External components
A topical cream with ufenamate and lidocaine, enhanced by antihistamines and vitamins, addresses the challenge of urine rash in menopausal women, offering significant symptom relief.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- KOBAYASHI PHARMA CO LTD
- Filing Date
- 2024-12-10
- Publication Date
- 2026-04-22
AI Technical Summary
Urine rash, particularly in post-menopausal women, is exacerbated by frequent urinary incontinence, vaginal discharge, and friction/pressure irritation from sanitary products, leading to significant discomfort and difficulty in treatment.
A topical composition containing ufenamate, lidocaine, and optionally antihistamines, tocopherol, allantoin, and panthenol, formulated as creams or emulsions, to provide anti-inflammatory, anesthetic, and soothing effects.
The composition effectively reduces urinary rash symptoms by 3-4 points on a 5-point scale within a week of daily application, showing superior efficacy over individual components.
Smart Images

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Abstract
Description
Technical Field
[0001] The present invention relates to an external composition used for improving urine rash.
Background Art
[0002] Urine leakage is a complaint of involuntary urine leakage. The number of complainants rapidly increases from the forties and tends to further increase with age. In response to this, the number of people using hygiene products such as urine leakage pads and urine leakage sheets in order to aim for a comfortable daily life is increasing. However, there is a situation where the use of such hygiene products and the like promotes urine rash. For example, there is also data showing that about 80% of people using urine pads are suffering from the pain of skin trouble (Non-Patent Document 1).
[0003] The lower urinary tract is the part where the structure is most different between women and men. Due to the characteristics of the urinary incontinence mechanism due to anatomical differences, urine leakage is particularly common in women (Non-Patent Document 2). In addition, since estrogen receptors are abundantly present in the urethra, bladder, and the anterior vaginal wall that supports them, atrophy of the urethra and vagina due to estrogen decline after menopause decreases urethral pressure and causes urinary incontinence. Menopause is a state in which estrogen is decreasing, and urinary incontinence in women rapidly increases after menopause (Non-Patent Document 3). In addition, the fact that the pelvic floor muscles are more likely to loosen in women than in men also contributes to the rapid increase in female urinary incontinence. Therefore, urine rash in women after menopause has specific intractability. Furthermore, there are many cases where female-specific circumstances such as the mixing of feces, pressure stimulation by underwear such as panties stockings, and frictional stimulation by the use of toilet paper further exacerbate the female-specific intractability of urine rash.
Prior Art Documents
Non-Patent Documents
[0004]
Non-Patent Document 1
[0005] The present invention aims to provide a topical composition used to improve urinary rash. [Means for solving the problem]
[0006] The inventors, after diligent research, discovered that a topical composition containing ufenamate and lidocaine derivatives exhibits excellent efficacy in improving urinary rash. This invention was completed by further research based on this finding.
[0007] In other words, the present invention provides inventions in the following embodiments. Item 1. A topical composition comprising (A) ufenamate and (B) lidocaine and / or a salt thereof, used for the improvement of urinary rash. Item 2. The topical composition described in Item 1, applicable to women past menopause. Item 3. (C) The topical composition according to item 1 or 2, further comprising an antihistamine. Item 4. The topical composition according to Item 3, wherein the (C) component is chlorpheniramine and / or a salt thereof. [Effects of the Invention]
[0008] The present invention provides an external composition used to improve urinary rash. [Modes for carrying out the invention]
[0009] The topical composition of the present invention is characterized by containing (A) ufenamate (hereinafter also referred to as "component (A)") and (B) lidocaine and / or its salt (hereinafter also referred to as "component (B)" or "lidocaine"), and is used to improve urinary rash. The topical composition of the present invention may further contain (C) an antihistamine (hereinafter also referred to as "component (C)"). Furthermore, the topical composition of the present invention may further contain (D) tocopherol and / or its derivatives (hereinafter also referred to as "component (D)" or "tocopherols"), (E) allantoin and its derivatives (hereinafter also referred to as "component (E)" or "allantoins"), and / or (F) panthenol, its derivatives, and / or their salts (hereinafter also referred to as "component (F)" or "panthenols"). The topical composition of the present invention will be described in detail below.
