Scientific Evidence Documenting that the Ingredients of the Hair Genesis Proprietary Formulation Work for Male and Female Hairloss
Ingredients shown to be Safe and Effective DHT Blockers
HairGenesis, a proprietary formulation of botanically derived components, combines the power of known 5-Alpha-Reductase (5AR) inhibitors (DHT Blockers, Anti-AndroGenetic Alopecia substances) into a powerful hair loss treatment regimen.
The individual substances used in the formulations comprising the HairGenesis™ treatment line were selected for inclusion after meticulous research. A great deal of basic science as well as independent clinical research supports the efficacy of certain botanicals as known inhibitors of 5AR. A small compilation of this independently derived data has been gathered below in support of the safety, efficacy and value of HairGenesis™.
Independent Scientific Data Supporting Hair Genesis Ingredients
- Liquid Saw Palmetto Extract
- LESr quality for extra strength potency
- Beta Sitosterol
- Essential Fatty Acids (EFAs)
- Proanthocyanidins (Procyanidin Oligomers)
Liquid Saw Palmetto Berry Extract
The Saw Palmetto is a small shrubby palm native to Florida and has a long folk history as an aphrodisiac and sexual rejuvenator. Recent studies have implicated saw palmetto as an effective treatment for benign prostatic hyperplasia (BPH). Investigators have found that the fatty and sterolic extracts (fatty acids: capric, caprylic, caproic, lauric, palmitic, and oleic; sterols: beta-sitosterol, stigmasterol, cycloartenol, luepol, lupenone and 24 methyl-cycloartenol) are the active molecular components responsible for its therapeutic action.
Scientific Research Shows That:
“In a large European study, one in which a pharmaceutical clinical trial model was closely followed, a saw palmetto product (permixon) was found to cause no change in standard blood tests and no change in serum prostate specific anagen levels (PSA) during a six month treatment period.” Carraro et al. Prostate vol. 29 pp.231-240 1996
“Among 1,098 patients with BPH (benign prostatic hyperplasia) in that study, the general safety profile of saw palmetto compared favorably with that of Finasteride (the chemical used in the drugs Propecia [for hairloss treatment] and Proscar [for prostate treatment] ), and sexual side effects were less common with the extract than with the drug Finasteride. In particular, the use of extract has not been associated with erectile dysfunction, ejaculatory disturbance, or altered libido.” Carraro et al. Prostate vol. 29 pp.231-240 1996
Liposterolic Extract Serenoa Repens (LESR)
“Aside from an occasional instance of GI upset, side effects of saw palmetto extract have not been reported” Bach et al. Phytomedicine pp. 105-111, 1996. “Pharmaceutical style evaluations have not yet been performed in the United States, partly because they are not required by law, and partly because the cost of such evaluations would be difficult to recoup with non-patentable products.” Marks and Tyler, Urology, vol. 53, 457-461, 1999
“LSESr was found to be a three fold more potent competitor of 5AR (5-Alpha-Reductase) than Finasteride when comparing the recommended therapeutic dose by the manufacturers for the treatment of BPH. (5mg per day vs. 320mg per day LSESr Note: The hairloss treatment drug Propecia = 1mg per day Finasteride.” (This suggests a fifteen-fold greater efficacy dose for dose in favor of LSESr) Delos et al., J. Steroid Biochem. Molec. Biol., vol. 48, pp 347-352, 1994
“Finasteride is a selective inhibitor of the type two isoform of 5AR (5-Alpha-Reductase), whereas LSESr markedly inhibited both type one and type two isoforms of 5-Alpha-Reductase.” (Type one 5-Alpha-Reductase predominates in tissue specific to the hair follicle morphology, whereas with type two there is evidence for the expression of both) Lehle et al., J. Steroid Biochem. Molec. Biol., vol 54, 273-279, 1995
“Naturopathic physicians have used LSESr as a tonic to naturally support the body in the treatment of genital/urinary tract disturbances, in men to increase testicle function, and in women with mammary gland disorders.” Murray, Vital Comm. 1990 pp 1-14
Research Abstract on LESR
Human prostatic steroid 5 Alpha-Reductase isoforms–a comparative study of selective inhibitors.
