In May 2011 it was announced that the FDA has cleared the HairMax LaserComb for the treatment of hair loss and the promotion of new hair growth in women.
Coming just a month after the FDA similarly cleared the LaserComb for male pattern baldness treatment (in addition to its already existing clearance for hair regrowth in men), this new clearance will be exciting news for men and women who want to tackle their hair loss without resorting to drugs.
The last hair loss treatment for women to be approved by the FDA was minoxidil, which came to the market for females in 1988. The HairMax LaserComb is now the first non-drug, home-use medical device cleared to treat the millions of men and women suffering from hereditary hair loss.
"Hair loss amongst women is a growing concern", says Dr. Matt Leavitt, Medical Advisor to Lexington. "In the past, women had only one FDA Approved drug ingredient to treat their hair loss. Now they have a clinically proven viable alternative. Upon review of Lexington's extensive clinical studies on female hair loss, the FDA has granted Clearance to this exciting new treatment option. I believe the HairMax will be able to offer help to the millions of women suffering from hair loss."
A key part of the clearance were the clinical trials conducted on the HairMax LaserComb, across 5 research locations in the US. A double-blind device-controlled clinical study conducted under Good Clinical Practices showed that 100% of subjects on the HairMax Lux 9 experienced hair growth at 6 months.
Furthermore, over the same period of time, females using the HairMax Lux 9 grew an average of 20.5 hairs per square centimeter, which is considered medically and scientifically significant. Most importantly, over 70% of the subjects using the HairMax Lux 9 reported improvement in thickness and fullness of their hair.
No serious side effects occurred and there were no other types of side effects caused by the HairMax Lux 9 in the study.
The double-blind control meant that not only did the patients not know if they were receiving treatment from a LaserComb rather than a control device, but the doctors doing the testing were also not aware.
The study was conducted under IRB (Investigational Review Board) protocols, and monitored by a CRO (Contract Research Organization).
Randy Veliky, Lexington COO said. "The HairMax Lux 9 FDA Clearance now expands the options for the treatment of both male and female pattern hair loss. For the first time, the combination of our patented technology, state of the art design and the proven efficacy will help relieve the suffering of the millions of men and women with hair loss."