Note: Descriptions are shown in the official language in which they were submitted.
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HAIR GROWTH / MAINTENANCE COMPOSITIONS AND METHODS
INVOLVING THE SAME
S Field of the Invention
This invention relates to ;hair growth/maintenance compositions and methods
for hair
growth/maintenance. More particularly the invention is concerned with
compositions for
application to the scalp which prevent hair loss, and provide for new hair
growth.
Background of the Invention
Hair loss, thinning of hair and baldness have been a fact of human life which
affects
countless people worldwide, both male and female. These conditions often cause
self
consciousness and acute embarrassment to the sufferer. Lack of confidence and
psychological disturbance can sometimes result.
IS
People have gone to great lengths to treat hair loss, thinning hair and
baldness, as is
evidenced by the myriad approaches used to deal with these problems. Non-
surgical
approaches appear to be largely ineffective. Insofar as surgical approaches
are concerned,
procedures such as implanting hair follicles taken from other portions of the
body into the
scalp are expensive, inconvenient and sometimes painful procedures. Generally,
other
surgical approaches also suffer these disadvantages.
Hair pieces or toupees are often used by people whose hair is thinning, and by
those who
have bald patches. These devices may be regarded as uncomfortable to wear, and
highly
embarrassing if dislodged during wear. Such devices may be expensive and often
have a
unnatural appearance which may not reflect the other hair colour of the
wearer. This is
particularly evident when the natural hair lightens, turning gray or white
with age.
Compositions directed to women suffering from hair loss resulting from factors
such as
hormonal changes or disturbances, age or the like, are generally in the form
of hair
firming gels. These products appear to attract dirt from the air, requiring
frequent
washing of the hair. These compositions may also irritate the scalp in some
people.
US Patent No. 4,737,362 ("Yoshizumi") describes hair treatment compositions
purported
to accelerate hair growth which contain bacterial derived lipase, a lipid
degrading enzyme
which appears to have an antibacterial activity. Such compositions have the
disadvantages
of causing hair dryness, scalp itchiness and irritation, an unpleasant odor
after application
to the skin, and possible skii~/scalp damage with prolonged use.
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The present invention addresses the problems of the prior art detailed above
and provides
a simple, cost effective and convenient solution to hair growth/maintenance.
S The inventor has surprisingly found that compositions containing immune
modulatory
compounds, namely compounds known to modulate the immune system, are
particularly
suitable in stimulating new hair growth and/or maintaining hair growth
(preventing hair
loss). The compounds are applied to the hair in a formulation containing water
and a
water soluble film forming polymer.
Summary of the Invention
In accordance with a first aspect of this invention there is provided a hair
growth/maintenance composition which includes water, a water soluble film
forming
polymer and an immune modulatory compound in an amount effective to promote
hair
IS growth/maintenance.
In another aspect of the invention, there is provided a method for hair
growth/maintenance
which includes applying to the scalp, or other areas of skin, a composition
comprising
water, a water soluble film forming polymer, and an immune modulatory compound
in an
amount effective to promote hair growth/maintenance.
In a still further aspect of the invention there is provided use of compounds
known to
modulate the immune system in combination with a film forming polymer and
water in the
manufacture of a medicament for the treatment of baldness and hair
maintenance.
Brief Description of the Drawings
In the figures, Figures 1 to ~0 depict the scalp of individuals treated with
the compositions
of the examples, at the beginning of treatment and after treatment.
Fig 1: Top view of the scalp of a 45 year old man prior to treatment (A), and
scalp after 3
months treatment (B).
Fig 2: Top view of the scalp of a 67 year old male showing a pronounced bald
patch prior
to treatment.
Fig 3: View from above of side and top of scalp of Fig 2 subject after 3
months treatment.
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PCT/AU99/00607
Fig 4: View of top of scalp of volunteer 001 before (A) and after 10 months
treatrnent
(B).
Fig S: View of rear of scalp of volunteer 002 before treatment (A), after 3
months
treatment (B) and after 6 months treatment (C).
Fig 6: Top view of the scalp of volunteer 004 before treatment (A) and after 3
months
treatment (B).
Fig 7: Top view of the scalp of volunteer 006 before treatment (A) and after 3
months
treatment (B).
Fig 8: Top view of the scalp of volunteer 008 before treatment (A) and
following 3
months treatment (B).
IS
Fig 9: Top view of the scalp of volunteer 009 before treatment (A) and after 3
months
treatment (B).
Detailed Description of the Invention
This invention relates to compositions which provide new hair growth, and
prevent hair loss.
