Composition and method for topical treatment of androgenic alopecia

This invention relates to the topical and oral treatment of hair loss, especially androgenic alopecia, by providing formulations that include anti-androgens, especially extracts of the saw palmetto plant, co-enzyme Q, and acetyl carnitine, and optionally stimulators of adenylate cyclase to stimulate hair growth, to increase the luster of hair, and to decrease hair graying.

TECHNICAL FIELD OF THE INVENTION
 This invention relates to the topical and oral treatment of hair loss,
 especially androgenic alopecia, by providing formulations that include
 anti-androgens, especially extracts of the saw palmetto plant, co-enzyme
 Q, and acetyl carnitine, and optionally stimulators of adenylate cyclase,
 to stimulate hair growth, to increase the luster of hair, and to decrease
 hair graying.
 BACKGROUND OF THE INVENTION
 Androgenic alopecia is an autosomal disorder which begins in puberty in
 genetically disposed individuals. Androgenic alopecia is also known as
 hereditary baldness, male pattern baldness, and seborrheic alopecia and
 occurs in males and females. The disorder is heterogeneous and increased
 circulating androgens are not the only causative factor. Historically,
 patients with male androgenic alopecia present with frontal recession of
 the hairline, especially at the temples and vertex, and androgenetic
 frontal hairline (incipient regression of terminal hairs into shorter thin
 hairs of the intermediate and vellous type). Minoxidil, available since
 1988, produces a maximum of only 40% cosmetic responses in selected
 patients with vertex balding who are young, recently diagnosed and display
 small areas of alopecia. The response to minoxidil is not seen for 4 to 10
 months and treatment must be maintained or the hairline regresses.
 Saw palmetto is a small, creeping palm (Serenoa repens) of the southeastern
 United States, having palmately divided leaves with one-ribbed segments
 and black, one-seeded fruit. It is a native American tree of South
 Carolina and Georgia and extracts of this tree have been used successfully
 to treat benign prostatic hypertrophy. Extracts of saw palmetto act as a
 multi-site inhibitor of the hormone dihydrotestosterone (DHT) which is
 responsible for prostatic hypertrophy. Saw palmetto blocks approximately
 50% of the binding of DHT to receptors in the prostate. It also blocks the
 uptake of DHT into the nucleus of prostatic cells, and strongly inhibits
 the action of the enzyme testosterone 5 alpha-reductase which reduces the
 conversion of testosterone to DHT.
 Methods and compositions for increasing the growth of hair are needed,
 especially in situations of hair loss due to androgenic alopecia. One
 composition should be easy to apply topically and should promote hair
 growth. Another composition should be orally administered and promote hair
 growth.
 SUMMARY OF THE INVENTION
 In one embodiment, the present invention provides an easy to use topical
 therapeutic composition and treatment for increasing the growth of hair.
 In another embodiment, the present invention provides a therapeutic
 composition and oral treatment for increasing the growth of hair and the
 luster of hair, and for decreasing the graying of hair.
 Accordingly, it is an object of the present invention to provide a
 treatment for hair loss through the topical application of anti-androgens
 in various formulations designed for topical application.
 It is an object of the present invention to provide a treatment for hair
 loss through the topical application of extracts of saw palmetto, which
 act as anti-androgens, in various formulations designed for topical
 application.
 Another object of the invention to provide a treatment for hair loss
 through the oral application of anti-androgens in various formulations
 designed for oral application, combined with co-enzyme Q and acetyl
 carnitine.
 It is another object of the invention to provide a treatment for hair loss
 through the oral application of saw palmetto extracts in various
 formulations designed for oral application, combined with co-enzyme Q and
 acetyl carnitine.
 Another object of the invention to provide a treatment for hair loss
 through the oral application of saw palmetto extracts in various
 formulations designed for oral application, combined with co-enzyme Q,
 acetyl carnitine, and stimulators of adenylate cyclase.
 Still another object of the invention is to provide a composition and
 treatment for hair loss through the topical application of anti-androgens
 combined with co-enzyme Q and acetyl carnitine in various formulations
 designed for topical application.
 Another object of the invention is to provide a composition and treatment
 for hair loss through the topical application of anti-androgens combined
 with stimulators of adenylate cyclase, co-enzyme Q and acetyl carnitine in
 various formulations designed for topical application.
 Still another object of the invention is to provide a composition and
 treatment for hair loss through the topical application of extracts of saw
 palmetto combined with co-enzyme Q and acetyl carnitine in various
 formulations designed for topical application.
