Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from palmaceae
Reexamination Certificate
1998-07-16
2001-12-25
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from palmaceae
C424S070100, C424S450000, C424S484000, C424S489000, C514S078000, C514S170000, C514S690000, C514S880000, C514S930000, C514S944000, C514S946000, C514S951000, C514S959000, C514S961000
Reexamination Certificate
active
06333057
ABSTRACT:
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 ac
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