Treatment of psoriasis

Abstract

The present invention relates to a topical preparation comprising, as an active ingredient, one or more low-potency class 6 corticosteroids, emulsified ointment BP, honey, one or more natural oils, and optionally salicylic acid; a method for producing the topical preparation; and a method for treating psoriasis or its symptoms in a subject by applying the topical preparation of the present invention to the subject requiring treatment of psoriasis or its symptoms.

Description

【Technical Field】 【0001】 The present invention relates to the treatment of psoriasis. 【Background Art】 【0002】 Psoriasis is an inflammatory disease characterized by various symptoms. The most typical symptoms are itchy rashes and scaly patches that appear on the knees, elbows, trunk, and scalp. Psoriasis is a common, long-term, i.e., chronic skin disease. 【0003】 In addition, the symptoms of psoriasis can repeat exacerbation periods when the symptoms worsen and remission periods when the symptoms subside. The remission period lasts an average of 1 to 12 months. However, the length of either the exacerbation period or the remission period may be difficult to predict in some cases. 【0004】 Therefore, psoriasis basically has the following three stages, namely, ● An acute phase characterized by itching and exacerbation of scales / rashes, ● A scaling phase characterized by thickening and / or discoloration of the affected area, and ● It may be characterized by a remission phase without itching, but with mild flaking, dryness, or skin redness. 【0005】 Existing products that have been commercially used to treat psoriasis and its symptoms are various, and some of them are shown in Table 1. 【Table 1】 【0006】 However, as a pharmaceutical pharmacist with more than 20 years of experience, the applicant has confirmed that none of these formulations are effective in the long term, and what patients can obtain is at most a short-term reduction in symptoms, and then psoriasis returns to its original severity. 【Summary of the Invention】 【Problems to be Solved by the Invention】 【0007】 Therefore, the development of alternative products that can provide long-term relief from psoriasis and its symptoms would be extremely useful. [Means for solving the problem] 【0008】 According to a first aspect of the present invention, a topical formulation is provided comprising, as an active ingredient, one or more low-potency class 6 corticosteroids, emulsified ointment BP, honey, one or more natural oils, and optionally salicylic acid. 【0009】 In one possible embodiment of the first aspect of the present invention, the topical formulation comprises, as an active ingredient, one or more low-potency class 6 corticosteroids, emulsified ointment BP, honey, one or more natural oils, and optionally salicylic acid. 【0010】 It goes without saying that low-potency Class 6 corticosteroids are well known to those skilled in the art. However, in particular, low-potency Class 6 corticosteroids may be selected from the group consisting of one or more Class B triamcinolone acetonide-type corticosteroids, one or more Class D betamethasone dipropionate-type corticosteroids, or any combination thereof. 【0011】 For example, class B triamcinolone acetonide-type corticosteroids are, Desonide 0.05% (w / w), Fluocinolone acetonide 0.01% (w / w), Triamcinolone acetonide 0.025% (w / w), or Triamcinolone acetate 0.025% (w / w), or any one or more combinations thereof may be selected. 【0012】 For example, class D betamethasone dipropionate-type corticosteroids are, Alclomethasone propionate 0.05% (w / w), or Betamethasone valerate 0.1% (w / w), or any one or more combinations thereof may be selected. 【0013】 In one possible embodiment of the first aspect of the present invention, the low-potency Class 6 corticosteroid is fluocinolone acetonide. In particular, the fluocinolone acetonide may have the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α) and have the structural formula shown in formula I. [ka] 【0014】 The formulation may contain approximately 0.0025% to 0.2% of class 6 low-potency corticosteroids, particularly approximately 0.0025% to 0.025% by weight of the entire formulation. 【0015】 In one embodiment of the present invention, the formulation contains, by weight, about 0.00625% to 0.01% of a class 6 low-potency corticosteroid, for example, about 0.0025% of a class 6 low-potency corticosteroid. 【0016】 In another possible embodiment of the present invention, the formulation contains about 0.025% by weight of a class 6 low-potency corticosteroid. 【0017】 In yet another possible embodiment of the present invention, the formulation contains about 0.2% of a class 6 low-potency corticosteroid by weight of the entire formulation. 【0018】 In one possible embodiment of the present invention, the low-potency Class 6 corticosteroid is fluocinolone acetonide. 【0019】 One or more corticosteroids may be formulated into a cream, foam, or ointment. In particular, the formulation may be an ointment. 【0020】 The honey is raw and unprocessed honey. Here, the honey refers to that in the hive box where it was produced. In particular, the preparation contains about 5% to about 10% honey based on the weight of the whole preparation. For example, the preparation may contain about 5%, or about 6%, or about 7%, or about 8%, or about 9%, or about 10% honey based on the weight of the whole preparation. 