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WO1994005302A1 - Compositions de traitement de la dermite contenant du soufre, de l'acide salicylique et un agent de liberation de groupe sulfhydryle - Google Patents

Compositions de traitement de la dermite contenant du soufre, de l'acide salicylique et un agent de liberation de groupe sulfhydryle Download PDF

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Publication number
WO1994005302A1
WO1994005302A1 PCT/GB1993/001874 GB9301874W WO9405302A1 WO 1994005302 A1 WO1994005302 A1 WO 1994005302A1 GB 9301874 W GB9301874 W GB 9301874W WO 9405302 A1 WO9405302 A1 WO 9405302A1
Authority
WO
WIPO (PCT)
Prior art keywords
salicylic acid
sulphur
physiologically acceptable
releasing agent
composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB1993/001874
Other languages
English (en)
Inventor
Aws Shakir Mustafa Salim
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to AU49745/93A priority Critical patent/AU4974593A/en
Publication of WO1994005302A1 publication Critical patent/WO1994005302A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Definitions

  • the present invention relates to the treatment of and protection against housewife dermatitis.
  • This dermatitis is troublesome and usually very difficult to treat.
  • the condition represents the injury inflicted on the skin of the fingers and hands following contact with household detergents, cleansing agents and purifying substances.
  • the dermatitis manifests itself by dryness, roughening, thickening and fissuring of the fingers and hand. Exposure to sunlight for long periods, air pollutants and environmental irritants, promote the dermatitis and enhance its severity.
  • the mechanism responsible for the development of housewife dermatitis is complex. Although an extensive range of products is available on the market, none is designed to combat the factors behind the development of the dermatitis and none opposes the mediators of skin injury and damage which represent the final common pathway through which irritants such as detergents, produce their adverse skin effects.
  • the present invention aims, therefore, at directly addressing these issues by providing a ⁇ ynergistic composition which not only effectively treats housewife dermatitis and enhances its healing, but also protects against the recurrence of this condition. It follows that application of this invention to the skin improves its condition and maintains its texture and vitality.
  • the invention provides a synergistic composition suitable for use in the treatment of housewife dermatitis, which composition comprises sulphur with salicylic acid and a physiologically acceptable, organic, in vivo sulphydryl group releasing agent.
  • This agent may be one of di ethylsulphoxide, cysteine, cystine, cysteamine or methionine wherein the carboxyl group has been esterified, preferably by lower alkyl having 1 to 6 carbon atoms, e.g. methyl, S-methyl substituted, ternary sulphonium, derivatives of methionine such as methionine-S-methyl sulphonium bromide, iodide or chloride.
  • the abovementioned compounds have one or more optically active centres, in particular in the case of the amino acids at the a ino-and carboxyl-substituted carbon.
  • the present invention extends to both individual isomers such as D- and L- isomers and enantio ers, and in the case where two or more optically active centres are present, diastereoisomers, as well as mixtures of isomers including racemic DL mixtures.
  • the application of the composition to the skin of the hands has been found in a surprising and very unexpected manner to improve its condition in a number of ways including protection against irritation, maintenance of texture and vitality, and in particular the protection against and treatment of housewife dermatitis.
  • the ingredients of the composition interact in a synergistic manner in that the sum of the action of all the ingredients used separately is less than that exhibited by the composition.
  • vasodilator such as menthol in order to further increase the effectiveness of the composition in the skin.
  • the present invention provides a composition of the invention in intimate admixture with a physiologically acceptable carrier, for use in improving the condition of the skin of the hands.
  • the present invention provides a topical formulation comprising a composition of the invention in intimate " admixture with a pharmaceutically acceptable vehicle.
  • vehicle should be 'acceptable' in terms of being generally non-deleterious to the skin of the subject being treated and compatible with the other ingredients of the formulation. It will of course be appreciated that certain individuals have significantly more sensitive skins than the average and that in these special cases alternative vehicles to those normally used may need to be tried.
  • Suitable vehicles are well known in the art being noted for example in such standard works as the British Pharmacopoeia and the British National Formulary and include ointment bases and cream bases as well as lotions, pastes, jellies, sprays, aerosols and bath oils.
  • Ointments and creams may contain oleaginous absorption colloidal clays, thickening agents such as gum tragacanth or sodium alginate and other pharmaceutically acceptable accessory ingredients such as humectants, preservatives, buffers and antioxidants which have utility in such formulations.
  • Cream formulations are usually preferred as being most acceptable to the majority of users.
  • a particularly convenient base is one utilizing cetomacrogol, comprising for example 30% w/v cetomacrogol emulsifying ointment (30% w/v cetomacrogol emulsifying wax, 20% w/v liquid paraffin wax, 50% w/v white soft paraffin) in freshly boiled and cooled purified water with for example 0.1% w/v chlorocresol or 0.08% w/v propyl hydroxybenzoate, 0.15% w/v methyl hydroxybenzoate and 1.5% w/v benzyl alcohol.
  • compositions of the present invention contain at least 0.5% w/w of each of the active ingredients, preferably from 1 to 20% w/w, and most preferably from 2 to 10% w/w.
  • compositions of the invention may be administered in a slow release or sustained release topical vehicle so that a prolonged therapeutic effect may be achieved.
  • the frequency of the topical application depends on the indication.
  • a liberal amount of the cream is gently rubbed for a few minutes into the skin of the hands 2 or 3 times a day. It is advisable to leave the evening application overnight to enhance the repair of the skin damage and to stimulate healing.
  • a once daily application suffices. Each application must be washed away with warm water before another one is used. Contact with the eyes and oral consumption must be avoided.
  • compositions should be prepared at a temperature of 25°C.
