] [Non-patent literature]

[0004] [Non-Patent Document 1] “Level of discomfort (for people who experience skin problems due to urinary pads)”, [online], May 2017, [Retrieved June 1, 2020], Internet<URL: https: / / www.kobayashi.co.jp / brand / kabunurse / trouble / > [Non-Patent Document 2] Homma, Yukio. Key points in the treatment of urinary incontinence, female urinary incontinence, Urology MOOK, Kanehara Publishing, 1992, 68-79 [Non-Patent Document 3] Masayasu Furuyama, Urinary incontinence and its management, Obstetrics and Gynecology, 2013, 80 (8), 1049-1055 Summary of the Invention [Problem to be solved by the invention]

[0005] An object of the present invention is to provide a composition for external use used to improve urinary rash. [Means for solving the problem]

[0006] As a result of intensive research, the present inventors have found that a composition for external use containing ufenamate and lidocaine shows excellent effects in improving urinary rash. Based on this finding, the present invention has been completed through further research.

[0007] That is, the present invention provides the following aspects. Item 1. A composition for external use containing (A) ufenamate and (B) lidocaine and / or a salt thereof, which is used to improve urinary rash. Item 2. The composition for external use according to Item 1, which is applied to post-menopausal women. Item 3. The composition for external use according to Item 1 or 2, further comprising an antihistamine (C). Item 4. The composition for external use according to Item 3, wherein the component (C) is chlorpheniramine and / or a salt thereof. Effect of the Invention

[0008] According to the present invention, there is provided a composition for external use used to improve urinary rash. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] The topical composition of the present invention contains (A) ufenamate (hereinafter also referred to as "(A) component") and (B) lidocaine and / or a salt thereof (hereinafter also referred to as "(B) component" or "lidocaines"), and is characterized in that it is used to improve urinary rash. The topical composition of the present invention may further contain (C) an antihistamine (hereinafter also referred to as "(C) component"). 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"), (E) allantoin and a derivative thereof (hereinafter also referred to as "(E) component" or "allantoins"), and / or (F) panthenol, a derivative thereof, and / or a salt thereof (hereinafter also referred to as "(F) component" or "panthenols"). The topical composition of the present invention will be described in detail below.

[0010] (A) Ufenamart The topical composition of the present invention contains ufenamate as component (A). Ufenamate is also called butyl flufenamate and is a known fat-soluble nonsteroidal anti-inflammatory drug. Component (A) alone does not have much effect in improving urinary rash, but the topical composition of the present invention can exhibit an excellent effect in improving urinary rash.

[0011] In the topical composition of the present invention, the content of component (A) is appropriately set depending on the efficacy to be exerted, and may be, for example, 1 to 20% by weight. From the viewpoint of further improving the effect of improving urinary rash, 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.

[0012] (B) Lidocaines The topical composition of the present invention contains lidocaine and / or a salt thereof as component (B). Lidocaine, also known as xylocaine, is a known drug known to have a local anesthetic effect. Component (B) is a local anesthetic that does not improve urinary rash by itself, but when combined with component (A), it dramatically improves the improving effect on urinary rash.

[0013] The salt of lidocaine is not particularly limited as long as it is pharma- ceutical acceptable, and specific examples include inorganic acid salts such as hydrochloride.

[0014] In the composition for external use of the present invention, one of lidocaine and its salts may be selected and used alone, or two or more of them may be used in combination. Among lidocaine and its salts, lidocaine is preferred from the viewpoint of further improving the effect of improving urinary rash.

[0015] The content of component (B) in the topical composition of the present invention may be appropriately set depending on the medicinal effect to be imparted, and may be, for example, 0.1 to 5 wt. %, preferably 0.2 to 2 wt. %, and more preferably 0.5 to 1.5 wt. % in terms of the total amount of component (B).

[0016] 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). For example, the total amount of component (B) per 1 part by weight of component (A) is, for example, 0.01 to 1.5 parts by weight, preferably 0.05 to 1 part by weight, and more preferably 0.1 to 0.5 parts by weight.

