Hair loss abstract
The present invention relates to a composition which is generally
useful for the treatment of skin and hair. More specifically, the
composition is useful for the treatment of androgenetica, also known
as androgenetic alopecia or pattern hair loss. In general, the composition
of the present invention comprises one or more phytoestrogens, one
or more natural herbal extracts, and optionally a pharmaceutically
and/or dermatologically acceptable carrier. Other embodiments of
the present invention comprise one or more phytoestrogens, one or
more natural herbal extracts, one or more substances selected from
the group consisting of vitamins, preferably b-complex vitamins,
minerals and brewer's yeast and optionally a pharmaceutically and/or
dermatologically acceptable carrier.
Hair loss claims
What is claimed is:
1. A composition comprising one or more phytoestrogens, one or
more herbal extracts and optionally a pharmaceutically acceptable
carrier.
2. The composition of claim 1 further comprising one or more substances
selected from the group consisting of vitamins, minerals and brewer's
yeast.
3. The composition of claim 1 wherein the phytoestrogens are selected
from a group consisting of genistein, daidzein, biochanin A, and
formononetin.
4. The composition of claim 1 wherein the phytoestrogens are provided
by red clover.
5. The composition of claim 1 wherein the herbal extracts are selected
from a group consisting of saw palmetto, African pygeum and stinging
nettles extract.
6. The composition of claim 2 wherein the vitamins are b-complex
vitamins.
7. The composition of claim 6 wherein the b-complex vitamins are
selected from a group consisting of biotin, thiamin, pyridoxine,
folic acid, riboflavin, niacinamide and nicotinic acid.
8. The composition of claim 2 wherein the composition comprises
one or more phytoestrogens, saw palmetto, one or more b-complex
vitamins and optionally a pharmaceutically acceptable carrier.
9. The composition of claim 8 wherein an active component of the
composition comprises 50-95% Saw Palmetto, 0-10% Biotin, 0.1-15%
Thiamin, 0.1-15% Pyridoxine, 0-10% Folic Acid, 0.1-15% Riboflavin,
1-20% Niacinamide, and 0.5-20% Phytoestrogens.
10. The composition of claim 9 wherein the active component comprises
85-95% Saw Palmetto, 0.01-3% Biotin, 0.1-5% Thiamin, 0.1-5% Pyridoxine,
0.05-3% Folic Acid, 0.1-5% Riboflavin, 0.5-7% Niacinamide, and 0.5-8%
Phytoestrogens.
11. The composition of claim 10 wherein the active component comprises
250 mg Saw Palmetto, 50 .mu.g Biotin, 2.3 mg Thiamin, 3.0 mg Pyridoxine
B6, 200 .mu.g Folic Acid, 2.6 mg Riboflavin, 7 mg Nicacinamide,
Daidzein 2 mg, Genistein 85 mcg, Biochanin 262 mcg, Formononetin
209 mcg.
12. The composition of claim 1 wherein an active component of the
composition comprises 80-99.5% herbal extract and 0.5-20% Phytoestrogens.
13. The composition of claim 1 wherein the pharmaceutical carrier
is DMSO.
14. The composition of claim 1 wherein the composition is incorporated
in liposomes.
15. A method for the prevention and treatment of hair loss on the
scalp of a mammal comprising administering to the mammal a therapeutically
effective amount of a composition comprising one or more phytoestrogens,
one or more herbal extracts and optionally a pharmaceutically acceptable
carrier.
16. The method of claim 15 wherein the composition further comprises
one or more substances selected from the group consisting of vitamins,
minerals and brewer's yeast.
17. The method of claim 16 wherein an active component of the composition
comprises 50-95% Saw Palmetto, 0-10% Biotin, 0.1-15% Thiamin, 0.1-15%
Pyridoxine, 0-10% Folic Acid, 0.1-15% Riboflavin, 1-20% Niacinamide,
and 1-20% Phytoestrogens.
