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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Any Updates on the Clinical Trials?

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  • Any Updates on the Clinical Trials?

    Any updates to when the clinical trials are going to be finished? how its going? Is it getting closer to finishing?! And Also will we be told the results of the study even if the FDA doesn't approve it as a medical device?

    I just would like to know if it gets aproval or if it doesnt.

  • #2
    Waiting also

    I noticed that no on has answered this particular post. Have the results from the testing come in yet?


    • #3
      Thank you for your post.

      We appreciate your continued interest while we undergo the arduous process of conducting a “multi-centered, double blind placebo, sham-controlled study.” We have recently concluded the study, submitted the data to our bio-statistician and are preparing our submission to the FDA, which we hope to have submitted in the next few days.

      We've been criticized by some people in the general public because it has taken so long, but please be realistic and understand that it is by nature, a demanding process. As you may know, our first clinical trial failed due to the incompetence of our former medical director. However, we studied and closely followed GCP (Good Clinical Practices) guidelines on this trial so as not to make any errors or leave any room for questioning.

      To ensure quality and customer satisfaction, Lexington International, LLC is an ISO 9001:2000 and ISO 13485:2003 certified company. Each of our devices is carefully manufactured by hand in Florida. The LaserComb is a precision medical instrument that follows all good manufacturing practices. In addition, the LaserComb has earned CE certification for conformity with the essential health and safety requirements set out in European Directives and adheres to United States regulations for laser safety.

      We're overly eager to release the results of our clinical study once we are able to do so. We are confident that we will soon be making a major milestone in the evolution of Hair Care!


      Lexington Int LLC


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