[0017] (C) Antihistamines The topical composition of the present invention may further contain an antihistamine as component (C) in order to further improve the effect of improving urinary rash.

[0018] The antihistamine is not particularly limited, and examples thereof include ethanolamine antihistamines such as diphenhydramine, bromodiphenhydramine, clemastine, chlorphenoxamine, diphenylpyraline, doxylamine, orphenadrine, and phenyltoloxamine; propylamine antihistamines such as chlorpheniramine, dimethindene, and talastine; ethylenediamine antihistamines such as mepyramine, methapyrilene, and tripelennamine; phenothiazine antihistamines such as alimemazine, hydroxyethylpromethazine, isothipendyl, mequitazine, oxomemazine, and promethazine; Piperazine antihistamines such as buclizine, cetirizine, homochlorcyclizine, cyclizine, hydroxyzine, levocetirizine, meclizine, and oxatomide; ketotifen, olopatadine, fexofenadine, loratadine, terfenadine, antazoline, azatadine, bamipine, cyproheptadine, deptropine, ebastine, emedastine, epinastine, mebhydroline, mizolastine, pimethixene, pyrobutamine, quifenadine, rupatadine, triprolidine, acrivastine, astemizole, azelastine, bilastine, desloratadine, and salts thereof. These antihistamines may be used alone or in combination of two or more.

[0019] The above salts are not particularly limited as long as they are pharma- ceutically acceptable, and include inorganic acid salts and organic acid salts. Inorganic acid salts include hydrochloride, hydrobromide, nitrate, sulfate, phosphate, etc. Organic acid salts include monocarboxylates such as acetate, trifluoroacetate, butyrate, palmitate, stearate, etc.; polycarboxylates such as fumarate, maleate, succinate, malonate, etc.; oxycarboxylates such as lactate, tartrate, citrate, salicylate, etc.; organic sulfonates such as methanesulfonate, toluenesulfonate, tosylate, napadisilate, diphenyldisulfonate, etc.; organic sulfates such as lauryl sulfate, etc. These salts may be used alone or in combination of two or more.

[0020] Of these (C) components, from the viewpoint of further improving the effect of improving urinary rash, preferred are ethanolamine antihistamines and propylamine antihistamines, more preferred are propylamine antihistamines, even more preferred are chlorpheniramine and salts thereof, and particularly preferred is chlorpheniramine maleate.

[0021] When the topical composition of the present invention contains component (C), the content of component (C) is not particularly limited and is set appropriately depending on the type of component (C). From the viewpoint of further improving the effect of improving urinary rash, the total amount of component (C) is, for example, 0.1 to 5% by weight, preferably 0.2 to 2% by weight, and more preferably 0.5 to 1.5% by weight.

[0022] Furthermore, when the topical composition of the present invention contains component (C), the ratio of component (C) 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 urinary rash, the total amount of component (C) per part by weight of component (A) is, for example, 0.01 to 1.5 parts by weight, preferably 0.05 to 1 part by weight, and more preferably 0.1 to 0.5 parts by weight.

[0023] (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 urinary rash.

[0024] 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.

[0025] 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, etc., diesters with phosphoric acid, etc. Among these tocopherol derivatives, from the viewpoint of further improving the effect of improving urinary rash, preferred are esters with carboxylic acids, and more preferred is tocopherol acetate.

[0026] 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.

[0027] 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 of them may be used in combination. Among the components (D), from the viewpoint of further improving the effect of improving urinary rash, 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.

[0028] 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 urinary rash, 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.

[0029] 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 urinary rash, 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.

[0030] (E) Allantoin The topical composition of the present invention may further contain allantoin and its derivatives as component (E) in order to further improve the effect of improving urinary rash.

[0031] Allantoin is a compound also known as 5-ureidohydantoin, and is a known drug that is known to have anti-inflammatory, cell activating, hemostatic, bactericidal, antiulcerative, and other effects.

[0032] The allantoin derivative is not particularly limited as long as it is pharma- ceutically acceptable, and specific examples thereof include allantoin chlorhydroxyaluminum, allantoin hydroxyaluminum, etc. These allantoin derivatives may be used alone or in combination of two or more.

