Hair loss abstract
A method and compound having betamethasone dipropionate and all-trans-retinoic
is disclosed for the treatment of hair loss. The method also includes
identifying any underlying conditions causing hair loss and administration
of a salve of betamethasone dipropionate and all-trans-retinoic
acid to the affected areas.
Hair loss claims
1. A composition for the treatment of hair loss comprising effective
a Vitamin A derivative, and
a carrier agent for said corticosteroid and said Vitamin A derivative.
2. The composition of claim 1, wherein the corticosteroid comprises
3. The composition of claim 1, wherein the Vitamin A derivative
comprises all-trans-retinoic acid.
4. The composition of claim 1, wherein the carrier agent is adapted
to suspend said corticosteroid and said Vitamin A derivative.
5. The composition of claim 2, wherein the effective amount of
betamethasone dipropionate is 0.05% by weight.
6. The composition of claim 3, wherein the effective amount of
all-trans-retinoic acid is 0.0125% by weight.
7. The composition of claim 1, wherein a range of ratios of said
corticosteroid to said Vitamin A derivative is between approximately
1:1 and 15:1.
8. The composition of claim 1, wherein the ratio of said corticosteroid
to said Vitamin A derivative is approximately 4:1.
9. The composition of claim 8, wherein said corticosteroid comprises
betamethasone dipropionate and said Vitamin A derivative comprises
Hair loss description
BACKGROUND OF THE INVENTION
I. Field of the Invention
The present invention relates to a compound and method of treatment
for hair loss, and more particularly, to a compound and method using
a compound having all-trans-retinoic acid and betamethasone dipropionate.
II. Description of the Prior Art
Restoration of human hair has been attempted for centuries. In
many cases, hair loss is merely covered by wigs or toupees. Many
medical treatments have been attempted over the years; however,
up until now, no treatment has been found which satisfactorily stimulates
hair growth for a wide variety of cases, including alopecia.
Each hair extends from a tube-like depression called a hair follicle.
The hair follicle extends from the surface of the skin into the
dermis and may pass into the subcutaneous layer. At the base of
the follicle is a group of epidermal cells which receive nourishment
from blood vessels that occur in a projection of connective tissue
at the base of the follicle.
As the epidermal cells divide and grow, older cells are pushed
toward the surface. The cells that move upward and away from the
nutrient supply become keratinized and die. Thus, hair is dead keratin,
just like scale, and is formed at a predetermined rate.
The normal rate of growth of hair is 1 cm per month. Each hair
follicle goes through a cycle of a growth stage (anagen hair), and
an involution or resting stage (telogen hair). The anagen stage
lasts about three years, while the telogen stage lasts only about
three months. Once the hair follicle reaches the end of the telogen
stage, the hair falls out. Eventually, the hair follicle produces
a new growing hair.
The cycle of hair activity for hair follicles is independent for
each hair follicle. However, when the hair follicles fail to regenerate
hair, baldness results.
Many causes of hair loss are known. Exposure to chemotherapy, X-ray
therapy, exposure to toxic chemicals, and topical chemicals on the
scalp can cause anagen hair loss. Hormonal imbalances, stress, nutritional
deficiency, and usage of many drugs can cause telogen effluvium.
The cause of alopecia areata is unknown, and male/female androgenetic
alopecia is caused by genetics. There are numerous other causes
of hair loss, as well.
It is known that the hair follicle is an immune-privileged organ,
and it has been postulated that hair growth may be regulated by
the immune system (Frusgate et al., Journal of Investigative Dermatology,
97: 417-420, 1991). Thus, in order to restore hair, it is necessary
to treat any underlying causes of the hair loss, such as disease,
stress, hormonal imbalance, or nutritional deficiency. It is known,
as disclosed by Olson (Alopecia Evaluation, Primary Care 1989: 16
(3), p. 765-787), to treat hair loss by making an evaluation of
the patient, including patient history, physical exam, and lab studies,
treating any treatable underlying causes of hair loss, and treating
alopecia with topical minoxidil and antiandrogens. However, treatment
with minoxidil has many undesirable side effects and hair growth,
if it occurs, takes place only as long as the minoxidil is being
used. Thus, in order to restore hair growth, it is desirable to
overcome the causes of alopecia and permit hair follicles to grow
hair without continuous stimulation, such as by minoxidil.
It is known to use various commercial shampoo preparations to strengthen
the hair. These shampoos typically include protein and affect only
dead keratin, not the hair follicle, and therefore cannot prevent
SUMMARY OF THE INVENTION
Applicant's method and compound for hair restoration produces hair
growth in all cases of hair loss arising from all of the previously-recited
causes for this condition. The rate of hair growth is greater than
previously known methods and compounds. The method includes first
identifying the causes of the patient's hair loss. The identification
step includes a complete patient history to identify dietary problems,
stress, genetic factors, and drug usage. Additionally, the patient
is given a physical exam for identifying hormonal imbalances and
disease. Then, an external examination of the scalp and condition
of the hair is made.
After the identification step, a diagnosis is made. Following the
diagnosis, an application of betamethasone dipropionate and all-trans-retinoic
acid is made to the patient. The betamethasone dipropionate and
all-trans-retinoic acid are administered together in a compound
applied topically to the scalp. The compound and method have been
found to effectively restore hair growth even after discontinuance
of use of the compound.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a block diagram of the method of treatment according
to the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Disclosed herein is a method of promoting hair growth using corticosteroids
in combination with Vitamin A derivatives. As best shown in FIG.
