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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

- Study provides clinical efficacy of the HairMax LaserComb in the treatment of Androgenetic Alopecia in males commonly known as 'male pattern baldness' -

BOCA RATON, Fla., April 20 /PRNewswire/ -- Findings of the pivotal clinical trial of the HairMax LaserComb that provided clear evidence of efficacy and safety to the U.S. Food and Drug Administration will be published in the prestigious peer review journal, Clinical Drug Investigation in May 2009. Results of the clinical trial were a key factor in the clearance of the device for marketing in January 2007 for the promotion of hair growth in males with Androgenetic Alopecia.

The six-month study, titled, "HairMax LaserComb(R) Laser Phototherapy Device in the Treatment of Male Androgenetic Alopecia," demonstrates that the device should be considered as first line therapy for all appropriate men with this condition.

According to Mr. Leonard Stillman, Director of Professional Services at Lexington International, "This is the first controlled clinical trial published that proved the clinical efficacy and safety of a laser phototherapy device for treating hereditary hair loss."

Clinical assessment of treated scalp sites was carried out by objective evaluation of macro-images using dot mapping and computer aided hair counts, and with subjective evaluations by physicians and patients.

The study showed that the HairMax LaserComb is an effective and well-tolerated laser phototherapy device for the treatment of certain classes of Androgenetic Alopecia in males.

The adverse event profile was similar in the two treatment groups and there were no reports of serious adverse events.

According to Mr. Stillman, "The HairMax LaserComb was introduced to the medical community in 2007. Since then, a large number of dermatologists have adopted the device for their patients and it has become a m
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SOURCE Lexington International, LLC
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