Pivotal Clinical Data Published For The Only Laser Phototherapy Device Cleared By The FDA For Hair Growth

Main Category: Dermatology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 21 Apr 2009 - 2:00 PDT

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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 mainstay 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.

The HairMax LaserComb utilizes a patented 'teeth' mechanism to part the hair to allow the laser energy to penetrate the scalp into the hair follicles. Many hair loss sufferers now have newfound hope in their battle to overcome hair loss. The HairMax LaserComb treatment is easy to use, only 10 to 15 minutes three times per week on their own schedule and in the comfort and privacy of their homes.

About Lexington International, LLC

Based in Boca Raton, Fla., Lexington International manufactures and distributes the HairMax LaserComb(R) to more than 90 countries and has provided new hope and satisfaction to tens of thousands of customers since 2001. The HairMax LaserComb is based on 20 years of international research and studies on the effects of Low Level Laser use. Both the press and users alike have universally taken to the HairMax LaserComb. Coverage has included Dateline NBC, TIME Magazine, as one of their "Inventions of the Year," as well as the November 2004 issue of Good Housekeeping Magazine. Lexington is a proud member of "Team Florida" and has participated in high-level, overseas trade missions with Governor Jeb Bush. Additionally, the company was awarded by the U.S. Department of Commerce for "Commercial and Export Achievement."

Source: Lexington International, LLC