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| 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 |
| Current 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 [Referenced By]
U.S. Patent Documents
| 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
What is claimed is:
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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