Hair loss abstract
A kit for use in determining the dosages and administering testosterone
for the treatment of hair loss and disorders involving the lubricating
function of the skin.
Hair loss claims
1. A kit for testing immune response to testosterone comprising
multiple sealed containers containing compositions wherein at least
two said containers have different concentrations of testosterone
or an ester of testosterone in a pharmaceutically acceptable aqueous
carrier wherein said compositions of differing concentration each
contain between 4 mg/ml and 0.00012 mg/ml testosterone or an ester
2. A kit of claim 1 wherein sealed containers are equipped with
droppers for dispensing the compositions therein.
Hair loss description
FIELD OF THE INVENTION
This invention provides a means of treating hair loss and other
dermatological problems of allergenic origin using desensitizing
doses of allergens.
BACKGROUND OF THE INVENTION
The treatment of dermatological problems related to hair loss has
been a topic of considerable study. The most widely used treatment
at the present time is topical application of minoxidil (Rogaine.TM.)
for restoration of hair loss on the crown of the head of individuals
with male pattern androgenic baldness of hereditary origin. The
method has several disadvantages. The hair produced is usually short,
thin, and often discolored. The hair loss resumes as soon as the
treatment with minoxidil is discontinued. That treatment does not
alleviate unattractive appearance of hair that arises from an abnormally
dry or oily scalp. Moreover, the use of minoxidil is effective in
only 10% to 20% of the patients suffering from hair loss.
There have been reports of treatment of premenstrual syndrome using
minidoses of progesterone as desensitizing allergens. No previous
disclosure of use of minidoses of androgens to relieve dermatological
problems of dryness, abnormal oil production and distribution, or
hair loss has been reported.
DESCRIPTION OF THE INVENTION
This inventor had noted that allergy treatment for sinus and nasal
conditions frequently resulted in improved moistness of the skin
and improved hair production and retention. However, when specific
allergic response to specific antigens more commonly used for treatment
of allergies was not indicated, or when such treatment did not result
in effective treatment of hair loss and other dermatological problems
of dryness or inappropriate oil production and distribution in the
skin, treatment with testosterone or house dust suspensions often
proved to be highly beneficial. The dosage is individualized in
accord with the teachings disclosed herein.
It is the purpose of this invention to provide means of treating
hair loss and skin problems by administration of very small doses
of testosterone or house dust allergens. While it has been common
to treat specific food and inhalant allergies with desensitizing
doses of specific food, pollen, and other antigenic materials, the
use of house dust suspensions is little used today to treat allergic
symptoms. It has now been found that many patients suffering from
hair loss and other dermatologic malfunctions, in particular, dry
scalp and abnormal distribution of oil, suffer from either allergy
to house dust or allergic response to testosterone.
It has also been found that when there is a familial history of
hair loss and abnormal lubricating function of the skin, treatment
using minidoses of testosterone to treat the chronic allergic conditions
can be of great value in restoring hair production and retention
and in improving skin condition. The hair distribution resulting
from the treatment disclosed herein is normal. Furthermore, the
hair produced in response to this treatment was attractive and normal
in appearance and was retained for a considerable period of time
after the treatment was discontinued. The skin of the patient treated
by the methods of the invention is usually soft and well lubricated.
Treatment with minidoses of testosterone alone or with or house
dust suspensions is relatively inexpensive. The testosterone therapy
is easily administered by the patient without use of equipment required
When the patient is believed to suffer from testosterone allergy,
the method of determining the appropriate dosage is essentially
the same as that used in determining appropriate dosage for use
in any regimen involving desensitization therapy by administration
of neutralizing doses of allergens. The optimal dosage is usually
in the range of 0.0006 to 2 mg. per day administered once daily
to the oral mucosa, preferably sublingually. When administered by
this route, the medication is usually absorbed in about 30 seconds.
The patient who is allergic to testosterone will usually show symptoms
of hypersensitivity to the highest dosages, and such symptoms of
hypersensitivity will not be seen at desensitizing dosage. Any ester
of testosterone or testosterone itself may be used in the manner
exemplified so along as an aqueous suspension can be prepared that
will be readily absorbed through the mucosa. Examples of such esters
are the alkyl and cycloalkyl esters of 1-6 carbons, which may be
branched or substituted with a phenyl substituent.
