Mr. C., 43-years-old, after taking B401 for 1.5 years, revealing reduced hairloss, thicker, denser hair, and increased coverage across middle of scalp.

Ms. H., 28-years-old, before and after taking B401 for 6 months.

Mr. L., 29-years-old, after taking B401 for one year, revealing increasedhair density and overall hair coverage.

Reversing Age-Related HairLoss in Men and Women

Over time, DHT’s miniaturizing effect can shrink large adulthairs, resulting in finer, vellus hairs only 10% as wide as normal andbarely an inch long. This leads to the “peach fuzz” common to earlystage balding. At this stage if the effects of DHT aren’t reversed orhalted in time, the hair follicles will shrink down until they eventuallyvanish, resulting in complete baldness in the affected area.

Male-pattern hair loss (Fig. 1), also known as androgeneticalopecia, is the most common form of balding, affectingroughly 40 million men in the US. Approximately 25 per-

cent of men with male-pattern hair loss will begin to lose their hairby age 30, and up to 66 percent will begin balding by age 60. Male-pattern hair loss is closely linked to androgens – sex steroid hormonessynthesized from cholesterol in the testes, ovaries and adrenal glands.The primary androgens – testosterone, pregnenolone, androstenedioneand DHEA (dehydroepiandrosterone) – normally regulate male andfemale sexual development and behavior by binding to receptors ontarget cells throughout the body.

Another androgen, dihydrotestosterone (DHT), has been identifiedby researchers as a primary cause of male pattern baldness. DHT issynthesized from testosterone by the enzyme 5-alpha-reductase.When DHT binds to receptors in the hair follicle, it causes the hairroots to shrink, or "miniaturize.” DHT has also been shown to shortenthe amount of time hair spends in the growing (anagen) phase fromas long as five years to as little as two months.

In 1998, researchers discovered that men genetically prone tomale pattern baldness have significantly higher numbers of androgenreceptors in the hair follicles located across the forehead and scalp– exactly those areas where hair loss first appears in androgenicalopecia. Additional research has shown that these androgen-sensitivefollicles also have significantly higher levels of 5-alpha-reductase (1.5to 3 times higher) and DHT than hair follicles from other areasof the scalp.

Reversing Age-Related HairLoss in Men and Women

U.S. Patented, Oral Herbal FormulaHalts Age-Related Hair Loss, Supports

Hair Growth in Men and Women

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Fig. 1. Progressive loss of hair as classified on the Hamilton–Norwoodchart, ranging from stages I through VII.

Fig. 2. Progression of receding hair in women with androgenetic hair lossis classified on the Ludwig scale, ranging from stages I through III.

Healthy Follicles for Healthy Hair

Hair follicles are among the most active and fastest growing struc-tures in the body. Human hairs are produced by follicles – specializedorgans that cover the entire body, with the exception of the palmsand soles of the feet. Follicles are composed of three major structures– the dermal papilla, hair matrix, and hair shaft. (Fig. 3)

The dermal papilla, a pear-shaped structure located at the baseof the hair follicle, is comprised of connective tissues and a capillaryloop containing tiny blood vessels that provide the nutrients requiredfor hair growth.

Female Pattern Hair Loss

Hair loss isn’t exclusively a male problem – approximately 50% ofall women over the age of 50 experience a similar condition, referredto as female androgenic alopecia (Fig. 2). Symptoms in women aregenerally less severe than those experienced by men, appearing asan overall thinning of hairs across the top of the head, and the gradualloss of hairs down the center part-line of the scalp. The reasonwomen experience milder symptoms is due to hormonal differences– women produce significantly lower amounts of testosterone thanmen (about 95% less on average). Women also produce lower levels– about 60 percent less than men – of the enzyme 5α-reductase thatconverts testosterone into DHT.

Additionally, women produce higher levels of another enzyme,aromatase (estrogen synthase), that converts testosterone into thefemale hormone, estradiol. While males also produce small amountsof aromatase, research has shown that aromatase levels in the frontaland rear scalp follicles in women are four to six times higher than inmen, which is why women rarely lose hair in these areas.

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Fig. 3. Cutaway schematic of a hair follicle showing structure of shaft, bulband microcirculatory vessels.

