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

The results of 4 clinical studies conclusively proving the efficacy and safety of the HairMax LaserComb was published in a peer review medical journal in April 2014 and here is a summation of the article.

"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.

This is the link to the clinical article:

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.”

You can view a video of the lead author of the clinical paper, Dr. Lawrence Schachner and Dr. Joquin Jimenez discussing the clinical paper at this link:
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are u going to be putting up your data?

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  • are u going to be putting up your data?

    any word on whats happening with this?

  • #2
    Dear Jack,

    Hello and thank you for your posting. I am attaching our most recent posting on the status of FDA.

    For the last 2 years Lexington has been focused on conducting scientific clinical trials and preparing a FDA 510K Submission. We are extremely excited about the potential of the LaserComb as our experience since the1980s has clearly demonstrated a very effective treatment for hair with a high degree of user satisfaction. Our company agenda is to qualify the HairMax LaserComb as an attractive, affordable and user friendly treatment.

    We budgeted a significant amount of funds and proceeded as professionally as possible. We strategically pursued the following tasks.

    -We hired a world authority on hair loss Dr. Martin Unger to coordinate the clinical trail
    -We wrote a comprehensive trial Protocol and presented it to a research ethics committee known as an IRB (Institutional Review Board)
    -We contracted with a leading laser research center with 2 clinical investigators.
    -We hired a Biostatistician to design the statistical model.
    -We hired an experienced FDA Consultant to communicate with the FDA and assist with our compliance
    -We presented a Pre-Ide directly to the FDA for their comments and guidance.
    -We finalized the 510k submission and had formal panel review.

    FDA Clearance of New devices and new ‘indications of use’ is an in-depth process with many factors considered. Once the submission is lodged they have 90 days for their comments and every time they ask a question another 90 day clock begins. A 510K submission assumes that there are ‘predicate device’ and ours was submitted on the basis of there being substantial equivalence of other light based devices (non hair related) in the market.

    At this stage the FDA has stated that they have not found other predicated devices cleared for 510k acceptance, they suggested that we need a ‘De Novo’ filing. They also requested a second phase study for OTC use from a further research site. It is common for the FDA to make this request especially for devices with new indications of use. This does not take away any merit of the strength and statistical significance of the clinical data we presented.

    Since our clinical results were statically significant and superior to any other product on the market we thought we would have clearance on our first attempt.

    We are continuing in our communications with the FDA to qualify each and every one of their requirements, beyond any reasonable doubt, and will continue and proceed with additional studies.

    As we hope everyone could appreciate FDA approvals and device clearance take years and require extensive scientific data, comprehensive FDA compliance documents and regulatory advisors to present a strong submission. Most rulings are through a panel decision with some variables based on objective and subjective information.

    As one of the Directors at Lexington International LLC, the developers of the LaserComb, who managed the process of the FDA submission I can state that we have great confidence in the HairMax LaserComb and the clinical results. We are continuing our scientific studies and submissions until we receive market clearance for medical regrowth claims.

    I only wish the process was less cumbersome and the tasks for clearance easier to define. In the meantime we will find out what the legalities are of publishing the clinical data on this site.

    Stay tuned……

    Best regards,

    David Michaels
    Managing Director


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