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HairGenesis™
Case Study 1
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Clinical
Experience #1
Non-Randomized Uncontrolled Clinical Study to Determine the Efficacy
of a New Treatment for Androgenic Alopecia (AGA)
Introduction
Androgenic Alopecia, an autosomally mediated
chronbiologic phenomenon, affects over 40 million men as well as 20
million women in America.1 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 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.3 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. Terminal hairs are long, coarse and pigmented, with the
bulb of the follicle seated deep in the dermis. 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.
Background
Androgenic Alopecia (AGA)
as well as Benign Prostatic Hyperplasia (BPH) are believed to
result from a genetic predisposition associated with 5alpha
dihydrotestosterone4, which is a highly bio-active metabolite
of the androgenic hormone testosterone. Although these disorders are
vastly different in physiology and presentation, the etiology of
each stems from this specific hormonal metabolism5.
In
developing treatment for AGA, various hormones such as
estrogen and other anti androgens have been tested and found
unsuitable due to undesirable side effects6, such as feminization
of male subjects. Therefore, it would be desirable to find a
treatment for AGA that minimizes the use of bio-effecting
drugs. It would be expected that natural ingredients will be
biologically more friendly to the user and suitable for long term
use with minimal side effects.
Mechanism of Action
This study contemplates
the benefit of a natural or organic composition and method of
treatment for Androgenic Alopecia (AGA) in order to reduce or
arrest the onset of symptomatology associated with this specific
disorder. The preferred formulation employs beta-sitosterol, saw
palmetto berry extract, lecithin, inositol, phosphatidyl choline,
niacin, and biotin in orally administered dosages. The method of
treatment is administering a dosage of the stated ingredients. In
one embodiment, the dosages may be combined in a single soft
gel capsule. The preferred quantities of each is as shown in
the following
Table 1:
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CAPSULE DOSAGE
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INGREDIENT
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DOSAGE
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Beta Sitosterol
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50 mg
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Saw Palmetto Berry Extract
(Standardized 85% to 95% liposterolic content)
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200 mg
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Lecithin
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50 mg
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Inositol
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100 mg
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Phophatidyl Choline
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25 mg
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Niacin
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15 mg
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Biotin
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100 mcg
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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 5alphaDHT
cellular and nuclear androgen receptor sites found within
succeptible scalp hair follicles. Unbound 5alphaDHT is thus
metabolized out of the body via primary excretion pathways
without triggering the secondary and pathological cascade of
events associated with this disorder.
Study Overview
The goal of this study is to determine the safety and
efficacy of a naturally derived oral formulation (HairGenesis™)
containing known anti-androgenic components, in arresting
and/or reversing onset of typical Androgenic Alopecia (AGA).
Statistical analysis to be determined by gross clinical evaluation,
patient reporting, and baseline, intra-study, and end point
photographic evidence.
Treatment Protocol
Orally, 1 softgel b.i.d. (twice a day). Participants to be followed
over the course of six months time period. Participants to report to
clinic one time per month during this period for follow up
investigator evaluation.
Adverse Events
Any participant adverse
event reported during this study to be fully documented per
standard protocol parameters.
Inclusion Parameters
Males and females between the ages of 18 and 55 who are
experiencing Androgenic Alopecia as determined by the Norwood Class
Scale, via clinical investigator evaluation.
Exclusion Parameters
 | Participants with
undetermined reason for hairloss
| Participants using other
medications on the scalp
| Participants with no
family history of hair loss
| Participants with red,
inflamed, infected, irritated or painful scalp
| Participants who have
been diagnosed with alopecia aereota, lupus,
erythematosus, or other non-male pattern alopecia.
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Clinical Impression Legend
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S=SUBJECTIVE
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S-1
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Follow
up evaluation
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S-2
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Other
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O=OBJECTIVE
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0-1
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Hairloss
continuing, no benefit
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0-2
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Hairloss
arrested, no further loss
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0-3
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Hairloss
reversed, noticeable thickening
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P=PLAN
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P-1
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Continuing
treatment
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P-2
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Discontinuing
treatment
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P-3
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Modifying
treatment
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Evaluation Analysis
(see accompanying statistics)
Incidence and degree of side effects, If any:
0% of participants reported drug interaction or side effects.
Incidence and degree of adverse events, If any:
0% of participants reported any adverse events.
Reduction in rate of hairloss, If any:
100% of participants reported hairloss arrested, no further loss.
Aesthetically meaningful change In caliber of affected scalp
hair, If any, as evidenced by clinical photography, patient
reporting and Investigator clinical Impression:
84% of participants reported hair loss reversed, noticeable
thickening via continued treatment.
Dramatic thickening reported:
0% of participants reported dramatic thickening.
Study Synopsis
This research study over
a six month period did not reveal any side effects, drug
interactions or adverse events. Based on the data gathered, all
participants (100%) in the study reported an arresting of
symptomatology commonly associated with Androgenic Alopecia and 84%
reported an aesthetically meaningful change in the caliber of
affected scalp hair. These findings were determined via investigator
observation, baseline, intra study, and endpoint photographic
evidence, as well as patient reporting. This study suggests a
highly efficacious and safe treatment methodology. Based on
these highly positive findings, further study is clearly indicated
and presently underway.
Exhibit A: Clinical Study Statistics
Exhibit B: Before and After Photos
Exhibit C: Before and After Photos
Exhibit D: Norwood Scale
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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Serving the nutritional
supplements needs for over 25 years. World-wide.
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forth by Federal Food and Drug agencies.
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product is laboratory tested and assayed. These clinical tests measure
consistent quality
and full potency of the active ingredients.
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finest quality nutritional ingredients are used…No artificial
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Therapeutic
Dosage