【0021】 One or more natural oils are preferably olive oil. More specifically, the olive oil is virgin olive oil extracted by the cold process method. The preparation may contain about 5% to about 10% of one or more natural oils based on the weight of the whole preparation. For example, the preparation may contain about 5%, or about 6%, or about 7%, or about 8%, or about 9%, or about 10% of one or more natural oils based on the weight of the whole preparation. 【0022】 In certain embodiments, the emulsifying ointment BP Emulsifying wax - 30% (w / w), White soft paraffin - 50% (w / w), and Liquid paraffin - 20% (w / w). 【0023】 Generally, the preparation contains emulsifying ointment BP to make the final preparation 100% based on the weight of the whole preparation. 【0024】 In particular, the salicylic acid may be the one shown in Formula II. 【Chemical formula】 【0025】 The preparation may contain about 2% to about 10% by weight of salicylic acid. For example, the preparation may contain about 2%, or about 3%, or about 4%, or about 5%, or about 6%, or about 7%, or about 8%, or about 9%, or about 10% of salicylic acid based on the weight of the whole preparation. 【0026】 A second embodiment of the present invention provides a formulation according to the first embodiment of the present invention for use in treating psoriasis or at least one symptom caused by psoriasis in a subject requiring treatment for psoriasis or at least one symptom caused by psoriasis. 【0027】 In particular, the target population is humans. The formulation may be in the form of a cream or an ointment. In particular, the formulation may be an ointment. 【0028】 A third aspect of the present invention provides the use of a compound comprising one or more class 6 low-potency corticosteroids, emulsified ointment BP, honey, one or more natural oils, and optionally salicylic acid, as described in the first aspect of the present invention, in the manufacture of a formulation for treating psoriasis or at least one symptom caused by psoriasis in a subject requiring treatment for psoriasis or at least one symptom caused by psoriasis. 【0029】 In particular, the target population is humans. The formulation may be in the form of a cream or an ointment. In particular, the formulation may be an ointment. 【0030】 A fourth aspect of the present invention relates to a method for treating psoriasis or at least one symptom caused by psoriasis in a subject requiring treatment for psoriasis or at least one symptom caused by psoriasis, the method comprising topically applying a formulation according to the first aspect of the present invention to an area of ​​skin of a subject suffering from psoriasis or at least one symptom caused by psoriasis. 【0031】 The method comprises a first step of selecting a specific formulation according to a first aspect of the present invention, the specific formulation having one or more concentrations of a class 6 low-potency corticosteroid suitable for a specific stage of psoriasis or its symptoms. Here, the specific stage is: Typically, the acute phase is characterized by itching, inflammation, scaling, and / or rash. Typically, the scaling stage is characterized by the formation of scales accompanied by thickening and / or discoloration of the affected area; and Typically, there is no itching, but one of the remission phases is selected, characterized by mild desquamation, dryness, and / or skin inflammation. 【0032】 In one possible embodiment of a fourth aspect of the present invention, if the subject is in the acute phase, the formulation may be an acute-phase formulation having one or more Class 6 low-potency corticosteroid concentrations of about 0.0125% by weight. Optionally, in this embodiment of the fourth aspect of the present invention, the formulation may contain salicylic acid. For example, the formulation may contain salicylic acid at a concentration of about 2%, or about 3%, or about 4%, or about 5%, or about 6%, or about 7%, or about 8%, or about 9%, or about 10% by weight of the entire formulation. 【0033】 In this embodiment of the present invention, the formulation may be applied twice daily to the affected area of ​​the subject's skin until the acute symptoms of psoriasis resolve, thereby inducing remission in the subject, followed by a gradual discontinuation of the acute formulation, including application once daily for about 5 days, and then application once daily every other day for the next 10 days. Typically, the subject may then use a formulation according to the first embodiment of the present invention (i.e., a remission formulation) during remission, containing about 0.0025% by weight of one or more low-potency class 6 corticosteroids. Typically, the remission formulation does not contain salicylic acid. 【0034】 In yet another possible embodiment of the fourth aspect of the present invention, when the subject is in the desquamating stage, the concentration of one or more low-potency class 6 corticosteroids in the formulation may be about 0.00625% by weight (i.e., desquamating formulation), and the formulation may further contain about 2% to about 10% by weight of salicylic acid. For example, the formulation may contain salicylic acid at a rate of about 2%, or about 3%, or about 4%, or about 5%, or about 6%, or about 7%, or about 8%, or about 9%, or about 10% by weight of the entire formulation. 