CA2245254A1

CA2245254A1 - Glycoside shampoo for treating psoriasis

Info

Publication number: CA2245254A1
Application number: CA002245254A
Authority: CA
Inventors: Soheyl Mottahedeh
Original assignee: Individual
Current assignee: Individual
Priority date: 1998-09-02
Filing date: 1998-09-02
Publication date: 2000-03-02

Abstract

A method is provided to treat and/or prevent microbially-induced as well as chronically endogenous skin diseases such as seborrheic dermatitis. eczema or psoriasis, by topical application to the skin and washing the skin in a shampoo containing an effective amount of a treatment composition containing an alkyl polyglycosides and iodine in a pharmaceutically acceptable vehicle.

Description

Glycoside shampoo for treating psoriasis F:(ELD OF THE INVENTION
The present invention refers to novel medicated shampoos for the treatment of skin disorders such as inflammatory dermatoses, seborrheic dermatitis, eczema and psoriasis and more particularly relates to topical treatment by topical application of those disorders with a pharmaceutical composition comprised of shampoo bases containing an alkyl polyglycoside and iodine.
BACKGROUND OF THE INVENTION
Inflammatory dermatoses describe a group of diseases involving the layers of skin below the epidermis that have an inflammatory component. Inflammation may be 1s triggered by a number of external events ranging from exposure to UV light from the sun to an allergen.
Seborrheic dermatitis is a skin disorder characterized by lesions produced by an abnormal increase (>2X) in the production and shedding of epidermal cells from the skin, particularly in hairy areas, body folds, and in and behind ears. Typically, the lesions have 2o definite borders with an inflamed appearance and are covered by scales having a greasy appearance.
Psoriasis is a skin disorder also characterized by lesions produced by an even greater abnormal increase (10-21)X) in the production of shedding of epidermal cells from the skin. Typically, psoriasis lesions, which are well-defined and a pink or dull red color, are 2s covered with silvery scales. In addition, capillaries in the skin in affected areas undergo swelling.
The causes of inflammatory dermatoses, seborrheic dermatitis., eczema and psoriasis are still in dispute and known topical treatments of the disorders are varied.
Treatment of said denmatoses has been discussed in the prior art. One approach to the treatments of 3o these disorders has involved the application of cytostatic agents to reduce the rate of cell growth and, thus, to decrease abnormal shedding of dead epidermal cells. Other treatments use corticosteroid products, others antibiotics. Still other products are composed of anti-fungal agents. All these approaches have their limitations -cytostatic agents, corticosteroids and antibiotics have side-effects, while anti-fungal agents described in prior art are insoluble in water and are not effective in penetrating the skin in combination with water based shampoos.
Among the most common treatment regimen for seborrheic dermatitis is a shampoo with zinc pyrithione as an active ingredient, such as discussed in "Announcing Two improvements in Head & Shoulders~", a 1995 advertisement publication of Procter &
Gamble, the manufacturer of Head & Shoulders~ shampoo.
Samuel L. Moschella, M.D. et al, in "Dermatology", in a chapter entitled "Papulosquamous Erruptions and exfoliative Dermatitis" W.B. Saunders Company, Third Edition, pgs. 610-611, 1992 states that microbiological studies have revealed that skin conditions such as psoriasis are associated with increased numbers of Staphylococcus aureus bacteria, and that improvements in psoriasis skin lesions are noticed when topical t5 and systemic antibiotics are administered.
W. von Rybinky and K.Hill in "Angewandte C'hemie Int.." in a chapter entitled "Alkyl Polyglycosides - Properties and Applications of a new Class of Surfactants"
Henkel KGaA, pgs. 1328-1345, 37, Ed. 1988 state that an alkyl polyglycosides (APG) is a nonionic fatty alcohol, a sugar derivative surfactant which is typically less irritating to 2o human skin than other surfactants. APGs show remarkable physiochemical properties which, in some cases, differ clearly from those of other anionic surfactants:
(a) mixtures with APGs lower surface tension of compositions (b) the surface quality on hydrophilic surfaces is improved and a two-dimensional aggregates - often referred as to "hemi-micelles" are formed by hydrophobic interactions of the alkyl chains. Such interactions 2s lead to a marked increase in the quantities adsorbed (c) APGs are non-toxic, readily biodegradable and suitable for use as co-surfactant in the formulation of particularly gentle products (d) the tensile strengths of permed hair tresses are far greater by treatment with APG solutions than by standard ether sulfate salutions (f) in the presence of an APG, the quantity of bactericidal agent can be reduced to about one quarter without 30 losing any bactericidal activity.