[0010] (A) Ufenamat The topical composition of the present invention contains ufenamate as component (A). Ufenamate, also known as butyl flufenamate, is a well-known lipid-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 according to the pharmacological effects to be exhibited, for example, 1 to 20% by weight. From the viewpoint of further improving the effect of improving urine 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 that has a local anesthetic effect. Component (B) is a local anesthetic and does not improve urinary rash on its own, but when combined with component (A), it dramatically improves the effect of improving urinary rash.
[0013] There are no particular restrictions on lidocaine salts as long as they are pharmaceutically acceptable, but specific examples include inorganic salts such as hydrochloride.
[0014] In the topical composition of the present invention, one of lidocaine and its salts may be selected and used alone, or two or more may be used in combination. Among lidocaine and its salts, lidocaine is preferred from the viewpoint of further improving the effect on urinary rash.
[0015] The content of component (B) in the topical composition of the present invention may be set appropriately according to the pharmacological effects to be imparted, but for example, the total amount of component (B) may be 0.1 to 5% by weight, preferably 0.2 to 2% by weight, and more preferably 0.5 to 1.5% by weight.
[0016] In the external composition of the present invention, the ratio of component (B) to component (A) is determined according to the respective contents of component (A) and component (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 From the viewpoint of further improving the effect of treating urinary rash, the topical composition of the present invention may further contain an antihistamine as component (C).
[0018] The antihistamine is not particularly limited. For example, ethanolamine-based antihistamines such as diphenhydramine, bromodiphenhydramine, clemastine, chlorphenoxamine, diphenylpyraline, doxylamine, orphenadrine, phenyltoloxamine, etc.; propylamine-based antihistamines such as chlorpheniramine, dimethindene, tarastine, etc.; ethylenediamine-based antihistamines such as mepyramine, metapyrylene, tripelennamine, etc.; phenothiazine-based antihistamines such as alimemazine, hydroxyethylpromethazine, isothipendyl, mequitazine, oxomemazine, promethazine, etc.; piperazine-based antihistamines such as buclizine, cetirizine, homochlorcyclizine, cyclizine, hydroxyzine, levocetirizine, meclizine, oxatomide, etc.; ketotifen, olopatadine, fexofenadine, loratadine, terfenadine, antazoline, azatadine, bamipine, cyproheptadine, deptropine, ebastine, emedastine, epinastine, mebhydroline, mizolastine, pimecrolimus, pyrrobutamine, kifendazole, rupatadine, triprolidine, acrivastine, astemizole, azelastine, bilastine, desloratadine, and salts thereof, etc. 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 pharmaceutically acceptable, and include inorganic acid salts and organic acid salts. Examples of inorganic acid salts include hydrochloride, hydrobromide, nitrate, sulfate, phosphate, etc. Examples of organic acid salts include monocarboxylic acid salts such as acetate, trifluoroacetate, butyrate, palmitate, stearate, etc.; polyvalent carboxylic acid salts such as fumarate, maleate, succinate, malonate, etc.; oxycarboxylic acid salts such as lactate, tartrate, citrate, salicylate, etc.; organic sulfonate salts such as methanesulfonate, toluenesulfonate, tosylate, napadisylate, diphenyldisulfonate, etc., and organic sulfate salts such as lauryl sulfate, etc. These salts may be used alone or in combination of two or more.
[0020] Among these component (C), from the viewpoint of further improving the effect of improving diaper rash, preferably ethanolamine-based antihistamines and propylamine-based antihistamines can be mentioned, more preferably propylamine-based antihistamines can be mentioned, still more preferably chlorpheniramine and its salts can be mentioned, and particularly preferably chlorpheniramine maleate can be mentioned.
[0021] When the external composition of the present invention contains component (C), the content of component (C) is not particularly limited and is appropriately set according to the type of component (C). However, from the viewpoint of further improving the effect of improving diaper rash, as the total amount of component (C), for example, 0.1 to 5% by weight, preferably 0.2 to 2% by weight, more preferably 0.5 to 1.5% by weight can be mentioned.
[0022] In addition, when the external composition of the present invention contains component (C), the ratio of component (C) to component (A) is determined based on the range of the above-mentioned content of each component. However, from the viewpoint of further improving the effect of improving diaper rash, per 1 part by weight of component (A), as the total amount of component (C), for example, 0.01 to 1.5 parts by weight, preferably 0.05 to 1 part by weight, more preferably 0.1 to 0.5 parts by weight can be mentioned.
