NEW YORK — Lexington has received clearance from the Food and Drug Administration for marketing the HairMax LaserComb Lux 9 to treat female pattern hair loss, the manufacturer has announced.
"Hair loss among women is a growing concern," said Matt Leavitt, medical adviser 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 [that] HairMax will be able to offer help to the millions of women suffering from hair loss."
The last hair-loss treatment for women to be approved by the FDA was minoxidil, which came to market for females in 1988. HairMax now is the first nondrug, home-use, over-the-counter medical device cleared to treat the estimated 80 million men and women suffering from hereditary hair loss.
What causes female hair loss? Such factors as:
Changes in the levels of androgens (hormones). For example, after reaching menopause, many women find that the hair on their head is thinner, while the hair on their face is coarser;
Family history of male or female pattern baldness; and
Damaged hair due to coloring or chemical straightening treatments.
What are the signs of female pattern hair loss? Hair thinning is different from that of male pattern baldness. In female pattern baldness:
Hair thins mainly on the top and crown of the scalp. It usually starts with a widening through the center hair part;
The front hairline remains; and
The hair loss rarely progresses to total or near total baldness, as it may in men.
The results of a double-blind, device-controlled clinical study conducted showed that 100% of subjects on the HairMax Lux 9 experienced hair growth at six months, the manufacturer stated. Over the same period of time, females on the HairMax Lux 9 grew an average of 20.5 hairs per cm squared. In addition, more than 70% of the subjects on the HairMax LaserComb 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 LaserComb Lux 9 in the study.
HairMax LaserComb Lux 9, which is most effective in early to moderate stages of hair loss, delivers laser energy to stimulate dormant and active hair follicles. To use the HairMax LaserComb Lux 9, treat hair for 11 minutes, every other day.
In April 2011, the FDA also granted clearance for marketing for three new models of the HairMax LaserComb for male pattern baldness.