18. The method of claim 17 wherein the active component comprises
85-95% Saw Palmetto, 0.01-3% Biotin, 0.1-5% Thiamin, 0.1-5% Pyridoxine,
0.05-3% Folic Acid, 0.1-5% Riboflavin, 0.5-7% Niacinamide, and 0.5-8%
Phytoestrogens.
19. The method of claim 18 wherein the active component comprises
250 mg Saw Palmetto, 50 .mu.g Biotin, 2.3 mg Thiamin, 3.0 mg Pyridoxine
B6, 200 .mu.g Folic Acid, 2.6 mg Riboflavin, 7 mg Nicacinamide,
Daidzein 2 mg, Genistein 85 .mu.g, Biochanin 262 .mu.g and Formononetin
209 .mu.g.
20. The method of claim 15 wherein an active component of the composition
comprises 80-99.5% herbal extract and 0.5-20% Phytoestrogens.
21. The method of claim 15 wherein the composition is administered
orally.
22. The method of claim 15 wherein the formulation is administered
topically.
23. A method for the prevention, reduction and elimination of hair
in androgen stimulated areas comprising administering to a mammal
a therapeutically effective amount of a composition comprising one
or more phytoestrogens, one or more herbal extracts and optionally
a pharmaceutically acceptable carrier.
24. The method of claim 23 wherein the composition further comprises
one or more substances selected from the group consisting of vitamins,
minerals and brewer's yeast.
25. The method of claim 19 wherein an active component of the composition
comprises 50-95% Saw Palmetto, 0-10% Biotin, 0.1-15% Thiamin, 0.1-15%
Pyridoxine, 0-10% Folic Acid, 0.1-15% Riboflavin, 1-20% Niacinamide,
and 0.5-20% Phytoestrogens.
24. The method of claim 25 wherein the active component comprises
85-95% Saw Palmetto, 0.01-3% Biotin, 0.1-5% Thiamin, 0.1-5% Pyridoxine,
0.05-3% Folic Acid, 0.1-5% Riboflavin, 0.5-7% Niacinamide, and 0.5-8%
Phytoestrogens.
25. The method of claim 24 wherein the active component comprises
250 mg Saw Palmetto, 50 .mu.g Biotin, 2.3 mg Thiamin, 3.0 mg Pyridoxine
B6, 200 .mu.g Folic Acid, 2.6 mg Riboflavin, 7 mg Nicacinamide,
Daidzein 2 mg, Genistein 85 .mu.g, Biochanin 262 .mu.g and Formononetin
209 .mu.g.
26. The method of claim 23 wherein an active component of the composition
comprises 80-99.5% herbal extract and 0.5-20% Phytoestrogens.
27. The method of claim 23 wherein the composition is administered
orally.
28. The method of claim 23 wherein the formulation is administered
topically.
29. A method for the prevention, reduction and elimination of acne
comprising administering to a mammal a therapeutically effective
amount of a composition comprising one or more phytoestrogens, one
or more herbal extracts and optionally a pharmaceutically and dermatologically
acceptable carrier.
30. The method of claim 29 wherein the composition further comprises
one or more substances selected from the group consisting of vitamins,
minerals and brewer's yeast.
31. The method of claim 30 wherein an active component of the composition
comprises 50-95% Saw Palmetto, 0-10% Biotin, 0.1-15% Thiamin, 0.1-15%
Pyridoxine, 0-10% Folic Acid, 0.1-15% Riboflavin, 1-20% Niacinamide,
and 0.5-20% Phytoestrogens.
32. The method of claim 31 wherein the active component comprises
85-95% Saw Palmetto, 0.01-3% Biotin, 0.1-5% Thiamin, 0.1-5% Pyridoxine,
0.05-3% Folic Acid, 0.1-5% Riboflavin, 0.5-7% Niacinamide, and 0.5-8%
Phytoestrogens.
