Medical Research - Bernstein Medical - Center for Hair Restoration
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A study published in the December 2015 issue of the Journal of Clinical and Aesthetic Dermatology suggests that Viviscal, an oral supplement designed for women with thinning hair, may promote hair growth. ((Ablon G, Dayan S. A Randomized, Double-blind, Placebo-controlled, Multi-center, Extension Trial Evaluating the Efficacy of a New Oral Supplement in Women with Self-perceived Thinning Hair. J Clin Aesthet Dermatol. 2015 Dec;8(12):15-21.)) The researchers noted a 79 percent increase in healthy, terminal hairs and an almost 12 percent increase in hair diameter in female patients who took the supplement for six months. The evidence suggests that Viviscal may be a useful supplement to current hair restoration treatments, or an alternative treatment in patients not indicated for hair transplant surgery or medical treatment with finasteride.

Background

Viviscal, produced by Lifes2good Inc., out of Chicago, Illinois, was launched in the U.S. in 2008. Its key ingredient is a proprietary mix of powders derived from sustainably-harvested shark and mollusk species. This “amino marine complex,” known as AminoMar C™, is blended with B and C vitamins, and minerals such as calcium, to make Viviscal “Professional Strength.” The active ingredients in the AminoMar complex are glycosaminoglycans (GAGs), a group of long-chain sugar molecules present in many living creatures. GAGs are especially adept at retaining water, and ingesting them may contribute to healthy hair and skin, although it is not clear if taken orally GAGs have any benefit in this regard. According to Viviscal, the beneficial effect on skin and hair of a fish- and protein-heavy diet was first observed in Inuit people in the late 1980s.

Dr. Glynis Ablon and her research team sought to determine if Viviscal “Professional Strength” tablets could successfully treat female hair loss. (The “Professional Strength” blend contains 25mg more of the AminoMar complex than the newer “Extra Strength” variety, as well as a different blend of extracts and additives.) If determined to be a viable treatment, Viviscal could be another option in an otherwise limited market of hair loss products for women. Many women with androgenetic alopecia (common genetic hair loss) are poor candidates for hair transplant surgery. Also, the use of Propecia (finasteride), the most effective hair loss medication available, is not indicated in women due to poor efficacy and the risk of potential side effects.

The Study & Findings

The study observed 40 women, aged 25-66, who self-reported some form of hair loss. An initial densitometry, to determine the progression of hair loss, was conducted on a 4cm2 target area of the frontal hairline. This was followed by the random distribution of either Viviscal or a placebo.

At 90 days on Viviscal, the researchers noted a 56% increase in terminal hairs in the target area and 10% increase in mean hair diameter. A nearly insignificant 1% rise was noted in the number of vellus hairs (non-mature or miniaturized hairs). Compared to the placebo group, the Viviscal group had 57% more terminal hairs, a 10% larger hair diameter, and 9% fewer vellus hairs.

At 180 days, compared to baseline, patients on Viviscal showed an almost 80% increase in terminal hairs, a hair diameter increase of 11.67%, and a 14% increase in vellus hairs. Compared to the placebo group at 180 days the Viviscal group had 77% more terminal hairs, an almost 10% larger hair diameter, and slightly more vellus hairs (1.5%).

Limitations of Ablon Study

The main limitation of the study lies in the potential conflict of interest between the researchers and Lifes2good. Dr. Ablon received a grant from Lifes2good as funding for the December 2015 study. In addition, no clear mechanism of action is proposed.  Finally, the cause of the volunteer’s hair loss was uncertain and probably represents several different diagnoses further confounding any explanation as to why the supplements might work.

Summary

Viviscal has the potential to supplement current treatments for hair loss or provide an alternative treatment for patients not indicated for hair transplant surgery or medical treatment. It would be especially useful for female patients who have relatively limited treatment options. It may also benefit men who are not good candidates for surgery. While the research findings are compelling, more investigation is necessary into the long-term efficacy of Viviscal and the effects of glycosaminoglycans on the hair growth cycle. Further study should be conducted by independent researchers in order to avoid the perception of a conflict of interest.

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A study published in the British Journal of Dermatology suggests that subcutaneous placement of testosterone pellets may boost hair regrowth in some women. ((Glaser RL, Dimitrakakis C, Messenger AG. Improvement in scalp hair growth in androgen-deficient women treated with testosterone: a questionnaire study. Br J Dermatol. 2012 Feb;166(2):274-8.))

This retrospective analysis examined patients who had androgen deficiency. Of the 285 patients studied, 76 had some degree of hair loss prior to beginning treatment. At one year on testosterone replacement 63% reported an increase in hair regrowth on the scalp.

Traditionally, elevated levels of androgens, such as testosterone, are felt to be the primary cause for common hair loss in both men and women. This is due to the seemingly adverse effect of androgens on hair follicles. This has held true for most men with patterned hair loss in whom DHT-blockers, such as Propecia (finasteride) and Avodart (dutasteride), have proven to be a potent remedy.

Given this, it was surprising that none of the 285 women in the study who had been treated with testosterone reported any hair loss after one year. In fact, of the 76 women who initially reported hair loss before the study, 63% reported positive hair regrowth at one year.

The researchers noted that patients with a “significantly higher body mass index (BMI)” were in the subset of those who did not regrow any hair. This suggests that a higher dose might be needed in some patients. ((Kapp N1, Abitbol JL2, Mathé H2, Scherrer B2, Guillard H2, Gainer E2, Ulmann A2. Effect of body weight and BMI on the efficacy of levonorgestrel emergency contraception. Contraceotion. 2015 Feb;91(2):97-104. doi: 10.1016/j.contraception.2014.11.001. Epub 2014 Nov 8.)), ((Lopez LM, Grimes DA, Chen M, Otterness C, Westhoff C, Edelman A, Helmerhorst FM. Hormonal contraceptives for contraception in overweight or obese women. Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD008452. DOI: 10.1002/14651858.CD008452.pub3)), ((Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, Gainer E, Ulmann A. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011 Oct;84(4):363-7. doi: 10.1016/j.contraception.2011.02.009. Epub 2011 Apr 2.))