Compositions which are conveniently applied to the scalp allow for ready
treatment of hair
loss, thinning hair and baldness. In a first aspect the invention provides a
hair
growth/maintenance composition which includes water, a water soluble film
forming
polymer, and an immune modulatory compound in an amount effective to promote
hair
growth/maintenance.
A hair growth/maintenance composition in accordance with this invention
represents a
significant advance in the treatment of hair loss, thinning hair and baldness.
On
application to the scalp, the composition forms a thin film over hair, hair
follicles and
scalp allowing maximum effectiveness. By hair growth is meant new hair growth.
Hair
maintenance means that hair follicles continue to produce hair rather than
regress and die.
The water soluble film forming polymer may be selected from one or more
natural or
synthetic water soluble film foaming polymers such as acacia, albumins, agar,
alginic acid
and its salts, bentinites, carbomer, carrageenan, carboxy methyl cellulose and
its salts,
salts of cellulose acetate phthalate, cyclodextrins, dextran, dextrins,
gelatin, hydroxy ethyl
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cellulose, hydroxy propyl cellulose, hydroxy propyl methyl cellulose, hydroxy
propyl
methyl cellulose phthalate, and other cellulose derivatives, ispaghula,
lecithins, lanoline
alcohols, maltodextrins, pectin, povidone, polyvinyl povidone, poly vinyl
acetate,
starches, tragacanths, and the like. The precise nature of the film forming
polymer is
S generally unimportant, as long as it forms a convenient thin film on
application to the
scalp.
Once the composition dries on the scalp, the composition is unnoticeable.
Where hair is
present on the scalp, the hair is imparted with greater body to give a more
full appearance,
which is also pleasing to the eye.
The immune modulatory compound is a compound which modulates the immune
response,
for example attenuating; facilitating or stimulating some aspect of the immune
response,
whether humoral or cellular, preferably immune stimulating compounds, such as
IS muramidase (otherwise known as lysozyme hydrochloride or globulin Gl),
interferons
such as interferon a, ~i and y, non-inflammatory interlukins, insulin-like
growth factor-1
(1GF-1), epidermal growth factor (EGF), extract of Echinacea, mannin,
heteroxylan,
arabinorhamnogalactan, ~i-glucan, and other compounds having immune
stimulatory
function. Muramidase is particularly preferred. Immune modulatory compounds do
not
induce cell transformationlimmortalisation (as may occur with fibroblast
growth factor,
TFG-13, keratinocyte growth factor, and the like) which may result in
cancerous states.
Interlukin la, interlukin 1(3, TNF-a, and TNF-[3 are specifically excluded as
these
proteins have been found to inhibit hair growth. The compositions of this
invention may
include two or more immune modulatory compounds.
The compositions of the present invention generally include from 0.01% to 10%
(w/w)
immune modulatory compound, preferably O.OS % to 1 % (w/w) - where the immune
modulatory compound is muramidase it is generally present in an amount from
about
0.01 % to about 10% (w/w), preferably about 0.05% to about 1 % (w/w). Where
the
immune modulatory compound is an interferon it is generally present in an
amount from
about lIU to about 10,000ILr. Where the immune modulatory compound is ~i-
glucan it is
generally present in an amount from about .Olmg to about 200mg/ml, preferably
about,
preferably about O.lmg to about SOmg/ml. Where the immune modulatory compound
is a
non-inflammatory interlukin (as can be readily determined in experimental
animals), such
as interlukin l~i(163-171) the compound is generally present in an amount from
O.Olmg to
100mg/ml, preferably O.lmg to 20mg/ml.
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The immune modulatory compounds may be in the form of any pharmaceutically
acceptable salts as are known in the art, such as hydrochloride and phosphate
salts.
The water soluble film forming polymer is generally present in an amount of
about 0.01
S to 10 % (w/w), preferably 0.05 % to 5 % (w/w), and more preferably 0.1 % to
1 % (w/w).
The composition of the invention may include conventional carriers,
excipients, buffers,
preservatives and wetting agents used in compositions for the application to
the skin or
scalp, such as ethylene diamine tetra acetic acid (EDTA), dextran, sodium acid
phosphate,
disodium phospohate, potassium acid phosphate, dipotassium phosphate, sadium
benzoate,
propyl hydroxy benzoate,. methyl hydroxy benzoate, buffering compounds, salts,
detergents (such as sodium lauryl sulphate, and sodium dodecylsulphate) and
emulsifiers,
and the like. Such components may be present in amounts from about 0.01 %
(w/w) to
about 10% (w/w). By way of example, detergents may be present in an amount
from
I S about 0.01 % (w/w) to about 5 % (w/w).