In "Diagnosis and Management of Cutaneous Fungal Infections", Clinical Mycology update, pgs. I-8, May 1995; it was shown that seborrheic dermatitis is increased in persons with yeast infections and that treatment with shampoos having anti-fungal agents reduces scalp fungi and clinical symptoms of seborrheic dermatitis and dandruff.
s U.S. Pat. No. 5,677,436 of Henkel KGaA describes that APGs are used primarily in small quantities for their synergistic relationship with other surfactants, low skin irritation and tendency to high foaming. Henkel's patent states that by adding an effective amount of their disclosed additives to an APG, the APG may be used as the primary surfactant in personal care product formulations, while at the same time exhibiting significantly 1o enhanced aesthetic properties based on the elimination or reduction in crystallization along with the resultant increase in viscosity of the APG.
U.S. Pat. No. 5,631,245 of Biodynamics Pharmaceuticals describes a method for medicating the inflammatory controlling system for treating the pathology of adverse inflammatory reactions. They react glucose, a nitrogen containing base, and either I5 methanol or ethanol to form the diglucosylamine which is declared to have extraordinary anti-inflammatory activity once it is formulated with a pharmaceutically acceptable carrier to make pharmaceutical compositions Which are effective in treating inflammations.
U.S. Pat. No. 4,316,983 of Bollag et al., describes neoplasmic compounds such as 2o sugar esters and glycosides to be used in the treatment of acne and psoriasis, as well as for inflammatory and allergic dermatoses.
U.S. Pat. No. 5,730,965 of Rapaport states that prior art shampoos composed of the active ingredient such as coal tar, zinc pyrithione and selenium selide do not work as well as the chloroxylenol-based shampoo in reducing the effects of seborrheic dermatitis 25 and/or dandruff flakes because they do not elicite an effective response in the epidermis, dermis and hair follicies, because chloroxylenol is more fat soluble in the fatty acid components of shampoo than traditional components which are not as soluble in fat.
Therefore, traditional shampoo components, such as zinc pyrithione, selenium or coal tar do not penetrate the skin as well.

