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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:

http://link.springer.com/article/10....257-013-0060-6

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: http://hairmaxpro.com/study-html/
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Another question regarding trials

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  • Another question regarding trials

    Has as a study been conducted where there has been a control group? One set of people using the LaserComb and a second set of people using a placebo. The Santino study does not use a control group, neither does the other studies I have seen.

    Can we see the study submitted for FDA approval? Was a control group used?

  • #2
    The problem is, what exactly would you use for a placebo?

    Comment


    • #3
      Placebo

      You could use something like a flashlight as a placebo. In drug trials, companies use sugar pills. You have to use a control group.

      Comment


      • #4
        Placebos …..controls…. urgh…..

        This has been the most agonizing issue of my last few years.

        It is our premise that for a hair growth study the best mode for a control is the ‘Base Line’ hair count. The use of a blinded control was considered for our first clinical study but our factors of the decision to use the Base Line were as follows:

        -Androgenetic alopecia is well documented and is known to be regressive. Additional data on hair loss would not add to our statistical analysis. We however used 11% increase in hair count to be considered regrowth which takes into account the placebo effect of Propecia/Minoxidil studies and any changes in waxing and weaning of the hair growth cycles.

        -We further considered the precedence of the laser hair removal clinical trials in which used the base line hair count as the control.

        -Most importantly we fell it was unethical to place tattoo marks in someone scalp with thinning hair and then closely trim the hair 5 times to perform hair counts. We feel that tattooing and trimming may lead to further hair thinning for that individual.

        - The only viable way of including a blind control is to issue a LaserComb without a laser. Users were instructed to read the user manual and watch the video which contains images of the laser light. We feel a control group would not be blind as laser light is visible, and there would be a high probability of noncompliance.

        Anyway during the design of our first trial we received a memo from the FDA accepting the base line as the control. However in the final panel review the FDA highlighted the lack of a placebo sham controlled study as one of their reasons for not clearing our device on this round. In case you’re interested some of the other items that were listed as our trial design deficiencies are that we did not diagnosis the etiology of the individuals hair loss and we did not correctly factor in the drop out rate in the statistical analysis.

        I once again comment that our clinical data was statistically significant and we felt the strength of the data should have justified clearance. But we are not in a position to question the FDA we only want to provide the necessary material and clinical data for ultimate clearance.

        So we are currently back to trial design phase and have our new protocol ready to submit to the FDA. This time we are covering all our bases (I hope) and have developed a sham device as the control.

        Regards,

        David Michaels
        Regards,

        Lexington Int LLC

        Comment


        • #5
          could you provide an update on the clinical trial phase?

          Are you currently designing a new test that will satisfy FDA requirements? Or are you actively conducting those tests? I'm confused about where you are in the process.

          Comment


          • #6
            Yes, we are starting a new multi center sham controlled study. The protocol is finished and should be submitted to the IRB (Institutional Review Board) and FDA this week.

            Regards,

            David Michaels
            Lexington Int LLC
            Regards,

            Lexington Int LLC

            Comment


            • #7
              multi center study

              How long will the multi center study last? Are you waiting for FDA approval of this latest protocol to begin the multi center study?

              Can you provide an update when you submit the new protocol to the FDA? I know you said sometime this week.

              Comment


              • #8
                Thanks for your continued interests.

                May we ask what is your great interest with the specific timing and ongoing updates?

                Regards,

                Davaid Michaels
                Lexington Int LLC
                Regards,

                Lexington Int LLC

                Comment

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