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  • By Dr. Alan Bauman

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

    The FDA has just confirmed that Allergan has registered Phase One clinical trials for safety and pharmacokinetics of a new bimatoprost formulation as a potential treatment for hair loss.  This new trial is based on the wildly popular Latisse Eyelash Growth product and turning it to a possible 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 female 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.

    About Dr. Alan Bauman

    Dr. Alan Bauman

    Dr. Alan J. Bauman is the Founder and Medical Director of Bauman Medical Group with expertise in medical evaluations, treatments and procedures to those who are looking to maintain, enhance or restore their own living and growing hair. You Can visit www.baumanmedical.com for more info on hair medical treatments and procedures.


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    Comments

    8 Comments so far

    1. jeanne sill on November 3, 2010 10:27 am

      I would desperately like to get into your clinical trial of latisse for female hair loss. I am 63 years old and have been loosing my hair for 3 years. I am very selfconcious about it and often avoid going out, to the beach, in the wind, etc. Please consider me for a candidate…

    2. terri on November 22, 2010 11:08 pm

      i have been using latisse(which i purchased for eyelash growth) frontal on my scalp in 2 part lines and hairline for 4 months and have seen no results.
      i use rogaine 6% and laser but have had no hair transplant procedures.

    3. Hair Loss Treatment on December 12, 2010 11:36 pm

      It would be nice to be one of the candidate for you will be tested with a product that will increase your hair growth for free

    4. hair loss products on March 30, 2011 9:32 pm

      I don’t like to be a candidate to test the product..

    5. hair regrowth on March 30, 2011 9:33 pm

      I want to test that product too..

    6. stop hair loss on March 30, 2011 9:34 pm

      i want to stop my hair loss problem..please help..

    7. laser comb treatment on March 30, 2011 9:34 pm

      i want laser comb treatment..

    8. Treatment for Hair Loss on March 30, 2011 9:47 pm

      The best proven and effective hair treatment is Leimo. This treatment has been approved by FDA. malain ka….?

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