[0033] In the topical composition of the present invention, one or more of allantoin and its derivatives may be selected and used as component (E) in the composition for external use of the present invention. Among these components (E), allantoin is preferred from the viewpoint of further improving the effect of improving urinary rash.

[0034] When the topical composition of the present invention contains component (E), the content of component (E) is not particularly limited. From the viewpoint of further improving the effect of improving urinary rash, the total amount of component (E) is, for example, 0.05 to 1.0 wt %, preferably 0.1 to 0.5 wt %, and more preferably 0.1 to 0.3 wt %.

[0035] Furthermore, when the topical composition of the present invention contains component (E), the ratio of component (E) 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 urinary rash, the total amount of component (E) per part by weight of component (A) is, for example, 0.01 to 0.2 parts by weight, preferably 0.02 to 0.1 parts by weight, and more preferably 0.02 to 0.06 parts by weight.

[0036] (F) Panthenols From the viewpoint of further improving the effect of improving urinary rash, the topical composition of the present invention may further contain panthenol, a derivative thereof, and / or a salt thereof as component (F).

[0037] Panthenol is a compound also known as provitamin B5, and is a known drug used as a cell activator, moisturizer, and the like.

[0038] Specific examples of the panthenol derivatives include pantothenyl ethyl ether, acetylpantothenyl ethyl ether, etc. These panthenol derivatives may be used alone or in combination of two or more.

[0039] In addition, panthenol and / or its salts are not particularly limited as long as they are pharma- ceutically acceptable, and specific examples include alkali metal salts such as potassium salts and sodium salts, alkaline earth metal salts such as calcium salts, etc. These salts may be used alone or in combination of two or more.

[0040] When the topical composition of the present invention contains component (F), one type may be selected from panthenol, a salt of panthenol, a derivative of panthenol, and a salt of a derivative of panthenol, or two or more types may be used in combination as component (F).

[0041] Among these panthenols, panthenol is preferred from the viewpoint of further improving the effect of improving urinary rash.

[0042] When the topical composition of the present invention contains component (F), the content of component (F) is not particularly limited. From the viewpoint of further improving the effect of improving urinary rash, the total amount of component (F) is, for example, 0.01 to 5.0% by weight, preferably 0.05 to 3.0% by weight, and more preferably 0.8 to 1.2% by weight.

[0043] Furthermore, when the topical composition of the present invention contains component (F), the ratio of component (F) 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 urinary rash, the total amount of component (F) per part by weight of component (A) is, for example, 0.002 to 1 part by weight, preferably 0.01 to 0.6 parts by weight, and more preferably 0.15 to 0.25 parts by weight.

[0044] Other Ingredients The topical composition of the present invention may contain other pharmacological ingredients, if necessary, in addition to the above-mentioned ingredients. Examples of such pharmacological ingredients include local anesthetics (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 (glycyrrhetinic acid, glycyrrhetinate, salicylic acid, glycol salicylate, methyl salicylate, indomethacin, felbinac, diclofenac sodium, loxoprofen sodium, etc.), Examples of the active ingredients include disinfectants (zinc oxide, benzalkonium chloride, dequalinium chloride, benzethonium chloride, cetylpyridinium chloride, isopropylmethylphenol, chlorhexidine hydrochloride, chlorhexidine gluconate, aqueous ammonia, sulfadiazine, lactic acid, phenol, etc.), antipruritic agents (diphenhydramine, 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.), mucopolysaccharides (sodium chondroitin sulfate, hyaluronic acid, etc.), 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 contained 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, isopropyl adipate, etc.), and the like. oily bases such as 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, isopropyl myristate, 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 oil (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 urine rash, an 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 urine rash, an 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 urinary rash and 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 inflammation of urinary rash. The topical composition of the present invention can be applied to anyone with urinary rash, without any particular restrictions. In addition, whether or not sanitary products such as urine pads and incontinence sheets are used does not matter, but the topical composition of the present invention is particularly preferably applied to urinary rash caused by contact irritation due to constant contact with these sanitary products and / or by the material of the sanitary products not being suitable for the skin.

