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14 The National Hair Journal Spring 2010
The National Hair Journal
Medical Section
P R O M O T I N G C O O P E R A T I O N B E T W E E N T H E A R T I S T R Y O F H A I R R E P L A C E M E N T A N D T H E S C I E N C E O F H A I R R E S T O R A T I O N the variable factors that influence AGA by observing N THE BEGIN- growth agonist.
how many ways people can suffer from the disease.
Some people lose hair in front, others only in back, while still others lose hair across the entire front and Dr. M: Hair Genesis was orig-
top of the scalp. So clearly it’s not simply about one factor, i.e. dihydrotestosterone. And so what we set out to do was to say, “Okay, we need a new hypothe- sis. If there are other things going on, wouldn’t you THE FOLLICLE
get a better clinical outcome if you could identify one or more of these other causative factors and then tar- get those contributing factors while simultaneously hitting dihydrotestosterone and 5-alpha-reductase?” Does Hair Genesis Belong pounds within saw palmetto, So that was our overarching hypothesis. We were fortunate to have sharp collaborators at the University of Albany and elsewhere who helped us think creatively about this part of the problem for a couple of years. Ultimately, we identified several A Google search for “hair loss treatments” delivers inflammation-related events in the hair follicle that 45,100,100 hits. Narrow it down to “hair loss seemed to be really important. From that, we went on lotions” and you get 1,100,100 with names like to identify a series of genetic markers that seemed Spironolactone, Phytologie PhytocyAne, Doo Gro relevant in the setting of pattern hair loss. We tested Mega and Triple Gro Tea Tree Oil. You get the point. our theory in a set of basic science experiments, for So how can a poor hair loss victim decide what works example using a well-respected analog for hair folli- and what is simply a money pit? The answer is well-controlled European trials that show that saw precipitated by the same metabolic chain of events cle biodynamics called HaCaT cells. These cells are research. Not just anecdotal evidence and friendly palmetto in high enough doses has a tendency to pro- that causes pattern hair loss. It may be helpful to a type of keratinocyte found in the skin and, specifi- testimonials, but serious studies validated by an inde- vide clinical benefits. So we began testing different think about dihydrotestosterone, or DHT, as the gaso- cally the hair follicle. Once we had identified the pendent third party. In this interview Geno compositions and formulations incorporating various line that causes the inferno in hair loss that damages important gene markers that were associated with Marcovici, PhD, Chief Scientific Officer at Advanced strengths of saw palmetto and its glycoside beta- hair follicles. In the prostate gland, DHT is triggered inflammation in the hair follicle, we designed a set of Restoration Technologies (ART) describes clinical sitosterol. We came up with a formula that showed by an enzyme called 5-alpha-reductase. 5-alpha- experiments where we actually went in and used a studies that culminated in Hair Genesis, a botanical- striking benefits in our clinic population. We went to reductase is like the match that lights the fuse, okay? type of irritant, called lipopolysaccharide, or LPS.
ly based hair care product that he claims is the only market with that formula in the mid-1990s.
In the prostate DHT causes pathological growth that Then we applied a formulation representative of our non-drug hair loss treatment tested and developed in results in pain on urination and the potential for latest generation of product and we were able to show collaboration with a university-based research team inflammation, infection, etc. In the hair follicle, the a statistically significant reduction in the level of key and the only non-drug hair loss treatment with a Dr. M: Hair Genesis is technically not a drug. It’s a
hormone causes the opposite effect in that the hair markers of inflammation. Given what we know demonstrable dual mechanism of action. The Hair naturally derived composition. This is significant follicle involutes, or becomes miniaturized. So it about inflammation and hair loss, from a basic sci- Genesis “Generation IV” regimen comprises oral when you consider the pluses and minuses of the occurred to me that if this stuff could block 5-alpha- ence standpoint, that’s a reasonable proof of principle softgels, a topical activator serum, and a special revi- pharmaceutically-based hair growth drugs. The ben- reductase in the prostate, why couldn’t we come up that you have a new mechanism of action as well as efits of the FDA-approved drugs are self-evident; with a way to reformulate some of the key fatty and a new way to treat the problem. So next, and to pro- clinical evidence indicates that you can slow down, sterols in saw palmetto into a composition that would tect our hard won efforts, we took the extra step of NHJ: Dr. Marcovici, you recently completed a hair
arrest, or in some cases reverse pattern hair loss. The going back to our IP council and filed a USPTO regrowth study. Could you tell readers of The downside however, is that both minoxidil and finas- NHJ: What happened next? Did you lock yourself
application to protect the novelty of what we’d come National Hair Journal in layman’s language, what this teride have been shown to present potentially signifi- away in a laboratory for six months, or form a new up with. We then submitted the results of our work all-natural productis, and how it can help their cant negative side effects. If you read the side of the to a well-respected journal, and that’s the link we sent bottle, or if you look it up online, you’ll find a lengthy Dr. M: This was in the mid-1990s and we had a
Dr. M: The formal name for the most common
list of negative side effects. So these are real caveats small laboratory and also a clinical facility. We also Dr. M: These new data, coupled with our previous
form of hair loss is “androgenetic alopecia.” That’s a when you consider how badly you want to protect had some nice relationships with collaborative clinical research, gave us the impetus to create our big word, but in layman’s terms “pattern hair loss” your hair. The nice thing about using naturally researchers, so we had access to the materials and Generation 4 Hair Genesis product formulations suffices. Let’s put hair loss in context. In the United derived substances is that you have a much stronger tools we needed. Because we were a hair clinic, we which are just now hitting the market.
