| United States Patent |
6,103,273 |
| Antoun |
August 15, 2000 |
Pharmaceutical composition comprising starch,
a compound comprising boron, a compound comprising zinc, and
water, and a method of using same to encourage hair growth
Abstract
A pharmaceutical composition for the treatment of alopecia
areata and male pattern baldness is preferably made from boric
acid, zinc oxide, and starch. The method of the present invention
comprises applying the pharmaceutical composition of the present
invention to a person's scalp. The pharmaceutical composition
of the present invention can comprise 10 parts by weight starch,
60 parts by weight boric acid, 40 parts by weight zinc oxide,
and 500 parts by weight water. The dry ingredients (starch,
boric acid, and zinc oxide) are mixed together, then the water
is added. The mixture is boiled for 20 minutes, stirring continuously.
The mixture will thicken, become smooth, and the final consistency
will have minute lumps within the liquid. Preferably, before
the pharmaceutical composition of the present invention is
applied to the scalp, the bald spots are scrubbed with either
pure lamb's wool or a soft-bristled brush made of animal hair.
This cleanses the residue from the skin. The pharmaceutical
composition of the present invention is then rubbed on the
bald spots. After 25 minutes, the scalp is rinsed, removing
any excess composition. This procedure is repeated daily for
15 days. The inventor has found that it usually takes three-fifteen
days for pores to open and fifteen days to three months for
fuzzy hair to appear. The inventor has found
that it takes approximately one to six months for hair
to grow to the point where it appears normal.
| Inventors: |
Antoun; Jacques (3630
General de Gaulle Dr., New Orleans, LA 70114) |
| Appl. No.:
|
262953 |
| Filed: |
June 21, 1994 |
| U.S. Class: |
424/642; 424/701
|
| Intern'l Class:
|
A61K 007/06 |
| Field of Search:
|
424/642,70,658,659,660
514/880,881 |
References Cited
| 124751 |
Mar., 1872 |
Lauer |
424/642. |
| 143133 |
Sep., 1873 |
Fehr |
424/642. |
| 415208 |
Nov., 1889 |
Johnson |
424/642. |
| 992937 |
May., 1911 |
Brodbeck |
424/642. |
| 2289125 |
Jul., 1942 |
Keil |
424/642. |
| 2652355 |
Sep., 1953 |
Ercoli |
424/642. |
| 4816254 |
Mar., 1989 |
Moss |
424/642. |
| 4911932 |
Mar., 1990 |
Clum et al. |
424/642. |
| 5015470 |
May., 1991 |
Gibson |
424/70. |
| Foreign Patent Documents |
| 2653996 |
May., 1991 |
FR. |
|
Primary Examiner: Gitomer; Ralph
Attorney, Agent or Firm: Garvey, Smith, Nehrbass &
Doody, L.L.C.
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This is a Continuation-in-Part of U.S. patent application Ser.
No. 07/863,795, filed Apr. 6, 1992, which is a Continuation-in-Part
of U.S. patent application Ser. No. 07/609,392, filed Nov. 5,
1990, U.S. Pat. No. 5,102,916, which is a Continuation-in-Part
of U.S. patent application Ser. No. 07/547,460, filed Jul. 3,
1990 now abandoned, all of which are hereby incorporated by
reference.
Claims
1. A pharmaceutical composition comprising 0.143%-3.93% by weight
starch, 1.00%-23.8% by weight of a compound comprising boron,
0.625%-15.8% by weight of a compound comprising zinc, and 69.4%-97.8%
water.
2. The pharmaceutical composition of claim 1, wherein:
the composition is prepared by boiling a mixture comprising
0.143%-3.93% by weight starch, 1.00%-23.8% by weight of a compound
comprising boron, 0.625%-15.8% by weight of a compound comprising
zinc, and 69.4%-97.8% water for approximately 20 minutes while
stirring continuously.
3. The pharmaceutical composition of claim 1, wherein:
the compound comprising boron is boric acid, and the compound
comprising zinc is zinc oxide.
4. The pharmaceutical composition of claim 1, wherein:
the starch comprises 0.769%-2.73% by weight of the composition;
the compound comprising boron comprises 5.22%-17.1% by weight
of the composition; and
the compound comprising zinc comprises 3.31%-11.2% by weight
of the composition.