The compositions of the present invention may be applied to the scalp by way
of direct
application, such as pouring a small amount of the composition on to the scalp
or on to the
fingers, and then rubbing this material over the scalp or affected areas.
Alternatively, the
composition may be sprayed using conventional spraying apparatus such as an
air-driven
spray arrangement, or misting arrangement, as are widely used in the
application of
perfumes and cosmetics formulations.
Compounds which assist in stabilizing the immune modulatory compound may be
included
in the composition, such as trehalose, a sugar well known for such a purpose.
Water constitutes the balance of the composition of the invention, the result
being a
solution of dissolved components in water which can be readily applied to the
scalp by
conventional means.
The compositions of the present invention preferably do not contain any
chemical
propellant, alcohol, artificial colourings, or chemicals which may cause scalp
irritation.
However, one or more such components may be present in amounts which do not
cause
scalp irritation.
The composition of the invention may be applied daily or at least once every
three days.
Generally, such use prevents hair loss within four weeks. Visible difference
in hair
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recovery, that is new hair growth, is generally observed over a two to twelve
month
period of continued use. Continued use of the product on a daily basis, or
once every
three days, prevents hair loss and actively promotes hair growth.
Subjects which may be treated according to this invention are human males and
females
who are subject to hair loss, hair thinning, and/or baldness. Animals
suffering from such
conditions may also be treated with the compositions of this invention.
In another aspect the invention provides a method for hair growth/maintenance
which
comprises applying to the scalp, or other areas of skin, a composition
comprising water, a
water soluble film forming polymer, and an immune modulatory compound in an
amount
effective to promote hair growth/maintenance.
In a method according to an aspect of this invention, a composition as
described above is
I S applied to the scalp or area of skin to which it is desired that hair
growth/maintenance
takes place. Application is preferably made to the scalp/skin on a once daily
basis. The
composition may be sprayed or poured on to the area to be treated and may be
gently
rubbed in with the forgers or conveniently brushed or combed through the hair
and scalp.
The composition forms a thin and unnoticeable film on the scalp or skin, and a
thin
unnoticeable film on any hair present. The composition imparts body or
fullness to
whatever hair remains which improves the appearance of the person being
treated, and
additionally prevents hair loss and promotes hair growth.
As mentioned above, hair loss is generally prevented within four weeks of
treatment and a
visible difference in hair recovery is observed generally within two to twelve
months of
continued use of the composition according to the invention.
The precise mechanism of action of the composition/method of the invention is
unclear.
Without wishing to be bound by any theory of action, the inventor believes
that immune
modulatory compounds may vmodulate the immune response at the level of the
hair follicle,
in cooperation with the film forming polymer, in a manner which prevents hair
loss and
stimulates new hair growth. The compositions of this invention may reverse an
abnormal
cycle associated with hair loss/baldness by extending the growth phase of hair
follicles and
reducing the regressional phase, which may explain the slowing/prevention of
the
balding/hair loss process and new hair growth in a natural manner.
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This invention will now be described with reference to the following non-
limiting
Examples.
Example 1
S
The following formulation was prepared:
Muramidase 100 mg
Gelatin 100 mg
Trehalose 100 mg
EDTA di sodium 140 mg
Dextran 250 mg
Sodium acid phosphate270 mg
Sodium phosphate 1160
mg
Propyl hydroxy benzoate30 mg
Methyl hydroxy benzoate90 mg
Purified water 100 ml
Other formulations were made where lysozyme was replaced with interferon-a,
interferon-Vii, interferon-y, interlukin-l~i(163-171) peptide, insulin-like
growth factor-1
(IGF)-1), epidermal growth factor (EGF), extract of Echinacea, mannin,
heteroxylan,
arabinorhamnogalactan, and ~3-glucan and non-inflammatory interlukins. All of
these
immune modulatory compounds are widely available from pharmaceutical/chemical
suppliers.
Example 2
Mrs K, a mature woman, began to loose a significant amount of hair each day
and
developed a visible receding hairline on the left side of her head, noticeable
from the front
of the scalp. To ameliorate this problem, Mrs K had used a non-alcohol pre-
spray on gel
to hold her hair in place to cover up the receding patch. This product
attracted dirt from
the air and rendered the hair unattractive to the eye. Frequent washing of the
hair was
required and this may have contributed to continued hair loss. A lysozyme
containing
composition, according to Example 1, was prepared and sprayed daily on to the
affected
area until the hair was slightly wet. Using either a comb, brush, or simply
the hand, the
slightly moist hair was used to form a shade over the receding area. After
three weeks,
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Mrs K noticed that hair loss was dramatically reduced, and that there was a
proliferation
of short hair growth on the affected area.
