Hair loss abstract
This invention is a method for reduction of hair loss and stimulation
of hair growth on the scalp of a human patient. The method comprises
the step of administering a presynaptic neurotoxin into the scalp
of the patient in a quantity and concentration to provide a therapeutically-effective
flaccid paralysis of the muscle tissue outside of the skull of the
patient. The result is a reduction in tissue tension in the desired
area of hair-growth without affecting any tissue not outside the
skull of the patient.
Hair loss claims
What is claimed is:
1. A method for reduction of hair loss and stimulation of hair
growth on the scalp of a human patient comprising the step of administering
a presynaptic neurotoxin into the scalp of the patient in the area
of the muscular band extending around the scalp defined by the frontal
muscles, temporal muscles, peri-auricular muscles and occipital
muscles in a quantity and concentration to provide a therapeutically
effective flaccid paralysis of the muscle tissue outside of the
skull of the patient to reduce tissue tension inside the area of
the muscular band to thereby reduce tissue tension in the desired
area of hair-growth on the scalp the perimeter of which is defined
by the muscular band without affecting any tissue not outside the
skull of the patient.
2. A method for reduction of hair loss and stimulate of hair growth
on the scalp of a human patient as claimed in claim 1 wherein the
presynaptic neurotoxin is a botulinum toxin.
3. A method for reduction of hair loss and stimulate of hair growth
on the scalp of a human patient as claimed in claim 1 wherein the
presynaptic neurotoxin is botulinum toxin A.
4. A method for reduction of hair loss and stimulate of hair growth
on the scalp of a human patient as claimed in claim 1 wherein the
presynaptic neurotoxin is administered by injection with a hypodermic
needle.
5. A method for reduction of hair loss and stimulate of hair growth
on the scalp of a human patient as claimed in claim 2 wherein the
presynaptic neurotoxin is administered by injection with a hypodermic
needle.
6. A method for reduction of hair loss and stimulate hair growth
on the scalp of a human patient as claimed in claim 3 wherein the
presynaptic neurotoxin is administered by injection with a hypodermic
needle.
7. A method for reduction of hair loss and stimulate of hair growth
on the scalp of a human patient as claimed in claim 1 wherein the
presynaptic neurotoxin is administered by injection with a hypodermic
needle in a circumferential manner around the periphery of the scalp.
8. A method for reduction of hair loss and stimulate of hair growth
on the scalp of a human patient as claimed in claim 2 wherein the
presynaptic neurotoxin is administered by injection with a hypodermic
needle in a circumferential manner around the periphery of the scalp.
9. A method for reduction of hair loss and stimulate of hair growth
on the scalp of a human patient as claimed in claim 3 wherein the
presynaptic neurotoxin is administered by injection with a hypodermic
needle in a circumferential manner around the periphery of the scalp.
10. A method for reduction of hair loss and stimulate of hair growth
on the scalp of a human patient as claimed in claim 1 wherein the
presynaptic neurotoxin is administered to the frontal, temporal
per-auricular and occipital muscles of the patient.
11. A method for reduction of hair loss and stimulate of hair growth
on the scalp of a human patient as claimed in claim 2 wherein the
presynaptic neurotoxin is administered to the frontal, temporal
peri-auricular and occipital muscles of the patient.
12. A method for reduction of hair loss and stimulate of hair growth
on the scalp of a human patient as claimed in claim 3 wherein the
presynaptic neurotoxin is administered to the frontal, temporal
peri-auricular and occipital muscles of the patient.
Hair loss description
BACKGROUND OF INVENTION
The present invention relates to a method of treating the scalp
to reduce hair loss and stimulate hair growth on the scalp.
Hair loss on the scalp is a problem that has plagued men and some
women since time immemorial. Great effort and expense has been spent
trying to prevent and reverse it.
It is now generally appreciated that there are several discernible
categories, of hair loss and, logically flowing from the distinctions
of the different categories, that each category in and to itself
need be separately considered if hair loss reduction or regrowth
is desired by any particular person suffering from hair loss.
The most common type of hair loss in men is male pattern baldness
or alopecia. Usually with alopecia, hair loss happens gradually
over many years. It starts out being most obvious on the crown of
the head and in the frontal region in men. For women afflicted with
alopecia, the hair loss, which provides a thinning effect, is more
spread out and is common after menopause. Despite this type of hair
loss being common, it is one of the categories that has met with
only very limited success on the part of scalp and hair specialists
in being able to reverse its effect.
As a result, in the vast majority of cases, namely males with androgenetic
alopecia or, as more commonly referred to as male pattern baldness,
short of invasive surgery or hair pieces, effective measures for
treatment are very limited.
Nevertheless, in regard to male pattern baldness, there are two
medications of which the inventors are aware presently on the market
which have shown some success. One of the medications uses as its
active ingredient minoxidil and is sold under the product name Rogaine
(a trade mark of Pharmacia & Upjohn Company). Rogaine(.TM.)
has been shown to reduce hair loss and stimulate hair growth in
up to 10 percent of men with male pattern baldness. It is a solution
that is applied externally directly to the scalp area and treatment
application must be exhaustively and regularly maintained. It is
also very expensive.