【0035】 In this embodiment of the present invention, the formulation may be applied twice daily to the affected area of ​​the skin until the scaling symptoms of psoriasis resolve, thereby inducing remission in the subject, followed by a gradual discontinuation of the use of the scaling formulation, including application once daily for about 5 days, and then application once daily every other day for the next 10 days. Typically, the subject may then use the formulation of the present invention (i.e., the remission formulation) during remission, containing one or more low-potency class 6 corticosteroid concentrations of about 0.0025% by weight. Typically, the remission formulation does not contain salicylic acid. 【0036】 In yet another possible embodiment of the fourth aspect of the present invention, if the subject is in remission, the concentration of one or more class 6 low-potency corticosteroids in the formulation may be about 0.0025% by weight (i.e., remission formulation). Typically, the remission formulation does not contain salicylic acid. 【0037】 A fifth aspect of the present invention provides a method for producing the formulation described in the first aspect of the present invention, the method comprising mixing one or more low-potency class 6 corticosteroids, emulsified ointment BP, honey, one or more natural oils, and optionally salicylic acid, as described in the first aspect of the present invention. [Examples] 【0038】 The subject matter disclosed herein will be described in more detail with reference to the representative embodiments set forth below. However, the representative embodiments described herein are not limited to those shown below and may be embodied in a variety of other forms. Rather, these embodiments are provided to ensure that this disclosure is thorough and complete and to fully convey the scope of the embodiments to those skilled in the art. 【0039】 Comparison of the formulation of the present invention with existing commercially available products 【0040】 The following are observational results from five case studies comparing the effectiveness of existing commercially available products prescribed by patients' physicians with the topical formulations of the present invention. Different formulations of the present invention were administered depending on the stage of the symptoms. ●P1 for the acute phase ●P2 for the scaling stage ●--P3 for remission 【0041】 Therapeutic preparations P1 for acute treatment 100g prescription - Class 6 low-potency corticosteroids such as fluocinolone acetonide - 0.0125% (w / w) - Raw honey - 5% (w / w) —Olive oil - 5% (w / w) - Add emulsified ointment BP until the total volume reaches 100g (w / w). ―Optional: Salicylic acid -5% (w / w) 【0042】 If salicylic acid is included, first weigh the salicylic acid and grind it into a powder. Next, add 0.00625% (w / w) of class 6 low-potency corticosteroid and mix until completely combined. If salicylic acid is not included, first weigh the specified amount of emulsified ointment BP, then add the class 6 low-potency corticosteroid and mix until completely combined. Gradually add the honey and olive oil and mix until uniform. 【0043】 The resulting product is a smooth, stable, and pleasantly fragrant cream, which is applied only to the affected area twice a day. 【0044】 After relief is achieved, apply this product once daily for 5 days, then every other day for the next 10 days, and discontinue over 2 weeks. Afterward, the patient will be in remission and may use the remission treatments described below. 【0045】 Phase 2 for treatment of the scaling stage 100g prescription — Class 6 low-potency corticosteroids such as fluocinolone acetonide - 0.00625% (w / w) — Raw honey - 5% (w / w) — Olive oil - 5% (w / w) — Salicylic acid - 5% (w / w) — Add emulsified ointment BP until the total volume reaches 100g (w / w). 【0046】 First, weigh the salicylic acid and grind it into a powder. Next, add 0.00625% (w / w) of class 6 low-potency corticosteroid and mix until completely combined. First, weigh the specified amount of emulsified ointment BP, then add the class 6 low-potency corticosteroid and mix until combined. Finally, gradually add the honey and olive oil and mix continuously until homogenized. 【0047】 The resulting product is a smooth, stable, and pleasantly fragrant cream, which is applied only to the affected area twice a day. 【0048】 The scaly stage is characterized by skin hardening, scaling, dryness, and itching, so it is necessary to add salicylic acid, which has a keratolytic effect. 【0049】 After relief is achieved, apply this product once daily for 5 days, then every other day for the next 10 days, and discontinue over 2 weeks. Afterward, the patient will be in remission and may use the remission treatments described below. 【0050】 Phase 3 treatment for remission 100g prescription — Class 6 low-potency corticosteroids such as fluocinolone acetonide - 0.0025% (w / w) — Raw honey - 10% (w / w) — Olive oil - 10% (w / w) — Add emulsified ointment BP until the total volume reaches 100g (w / w). 【0051】 Weigh out the specified amount of PB emulsified ointment and add 0.0025% (w / w) of class 6 low-potency corticosteroid, and mix until completely combined. Finally, gradually add the honey and olive oil, and mix continuously until homogenized. 