5. The pharmaceutical composition of claim 1, wherein:
the starch comprises 1.48%-1.86% by weight of the composition;
the compound comprising boron comprises 9.73%-12.1% by weight
of the composition; and
the compound comprising zinc comprises 6.24%-7.82% by weight
of the composition.
6. The pharmaceutical composition of claim 1, wherein:
the starch comprises about 1.64% by weight of the composition;
the compound comprising boron comprises 9.84% by weight of the
composition; and
the compound comprising zinc comprises 6.56% by weight of the
composition.
7. The pharmaceutical composition of claim 6, wherein:
the compound comprising boron is boric acid; and
the compound comprising zinc is zinc oxide.
8. A pharmaceutical composition, consisting essentially of:
starch, a compound comprising boron, a compound comprising zinc,
and water.
9. The pharmaceutical composition of claim 8, wherein:
the compound comprising boron is boric acid, and
the compound comprising zinc is zinc oxide.
10. The pharmaceutical composition of claim 8, consisting essentially
of:
0.143%-3.93% by weight starch,
1.00%-23.8% by weight of the compound comprising boron,
0. 625%-15.8% by weight of the compound comprising zinc, and
water.
11. The pharmaceutical composition of claim 8, consisting essentially
of:
0.769%-2.73% by weight starch,
5.22%-17.1% by weight of the compound comprising boron,
3.31%-11.2% by weight of the compound comprising zinc, and
water.
12. The pharmaceutical composition of claim 8, consisting essentially
of:
6.24%-7.82% by weight starch,
9.73%-12.1% by weight of the compound comprising boron,
6.24%-7.82% by weight of the compound comprising zinc, and
water.
13. A method of treating alopecia areata or male pattern baldness
in a person in need of such treatment comprising:
topically administering to the person in need of treatment a
therapeutically effective amount of a pharmaceutical composition
comprising a compound comprising zinc, a compound comprising
boron, and a suitable carrier for topical application of the
pharmaceutical composition, the suitable carrier being a mixture
of starch and water.
14. The method of claim 13, wherein the pharmaceutical composition
comprises 0.143%-3.93% by weight starch, 1.00%-23.8% by weight
of the compound comprising boron, 0.625%-15.8% by weight of
the compound comprising zinc, and water.
15. The method of claim 13, wherein the pharmaceutical composition
comprises 0.769%-2.73% by weight starch, 5.22%-17.1% by weight
of the compound comprising boron, 3.31%-11.2% by weight of the
compound comprising zinc, and water.
16. The method of claim 13, wherein the pharmaceutical composition
comprises 1.48%-1.86% by weight starch, 9.73%-12.1% by weight
of the compound comprising boron, 6.24%-7.82% by weight of the
compound comprising zinc, and water.
17. The method of claim 16, wherein:
the compound comprising boron is boric acid, and
the compound comprising zinc is zinc oxide.
18. The method of claim 13 wherein the pharmaceutical composition
comprises a solution made by boiling the compound comprising
zinc, the compound comprising boron, the starch, and the water.
19. The method of claim 13, wherein:
about 30 ml of the pharmaceutical composition is administered
topically at least five times per week for three weeks, and
is rinsed off approximately 20-30 minutes after being administered
topically.
20. A process of preparing a pharmaceutical composition by boiling
a mixture comprising water and 0.143%-3.93% by weight starch,
1.00%-23.8% by weight of a compound comprising boron, 0.625%-15.8%
by weight of a compound comprising zinc for approximately 20
minutes while stirring continuously.
21. The product produced by the process of claim 20.
22. The product of claim 21, wherein:
the compound comprising boron is boric acid, and
the compound comprising zinc is zinc oxide.
23. A method of treating alopecia areata or male pattern baldness
in a person in need of treatment consisting essentially of:
topically administering to the person in need of treatment an
effective amount of the product of claim 21.
24. A composition comprising:
6 percent to 20 percent by volume of the product of claim 21
and the balance shampoo.
Description
SPECIFICATION
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to pharmaceutical compositions
for and methods of encouraging hair growth.