33. The method of claim 32 wherein the active component comprises
250 mg Saw Palmetto, 50 .mu.g Biotin, 2.3 mg Thiamin, 3.0 mg Pyridoxine
B6, 200 .mu.g Folic Acid, 2.6 mg Riboflavin, 7 mg Nicacinamide,
Daidzein 2 mg, Genistein 85 .mu.g, Biochanin 262 .mu.g and Formononetin
209 .mu.g.
34. The method of claim 29 wherein an active component of the composition
comprises 80-99.5% herbal extract and 0.5-20% Phytoestrogens.
35. The method of claim 29 wherein the composition is administered
orally.
36. The method of claim 29 wherein the formulation is administered
topically.
Hair loss description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application claims priority to and incorporates by
reference the entire contents of both, U.S. Provisional Application
No. 60/154,570 filed Sep. 17, 1999 and U.S. application Ser. No.
09/637,097 filed Aug. 10, 2000.
FIELD OF THE INVENTION
[0002] This invention relates to a composition which is generally
useful for the treatment of skin and hair. More specifically, the
composition is useful for the treatment of androgenetica, also known
as androgenetic alopecia or pattern hair loss. In general, the composition
of the present invention comprises one or more phytoestrogens, one
or more natural herbal extracts, and optionally a pharmaceutically
and/or dermatologically acceptable carrier. Other embodiments of
the present invention comprise one or more phytoestrogens, one or
more natural herbal extracts, one or more substances selected from
the group consisting of vitamins, preferably b-complex vitamins,
minerals and brewer's yeast and optionally a pharmaceutically and/or
dermatologically acceptable carrier.
BACKGROUND OF THE INVENTION
[0003] Alopecia has been a problem afflicting mankind and animals
for thousands of years. In many individuals, alopecia causes embarrassment,
psychological problems, including depression, and can affect one's
self image and feelings of sexuality. Alopecia has been hypothesized
to have various etiologies in males and females, many of which involve
gonadal steroids. The loss of hair from the scalp is more common
in men (e.g., male pattern baldness or androgenic alopecia) than
in women (e.g., female pattern baldness). Cosmetic research has
devoted millions of dollars and countless hours of research to solve
this problem.
[0004] Human hair undergoes a normal growth cycle commonly known
as the pilar cycle. During the pilar cycle, hair forms, grows and
falls out, before being replaced by a new hair shaft, which appears
in the same follicle. Humans typically have about 100,000 to 150,000
hairs on their scalps, and it is normal to lose about 50 to 150
hairs daily.
[0005] The pilar cycle can be broken down into three successive
phases: the anagen phase the catagen phase and the telogen phase.
During the anagen phase, the hair undergoes a period of active growth
associated with an intensive metabolic activity in the bulb. The
subsequent catagen phase is transitory and marked by a slowing-down
of mitotic activity. The final telogen phase corresponds to a period
of rest for the follicle, with the hair being shed. The hairs on
the head are always in different stages of the cycle, so it is normal
to loose scalp hair everyday.
[0006] It also must be explained that hair growth depends on whether
the hair growth selected for treatment is androgen-stimulated hair
growth (e.g., beard hair and torso hair generally in humans) or
hair growth that is not androgen-stimulated (e.g., scalp hair in
humans). Administration of an antiandrogen formulation topically
in a dermatologically acceptable vehicle to an area of skin having
androgen-stimulated hair growth or by administering the formulation
by oral means, injection, suppository or other sublingual forms
in general causes a reduction in hair growth. Topical application
of the compound in a dermatologically acceptable vehicle to an area
of skin having hair growth (i.e., from the scalp) that is reduced
in the presence of androgens or by administering the formulation
by oral means, injection, suppository or other sublingual forms,
(e.g., because of androgenic alopecia) in general causes an increase
in hair.
[0007] In male pattern hair loss, the normal hair growth cycle
is disrupted and more than the average number of hairs are shed
per day without having the old hairs replaced by new ones. Male
pattern hair loss is determined by a combination of male hormones
(androgens) and heredity. Men susceptible to male pattern baldness
usually experience the onset sometime in their 20's and it becomes
more common as they age. Androgenetic alopecia is the most common
type of hair loss in men, with approximately 50% of men experiencing
this hair loss to some degree by the age of 50.