【0052】 The resulting product is a smooth, stable, and pleasantly fragrant cream, which is applied in small amounts to the affected area twice a day. 【0053】 Treatment with remission-promoting agents should be administered after treatment of the acute and scaling phases. 【0054】 During remission, the goal is to keep the skin in a "calm" state and prevent relapse. For this reason, even very small amounts (0.0025% (w / w)) of low-potency Class 6 corticosteroids have been found to be effective in preventing inflammation and eliminating itching that may occur during remission. 【0055】 case study Case 1 A 50-year-old adult male had been receiving treatment for approximately one year with a combination of commercially available medications: chlorphenoxamine hydrochloride (Allergex®) cream, NomoSpore (bacitracin, neomycin, polymyxin B, and cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, and white petrolatum), and clobetasol propionate (Dovate®). At the time of initial treatment with formulation P1 of the present invention, the subject presented with acute psoriasis, exhibiting itching, skin damage, and cuts on the lower legs. 【0056】 By the end of the first week of treatment with formulation P1, the subjects reported a reduction in itching within 2-3 days, and their skin condition showed less inflammation than at the start of treatment. By the end of the second week of treatment, the cuts had begun to close, and the inflammation of the skin condition had further decreased compared to the first week. By the end of the third week, the skin condition was almost normal. At the end of the fourth week, the subjects were switched to formulation P3 for maintenance management of psoriasis, and no recurrence was observed after 3 months of follow-up. 【0057】 Case Study 2 A 35-year-old adult male had been receiving treatment for more than three years with a combination of commercially available medications. Specifically, chlorphenoxamine hydrochloride (Allergex®) tablets and cream, Vaseline® (petrolatum, palmitic acid, stearic acid, mineral oil, glycerin, glyceryl stearate, cetyl alcohol, potassium hydroxide), and Dovonex® cream (calcipotriene hydrate equivalent to 50 μg / g of calcipotriene anhydride in a cream base consisting of cetearyl alcohol, ceteth-20, diazolidinyl urea, dichlorobenzyl alcohol, disodium hydrogen phosphate, disodium edetate, dl-α-tocopherol, glycerin, mineral oil, and petrolatum). At the time of initial treatment with formulation P2 of the present invention, the subject presented with scaly psoriasis, exhibiting a skin condition characterized by extreme dryness, scaling, and itchiness on both feet above the ankles. 【0058】 By the end of the first week of treatment with formulation P2, the subject reported reduced itching, and most of the scaling had cleared compared to the start of treatment. By the end of the second week of treatment, the subject was able to transition to formulation P3 for maintenance management of psoriasis. One month after the start of treatment, the subject experienced a mild exacerbation, but the exacerbation resolved after two days of treatment with formulation P1. The subject was then able to return to formulation P3 and continue maintenance management of psoriasis, and no further exacerbations were observed thereafter. 【0059】 Case Study 3 A 6-year-old girl had been treated with an aqueous emulsion ointment for approximately two years. At the time of initial treatment with the remission formulation P3 of the present invention, the subject presented with severely itchy inflammatory skin patches on her body. The subject reported relief within one week of treatment and remained symptom-free for six months using formulation P3. 【0060】 Case 4 A 65-year-old adult woman had been receiving treatment for approximately two years using a combination of commercially available medications. These included Skincalm™ (infused oils (calendula, Oregon graperoot, comfrey leaf, comfrey root, chamomile, olive oil), distilled water, shea butter, glycerin, beeswax, vegetable emulsifying wax, borage oil, emu oil, vitamin E, potassium sorbate) and Zam-buk™ (paraffin wax, light-colored rosin (colophony), eucalyptus oil, camphor, thyme oil, and sassafras oil). At the time of initial treatment with the remission formulation P3 of the present invention, the subject exhibited dryness, itching, and discoloration on both shins due to psoriasis. The subject reported relief within one week of treatment and remained symptom-free for six months using formulation P3. 【0061】 Case Study 5 An 8-year-old girl had been treated for approximately 6 months with a combination of commercially available medications: olive oil, followed by a mixture of Dovate (registered trademark), coal tar, and salicylic acid. At the time of initial treatment with the scaling-stage formulation P2 of the present invention, the subject presented with a dry and itchy skin condition on the back of the neck due to psoriasis, and dryness and scaling on the scalp. Within 3 days of starting treatment with P2, the subject reported a reduction in symptoms and disappearance of scaling. Subsequently, the subject transitioned to the remission-stage formulation P3 and remained asymptomatic for 8 months without exacerbation.