Summary

By correlating higher levels of testosterone with more hair growth and/or retention in women, the study bolsters the idea that hair loss in men and women is caused by different mechanisms. Though not conclusive, the study opens the idea that testosterone implantation can effectively treat hair loss in women.

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International Journal of Trichology - Oct-Dec 2012

Research published in the International Journal of Trichology in 2012 found that the antiandrogen ((Alonso R, Prieto L, Hernandez C, Mas M. “Antiandrogenic effects of the pineal gland and melatonin in castrated and intact prepubertal male rats.” J Endocrinol. 1978 Oct; 79(1):77-83.)) and antioxidant ((Tan DX, Chen LD, Poeggeler B, Manchester LC, Reiter RJ. “Melatonin: A potent, endogenous hydroxyl radical scavenger.” Endocr J. 1993;1:57–60.)) properties of the hormone melatonin could be made into a topical solution for the treatment of early stage androgenetic alopecia, or common male and female pattern baldness. Four different study designs observed that daily application of the melatonin solution to the scalp reduced hair loss and, in some cases, caused new hair growth. ((Fischer, Tobias W et al. “Topical Melatonin for Treatment of Androgenetic Alopecia.” International Journal of Trichology 4.4 (2012): 236–245. PMC. Web. 25 Mar. 2015.))

Background

Melatonin is primarily known as a neurohormone that is produced in the brain’s pineal gland and is involved in regulating the body’s physiological response to natural cycles of light and darkness, called circadian rhythms. ((Lerner AB, Case JD, Takahashi Y. “Isolation of melatonin, a pineal factor that lightens melanocytes.” J Am Chem Soc.1958;80:2587.)) More recent research showed that not only is melatonin produced by other organs, including the skin, ((Slominski A, Pisarchik A, Semak I, Sweatman T, et al. “Serotoninergic and melatoninergic systems are fully expressed in human skin.” FASEB J. 2002 Jun;16 (8):896-8. Epub 2002 Apr 23.)) but melatonin is produced by, and melatonin receptors are found in, hair follicles. ((Fischer TW, Slominski A, Tobin DJ, Paus R. Melatonin and the hair follicle. J Pineal Res. 2008 Jan; 44(1):1-15.)), ((Fischer TW. “The influence of melatonin on hair physiology.” Hautarzt. 2009 Dec; 60(12):962-72.)), ((Kobayashi H, Kromminga A, Dunlop TW, et al. “A role of melatonin in neuroectodermal-mesodermal interactions: the hair follicle synthesizes melatonin and expresses functional melatonin receptors.” FASEB J. 2005 Oct; 19(12):1710-2.)) In year 2000, a low dose of melatonin was found to stimulate hair follicle growth in a laboratory setting. ((Fischer TW, Fischer A, Knöll B, Hipler UC, Elsner P. “Melatonin in low doses enhances in vitro human hair follicle proliferation and inhibits hair growth in high doses.” Arch Derm Res. 2000;292:147.))

In the 2012 study commissioned by ASATONA AG; out of Zug, Switzerland; a solution consisting of a 0.0033% concentration of melatonin, along with the antioxidant ginkgo biloba and important micronutrient biotin, was tested for its efficacy in slowing hair loss and its safety and tolerability. This was the first attempt to confirm the in vitro year 2000 findings in a clinical setting.

Findings

From January 2003 to October 2006 the melatonin solution was subjected to five rounds of testing, each with a different study design. The first study tested the safety of the solution in a double-blind, placebo-controlled cross-over study on four fertile and four postmenopausal healthy women. This test found a slightly elevated, but not significantly different, serum melatonin level after 14 days of treatment compared to placebo. There were no safety or health impacts of the treatments.

The second phase of the study found a significant reduction in severity of hair loss in 30 patients with early hair loss after 30 days of treatment, with a further significant drop after 90 days. The importance of the study is limited, however, due to the fact that there was no placebo employed to act as a study control. Also, the results were, in part, obtained through subjective questionnaires completed by the patients.

Phase three was a more reliable and objective open-label, clinically controlled study involving 35 men with androgenetic alopecia. In this study, researchers used TrichoScan, a sensitive software and hardware package that uses epiluminescence to measure hair loss. Hair density was found to increase in over half of the subjects. The average increase in density was 29% after three months and 41% at six months.

In study four, hair stylists at four salons performed a standardized before-and-after comparison on 40 male and 20 female patients with early stage hair loss who applied the treatment for 90 days. Female patients experienced significant reductions after 40 days and further significant reduction after another 40 days. Hair loss in the male patients was stable throughout the treatment.

Study five was a large-scale, open-label, multi-center study involving 1891 female and male patients with early stage androgenetic alopecia. After 90 days of treatment, the proportion of patients with a positive hair pull test (which indicates ongoing hair loss) fell from 61.6% to 7.8%. Negative hair pull tests, which indicate no hair loss, rose from 12.2% to 61.5% in the same period. Using standardized examination forms, investigators found significantly reduced hair loss in two-thirds of patients. New hair growth was measured in 22.5% of patients. Further, the proportion of patients with moderate to severe presentation of the skin condition seborrhea dropped by over 30%.

Summary

Topical application of the solution containing melatonin, ginkgo biloba and biotin was found to reduce hair loss, and in some cases grow new hair. Incidence of seborrhea was also reduced by the treatment. While the exact mechanism for this result is unknown, if effective, it is likely related to the antioxidative effect of melatonin and/or a melatonin receptor-mediated antiandrogenic effects. More research on melatonin needs to be conducted, but this study acts as a proof of concept for the use of melatonin as a treatment for early hair loss in men and women and potentially as a treatment for seborrhea. Currently, only two medications are approved by the Food and Drug Administration (FDA) for the treatment of hair loss, finasteride and minoxidil, and so the addition of a third type of medical treatment might be beneficial for patients who are not indicated for those drugs or would prefer an alternative treatment.

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Since 1993, minoxidil has been the most successful topical treatment for hair loss in both men and women, yet its exact mechanism of action remains unknown.

