Botox maker Allergan is about to launch clinical trials of a hair-growth treatment similar to its drug Latisse, which stimulates the growth of eyelashes.
The Phase 1 trial, scheduled to start this month, will focus on the safety of two formulations of bimatoprost, which is the active ingredient in Latisse.
This phase of the trials will include a total of about 28 patients — men with moderate male-pattern baldness and women with moderate female-pattern hair loss.
The FDA approved Latisse as a treatment for 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.
Hair-restoration expert Dr. Alan Bauman of Boca Raton, Fla., reported “modest hair growth” among patients who have been applying Latisse daily to their scalp.
Irvine-based Allergan might want more impressive results than that in order to make its hoped-for baldness remedy more commercially successful.
Bauman predicted that “Allergan will likely test a stronger concentration for the use on the scalp than the 0.03% bimatoprost found in Latisse.”
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,” Bauman said. Those conditions affect an estimated 60 million-100 million Americans, he said.
The clinical trial will be run out of Tempe, Ariz. It is scheduled to be completed in February.