OBJECT OF THE INVE:hITION
It is therefore an object of the present invention to provide an effective treatment for inflammatory dermatoses, seborrheic dermatitis, eczema and psoriasis, and resultant dandruff, itching sequelae or scaling.
s It is yet a further object to provide a shampoo having therapeutic and cosmetic properties derived from an optimized number of natural materials that are non-irritating and environmentally responsible.
It is yet a further object to provide a shampoo, wherein the active ingredient is anti-microbial.
to It is yet a further object to provide a shampoo wherein the anti-microbial active ingredient is soluble in fatty acids of the shampoo for better penetration to the skin during a shampoo wash.
It is yet another object to improve over the disadvantages of the prior art.
1 s BRIEF SUMMARY OF THE INVENTION
In keeping with these objects and others which may become apparent, according to the present invention, a method is provided for preventing and/or treating inflammatory dermatoses, seborrheic dermatitis of the scalp and other hair bearing areas, dandruff, 2o acne, eczema or psoriasis, by topical application of a therapeutic camposition, preferably a composition containing effective amounts of a.n alkyl polyglycosides (APG) and iodine, to the affected area of the skin. An alkyl polyglycossides (APG) / iodine composition in a pharmaceutically acceptable earner is applied in a pharmaceutically acceptable vehicle, such as a shampoo or hair rinse, in a concentration of from at least two and half (2.5) 2s percent to ten (10) percent by weight, preferably about four and half (4.5) percent by weight, generally by frequent periodic application, such as once or twice daily application.
Tests on humans show that topical application of a pharmaceutically acceptable composition containing from about four and half (4.5) of APG + iodine prevents or 3o reduces by at least 80% inflammatory dermatoses, seborrheic dermatitis, scalp dandruff and psoriasis. Tests also show that when such compositions are applied, there is a dramatic reduction of itching and scaling of the skin within two (2) to four (4) weeks.
APG/iodine shampoo treatment compositions work better than prior art in reducing the effects of inflammatory dermatoses, seborrheic dermatitis, dandruff, eczema and s psoriasis because of a combination of the following factors: (a) they are water and fat-soluble and thus able to penetrate better the epidermism, dermis and hair follicies of the skin, (b) they penetrate deeper because of their lower surface tension property derived from the synergistic relationship of APG with other surfactants {c) "hemi-micelles" are formed by hydrophobic interactions of the alkyl chains leading to a marked increase in Io the quantity of shampoo adsorbed by the skin (d) the APG presence has a boosting effect (about X4) on the bactericidal property of iodine which de-activates Staphylococcus aureus bacteria and improves remarkably psoriasis skin lesions (e) APGs give higher tensile strength to permed hair tresses than when treated with standard ether sulfate, and (fj the gentle APG solutions have low skin irritation, tendency to high foaming, are cost-t 5 effective and originate from natural materials such as corn, potato starch and coconut, palm kernel oil and alike natural sources of glucose.
DETAILED DESCRIPTION OF THE PREFERRED F,MBODIMENTS
2o In accordance with the present invention, a method is provided for the prevention and/or treatment of inflammatory dermatoses, seborrheic dermatitis. of the scalp and other hair bearing areas, dandruff, eczema or psoriasis which may accompany this skin condition. The method compromises the topical application of suitable composition containing alkyl polyglycosides (APG) and iodine. The topical application to the skin of 25 the user may be, but not limited to, by a shampoo or hair rinse.
In general, the treatment composition suitable for use in accordance with the invention containing APG/iodine combination may be applied in the dernlatological acceptance vehicle such as a gel, lotion or cream base. Other suitable formations will be apparent to those skilled in the arts.
3o In the present invention, the method for the prevention and/or treatment of inflammatory dermatoses, seborrheic dermatitis of the scalp and other hair bearing areas, dandruff, eczema or psoriasis is by application of a shampoo containing an APG/iodine composition in a concentration of two and half {2.5) to about ten ( 10) percent by weight of the total composition, and preferably about four and half (4.S) percent to the total weight of the composition. Treatment compositions containing concentrations up to about sixty (60) percent by weight of an APG/iodine composition will not cause any appreciable side effects. An APG/iodine composition suitable for use in the treatment compositions of the invention will improve the condition of the skin and hair to which it is applied, preferably by frequent periodical application over an extended period of time without undue irritation to the skin or any other side effects.
o The topical preparation described above is formulated in any suitable topical hair and skin care carrier such as a shampoo, cream, shaving cream, lotion, gel, which may or may not be emulsii=ied and may contain ingredients to improve, modify, or stabilize the formulation physically or cosmetically. These inl,~redients may include {in any combination), but are not limited to:
1. a pharmaceutical carrier, solvent, diluent, or carrier such as water, a water soluble alcohol selected from the group of methanol, ethanol, propanol, isopropanol, butanol, sec-butyl alcohol, tent-butyl alcohol, ethylene glycol, and propylen glycol-water solutions, methylcellulose or paraphin, waxes, cellulose derivatives, mineral oils, vegetable oils, petroleum derivatives, beeswax, glyceryl stearate, glycol stearate, cetyl 2o alcohol, steryl alcohol and other similar agents, anhydrous lanolin, white petrolatum, olive oil, polyhydrics, and the like, ethanolpolysorbate 80 solutions, and jojoba oils, and any mixture thereof.
2. shampoo components such as laureth sulfate, soldium lauryl sulfate, ammonium lauryl sulfate, ammonium laureth sulfate, sodium laureth sulfate, ammonium xylenesulfate, ammonium chloride, dipropylene glycol, methyldibrome glutanronitrile, benzophenome-4, magnesium aluminium silicate, cocamide DEA, cocamide triethanolamine, cocamidopropyl betaine, hexylene glycol, methylparaben, propylparaben, hydroxypropyl methylcellulose, citric acid, coco hydrolized soy protein, PEG stearate and glycol stearate, PEG-6-32-stearate; PEG-6 stearate;
polysorbate 80, 3o potassium methyl sulfate, potassium butyl sulfate, sodium tetrapropylene benzene sulfonate, dodecyl trimethyl ammonium chloride, lauric diethanolamide, cetrimide, cetomacrogol, oleyl alcohol; alkylene polyols; oleic acids; urea;
pyrrolydones;
surfactants; vegetable oil PEG-6 complexes; caprylic triglyceride; capric triglyceride;
glyceryl caprylate; glyceryl caprate; PEG-8 caprylate; PEG-8 caprate;
ethoxydiglycol;
and related fragrances and colors and any mixture thereof s 3. a bactericide or anti-fungal agent serving also as a preservative to inhibit or prevent microbiological contamination selected from the group of bactericides such as active iodine (iodophor), chlorine, fluorine, bromine, quaternary ammonium compounds such as benzalkonium chloride, natural extracts from tee tree oil, echinacea, or other natural extracts and any mixture thereof.
4. an alkyl polyglycosides (APG) selected from the group consisting of short-chain APG
with 8 to 10 carbon atoms (C8-10) or of medium-chain APG (C12-14) or of long-chain APG (C16-18).