 These and other objects, features and advantages of the present invention
 will become apparent after a review of the following detailed description
 of the disclosed embodiments.
 DETAILED DESCRIPTION OF THE INVENTION
 The following United States provisional Patent Applications are
 incorporated by reference herein in their entirety, Serial Numbers
 60/000,842 and 60/005,643 filed on Jul. 3, 1995 and Oct. 19, 1995,
 respectively.
 The term "saw palmetto" refers to a native American tree often found in the
 southeastern part of the United States, especially in Georgia and Florida.
 As used in the present context, the term "saw palmetto" includes extracts
 of the saw palmetto tree. These extracts may be present as oil extracts
 among other forms.
 The term "androgen" refers to testosterone and its precursors and
 metabolites, and 5-alpha reduced androgens, including but not limited to
 dihydrotestosterone. Androgen refers to androgens from the testis, adrenal
 gland, and ovaries, as well as all forms of natural, synthetic and
 substituted or modified androgens.
 It is to be understood that other agents which affect the synthesis,
 metabolism, site of action, and function of androgens are considered
 within the scope of the present invention when combined with acetyl
 carnitine and co-enzyme Q. Included within the scope of this invention are
 drugs, extracts, chemicals, or other agents which affect the biosynthesis,
 enzymatic conversion, binding to receptors, and metabolism of androgens.
 Agents which modify the translocation of androgens to the nucleus or the
 second messenger systems that transduce intracellular signals are also
 considered within the scope of this invention when combined with acetyl
 carnitine and co-enzyme Q. Agents which affect the synthesis, release, and
 function of hypothalamic and pituitary hormones which affect the synthesis
 or release of testosterone are also included in the scope of this
 invention when combined with acetyl carnitine and co-enzyme Q for
 stimulating hair growth. Accordingly, methods for stimulating hair growth
 which employ acetyl carnitine and co-enzyme Q combined with agents
 described in this paragraph which affect the synthesis, release, efficacy,
 or metabolism of androgens are considered within the scope of this
 invention. Accordingly, molecules which affect hypothalamic synthesis and
 secretion of gonadotropin releasing hormone (GnRH), GnRH agonists (such as
 leuprolide and gonadorelin) which affect pituitary release of
 gonadotropins, ketoconazole and liarazole which affect testosterone
 synthesis in the testis, finasteride and saw palmetto extract which affect
 conversion of testosterone to dihydrotestosterone by 5-alpha reductase in
 its various forms in extraglandular tissues, and flutamide and cyproterone
 acetate which affect binding of androgen to its receptor, are all
 considered within the scope of this invention. The aforementioned
 molecules in this paragraph are collectively defined as "anti-androgens"
 within this application.
 The term "androgenic alopecia" refers to an autosomal disorder which begins
 in puberty in genetically disposed individuals. Androgenic alopecia is
 also known as hereditary baldness, male pattern baldness, and seborrheic
 alopecia. Androgenic alopecia may occur in males and females.
 The term "acetyl carnitine" refers to various forms of acetyl carnitine,
 including but not limited to, D,L-carnitine, and acetyl-L-carnitine
 hydrochloride which is usually employed in a 1% to 5% solution. Acetyl
 carnitine (PCAA, Houston, Tex.) is thought to decrease in senescence and
 down regulation. Although not wanting to be bound by this statement, it is
 believed that the decrease in acetyl carnitine compromises the transport
 of fatty acids from the cytosol into the inner mitochondrial membrane of
 the mitochondria, thereby impairing the physiological function of the
 follicle, perhaps through effects on fatty acid oxidation and ATP
 production. Acetyl carnitine is believed to improve fatty acid metabolism
 by stimulation of cardiolipin which affects the activity of the inner
 mitochondrial membrane, affecting its permeability and function for proton
 transport. Acetyl carnitine is also believed to synergize with co-enzyme Q
 in the revitalization of senescent hair follicles.
 The term "co-enzyme Q" refers to several forms of co-enzyme Q including
 co-enzyme Q0, co-enzyme Q2, co-enzyme Q6, co-enzyme Q7, co-enzyme Q9 and
 co-enzyme Q 10, and are all considered within the scope of this invention.