The other of the medications uses finasteride as an active ingredient
and is sold under the product name Propecia (a .TM.of Merck &
Co., Inc.). Propecia(.TM.) is in pill form and taken orally. It
also requires consistent application. The pill must be taken on
a regular basis.
In both of the above cases, however, the method of action appears
uncertain and both require constant attention and application of
the user.
There is a need for a method of dealing with alopeccia or male
pattern baldness that does not require either of external application,
extensive effort or time of the user and which is economical.
It is an object of the present invention to provide a method of
dealing with alopeccia or male pattern baldness that does not require
external application, that does not require extensive effort of
the user and which is economical to use.
SUMMARY OF THE INVENTION
According to an aspect of this invention there is provided a method
for reduction of hair loss and stimulation of hair growth on the
scalp of a human patient comprising the step of administering a
presynaptic neurotoxin into the scalp of the patient in a quantity
and concentration to provide a therapeutically-effective flaccid
paralysis of the muscle tissue outside of the skull of the patient
to reduce tissue tension in the desired area of hair-growth without
affecting any tissue not outside the skull of the patient.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be more readily understood after reading the
following detailed description of the preferred embodiment of the
invention in combination with the drawings in which:
FIG. 1 is illustration of a perspective view of a patient's head
showing the administration of an injection into the patient's scalp
being made in accordance with the method of this invention; and
FIG. 2 is an illustration showing the side of the patient's head
with the musculature of the side of the scalp outlined in phantom;
FIG. 3 is an illustration showing the front of a patient's head
with the musculature of the front of the scalp outlined in phantom;
FIG. 4 is an illustration showing the back of a patient's head
with the musculature of the back of the scalp outlined in phantom;
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIG. 1 of the drawings, there is shown the administration
of a presynaptic neurotoxin by a qualified health care worker using
a hypodermic needle 10 to the scalp of the patient, generally referred
to by the numeral 12, in a quantity and concentration, as will be
more fully described below, to provide a therapeutically-effective
flaccid paralysis of the muscle tissue shown in the area of the
band delineated and located approximately between broken lines 14
and 16 in FIGS. 1, 2, 3 and 4, outside of the skull of the patient
to reduce tissue tension in the desired area of hair-growth without
affecting any tissue not outside the skull of the patient.
Preferably, the presynaptic neurotoxin used is a botulinum toxin,
namely botulinim toxin A. Preferably, it is injected, after being
reconstituted with normal saline or other suitable and pharmaceutically
acceptable carrier or diluent to achieve the desired concentration
and volume of injectant, into the frontal muscle as at 18, into
the temporal muscles as at 20, and into the occipital muscles as
at 22 in a circumferential manner around the periphery of the scalp.
As mentioned above, the periphery of the scalp can be represented
approximately by a band between broken lines 14 and 16. The exact
location of the band will vary with each individual, depending on
the location of each individual's scalp musculature. It will be
appreciated by those skilled in the art that the peri-auricular
group 20 includes the superior auricular muscle as well as the posterior
auricular muscle and the anterior portions of the occipital muscle
shown in FIG. 3.
Also, in each case, the injections are placed to the areas of the
scalp as required for treating the baldness. For effective placing
of the injections, the inventors have realized that the anatomy
of the scalp can be conceptualized tension-wise as trampoline-like.
Over the scalp area, the layers beneath the skin are an unyielding
fibrous layer called an aponeurosis (galea aponeurotica). The muscles
surrounding the scalp in the band defined by broken lines 14 and
16 are analogous to the springs which would tension and hold taut
the tarp of the trampoline. Blood vessels carrying oxygen and nutrients
must traverse this area to provide a suitable environment for hair
follicles to flourish. When the muscles surrounding the scalp tighten,
the areas of scalp mechanically under the highest tension are the
vertex and frontal areas. Thus, the most common areas of male pattern
baldness correspond to the areas under highest tension. The inventors
have found that by reducing the tension of the musculature surrounding
the scalp, tension in tissue of the frontal and vertex areas is
also effectively reduced. This reduction of tension in the frontal
and vertex areas permits an increase of blood flow into that area
of the scalp. So it is the ring of musculature surrounding the scalp
controls the tension in the target areas. When it is relaxed, the
tissue of the whole scalp relaxes. So it is that the tissue in the
central area of the scalp 29 is most effectively reduced in tension
by reducing muscular tension of the frontal muscles as at 18, into
the temporal muscles as at 20, and into the occipital muscles as
at 22 in a circumferential manner around the periphery of the scalp.
Therefore, a complete circumferential distribution of the toxin
present invention around the periphery of the scalp of the person
suffering from hair loss is preferable so that a complete circumferential
distribution of the toxin is achieved by relaxing the muscle areas
responsible for tensioning the underlying tissue of the bald areas.