Lehlé C; Délos S; Guirou O; Tate R; Raynaud JP; Martin PM
J Steroid Biochem Mol Biol, 54: 5-6, 1995 Sep, 273-9
The present study describes the independent expression of the Type 1 and 2 isoforms of human 5-Alpha-Reductase in the baculovirus-directed insect cell expression system and the selectivity of their inhibition. The catalytic properties and kinetic parameters of the recombinant isozymes were consistent with published data. The Type 1 isoform displayed a neutral (range 6-8) pH optimum and the type 2 isoform an acidic (5-6) pH optimum. The Type 2 isoform had higher affinity for testosterone than did the Type 1 isoform (Km = 0.5 and 2.9 microM, respectively). Finasteride and turosteride were selective inhibitors of the Type 2 isoform (Ki (type 2) = 7.3 and 21.7 nM compared to Ki (type 1) = 108 and 330 nM, respectively). 4-MA and the lipido-sterol extract of Serenoa Repens (LSESr) markedly inhibited both isozymes (Ki (type 1) = 8.4 nM and 7.2 micrograms/ml, respectively; Ki (type 2) = 7.4 nM and 4.9 micrograms/ml, respectively). The three azasteroids were competitive inhibitors vs. substrate, whereas LSESr displayed non-competitive inhibition of the Type 1 isozyme and uncompetitive inhibition of the Type 2 isozyme. These observations suggest that the lipid component of LSESr might be responsible for its inhibitory effect by modulating the membrane environment of 5-Alpha-Reductase. Partially purified recombinant 5-Alpha-Reductase Type 1 activity was preserved by the presence of lipids indicating that lipids can exert either stimulatory or inhibitory effects on human 5-Alpha-Reductase.
One of the most profoundly significant developments in the past few years is the discovery of the action in the body of the plant sterols and sterolins. These are potent phytochemicals found in a variety of botanical sources. There are a number of different sterols and these include the principal phytosterol, which is known as sitosterol.
In addition to sitosterol the most common sterols include campesterol, sitostanol and stigmasterol. The glucoside of sitosterol is known as sitosterolin and in plants it is always found together with the sterol. The ratio of sterol to sterolin varies in the plant kingdom ranging from 5% to 10% but in some cases being higher as in the case of potatoes.
Sterols are essential cell membrane components and the maintenance of adequate serum levels in humans seems to be necessary for an efficient immune system. Seeds are the richest source of the sterols and sterolins and yet, the refining processes applied by the food industry render the staple foods useless, because they remove the sterols and sterolins to make the product more appealing to the eye.
For instance, in order to prevent precipitation of the fats in so-called “cold pressed oils,” the oil is heated and refined to remove the sterols / sterolins. Sterols and sterolins have been shown to modulate the functions of the T-Cells both in vitro and in vivo by enhancing their cellular division.
Recent research conducted by Professor Patrick Bouic and his research team at the University of Stellenbosch Medical Faculty and published in the International Journal of Immunopharmacology is providing an entirely new medical approach to the treatment of autoimmune diseases and other chronic diseases that only manifest themselves when the afflicted individuals are at cause. International medical and scientific interest on this breakthrough has been overwhelming.
Beta Sitosterol assists in the conversion of linoleic acid to polyunsaturated fatty acids. This process is essential for the conversion of the Omega 6 fatty acids to prostaglandins and leukotrienes. Prostaglandins and leukotrienes are hormone like substances that are involved in immune support; they assist in the reduction of thrombo-embolic disorders by reducing platelet aggregation and they also assist in the reduction of inflammatory metabolites.
Beta Sitosterol can be metabolized to pregnenolone and therefore to DHEA and the other hormones derived from pregnenolone and its analogues. In the human body there is a steady decline with age in the production of DHEA, which is the master hormone responsible for the synthesis of estrogen, progesterone, testosterone, cortisol and others.
