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Research and developments about the medical treatment for hair loss and related topics.

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. 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.

A review of research on the efficacy of Viviscal, published in the September 2015 issue of the Journal of Drugs in Dermatology, suggests that the oral supplement may increase hair volume as well as the thickness of healthy, terminal hairs. The article presented more than two decades of research on the hair regrowth product and also included a discussion with a roundtable of dermatology and plastic surgery experts. Both the research review and roundtable discussion point to the benefits of Viviscal, however the article’s conclusions can be questioned due to the appearance of a conflict of interest between the researchers and Lifes2good, Inc., the company that produces Viviscal. Additional independent research needs to determine if Viviscal is a viable and effective hair loss treatment.

International Journal of Trichology - Oct-Dec 2012Topical 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.

A new 4-year study, published in the journal European Urology, found that men who take dutasteride (part of a class of medications called 5-alpha reductase inhibitors) and who also drink heavily (more than seven alcoholic drinks per week) have a greater risk of developing high-grade prostate cancer than men who take dutasteride and do not drink.

Hair loss caused by androgenetic alopecia can be stopped by existing medications, but to date, only two FDA-approved drugs are available for treatment of AGA: finasteride (Proscar ®) and topical minoxidil (Rogaine®). Unfortunately, up to 3 out of 10 individuals will not respond to one or more of these drugs. Because of this, researchers have searched for alternate treatments, especially for women since finasteride is not approved for use in female patients.

Could the 5α-reductase inhibitors (5ARIs) dutasteride and finasteride increase the risk of developing male breast cancer? A 2013 study published in the Journal of Urology found no evidence for a link between 5ARIs and male breast cancer.

Could a recently FDA-approved drug for rheumatoid arthritis also be a cure for a common type of hair loss called alopecia areata? The drug is called Xeljanz, and that’s what Dr. Brett King, assistant professor of dermatology at Yale, is hoping.

Recent news reports, coupled with warnings from Merck and the FDA, about Propecia’s possible persistent sexual side effects have caused growing concern about this popular hair loss treatment. An increasing number of men now fear that Propecia (finasteride 1mg) will cause permanent sexual dysfunction.

A 2014 meta-analysis, however, found that the number of self-reported cases of persistent sexual dysfunction by patients given finasteride was statistically no different from the number reported by patients given a placebo.

This latest research supports the conclusion of existing literature that there is no correlation between finasteride use and persistent or permanent sexual dysfunction. That said, this is an important issue that still needs to be studied.

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 (A.G. Messenger & J. Rundegren, 2004) 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 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 (Cheng-Lung Hsu, Jai-Shin Liu,An-Chi Lin, Chih-Hsun Yang, Wen-Hung Chung, & Wen-Guey Wu, 2014).

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.

The results of an 18-year study, just published in the New England Journal of Medicine, showed that finasteride does not increase the likelihood of death from prostate cancer in men who take the drug. Early results from the same study had suggested that finasteride might increase the risk of developing higher grade tumors; however, follow-up results from the long-term study show that men taking the drug do not have an increased risk.

The central finding of a 2004 study led by Italian researcher Dr. Antonella Tosti, in which he and his team investigated sexual dysfunction in hair loss patients being treated for androgenetic alopecia, was that there was no statistically significant change in sexual function after four to six months of treatment with finasteride 1mg (Propecia).

Interestingly, the research team found that sexual side effects were actually less common than reported in the clinical trials of the drug.

The 2011 study published by a research team led by Dr. Alfredo Rossi, is the first comprehensive investigation on long-term safety and efficacy of finasteride 1mg (Propecia).

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. Continue reading this article.

On April 11, 2012, the U.S. Food and Drug Administration (FDA) announced changes to the professional labels for Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) to expand the list of sexual adverse events reported to FDA as some of these events have been reported to continue after the drug is no longer being used (note that erectile dysfunction after stopping use of these drugs was added as a known event in 2011). The new label changes include:

  • A revision to the Propecia label to include libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.
  • A revision to the Proscar label to include decreased libido that continued after discontinuation of the drug.
  • A revision to both the Propecia and Proscar labels to include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation.

Journal of the American Academy of DermatologyA double-blind scientific study published in the May 2012 issue of the Journal of the American Academy of Dermatology has found that latanoprost, a drug that mimics naturally-derived compound molecules called prostaglandins, significantly increases hair density on the scalp after 24 weeks of treatment in young men with mild hair loss.

Journal of the American Academy of DermatologyLatisse, which is the brand name for the drug bimatoprost, has been found to effectively and safely grow eyelashes in a double-blinded scientific study published in the May 2012 issue of the Journal of the American Academy of Dermatology.

