In January 2007, the HairMax LaserComb® became the first medical laser device to receive FDA Clearance for the "Promotion of Hair Growth" in males.
The HairMax LaserComb is also a non-topical, drug free treatment option – something that makes the HairMax highly distinct from the other clinically proven products.
HairMax Studies and the FDA Clearance Process
After years of extensive research and randomized clinical studies, Lexington International submitted the results of its six-month, multi-center placebo controlled clinical trials in 2006. The data collected from the trials indicated that 93% of the participants, all males aged 30-60, had a mean increase of 19 terminal hairs/cm2 – a medically significant increase, and evidence that the HairMax is a viable treatment option for those wishing to avoid the use of drugs and/or topicals.
The studies also showed that there were no serious adverse effects in any of the trial participants.
The official FDA indication is for "the Promotion of Hair Growth in males with Androgenetic Alopecia who have Norwood Hamilton Classifications of IIa-V and Fitzpatrick Skin Types I to IV." Lexington has completed an additional study on females and has submitted the results to the FDA for review. (The clinical trial to assess the efficacy of the HairMax LaserComb laser hair growth treatment in females was just completed and will be reported on at a later date.)
Study Significance
Hand-in-hand with Lexington International’s unwavering commitment to customer satisfaction, the makers of the product pursued these costly clinical trials to help put our customers’ minds at ease while solidifying the effectiveness of the HairMax.
To put it simply, we know about the countless products on the market that promise to re-grow hair, but end up having little or no effectiveness. And apart from draining your pocket, they do nothing to improve your hair loss problem.
The clearance of the HairMax LaserComb for marketing means that all data submitted was subject to intense scrutiny and review before being cleared for marketing. When a company receives this clearance, there are stringent rules and high standards put into place covering all aspects of manufacturing and quality control. The HairMax LaserComb is the only Laser PhotoTherapy device that was reviewed by the FDA and cleared for marketing. Our clinical data was submitted to the FDA and rigorously reviewed.
It is this milestone clearance that allows us to ensure the effectiveness of the HairMax.
A Truly Unique Alternative
The FDA clearance of the HairMax LaserComb® has significant implications for the Hair Loss Treatment industry. Currently, there are only two other approved treatment modalities available, but with the addition of the HairMax, there is now a viable alternative to these methods. With the HairMax, no longer do you need to worry about ongoing expenses or deal with negative side effects.
Note that while the HairMax works well as a standalone treatment, it is possible to use it in conjunction with the other approved therapies of your choosing. Remember, fighting hair loss is an uphill battle and the FDA clearance of the HairMax* now makes you one step closer to winning your battle with hair loss.