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Hair Genesis
- Study Clinical Trial 1
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A Non-Randomized UnControlled
Clinical Study to Determine the Efficacy of
HairGenesis,
a non-Drug / Botanical Hairloss Treatment Remedy for
Androgenetic Alopecia (AGA), also known as Pattern Hairloss in Men and
Women
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    Introduction
to Pattern Hairloss in Men and Women |
Androgenic Alopecia, or pattern hair loss in a man or woman, is an autosomally mediated
chronobiologic phenomenon, affects over 40 million men as well as 20 million women in
America. To date, there has been no safe, efficacious method of treating and/or reversing
the progression of this disorder without presenting known negative side effects.
There have been numerous proposed treatments for baldness, but only a few have provided effective treatment over a wide range of patients, and none have been based on naturally occurring substances. Androgenic Alopecia
(AGA) which describes male pattern alopecia, is considered to be a genetically based disorder 2 and commonly characterized by thinning and loss of hair in affected individuals within a given pattern on the scalp of the head.
This hairloss disorder progresses by causing the affected hair follicles to become smaller and correspondingly, the hair becomes finer. Eventually, the fine
hairs may be lost and, thus, baldness results in the affected area. Hair has been classified as being of at least two distinct types, terminal and vellus.
Terminal hairs are long, coarse and pigmented, with the bulb of the follicle seated deep in the dermis.
A vellus hair is short, fine, thin, and non-pigmented, with the bulb of the hair follicle seated superficially in the dermis of the scalp.
During the thinning stage of
alopecia, the hairs in the affected area are believed to transform from terminal to
vellus. It is this transformation to vellus hairs that is equated to baldness. The core of the phenomenon is associated with structural miniaturization.
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    Preferred
Dosage
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The preferred dosage is stated with respect to cholestatin 45%
Beta Sitosterol. A dosage from 40 mg to 60 mg each twelve hours has
been found most effective. According to the capsule formulation of Table
1, a gel capsule containing 50 mg of Beta Sitosterol is taken twice per day such as each morning and evening. The preferred dosage is stated with
respect to an extract of standardized 85 % to 95% liposterolic content.
A dosage of from 160 mg to 240 mg each twelve hours has been found most effective. According to the capsule formulation of Table 1, a gel capsule containing 200 mg of standardized saw palmetto extract is taken twice per day such as each morning and each evening.
According to another aspect, the invention provides a means for emulsifying
Beta Sitosterol and Saw Palmetto extract, or an emulsifier system component
that aids the other components in penetrating the stomach lining. A suitable emulsifier is lecithin,
inositol, or preferably a mixture of both. The preferred dosage of Table I is stated with respect to lecithin consisting
of 61-64% phosphatides, for which the dosage is 50 mg each twelve hours. The preferred dosage of inositol is 100 mg each twelve hours. These emulsifier system components can be varied in dosage by a large factor without harm or toxicity.
As means of protecting follicles from degeneration due to oxidation, free
radicals and metabolic by-products, the treatment provides and antioxidant component such as phosphatidyl
choline. An orally administered dosage of 25 mg per twelve hours provides a general antioxidant prophylactic
effect throughout the body.
A vasodilator component is also provided, wherein preferred elements are niacin, biotin, and preferably both. Niacin, or vitamin B3, generally
promotes circulation and is beneficial in maintaining and promoting circulation to the follicles. D-Biotin, or vitamin H, compliments the effects of niacin.
These dosages are approximate and may be varied by a large factor such as 50% or more.
The shell of a gel capsule may be formed of gelatin, glycerin, water,
titanium dioxide, and such other pigments as may be desired. The preferred
dosage of Table I provides a suitable quantity of each ingredient for
treatment at twelve hour intervals.
In the dosages and treatments,
Beta Sitosterol and saw palmetto berry extract are considered the active ingredients. Their disclosed dosage
is suitable for achieving effective treatment with intermittent administration
approximately at twelve hour intervals. The remaining components are administered in a mixture with the active ingredients for internal administration and may be considered supplemental to enhance the action of the active ingredients.
The formulation is believed to function on a molecular level via competitive mechanical inhibition of the T1 and T2
5-Alpha-DHT cellular and nuclear androgen receptor sites found within susceptible scalp hair follicles. Unbound
5 Alpha DHT is thus metabolized out of the body via primary excretion
pathways without triggering the secondary and pathological cascade of
events associated with this disorder.
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    Exclusion
Parameters |
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Participants with undetermined reason for hairloss
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Participants using other medications on the scalp
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Participants with no family history of hair loss
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Participants with red,
inflamed, infected,
irritated or painful
scalp
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Participants who have
been diagnosed with
alopecia areata, lupus,
erythematosus, or other non-male pattern
alopecia types of
hairloss
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    Clinical
Impression Legend |
S=SUBJECTIVE |
S-1 |
Follow up evaluation |
S-2 |
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Other |
O=OBJECTIVE
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O-1 |
Hairloss continuing, no benefit |
0-2
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Hairloss arrested, no further loss |
0-3 |
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Hairloss reversed, noticeable thickening |
P=PLAN |
P-1 |
Continuing treatment |
P-2 |
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Discontinuing treatment |
P-3 |
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Modifying treatment |
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    Exhibit
A - Clinical Study Statistics |
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    Exhibit
B - Before / After Photos using HairGenesis |
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    Exhibit
C - Before / After Photos using HairGenesis |
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    Exhibit
D - Norwood Hair Loss Scale |
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    References |
The Bald Truth, Fischer, David,
US News and World Report, v123n5, pp 44-50 August 4,
1997
His Health: The
Buzz on Baldness, Leaf, Clifton, American
Health vl5, n9 November, 1996 pp 34-35
HAIR! From
personal Statement to Personal Problem, Pine, Devera,
FDA Consumer, December 1991 25(10): pp 20-23
Management of
Alopecia, Source: UTMB Dept of Otolaryngology Grand
Rounds Presentation, September 9, 1998. Facility:
Karen Calhoun, MD Resident: Kyle Kennedy, MD
Alopecia,
(Baldness), Source: UTMB Dept of Otolaryngology Grand
Rounds, April 30, 1997, Resident Physician:
Chris Thompson, MD, Faculty: Karen Calhoun, MD, FACS,
Series Editor: Francis B. Quinn, Jr., MD, FACS
Management of
Alopecia, Source: UTMB Dept of Otolaryngology Grand
Rounds Presentation, September 9, 1998. Facility:
Karen Calhoun, MD Resident: Kyle Kennedy, MD
The Bald Truth,
Fischer, David, US News and World Report,
v123n5, pp 44-50 August 4, 1997
Management of
Alopecia, Source: UTMB Dept of Otolaryngology Grand
Rounds Presentation, September 9, 1998. Facility:
Karen Calhoun, MD Resident: Kyle Kennedy, MD
Estrogen-induced
gynecomastia following use of estrogen-containing
local agents. Schmidt KU: Wagner G; Mensing H,
Dtsch Med Wochenschr, 112: 23, 1987 Jun 5, 9268
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