2. General Background of the Invention
Hair loss occurs in many persons. Two relatively
common causes of hair loss are male pattern baldness
and alopecia areata. Alopecia areata is a disease affecting
about two million people in the United States. It causes hair
to fall out quickly, from scattered spots in the size a quarter
to complete loss of all bodily hair, including
the hair on the scalp. More information about
alopecia areata can be obtained from the National Alopecia Areata
Foundation (NAAF), P.O. Box 150760, San Rafael, Calif. 94915-0760,
(415) 456-4644, Fax: (415) 456-4274. The NAAF publishes a bi-monthly
newsletter.
The inventor of the present invention is aware of a commercially
available pharmaceutical composition for encouraging hair
growth--Rogaine.RTM. with minoxidil, commercially available
from the Upjohn Company. However, Rogaine.RTM. is relatively
expensive and has been shown to cause hair regrowth
in only about 63% of the women who have tried it (as opposed
to 39% of women in a placebo group). According to an August
1991 newspaper article, only 39 percent of men using Rogaine.RTM.
in clinical trials either grew new hair or stopped
losing hair after six to eight months on the drug.
Upjohn advises that at least four months of treatment applying
Rogaine twice a day are necessary before results can be seen
with it. Further, newly grown hair is usually
lost within a few months of stopping treatment with Rogaine.
Dr. Rudolf Japple has reportedly obtained U.S. and foreign patents
on the use of the drug diphencyprone in the topical treatment
of alopecia areata. The inventor is not aware of the effectiveness
of this drug for the treatment of alopecia areata.
Thus, until now, there has been no effective relief for many
persons suffering from hair loss due to male pattern
baldness or alopecia areata.
Boric acid (H.sub.3 BO.sub.3) is a mild antiseptic. It also
has been used as a germicide. Borax is sodium tetraborate (Na.sub.2
B.sub.4 O.sub.7) and is used as a laundry water softener. Its
effect as a water softener is similar to that of ammonia.
Zinc ointment comprises zinc oxide and zinc stearate. Zinc ointment
is used for treating various eruptions of the skin. Zinc stearate
is an insoluble soap used as a dusting powder for infants. It
has antiseptic properties but is irritating to mucous membranes.
Zinc undecylenate is used in the treatment of athlete's foot.
U.S. Pat. No. 2,289,125 discloses a topical treatment for fungus
infections of the skin in which, among other ingredients, boric
acid, zinc oxide and corn starch are used. It is mentioned that
the treatment can be mixed with water.
U.S. Pat. No. 2,652,355 describes a fungicidal topical composition
in which cornstarch, zinc oxide and boric acid are primary ingredients.
U.S. Pat. No. 4,816,254 discloses an ointment in which boric
acid, zinc oxide and gum powder are used to treat irritated
skin.
U.S. Pat. No. 124,751 describes a zinc oxide composition to
treat dandruff.
U.S. Pat. No. 992,937 discloses a composition in which boric
acid, zinc oxide and talc are used to treat irritated skin.
U.S. Pat. No. 4,911,932 discloses a composition in which a composition
containing, among other ingredients, borax, zinc oxide and water,
is used to treat irritated skin.
None of the cited patents suggest a pharmaceutical composition
consisting essentially of a compound comprising boron, a compound
comprising zinc, starch, and water. Further, none of the patents
suggest using a pharmaceutical composition containing a compound
comprising boron, a compound comprising zinc, starch, and water
to treat alopecia areata or male pattern baldness.
SUMMARY OF THE INVENTION
The present invention comprises a pharmaceutical composition
which has been found to encourage hair growth
in humans. The pharmaceutical composition of the present invention
consists essentially of water, a compound comprising boron,
a compound comprising zinc, and starch ((C.sub.6 H.sub.10 O.sub.5).sub.x).
The method of the present invention comprises applying a pharmaceutical
composition containing a compound comprising boron, a compound
comprising zinc, starch, and water to a person's scalp to treat
alopecia areata or male pattern baldness.