A 2004 review of minoxidil’s possible mechanisms of action ((Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004;150(2):186-94.)) suggests that the best evidence supports the idea that minoxidil causes hair follicles in the later phases of their resting phase (telogen) to shift prematurely into an active growth phase (anagen) sooner than they otherwise would; this causes a rapid increase in hair growth. They also found good evidence that minoxidil works to thicken the hair by increasing hair diameter.

While minoxidil’s effects on other critical factors known to affect hair growth — such as cell proliferation, collagen synthesis, vascular endothelial growth factor and prostaglandin synthesis — remain uncertain, more recent research has found evidence that it may also suppress the androgen-androgen receptor responsible for androgenetic alopecia. ((Hsu CL, Liu JS, Lin AC, Yang CH, Chung WH, Wu WG. Minoxidil may suppress androgen receptor-related functions. Oncotarget. 2014;5(8):2187-97.))

Understanding minoxidil’s exact mechanism of action remains today an important line of research both for the development of better hair loss treatments and for a better understanding of the biology of hair growth.

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Progress towards hair cloning may have just have shifted up another gear thanks to scientists at the University of Pennsylvania and the New Jersey Institute of Technology. The breakthrough study published January 28th, 2014 is the first to show the successful transformation of adult human skin cells into quantities of epithelial stem cells necessary for hair regeneration.

The researchers, led by Dr. Xiaowei “George” Xu, started with human skin cells called dermal fibroblasts, then transformed those into a type of stem cell called induced pluripotent stem cells (iPSCs). These were then transformed into epithelial stem cells (EpSCs). This important step had never been achieved before in either humans or mice. The epithelial stem cells were combined with mouse dermal cells, that can be induced to form hair follicles, and then grafted on a mouse host. The epithelial cells and dermal cells then grew to form a functional human epidermis and follicles structurally similar to human hair follicles. The exhibits that accompany the study include photographic evidence of human hairs.

Figure 5 - Generation of folliculogenic human epithelial stem cells from induced pluripotent stem cellsHair shafts (arrowheads) formed by induced pluripotent stem cell-derived epithelial stem cells compared to mouse hair (arrows). — Credit: Ruifeng Yang, Perelman School of Medicine, University of Pennsylvania

The main breakthrough in the study came when the research team carefully timed the addition of growth factors to the iPSCs. Previous research showed the ability for iPSCs to be transformed into a common type of cell found in the skin called keratinocytes. By timing the addition of the growth factors, they were able to turn over 25% of the iPSCs into epithelial stem cells in a little more than two weeks. This “mass production” of epithelial stem cells holds tremendous promise for the development of a hair regeneration treatment. On this development, Dr. Xu said, “This is the first time anyone has made scalable amounts of epithelial stem cells that are capable of generating the epithelial component of hair follicles.”

As noted in a University of Pennsylvania press release on the news, there are two types of stem cell that are critical in hair follicles: epithelial stem cells and dermal papillae. While this study only achieved success in the creation of epithelial stem cells, we have extensively covered Dr. Angela Christiano’s ground-breaking research into the induction of dermal papillae into hair follicles (a process she calls hair follicle neogenesis).

“When a person loses hair, they lose both types of cells. We have solved one major problem, the epithelial component of the hair follicle. We need to figure out a way to also make new dermal papillae cells, and no one has figured that part out yet,” said Dr. Xu.

Once that it is done, we must also find a way to have the epithelial and dermal components of the follicle interact before one will be able to produce cosmetically useful hair. But with each successive breakthrough, the time when a scientist can use hair cloning techniques to regenerate human hair, and the surgeon can implant them into a person’s scalp, draws ever closer.

Reference
Yang R, Zheng Y, Xu X. Generation of folliculogenic human epithelial stem cells from induced pluripotent stem cells. Nature Communications. 2014.

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Crown Balding and Heart Disease Linked in British Medical Journal Study

A new meta-analysis of six studies, published in the British medical journal BMJ Open, has found a linkage between balding at the crown and coronary heart disease. While the top-line result of the study may be alarming, let us look first at some of the key facts.

  • While the study showed a modest link between crown balding and heart disease, the link was not as strong as for other heart disease indicators such as smoking, obesity, cholesterol levels and blood pressure.
  • There was no link established for men with a receding hair line.
  • Key indicators of heart disease — high blood pressure, high LDL cholesterol, and smoking — are present in about half of Americans, according to the Center for Disease Control in America. So this is a health issue faced by many Americans, hair loss or not.
  • Importantly, the most appropriate response if you have balding at the crown (and particularly crown balding at an early age), is not to worry first and foremost about your hair, but to concentrate on basic heart health and maintaining a healthy lifestyle. Discuss these issues and any concerns with your primary care physician.

Researchers at the University of Tokyo in Japan compiled information from six different studies with a combined total of almost 37,000 male participants. The studies were published between 1993 and 2008. Although one of the six studies did not find a link between baldness and coronary heart disease, the other five studies did find a link with the strength of the association differing in each study. In general, the more severe the balding at the crown, the more likely there was an association with heart disease. In addition, early onset of vertex balding — i.e. early balding at the crown — was found to be associated with the early development of more significant heart disease.

More research needs to be done to investigate the actual medical causes of the linkages shown.

An article on the BBC News website quotes a cardiac nurse from the British Heart Foundation discussing the findings:

“Although these findings are interesting, men who’ve lost their hair should not be alarmed by this analysis. Much more research is needed to confirm any link between male pattern baldness and an increased risk of coronary heart disease. In the meantime, it’s more important to pay attention to your waistline than your hairline.”

Image c/o BBC online

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A study of Australian men between the ages of 40 and 69 suggests that men who were mostly bald by the age of 40 were more likely to develop prostate cancer in their 50s or 60s. The Melbourne Collaborative Cohort study of about 10,000 men showed that men who have high levels of testosterone may be more vulnerable to cancerous prostate tumors.

The team of scientists that conducted the long-term study, which was published in the journal Cancer Epidemiology, Biomarkers and Prevention, reported that both baldness and prostate cancer are age-related and androgen dependent conditions, so these findings are not surprising. The statement said, “We found that baldness at the age of 40 might be a marker of increased risk of prostate cancer.”