 Several of these forms are also known as ubiquinones and may be obtained
 from PCAA (Houston, Tex.). Various forms of co-enzyme Q (PCAA, Houston,
 Tex.) are utilized because it is believed that the senescent hair
 follicles are metabolically reduced through reduced activity of
 respiratory enzymes. Although not wanting to be bound by this statement,
 it is believed that co-enzyme Q, especially co-enzyme Q10, increases
 respiratory levels compatible with hair formation. Although not wishing to
 be bound by this statement, it is believed that supplementation with
 co-enzyme Q facilitates removal of excess protons accumulated at the inner
 mitochondrial membrane due to prolonged down regulation, acts as an
 antioxidant, and promotes normalization of oxidative function (Shigenaga,
 M. et al. Proc. Soc. Natl. Acad. Sci. USA 99: 10771-10778, 1994).
 The term "lecithin" is used to mean a phosphatide called
 phosphatidylcholine and can be isolated from soybean, eggs and other
 sources including, but not limited to, heart, brain, and liver. Lecithin
 is a mixture of the diglycerides of stearic, palmitic, and oleic acids,
 linked to the choline ester of phosphoric acid. Soybean lecithin is a
 preferred lecithin and may contain the following acids; palmitic, stearic,
 palmitoleic, oleic, linoleic, linolenic and arachidonic as described in
 the Merck Index (Ninth edition, 1976, page 711).
 The term "PLURONIC" refers to poloxamer compounds and are sold collectively
 under the trademark PLURONIC (BASF, Parsippany, N.J.). PLURONIC F-127
 corresponds to poloxamer 407, a polyoxypropylene/polyoxyethylene block
 copolymer described by Schmolka in the Journal of Biomedical Materials
 Research 6: 571-582, (1972). As used in this application, the terms
 PLURONIC organogel, poloxamer organogel, and
 polyoxyethylene/polyoxypropylene organogel are synonymous.
 "Topical" application is used to mean local administration of the
 composition and its various embodiments, for example, in the treatment of
 alopecia. The composition according to the present invention can be in the
 form of solutions, lotions, salves, creams, ointments, liposomes, sprays,
 gels, roller sticks or any other method using micelles and
 pharmaceutically acceptable penetration enhancers. In one embodiment, the
 composition may be applied to the scalp at bedtime and again after
 showering in the morning for a total of two applications per day.
 The "enhanced penetration" caused by compositions of this invention as used
 in topical application with this method, means increased penetration into
 the skin, and is achieved with compounds such as lecithin organogel,
 PLURONIC organogel (BASF, Parsippany, N.J.), N-decylmethyl sulfoxide
 (NDMS), and ethoxydiglycol:ethanol, and can be observed in many ways known
 to those skilled in the art.
 "Oral administration" refers to the administration of the compositions of
 the present invention into the gastrointestinal tract in any form,
 including but not limited to the following, tablets, powders, suspensions,
 solutions, lozenges, and lollipops.
 The present invention includes a composition for topical treatment of
 androgenic alopecia comprising antiandrogens, including but not limited to
 saw palmetto extracts, combined with co-enzyme Q and acetyl carnitine.
 These compounds are delivered topically combined with delivery vehicles
 and penetrating agents optionally containing lecithin, isopropyl
 palmitate, lecithin organogel, PLURONIC F-127 organogel, NDMS,
 ethoxydiglycol:ethanol and/or water. When co-enzyme Q is used in the
 absence of organogels, it is first dissolved in ethoxydiglycol:ethanol and
 then in Tween, such as Tween 20 or Tween 80, glycerol, castor oil, olive
 oil, or another appropriate agent. For example, these agents are useful in
 the formation of the composition of the present invention as a roller for
 topical application.
 In one embodiment, therapeutically effective amounts of the following
 compounds may be combined at the indicated concentrations expressed per
 120 ml of formulation for topical application: saw palmetto (1 g to 20 g),
 co-enzyme Q (0.1 g to 10 g), and acetyl carnitine (0.1 g to 20 g).
 Preferred concentrations of these compounds for use in topical application
 are provided in Example 4.
 Another preferred penetrating agent and delivery vehicle is lecithin
 organogel which is a combination of lecithin, isopropyl pannitate and
 water. Lecithin organogels have been described as vehicles that are useful
 in facilitating the delivery of low molecular weight compounds
 transdermally (Willimann, H., et al., "Lecithin Organogel as Matrix for
 Transdermal Transport of Drugs", J. Pharm. Sci., Vol. 81, 1992, which is
 incorporated herein by reference). The lecithin organogels are obtained by
 adding small amounts of water to a solution of lecithin in organic
 solvents. Generally, lecithin organogels are prepared at room temperature
 by first dissolving lecithin in an organic solvent such as isopropyl
 palmitate and then adding enough water while stirring to obtain the
 desired gel. Preparation of a variety of lecithin gels, all of which are
 appropriate in practicing the present invention, are described in
 Scartazzini, et al. Journal of Physical Chemistry, Vol. 92, pgs. 829-833
 (1988) and Luisi, P. L. et al. Colloid and Polymer Science, Vol. 268, pgs.