[0023] (D) Tocopherols From the viewpoint of further improving the effect of improving diaper rash, the external composition of the present invention can further contain tocopherol and / or its derivative as component (D).
[0024] Tocopherol is a known compound known as vitamin E. Tocopherol may be any of the d-form, l-form, and dl-form, but preferably the dl-form can be mentioned. Also, tocopherol may be any of the α-form, β-form, γ-form, and δ-form, but preferably the α-form can be mentioned.
[0025] Derivatives of tocopherol are not particularly limited as long as they are pharmaceutically acceptable, but examples include esters with carboxylic acids such as acetic acid, nicotinic acid, and succinic acid, and diesters with phosphoric acid. Among these tocopherol derivatives, esters with carboxylic acids are preferred, and tocopherol acetate is even more preferred, from the viewpoint of further improving the effect of treating urinary rash.
[0026] Furthermore, the tocopherol derivative may be the d-isomer, l-isomer, or dl-isomer, but the dl-isomer is preferred. Moreover, the tocopherol derivative may be the α-isomer, β-isomer, γ-isomer, or δ-isomer, but the α-isomer is 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 may be used in combination. Among the components (D), from the viewpoint of further improving the effect of improving urine rash, a derivative of tocopherol is preferred, more preferably an ester of tocopherol with a carboxylic acid, even more preferably tocopherol acetate, and particularly preferably d-α-tocopherol acetate, l-α-tocopherol acetate, and dl-α-tocopherol acetate.
[0028] The amount of component (D) in the external composition of the present invention is not particularly limited, but from the viewpoint of further improving the effect of improving urine 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 external composition of the present invention contains component (D), the ratio of component (D) to component (A) is determined based on the aforementioned content ranges of each component. However, from the viewpoint of further improving the effect of improving urine rash, a total amount of component (D) per 1 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) Allantoins From the viewpoint of further improving the effect of treating urinary rash, the topical composition of the present invention may further contain allantoin and its derivatives as component (E).
[0031] Allantoin, also known as 5-ureidohydantoin, is a well-known drug that possesses anti-inflammatory, cell-activating, hemostatic, bactericidal, and anti-ulcer effects.
[0032] While there are no particular limitations on allantoin derivatives as long as they are pharmaceutically acceptable, specific examples include allantoin chlorohydroxyaluminum and allantoin hydroxyaluminum. These allantoin derivatives may be used individually or in combination of two or more.
[0033] In the topical composition of the present invention, one of allantoin and its derivatives may be selected as component (E), or two or more may be used in combination. Among these components (E), allantoin is preferred from the viewpoint of further improving the effect of treating urinary rash.
[0034] While there are no particular limitations on the content of component (E) in the external composition of the present invention when it contains component (E), from the viewpoint of further improving the effect of improving urine rash, the total amount of component (E) is, for example, 0.05 to 1.0% by weight, preferably 0.1 to 0.5% by weight, and more preferably 0.1 to 0.3% by weight.
[0035] Furthermore, when the external composition of the present invention contains component (E), the ratio of component (E) to component (A) is determined based on the aforementioned content ranges of each component. However, from the viewpoint of further improving the effect of improving urine rash, for example, the total amount of component (E) per 1 part by weight of component (A) is 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 treating urinary rash, the external composition of the present invention may further contain panthenol, its derivatives, and / or salts thereof as component (F).
[0037] Panthenol, also known as provitamin B5, is a well-known drug used as a cell activator, moisturizer, and for other purposes.
[0038] Examples of panthenol derivatives include pantothenyl ethyl ether and acetyl pantothenyl ethyl ether. These panthenol derivatives may be used individually or in combination of two or more.
[0039] Furthermore, the panthenol and / or its salts are not particularly limited as long as they are pharmaceutically acceptable, but specific examples include alkali metal salts such as potassium salts and sodium salts, and alkaline earth metal salts such as calcium salts. These salts may be used individually or in combination of two or more.
[0040] If the topical composition of the present invention contains component (F), one may be selected from panthenol, a salt of panthenol, a derivative of panthenol, or a salt of a derivative of panthenol, or two or more may be used in combination as component (F).