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Q: As a Propecia user, I was alarmed when I read headlines last year about a new study indicating very high rates of depression and erectile dysfunction caused by Propecia, with symptoms persisting even after the drug was stopped. However, when I read the articles, this “study” appeared to be survey of 61 men who had taken Propecia and already reported sexual problems who were then asked about symptoms of depression. These rates of depression were compared to a small survey of men who had hair loss but had never taken Propecia.

Anyone with a basic understanding of statistics would know such a survey was deeply flawed. First, it is a textbook example of a bad data sample — to get sound results you have to start with an unbiased and random group of people who took the drug, not a self-selected group of men already suffering symptoms. The study also confuses correlation with causation — because these men are suffering from ED or depression does not necessarily mean it was caused by the drug. Am I missing something here, or did the media just report these “findings” with no scrutiny on what was actually studied? — Jonathan, Brooklyn, NY

A: Jonathan, I think you’re right on the mark. The way the study was conducted raises a lot of concern about the accuracy of the findings. It is really important that additional data is obtained in a controlled way, as this will be most useful for physicians in advising patients. I addressed concern on these reports last year. The issue of persistent sexual dysfunction as a side-effect of finasteride (Post-Finasteride Syndrome) is an on-going issue that we take very seriously. I sit on the International Society of Hair Restoration Surgery (ISHRS) Task Force on Finasteride Adverse Events, so this is an issue that we watch very closely.

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Q: I have heard that side effects from finasteride can persist even after stopping the medication. What is the most current information on this issue? — S.V., Short Hills, N.J.

A: For the past two years I have been on the International Society for Hair Restoration Surgery (ISHRS) Task Force on Finasteride Adverse Events and struggling to make sense of this issue. There seems to be a disconnect between the relatively low incidence of side effects that we, as physicians, see in our practices, what published controlled studies have shown, and what is now being reported on the internet and in some instances in the media. For example, a 2012 study by Sato of 3,177 Japanese men published the Journal of Dermatology, showed a 0.7% incidence of adverse reactions to finasteride 1mg and no persistent side effects after stopping the medication.

That said, there has been a recent increase in anecdotal reports of side effects from finasteride as well as reports of persistent side effects after the medication has been discontinued (referred to as “Post-finasteride Syndrome”).

The FDA

Based on post-marketing reports of sexual dysfunction, in April 2012, the FDA announced changes to Propecia (finasteride 1 mg) labeling to expand the list of sexual adverse events and that some of these events had been reported to continue after the drug is no longer being used. It is important to note that no new clinical studies were reviewed to evaluate these adverse events and that the FDA is not aware of any additional controlled clinical studies conducted to evaluate these adverse events or to determine their cause or duration. (see FDA Label Changes for Finasteride 2012)

The FDA states that despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs. The FDA states that it believes that finasteride remains a safe and effective drug for its approved indications, but also advises that healthcare professionals and patients should consider this new label information when deciding the best treatment option.

The difficulty with interpreting anecdotal information is significant. The following need to be considered; first, sexual dysfunction, both temporary and persistent, is quite common in the general population and patients may have new-onset sexual dysfunction from some other, unrelated, cause and second, patients may have real (physiologic) side effects from the medication and then have psychological after effects. It is so difficult to sort these factors out.

The ISHRS

The Finasteride Symposium at the 2012 ISHRS, of which I was a panelist, explored safety issues with finasteride. Dr. Akio Sato presented his data (quoted above) suggesting that finasteride side effects are uncommon and that persistent side effects were not seen. Dr. Freedland, a urologist and featured guest speaker at the ISHRS symposium, questioned whether long-term effects of a slight elevation in estrogen levels could have adverse effects on the prostate. The panel discussed the paper of Dr. Michael Irwig at George Washington University that appeared in The Journal of Sexual Medicine this year. In his survey of 54 patients of men who had persistent sexual side effects three or more months after the discontinuation of finasteride, he reported that sexual dysfunction continued for many months or years in the majority of the patients.

Difficulties in interpreting this study are that it assumed that the patient’s sexual dysfunction were caused by finasteride when, in fact, there is no way of knowing that finasteride was the actual cause of the side effects (this would need a blinded, placebo-controlled study). A second reason that makes interpretation difficult is that, because there was selection bias in the Irwig survey, there is no way of knowing if these patients are representative of the population of men on finasteride. That said, the data presented by Dr. Irwig stresses the importance of having more clarity on the potential side effects of finasteride, since it is so widely prescribed.

It was clear from the presentations and questions asked, that many issues are still unresolved. All in attendance agreed that further research is urgently needed. In the short term, it is most important that all patients who are having problems can have easy access to doctors with expertise in this area, so that they can be diagnosed properly and treated.

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Q: Dr. Bernstein, I am an attending at Mass General Hospital in Boston and would like to ask you regarding your experiences using finasteride for male androgenetic alopecia. While I have not noticed any side effects in the patients that I have been treating, I increasingly get questions regarding side effects based on the recent media attention to reports of potentially permanent problems regarding libido or erectile dysfunction. I know that in the literature there is a slight increase of reversible sexual dysfunction (~4% vs. ~2% in placebo) with Propecia, and no convincing evidence to date in the medical literature that have used controlled studies regarding permanent problems even after discontinuing Propecia. — S.Z., Boston, Massachusetts

A: That is correct.

Q: I know that you have treated many patients over a long period of time, and I was thus wondering what your take is on potentially permanent sexual dysfunction after taking finasteride. Have you seen any convincing reports/patients or do you have any concerns regarding irreversible side effects?

A: I have seen 5 cases in over 10,000 patients on finasteride that complained of this but, of course, there is no way to know for sure if there is a cause and effect relationship. As you know, real side effects may be followed by psychological ones and if the sexual dysfunction has another cause, then stopping finasteride would have no effect on the symptoms. The incidence of intermittent or persistent sexual dysfunction in the general population of men is about 30%, so one would expect these numbers to be much higher just due to the normal incidence. It is really a difficult situation to understand. The experience that my colleagues and I have in our practices is much different than one would expect after reading the numerous anecdotal reports on the internet.

Q: Would you think it is safe to say that any potential sexual dysfunction is reversible after discontinuing the use of finasteride?