By the age of 70 the DHEA production can be down to 10% or 20% of the levels found in a twenty year old, thus sitosterol supplements have an enormous potential for supporting the endocrine system in elderly people and, by implication, increasing their longevity.
Research Abstract on Beta Sitosterol
Beta-Sitosterol for the treatment of benign prostatic hyperplasia: a systematic review.
Wilt TJ; MacDonald R; Ishani A
The VA Coordinating Center of the Cochrane Collaborative Review Group in Prostatic Diseases and Urologic Malignancies, 13/Minneapolis, VA, USA.
BJU Int, 83(9): 976-83 1999 Jun
Abstract Objectives: To conduct a systematic review of the evidence for the efficacy of beta-sitosterol in men with symptomatic benign prostatic hyperplasia (BPH). METHODS: Studies were identified through Medlinetrade mark (1966-98), EMBASEtrade mark, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with study authors and pharmaceutical companies. Randomized trials were included if: men had symptomatic BPH; plant extract preparations contained beta-sitosterols; a control group received placebo or a pharmacological therapy; and treatment duration was >/=30 days. Study characteristics, demographic information, enrolment criteria and outcomes were extracted.
Results: Four trials comprising a total of 519 men met the inclusion criteria. All were double blind and lasted 4-26 weeks. Three studies used nonglucosidic beta-sitosterols and one used a preparation that contained only beta-sitosterol-beta-d-glucoside. Compared with placebo, beta-sitosterol improved urinary symptom scores and flow measures. For the two studies reporting the International Prostate Symptom Score (IPSS), the weighted mean difference (WMD) against placebo was -4.9 IPSS points (95% confidence interval, CI, -6.3 to-3.5). The WMD for peak urinary flow rate was 3.91 mL/s (95% CI 0.91 to 6.90, four studies) and for residual volume the WMD was -28.62 mL (95% CI-41.42 to-15.83, four studies). Beta-sitosterol did not reduce prostate size.The trial using pure beta-sitosterol-beta-d-glucoside (WA184) showed no improvement in urinary flow measures. Withdrawal rates for men assigned to beta-sitosterol and placebo were 7.8% and 8.0% (not significant), respectively. CONCLUSION: beta-sitosterol improves urological symptoms and flow measures. However, the existing studies are limited by short treatment duration and lack of standardized beta-sitosterol preparations. Their long-term effectiveness, safety and ability to prevent the complications of BPH are unknown.
Essential Fatty Acids (EFA)
GLA, ALA, Linoleic Acid and Palmitoleic Acid
Gamma Linolenic Acid (GLA), Alpha Linolenic Acid (ALA), Linoleic and Oleic Acid are essential fatty acids found in plant oils. These fatty acids have been individually proven to inhibit 5-Alpha Reductase. The essential fatty acids are among the most powerful inhibitors of 5-Alpha Reductase known today. They have been demonstrated to inhibit both Type 1 and Type 2 isoforms of the enzyme 5AR. This is in marked contrast to finasteride, which has been shown efficacious only in the inhibition of Type 2 5AR. Importantly for the purposes of considering value in combating pattern hair loss; the Type 1 isoenzyme is present in high concentrations in the scalp, sebaceous glands, and the skin. It has also been shown that GLA, ALA and Oleic acid have potent anti-inflammatory properties.
Research Abstract on Gamma-Linolenic Acid
Liang T; Liao S
Journal of Investigational Dermatology: 1997 Aug; 109 (2): 152-7
Certain unsaturated aliphatic fatty acids, such as gamma-linolenic acid, inhibit 5alpha-reductase activity in vitro and in vivo. Hamster flank organ growth, as measured by the increase in the area of pigmented macule, is dependent on androgen. When one of the paired flank organs of a castrated hamster was treated topically with testosterone, the treated organ, but not the contralateral flank organ, became larger and darker. Topical application of gamma-linolenic acid to the testosterone-treated flank organ suppressed this testosterone effect. Other fatty acids that were not inhibitors of 5alpha-reductases were not active. Topical treatment of hamster flank organs with 5alpha-dihydrotestosterone also stimulated the growth of the organ. This 5alpha-dihydrotestosterone-dependent activity, however, was not significantly affected by gamma-linolenic acid, suggesting that flank organ growth was dependent on 5alpha-dihydrotestosterone and that gamma-linolenic acid acted by inhibiting 5alpha-reductase. With intact male hamsters, the endogenous androgen-dependent growth of flank organs is also suppressed by topical treatment with gamma-linolenic acid.