[0008] In addition to adrogenetic alopecia, other factors may influence
hair loss, many of which are temporary. Amongst these factors include
stress of an illness or major surgery, medicines, such as those
used in chemotherapy, blood thinners, antidepressants, excessive
amounts of vitamin A and certain disease states like diabetes.
[0009] A number of pharmaceutical treatments have been proposed
for treating male pattern hair loss, such as Minoxidil. Minoxidil
is applied topically to the scalp and has been shown to stimulate
hair growth in individuals with androgenetic alopecia. Another medication
utilized for treatment of adrogenetic alopecia is Finisteride. Finisteride,
a prescription antiandrogen medication, is an inhibitor of type
II 5-alpha-reductase and has been shown to be effective in decreasing
scalp DHT (dihydrotestosterone) by inhibiting conversion of testosterone
to DHT. Scientists believe that DHT contributes to the shortening
of the growth phase and thinning of the hair. Oral administration
of Finisteride slowed hair loss, increased hair growth and improved
the appearance of hair. Other anitandrogen medications which interfere
with DHT binding at hormone receptor sites on hair follicle cells
are Spironolactone, Cyproterone acetate, Estrogens and Cimetidine.
[0010] Pharmaceutical treatments have various disadvantages which
deter their use. Limited results in the treatment of hair loss is
one such disadvantage. Also, side effects, such as diminished sexual
function, has been attributed to various pharmaceutical treatments.
Finally, the high cost of long-term treatment with pharmaceutical
treatments has deterred their widespread use.
[0011] Another medicant believed to treat hair loss and stimulate
hair growth is the use of herbal extracts or a combination of multiple
herbal extracts. See for example, U.S. Pat. No. 5,972,345. Many
herbal extracts, which have been found to be useful in the treatment
of benign prostatic hyperplasia, are further believed to have a
natural affect on the skin and hair. One such herbal extract is
the extract of the berries of Saw Palmetto. Saw Palmetto berries
contain an oil with a variety of fatty acids and phytosterols. The
fat soluble extract of Saw Palmetto berries has been shown to inhibit
the conversion of testosterone, which is thought to be responsible
for the enlargement of the prostrate. In addition, Saw Palmetto
extract inhibits the binding of DHT to receptors, thus blocking
DHT's action and promoting the breakdown of the potent compound.
Other herbal extracts, such as African Pygeum and Stinging Nettles
Extract have been known as having potential in stimulating hair
growth and more generally improving condition of the hair and skin.
[0012] The disadvantage of the utilization of herbal extracts or
a combination of such extracts are that they fail to provide all
of the necessary components to provide the optinmum treatment for
hair loss. Furthermore, herbal extract formulations often do not
provide an adequate proportion of each individual component which
provides an efficient coaction among the various components.
SUMMARY OF THE INVENTION
[0013] In general, the composition of the present invention comprises
one or more phytoestrogens, one or more natural herbal extracts,
and optionally a pharmaceutically and/or dermatologically acceptable
carrier. Other embodiments of the present invention comprise one
or more phytoestrogens, one or more natural herbal extracts, one
or more substances selected from the group consisting of vitamins,
preferably b-complex vitamins, minerals and brewer's yeast and optionally
a pharmaceutically and/or dermatologically acceptable carrier.
[0014] It been discovered that embodiments of the composition of
the present invention are generally useful for all types of skin
and hair treatment. As previously mentioned, various embodiments
of the composition are useful for the treatment of hair loss, and
is especially useful for treatment of androgenetic alopecia. Furthermore,
embodiments of the composition also may be utilized for the reduction
or elimination of hair in areas of the human body which are androgen
stimulated (i.e. the face or torso). Also, embodiments of the composition
are effective in the prevention and treatment of acne.