  • the powder form of the active ingredients is mixed well in a glass or stainless steel container and then the appropriate amount of cetomacrogol 'A' is added and mixed for 10 minutes. When menthol is being used, this should first be finely ground.
  • the composition is allowed to stand for one hour then placed in dark-coloured non-transparent glass containers and stored at temperatures not exceeding 26°C. After preparation, the formulation should not be used for at least 12 hours and should not be left for too long exposed to the air or direct sunlight.
  • Example 1 The formulations illustrated in Example 1 may be used l to 3 times daily depending on whether the application is being administered for prophylactic or therapeutic reasons. To protect the skin of the hands and fingers against the damage incurred by detergents and household agents, and to maintain its texture and prevent drying up, a once daily application is generally recommended. A liberal amount of the cream is spread over the skin of the hands and gently rubbed in for a few minutes. For therapeutic purposes, a second application is indicated and preferably used in the evening and left overnight. A fresh application should not be used without having washed away the previous one, and this may be done using warm water alone.
  • Treatment may be for a few days or weeks depending on each case and in particular the individual's existing skin condition and requirements.
  • Consecutive females who had been diagnosed to have housewife dermatitis (roughening, thickening and fissuring of the skin of the fingers and hands) were prospectively randomized (by drawing sealed envelopes) on a double blind basis, to treatment with various agents presented in a cetomacrogol 'A' base or with this base alone (control group) , to study the therapeutic effect of their twice daily application for four weeks as shown in the Table below.
  • Ten females were allocated to each group and the overall age range for the study was 33 to 57 years. A successful therapeutic outcome was judged objectively by observing a complete healing of all the fissuring coupled with a return of the skin texture to its original smoothness.
  • Housewife dermatitis refers to thickening, roughening and fissuring of the skin of the fingers alone or with that of the main part of the hand. Twenty-four females (age range 37 to 51 years - mean 41) randomized to the control group and 22 females (age range 34 to 57 years - mean 44) randomized to the treatment group were fully evaluable. While no beneficial therapeutic effect occurred in the control group, this was realized in all the active therapy group cases (100%) . These women were observed to have acquired complete healing of their skin's fissures and a return of the skin's smoothness and originally normal texture and appearance.
  • Example l.A The efficacy of the formulation described under Example l.A in affording symptomatic relief, was examined in women who complained of itching and hyperaesthesia upon contact with detergents and other household chemicals but who had no obvious signs of dermatitis.
  • the formulation or its base were applied onto the hands twice daily for ten days during the period of exposure. Twenty controls (age range 30 to 47 years - mean 35) and 23 treatment cases (age range 34 to 52 years - mean 41) were fully evaluable. Complete symptomatic relief was attained by all the active therapy cases (100%) , but in none of the controls. No adverse effects, allergies or hypersensitivities were incurred by the active treatment.
  • C The efficacy of the formulation described under Example l.A in affording symptomatic relief, was examined in women who complained of itching and hyperaesthesia upon contact with detergents and other household chemicals but who had no obvious signs of dermatitis.
  • the formulation or its base were applied onto the hands twice daily for ten days during the period of exposure. Twenty controls
  • Example l.B The prophylactic effect of the formulation described under Example l.B against the recurrence of housewife dermatitis, after it had been successfully treated, was investigated. All women were instructed to continue their routine housework as they did before seeking treatment for their dermatitis, and were instructed to apply their regimen as a hand cream, but leaving it overnight and washing it away in the morning with warm water. Treatment lasted for four months (end point of the study) . Thirty females (age range 30 to 51 years - mean 36) in the control group and 28 females (age range 34 to 57 years - mean 37) in the active therapy group were fully evaluable. Complete protection against the recurrence of housewife dermatitis with maintenance of the hands' smoothness and normal skin texture was observed in all members of the active therapy group (100%) , but in none of the controls.
  • the formulations were applied twice daily for ten days onto the shoulders and arms. Each application consisted of a liberal amount of cream spread over the shoulders and arms then gently rubbed in for a few minutes. Three hours later, the application was washed away with warm water. Physical examination was carried out once every day during the ten days of study. Similarly, standard haematology and biochemistry tests (including liver and urinary function tests, blood glucose, serum amylase and blood gases) with urine examination were performed every day. An electrocardiogram with cardiac enzymes' level estimation were taken every other day.
  • sulphur with salicylic acid and sulphydryl group releasing agent components are_generally used in similar amounts, by weight, in the synergistic compositions of the invention, other ratios may also be used. Generally there is used a ratio of from 30:1 to 1:10, preferably from 15:1 to 1:5, most preferably from 3:1 to 1:1, by weight.
  • sulphur and salicylic acid may also be varied e.g. between 10:1 and 1:5, preferably 5:1 to 1:1, advantageously approximately 2:1.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention se rapporte à des compositions synergiques comprenant du soufre et de l'acide salicylique ou un ester ou sel physiologiquement acceptable de ce dernier, ainsi qu'un agent organique physiologiquement acceptable de libération in vivo de groupe sulfhydryle. L'invention se rapporte également à leur utilisation dans des formulations et des méthodes thérapeutiques et prophylactiques contre la dermite de la ménagère, et permettant de protéger la peau et d'en améliorer l'état.
PCT/GB1993/001874 1992-09-04 1993-09-03 Compositions de traitement de la dermite contenant du soufre, de l'acide salicylique et un agent de liberation de groupe sulfhydryle Ceased WO1994005302A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU49745/93A AU4974593A (en) 1992-09-04 1993-09-03 Dermatitis treatment compositions containing sulphur, salicylic acid and a sulphydryl group releasing agent