The effect of gamma-linolenic acid is localized at the site of its application; topical application of gamma-linolenic acid did not affect the androgen-dependent growth of other organs such as testis, epididymis, seminal vesicle, and prostate. Gamma-linolenic acid, with low toxicity and absence of systemic effect, may be potentially useful for treatment of androgen-dependent skin disorders.
Research Abstract examining Gamma-Linolenic Acid against other Fatty Acids in the Inhibition of 5-Alpha-Reductase
Liang T; Liao S
Journal of Biochemistry, 1992 Jul 15, 285 (Pt 2): 557-62
Human or rat microsomal 5-Alpha-Reductase (5AR) activity, as measured by enzymatic conversion of testosterone into 5 alpha-DiHydroTestosterone or by binding of a competitive inhibitor, [3H] 17 beta-NN-diethulcarbamoyl-4-methyl-4-aza-5 alpha-androstan-3-one ([3H] 4-MA) to the reductase, is inhibited by low concentrations (less than 10 microM) of certain polyunsaturated fatty acids. The relative inhibitory potencies of unsaturated fatty acids are, in decreasing order: gamma-linolenic acid greater than cis-4, 7,10,13,16,19-docosahexaenoic acid = cis-6, 9,12,15-octatetraenoic acid = arachidonic acid = alpha-linolenic acid greater than linoleic acid greater than palmitoleic acid greater than oleic acid greater than myristoleic acid. Other unsaturated fatty acids such as undecylenic acid, erucic acid and nervonic acid, are inactive. The methyl esters and alcohol analogues of these compounds, glycerols, phospholipids, saturated fatty acids, retinoids and carotenes were inactive even at 0.2 mM. The results of the binding assay and the enzymatic assay correlated well except for elaidic acid and linolelaidic acid, the trans isomers of oleic acid and linoleic acid respectively, which were much less active than their cis isomers in the binding assay but were as potent in the enzymatic assay. Gamma-linolenic acid had no effect on the activities of two other rat liver microsomal enzymes: NADH: menadione reductase and glucuronosyl transferase. Gamma-linolenic acid, the most potent inhibitor tested, decreased the Vmax. And increased Km values of substrates, NADPH and testosterone, and promoted dissociation of [3H] 4-MA from the microsomal reductase. Gamma-linolenic acid, but not the corresponding saturated fatty acid (stearic acid), inhibited the 5 alpha-reductase activity, but not the 17 beta-dehydrogenase activity, of human prostate cancer cells in culture. These results suggest that unsaturated fatty acids may play an important role in regulating androgen action in target cells.
Research abstract on Palmitoleic Acid
Enhancement of propylene glycol distribution in the skin by high purity cis-unsaturated fatty acids with different alkyl chain lengths having different double bond position.
Taguchi K; Fukushima S; Yamaoka Y; Takeuchi Y; Suzuki M
Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Kobe Gakuin University, Japan.
Biol Pharm Bull, 22(4): 407-11 1999 Apr
Enhancement of skin distribution of propylene glycol (PG) in the skin by high purity cis-unsaturated fatty acids with different alkyl chain lengths was studied in the rat using Fourier transform/attenuated total reflection (FT-IR/ATR) analysis. Two fatty acids with the double bond at the delta9 position, palmitoleic acid (omega7, delta9) and oleic acid (omega9, delta9), enhanced PG flux into the dermis and increased the dermal steady state level of PG. In contrast, myristoleic acid (omega5, delta9) was extremely weak in its action. A positional effect of the omega chain was observed. The rate of skin structural alteration increased in proportion to omega chain length. The application of three fatty acids with the double bond at the omega9 position, oleic acid (omega9, delta9), gondoic acid, (omega9, delta11), erucic acid (omega9, delta13) enhanced PG distribution in the skin. While nervonic acid (omega9, delta15) did not increase PG distribution in the skin, the relationship of the delta/omega ratio to parameters characterizing the action of enhancers (PG (peak area max), T (max alteration), and the slope) suggest that skin distribution increases as the position of the double bond is shifted toward the hydrophilic end. It is therefore likely that the ratio of the delta/omega chain length of the cis-unsaturated fatty acid determines the efficacy of these compounds as skin penetration enhancers. An adequate molecular volume may be required for cis-unsaturated fatty acids to act as enhancers.
