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How can Hair Genesis Products combat Male & Female Pattern Hair Loss?

Thoroughly cleanse the scalp and hair follicles, helping to remove harmful DHT...

Help prevent harmful DHT from binding (locking) inside the hair follicles Androgen Receptor Sites (ARS)...

Then help strengthen and protect the hair follicles and roots with nutrients ...

Further helps to inhibit / block the production of more DHT in the body & on the scalp ... 

Now also helps to combat a second major cause of pattern hair loss: Inflamation in the hair follicles ...

Hair Genesis is the only hairloss treatment product on the market (whether drug or botanical) which combats TWO(2) significant causes of hairloss: harmful DHT plus Inflammation in the hair follicles ...

Hair Genesis is the only botanical hair loss treatment product which has multiple independent, third party research studies and also the only non-drug hairloss product for Men and Women with any research study results which have been published in peer-reviewed medical journals ...

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The New and Improved HairGenesis - Generation 4 Hair Loss Treatment Products are an Advanced Group of Formulas: They now treat TWO (2) major causes of Pattern Hairloss in Men and Women. No other hairloss product (whether drug or botanical) does this!! ( and Supported by New University Based Research )

HairGenesis Clinical Study A

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

Table of Contents
Introduction Clinical Impression Legend
Background Evaluation and Analysis
Mechanism of Action Study Synopsis
Study Overview Exhibit A: Clinical Study Statistics
Treatment Protocol Exhibit B: Before & After Photos
Adverse Events Exhibit C: Before & After Photos
Inclusion Parameters Exhibit D: Pattern Hairloss Chart
Exclusion Parameters References

Introduction to Pattern Hairloss for Men and Women

Androgenetic Alopecia, or pattern hair loss in a man or woman, an autosomally mediated chronbiologic 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. Androgenetic 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 hair loss 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 the related male Benign Prostatic Hyperplasia (BPH) are believed to result from a genetic predisposition associated with 5alpha DiHydroTestosterone (DHT), 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 clinical 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 oral softgel capsule. The preferred quantities of each  is as shown in the following Table 1:

Table - 1 Formula Ingredients

One Oral Softgel Capsule

Ingredients Dosage a mount
Beta Sitosterol 50 mg
Saw Palmetto Berry Extract (Standardized
    85% to 95% liposterolic content)
200 mg
Lecithin 50 mg
Inositol 100 mg
Phophatidyl Choline 25 mg
Niacin 15 mg
Biotin 100 mcg
Formula Dosage

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.

Overview

The goal of this follow up study is to compile additional research data in order to either challenge or corroborate data previously gathered within the Clinical Research Study #1 titled "A NON-RANDOMIZED UNCONTROLLED CLINICAL STUDY TO DETERMINE THE EFFICACY OF A NEW TREATMENT FOR ANDROGENETIC ALOPECIA (AGA)" May 1997 through February 1998. Statistical analysis to be determined by gross clinical evaluation, patient reporting, and baseline, intra-study, and end point photographic evidence.

Treatment Protocol

Orally, one (1) HairGenesis™ Softgel twice a day. Participants to be followed over the course of six months time period. Participants to report to the 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 Androgenetic Alopecia ( AGA) - commonly known as Pattern Hair Loss in Men or Women) as determined by the Norwood Class Scale, in a clinical investigator evaluation.

Exclusion Parameters
  1. Participants with undetermined reason for hairloss

  2. Participants using other medications on the scalp

  3. Participants with no family history of hair loss

  4. Participants with red, inflamed, infected, irritated or painful  scalp

  5. Participants who have been diagnosed with alopecia areata, lupus, erythematosus, or other non-male pattern alopecia types of  hairloss

Evaluation and Analysis

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 stopped with 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 and noticeable thickening of their hair with continued hairloss treatment.

Dramatic thickening reported:
0% of participants reported dramatic thickening.

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 (Pattern Hair Loss) 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.

Clinical Impression Legend
S=SUBJECTIVE S-1 Follow up evaluation
S-2 Other
O=OBJECTIVE O-1 Hairloss continuing, no benefit
0-2 Hairloss arrested, no further loss
0-3 Hairloss reversed, noticeable thickening
P=PLAN P-1 Continuing treatment
P-2 Discontinuing treatment
P-3 Modifying treatment
Clinical Statistics - Exhibit A

Research studies HairGenesis hairloss treatment clinical results

Before and After Pictures - Exhibit B

before and after photos using HairGenesis hairloss treatment products

Before and After Pictures - Exhibit C

before and after photos using HairGenesis hairloss treatment products

Norwood Pattern Hair Loss Chart - Exhibit D

Norwood hair loss diagrams for pattern hairloss in men

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

HairGenesis
New And Improved
Generation 6

Unique & Patent-Pending non-Drug Botanical Hairloss treatment products, using multiple proven natural DHT Blockers in all products to Block DHT, plus combat  Inflammation in the hair follicles, a second major cause of pattern hair loss in both Men and Women!

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Pattern Hairloss Diagram

Norwood pattern hair loss chart for men

Hairloss in Men typically follows a pattern with a Frontal Receding Hair line or balding patch at the Back of the scalp, then increases ... read more 4

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Hair Genesis™ works. Most hair loss products have little or no research on their products or formulations. HairGenesis™ has more research and more clinical studies. No other non-drug / botanical hair loss product has
ANY study results accepted and published in peer-reviewed medical journals. We have TWO published studies.
Hair Genesis™ is simply the best hairloss treatment product for Male or Female pattern hairloss.

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