Fig. 4. Three stages of human hair growth: Anagen (growth) phase, lastsfrom two to six years; Catagen (transitional) phase, lasts from one to twoweeks; Telogen (resting) phase, lasts five to six weeks.

The papilla is surrounded by the “matrix” – a bulb-shaped col-lection of specialized epithelial cells that produce a protein, keratin,that actually forms the hair fiber. The matrix also containsmelanocytes, specialized pigment cells that infuse the growing hairshaft with melanin, the compound that gives otherwise transparenthair its natural coloring.

Different types of melanin produce different colors – yellow, rust,brown, and black – that combine to produce a wide variety of haircolors, ranging from blond to brown to pitch-black. Red hair is the

The entire process – growth, transition and rest – makes up onecomplete hair cycle. Each hair follicle is limited to the number ofhair cycles that can be completed – estimated to be between 20 and25 cycles – before reverting to vellus hairs (peach fuzz) and eventu-ally disappearing.

Human Aging and Hair Appearance

In humans, the hair-growing (anagen) phase is at its longest –ranging up to seven years – and the transition/resting phases areat their shortest – lasting only about four months – throughoutyouth and adolescence. As a result of the great amount of timedevoted to supporting hair growth in adolescence, hair is at itshealthiest and most attractive throughout this phase of life.

Beginning at around age 35, changes in hair cycles begin to affectthe density and overall appearance of hair. With each successivecycle, the amount of time spent in the growing phase is reduced,resulting in shorter, thinner hairs. Additionally, the amount of timespent in the resting phase lengthens, extending the period betweenwhen a hair falls out and when a new one grows back. The resultof these changes is a gradual reduction in overall hair density andappearance.

Changes in hair color also begin to appear, as pigment-producingmelanocytes gradually die out, causing hairs to slowly turn gray.

Excessive Hair Loss

While gradual hair loss is a normal part of human aging, for manypeople excessive hair loss, or balding, is a significant source of anxiety.Based on several characteristics, hair loss can be roughly dividedinto two categories – temporary and permanent. Temporary hair loss,which is usually caused by excessive stress, poor diet, hormonal imbal-ance and endocrine dysfunction, can often be restored within six monthsto two years after eliminating the underlying cause(s). Permanent hairloss is caused by genetics and is considered irreversible.

Medical Options for Hair Loss

An ideal solution for hair loss would be one that 1) promotes new

result of another type of coloring agent, the iron-containing pigmentcalled trichosiderin.

Three Stages of Hair Growth

Mature human hair growth occurs in three distinct phases – growth,transition and rest – that are collectively referred to as the hair cycle(Fig. 4).

1. Growth Phase (Anagen): Each hair cycle begins witha growth (anagen) phase. This is marked by rapid cell division inthe hair matrix that builds up layers of keratin to form a single hairshaft that grows out from the follicle at a rate of up to one inch permonth. This growth phase typically lasts two to six years. At anygiven time, about ninety percent of all scalp hairs are in the activegrowing phase.

2. Transitional Phase (Catagen): At the end of the an-agen phase, hair growth ceases and the follicle enters the transition(or catagen) phase. During this phase hair matrix cells begin to dieoff as the follicle base and bulb begin to shrink. Over time, thisshrinkage (miniaturization) pinches off the lower hair bulb, cuttingoff access to the blood vessels and circulation necessary for hairgrowth. At any given time, one to two percent of all hair folliclesare in this transition phase, which lasts one to two weeks.

3. Resting Phase (Telogen): The final stage of the haircycle is the resting (or telogen) phase. During this phase, the maturehairs reside in the follicle for five to six weeks before falling out.Approximately 10 percent of all hairs are in this transition periodat any given time, accounting for normal shedding of betweenthirty and fifty hairs each day.

After shedding the hair shaft, the follicle begins a new cycle of hairgrowth, marked by the swelling of the dermal papilla and the forma-tion of a new capillary loop. As blood vessels reattach to the papilla,they grow and expand four-fold to provide the hair matrix with thenutrients necessary for growing new hair.

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hair growth while extending the anagen (growing) phase, 2) length-ens the catagen (transitional) phase, and 3) shortens the telogen(resting) phase.

The two most widely used medical treatments for androgenicalopecia – Propecia® and Rogaine® – offer partial solutions by ad-dressing hair loss in two completely different ways. Propecia primarilyworks to halt hair loss by blocking the production of the follicle-damaging hormone, DHT, while Rogaine aims to support hair growthby increasing blood flow to the hair roots.