A: I don’t think that anyone knows at this point. The FDA is coming down on the side of caution and saying that it is possible, although it is not based on any new studies. If the phenomenon is real, the possible mechanism is not yet known.

Q: In the relatively few patients that I have treated with Propecia, they did not even report temporary problems regarding libido or erectile dysfunction. Do you think they are real or rather attributed to Propecia simply because the patient is made aware of these potential side effects?

A: I think that psychological effects may account for many cases. At this time, it is still not clear if a physiologic “post-finasteride syndrome” is real. A lot more work needs to be done before we have a definitive answer to this question.

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Japanese Researchers Bioengineer Hair Follicles from Stem Cells, Dermal PapillaeCredit: Tokyo University of Science

Japanese researchers have demonstrated that scientists can bioengineer viable, hair-producing follicles from epithelial stem cells and dermal papilla cells. Using these components, the team produced follicles that exhibit both the normal hair cycle and piloerection (the reflex contraction of a tiny muscle in the hair follicles which creates what is commonly referred to as “goose bumps”). The bioengineered follicles also developed the normal structures found within follicles and formed natural connections with skin tissues, muscle cells, and nerve cells.

The scientists used a breakthrough type of hair multiplication to achieve a functional bioengineered hair follicle. In hair multiplication, germinative cells are harvested non-surgically and then multiplied outside the body in a laboratory. These cells are then injected into the skin where they, ideally, grow into hair follicles. The Japanese research team takes this concept one step further by first combining the stem cells and dermal papillae in the laboratory to create a germ of the hair follicle. This germ is then implanted into the scalp where it grows into a viable hair follicle.

The study opens the door to treat common baldness (androgenetic alopecia) and a host of other medical conditions that can cause hair loss.

View the Hair Cloning section to read more on hair multiplication and hair cloning methods.

Reference:

Koh-ei Toyoshima, Kyosuke Asakawa, Naoko Ishibashi, Hiroshi Toki, Miho Ogawa, Tomoko Hasegawa, Tarou Irié, Tetsuhiko Tachikawa, Akio Sato, Akira Takeda, Takashi Tsuji. Fully functional hair follicle regeneration through the rearrangement of stem cells and their niches. Nature Communications, 2012; 3: 784 DOI: 10.1038/ncomms1784

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Could it be that Vitamin D is the cure for baldness that scientists have been looking for all these years? New research on Vitamin D, and its receptors in hair follicles, has taken us down a previously untrodden path that could, potentially, lead to new medical treatments for hair loss.

The Vitamin D receptor was previously known to stimulate hair follicles, which were in the dormant phase of hair growth, to grow hair when activated. The research into Vitamin D and its effect on hair and skin, centers around this receptor.

One group of researchers — based in San Francisco, California — has discovered that a molecule, called MED, suppresses the Vitamin D receptor, thereby preventing the follicle from growing a new hair. Their research in mice found that blocking the MED molecule allowed mice to grow more hair. A second research team, from Harvard Medical School, has found a molecule that activates the receptor. However, they have been unable to use the molecule to grow new hair.

A third research group, based in Japan, used Vitamin D to stimulate stem cells to become hair-producing follicles in rats. Dr. Kotaro Yoshimura says of the study, “The results suggest that it may be useful in expanding human [dermal papilla cells (DPCs)] with good quality, and help establish a DPC transplantation therapy for growing hair.” His colleague on the study, Dr. Noriyuki Aoi, said, “We found that treating the dermal papilla cells with [Vitamin D] significantly enhanced the growth of new hair over that of the control group. We also observed a better rate of maturation of the follicles. In other words, the hair grew thicker and lasted longer.”

While the third group appears to be the closest to achieving hair growth from a Vitamin D-based treatment, viable treatments in humans are still many years away. As we have indicated in other posts on the Hair Transplant Blog, there is a great deal of ongoing medical research into the causes and treatment of hair loss. The way the field has progressed over the last 5 years it seems to be just a matter of when, not if, a cure for baldness is available to the public.

Read more about ongoing medical research on the causes of and treatments for hair loss

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Led by Dr. A. Sato, a Japanese team of medical researchers published the largest finasteride study ever performed, “Evaluation of efficacy and safety of finasteride 1mg in 3,177 Japanese men with androgenetic alopecia.” It investigated the effects of finasteride over a 3 1/2 year period in men with androgenetic alopecia, or common baldness.

The study found that patients who had experienced hair loss for an extended period of time and were treated with finasteride exhibited notable hair growth. While a fairly small proportion of patients with a hair loss duration over 10 years exhibited “greatly increased” growth, 85% of patients with hair loss duration of more than 15 years experienced “moderate” or “slightly increased” growth. Physicians have thought that people with advanced hair loss do not respond as well as patients in the early stages of hair loss. However, in light of the results of this study, that determination should be reconsidered.

Further, the same study found that the initial age of a hair loss patient at the time of commencing treatment has little to no effect on the outcome. While the efficacy studies that are included in the Propecia package insert were conducted in men 18 to 41 years old, men over 41 appear to respond as well as the younger group. Adverse reactions occurred in only 0.7% of the study population and the Sato study found no increase in adverse safety events over time.

In summary, the Sato study showed an increased response rate to finasteride 1mg with increasing duration of treatment. In addition, it is effective in a larger portion of the male population with androgenetic alopecia than previously thought.

Reference:

Sato A, Takeda A. Evaluation of efficacy and safety of finasteride 1mg in 3,177 Japanese men with androgenetic alopecia. J Dermatol 2012; 39: 27–32.

Download the Sato study on finasteride

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RepliCel Life Sciences; a company out of Vancouver, Canada; is studying the use of hair cloning techniques to treat male pattern baldness and hair loss in women.

The study is in progress, but analysis of the 6-month interim results of the first phases has been published. The preliminary results at 6 months show that almost two-thirds of subjects (10 out of 16, or 63%) received a greater than 5% increase in hair density at the injection site. Of that group of 10 subjects, seven of them saw hair density improve by more than 10%. In one subject vellus hair density increased 24.9%, terminal hair density increased 14.5%, overall hair density increased by 19.2%, and cumulative thickness per area increased by 15.4%. There were no significant adverse safety events reported in the first 6 months of the trial.