 356-374 (1990), both of which are incorporated herein by reference. The
 lecithin organogel preferably comprises 1:1 to 1.5:5 (weight/vol) of soy
 lecithin (PCAA, Kinghurst, Houston, Tex.) to isopropyl palmitate (PCAA) (1
 g:1 ml). Other penetrating agents may be used in the composition of the
 present invention.
 The formation of organogels containing lecithin dissolved with isopropyl
 palmitate or other solvents, and water, has been described by Luisi et
 al., Colloid and Polymer Science 268: 356-374 (1990) and Scartazzini et
 al., The Journal of Physical Chemistry 92: 829-833 (1988). Willimann et
 al., Journal of Pharmaceutical Sciences 81:871-874 (1992), examined the
 efficacy of lecithin organogels for use in the transdermal delivery of
 drugs such as scopolamine and broxaterol. Willimann et al., also observed
 that lecithin organogels had no detrimental effect on skin when compared
 to control samples treated with physiological saline (see page 872, column
 2, paragraph 3, Journal of Pharmaceutical Sciences 81:871-874 (1992)).
 The present invention optionally includes lecithin (20% -98%) dissolved
 with isopropyl palmitate or other solvents in combination with an
 approximately 10% -20% solution of PLURONIC F-127 (BASF, Parsippany,
 N.J.), otherwise known as poloxamer 407, in a ratio of approximately 1:3
 to 1:4. This ratio may be varied by one of ordinary skill in the art.
 Other PLURONICS may be used in the present invention. It is to be
 understood that the soy lecithin of the present invention is a preferred
 lecithin source and may be dissolved in isopropyl palmitate to achieve a
 final concentration in the composition of from approximately 20% -98%,
 with a more preferred final concentration of from approximately 20%-40%.
 Lecithins may optionally be derived from eggs, and organs such as heart,
 brain, and liver, and used at concentrations of approximately 20%-99%,
 with more preferred final concentrations of from approximately 20%-40%.
 The composition according to the present invention can be in the form of
 lotions, salves, creams, ointments, liposomes, sprays, micelles, or gels.
 The desired form is lotions, ointments and salves. Liposomes are described
 in detail by Oleniacz in U.S. Pat. No. 3,957,971, the entirety of which is
 hereby incorporated by reference.
 Another delivery vehicle is n-Decylmethyl sulfoxide (NDMS obtained from
 PCAA 10925). NDMS is optionally present at a concentration of between
 approximately 0.01% and 1% by weight, with a preferred concentration of
 between approximately 0.05% and 0.5% by weight, with the most preferred
 concentration of approximately 0.125% by weight. NDMS is dissolved in 10
 ml of a 75% solution of ethanol. Next, acetyl carnitine is dissolved in
 purified water. Co-enzyme Q is added to 2 to 5 ml of ethoxydiglycol and
 then to 10 ml of 70% ethanol plus Tween 80. Finally, purified water is
 added to a final volume of 120 ml.
 A gelling agent optionally may be added to the formulation. Gelling agents
 that are suitable for use in the present invention include, but are not
 limited to, cellulose, cellulose ethers, carboxymethylcellulose,
 alginates, polyacrylates, bentonite, gelatin, tragacanth,
 polyvinylpyrrolidone, polyvinyl alcohol, and
 polyoxyethylene/polyoxypropylene block copolymers, some of which are known
 as poloxamers. The poloxamer compounds are sold collectively under the
 trademark PLURONIC (BASF, Parsippany, N.J.). PLURONIC F-127 corresponds to
 poloxamer 407. Other PLURONICS may be used in the present invention. As
 used in this application, the terms PLURONIC organogel, poloxamer
 organogel and polyoxyethylene/polyoxypropylene organogel are synonymous.
 A preservative, such as benzyl alcohol (1%) or potassium sorbate, may be
 added to the composition. An antioxidant, including but not limited to
 antioxidants such as vitamin E, proanthocyanidin, or lipoic acid, may be
 added to lecithin organogels and PLURONIC organogels. Other preservatives
 well known to those of ordinary skill in the art can be used in the
 composition.