Typically, when hair loss is limited to the scalp
area, about 30 ml of the pharmaceutical composition is administered
topically at least five times per week for three weeks, and
is rinsed off approximately 20-30 minutes after being administered
topically. More of the pharmaceutical composition is typically
used if hair loss is not limited to the scalp
area.
The pharmaceutical composition of the present invention can
consist essentially of, by weight, 0.143%-3.93% starch, 1.00%-23.8%
boron-containing compound, 0.625%-15.8% zinc-containing compound,
and the balance water.
Preferably, in the pharmaceutical compound of the present invention
and in the pharmaceutical compound used in the method of the
present invention, the compound comprising boron is boric acid
and the compound comprising zinc is zinc oxide.
One can mix the pharmaceutical composition of the present invention
with commercially available shampoo for normal hair
to help maintain the work of the pharmaceutical composition
between treatments.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The pharmaceutical composition of the present invention comprises
a zinc-containing compound and a boron-containing compound in
a carrier suitable for topical application. Preferably, the
zinc-containing compound is zinc oxide, the boron-containing
compound is boric acid, and the carrier suitable for topical
application is a mixture of starch and water.
The pharmaceutical composition of the present invention is preferably
made from starch, zinc oxide, boric acid, and water.
It is believed that the present invention works because the
zinc oxide cleans the skin, the boric acid kills germs, and
the starch assists in penetration of the zinc oxide and boric
acid into the pores of the skin. It is believed by the inventor
that the starch stretches the skin to allow the zinc oxide and
boric acid to get into the pores of the skin. The starch also
acts as a carrier to hold the zinc oxide and boric acid in place
on the scalp or other affected area.
It is believed that other zinc compounds may be substituted
for zinc oxide, other boron compounds which provide boron ions
can be substituted for boric acid, and another carrier could
be substituted for starch and water.
The pharmaceutical composition of the present invention can
consist essentially of, by weight, 0.143%-3.93% starch, 1.00%-23.8%
boron-containing compound, 0.625%-15.8% zinc-containing compound,
and the balance water (as in Table 1 when zinc oxide and boric
acid are used). More preferably, the pharmaceutical composition
of the present invention consists essentially of, by weight,
0.769%-2.73% starch, 5.22%-17.1% boron-containing compound,
3.31%-11.2% zinc-containing compound, and the balance water
(as in Table 2 when zinc oxide and boric acid are used). Even
more preferably, the pharmaceutical composition of the present
invention consists essentially of, by weight, 1.48%-1.86% starch,
9.73%-12.1% boron-containing compound, 6.24%-7.82% zinc-containing
compound, and the balance water (as in Table 3 when zinc oxide
and boric acid are used).
The present invention also comprises a method of treating alopecia
areata or male pattern baldness in a person in need of treatment
comprising topically administering to the person in need of
treatment a therapeutically effective amount of a pharmaceutical
composition comprising water, starch, a compound comprising
zinc, and a compound comprising boron.
The pharmaceutical composition used in the method of the present
invention comprises 0.143%-3.93% by weight starch, 1.00%-23.8%
by weight of the compound comprising boron, 0.625%-15.8% by
weight of the compound comprising zinc, and water (as in Table
1 when zinc oxide and boric acid are used). More preferably,
the pharmaceutical composition comprises 0.769%-2.73% by weight
starch, 5.22%-17.1% by weight of the compound comprising boron,
3.31%-11.2% by weight of the compound comprising zinc, and water
(as in Table 2 when zinc oxide and boric acid are used). Even
more preferably, the pharmaceutical composition comprises 1.48%-1.86%
by weight starch, 9.73%-12.1% by weight of the compound comprising
boron, 6.24%-7.82% by weight of the compound comprising zinc,
and water (as in Table 3 when zinc oxide and boric acid are
used). Preferably, the compound comprising boron is boric acid,
and the compound comprising zinc is zinc oxide.
TABLE 1
______________________________________
Parts by wt.
% by wt.
______________________________________
Starch: 1-20 parts 0.143%-3.93%
Boric acid: 6-120 parts 1.00%-23.8%
Zinc oxide: 4-80 parts .625%-15.8%
Water: 500 parts 69.4%-97.8%
______________________________________
TABLE 2
______________________________________
Parts by wt.
