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Allergan initiates FDA clinical trial of Bimatoprost(Latisse) for Scalp Hair Growth

Phase One Clinical Trial Tests Safety of Lash Growth Drug for Scalp Hair Growth

As I mentioned in a post over one year ago, (www.BaumanBlog.com September 2009), the FDA has confirmed that Allergan has now registered Phase One clinical trials for safety and pharmacokinetics of a new bimatoprost formulation as a potential treatment for hair loss.

If Phase One (safety) trials are successful and Phase Two and Three trials (efficacy) are eventually completed, bimatoprost could become the third FDA-approved drug for the treatment of baldness in men and only the second FDA-approved drug for women with hereditary hair thinning or female pattern baldness--conditions which affect an estimated 60-100 Million Americans.

Although not yet listed on the Allergan.com website this morning, the twenty-eight patient clinical trial (www.clinicaltrials.gov  #NCT01189279), was formally registered with the FDA in August 2010 and posted last week (October 14, 2010) on the FDA's website.  As of this morning, the trial was listed as "Not yet open for patient recruitment."  However, this trial is set to begin before the end of this month, with data collection expected to be completed in February 2011.

According to information registered with the FDA, two separate bimatoprost formulations will be tested on human subjects in a double-blind, randomized trial primarily aimed at studying the pharmacokinetics of the new formulation of the drug.  In a Tempe, AZ clinical study site, male and femal patients (18-64 yrs of age) will apply the bimatoprost formulations onto pre-specified areas of balding scalp and be monitored for 'local scalp tolerability' and cardiovascular changes via ECG at specific intervals (day-1, day-17 and day-20).

Patients included in the study will be males with moderate male pattern baldness and females with moderate female pattern hair loss who are non-smokers or nicotine-free for >30 days, have not used bimatoprost or other prostaglandin analogs within the past three months, had no prior hair growth procedures (hair transplant or laser therapy) or prior use of hair growth drugs (finasteride, minoxidil) within six months.

At this time, it is not known what concentration(s) of bimatoprost are being tested.

Allergan holds an FDA approval for eyelash growth for their topical prostaglanding analog, Latisse(bimatoprost 0.03%).  Currently, the use of bimatoprost for hair growth on the scalp would be considered an 'off-label' use of the drug.

At Bauman Medical Group, we already have a number of male and female patients who are successfully using a daily dose of Latisse (bimatoprost 0.03%) on their scalp for hair growth.  None to date have reported irritation and we have measured modest hair growth using the HairCheck Trichometer in those patients and photographed increases in visible coverage of the scalp.  It is the author's personal opinion that Allergan will likely test a stronger concentration for the use on the scalp than the 0.03% bimatoprost found in Latisse.

For more information regarding Latisse/bimatoprost for scalp hair growth, eyelash growth or other hair restoration options, please visit www.baumanmedical.com or email doctorb@baumanmedical.com


New Genetic Androgen Sensitivity Test Helps Predict Finasteride Response in Female Hair Loss Sufferers

New Genetic Androgen Sensitivity Test Helps Predict Finasteride Response in Female Hair Loss Sufferers is now available at Bauman Medical Group in Boca Raton, FL

BOCA RATON, FL - A new simple genetic test could help tens of millions of female hair loss suffers determine whether or not finasteride (brand name: Propecia) may be an effective treatment for them to regain lost hair.

Cheek-swab Although finasteride remains the primary FDA-approved treatment for male pattern hair loss, doctors have been reluctant to prescribe it ‘off-label’ for women with hereditary hair loss (androgenetic alopecia or AGA) due to the risk of potential birth defects in sons of women of childbearing age and conflicting studies regarding its effectiveness. However, anecdotal reports in the medical literature of the successful treatment of women with finasteride have spurred scientists to develop a new test to help doctors more accurately select female patients who might respond to the treatment.

“We know that finasteride is 90-percent effective for male pattern hair loss, but we’ve seen only a about 50/50 success with our female patients,” said Alan J. Bauman, M.D., a board-certified hair restoration surgeon whose practice is divided equally between male and female patients. “Prior to this test, we’ve taken the wait-and-see approach with female patients. For those women who did not respond well to the treatment, it was a waste of time and money. This new test will be a tremendous asset in our fight against female hair loss, as we now have a scientific way of predicting how a woman may respond to finasteride before prescribing it.”