[0041] Among these panthenol compounds, panthenol is preferred from the viewpoint of further improving the effect of treating urinary rash.
[0042] While there are no particular limitations on the content of component (F) in the external composition of the present invention when it contains component (F), from the viewpoint of further improving the effect of improving urine 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 external composition of the present invention contains component (F), the ratio of component (F) to component (A) is determined based on the aforementioned content ranges of each component. However, from the viewpoint of further improving the effect of improving urine rash, for example, the total amount of component (F) per 1 part by weight of component (A) is 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, in addition to the components described above, optionally contain other pharmacological components. Such pharmacological components include, for example, local anesthetics (dibucaine, procaine, tetracaine, bupivacaine, mepivacaine, chloroprocaine, propalacaine, meprilcaine, or salts thereof), alkyl benzoates (e.g., ethyl aminobenzoate, diethylaminoethyl parabutylaminobenzoate hydrochloride), orthocaine, oxethazaine, oxypolyentoxydecane, belladonna extract, percaminase, tesitdecitin, etc.), and anti-inflammatory agents (glycyrrhetinic acid, glycyrrhetinate, salicylic acid, glycol salicylate, methyl salicylate, indomethacin, felbinac, diclofenac sodium, loxoprofen sodium, etc.). Examples of antiseptics include bactericides (zinc oxide, benzalkonium chloride, decalinium chloride, benzethonium chloride, cetylpyridinium chloride, isopropylmethylphenol, chlorhexidine hydrochloride, chlorhexidine gluconate, ammonia water, sulfadiazine, lactic acid, phenol, etc.), antipruritic agents (diphenhydramine, crotamiton, thianthol, etc.), skin protectants (collodion, castor oil, etc.), blood circulation promoting ingredients (nonyl vanillylamide, benzyl nicotinate, 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 components mentioned above, other bases and additives commonly used in topical skin preparations may be included as needed. Such bases and additives are not particularly limited to those that are pharmaceutically acceptable, but examples 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 hydrocarbons, petrolatum, etc.); waxes (beeswax, carnauba wax, candelilla wax, ceresin, rice wax, microcrystalline wax, etc.); and ester oils (isopropyl myristate, isopropyl adipate). 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; and 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, and their phosphates and phosphates (POE cetyl ether sodium phosphate, etc.), 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 esters (glyceryl monostearate, etc.), hydrogenated soybean phospholipids, 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-cineole, citronellal, farnesol, etc.), coloring agents (tar dyes (Brown No. 201, Blue No. 201, Yellow No. 4, Yellow No. 403, etc.), cocoa pigment, chlorophyll, aluminum oxide, etc.), viscosity modifiers (carboxyvinyl polymer, hypromellose, polyvinylpyrrolidone, sodium alginate, ethylcellulose, hydroxyethylcellulose, sodium carboxymethylcellulose, xanthan gum, carrageenan, etc.), pH adjusters (phosphoric acid, hydrochloric acid, citric acid, chlorine Additives include sodium euthenate, succinic acid, tartaric acid, sodium hydroxide, potassium hydroxide, triethanolamine, triisopropanolamine, etc.; humectants (dl-pyrrolidone carboxylate sodium 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; UV absorbers; chelating agents; adhesives; buffers; solubilizers; preservatives; and other additives.
[0046] Characteristics, Formulation, etc. The properties of the external composition of the present invention are not particularly limited, and examples include aqueous liquid compositions, aqueous gel compositions, oily gel compositions, and emulsion compositions. Among these, emulsion compositions are preferred from the viewpoint of further improving the effect of treating urinary rash. The emulsion state of the emulsion composition may be either oil-in-water or water-in-oil, but oil-in-water is preferred from the viewpoint of further improving the effect of treating urinary rash.
[0047] The formulation form of the topical composition of the present invention is not particularly limited, and examples include lotions, emulsions, ointments, creams, etc. Among these, emulsions and creams are preferred from the viewpoint of further improving the effect of treating urine rash and from the viewpoint of ease of application.
[0048] Examples of the external composition of the present invention include pharmaceuticals, quasi-drugs, cosmetics, and the like. Among these formulations, pharmaceuticals are preferred.