1, Applicant's method includes the steps of identifying the underlying
cause of hair loss 10; conducting a physical examination 14; and
administering a compound of all-trans-retinoic acid and betamethasone
dipropionate to the scalp of the patient 30.
As stated above, there are many known causes for hair loss. These
causes include genetic disorder, hormonal imbalance, nutritional
deficiency, and stress. Additionally, many external occurrences
may result in hair loss, such as chemotherapy, toxic exposure, drugs,
and X-ray therapy. Thus, the identification step 10 includes making
a complete patient history 12. The patient history includes obtaining
information regarding drugs, major illnesses, weight loss or gain,
major stress occurrences, as well as family background for genetic
The identification step 10 also includes making an examination
of the scalp and hair and an examination of the patient's physical
condition 14. The physical examination may include the taking of
blood pressure readings, a thyroid exam, and lab studies to determine
whether any physiological imbalances are causing the hair loss.
After evaluating the patient's condition, a diagnosis may be made
as to the causes of hair loss. After the diagnosis, the patient
is treated with a compound containing a corticosteroid in combination
with a Vitamin A derivative. As set forth below, the preferred embodiment
is in the form of a topical gel containing a suspension of betamethasone
dipropionate as the preferred corticosteroid, and all-trans-retinoic
acid as the preferred Vitamin A derivative.
Betamethasone dipropionate is a steroid and has a tendency to thin
the dermis. All-trans-retinoic acid is also administered in combination
with betamethasone dipropionate. However, one of the well-known
side effects of all-trans-retinoic acid is that it acts to thicken
the skin. Thus, when used in combination with each other, the negative
side effects of betamethasone dipropionate and all-trans-retinoic
acid act to cancel each other out while synergistically producing
a large amount of hair. In the preferred embodiment, the betamethasone
dipropionate and all-trans-retinoic acid are applied in combination
with each other as a topical preparation in the form of a gel. The
ratio of betamethasone dipropionate to all-trans-retinoic acid ranges
from 1:1 to 15:1, with 4:1 being the preferred ratio.
Initially, the user should apply the salve of the present invention
once a day. Applicant's experimental data has disclosed that by
doubling the amount of betamethasone dipropionate while leaving
unchanged the amount of all-trans-retinoic acid, (i.e., from a 2:1
to a 4:1 ratio) a significant increase in the efficacy of the salve
is achieved. The salve of the present invention may be provided
in the form of a gel, an ointment, a cream, or a liquid.
In the preferred embodiment of the compound, a topical gel was
formed having betamethasone dipropionate and all-trans-retinoic
acid as main active ingredients. The gel is made in 4800 g batches.
600 mg of pure all-trans-retinoic acid powder, 1200 mg of pure betamethasone
dipropionate powder, 2400 g of 0.05% betamethasone dipropionate
lotion (available from Lemmon Laboratory in Sellersville, Pa.) and
2400 g of Liqua-Gel.TM. (available from Paddock Laboratory in Minneapolis,
Minn.) were weighed out on an analytical balance. The all-trans-retinoic
acid powder and the betamethasone dipropionate powder were ground
together with a mortar-and-pestle. The betamethasone dipropionate
lotion and the Liqua-Gel were then added to the ground powders in
order to put them into suspension. The resulting compound contains
0.05% by weight betamethasone dipropionate and 0.0125% by weight
all-trans-retinoic acid, for a corticosteroid-to-Vitamin A derivative
ratio of 4:1.
The gel was applied to the scalp of a patient diagnosed with male-pattern
baldness. The patient had scar tissue on the scalp resulting from
scalp reduction surgery. The gel was applied in a thin layer to
the patient's scalp once per day. Visible hair re-growth around
the periphery of the hairless area was evident after one month.
After four months, virtually all of the previous hairless area was
covered with hair, with new hair growth covering through scar tissue.
The same protocol as outlined in Example 1 was followed, except
the resulting compound contained 0.025% by weight betamethasone
dipropionate and 0.0125% by weight all-trans-retinoic acid, or a
corticosteroid-to-Vitamin A derivative ratio of 2:1.
This compound was found to be about half as effective on patients
suffering from hair loss, as compared to the compound containing
a 4:1 ratio of betamethasone dipropionate to all-trans-retinoic
acid, which was found to be 100% effective on patients suffering
from hair loss for any reason whatsoever.
In patients for which the compound containing a 2:1 ratio of betamethasone
dipropionate to all-trans-retinoic acid was effective, the compound
took approximately three to four times as long to show visible results
of hair growth as the compound containing a 4:1 ratio. Finally,
the compound containing the 2:1 ratio did not dissolve scar tissue.
The gel is applied to the affected scalp once a day. Since any
excess gel will dry on the scalp and flake, the gel should be applied
in as thin a coat as possible. Although it is possible to rub the
gel into affected portions of the scalp, it is not necessary to
do so, as it has been found that mere contact by the gel with the
scalp produces desired results. Outstanding results, including hair
growth within one week of applying the compound, were observed.
It is believed that treatment will be successful with other proportions
of the active ingredients, as well as different combinations of
a corticosteroid in combination with a Vitamin A derivative.
It is believed that the corticosteroid and the Vitamin A derivative
work synergistically together to cancel out the harmful side effects
of each other in order to rejuvenate the hair follicles in the scalp.
It is understood, of course, that the invention is not limited
to the particular embodiments described herein. For instance, it
is within the contemplation of the invention to use any corticosteroid
or any Vitamin A derivative, and the proportions described may be