Androgen Sensitivity is calculated from an epigenetic weighted evaluation of the CAG alleles on the Androgen Receptor (AR-CAG) gene obtained from a simple cheek swab. Implicated in a number of medical conditions like acne, hirsutism and polycystic ovary syndrome, androgens can also interfere with hair growth in many who are genetically susceptible to hereditary hair loss. New, soon-to-be-published studies suggest that female patients who have a high degree of sensitivity to androgens are much more likely to benefit from finasteride a drug which decreases the production of the androgen hormone DHT (dihydrotestosterone), a known trigger for hair loss in men.

“If a woman’s score on this test shows a strong androgen sensitivity (bi-allelic CAG repeat score <24), she’s likely to have a benefit from treatment with finasteride,” Dr. Bauman said. “In fact, early studies suggest that she could see a 25-percent improvement in her hair count within the first six months.”  

Dr. Bauman is one of the first U.S. physicians to be able to provide this test for women with hair loss. Dr. Bauman recommends that those concerned about hair loss seek advice from medical professionals who have experience and expertise in diagnosis and have access to results-tracking technology--like microscopic hair density measurements and the HairCheck Trichometer--before starting any therapy.  For more information, visit his website at www.baumanmedical.com.


About Dr. Alan Bauman:
Alan J. Bauman, M.D., founder of Bauman Medical Group in Boca Raton, Florida, is an internationally renowned and board-certified hair transplant surgeon.  Dr. Bauman is certified by the American and International Board of Hair Restoration Surgery and recommended by the American Hair Loss Association. He is a featured lecturer at national and international medical conferences and Live Surgery Workshops. Dr. Bauman is regularly consulted by national news media organizations, and has been featured in Newsweek (http://www.msnbc.msn.com/id/15768086/site/newsweek/%22target=_blank%22), The New York Times, Cosmo, Vogue, Allure, Harpers Bazaar, Men's Health (http://www.scribd.com/doc/34049683/Men-s-Health-Magazine-Hair-Transplant-Dr-Alan-Bauman), NBC Today (http://www.youtube.com/watch?v=iOA2QmSXmSg&feature=related), CBS Early Show, ABC Good Morning America, Extra, Access Hollywood, and Dateline NBC (http://www.youtube.com/watch?v=ThL7ZgFIgtc).
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New Female Genetic Hair Loss Test and NeoGraft FUE on NYU Doctor Radio

image from farm3.static.flickr.com

Hair Loss Info for Men and Women: TONIGHT on NYU's "DOCTOR RADIO" Sirius114/XM119

Learn about the latest diagnostic tests, advanced treatments and breakthrough procedures for hair loss and hair restoration tonight, Oct 7th 6:30PM ET, LIVE on Sirius114/XM119 on Doctor Radio hosted by Laurel Geraghty with special guest, renowned hair loss expert, Dr. Alan J. Bauman.

Topics will include new genetic test for female hair loss and 'androgen sensitivity' (which can help predict the response to treatment), NeoGraft FUE (no scalpe/no stitch hair transplant), Low Level Laser Therapy with LaserCap, HairCheck (Hair Mass Index hair growth tracking using a trichometer) and much more!

Tweet questions in advance to http://www.twitter.com/@DrAlanBauman and we will answer as many as possible on the air!

 

Dr. Alan J. Bauman, M.D. is certified by the American Board of Hair Restoration Surgery and recommended by the American Hair Loss Association. He is the Medical Director of Bauman Medical Group http://www.baumanmedical.com


Androgen Sensitivity Genetic Test for Women With Hair Loss

Dna Can we better predict off-label treatment success in female hair loss if we use genetic testing?

Propecia (finasteride) is the most-commonly prescribed treatment for men with male pattern hair loss, but when tested scientifically on women with hair loss, the published data was contradictory.  Some studies showed that finasteride was of no benefit for women, but yet several anecdotal reports in the literature appeared which seemed to show that there was some improvement in some female patients.