Option 1: Block Production of DHT

Propecia (Finasteride), is an oral prescription drug from Merck &Co. that was first marketed as Proscar® for the treatment of enlargedprostate (benign prostatic hyperplasia or BPH). Overabundance ofDHT has been established as a contributing factor in the developmentof BPH and prostate cancer. Proscar (5 mg finasteride) has beenshown to effectively lower DHT levels by preventing the enzyme,5-alpha-reductase, from converting testosterone into DHT. Soon afterProscar was approved, Merck researchers noted that men taking finas-teride were showing signs of hair regrowth. This led Merck to begintesting a lower dose of the drug finasteride as a potential treatment forhair loss, and in 1997 the FDA approved Propecia™ (finasteride 1 mg)for the treatment of androgenic alopecia in men.

Following its introduction, Propecia was shown to be highlyeffective at decreasing DHT concentrations in the blood (by up to70%), and the scalp (by up to 60%) to reverse DHT-related hairloss of the vertex (at top of head) and anterior mid-scalp area.Unfortunately, there were some serious side effects.

In addition to being present in hair follicles, 5-alpha-reductase isalso abundant in the prostate and seminal vesicles, where it plays avital role in the healthy development and maintenance of normalphysiological functions. Reduction of DHT in these organs has nowbeen linked to unwanted side effects in men, including decreasedlibido, sexual dysfunction, and a reduction of mature sperm count.Additionally, women cannot use Propecia, and Merck explicitlywarns women who are or may be pregnant not to even handle

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crushed or broken Propecia tablets, since the active ingredient maycause abnormalities of a male baby’s sex organs.

Option 2: Stimulate Blood Flow to Follicles

Minoxidil (Rogaine) was originally developed as an oral drug for thetreatment of hypertension, based on its ability to relax vascularsmooth muscles and produce peripheral vasodilation. By directlystimulating circulation to the hair follicles, Minoxidil was found toextend hair and redirect resting hair follicles into new growth.

Animal experiments have shown that Minoxidil works, in part, byincreasing vascular endothelial growth factor (VEGF) to promote hairgrowth and reactivate dormant hair follicles. However, when takenorally to restore hair, minoxidal was also found to have a number ofside effects, including unwanted hair growth in women (hirsutism).Most of these side effects were averted by the introduction of a topicalform of Rogaine for use as an external-use hair-restorer in 1988.

Clinical literature shows that Minoxidil performs excellentlyin preventing hair loss (80%), but less than 20% of patients withandrogenetic alopecia experience actual hair growth. Clinicalobservations indicate that the effects of Minoxidil can be seenwithin 6-12 months of continual use. Yet once treatment hasstopped, within three months all hair growth effects disappear andrevert back to the untreated state.

A New Option for Healthy Hair

In Traditional Chinese Medicine (TCM), conditions such as hair lossare addressed by balancing both the “surface” and “root” levels ofthe problem. Now, after ten years of intensive research, development,and clinical evaluation, a patented, all-natural herbal TCM supple-ment is available in the United States to aid in halting age-relatedhair loss while promoting healthy hair growth.* By promotinghealthy circulation in the tiniest blood vessels (microcapillaries)that supply nutrients and oxygen to the hair follicles, the formulasupports thicker, healthier hair, improved skin tone and overallhealth and vitality.*

* These statements have not been evaluated by the Food and Drug Administration.

Accidental Discovery Leads to Breakthrough

Serendipity, defined as the accidental discovery of somethingunexpected, played a key role in the development of the new herbalhair restoration formula, B401. In 2002, a leading medical lab inTaiwan had recruited a team of herbal researchers and veterinariansto work on developing a new, natural treatment for a common in-flammatory skin disease that causes painful skin blisters and hairloss in household pets.

After two years of R&D, the team developed an all-natural herbalformula that was just as effective as the antibiotics and steroids com-monly used to treat afflicted animals, but with the added benefit ofbeing free of the dangerous side effects that typically limit the useof such drugs in pets (Fig. 5).

