Treatment of hair loss and dermatological problems

It has been found that loss of hair and malfunction of the lubricating function of the skin can be treated with small mounts of testosterone or house dust antigen given in desensitizing doses. Treatment with minidoses of testosterone or house dust suspensions is relatively inexpensive.

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 (Rograine.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 is 
discontinued. The treatment does not alleviate unattractive appearance of 
hair that arises from 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 moisture 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 malfunction, in 
particular from 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 is discontinued. The skin 
of the patient treated by the methods of the invention is usually soft and 
well lubricated. 
Treatment with minidoses of testosterone or house dust suspensions is 
relatively inexpensive. The testosterone therapy is easily administered by 
the patient without use of equipment required for injection.

EXAMPLE 
Testosterone Therapy 
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 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 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 after administration. 
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 is condition should be taken into consideration. The appropriate 
dose is that at which pre-existing allergic symptoms disappear. 
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 homeopatic medication 
and antigens. An example of such a device is the Vega machine made in 
German. That device is designed particularly to determine optimum dosage 
of homeopatic 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 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. 
EXAMPLE 
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 accord with the teachings herein often offers 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 is 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. 
Discussion 
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. The effects of house 
dust with its many air pollutants on skin and hair can now be treated in 
accord with the teachings of the invention. 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. However, if familial 
history of hair loss is reported, treatment with minidoses of testosterone 
should be considered. 
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.