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB9218771.5 1992-09-04
GB929218771A GB9218771D0 (en) 1992-09-04 1992-09-04 Synergistic composition for dermatitis treatment
CN94104807.1A CN1108537A (zh) 1992-09-04 1994-03-16 家庭主妇型皮炎的治疗

Publications (1)

Publication Number Publication Date
WO1994005302A1 true WO1994005302A1 (fr) 1994-03-17

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1993/001874 Ceased WO1994005302A1 (fr) 1992-09-04 1993-09-03 Compositions de traitement de la dermite contenant du soufre, de l'acide salicylique et un agent de liberation de groupe sulfhydryle

Country Status (4)

Country Link
CN (1) CN1108537A (fr)
AU (1) AU4974593A (fr)
GB (1) GB9218771D0 (fr)
WO (1) WO1994005302A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5645825A (en) * 1995-06-07 1997-07-08 The Procter & Gamble Company Depilatory compositions comprising sulfhydryl compounds
US5681852A (en) * 1993-11-12 1997-10-28 The Procter & Gamble Company Desquamation compositions
US5683705A (en) * 1996-03-29 1997-11-04 Estee Lauder, Inc. Sulfur-based amides and bis-amides useful against skin disorders
US5821237A (en) * 1995-06-07 1998-10-13 The Procter & Gamble Company Compositions for visually improving skin

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1012585A (en) * 1963-05-01 1965-12-08 Barnes Hind Lab Inc New compositions for use in acne and like conditions
JPS58198421A (ja) * 1982-05-14 1983-11-18 Reiko Kosaka 皮膚脱色及び皮膚疾患治療用組成物
GB2177917A (en) * 1985-07-09 1987-02-04 Aws Shakir Mustafa Salim Dermatologically active substances

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1012585A (en) * 1963-05-01 1965-12-08 Barnes Hind Lab Inc New compositions for use in acne and like conditions
JPS58198421A (ja) * 1982-05-14 1983-11-18 Reiko Kosaka 皮膚脱色及び皮膚疾患治療用組成物
GB2177917A (en) * 1985-07-09 1987-02-04 Aws Shakir Mustafa Salim Dermatologically active substances

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Section Ch Week 8401, Derwent World Patents Index; Class B05, AN 84-002869 *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5681852A (en) * 1993-11-12 1997-10-28 The Procter & Gamble Company Desquamation compositions
US5645825A (en) * 1995-06-07 1997-07-08 The Procter & Gamble Company Depilatory compositions comprising sulfhydryl compounds
US5821237A (en) * 1995-06-07 1998-10-13 The Procter & Gamble Company Compositions for visually improving skin
US5897857A (en) * 1995-06-07 1999-04-27 The Procter & Gamble Company Depilatory compositions comprising sulfhydryl compounds
US5683705A (en) * 1996-03-29 1997-11-04 Estee Lauder, Inc. Sulfur-based amides and bis-amides useful against skin disorders
US5948418A (en) * 1996-03-29 1999-09-07 Estee Lauder, Inc. Sulfur-based amides and bis-amides useful against skin disorders

Also Published As

Publication number Publication date
GB9218771D0 (en) 1992-10-21
AU4974593A (en) 1994-03-29
CN1108537A (zh) 1995-09-20

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