5. anti-oxidants, vitamins, minerals, botanical or animal extracts to protect the formulation from degradation and extend shelf life to enhance the performance of the 1 s product.

6. anti-oxidants, vitamins, minerals, botanical or animal extracts to protect, prepare, or mediate the action of the product on the dermis, by interaction with the product of the dermis or both, anti-oxidants include yucca extract and the like.
The treatment compositions used in the practice of the invention are intended to be 2o applied to and subsequently removed by shampoo washing, rinsing, or the like.
Generally, the topical applications are applied periodically such as one or two times a day. Significant clinical improvement may be observed after two (2) to four (4) weeks of daily treatment, wherein the extent of the seborrheic dermatitis rash and/or dandruff flakes and/or psoriasis plaques are substantially reduced, with a relief of itching and 25 scaling.
Suitable APG/iodine shampoo treatment compositions work in reducing the effects of seborrheic dermatitis and/or dandruff flakes and/or psoriasis plaques by virtue of APG/iodine combination eliciting a response in the epidermis and dermis and their penetration through hair follicies. Better than conventional treatments, such as selenium, 3o zinc pyrithione, or coal tar which are non water- soluble, APG/iodine shampoo is more fat soluble in the fatty acids components of shampoo than traditional components, such as zinc pyrithione, selenium or coal tar which do not penetrate the skin as well.
Compositions that may be applied in accordance with the method of treatment of inflammatory dermatoses, seborrheic dermatitis of the scalp and other hair bearing areas, s dandruff, acne, eczema or psoriasis of the present invention are illustrated by the following typical cosmetically acceptable compositions for topical application to human skin.

Claims

What is claimed is:

1. A method for topical application to a mammal subject comprising ~ 5-85% amount by weight of a pharmaceutical carrier;
~ 10-30% amount by weight of shampoo components;
~ 0.3-5% amount by weight of a bactericide;
~ 0.5-5% amount by weight of an alkyl polyglycosides;
~ 0.0-5% amount by weight of anti-oxidants to extend the performance of the product; and ~ 0.0-5% amount by weight of anti-oxidants to interact with the product of the dermis.

2. A method according to claim 1, wherein the pharmaceutical carrier is a solvent, diluent, or carrier selected from the group consisting of water, a water soluble alcohol selected from the group of methanol, ethanol, propanol, isopropanol, butanol, sec-butyl alcohol, tert-butyl alcohol, ethylene glycol, propylene glycol-water solutions, methylcellulose or paraphin, waxes, cellulose derivatives, mineral oils, vegetable oils, petroleum derivatives, beeswax, glyceryl stearate, glycol stearate, cetyl alcohol, steryl alcohol and other similar agents, anhydrous lanolin, white petrolatum, olive oil, polyhydrics, ethanolpolysorbate 80 solutions, jojoba oils and any mixture thereof.

3. A method according to claim 1, wherein the shampoo components are selected from the group consisting of laureth sulfate, soldium lauryl sulfate, ammonium lauryl sulfate, ammonium laureth sulfate, sodium laureth sulfate, ammonium xylenesulfate, ammonium chloride, dipropylene glycol, methyldibrome glutanronitrile, benzophenome-4, magnesium aluminium silicate, cocamide DEA, triethanolamine, cocamidopropyl betaine, hexylene glycol, methylparaben, propylparaben, hydroxypropyl methylcellulose, citric acid, coco hydrolized soy protein, PEG stearate and glycol stearate, PEG-6-32-stearate;

PEG-6 stearate, polysorbate 80, potassium methyl sulfate, potassium butyl sulfate, sodium tetrapropylene benzene sulfonate, dodecyl trimethyl ammonium chloride, lauric diethanolamide, cetrimide, cetomacrogol, oleyl alcohol; alkylene polyols; oleic acids; urea; pyrrolydones; surfactants; vegetable oil PEG-6 complexes;
caprylic triglyceride; capric triglyceride; glyceryl caprylate; glyceryl caprate; PEG-8 caprylate;
PEG-8 caprate; ethoxydiglycol; and related fragrances and colors and any mixture thereof

4. A method according to claim 1, wherein the bactericide is selected from the group consisting of active iodine (iodophor), chlorine, fluorine, bromine, benzalkonium chloride, plant extracts such as tee tree oil, echinacea and any mixture thereof.

5. A method according to claim 1, wherein the alkyl ployglycosides is selected from the group consisting of (C8-10) alkyl glycosides or (C12-14) alkyl glycosides or (C16-18) alkyl glycosides.