During testing, the patient should be placed in a quiet environment
where he is made as comfortable and relaxed as possible. A dose
of testosterone is then administered sublingually, and the patient
is asked to indicate any symptoms that appear after administration
of the testosterone. Symptoms most frequently reported are headache,
drowsiness, inability to concentrate, tiredness, sudden lack of
energy, sweating of the palm of the hands, visual disturbances of
any kind (including blurring) or a light headed feeling. Any dosage
that causes such a symptom is considered a provoking dose and is
deemed excessive. It should be noted that all of the mentioned symptoms
are common to persons suffering acute allergic reactions. An appropriate
dose is that at which symptoms of allergy are no longer experienced
If the patient is currently suffering from symptoms of allergy
such as sinus problems, migraine headaches, nasal stuffiness, hot
flashes, joint stiffness, inability to concentrate, anxiety, or
visual disturbances before administration of the testosterone, he
may actually note a relief of symptoms within up to 30 minutes after
administration. Such relief would indicate that the dose administered
is a desensitizing dose. Any change in condition should be taken
into consideration. The appropriate dose is that at which pre-existing
allergic symptoms disappear. In fact, the methods of the invention
should be tried on patients suffering from such allergies if other
conventional means of treatment prove ineffective, since allergic
symptoms may be due to inappropriate response to testosterone.
It has now been found that treatment of patients with symptoms
of premenstrual syndrome may be accomplished by methods of the invention,
namely, testing with small dilutions of testosterone, as taught
herein, followed by treatment with appropriate desensitizing doses
The methods of the invention have also proved useful elderly persons
suffering from generalized hair loss.
The process of determination of appropriate dosage usually is inaugurated
using a dose of 0.05 ml of an aqueous composition containing 20
mg per ml. of testosterone to deliver a dose of 1 mg. The testosterone
is then administered daily in successive 1:4 dilutions using 1 ml
of the last concentration to 4 ml of distilled water to be continued
until the appropriate dosage is reached. The smallest dosage used
is 0.0006 mg. For purposes of this application, the dosage will
be delineated #1 to #7, with #1 being a dose of 1 mg. and #7 being
0.0006 mg. It may, thereafter, be wise to further optimize the dosage
by administration of 0.1 ml, 0.15 ml or 0.2 ml of a dose near the
end point at which adverse allergic symptoms are relieved or at
which symptoms of acute allergic response no longer occur.
The response of individuals to antigens varies greatly. The most
commonly used dosage is taught herein merely as a guide to most
common usage. In fact, the treatment described herein will be found,
in some individuals, to require much lower dosages than provided
with dilution #7. It must be stressed that in each and every case
the individual dosage should be individually determined using the
methods taught herein with continuing serial dilutions until appropriate
dosage is determined.
It is also possible to determine appropriate dosage using an electronic
medical device for determining appropriate dosage of homeopathic
medications and antigens. An example of such a device is the Vega
machine made in Germany. That device is designed particularly to
determine optimum dosage of homeopathic medications and of foods
and inhalant antigens used in the treatment of food and respiratory
allergies. The device uses electric currents in the body to establish
the amount of the allergens compatible with the needs and tolerance
levels of each patient.
It is important, in determining correct dosage, that the practitioner
avoid all suggestion of symptoms that are expected in the evaluation.
The most common dosage dilutions found to be useful for treatment
are #2 (4 mg/ml) for a dose of 0.2 mg in 0.05 ml or #3 (0.8 mg/ml)
for a dose of 0.04 mg in 0.05 ml. for men and #3 or #4 (0.16 mg/ml)
for a dose of 0.008 mg. in 0.05 ml. for women. During testing, one
in 10 subjects did not react at all to the testosterone testing
the first time. However, on repetition, 50% of these subjects did
respond. At #7 the concentration of testosterone is 0.0012 mg/ml.
Once the appropriate treatment dosage is determined, the subject
is advised to administer that dosage once a day and to report any
change in hair loss and/or skin condition. When noticeable improvement
occurs, the dosage is continued for two months after which the frequency
of administration may be decreased to every other day (q.o.d.).
If no advantage is lost at the q.o.d. frequency of administration,
that regimen is continued indefinitely. If there is increase in
hair loss or malfunction of skin lubrication, the daily administration
is resumed. After a period of sustained improvement, even lower
dosages may be tried.
When improvement is lacking or insufficient, the dosage may be
increased every four or five days by 0.05 ml of the dilution prescribed
up to a maximum of 0.25 ml. If that dosage is insufficient, the
dosage will be increased by moving to the next stronger dilution
of the testosterone. The same method of increasing dosage is used
if the hair growth and retention is not sustained.
If the dosage given provokes an untoward symptom, it is an indication
that a provoking dose has been administered. At that time, administration
of the next weaker dosage should be instituted.
The method of treatment described herein has also been used successfully
for treating men suffering from hormonally caused sexual disfunction.
For best results, the appropriate dosage should be taken between
10 and 60 minutes prior to intercourse. When used in accord with
the teachings herein improvement of varying degree has been noted
in 40% of males.