Claims

[Claim 1] A topical preparation comprising one or more low-potency class 6 corticosteroids, emulsified ointment BP, honey, one or more natural oils, and optionally salicylic acid as active ingredients. [Claim 2] A topical preparation according to claim 1, comprising one or more low-potency class 6 corticosteroids, emulsified ointment BP, honey, one or more natural oils, and optionally salicylic acid as active ingredients. [Claim 3] The topical formulation according to claim 1 or 2, wherein the Class 6 low-potency corticosteroid(s) is selected from the group consisting of one or more Class B triamcinolone acetonide-type corticosteroids(s), one or more Class D betamethasone dipropionate-type corticosteroids(s), or any combination thereof. [Claim 4] The aforementioned class B triamcinolone acetonide-type corticosteroid(s) Desonide 0.05% (w / w), Fluocinolone acetonide 0.01% (w / w), Triamcinolone acetonide 0.025% (w / w), or The topical formulation according to claim 3, selected from one or more of the following: triamcinolone acetate 0.025% (w / w), or any combination thereof. [Claim 5] The aforementioned Class D dipropionate betamethasone-type corticosteroid(s) Alclomethasone propionate 0.05% (w / w), or The topical formulation according to claim 3, comprising one or more of the following: betamethasone valerate 0.1% (w / w), or any combination thereof. [Claim 6] The topical preparation according to any one of claims 1 to 4, wherein the Class 6 low-potency corticosteroid has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α) and the structural formula is fluocinolone acetonide shown in formula I. 【Chemistry 1】 [Claim 7] A topical formulation according to any one of claims 1 to 6, comprising approximately 0.0025% to approximately 0.0125% by weight of the Class 6 low-potency corticosteroid in the entire formulation. [Claim 8] The topical formulation according to claim 7, comprising approximately 0.0125% by weight of the class 6 low-potency corticosteroid in the entire formulation. [Claim 9] The topical formulation according to claim 7, comprising approximately 0.00625% by weight of the class 6 low-potency corticosteroid in the entire formulation. [Claim 10] The topical formulation according to claim 7, comprising approximately 0.0025% by weight of the Class 6 low-potency corticosteroid in the entire formulation. [Claim 11] The topical formulation according to any one of claims 1 to 10, wherein one or more corticosteroids are formulated into a cream, foam, or ointment. [Claim 12] The topical formulation according to any one of claims 1 to 11, wherein the honey is raw, unprocessed honey. [Claim 13] The topical formulation according to claim 12, wherein the formulation contains honey in an amount of about 5% to about 10% by weight of the entire formulation. [Claim 14] The topical formulation according to any one of claims 1 to 13, wherein the one or more natural oils is olive oil including virgin olive oil extracted by the cold process method. [Claim 15] The topical formulation according to claim 14, wherein the formulation contains one or more natural oils in an amount of about 5% to about 10% by weight of the entire formulation. [Claim 16] The emulsified ointment BP described above, Emulsifying wax - 30% (w / w), White soft paraffin - 50% (w / w), and A topical formulation according to any one of claims 1 to 15, comprising liquid paraffin - 20% (w / w). [Claim 17] The topical formulation according to any one of claims 1 to 16, wherein the formulation comprises an amount of emulsified ointment BP by weight to achieve a final formulation concentration of 100% by weight. [Claim 18] The topical formulation according to any one of claims 1 to 17, wherein the salicylic acid has the formula of formula II. 【Chemistry 2】 [Claim 19] The topical formulation according to any one of claims 1 to 18, wherein the formulation contains salicylic acid in an amount of about 2% to about 10% by weight of the entire formulation. [Claim 20] A topical preparation according to any one of claims 1 to 19, which is in the form of a cream or ointment. [Claim 21] A topical formulation according to any one of claims 1 to 20, for use in a method of treating psoriasis or at least one symptom caused by psoriasis in a subject requiring treatment for at least one symptom caused by psoriasis or psoriasis. [Claim 22] The use of one or more Class 6 low-potency corticosteroids, emulsified ointment BP, honey, one or more natural oils, and