Phase I/IIa of the RepliCel study involved injecting male and female subjects with their own (autologous) dermal sheath cup cells (DSCC), which were replicated or cloned using RepliCel’s laboratory technology. A preliminary analysis of the safety of the injections, as well as a preliminary analysis of the efficacy of the treatment in growing hair, was announced in May 2012 and presented to the European Hair Research Society in June 2012. Subjects in this part of the study will continue to be monitored for any adverse physical reactions and to assess hair growth at 12 months and 24 months after treatment.

Phase IIb of the study is designed to help the RepliCel researchers formulate the optimal treatment for hair growth. Some of the treatment regimens that will be tested include the use of different concentrations of cells and different treatment schedules, plus the effects of single injections versus repeat injections. The final protocols for Phase IIb are currently being worked out, with the clinical trial expected to begin in late 2012.

Reference:

Lortkipanidze, N. Safety and Efficacy Study of Human Autologous Hair Follicle Cells to Treat Androgenetic Alopecia. In Clinicaltrials.gov. Retrieved July 26, 2012, from http://clinicaltrials.gov/ct2/show/NCT01286649.

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In what might be another illuminating discovery on the inner-workings of hair growth, Yale University scientists have discovered that cells from the fat layer in the skin of mice contribute to the stimulation of hair follicles.

An article by ABC News quotes the lead researcher, Valerie Horsley, saying, “The fat cells are important for hair growth. If they’re not there, the hair won’t grow. We don’t know for sure if it’s a cure for baldness, but I’m hopeful that we can get human cells to do the same as the mice cells.”

Dr. Bernstein, who was interviewed for the article, called the findings, “an interesting development in understanding why millions of people go bald.”

“It’s an important step. Mice models are not necessarily applicable to humans, but this is how we start to make discoveries,” he said.

Bernstein noted that the study’s findings don’t [directly] address genetic hair loss, in which a hormone called DHT causes hair follicles to shrink.

Dr. Horsley suggested that the next round of research should focus on finding out what cells are being effected by the fat cells, and why. She said, ”It’s very exciting because we really knew nothing about the fat in the skin. I’m hoping we can extend the research.”

Read more about research into the causes and mechanisms around hair loss in posts assigned to the tag “Stem Cells.”

Read the original article at ABCNews.com

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Q: Have there been any lab studies proving that Saw Palmetto works to prevent hair loss? — A.B., Yonkers, NY

A: There have been no verifiable clinical studies that show saw palmetto can stop hair loss or cause hair to re-grow. There have been some preliminary tests showing that saw palmetto may be able to inhibit 5-alpha-reductase, but its usefulness for androgenetic hair loss has not been documented in controlled studies.

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Following some new research on stem cells, and their relationship with androgenetic alopecia (genetic hair loss), an article on stem cells and the way they organize hair growth was published in the April 29th issue of the journal Science.

At issue is not the conversion of hair follicle stem cells into the progenitor cells that stimulate hair growth, as with the prior research, but the ways in which large numbers of stem cells coordinate the cycle of hair growth over thousands of hair follicles. How do all of those hair follicle stem cells know when to grow hair, and how do they know what their “neighbor” hair follicles are doing?

The researchers studied hair growth patterns in rabbits and mice and discovered that certain types of molecules, which were previously known to act as a signaling mechanism for stem cells in maintaining an individual hair follicle’s growth cycle, were also important in enabling large groups of stem cells to coordinate their activity.

The scientists found that hair stem cells coordinate their regeneration with each other with the aid of a pair of molecular activator WNT and inhibitor BMP. When WNT and BMP signals are used repetitively among a population of thousands of hair follicles across the entire skin surface, complex regenerative hair growth behavior emerges via the process of self-organization.

Perhaps more importantly, they found that the stem cell communication pathway present in rabbits and mice is far more robust than in men and women.

“When each human hair follicle wants to regenerate, it can only count on itself; it’s not getting help from other follicles,” Chuong said. “But when a rabbit hair follicle regenerates, it can count on two inputs: its own activation, and the activation signal from its neighbors. Rabbits have a very active hair growth, and that is essential for their survival in the wild.”

The article suggests that if there was a way to manage that process in humans, or “turn back on” the stem cell communication process in human hair follicles, then a treatment could be developed which would substantially increase the number of hair follicles that produce healthy hair.

Read a summary of this new research at ScienceDaily.com.

For more discussion on recent research, visit the Hair Cloning topic.

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Robert M. Bernstein, M.D., F.A.A.D., Renowned Hair Transplant Surgeon and Founder of Bernstein Medical – Center for Hair Restoration in New York, is Studying Four Applications of ACell MatriStem™ Extracellular Matrix in a Type of Hair Cloning, Called Hair Multiplication, as well as in Current Hair Restoration Procedures.

New York, NY (PRWEB) March 15, 2011 – Robert M. Bernstein, M.D., F.A.A.D., Clinical Professor of Dermatology at Columbia University in New York and founder of Bernstein Medical – Center for Hair Restoration, has been granted approval by the Western Institutional Review Board (WIRB) to study four different applications of the ACell MatriStem extracellular matrix (ECM) in hair restoration.

Hair Cloning with ACell MatriStemHair Cloningwith ACell MatriStem

Two of the studies include its use in a type of hair cloning, called hair multiplication, where plucked hairs and transected follicular units are induced to generate new hair-producing follicles. The other two areas of study include evaluating the use of the ECM in current hair transplant procedures to enhance hair growth and facilitate wound healing.

Approval by the WIRB allows the researchers to conduct double-blinded, bilateral controlled studies. Controlled studies are the best way to increase the objectivity of the research and insure the validity of the results.

“The medical research we are performing is important because it may lead to hair multiplication as a way to increase a person’s supply of donor hair. In this way, patients would no longer be limited in the amount of hair which can be used in a hair restoration procedure,” said Dr. Bernstein. “Additionally, in the near-term, the extracellular matrix may be able to improve the cosmetic benefit of current hair transplant procedures. We are simultaneously pushing the boundaries of hair cloning methods and follicular unit transplantation.”