The object of the injections is to reduce scalp tension. The relative
contribution of these muscles to scalp tension will vary in different
individuals and, accordingly, it would not be necessary in some
individuals to target all these muscle groups to reduce scalp tension.
The relative contribution and therefore importance can be readily
determined through clinical assessment. Specific factors to be considered
would be apparent to the compotent health care worker and depend
upon the specific patient, such factors would include scalp muscle
bulk and the muscle's ability to move the scalp when contracted
voluntarily or by point stimulation.
Diluted botulimim toxin A, the preferred presynaptic neurotoxin,
can be deposited in an extra muscular site close to the target muscle
but preferably is deposited within the target muscle bodies. As
illustrated, it is injected preferably with a fine gauge hypodermic
needle or EMG needle but may also be delivered by other modes, acceptable
in the art, such as iontophoresis or pneumatic techniques. The muscle
to be or affected by administration of presynaptic neurotoxin can
be determined or confirmed through digital palpation or through
electromyographic guidance.
Subject to the specific situation of the patient, generally each
patient can receive injections of approximately 0.1 ml of botulinum
toxin diluted to 10 units per 0.1 ml in a pattern whereby a radius
of 1.5 cm drawn from the center of the injection site overlaps a
similar radius of the adjacent injection site. Reasonably, a larger
volume of higher concentration of botulinum toxin A will allow for
more space between the injections sites. The number of injections
and their spacing over the band defined by broken lines 14 and 16
were, in the case study, were about 1.5 to 3 cm apart and this was
found to be effective. The adequacy of the injection technique can
be monitored through an objective increase in scalp mobility through
digital pressure or through an increase in transcutaneous partial
oxygen pressure measurements. A reading taken in the area with hair
loss which equals or approaches that of a standardized hair bearing
area such as the temporal scalp can be taken as indicative of an
adequate response to the technique and therefore adequate performance
of the technique.
The administration of the presynaptic neurotoxin produces a reversible,
flaccid paralysis of the muscle tissue very local to the area of
injection which should remain for a period of three to nine months,
if properly administered. The procedure need only be repeated periodically
as necessary to maintain laxity of the scalp muscles necessary to
permit hair growth. The process therefore requires relatively little
effort of the patient and is without the tedious requirement of
repetitive application as is the case with some of the proposals
in the prior art.
The patient thereby is able to continue on with his life without
worry about treatment and need not attend to his scalp except in
the normal manner.
It will be appreciated by those skilled in the art that chemicals
used as toxins in humans for health purposes must be empirically
tested before they can be readily used by the public or by health
care workers. The properties of any given chemical in a particular
situation cannot be predicted with absolute certainty without proper
testing. Although the qualities of the toxin required to achieve
the results of the present invention are known and described herein,
there is only at this time one toxin known to work and that has
been tested. As described in the preferred embodiment, that toxin
is botulinim toxin A manufactured by Allegan Inc. of Irvine, Calif.
However, other toxins which would imitate botulinim toxin A's qualities
in paralyzing muscle tissue safely could also be used. It is the
qualities of botulinim toxin A that are desired for this invention
and if a substitute toxin with the necessary qualities, as claimed
in the broadest claim herein, was to become available, it would
be apparent to a person skilled in the art as falling within the
scope of this invention.
The tissue environment surrounding the hair follicles is chiefly
governed by factors such as local oxygen supply, nutrients and biochemical
mediators. The relative concentration of these factors as well as
the biochemical reactions they are involved in is quite dependent
on the blood supply to the tissues. By using the arterial vessels
as described above, blood supply is provided to the central areas
of the scalp from the periphery. The inventors have found that injection
of a presynaptic neurotoxin improves the tissue environment surrounding
the hair follicles by reducing scalp tension and, by doing so, improves
bloodflow through the arteries. In turn, the tension in hair-bearing
tissue is reduce and hair growth is stimulated.
For illustrative purposes in using the invention, the following
is an actual case study in the use of the invention: A healthy 39
year old non-smoker with Hamilton class V male pattern baldness
was injected instramuscularly with 100 units BTX-A diluted to 10
units per 0.1 ml in normal saline. The frontal, temporal, peri-auricular
and occipital muscles were injected with a fine gauge hypodermic
needle in a circumferential manner around the periphery of the scalp
as described above. The vertex was photographed as well, position
of frontal sentinel hairs and average daily hair loss collected
in a fine toothed comb. At 6 months scalp tension increased and
a further 100 unite of botulinim toxin A was injected in a manner
similar to the first injection. At 1 year, post treatment, daily
hair loss was reduced by 76 percent and the frontal sentinel hair
was 1 cm forward of its predecessor.
The above example is given to show actual results achieved using
this invention and is given for illustrative purposes of its effect.
It will be apparent to those skilled in the art reading this specification
as a whole that there are alternatives to following the exact procedure
as outlined in the method described as the preferred embodiment
herein without deviating from the scope of the invention. It is
not intended that the present specification be read in a limiting
manner but that the scope of the invention be appreciated as set
out in the appended claims. |