States, 40 million men are believed to be affected by safety profile. You don’t see the sort of teratogenic had a built in population of highly motivated folks NHJ: Do the medical and research communities,
pattern hair loss, and perhaps the more surprising sta- effects, (i.e. feminizing birth defects), pulmonary who were keen to help us find ways to help them stop accept your results and your conclusions/ tistic is that 20 million women in America are also edema, loss of libido, etc. that you do with the drug- losing their hair. From these people, we selected Dr. M: Yes.
affected. These statistics can be extrapolated out to based choices. Another thing we found particularly appropriate individuals - which for us meant relative- NHJ: What would it take to go to the next step and
much larger numbers when you consider the global compelling was data from several investigators that ly young to middle aged people in generally good conduct a study that would satisfy the Federal Drug suggested that carefully composed extracts of saw health and also in the early stages of hair loss – and palmetto potentially offered between a 3-fold and 15- we put them on various test compositions to see what Dr. M: If we were interested in characterizing
fold greater efficacy in inhibiting the pathogenic five sort of response we would get. From that early work, Hair Genesis as a drug, there’s a research regimen alpha-reductase enzyme without triggering concomi- we developed a set of formulas that became the prod- protocol we’d have to follow. However, our pref- tant negative side effects. So we thought that this was uct we market advanced versions of today. We origi- erence is to remain an all-natural or a cosmetic a set of substances worth investigating. After several nally called the line “ProAcTabs,” but then we came product. We’re operating under the auspices of the years of work we were able to demonstrate clinical up with a little bit better name, “Hair Genesis®.” 1993 DSHAE (Dietary Supplement Health and benefits through two open-label studies before went NHJ: What is involved in setting up a clinical study?
Education Act) rule. So though we’re fairly confi- to market. An “open-label” study, as you may know, Dr. M: To validate the clinical efficacy of Hair
dent that the product does even more good in the is a study where the test material is dispensed with an Genesis we needed to test the product under scientif- hair follicle than we describe, we prefer to under open label meaning that the investigator and study ically rigorous conditions. We enlisted a third-party subject are aware that the active material is being test- clinical facility that was in the business of conducting NHJ: What new research is planned?
ed. This is in contrast to a placebo-controlled blind- independent tests like this one. The entire process Dr. M: We’d like to do a multi-arm study where we
ed study where an inert material is dispensed to part was carefully monitored by an institutional review might have gender-specific populations. We might of the study population while another group receives board, or IRB, which exists to ensure that everything even test Hair Genesis against some of the well- is done according to highly stringent FDA regula- NHJ: What is the significance of the test subjects
tions. The study was undertaken in 1999 and the data NHJ: Who could benefit from Hair Genesis? Is it
knowing they are using an active product? Is it to gathered between the end of ’99 and early 2000. The ensure compliance so they will stay with the pro- results were clearly in favor of treatment. The place- Dr. M: Yes, the product works equally well in women
bo population continued to experience hair loss, and men. However, the regimen is most beneficial Dr. M: Not really. The benefit of an open-label
while the treatment population showed a complete when it is begun early in the disease process. As an study is that it constitutes what’s called a proof of arresting of the progression of loss. Two out of three analogy, our viewpoint is that a parachute works best principle. If you see a demonstrable benefit under participants actually had thicker hair at the end of the before you hit the ground. For people who have lost population. Hair loss has always been acutely dis- open-label conditions, then there’s a reasonable prob- trial. So that was a fairly impressive outcome.
most or all of their hair, laser therapy’s not going do it, tressing. Until recently, there hasn’t really been much ability that you’d achieve similar results randomizing NHJ: How do these results compare with other test-
and Hair Genesis is probably not going to do it either.
that’s been effective in treating the disorder. Going the study subjects and going to a full double-blind The hair follicle at some point loses the ability to hear back to ancient times in Egypt, historians have dis- trial. That’s what we did in the late 1990s and 2000.