% by wt.
______________________________________
Starch: 5-15 parts .769%-2.73%
Boric acid: 30-90 parts 5.22%-17.1%
Zinc oxide: 20-60 parts 3.31%-11.2%
Water: 500 parts 75.2%-90.1%
______________________________________
TABLE 3
______________________________________
Parts by wt.
% by wt.
______________________________________
Starch: 9-11 parts 1.48%-1.86%
Boric acid: 54-66 parts 9.73%-12.1%
Zinc oxide: 36-44 parts 6.24%-7.82%
Water: 500 parts 80.5%-83.5%
______________________________________
To make the pharmaceutical composition of the present invention,
the dry ingredients (starch, boron-containing compound, and
zinc-containing compound) are mixed together, then the water
is added. The mixture is boiled for an appropriate amount of
time, stirring continuously.
Preferably, in the pharmaceutical composition of the present
invention and in the pharmaceutical composition used in the
method of the present invention, the boron-containing compound
is boric acid and the zinc-containing compound is zinc oxide.
For example, the pharmaceutical composition of the present invention
can comprise 10 parts by weight starch, 60 parts by weight boric
acid, 40 parts by weight zinc oxide, and 500 parts by weight
water. The dry ingredients (starch, boric acid, and zinc oxide)
are mixed together, then the water is added. The mixture is
boiled for about 20 minutes, stirring continuously. The mixture
will thicken, become smooth, and the final consistency may have
minute lumps within the liquid. When a greater quantity of the
dry ingredients is used, it may be desirable to boil the mixture
for fewer than 20 minutes.
Preferably, before the pharmaceutical composition used in the
method of the present invention is applied to the scalp of a
subject in need of treatment, the bald spots are scrubbed with
either pure lamb's wool or a soft-bristled brush made of animal
hair. This cleanses residue from the skin; also,
100% wool is believed to help increase blood circulation. The
pharmaceutical composition of the present invention is then
rubbed on the bald spots and remains on the affected areas for
5-50 minutes, more preferably 10-40 minutes, even more preferably
20-30 minutes, and most preferably 25 minutes. The affected
areas are then rinsed, removing any excess composition. If possible,
this procedure is preferably repeated daily for 15 days. Thereafter,
the procedure is preferably repeated 4 or 5 times per week for
2 or 3 months. Thereafter, the procedure is preferably repeated
1 or 2 times per week or per month.
The inventor has found that it usually takes three-fifteen days
for pores to open and fifteen days to three months for fuzzy
hair to appear. The inventor has found that it
takes approximately one to six months for hair
to grow to the point where it appears normal.
In the United States, four men suffering from alopecia areata
have been treated, fourteen men and three women have been treated
for male pattern baldness, and two women were treated for hair
thinning. Fifteen persons in Lebanon and over ten persons in
Spain have also been treated with the method of the present
invention. All persons who were treated experienced new hair
growth. Four specific examples follow from males treated
in the United States. In each of these examples, the subjects
were not concurrently treated with any other pharmaceutical
composition or drug.
______________________________________
Composition A
Parts by wt.
% by wt.
______________________________________
Starch: 10 parts 1.64%
Boric acid: 60 parts 9.84%
Zinc oxide: 40 parts 6.56%
Water: 500 parts 81.97%
Total: 610 parts 100%
______________________________________
EXAMPLE 1
A pharmaceutical composition (Composition A) was made by mixing
10 grams of Argo.RTM. pure starch with 60 grams of boric acid
obtained from Crystal, Canning Road, Seffner, Fla., and 40 grams
of zinc oxide obtained from Humco Laboratory, Texarkana, Tex.
75501, then adding 500 milliliters of water and boiling for
20 minutes, stirring continuously. The composition thickened
and became smooth. The final consistency was a colloidal suspension
in liquid.
D., a white male, lost about 80% of his hair at
the age of 42 years. He also lost hair on his
arms and legs. He was diagnosed by a dermatologist as having
alopecia areata, and was treated by the dermatologist by being
given Quaterzone ointment and injections of cortisone. The treatment
lasted one year, but yielded no positive results.
D. was 44 years old at the time the treatment of the present
invention began.