As the lab director reviewed the research team’s final report, hisattention was drawn to a section that detailed a surprising observa-tion. In addition to regrowing all of their lost hair at a surprisinglyrapid rate, all of the treated animals were maintaining thicker,healthier fur coats, even during warm periods when seasonal shed-ding of hair was expected.

Intrigued by this unexpected finding, the researchers decided totest the formula on a group of dogs suffering from Alopecia X. Alsoreferred to as Black Skin disease, Alopecia X causes hair loss onboth sides of a dog’s body and is generally considered an untreatabledisorder. After a few months of treatment with B401, the animalshad completely recovered from the condition and regrown all oftheir previously lost hair (Fig. 6).

Early Success with Human Volunteers

Inspired by the formula’s ability to halt hair loss and restore hairgrowth in animals, the researchers decided to see how the formulaworked in humans. The results of a small trial with five volunteersexperiencing abnormal hair loss were promising, and the lab approveda full-scale program designed to optimize and refine the formula forlong-term human use.

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Fig. 6. Left side, serious loss of hair due to Alopecia X. Right side, sameanimal following two months of treatment with B401, showing gradualreturn to normal hair growth.

Fig. 5. Left side, dog prior to treatment. Right side, results followingfour weeks of treatment with experimental herbal hair support formula,B401, resulting in a gradual return to normal hair growth.

Human Trials – Alopecia Areata

The earliest trials involved a group of patients diagnosed with Alope-cia areata, or “spot areata.” In early stages, Alopecia areata causesclumps of hair to fall out with a gentle pull, leaving patients with oneor more bare spots on the scalp.

Alopecia areata occurs in young people at a rate of approximately17 per 100,000 per year, and while the condition isn’t harmful, thepsychological impact is problematic for young patients. Fortunately,the condition is generally temporary, and 80% of the patients even-tually self-heal.

In addition to the form seen in younger people, a more pervasiveform of Alopecia areata appears in women (and occasionally men)over the age of 35. Also characterized by extensive hair loss, the con-dition usually clears up within one to two years, but the psychologicalstress of going bald makes this condition a profitable area for treat-ments at hair loss centers.

The most common treatment for Alopecia areata involves monthlyinjections of corticosteroids, and twice-a-day external application of5% minoxidil. Treatment generally requires 8-12 weeks before hairbegins to regrow.

• Case 1: Mr. W. was a 50-year-old sales manager who had lost alarge amount of hair in the occipital region. He came to the researchcenter after being treated with steroid medications for one month.The steroids had not alleviated his alopecia areata, and the area ofhair loss was continuing to spread. After one month of taking B401,Mr. W. reported significant improvement in his condition, and withintwo months all of his hair was restored.

• Case 2: C. was a 15-year-old student with several bald spotsacross the back of her head. By the time C. came to the center, shehad already completed a month of conventional drug treatmentwithout any improvement and was emotionally stressed from ad-ditional hair loss. After taking B401 for one month, her hair lossstopped and new hair started to grow back. Within several monthsall of her hair was restored.

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• Case 3: A family brought in a 10-year-old student who hadbegun to lose her hair. She was treated by both Chinese and Westerndoctors, but there was no improvement and her hair loss wasincreasing. After 50 days of treatment with B401 her conditionhad improved significantly, with older bald spots filling in, andhair loss at newer spots significantly slowed.

Human Trials – Male Pattern Hair Loss

Following the Alopecia trial the lab began evaluating B401 for malepattern baldness. Early results revealed that most men with stage 3or 4 hair loss reacted within six months, regrowing fine hairs on thetop of the scalp that grew thicker and longer over time. Men withstage 4 to 5 hair loss were more likely to experience significantregrowth; however, improvements in stage 7 male-pattern baldnesswere only noticeable close up, with thinner hairs becoming thickerand longer, but with little change on the forehead.

The images on the following pages (Figures 7 through 9) docu-ment the results of three separate cases of male pattern baldness aftertreatment with B401.

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Fig. 10. Ms. Y., 26-years-old, diagnosed July 21, 2006, arrived atthe clinic after being told her condition was incurable.

Fig. 9.Mr. D., 40-years-old, after taking B401 for eight months, revealingreduced hair loss and regrowth of original hair across top of scalp.

Fig. 8. Mr. L., 29-years-old, after taking B401 for one year, revealing in-creased hair density and overall hair coverage.

