Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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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
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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.
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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.
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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
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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,
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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,
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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
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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.