Proanthocyanidins (Procyanidin Oligomers)
Procyanidin Oligomers (also known as Proanthocyanidin) are naturally derived ingredients that have shown to stimulate hair growth with a mechanism of action thought by some investigators to be similar to that of Minoxidil (Rogaine™). Recent studies have shown that Procyanidin Oligomers promote growth stimulation activity of hair epithelial cells in vitro and stimulate anagen induction in hair follicles in vivo.
Research Abstract on Procyanidin Oligomers
Procyanidin Oligomers selectively and intensively promote proliferation of mouse hair epithelial cells in vitro and activate hair follicle growth in vivo.
J Invest Dermatol 1999 Mar; 112 (3): 310-6
Takahashi T, Kamiya T, Hasegawa A, Yokoo Y Tsukuba Research Laboratories, Kyowa Hakko Kogyo, Ibaraki, Japan.
We have previously reported that proanthocyanidins extracted from grape seeds possess growth-promoting activity toward murine hair epithelial cells in vitro and stimulate anagen induction in hair cycle progression in vivo. This report constitutes a comparison of the growth-promoting activity of procyanidin oligomers and the target cells of procyanidins in the skin. Results show that procyanidin dimer and trimer exhibit higher growth-promoting activity than the monomer. The maximum growth-promoting activity for hair epithelial cells with procyanidin B-2, an epicatechin dimer, reached about 300% (30 microM) relative to controls (=100%) in a 5 d culture. Optimum concentration of procyanidin C-1, an epicatechin trimer, was lower than that of procyanidin B-2; the maximum growth-promoting activity of procyanidin C-1 was about 220% (3 microM). No other flavonoid compounds examined exhibit higher proliferative activities than the procyanidins. In skin constituent cells, only epithelial cells such as hair keratinocytes or epidermal keratinocytes respond to procyanidin oligomers. Topical application of 1% procyanidin oligomers on shaven C3H mice in the telogen phase led to significant hair regeneration [procyanidin B-2, 69.6% +/- 21.8% (mean +/- SD); procyanidin B-3, 80.9% +/- 13.0%; procyanidin C-1, 78.3% +/- 7.6%] on the basis of the shaven area; application of vehicle only led to regeneration of 41.7% (SD = 16.3%). In this paper, we demonstrate the hair-growing activity of procyanidin oligomers both in vitro and in vivo, and their potential for use as agents to induce hair growth.
PMID: 10084307, UI: 99181798
Biotin, also known as Vitamin H, aids in the utilization of protein, folic acid, Pantothenic acid, and Vitamin B-12, and has also been shown to promote healthy hair. A deficiency of biotin may lead to extreme exhaustion, drowsiness, muscle pain, loss of appetite, depression, loss of skin tone, and hair loss.
Research Abstract on Biotin
Vitamin and dermatology
Yoshikawa K Address Department of Dermatology, Osaka University Graduate School of Medicine
Nippon Rinsho, 57(10): 2385-9 1999 Oct
Vitamin A, B1, B2, B6, B12, biotin, nicotinic acid, panthotenic acid, vitamin C, E and K has been used for various skin disorders. The use is mostly based on the similarity of the skin manifestations seen in their deficiencies, except for the rare cases of clear deficiency like pellagra. Recent introduction of vitamin A and D analogues for psoriasis and keratinization disorders resulted in significant progress in clinical dermatology. Application of vitamin C, E and beta-carotene++ for UV-induced skin damages are being studied, and the vitamins will be more important in dermatology in the future.