Hair multiplication, a variation of what is popularly known as hair cloning, is a procedure where partial hair follicles are stimulated to form whole follicles. These parts can either be from hairs derived from plucking or from follicles which have been purposely cut into sections. Generally, damaged follicular units will stop growing hairs. However, there is anecdotal evidence that an extracellular matrix applied to partial follicles may stimulate whole follicles to grow and, when applied to wounds, may stimulate the body’s cells to heal the damaged tissue.

This new medical research also attempts to show that ACell can improve the healing of wounds created when follicular units are harvested for hair transplant surgery. Currently, in follicular unit hair transplant procedures, a linear scar results when a surgeon incises the patient’s scalp to harvest follicular units. Occasionally, this scar can be stretched, resulting in a less-than favorable cosmetic result. If ECM can induce the wound to heal more completely, the linear scar may be improved. The extracellular matrix may also benefit general hair growth in hair transplantation in that the sites where hair is transplanted, called recipient sites, can be primed with ECM to encourage healthy growth of the hair follicle.

Dr. Bernstein is known world-wide for pioneering the hair restoration procedures of follicular unit transplantation (FUT) and follicular unit extraction (FUE). Follicular units are the naturally-occurring groups of one to four hair follicles which make up scalp hair. These tiny structures are the components which are transplanted in follicular unit hair transplants.

While hair cloning has been of great interest to hair restoration physicians and sufferers of common genetic hair loss, the method by which this can be achieved has yet to be determined. The use of ACell’s extracellular matrix to generate follicles is a promising development in achieving this elusive goal. In addition to the longer term implications of using ECM in hair multiplication, its impact on hair restoration will be more immediate if it can be proven effective when used in current FUT procedures.

About Dr. Robert M. Bernstein:

Dr. Bernstein is a certified dermatologist and pioneer in the field of hair transplant surgery. His landmark medical publications have revolutionized hair transplantation and provide the foundation for techniques used by hair transplant surgeons across five continents. He is respected for his honest and ethical assessment of a patient’s treatment options, exceptional surgical skills, and keen aesthetic sense in hair transplantation. In addition to his many medical publications, Dr. Bernstein has appeared as a hair loss or hair transplantation expert on The Oprah Winfrey Show, The Dr. Oz Show, Good Morning America, The Today Show, The Discovery Channel, CBS News, Fox News, and National Public Radio; and he has been interviewed for articles in GQ Magazine, Men’s Health, Vogue, the New York Times, and others.

About Bernstein Medical – Center for Hair Restoration:

Bernstein Medical – Center for Hair Restoration is a state-of-the-art hair restoration facility and international referral center, located in midtown Manhattan, New York City. The center is dedicated to the diagnosis and treatment of hair loss in men and women. Hair transplant surgery, hair repair surgery, and eyebrow transplant surgery are performed using the follicular unit transplant (FUT) and follicular unit extraction (FUE) surgical hair restoration techniques.

Contact Bernstein Medical – Center for Hair Restoration:

If you are a journalist and would like to discuss this press release, please email us or call us today (212-826-2400) to schedule an appointment to speak with Dr. Bernstein.

View the press release at PRWeb.

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Sometimes an “accident” in the laboratory can lead to a remarkable breakthrough. Penicillin, Botox, Viagra, and Minoxidil — the active ingredient in Rogaine — were all unintended discoveries that led to treatments for a variety of conditions.

A similar twist of fate, this time by researchers at UCLA, could lead scientists to a new hair loss treatment.

Mice had been bred to overproduce a stress hormone that causes them to lose their hair. The scientists’ intention was to study the effects of a chemical compound, called astressin-B, on blocking the effects of stress on the mouse colon.

What they saw, however, surprised them. The mice that were treated with the chemical had fully regrown their hair. After repeating the results, the researchers injected the chemical into young mice, which were similarly genetically altered but had yet to lose their hair. Those mice never lost their hair despite the fact that they, too, were bred to overproduce the stress hormone.

Whether this discovery will lead to a drug that cures common baldness in human beings, or whether such a cure will only affect hair loss due to stress, is unknown at this early stage.

For further reading on this discovery, see articles in Dermatology Times and the New York Times, as well as the primary scientific publication in the journal PLoS ONE.

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Research published in the January 2011 issue of the Journal of Clinical Investigation (Vol. 121, issue 1) reveals another breakthrough in the medical community’s understanding of the causes of — and possible cure for — androgenetic alopecia, or common male pattern baldness. The new research shows that the presence of a certain type of cell, called progenitor cells, is significantly reduced in men with common baldness compared to men who are not bald.

An article on AOL, which calls these “faulty” stem cells the root of hair loss in men, sheds light on the findings:

Using cell samples from men having hair transplants, a team led by University of Pennsylvania dermatologist Dr. George Cotsarelis compared follicles from portions of bald scalp to follicles from scalp areas with hair.

They learned that on the same person, the bald patches had an equal number of stem cells as the patches with hair. But they did find a difference: the areas of bald scalp had a significantly lower number of a more mature type of cell, called a progenitor cell.

That finding suggests that stem cells in parts of the head without hair have malfunctioned, losing their ability to convert into progenitor cells. ((AOL, “Scientists Trace Root of Male Hair Loss to Faulty Stem Cells,” January 5th 2011))

The study showed that, contrary to conventional wisdom, it is not the total “number” of stem cells that causes hair loss. In fact, the scientists’ original hypothesis was that, “the miniaturization of the hair follicle seen in [androgenetic alopecia] may result from loss of hair follicle stem cells.” That hypothesis turned out to be inaccurate. Instead, the authors of the study indicate that the findings:

…Support the notion that a defect in conversion of hair follicle stem cells to progenitor cells plays a role in the pathogenesis of [androgenetic alopecia]. ((J Clin Invest. doi:10.1172/JCI44478.))

The study’s results suggest that further research into the mechanism for the conversion of hair follicle stem cells to progenitor cells is warranted. If scientists can devise a way to correct that mechanism, then, in theory, stem cells in men who are predisposed to have androgenetic alopecia can be converted to progenitor cells at a normal rate. That correction would, in theory, eliminate that person’s susceptibility to the hair follicle miniaturization which causes hair loss, and would effectively cure his male pattern baldness.