[0015] One embodiment of the present invention comprises 80-99.5%
herbal extract and 0.5-20% Phytoestrogens. Another preferred embodiment
of the present invention comprises 85-95% herbal extract, 0.01-3%
Biotin, 0.1-5% Thiamin, 0.1-5% Pyridoxine, 0.05-3% Folic Acid, 0.1-5%
Riboflavin, 0.5-7% Niacinamide, and 0.5-8% Phytoestrogens. The percentage
amounts reflect the "by mass" percentages and do not consider
the amount of carrier, if a carrier is added to the composition.
[0016] The composition can be administered by various means including
topical application, oral administration, injection, sublingual
administration or any other systematic form of administration.
[0017] These and other aspects of the invention will be evident
upon reference to the following detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 depicts the top view of the head of subject #1 following
administration of the present invention for a period of one month.
[0019] FIG. 2 depicts the top view of the head of subject #1 following
administration of the present invention for a period of three months.
[0020] FIG. 3 depicts the rear view of the head of subject #1 following
administration of the present invention for a period of one month.
[0021] FIG. 4 depicts the rear view of the head of subject #1 following
administration of the present invention for a period of three months.
[0022] FIG. 5 depicts a magnified view of a portion of the head
of subject #1 following administration of the present invention
for a period of one month.
[0023] FIG. 6 depicts a magnified view of the head of subject #1
following administration of the present invention for a period of
three months.
[0024] FIG. 7 depicts the right side view of the head of subject
#1 following administration of the present invention for a period
of one month.
[0025] FIG. 8 depicts the right side view of the head of subject
#1 following administration of the present invention for a period
of three months.
[0026] FIG. 9 depicts the left side view of the head of subject
#1 following administration of the present invention for a period
of one month.
[0027] FIG. 10 depicts the left side view of the head of subject
#1 following administration of the present invention for a period
of three months.
[0028] FIG. 11 depicts the top view of the head of subject #2 following
administration of the present invention for a period of one month.
[0029] FIG. 12 depicts the top view of the head of subject #2 following
administration of the present invention for a period of three months.
[0030] FIG. 13 depicts the rear view of the head of subject #2
following administration of the present invention for a period of
one month.
[0031] FIG. 14 depicts the rear view of the head of subject #2
following administration of the present invention for a period of
three months.
[0032] TABLE 1 depicts the terminal hair counts of subjects 1 and
2.
[0033] TABLE 2 depicts the percentage increase in terminal hair
counts at three months for subjects 1 and 2.
DESCRIPTION OF THE INVENTION
[0034] As previously mentioned, the composition of the present
invention comprises one or more phytoestrogens, one or more natural
herbal extracts, and optionally a pharmaceutically and/or dermatologically
acceptable carrier. Other embodiments of the present invention comprise
one or more phytoestrogens, one or more natural herbal extracts,
one or more substances selected from the group consisting of vitamins,
preferably b-complex vitamins, minerals and brewer's yeast and optionally
a pharmaceutically and/or dermatologically acceptable carrier. Each
component of the composition is prepared according to the traditional
procedures known in the art, then combined in a suitable composition
for administration to the patient for treatment.
[0035] The combining of the various components may be performed
by the simple mixture of all the components in a single pot operation.
For example, adding one or more phytoestrogens to a mixing container,
subsequently adding one or more herbal extracts to the same container
and then mixing the individual components together. This process
can be utilized in the mixture of all the various components described
herein when preparing a composition of the present invention. It
is noted that various embodiments of the present invention may be
prepared utilizing other procedures which adequately provide a uniform
distribution of the individual components throughout the composition.
[0036] The phytoestrogens referred to in the previously described
composition of the present invention include, but are not limited
to the following: 1) Isoflavones, such as genistein, daidzein, biochanin
A, and formononetin; 2) Lignans, or Resorcyclic Acid Lactones, such
as matairesinol, secoisolariciresinol, enterolactone and enterodiol;
3) coumestans, such as coumestrol and 4) Equol, which is an estrogenic
substance that results when intestinal bacteria break down either
formononetin or daidzein. It has been found that the composition's
inclusion of phytoestrogens enhances, accelerates and controls the
systematic involvement of all the substances, in particular the
herbal extracts, included in the composition.
