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 firstname.lastname@example.org