[0050] In addition, the composition for external use of the present invention is particularly preferably applied to post-menopausal women (i.e., menopausal women and women who have passed menopause). Urinary rash in post-menopausal women is uniquely difficult to treat due to the frequent occurrence of urinary incontinence or, in addition to the frequent occurrence of urinary incontinence, the inclusion of vaginal discharge, pressure irritation from underwear such as pantyhose, and / or friction irritation from the use of toilet paper, which are unique to women. The composition for external use of the present invention is excellent in the effect of improving inflammation of urinary rash, and is therefore particularly effective for such difficult-to-treat urinary rash unique to menopausal women.

[0051] The topical composition of the present invention can be applied to the skin having urinary rash by applying it 1 to 6 times a day. In order to more effectively improve the urinary rash, the topical composition of the present invention is preferably applied for, for example, 5 days or more, preferably 1 week or more. EXAMPLES

[0052] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples.

[0053] Test Example 1 The topical composition shown in Table 1 was prepared as an oil-in-water emulsion composition (cream). Five postmenopausal women complaining of urinary rash were asked to apply the topical composition to the affected area three times a day for one week. These subjects were aware of serious urinary rash due to urinary incontinence, as well as the use of sanitary products such as urine pads or incontinence sheets made of materials that do not suit the skin, vaginal discharge, pressure irritation from underwear such as pantyhose, and / or friction irritation from the use of toilet paper. In addition, none of the subjects had shaved their delicate areas. After one week, the subjects were given a 5-point VAS score (0 being no improvement and the upper limit of 4 being complete recovery) to evaluate their satisfaction with the improvement of their urinary rash symptoms, and the average score was calculated to evaluate the "urinary rash improvement effect" according to the following criteria. The results are shown in Table 1.

[0054] <Evaluation criteria for urinary rash improvement effect> ◎: 3.0 or higher ○: 2.0 or more and less than 3.0 △: 1.0 or more and less than 2.0 ×: Less than 1.0

[0055] [Table 1]

[0056] As shown in Table 1, the topical composition of Comparative Example 1, which contained only ufenamate as the active ingredient, did not have much effect, and in the case of Comparative Example 2, which contained only lidocaine as the active ingredient, almost no effect was observed. However, the topical composition of Example 1, which contained ufenamate and lidocaine, was highly effective in improving urinary rash.

[0057] Test Example 2 The topical composition shown in Table 2 was prepared as an oil-in-water emulsion composition (cream). Seven postmenopausal women complaining of urinary rash were asked to apply the topical composition to the affected area three times a day for one week. These subjects were aware of serious urinary rash due to urinary incontinence, as well as the use of sanitary products such as urine pads or incontinence sheets made of materials that do not suit the skin, vaginal discharge, pressure irritation from underwear such as pantyhose, and / or friction irritation from the use of toilet paper. In addition, none of the subjects had shaved their private parts. After one week, the satisfaction with the improvement of the symptoms of urinary rash was evaluated using a 10-point VAS (0 being no improvement and the upper limit of 9 being complete recovery), and the average score was calculated as the "urinary rash improvement effect." The results are shown in Table 2.

[0058] [Table 2]

[0059] As shown in Table 2, the topical composition of Comparative Example 3, which contained chlorpheniramine maleate and tocopherol acetate, did not show much effect, but the topical composition of Example 2, which also contained ufenamate and lidocaine, showed a high effect in improving urinary rash, and its effect was recognized to be superior to that of the topical composition of Example 1.

[0060] Prescription Examples External compositions were prepared with the compositions shown in Tables 3 and 4. All external compositions were highly effective in improving urinary rash in postmenopausal women.

[0061] [Table 3]

[0062] [Table 4]

Claims

1. 1. A composition for external use comprising (A) ufenamate and (B) lidocaine and / or a salt thereof, which is used to improve urinary rash.

2. The topical composition according to claim 1 , which is applied to post-menopausal women.

3. The composition for external use according to claim 1 or 2, further comprising (C) an antihistamine.

4. The composition for external use according to claim 3, wherein the component (C) is chlorpheniramine and / or a salt thereof.

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