Synopsis: Topical bimatoprost was FDA approved in December 2008 for the treatment of eyelash hypotrichosis (thinning eyelashes). Since its approval, there has been interest in its “off label” for hair growth in other areas, such as the scalp or eyebrows, but there has yet to be published scientific evidence to support this use. We report one of the first cases of significant eyebrow hair growth in a patient after use of topical bimatoprost for eyebrow hypotrichosis.

Synopsis: The discovery of the Androgen Receptor (AR) gene and related genes has expanded our knowledge on the genetics of common baldness (androgenetic alopecia). Recent basic science and clinical studies have lead to a better understanding of the pathogenesis of hair loss in both men and women. These genetic advances have lead to the development of a new screening test for androgenetic alopecia. In addition to the two currently approved FDA medications (minoxidil and finasteride) the FDA has approved a laser hair comb for the treatment of hair loss. Further studies are needed to verify the accuracy and validity of the genetic screening test and the efficacy of the laser hair comb.

In response to anecdotal evidence of sexual side effects continuing after stopping Propecia (finasteride 1mg), the International Society of Hair Restoration Surgery (ISHRS) has published a press release for the hair restoration community about the safety and efficacy of the drug. The release notes that scientific data gathered from extensive testing finds no correlation between persistent sexual dysfunction and Propecia.

Latisse, the brand name for the drug bimatoprost, is commonly used to promote eyelash growth in women who want their eyelashes to be longer, thicker, and darker, typically for cosmetic reasons.

In a publication on ClinicalTrials.gov, Allergan, the pharmaceutical company that produces Latisse, has announced a new study on the safety and efficacy of a new formulation of bimatoprost for use as a topical hair loss treatment for general baldness.

In the study, 416 men with male pattern hair loss (MPHL) ages 21 to 45 years old, were randomized to receive dutasteride 0.05, 0.1, 0.5 or 2.5 mg, finasteride 5 mg, or placebo daily for 24 weeks. The results of the study showed that dutasteride increased hair counts in a dose-dependent fashion and dutasteride 2.5 mg was superior to finasteride 5mg at 12 and 24 weeks.

[…]

Concerning possible sexual adverse events, there was no evidence in the present study that either dutasteride or finasteride was associated with impotence. However, 9 men in the 2.5-mg dutasteride group complained of decreased libido, compared with 1 man in the 0.5-mg dutasteride group and 3 men in the finasteride group. As with previous studies with finasteride, this adverse event was characterized as either mild or moderate in severity and often resolved with a continuation of the medication. In the 4-year follow-up of the phase III trials in BPH, dutasteride (0.5 mg) was well tolerated and the incidence of the most common sexual adverse events was low and tended to decrease over time.

The progressive decrease in hair shaft diameter that causes thinning (also called miniaturization) characteristic of male pattern baldness, can be decreased by the use of the DHT blocker Propecia (chemical name finasteride). Most men undergoing hair restoration surgery have some existing hair in the area that is to be transplanted that will thin over time and, in fact, may thin a bit more quickly as a result of the surgery. For men undergoing surgical hair restoration, the thinning of the surrounding hair can diminish the overall impact of the hair transplant. Even though Propecia has no effect on the transplanted hair, it can help to maintain the patient’s surrounding hair and is, therefore, useful as an adjunct to hair transplant surgery, to enable the patient to obtain a better overall result.

The present study looks to see if Propecia given from one month before surgical hair restoration until eleven months after, can increase hair growth in the area surrounding the hair transplant. In the study, consisting of almost eighty men divided into two groups in a double-blind fashion were either given Propecia or a placebo. Growth was recorded by hair counts and by photos.

The study showed that Propecia was substantially better than the control group in increasing hair counts and in increasing visible fullness when patients started Propecia a month before their hair transplant and were on the medication for one year.

SUMMARY of Dr. Epstein’s Abstract from his presentation at the International Society of Hair Restoration Surgery, 2005 – Sydney, Australia

Dihydrotestosterone (DHT) is known to be the more potent androgen in both Benign Prostatic Hyperplasia (BPH) and in Androgenetic Alopecia (AGA). Testosterone is converted to DHT by the enzyme 5-α reductase in several organs including the prostate, hair follicles, skin, liver and sebaceous glands. 5-α reductase exists in two isoforms: type 1 and type 2. Type 2 is the predominant enzyme in prostate and hair follicles. Finasteride, approved in 1992, inhibits the type 2 isoenzyme, and is available in two doses: 1mg dose for AGA, and 5mg for BPH. Dutasteride, approved in January 2003 to treat BPH, is a dual inhibitor of both isoenzymes.

Bernstein Medical Center for Hair Restoration

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