D. was treated with Composition A using the method of the present
invention. Each treatment consisted of washing the hair
and scalp, rinsing, then applying composition A and allowing
it to remain on the affected area for about 25 minutes. Initially,
he had a treatment six days per week for three weeks. Then,
for two or three months, D. had 4 or 5 treatments per week.
Thereafter, D. had about a treatment per week for about 15 months.
At the age of 46 years, after approximately 220 treatments over
19 months, D. had nearly 100% hair regeneration.
EXAMPLE 2
At the age of 8, F., a white male, was diagnosed with alopecia
areata by a medical doctor in the United States. Around the
age of 16, F. had an onset of alopecia areata, lost patches
of hair on his head and on other parts of his
body. Until the age of 19, F. was treated with cortisone injections,
Retin A 0.05%, Dithrocreme 0.025%, and Rogaine.RTM., but with
limited success. At the age of 20, F. was treated with Composition
A, using the method of the present invention.
Initially, he had a treatment six days per week for two months.
Then, for six months, F. had 2 or 3 treatments per week. Thereafter,
F. had about 4 treatments per week for two or three months.
Thereafter, he had a treatment every 3 weeks.
F. had approximately 400 treatments during a period of about
three years.
Within eight weeks, F. began to experience regrowth of hair
on his scalp and other affected areas. After thirty months,
new hair completely covered the affected areas.
EXAMPLE 3
B., a white male, suffering from male pattern baldness, experienced
severe thinning over approximately 50% of his scalp (top and
rear). B. tried Dejojoba shampoo for six months, and Helsinkey
shampoo for six months, but reported that the shampoos helped
the hair grow very little.
B. was then treated with Composition A, using the method of
the present invention 6 times a week for three weeks. Then,
he was treated once per month for about 13 months. He had a
total of about 45 treatments over 14 months.
Within three months, B. began to experience regrowth of hair
on the affected area of his scalp. The new hair
was initially fine, with thicker hair coming in
after approximately seven months, the number of hairs per unit
area in the affected areas increased to approximately 40%-50%
of the rest of the scalp, up from about 10%.
EXAMPLE 4
R., a white male, began losing hair in spots at
the age of 26. He lost approximately 20% of the hair
on his scalp. He also lost hair on his chin and
arm. He was diagnosed by a dermatologist as having alopecia
areata, and the dermatologist prescribed Quaterzone. He used
Quaterzone for three weeks, without success. He also tried AG
Pro, an over-the-counter product, for about a month, but with
little improvement.
R. was treated using the method of the present invention, initially
receiving 6 treatments per week for 3 weeks. Then, he received
2 treatments per week for 3 months. Thereafter, he received
a treatment every 2 or 3 months. About twenty months after beginning
treatment (about 40 treatments), R. again has a full head of
hair, and the spots where he was missing hair
elsewhere on his body have filled in with hair.
As evidenced by the examples presented herein, the pharmaceutical
composition of the present invention, produced by the process
of the present invention, when applied in accordance with the
method of the present invention, can help in the treatment of
alopecia areata and male pattern baldness.
Perhaps another suitable carrier could be substituted for starch
in the pharmaceutical composition of the present invention.
One can mix the pharmaceutical composition of the present invention
(such as Composition A) with commercially available shampoo
for normal hair and use every day or every other
day. In such a case, the pharmaceutical composition of the present
invention preferably comprises 6% to 20% by volume of the mixture
of shampoo and pharmaceutical composition. For example, most
preferably one can mix 1 part by volume of the pharmaceutical
composition of the present invention (such as Compositon A)
with 4 parts by volume of commercially available shampoo for
normal hair and use every day or every other day.
This shampoo of the present invention should be left on the
scalp or other affected area for 5-10 minutes, then rinsed off.
The shampoo of the present invention can help maintain the work
of the pharmaceutical composition between treatments. The shampoo
to mix with Composition A could comprise, for example, Quantun
shampoo for normal hair, Terma Fuse shampoo for
normal hair, or Zachi shampoo for normal hair.
The foregoing embodiments are presented by way of example only;
the scope of the present invention is to be limited only by
the following claims.
* * * * *
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