optionally salicylic acid, in the manufacture of a formulation for treating psoriasis or at least one symptom caused by psoriasis in a subject requiring treatment for psoriasis or at least one symptom caused by psoriasis, as described in any one of claims 1 to 19. [Claim 23] The use according to claim 22, wherein the formulation is in the form of a cream or ointment. [Claim 24] A method for treating psoriasis or at least one symptom caused by psoriasis in a subject requiring treatment for at least one symptom caused by psoriasis, the method comprising topically applying a formulation according to any one of claims 1 to 20 to an area of ​​skin of the subject suffering from psoriasis or at least one symptom caused by psoriasis until the psoriasis or at least one symptom caused by psoriasis subsides. [Claim 25] The method comprises a first step of selecting a specific formulation, wherein the specific formulation has concentrations of one or more Class 6 low-potency corticosteroids and optionally salicylic acid in the formulation that are suitable for a specific stage of the psoriasis or its symptoms, wherein the specific stage is The acute phase includes symptoms such as itching, inflammation, scaling, and / or rash. The scaling stage includes symptoms of thickening and / or discoloration of the affected area, and the formation of scales, and One of the remission phases is selected, which includes symptoms of mild desquamation, dryness, and / or skin inflammation, although there is no itching. The appropriate concentrations of one or more Class 6 low-potency corticosteroids and optionally salicylic acid are selected from the following: If the subject is in the acute phase, the formulation is an acute phase formulation in which the concentration of one or more class 6 low-potency corticosteroids is approximately 0.0125% by weight of the entire formulation, and optionally, the formulation contains approximately 2% to approximately 10% salicylic acid. When the subject is in the scaling stage, the formulation is a scaling stage formulation comprising one or more class 6 low-potency corticosteroids at a concentration of about 0.00625% by weight of the entire formulation, and salicylic acid at a concentration of about 2% to about 10% by weight of the entire formulation. The method according to claim 24, wherein, when the subject is in the remission phase, the formulation is a remission formulation in which the concentration of one or more class 6 low-potency corticosteroids is approximately 0.0025% by weight of the entire formulation, and salicylic acid is not present in the formulation. [Claim 26] The method according to claim 25, wherein if the subject is in the acute phase, the preparation is applied twice a day to the affected area of ​​the subject's skin until the acute symptoms of psoriasis are resolved, thereby causing the subject to enter the remission phase, followed by a gradual discontinuation of the use of the acute phase preparation, including application once a day for approximately five days, then application once a day every other day for approximately the next ten days, and finally, the subject is treated with the remission phase preparation as needed. [Claim 27] The method according to claim 25, wherein if the subject is in the scaling stage, the preparation is applied twice a day to the affected area of ​​the subject's skin until the scaling stage symptoms of psoriasis are resolved, thereby causing the subject to enter the remission stage, followed by a gradual discontinuation of the use of the scaling stage preparation, including application once a day for approximately five days, then application once a day every other day for the next approximately ten days, and finally, the subject is treated with the remission stage preparation as needed. [Claim 28] The method according to claim 25, wherein if the subject is in the remission phase, the remission phase preparation is applied as necessary. [Claim 29] The method according to any one of claims 25 to 28, wherein the remission preparation is applied to the affected skin requiring treatment by the subject about twice a day. [Claim 30] A method for producing a topical preparation according to any one of claims 1 to 20, comprising mixing one or more low-potency class 6 corticosteroids, emulsified ointment BP, honey, one or more natural oils, and optionally salicylic acid until well combined.

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