Example 3
Mr J, a mature man, has a receding hair line from both sides of the scalp and
was loosing
hair on a daily basis, which had become quite visible. Mr J began applying the
muramidase composition according to Example 1 to the affected area on a daily
basis. As
a control, a small amount of the composition was sprayed on to the right elbow
using the
left side of the elbow as a control. Patch tests were also carried out where
the composition
was sprayed on both wrists, where Mr J had very fine short hairs, such that
any growth
was visible and able to be monitored. In this test, the composition was rubbed
on to the
surface of the skin for ten seconds at one forger width across each wrist.
After two
months there was a noticeable hair growth on the balding patch of the scalp
and also hair
growing visibly long and thick on the test patches with no additional hair
growth on the
IS control sites.
After twelve months of use on a daily basis of the muramidase containing
composition,
Mrs K and Mr J no longer have a receding hair problem, and their hair has
visibly grown
back.
Example 4
The composition containing muramidase has been tested on approximately one
hundred
people, suffering from various stages of thinning hair, hair loss and
baldness. The
majority of test subjects have found that hair loss has been prevented after
about four
weeks of use and that new hair growth is observed.
It has also been observed that the hair growth is generally the original
colour of the hair of
the person. If the user of the composition is already white/gray hair, the new
hair growth
is not generally white/gray hair but the original hair colour of the person
prior to the hair
turning white/gray.
Figure 1 shows the photograph of a scalp of a forty five year old user who had
been bald
for more than fifteen years. Following daily application of the composition,
according to
Example 1, hair follicle and new hair growth is visible only after two months
of use, as is
evident in Figure 2.
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Figure 3 shows a photograph the scalp of a sixty seven year old male, with a
bald patch
among white hair with very little side growth. After application of the
composition,
according to example 1, for three months the new growth of black hair can be
seen in
figure 4, which hair was not present before treatment.
Results of a pilot study on 6 individuals who applied the composition
according to
Example 1 containing muramidase to their scalp on a daily basis is set out
below.
VolunteerGender Age Baldness Time in Comments
No. history Treatment
001 M 35 10 years 14 months Dense fine hair
covering
the whole crown
002 M 46 20 years 12 months Most improvement
at
vertex region, being
site
of baldness
004 M 32 4 years 9 months Stopped hair thinning
006 M 26 7 years 8 months General increase
in hair
density
008 M 57 5 years 8 months General increase
in
density with most
improvement at vertex
region
009 M 45 20 years 6 months General increase
I in hair
density
Results obtained are shown in Figures 4-9, relating to volunteers 001 to 009
respectively
after 3 months treatment. What these figures show is that after 3 months
treatment hair
loss has not occurred, and new hair growth has been established. Control
subjects treated
with a composition which did not include muramidase and a film forming polymer
(controls) were not effective.
In another set of experiments, compositions according to Example 1 but
containing
interferon-a, interferon-(3, interferon-y, interlukin-l~i(163-171) peptide or
other non-
inflammatory interlukins, insulin-like growth factor-1 (1GF-1), extract of
Echinacea,
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mannin, heteroxylan, arabinorhamnogalactan, or (3-glucan in place of
muramidase were
tested. In the treated subjects new hair growth and prevention of hair loss
was observed
which was quite satisfactory. However in comparison the results achieved with
muramidase were exceptional..
The compositions of the invention prevent hair loss, that is, provide
maintenance of hair,
and provide new hair growth.
Those skilled in the art will appreciate that the invention described herein
is susceptible to
variations and modifications other than those specifically described. It is to
be understood
that the invention includes all such variations and modifications which fall
within its spirit
and scope. The invention also includes al( of the steps, features,
compositions and
compounds referred to or indicated in this specification, individually or
collectively, and
any and all combinations of any two or more of said steps or features.
Throughout this specification, unless the context requires otherwise, the word
"comprise",
or variations such as "comprises" or "comprising" or the term "includes" or
variations
thereof, will be understood to imply the inclusion of a stated element or
integer or group
of elements or integers but not the exclusion of any other element or integer
or group of
elements or integers. In this regard, in construing the claim scope, an
embodiment where
one or more features is added to any of claims is to be regarded as within the
scope of the
invention given that the essential features of the invention as claimed are
included in such
an embodiment.
