Botox maker Allergan has begun
Phase 2 clinical trials of a possible hair-growth treatment for men
and women based on the active ingredient in its drug Latisse, which
stimulates the growth of eyelashes.
The company has already conducted Phase 1 clinical trials, which
tested the safety and stability of the medication, said Scott
Whitcup, Allergan’s chief scientific officer and executive vice
president of research and development.
Two separate sets of Phase 2 clinical trials are under way to
measure how well the drug, bimatoprost, works to fight male-pattern
baldness in men and hair-thinning in women, he said. Results could
be available by late 2012.
“We see a potential market not only for male-pattern baldness, which
is a huge market, but … for female hair thinning, that could be a
very beneficial product as well,” Whitcup said in a recent
conference call with stock analysts.
In one clinical trial, Allergan is recruiting 300 men who suffer
from male-pattern baldness. They will test how well bimatoprost
works at three different strengths in comparison to an inactive
solution and to minoxidil (Rogaine).
For the second clinical trial, Allergan is recruiting 300 women who
suffer from female-pattern hair thinning for a similar test.
Whitcup said he didn’t expect early FDA approval of Allergan’s
potential hair treatment. After the Phase 2 trials are completed
next year, the agency will require two more Phase 3 trials, he said.
That final set of tests is used to confirm a drug’s “effectiveness,
monitor side effects, compare it to commonly used treatments, and
collect information that will allow the drug or treatment to be used
safely,” according to the National Library of Medicine.
In 2008, the FDA approved bimatoprost, which is sold under the name
Latisse, as a treatment for sparse eyelashes, with a warning that it
can cause hair growth on other parts of the body that come in
contact with the drug. Some doctors have already tried using Latisse
as an “off-label” treatment for hair loss.
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