[0037] In one embodiment of the present invention, red clover is
utilized as a source of phytoestrogens. Red clover can be used either
by direct incorporation into the present composition or utilized
to synthesize the phytoestrogens, which are subsequently incorporated
into the composition. The incorporation of red clover directly into
the composition also provides vitamin A, vitamin C, B-complex, calcium,
chromium, iron and magnesium to the composition.
[0038] The composition also includes one or more anti-androgen
herbal extracts. An herbal extract generally is the solution or
preparation containing the active principles of the plant, herb,
drug, juice or the like. Saw Palmetto, African Pygeum and Stinging
Nettles Extract are examples of such herbal extracts. However, any
herbal extract having anti-androgen characteristics may be used
in the present invention.
[0039] One embodiment of the present invention includes Saw Palmetto
as a component of the composition. As previously described Saw Palmetto
is a small palm tree with large leaves and largedeep red black berries.
Saw Palmetto berries contain an oil with a variety of fatty acids
and phytosterols. The fat soluble extract of Saw Palmetto berries
has been shown to inhibit the conversion of testosterone, which
is thought to be responsible for the enlargement of the prostrate.
In addition, Saw Palmetto extract inhibits the binding of DHT to
receptors, thus blocking DHT's action and promoting the breakdown
of the potent compound.
[0040] Another component utilized in various embodiments of the
composition of the present invention are vitamins and preferably
b-complex vitamins. Generally, these embodiments incorporate one
or more of the following b-complex vitamins: Biotin, Thiamin, Pyridoxine,
Folic Acid, Riboflavin, Niacinamide and Nicotinic acid. It is noted
that present invention may also include the addition of other vitamins
and minerals into the present composition.
[0041] Embodiments of the composition of the present invention
may also include the addition of minerals and/or brewer's yeast.
Brewers yeast is an excellent source of several nutrients including
thiamin (vitamin B1), riboflavin (vitamin B2), nicotinic acid (Vitamin
B3), pyridoxine (vitamin B6), pantothenic acid (Vitamin B5), biotin
and folic acid, as well as some minerals and trace minerals, especially
Chromium and Selenium. It also contains about 810 percent nucleic
acid, which may have an immune enhancing effect.
[0042] As previously mentioned one embodiment of the present invention
comprises 80-99.5% herbal extract and 0.5-20% Phytoestrogens as
the active component of the composition. Additional embodiments
of the present invention comprise as an active component of the
composition 50-95% herbal extract, 0-10% Biotin, 0.1-15% Thiamin,
0.1-15% Pyridoxine, 0-10% Folic Acid, 0.1-15% Riboflavin, 0.5-20%
Niacinamide, and 0.5-20% Phytoestrogens. The percentage amounts
reflect the "by mass" percentages and do not consider
the amount of carrier, if a carrier is added to the composition.
A preferable embodiment of the active component of the composition
comprises 85-95% herbal extract, 0.01-3% Biotin, 0.1-5% Thiamin,
0.1-5% Pyridoxine, 0.05-3% Folic Acid, 0.1-5% Riboflavin, 0.5-7%
Niacinamide, and 0.5-8% Phytoestrogens. Again, the percentage amounts
reflect the "by mass" percentages and do not consider
the amount of carrier, if a carrier is added to the composition.
[0043] It has been discovered that embodiments of the composition
are generally useful for all types of skin and hair treatment. As
previously mentioned, the composition of the present invention is
useful for the treatment of hair loss, and is especially useful
for treatment of androgenetic alopecia. Furthermore, embodiments
of the composition also may be utilized for the reduction or elimination
of hair in areas of the human body which are androgen stimulated
(e.g. the face or torso). Also as previously mentioned, embodiments
of the composition of the present invention are also useful in treatment
of acne. These embodiments of the composition of the present invention
are effective in the treatment and prevention of the previously
mentioned conditions due to their inhibiting characteristic in reducing
androgen from reaching androgen receptor sites. The composition's
active role in inhibiting androgen from reaching androgen receptor
cites is linked to the treatment and prevention of hair loss from
the scalp, the reduction of hair growth in androgen stimulated cites
and the treatment and prevention of acne.
