In February 2007, the HairMax LaserComb became the first medical laser device to
receive FDA clearance for the promotion of hair growth.
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The HairMax 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 an increase of 19
terminal hairs/cm – 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 males whose hair-loss patterns are consistent
with Norwood-Hamilton types IIA to V and whose skin colors fall under
Fitzpatrick types I to IV.
Why Submit Clinical Trials?
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 FDA is considered the highest standard by which medical devices and products
are cleared for use by the public. Our clinical data was submitted to the FDA’s
statisticians and analysts and was reviewed rigorously over a period of 11
months. During this time, the data from our clinical study was compared to other
products on the market and was deemed medically significant by the professionals
at the FDA.
It is this milestone clearance that allows us to ensure the effectiveness of the
HairMax.
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Customer Satisfaction is of Primary Importance
Clinically Proven to Promote Hair Growth
Greater than 90% User Satisfaction Reported
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