 Agents for improving the aroma of the formulation for topical application
 can optionally be added to the composition. A desired aroma improving
 agent is honey almond oil (PCAA). Other aroma improving agents include,
 but are not limited to, avocado oil, sesame oil, castor oil, olive oil,
 grapeseed oil, clove oil, groundnut oil, corn oil, lemon oil, coconut oil,
 lime oil, hazelnut oil, jojoba oil, carthamus oil and wheatgerm oil. The
 oils can be added individually or in combination. It is to be understood
 that various fragrances and assorted floral scents may be optionally added
 to the composition and are commercially available (PCAA). Stabilizers,
 antioxidants, preservatives, humectants, regreasing agents, solvents or
 auxiliaries can be added to improve stability and/or adhesiveness of the
 formulations. Cosmetic agents such as panthenol may also optionally be
 added to the formulation.
 In addition, antimicrobial agents can be optionally added to the
 composition of the present invention. Addition of an antimicrobial agent
 is desirable when treating inflammatory conditions associated with loss of
 hair.
 The composition of the present invention can be administered topically
 twice daily or several times per day depending upon the nature and
 severity of the condition being treated. The lecithin organogel or
 PLURONIC organogel may be wiped off about 1 hour after application if
 desired since the active ingredients are absorbed rapidly.
 The present invention also includes formulations for the treatment of
 androgenic alopecia that may be administered orally. These formulations
 for oral administration do not contain penetration enhancers such as NDMS
 or lecithin organogel. The present invention includes a composition for
 oral treatment of androgenic alopecia comprising anti-androgens such as
 saw palmetto extracts combined with co-enzyme Q and acetyl carnitine.
 Typical concentration ranges for these compounds used in oral
 administration are the following; saw palmetto (10 mg -1 g), co-enzyme Q
 (10 mg -250 mg), and acetyl carnitine (250 mg -2 g). A preferred
 composition for administration as a pill into the oral cavity twice daily,
 at approximately 12 hour intervals, is saw palmetto (160 mg), co-enzyme
 Q10 (30 m-180 mg), and acetyl carnitine (1 g). These compounds for oral
 administration are delivered into the gastrointestinal tract in any form,
 including but not limited to the following; tablets, powders, suspensions,
 solutions, lozenges, lollipops, through catheters, and various tubes,
 including but not limited to nasogastric, gastric, duodenal, jejeunal,
 ileal and colonic tubes. When administered into the oral cavity, various
 compounds may be added to improve the flavor and consistency of the
 composition. For example, the composition could be administered into the
 oral cavity in the form of a cherry flavored lozenge, or a grape flavored
 syrup.
 While not wanting to be bound by this statement, it is believed that DHT
 affects adenylate cyclase in the hair follicle, thereby modulating keratin
 production and affecting hair quality and formation. Accordingly, it is
 within the scope of this invention to include stimulators of adenylate
 cyclase in conjunction with anti-androgens to stimulate activity of the
 hair follicle and increase hair growth. In one embodiment, the drug
 forskolin, a stimulator of adenylate cyclase, is combined with
 anti-androgens, such as saw palmetto extracts, co-enzyme Q and acetyl
 carnitine, and a penetrant for topical application. For topical
 application, a concentration of about 0.1% to 10% may be used with a
 preferred concentration of 1% to 5% forskolin per 120 ml of formulation.
 In oral preparations, forskolin is included at a concentration of about
 0.2 mg to 100 mg, with a preferred concentration of about 2 mg to 20 mg,
 together with anti-androgens, such as saw palmetto extracts, co-enzyme Q
 and acetyl carnitine. It is understood that these dosages of forskolin are
 preferred dosages and that other dosages may suggest themselves to those
 skilled in the art. Similarly, other stimulators of adenylate cyclase will
 be administered at dose ranges specific for each stimulator.

This invention is further illustrated by the following examples, which are
 not to be construed in any way as imposing limitations upon the scope
 thereof. On the contrary, it is to be clearly understood that resort may
 be had to various other embodiments, modifications, and equivalents
 thereof which, after reading the description herein, may suggest
 themselves to those skilled in the art without departing from the spirit
 of the present invention.