[0044] As previously mentioned, embodiments of the composition
are suitable for providing an anti-androgenic effect when administered
to a patient. The administration of such embodiments of the composition
may be facilitated by topical application, oral administration,
injection, suppository, sublingual forms or any other mode which
is acceptable in administration of such compositions.
[0045] In one embodiment of the present invention, the composition
is administered orally to a patient. Oral dosage unit compositions
include tablets, capsules, liquids and other conventional oral forms.
In a tablet the composition may be alone or present in an amount
of from about 10-100 percent by weight, with the inert carrier constituting
the remainder of the tablet. Typical pharmaceutically acceptable
carriers include ingredients such as talcum, maize starch, polyvinyl
pyrrolidone and lactose, together with a small amount of a tabletting
agent such as magnesium stearate. As also mentioned, liquid oral
dosage unit formulations may also be used in which the compositions
are incorporated into vehicles conventionally used for lipid soluble
compounds. Also, suppositories with the composition are also contemplated,
to provide a rectal suppository administration of the drug, which
form takes advantage of the usual suppository ingredients.
[0046] The high potency of the composition permits relatively low
dosages both systemically, via oral or suppository routes, or through
topical (transdermal) application. As previously mentioned the composition
may be administered without the utilization of a pharmaceutically
acceptable carrier. However, if a carrier is present, the concentration
of the active composition is from about 10-100 percent by weight
of the composition, and generally from about 40 to 50 percent, is
useful. Topical application on an infrequent basis, through a sustained
release delivery, may indicate a relatively higher amount of the
compositions, preferably in the range of from about 50-100 percent
by weight. A relatively lower concentration of the composition is
indicated where a larger surface area is treated, such as the back,
chest, etc., e.g., a concentration of from about 0.1-49 percent
by weight.
[0047] Generally, a single oral dosage unit of the composition
is administered as one oral dosage unit several times per day, in
general up to about four times per day and preferably twice a day.
For a normal adult male this comprises an amount of about 200 mg
to 1000 mg per oral dosage unit and preferably from about 400 mg
to 600 mg per oral dosage unit form. As previously mentioned the
topical application of the composition may include a larger amount
per topical dosage unit of the composition than the oral dosage
unit. The general localization of the composition allows for a larger
dosage to be administered.
[0048] The topical administration of the composition to a patient
may also generally include a pharmaceutically and dermatologically
acceptable carrier suitable for topical administration. Pharmaceutically
acceptable carriers include, but are not limited to, an alcohol,
salve, suspension, emulsion, ointment, cream, powder or spray. In
a preferred embodiment, an alcohol such as ethanol and isopropanol
are employed as pharmaceutically and dermatologically acceptable
carriers. For deeper penetration the composition may be incorporated
in liposomes or mixed with a penetration enhancer such as DMSO.
[0049] In another embodiment, the composition is provided in a
sustained release composition for transdermal application to the
skin of a patient. The sustained release carrier should be one which
will maintain the composition at the skin and permit release to
the skin for a period of preferably a minimum of about six to eight
hours. An example of a sustained release carrier is polyvinyl alcohol
with a molecular weight of at least 8,000. For example, a polyvinyl
alcohol having a molecular weight of about 20,000 is suitable for
use with the composition. However any suitable sustained release
carrier may be utilized with the composition.
[0050] A further embodiment provides a skin composition suitable
for topical administration to a patient to be exposed to ultraviolet
light which includes both the composition of the present invention
and an ultraviolet screening agent such as para-aminobenzoic acid
or cocoa butter.
