Landmark HairMax LaserComb Clinical Study Results Published, Proving Efficacy and Safety In Treating Hair Loss

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Lexington Int’l is pleased to announce the publication today in a peer-review medical journal, the results of four major clinical studies. These studies provided conclusive proof of the efficacy and safety of the HairMax LaserComb as a first line treatment of pattern hair loss in men and women.

Lexington Int’l pioneered home-use laser phototherapy treatment of hereditary hair loss, with the introduction of the HairMax LaserComb® in 2001. The results of four clinical studies on the treatment of male and female pattern hair loss with the HairMax LaserComb, was just published today in a peer-review journal, The American Journal of Clinical Dermatology. The article, Efficacy and Safety of a Low-level Laser Device in the Treatment of Male and Female Pattern Hair Loss: A Multicenter, Randomized, Sham Device-controlled, Double-blind Study was co-authored by renowned experts in the field of hair disorders. The results of these studies have now provided robust and conclusive evidence that the HairMax LaserComb is both effective and safe for the treatment of pattern hair loss in men and women.

The four clinical studies were conducted under strict Good Clinical Practice Guidelines at multiple study sites, including major teaching institutions of dermatology such as the Cleveland Clinic, University of Minnesota and University of Miami. Enrolled in the study were 225 males and females diagnosed with androgenetic alopecia (male and female pattern hair loss). Subjects received either the HairMax LaserComb or a sham (inactive) device in a randomized, blinded manner so that no one knew which device they were on. The primary efficacy analysis was based on the change in hair count after 26 weeks treatment with the HairMax LaserComb, compared to change in hair count with the sham (inactive) device.

The results of the studies showed that there was an average increase in terminal hair count of over 20 hairs per cm² (equivalent to over 139 hairs per square inch). Additionally, a higher percentage of lasercomb-treated subjects reported overall improvement in hair loss condition and thickness and fullness of hair in self-assessment, compared with sham-treated subjects. No serious adverse events were reported in any subject receiving the lasercomb in any of the studies.

The authors concluded that: “Our results suggest that low-level laser treatment may be an effective option to treat pattern hair loss in men and women”. They also concluded that “Low Level Laser Therapy [LLLT] may provide a promising treatment option for patients who do not respond to either finasteride or minoxidil, and who do not want to undergo hair transplantation.”

The authors also had this overall observation: “…… while topical minoxidil solution or foam is widely used to treat pattern hair loss and is generally well tolerated, the treatment needs to be applied one or twice daily, and be in contact with the scalp for at least 4 hours. Such application can be impractical for many users, leading to noncompliance and reduced efficacy. As an alternative, the lasercomb treatment is safe and easy to apply, with 8-15 minutes of treatment three times per week, and leaves no residue on the scalp. Such user friendliness of the lasercomb may lead to better patient compliance and improved efficacy.”

Dr. Lawrence Schachner, Chairman of the Department of Dermatology at the Miller School of Medicine of the University of Miami, and senior author of the article said: “The results of these clinical studies provide further evidence that the HairMax LaserComb may be utilized as an effective option for treating androgenetic alopecia in men and women.”

David Michaels, Managing Director of Lexington Int’l said: “We have invested considerable resources to prove the efficacy and safety of the HairMax LaserComb with expertly designed clinical studies, and the results of these studies validated this objective. The publication of these unprecedented studies by some of the preeminent experts in the treatment of hair loss, provide conclusive proof of the efficacy and safety of the HairMax.”

About Lexington International, LLC

Based in Boca Raton, Lexington Int’l is a pioneer in the development of advanced hair loss treatments and laser hair growth products. The HairMax LaserComb is the only laser phototherapy medical device with 6 FDA Clearances for the treatment of hereditary hair loss in both men and women. The HairMax is also the only laser phototherapy device to have the results of 7 clinical studies proving efficacy and safety of the device, published in two peer-review medical journals. Since 2001, in over 165 countries worldwide, Lexington Int’l., LLC has helped hundreds of thousands of individuals to treat their hair loss and improve the condition of their hair. For more information please visit: http://www.hairmax.com.

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Leonard Stillman

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