6. A method according to claim 1, wherein the anti-oxidants may be selected from a group of vitamins, minerals, botanical or animal extracts to protect the formulation from degradation and extend shelf life to enhance the performance of the product.

7. A method according to claim 1, wherein the anti-oxidants may be selected from a group of vitamins, minerals, botanical or animal extracts to protect, prepare, or mediate the action of the product on the dermis, by interaction with the product of the dermis or both.

8. A method according to claim 1, wherein the topical formulation is a therapeutic shampoo.

9. A method according to claim 1, wherein the topical formulation is an anti-inflammatory and/or anti-seborrheic and/or anti-dandruff andlor anti-eczema.

10. A method according to claim 1, wherein the topical formulation is a method of treatment of psoriasis vulgaris, psoriasis eruptive, psoriasis erythrodermic and psoriasis pustular.

11. A method according to claim 1, wherein the topical is a hair conditioner.

12. A method according to claim 1, wherein the topical is a hair care or hair treatment product, for hair growth or for regrowth of hair.

13. A method according to claim 1, wherein the topical is a detergent.

14. A method according to claim 1, wherein the topical is a liquid soap.

15. A method according to claim 1, wherein the topical is an antiperspirant or deodorant product.

16. A method according to claim 1, wherein the topical is a cosmetic product.

17. A method according to claim 1, wherein said composition is a topical drug product.

18. A method according to claim 1, wherein the topical formulation is an anti-fatigue shampoo.

19. A method according to claim 1, wherein the topical formulation is an ointment.

20. A method according to claim 1, wherein the topical formulation is an insect repellent.

21. A method according to claim 1, wherein the topical formulation is a paste.

22. A method according to claim 1, wherein the topical formulation is a gel.

23. A method according to claim 1, wherein the topical formulation is a cream.

24. A method according to claim 1, wherein the topical formulation is a lotion and moisturizer.

25. A method according to claim 1, wherein the topical formulation is a bath additive.

26. A method according to claim 1, wherein the topical formulation is a spray.

27. A method according to claim 1, wherein the topical formulation is as follows:
Component ~~~~Usage Range (% w/w) Purified Water ~~~Balance to 100%
Lauryl ~~~~Sulfate 12-16 Iodine ~~~3-5 Alkyl Polyglycosides~~ 0.5 - 2 Surfactant 1 ~~~0-2 Laureth Sulfate~~~0.1-0.5 Ethylen Glycol Distearate~~0.1-0.5 Pearling Agent ~~~0.1-0.5 Fragrance ~~~0-1 Color ~~~0-1

28. A method according to claim 27, wherein the alkyl polyglycosides is selected from the group consisting of (C8-10) alkyl glycosides, the Lauryl Sulfate is sodium lauryl sulfate, the Laureth Sulfate is sodium laureth sulfate, the Surfactant 1 is cocamide DEA

29. A method according to claim 27, wherein the alkyl polyglycosides is selected from the group consisting of (C8-10) alkyl glycosides, the Lauryl Sulfate is ammonium lauryl sulfate, the Laureth Sulfate is ammonium laureth sulfate, the Surfactant 1 is coco hydrolized soy protein

30. A method according to claim 27, wherein the alkyl polyglycosides is selected from the group consisting of (C12-14) alkyl glycosides, the Lauryl Sulfate is sodium lauryl sulfate, the Laureth Sulfate is sodium laureth sulfate, the Surfactant 1 is cocamide DEA

31. A method according to claim 27, wherein the alkyl ployglycosides is selected from the group consisting of (C12-14) alkyl glycosides, the Lauryl Sulfate is ammonium lauryl sulfate, the Laureth Sulfate is ammonium laureth sulfate, the Surfactant 1 is coco hydrolized soy protein

32. the group consisting of (C16-18) alkyl glycosides, the Lauryl Sulfate is sodium lauryl sulfate, the Laureth Sulfate is sodium laureth sulfate, the Surfactant 1 is coco hydrolized soy protein

33. A method according to claim 27, wherein the alkyl polyglycosides is selected from the group consisting of (C 16-18) alkyl glycosides, the Lauryl Sulfate is ammonium lauryl sulfate, the Laureth Sulfate is ammonium laureth sulfate, the Surfactant 1 is coco hydrolized soy protein

34. The composition of claim 27, wherein the Pearling agent is Zohar Egds 771 in a concentration of from 0.1% to about 0.2% weight.

35. A method according to claim 1, wherein the pH of the composition is in the range of 1 to 7.

36. A method according to claim 1, wherein the pH of the composition is in the range of 3 to 6.8.

37. A method according to claim 1, wherein the topical formulation alleviates skin disorders on animal subjects.