Over the years at Bauman Medical Group, we've noticed that some women with hair loss who were prescribed Propecia(finasteride) certainly tend to improve while others do not.  Recently, genetic hair loss testing for men has been able to more accurately predict their chances of responding to Propecia (finasteride), so why not a similar test for women? 

A recent discussion with the company who created HairDX, the first non-invasive genetic tests for hair loss, has revealed that pilot studies on women looking specifically at "androgen sensitivity" have been successful in predicting the chances of successful treatment with Propecia (finasteride). Identifying the certain populaton of women suffering from hair loss who also have a high degree of androgen sensitivity can help determine which women are more likely to benefit from medical therapy.  More details regarding the "Androgen Sensitivity Genetic Test For Women" are forthcoming.

Propecia/Finasteride blocks the creation of dihydroestosterone (DHT), a potent androgen found in both men and women and also the known trigger for male pattern hair loss.  Keep in mind that Propecia is FDA-approved for men only and is contraindicated in women of childbearing age due to the potential risk to a developing male fetus.  Use of finasteride in women would be an 'off label' prescription.

For more information on Propecia / Finasteride in the treatment of female hair loss and the NEW Androgen Sensitivity Genetic Test, please contact Dr. Alan J. Bauman at 561-394-0024 or doctorb@baumanmedical.com

Dr. Alan J. Bauman, M.D.

http://www.baumanmedical.com


Eyelash Transplant Training

Dr. Alan J. Bauman demonstrating his eyelash transplant technique during a Live Surgery Workshop
Over the years at Bauman Medical Group, we've trained a number of hair transplant surgeons and other physicians in the field of cosmetic surgery in the detalied techniques of eyelash transplant surgery.  Our intensive one-on-one training programs for surgeons and their staff includes topics such as patient selection, pre-op prep, anesthesia techniques, graft harvesting/dissection, single and multiple-follicle graft implantation, post-op care, complications/sequelae management, lash maintenance/trimming/tinting/perming, etc. as well as the latest instrumentation, etc.

While we don't publish a list of physicians who have been trained, we will be happy to verify if your eyelash transplant surgeon has received this kind of intensive training at Bauman Medical Group.  To verify if your surgeon has completed an eyelash transplant (or other) training course with Dr. Alan Bauman, please email doctorb@baumanmedical.com directly. 

Dr. Alan J. Bauman, M.D. is a full-time hair transplant surgeon who is certified by the American Board of Hair Restoration Surgery and is recommended by the American Hair Loss Association.  Dr. Bauman has been performing eyelash transplant surgery since 1999, has lectured on and demonstrated his technique at ISHRS Live Surgery Workshop events, and has authored medical textbook chapters on eyelash transplantation--the most recent of which appear in Hair Transplantation (Avram/Rogers 2010) and Hair Transplantation 5th ed. (Unger/Shapiro 2011). 

More info: http://www.eyelash-transplant.com


Bauman Medical is a proud sponsor of Boca Raton Wine and Food Festival

Boca-food-and-wine

"A Culinary Affair" on 10.10.10

www.bocaratonwineandfoodfestival.com

Please your palate, step into your stride and mingle among the best chefs in south Florida at the 1st Annual Boca Raton Wine & Food Festival on Sunday, October 10th, 2010.

As you stroll down East Camino Real feeling the balmy breeze as the sun sets and excitement as evening ascends, you will be embraced in sensory delight. Exotic wines and culinary feasts representing seven regions around the world will proliferate.

You will enjoy fine artisanal wine and distinctive food pairings, regional sights and sounds and the most tantalizing foods imaginable to stimulate your taste buds. And this is just the first course!

Cooking demonstrations, wine pairing explanations and cultural revelations abound as you meet and learn from brilliant sommeliers and extraordinarily talented chefs.

The Boca Raton Wine & Food Festival brings you face-to-face with those who have made their lives -- their craft. This is the time for you to dine, drink fine wine and experience A Culinary Affair like no other!

 

http://www.bocaratonwineandfoodfestival.com/sponsors.html

 

Dr. Alan Bauman and Bauman Medical Group (Greater Boca Raton Chamber of Commerce Small Business Leader of the Year 2009) is proud to be a "Champagne Sponsor" of the Boca Raton Wine and Food Festival.