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Pivotal Clinical Data Published for the Only Laser Phototherapy Device Cleared by the FDA for Hair Growth
Date:4/20/2009

ainstay in their treatment protocols for this psychologically distressing condition."

Mr. Stillman also noted that male pattern baldness affects more than 50 million men in the U.S. and many more millions of men worldwide.

Study Design and Results

The four-center, double-blind, sham-device (placebo), controlled study was designed to compare the results of treatment of subjects randomized in a blinded fashion to either the HairMax LaserComb or the sham-device per a protocol approved by an Investigational Review Board (IRB) and performed in accordance with Good Clinical Practices. Subjects were required to have a Norwood Hamilton classification of IIa to V based on the Male Classification System of Hair Loss, and have Fitzpatrick Skin Type Scale I through IV.

Of the patients who completed the six-month study, subjects in the HairMax LaserComb treatment group exhibited significantly greater increase in mean terminal hair density than that seen in subjects treated with the sham-device.

Mr. Stillman further commented, "The results of the study accomplished an important goal. By conducting a well-designed and controlled efficacy trial, results showed that the HairMax LaserComb is truly an effective, convenient, well-tolerated treatment for hair loss caused by Androgenic Alopecia in males."

About the HairMax LaserComb

The laser energy emitted by the HairMax LaserComb is hypothesized to increase the biological molecule ATP which in turn increases cellular metabolism and cellular activity. The hair follicle then has the building blocks and energy to transform from a weakened follicle to one that is healthy and capable of producing thick terminal hair. The enhanced environment in turn invigorates the hair follicle which produces healthier hair, prevents further hair loss and stimulates the re-growth of thicker terminal hair.


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SOURCE Lexington International, LLC
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