Human Trials – Alopecia Totalis

Following the positive outcome of the male pattern baldness trials,the researchers began to test the new formula on several womendiagnosed with Alopecia totalis, a condition that causes lymphocytesto attack hair follicles during the growth phase of the hair cycle. Inextreme cases, Alopecia totalis can result in the total loss of hair onthe head, face, eyebrows and eyelashes within six months. Fullrecovery is rare, and even with effective treatment, new hairgrowth in patients with alopecia totalis is often incomplete.

• Case 1: Ms. Y., 26-years-old, was diagnosed with Alopecia totalisin July, 2006. Early signs of hair loss were attributed to stress fromwork and school, but within two months all of the hair on her head,eyebrows included, had dropped out. Conventional treatment at twoWestern hospitals failed to address the problem, and by the time Ms.Y. entered the B401 trial all that remained of her hair were a fewblack strands in the occipital region (Fig. 10). After taking B401 for

Fig. 7. C., 43-years-old, after taking B401 for 1.5 years, revealing reducedhair loss, thicker, denser hair, and increased coverage across middle ofscalp.

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Fig. 12. Ms. Y., 26-years-old, after taking B401 for 18 months. Fig. 13. Ms. H., 28-years-old, prior to taking B401.

six months, new hair began to appear (Fig. 11). After two years oftreatment, Ms. Y. fully regrew her hair. (Fig. 12) Two years after thecompletion of her initial treatment, Ms. Y. reports that her hair is stillfull and strong, with good volume and no further loss.

• Case 2:Ms. L. had previously tried every other available treatmentto reverse her hair loss, but all failed. She had been completely baldfor eight years by the time she enrolled in the trial. After taking theformula for six months, there was no improvement in her conditionand Ms. L. decided to discontinue treatment.

• Case 3:Ms. H., 28-years-old, experienced serious, unexplained hairloss in the summer of 2007, and within two months had lost all of herhair, including eyebrows (Fig. 13). Ms. H. began to experience newhair growth within one month of taking B401 (Fig. 14). Significantly,Ms. H. reported that her previously white hair was growing back in hernatural color, black (Fig. 15). The researchers expected that newlyFig. 11. Ms. Y., 26-years-old, after taking B401 for six months.

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grown hair would not regain its original color for at least 2 or 3 full haircycles, so her case was especially interesting. Ms. H. reached a near-full recovery in six months (Fig. 16). Unfortunately, Ms. H. stoppedtaking B401 after her initial treatment and experienced a relapse aftersix months.

Fig. 14.Ms. H., 28-years-old, after taking B401 for 2 months, revealngthickening, longer hairs in occipital region.

NOTE: Each of the cases of Alopecia Totalis discussedabove resulted in completely different outcomes: the firstwas successful, the second ineffective, and the third a re-lapse. Note that in the third case, researchers had previ-ously predicted that newly grown hair would not regain itsoriginal color for at least two or three full hair cycles, so hercase was especially interesting.

From these three cases the scientists concluded thatthe longer one waits before beginning treatment with B401,the greater the chances for permanent and unrecoverabledamage to hair follicles. The scientists also concluded thatearly treatment at the first signs of hair loss improves theprobability of total recovery. Additionally, treatments haveto be continued until the underlying condition is eliminatedto prevent a future recurrence of hair loss.

Fig. 15. Ms. H., 28-years-old, after taking B401 for 2 months.

Fig. 16. Ms. H., 28-years-old, after taking B401 for 6 months.

B401 Shown to Increase Hair Growth Factors

Animal studies commissioned by the Agriculture Department ofTaiwan and completed by the Institute of Animal Science, found thatB401 enhanced levels of Vascular Endothelial Growth Factor (Fig.17) and Hepatocyte Growth Factor (Fig. 18) in hair follicles. Ad-ditionally, B401 was shown to increase the number of active hairfollicles (Fig. 19), while promoting faster growth and increasedlength of individual hairs (Fig. 20, next page).