[0051] Another embodiment of the invention is the incorporation
of the composition into a shampoo which is advantageously provided
for sufferers of skin problems and particularly, male pattern baldness.
The shampoo comprises conventional shampoo ingredients having incorporated
therein the composition of the present invention.
[0052] The following examples depict testing performed utilizing
various embodiments of the present invention.
EXAMPLE 1
[0053] After informed consent was given a healthy Caucasian male
subject (age 32) with male patterned alopecia volunteered for observation
regarding hair growth promoting activity of the composition of the
present invention. The composition of the invention utilized in
the observation was as follows:
1 Saw Palmetto 250 mg B-Complex Vitamins: Biotin 50 .mu.g Thiamin
Pyridoxine B6 3.0 mg Folic Acid 200 .mu.g Riboflavin 2.6 mg Nicacinamide
7 mg Phytoestrogens: Daidzein 2 mg Genistein 85 .mu.g Biochanin
262 .mu.g Formononetin 209 .mu.g
[0054] It was recorded that before taking the composition the patient
had dramatic hair loss on the frontoparietal area of the head. The
patient was instructed to take one unit dosage orally twice a day
for a six month period. He was also instructed to report any potential
side effects and any subjective changes in hair loss. At one month
the patient noted a marked decrease in the amount of hair loss and
also noted new hair growth. FIGS. 1, 3, 5, 7, and 9 depict the top,
rear, left side, right side and magnified views of the patient's
head at one month. The patient reported again at three months the
marked decrease in hair loss and a further significant increase
in the amount of new hair growth. FIGS. 2, 4, 6, 8 and 10 depict
the top, rear, left side, right side and magnified views of the
patient's head at three months which correspond to the respective
areas shown in FIGS. 1, 3, 5, 7, and 9. It is noted that the patient
reported a significant improvement in his acne since taking the
composition. Furthermore, the patient did not experience any untoward
side effects from taking the composition.
EXAMPLE 2
[0055] After informed consent was given a healthy caucasian male
subject (age 47) with male patterned alopecia volunteered for observation
regarding hair growth promoting activity of the composition of the
present invention. The composition of the invention utilized in
the observation was as follows:
2 Saw Palmetto 250 mg B-Complex Vitamins: Biotin 50 .mu.g Thiamian
Pyridoxine B6 3.0 mg Folic Acid 200 .mu.g Riboflavin 2.6 mg Nicacinamide
7 mg Phytoestrogens: Daidzein 2 mg Genistein 85 .mu.g Biochanin
262 .mu.g Formononetin 209 .mu.g
[0056] It was recorded that before taking the composition the patient
had dramatic hair loss on the frontoparietal area of the head. The
patient was instructed to take one unit dosage orally twice a day
for a six month period. He was also instructed to report any potential
side effects and any subjective changes in hair loss. At one month
the patient noted a marked decrease in the amount of hair loss and
also noted new hair growth. FIGS. 11 and 13 depict the top and rear
views of the patient's head at one month. The patient reported again
at three months the marked decrease in hair loss and a further significant
increase in the amount of new hair growth. FIGS. 12, and 14 depict
the top and rear view of the patient's head at three months, which
correspond to the respective areas shown in FIGS. 11 and 13. The
patient did not experience any untoward side effects from taking
the composition. The patient did not experience any untoward side
effects from taking the composition.
[0057] Table 1 depicts the hair count results for subjects 1 and
2. The table illustrates an increase of approximately 350 terminal
hairs for subject #1 and 200 terminal hairs for subject #2 following
three months of administration of the formulation described in the
previously mentioned examples. The increase in terminal hair counts
equates to approximately a 60% increase for subject #1 and a 175%
increase for subject #2. These percentages are illustrated in Table
2.
[0058] While the invention has been described in conjunction with
specific embodiments thereof, it is evident that many alternatives,
modifications, and variations will be apparent to those skilled
in the art in light of the foregoing description. Accordingly, it
is intended to embrace all such alternatives, modifications, and
variations which fall within the spirit and broad scope of the invention. |