 Example 1
 Topical Application of Saw Palmetto Extracts Increase Hair Growth in Males
 with Alopecia
 A 52 year old male at the first recognition of alopecia at the temples and
 frontal recession of the hairline applied the formulation of the present
 invention as described below. The composition consisting of the
 formulation of saw palmetto, co-enzyme Q and acetyl carnitine was used in
 PLURONIC organogel and NDMS twice a day at the right (R) triangulus for a
 period of 3 weeks. One morning, large numbers of vellous hairs were
 evident. Treatment was then extended to the left (L) triangulus where
 vellous hair growth also occurred. The frontal scalp line was treated with
 the formulation for a period of 3-4 weeks and intermediate hairs were
 observed among the anagen hairs. The hair was decisively more mature in
 appearance. Analysis of root hairs of the frontal scalp line indicated an
 marked increase in the percent of telogen follicles to 35% from the normal
 20% and an increase in the percent of catogen follicles.
 Five individual volunteers from 52 to 56 years of age and another three
 individual volunteers from 31 to 38 years of age were treated with the
 topical application of saw palmetto extracts in the composition described
 in the preceding paragraph. Alopecia in these individuals varied from a
 rating of Hamilton 2 to Hamilton 8. Totally bald scalp devoid of pigmented
 hair from 5 to 25 years responded to the disclosed treatment of this
 invention in an interval of time directly correlated with age, rapidity of
 hair loss and duration of baldness. In general terms, younger men who were
 bald for less time responded to the treatment faster than individuals such
 as older men who were bald for longer periods. Photographs of the scalp of
 these individuals verified increased hair growth.
 Example 2
 Lecithin Organogel Composition Prepared With Pluronic
 A preferred composition for delivery of the formulation of saw palmetto,
 co-enzyme Q and acetyl carnitine was prepared as described below. The
 lecithin organogel was prepared by dissolving 20 g of soy lecithin
 granules (PCAA) in 20 ml of isopropyl palmitate (PCAA). The mixture was
 stirred periodically for 24 hours until the soy lecithin granules were
 dissolved. The PLURONIC gel 20% stock solution was prepared by dissolving
 16 g of PLURONIC F127 powder (BASF, Parsippany, N.J.), also called
 poloxamer 407, in 80 ml of purified water. Potassium sorbate (160 mg;
 PCAA) was added to the PLURONIC gel 20% stock solution as a preservative.
 This was placed in the refrigerator at about 4.degree. C. for about 24
 hours and stirred periodically.
 The composition was prepared by mixing 20 ml of the lecithin organogel with
 2 ml of the honey almond oil (PCAA) until a smooth mixture was prepared.
 Honey almond oil was added for fragrance. Next, 80 ml of the PLURONIC gel
 20% stock solution was mixed in until a gel formed. A blender was used for
 this mixing step at room temperature with disinfected equipment. The gel
 was stored at room temperature.
 Example 3
 Lecithin Organogel Composition Prepared Without Pluronic
 In another embodiment of the present invention for delivery of the
 formulation, the composition described in Example 2 was prepared using
 lecithin organogel without the addition of the PLURONIC gel 20% stock
 solution. The final concentration of lecithin organogel was in the range
 of 20-45 % by modifying the ratio of lecithin organogel to water.
 Example 4
 Compositions For The Topical Treatment Of Androgenic Alopecia
 Extracts of saw palmetto are added at a concentration of 5 g to 7.5 g per
 120 ml of formulation to the compositions of Examples 2 and 3 in effective
 therapeutic concentrations. Next, therapeutically effective amounts of
 co-enzyme Q10 (0.5 g to 1 g per 120 ml of formulation) and acetyl
 carnitine (1 g to 2 g per 120 ml of formulation) are added to this mixture
 of saw palmetto in the compositions of Examples 2 and 3 to create the
 formulation for topical treatment of alopecia.
 Example 5
 Compositions And Methods For The Treatment Of Androgenic Alopecia By Oral
 Administration
 A composition for treatment of androgenic alopecia by oral administration
 comprises saw palmetto extracts (160 mg), combined with the following
 components selected from the group comprising co-enzyme Q10 (30 mg to 180
 mg) and acetyl carnitine (1 gm).
 These compounds are usually delivered twice daily into the gastrointestinal
 tract in forms including, but not limited to the following; tablets,
 powders, suspensions, solutions, lozenges, and lollipops, and also through
 catheters, and various tubes, including but not limited to nasogastric,
 gastric, duodenal, jejeunal, ileal and colonic tubes. These compounds are
 delivered into the oral cavity in the form of tablets which may be chewed,
 dissolved or swallowed or as powders, suspensions, optionally combined
 with various excipients, flavor enhancers or other compounds to enhance
 the texture of the composition.
 It should be understood, of course, that the foregoing relates only to
 preferred embodiments of the present invention and that numerous
 modifications or alterations may be made therein without departing from
 the spirit and the scope of the invention.