Progenitor Cells vs. Stem Cells

Compared to stem cells, progenitor cells are further along in the process of differentiating into their target tissue, in this case mature hair follicles. Whereas stem cells are pluripotent, meaning that they can differentiate into a number of types of cells, progenitor cells are already committed to a specific cell line. Another important difference between stem cells and progenitor cells is that stem cells can replicate indefinitely, whereas progenitor cells can only divide a limited number of times.

For further reading on this stem cells and the causes of hair loss, here are some links:

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Q: I heard about the Lgr5 gene being a breakthrough in hair cloning. What’s the latest on that?

A: Many scientists feel that adult stem cells house the answer to cloning (regeneration) of hair follicles. One of the problems of hair cloning, however, is that the cells, once duplicated, “forget” that they are hair follicle cells.

It has recently been discovered that the Lgr5 gene, located in stem cells, appears to contain the “global marker” present in all adult hair follicles. If Lgr5 gene is the “calling card” of the cell, it may carry the cell lineage and shoulder the responsibility of signaling to surrounding stem cells what they are actually supposed to do as they multiply.

Recent experiments have shown that these Lgr5 cells maintain the cells ability to differentiate as hair follicles after many generations of being multiplied in the test tube and, therefore, have the potential of serving as the building blocks of entire new hair follicles. The successful exploitation of this gene would eliminate a major barrier to cloning hair.

Reference
Haegebarth A, Clevers H: Wnt signaling, lgr5, and stem cells in the intestine and skin. Am J Pathol. 2009 Mar; 174(3):715-21.

For more on how hair cloning works, visit our page on hair cloning and multiplication.

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Q: Have there been any studies showing the difference between men and women in their response to laser treatments for hair loss?

A: In the International Journal of Cosmetic Surgery and Aesthetic Dermatology (Vol. 5, Number 2; 2003), a study on low level laser therapy (LLLT) was conducted which indicated that there was a 55% increase of growth (hair count) in the temporal area as well as 64% in the vertex of the female subjects who were treated with LLLT for hair loss. The study also indicated a 74% increase in the hair counts of the male subjects in the temporal area and 120% in the vertex region. These results would initially indicate that LLLT works better in men than in women, but there were four times as many men in this study so the results might be different in a larger test group.

However, even in this notably smaller female group, the tensile strength of the hair increased dramatically over the tensile strength observed in the male subjects after treatment. This would indicate that, at least in this study, there was not only an increased hair count in women, but the tensile strength of that hair was greatly improved as well. This would be initially indicative that LLLT may be found to be more beneficial to women than to men.

It is important to note that this study was published in 2003. Further studies need to be conducted to confirm the initial results and to further elucidate the possible mechanisms of low level laser light therapy in both men and women with alopecia. As important, long term data needs to be accumulated to show the continued efficacy of this treatment. It had been our clinical experience that LLLT is not as effective as one would assume from the results of the initial studies.

Visit the page on Laser Therapy for more information, or read more answers to questions about laser therapy.

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The advantage of using embryonic stem cells in cloning research, organ transplantation, and in finding cures for disease, is that these cells are basically “unprogrammed.” This means that the stem cell has not yet determined what it will grow to become so, in theory at least, scientists can manipulate them into becoming anything that they are programmed to be.

Two teams of scientists working independently (Kazutoshi Takahashi and Shinya Yamanaka at Kyoto University, Japan and James Thompson’s team at the University of Wisconsin) announced that they had successfully replicated the biological abilities of the embryonic stem cell using only skin cells. Called “induced pluripotent stem cells” these former skin cells were programmed to become other types of cells, acting in the same way as the embryonic stem cells.

This transformation was accomplished by introducing four basic genes into skin cells, via a viral carrier. These genes cause the adult skin cells to revert and become the equivalent of embryonic stem cells. The breakthrough is in the ability to “unprogram” skin cells so that they revert to cells that have the same response and abilities as embryonic stem cells.

The debate regarding embryonic stem cells has been focused on the harvesting of the cells. A fertilized embryonic egg is allowed to mature until it formed blastocysts. These blastocysts contain the newly formed stem cells. When these stem cells are removed, the embryo is destroyed. If skin cells can be successfully converted to stem cells, this could negate the ethical questions of the use of embryonic stem cells and produce a large amount of readily available stem cells for research.

Caution must be taken with this new technology. For example, one of the genes used to unprogram the skin cells is carcinogenic (cancer-causing).

Research must also be done to verify that these reprogrammed cells don’t have subtle differences between themselves and true embryonic stem cells.

Although the ability to “unprogram” skin cells to form pluripotent stem cells is a significant breakthrough, it is important to stress that this is still a research tool and it will take quite some time before it is known if these cells can truly substitute for stem cells in the treatment of disease.

References:

Kazutoshi T, Tanabe K, Ohnuki M, Narita M, Ichisaka T, Tomoda K, Yamanaka S: Induction of Pluripotent Stem Cells from Adult Human Fibroblasts by Defined Factors: Cell (2007), 131, 1-12.

Kolata G, Scientists Bypass Need for Embryo to Get Stem Cells, New York Times, 2007; A-21:23.

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Dermatologic Surgery - January 2000 Vol26 Issue1The innovations Dr. Bernstein has described through his medical publications are now a part of history. In the Millennium Paper of the journal Dermatologic Surgery, a comprehensive history of the field of dermatologic surgery cites Dr. Bernstein as being one of the three physicians who played a leading role in hair transplantation in the 1980′s and 1990′s.

“Millennium Paper: A History of Dermatologic Surgery in the United States,” draws on research and papers authored over the past 100 years to develop a timeline of the most important advances. The article appears in the January 2000 issue of Dermatologic Surgery (Volume 26, Issue 1).

Dr. Bernstein’s 1995 publication ‘Follicular Transplantation’ was the first to describe the use of naturally-occurring follicular units as the basis for surgical hair restoration. This paper and others have secured Dr. Bernstein’s place in the “long and distinguished history” of cutaneous surgery.

Reference
Millennium Paper: A History of Dermatologic Surgery in the United States. Dermatologic Surgery 2000; 26(1): 5-11.

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