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Key to Restoring Hair Growth Cycles

Modifying hair follicle growth cycles is a complicated matter. Currentresearch has identified numerous growth factors and hormones knownto be involved in hair proliferation and growth. For example, FibroblastGrowth Factor 3 (FGF-3) and Fibroblast Growth Factor 5 (FGF-5) aidin shifting follicles from hair growth to follicle degradation. Conversely,Insulin-like Growth Factor (IGF-1) and Fibroblast Growth Factor 7(FGF-7) have been shown to support hair growth by lengthening the tel-ogen (growth) phase of hair follicles. Additionally, Vascular EndothelialGrowth Factor (VEGF), Hepatocyte Growth Factor (HGF) and Endothe-lial Cell Growth Factor (EGF) aid in extending the hair growth period.

Currently, these growth factors and hormones are useful for filteringhair growth regulators and interpreting their mechanism of action. Giventhe gap between basic research (in vitro) and clinical applications (oral),current treatments are limited to topical hair growth products. Saw pal-metto extract, for example, has been shown to inhibit 5α-reductase invivo, but has no effect when taken orally, which is why it is commonlyused in topical hair products. Adenosine, which has been shown to en-hance FGF-7 levels in hair follicles, is another popular ingredient fortopical hair tonics. And several plant extracts are commonly added tohair creams to block the effects of FGF-5. Nevertheless, these treatmentsare limited to targeting “surface” issues, bypassing deeper “root” issuescontributing to hair loss.

Fig. 17. Increase in local hair follicle expression of Vascular En-dothelial Growth Factor following administration of B401 for 28 days.

Fig. 18. Increase in Hepatocyte Growth Factor concentration follow-ing administration of B401 for 28 days.

Fig. 19. Increase in the number of active hair follicles following ad-ministration of B401 for 28 days.

B401 Patents Approved in U.S. and TaiwanAfter years of development, B401 was released as a new food-basedformulation in 2008. In 2010, patents for B401 were approved in theUnited States (Patent Number: U.S. 7,838,048 subject: Medical herbcomposition for inhibiting shedding of a mammal's hair and methodfor preparing the same) and Taiwan (Patent Number I 329 491. Title:Chinese medicine composition for hair loss reduction and its prepara-tion method). According to the Intellectual Property Office of Taiwan,B401 is the first, and only, patent ever granted for a hair-loss formula.Patents have also been approved in Germany and China, with additionalapplications pending in Europe and Asia.SummaryB401 has been shown to support hair health by combining select“essence tonic” herbs traditionally used to reduce excessive hair loss,with botanical ingredients known to enhance circulation to the skin andscalp.* The result is a unique, patented, all-natural oral herbal supple-ment that addresses age-related hair loss in humans by promotinghealthy hair growth, skin complexion, energy and vitality.* Clinicalcases indicate that, if used uninterruptedly and in sufficient amounts,B401 can halt abnormal hair loss in approximately 85% of subjectswithin four to eight weeks.* New hairs generally begin to appear onthe scalp within three to six months, and original hair color has beenreported to emerge among white hairs after six months.*AvailabilityB401 herbal hair support formula for men and women is availableexclusively in the United States as PriaPlex®.

Additional Health BenefitsIn addition to halting hair loss and increasing hair growth, theproprietary blend of herbs in B401 have been shown to benefitoverall health.* Subjects taking B401 report increased levels ofvitality and energy after 1 to 2 weeks, and improved skin tone andcomplexion after 6 to 8 weeks.* Animal tests show that the formulaexerts anti-fatigue and liver-protective functions, and in vitro trialshave identified significant antioxidant activity and anti-aging benefits.

Limits of Current U.S. Patented Hair ProductsTo date only 64 U.S. patents have been granted for inventions addressinghuman hair issues. Of these, 59 are for products limited exclusively toexternal (topical) use only. And while the remaining five patents coverproducts intended for internal use, they contain active ingredients thatare not recommended for long term use. Significantly, B401 is the onlyoral, medicinal herbal formulation ever granted a U.S. patent forreducing hair loss and supporting healthy hair growth. Most impor-tantly, because the patent covers commonly used herbal ingredients,the formulation is safe for long term use.

Fig. 20. Increase in hair growth following administration of B401for 15 days.

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* These statements have not been evaluated by the Food and Drug Administration.This product is not intended to diagnose, treat, cure, or prevent any disease. Theinformation in this booklet is not intended to provide personal medical advice, whichshould be obtained from a medical professional.© Copyright 2014 Tango Advanced Nutrition, Inc. All rights reserved. All trademarksand service marks are the properties of their respective owners.