House Dust Antigen
Many dermatologic problems that cause hair loss and scalp problems
result from allergies. Allergy to house dust appears to be a very
common cause of such dermatologic problems. The use of house dust
antigen in desensitizing doses in conjunction with desensitization
to testosterone in accord with the teachings herein often offers
improved relief from symptoms of hair loss and dry scalp.
The patients were first tested for hypersensitive response to house
dust in the usual manner by intradermal administration. If hypersensitivity
was evidenced, the treatment protocol was initiated.
House dust antigen in suspension has been used for many years.
The product of two manufacturers, Alpyral (brand name), made by
Hollister-Stier Laboratories and Al-Center (brand name) made by
Center Laboratories are both readily available. The Alpyral has
a concentration of 20,000 PNU (protein nitrogen units) per ml.,
while the Al-Center antigen has a concentration of 10,000 PNU per
ml. The former is often preferred, since the volume of suspension
needed for a response is less. Therefore, the patient suffers less
discomfort at the injection site.
The instructions of the manufacturer are followed in the usual
manner to initiate treatment. The most common protocol requires
administration of increasing dosage at intervals of 3-4 days (twice
weekly). The doses are increased with each injection, usually beginning
using increasing doses at 25 PNU, 75 PNU, 200 PNU, 500 PNU and 1,000
PNU. After dosage of 1000 PNU is reached, the antigen is administered
at weekly intervals with progression to 2000 PNU, 4000 PNU and 6000
PNU. After dosage of 6000 PNU is reached, weekly injections at that
dosage are given weekly until definite decrease in the amount of
hair loss and improvement in condition of the scalp is observed.
Occasionally administration of 6000 PNU results in pain and swelling
at the injection site. When this occurs, it is necessary to repeat
a lower dosage several times before advancing to the 6000 PNU dosage.
While discomfort caused by higher dosage is troublesome, serious
side effects from use of house dust suspension has not been reported.
It should be noted that the sensitivity of patients to house dust
antigen varies greatly. Some patients are very sensitive to house
dust antigen, they may require far less antigen for treatment. In
some instances the dosage required for maintenance was as little
as 5 PNU until a favorable response was obtained. Determining the
correct dosage may require use of very small amounts of antigen,
possibly starting with 1 PNU dosage with continued decrease or increase
in amount administered until the appropriate dosage is determined.
Regardless of the dosage given initially for maintenance, as soon
as results are clearly evidenced, it is wise to attempt to maintain
progress with less frequent administration. If sufficient advantage
is maintained with administration at two week intervals, it is desirable
to administer the antigen even less frequently.
If no improvement in scalp condition or hair retention is noticed
after about two months and if there is no undue discomfort at the
injection site the maintenance dosage of the house dust antigen
preparation may be increased to 8000 PNU. After two months at the
8000 PNU dosage level, the dosage can be increased to 10,000 PNU
if results of treatment are not satisfactory.
If improvement in the scalp condition and hair retention is not
seen in 12 months, it can be suspected that this treatment will
not result in improvement. However, it should be noted that positive
results have been initially noted at the end of two years of treatment.
It is believed that failure to recognize and treat effects of house
dust and testosterone allergies results in many cases of baldness
and disfunction of the lubricating activity of the skin. It is suggested
that any patient presenting with unacceptable amount of hair loss
and disturbance of the lubricating function of the skin should be
considered as a candidate for desensitization treatment. If the
patient is found, during skin testing, to be allergic to house dust,
treatment in accord with the teachings using that allergen should
be considered. If familial history of hair loss is reported, treatment
with minidoses of testosterone should be considered. The minidoses
of testosterone may be given in conjunction with housedust desensitization.
The levels of testosterone used by the method of the invention
do not in any way effect the hormonal balance of the body, since
the amount of testosterone naturally produced and present in the
body is so much higher than the minidoses delivered during treatment
that the effect on systemic hormonal level is negligible.
Compositions containing the small amounts used in testing and treating
patients can be provided in ampules, vials, or bottles with dropper
tops for purposes of testing and treatment. The bottle with a top
appropriate for dispensing the medication in drop form is particularly
useful for dispensing the composition to the patient for self-administration.
The vials or ampules with graduated concentration of the testosterone
would be appropriate for dispensing to physicians for use in testing
patients to determine dosage required.
Appropriate dosages may also be provided as buccal tablets wherein
the testosterone is formulated as an inclusion complex with cyclodextrine.
See particularly U.S. Pat. No. 4,727,064 to Pitha, which is incorporated
herein by reference. Dosage may also be provided using a patch prepared
in accord with the teachings of U.S. Pat. 4,978,532 to El-Rashidy,
which is incorporated herein by reference.