[0049] Purpose The topical composition of the present invention is used to improve inflammation caused by urinary rash. The topical composition of the present invention can be applied without particular limitations to any person with urinary rash. It can also be applied regardless of whether or not sanitary products such as urinary pads or incontinence sheets are used, but the topical composition of the present invention is particularly preferred for urinary rash caused by contact irritation from constant contact with these sanitary products, and / or irritation from the materials of the sanitary products to the skin.
[0050] Furthermore, the topical composition of the present invention is particularly preferable for women in menopause and beyond (i.e., women in menopause and women who have passed menopause). Urine rash in women in menopause and beyond exhibits uniquely difficult-to-treat characteristics due to factors specific to women, such as frequent urinary incontinence, or frequent urinary incontinence in addition to vaginal discharge, pressure irritation from underwear such as pantyhose, and / or friction irritation from the use of toilet paper. Because the topical composition of the present invention has excellent effects in improving inflammation caused by urine rash, it is particularly effective for such difficult-to-treat urine rash specific to menopausal women.
[0051] The topical composition of the present invention can be applied to skin affected by urine rash by applying it 1 to 6 times a day. Furthermore, to obtain a more effective improvement in urine rash, it is preferable to apply the topical composition of the present invention for, for example, 5 days or more, preferably 1 week or more. [Examples]
[0052] The present invention will be described in detail below with reference to examples, but the present invention is not limited to these examples.
[0053] Test Example 1 Topical compositions with the compositions shown in Table 1 were prepared as oil-in-water emulsions (creams). Five post-menopausal women complaining of urinary rash were instructed to apply the prepared topical compositions to the affected area three times a day for one week. These subjects experienced severe urinary rash due to urinary incontinence, the use of sanitary products such as incontinence pads or incontinence sheets made of materials unsuitable for their skin, vaginal discharge contamination, pressure irritation from underwear such as pantyhose, and / or friction irritation from toilet paper. None of the subjects shaved their genital area. After one week, satisfaction with the improvement of urinary rash symptoms was rated on a 5-point VAS scale (0 representing no improvement, with a maximum of 4 representing complete recovery), and the average score was calculated. The "urinary rash improvement effect" was evaluated according to the following criteria. The results are shown in Table 1.
[0054] <Evaluation Criteria for Improving Urine-Related Skin Irritation> ◎: 3.0 or higher ○: 2.0 or higher, less than 3.0 △: 1.0 or higher, 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, showed little 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 both ufenamate and lidocaine, showed a high effect in improving urine rash.
[0057] Test Example 2 Topical compositions with the compositions shown in Table 2 were prepared as oil-in-water emulsion compositions (creams). Seven post-menopausal women who complained of urinary rash were given the prepared topical compositions to apply to the affected area three times a day for one week. These subjects experienced severe urinary rash due to urinary incontinence, the use of sanitary products such as urine pads or incontinence sheets made of materials that did not suit their skin, vaginal discharge contamination, pressure irritation from underwear such as pantyhose, and / or friction irritation from the use of toilet paper. None of the subjects shaved their genital area. After one week, satisfaction with the improvement of urinary rash symptoms was rated on a 10-point VAS scale (0 representing no improvement, with an upper limit of 9 representing 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. However, the topical composition of Example 2, which further contained ufenamate and lidocaine, showed a high effect in improving urine rash, and its effect was found to be superior to that of the topical composition of Example 1.
[0060] Prescription examples Topical compositions with the compositions shown in Tables 3 and 4 were prepared. All of the topical compositions showed a high efficacy in improving urinary rash in women after menopause.
[0061] [Table 3]
[0062] [Table 4]
Claims
1. A topical composition comprising (A) ufenamate, (B) lidocaine and / or a salt thereof, and (C) an antihistamine, which is applied to women after menopause and used to improve urinary rash.
2. The topical composition according to claim 1, wherein the (C) component is chlorpheniramine and / or a salt thereof.
Citation Information
Patent Citations
Absorption-promoting agent and external preparation containing the same
JP1992275235A
Ufenamate preparation for external use
JP1999302167A
Antipruritic agent for external use
JP2005206523A
External composition
JP2019156772A
Skin external composition
JP2020033311A