Analysis of Results of Safety and Efficacy of the HairMax LaserComb From Six Clinical Studies Indicates Excellent Risk to Benefit Profile in Treating Hereditary Hair Loss

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An analysis undertaken to assess the safety and efficacy of the HairMax LaserComb from 6 double blind clinical studies with 460 subjects found that no serious side effects occurred in any of these studies which proved the efficacy of the device in treating androgenetic alopecia (hereditary hair loss) in men and women. This analysis combined with the fact that there have never been any reports of serious side effects occurring in the over 10 years the HairMax has been on the market, demonstrates that the HairMax LaserComb has an excellent risk to benefit profile.

Treating hereditary hair loss in men and women requires serious considerations regarding not only efficacy, but safety. Lexington Int'l has recently completed an analysis of the efficacy and safety of the HairMax LaserComb in 6 double-blind, device clinical trials of androgenetic alopecia with 460 male and female subjects.

The first part of the analysis demonstrated the efficacy of the device. Presently, there are 2 drugs with FDA approval, and 1 non-drug product with FDA Clearance, the HairMax LaserComb® laser phototherapy medical device for treating the condition. In each and every study, conclusive proof that the HairMax is effective in treating androgenetic alopecia (hereditary hair loss) was found, and that these results are predictable, consistent, and comparable to the drugs approved for treating this condition.

The second part of the analysis was to assess the safety of the subjects in the clinical studies..The results of the analysis of all 6 studies showed that no serious side effects occurred and that any side effects reported were similar to those reported with the control (placebo) device.

Link to description of the clinical trials:

http://clinicaltrials.gov/ct2/results?term=hairmax

Since hair loss is an aesthetic condition, the risk to benefit profile has to be considered before using a product for treatment. The HairMax has been marketed since 2001 and has been used successfully by hundreds of thousands of individuals to treat their hair loss. Since that time, there has never been any reports of serious side effects occurring. This combined with the analysis of the safety and efficacy results from the 6 clinical trials yields an excellent risk to benefit equation for the HairMax, making the device the obvious choice of treatment for men and women suffering from hair loss.

This is the official indication for the HairMax LaserComb:

The HairMax Advanced 7, Lux 9, and the Professional 12 models are indicated to treat Androgenetic Alopecia, and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V and in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and who both have Fitzpatrick Skin Types I to IV.

The HairMax LaserComb is available in 3 models without a prescription; the HairMax Advanced 7, the HairMax Lux 9, and the HairMax Professional 12, with prices starting at $295.00 which makes the device easily affordable. The HairMax is cordless, and is easy to use in the convenience of ones’ home - once a day for 8-15 minutes, just 3 times a week.

Based on its proof of efficacy and its excellent safety profile , the HairMax must be considered by men and women as a first line treatment option for their hair loss. Many dermatologists are also making the choice to include the HairMax as part of their treatment armamentarium, due to the excellent risk to benefit equation and patient satisfaction resulting from treatment with the device.

Mr. Leonard Stillman, Director of Professional Services said, “Our extensive clinical study program was designed to assure that the HairMax is not only effective, but safe to treat hair loss. The analysis of the efficacy and safety of all of the clinical trials provides assurance to those considering using the HairMax that they can do so with confidence, knowing that the device offers a high level of safety in treatment.”

About Lexington International, LLC

Based in Boca Raton, Lexington International is a manufacturer and developer of advanced medical laser devices to treat hair loss and scalp disorders. Lexington Int’l markets the only laser phototherapy device which has published results of clinical trial proving efficacy and safety in a peer review journal. The company, was one of just 14 leading manufacturing exporting companies nationwide to receive the 2009 U.S. President’s “E” Award, which recognizes successes in world markets and subsequent contributions to the U.S. economy. Over the past 10 years and in over 155 countries worldwide, Lexington has helped hundreds of thousands of individuals to treat their hair condition and enrich their lives. (http://www.hairmax.com)

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Leonard Stillman

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