Dr. M: Outside of the big drug companies, to my
a signal or to receive a signal to return to healthy vig- covered that they used crocodile dung and all sorts of The results of that placebo-controlled, IRB moni- knowledge no one else is doing serious research in orous growth. So our suggestion is that it’s better to interesting substances that were purported to thicken tored, double-blind study still represent the only the category. If you go to Pubmed.com also known start any treatment sooner rather than later and we find the hair. And in the 19th Century, the term snake oil example of a non-drug-based hair-loss treatment to as Medline and type in “botanical” and “hair loss,” our clients are most happy when they use Hair Genesis came into widespread use because they actually show clinical efficacy in pattern hair loss. That par- only one research study comes up, and that is our as a hair maintenance program rather than trying to extracted oil from rattlesnakes and other reptiles as a ticular study is available for anyone to see on clinical trial. If you think about it, it’s astounding that hair growth accelerant. Today, we have more respon- nobody else has thought it important to validate their NHJ: Does Hair Genesis arrest hair loss or promote
sible choices… though a quick surf around the web NHJ: People searching for hair loss remedies online
products using the same high level of scientific could easily make you think otherwise.
will be presented with a list of products, some Hair Genesis inhibits the factors that are NHJ: The FDA, has officially approved two hair
authentic, many unscrupulous. Why should they NHJ: How do your results compare with Rogaine?
known to trigger hair loss. So if you can block 5- growth drugs. Is that where the hair regrowth story Dr, M: We compare favorably with finasteride where alpha-reductase, and if you can reduce the pathologic Dr. M: A valid question. Here’s why. We were the
two out of three patients showed a response. Where inflammation of the hair follicle, then you can, from an first to market with a botanically based hair loss treat- I think we have potentially an inside track is the fact anatomical and physiological standpoint, preserve presently indicated for pattern hair loss. The first is ment in 1996. At the time there just wasn’t anything that our product line doesn’t suffer from the negative those structures so that they can produce a more robust Minoxidil, which originally was a blood pressure else like Hair Genesis® out there. We opened the caveats that finasteride, dutasteride, and minoxidil product, which is the hair shaft. othing grows new hair.
medication. It is a topical product and is now trade door to naturally derived substances in the hair loss You die with the same number of hair follicles that you named Rogaine. The second is Finasteride, which is treatment category. Early compositions of Hair NHJ: What is Advanced Restoration Technologies
were born with. Pattern hair loss is miniaturization of an inhibitor of the Type 2 5-alpha-reductase enzyme, Genesis incorporated minoxidil and some of our the structures and sub-compartments of the hair folli- a key enzyme associated with androgen metabolism competitors took a page from our playbook. A couple Dr. M: We realized that pattern hair loss is not sim-
cle. But if you can get ten hairs that are twice as thick, that in genetically susceptible individuals triggers the of years later however, new data suggested that there ply the result of 5 alpha reductase mediated dihy- it’s as good as having twenty hairs.
disorder. The third drug is a dual inhibitor of both were naturally occurring substances that could actu- drotestosterone damaging the follicle, even though NHJ: Final question; how did you get into the thin-
Type 1 and Type 2 5-alpha-reductase and that is ally outperform Minoxidil plus saw palmetto. We most of our competitors have been chasing that called Dutasteride. It is sold under various trade used those compositions in the 2002 published IRB- metabolism forever. AGA is known as a complex Dr. M: My mother was a manicurist for 45 years, my
trait disorder. This means that there are numerous dad a hairstylist from Europe. So I started out with NHJ: Dutasteride has not received FDA clearance.
NHJ: What is the plant or tree from which saw pal-
factors, genetic, biochemical, epigenetic and environ- perm solution in my blood. (Laughs) I’m married to mental that are responsible for triggering the onset a hair scientist. I guess you could say I’m contin- Dr. M: I think it’s in Phase 3 trials at this point, but
Dr. M: The saw palmetto tree is like a weed version
and progression of the disease. One can appreciate

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