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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What ‘Clinically Proven’ Means in Choosing a Hair Loss Product

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  • What ‘Clinically Proven’ Means in Choosing a Hair Loss Product

    Choosing a product to treat hair loss can be a very difficult decision, what with all the information on the internet claiming that they are ‘clinically proven’ to work. Therefore, it is vital to really understand what this term actually means and what you should look for when deciding which product to buy, that makes this claim.

    There are actually 2 terms used in product advertising:

    ‘Clinically Shown’ which generally describes a product for which there is no scientific proof it is effective from scientific clinical trials.

    ‘Clinically Proven’ which generally means that results were proven in well-controlled clinical trials to be both safe and effective.

    The most powerful evidence that a product works is when it is ‘clinically proven’ in treating hair loss, based on results of well conducted clinical trials. If you are considering a product to purchase and you see the term ‘clinically proven’, it is vital to find out if the clinical trials conducted that “proved” a product works for hair loss, are available for you to review and study, in order to judge its scientific validity. If the actual study is not available to you, then you should be skeptical in considering the claims being made for that product in treating hair loss.

    The first consideration in judging the validity of a clinical study is to see where they were conducted. If they were conducted at university settings, it will give you evidence that they are well designed for proving its efficacy in hair loss. Many studies for hair loss claim a product is ‘clinically proven’, when they were perhaps conducted in a doctors’ office or a research center. However, if clinical studies for hair loss were conducted at multiple university settings, this add much more power to the results, rather than a simple study done at 1 or 2 locations in a doctors’ or testing center location.

    The second consideration to judge validity, is how many patients were enrolled in the studies to prove that it works in treating hair loss. There is a mathematical formula available that calculates the study number of patients that have to be clinical studies, to assure that the results are ‘clinically proven’. Many products for hair loss have only conducted a study or two, with a small number of subjects enrolled, which means that the results are not nearly as conclusive as they are when there are large numbers of subjects are in the study.

    The third consideration of one of utmost importance is whether a product for hair loss has compared the active product against a sham device. It is impossible to ‘clinically prove’ a product works in treating hair loss if it was not compared against an inactive device, since there would be no way to know how it compares to “no active treatment”. If a company claims that their product is ‘clinically proven’ for treating hair loss and has not compared their products against an inactive device than that product is NOT ‘clinically proven’ – it is only ‘clinically shown’. The study has no scientific validity.

    Another ‘bonus’ in judging the validity of the clinical studies, is if the results were published in a peer review medical journal. If the results were published in a peer review journal, then the article has been the subject of rigorous third party review that is in no way connected to a a company, and provides assurances that the article adheres to high scientific standards.

    Once you review a clinical study you will see the term ‘p value’, and this is what it means. In analyzing clinical results, a ‘p-value’ analysis is performed which helps to determine the significance of the clinical results in treating hair loss. Hypothesis tests are used to test the validity of a claim that is made about a population. Without getting into the details of this statistical analysis, you will see a ‘p’ value next to the results of the primary test of efficacy, which shows the likelihood that any differences between the active and the inactive device was related to chance. The highest ‘p’ value, i.e. >0.0001 means that the likelihood that the results came from chance, was >0.1% (or less than 1 in a thousand). A ‘p’ value of >0.05 means that the likelihood that it resulted from chance was less than 5%, etc. This observation on the ‘p’ value found gives a good idea as to how effective a treatment is for hair loss.

    The HairMax® has met ALL of the criteria for clinical study excellence and can therefore categorically state that it is in fact ‘clinically proven’ to effectively treat hair loss. This is because, there have been:

    A total of 6 double-blind clinical studies conducted to date

    A very large number of subjects were studied

    They were conducted at multiple university settings, and

    The HairMax was compared to a control device at all centers.

    The results in the difference in hair count from the HairMax compared to the sham device was always p= >0.0001 in all studies. There are NO other laser phototherapy devices on the market that meet every one of these vital criteria. The HairMax has been proven conclusively over and over again, that it is absolutely beyond a shadow of a doubt, ‘clinically proven’ to be effective in treating hair loss.

    See for yourself – here is a link to the clinical paper published in a peer review journal, which conclusively proved the efficacy and safety of the HairMax® in four clinical studies.

    In conclusion, the term ‘clinically proven’ in treating hair loss is a very important and precise term. You must carefully study the clinical design and results of other products for hair loss, and only then will you be able to know if that product is really ‘clinically proven’, and not just ‘clinically shown’.
    Last edited by LAS; 01-23-2018, 12:31 PM.

  • #2
    can't support positive results now at 25 weeks post Ultima 12 laser comb use

    "In conclusion, the term ‘clinically proven’ in treating hair loss is a very important and precise term. You must carefully study the clinical design and results of other products for hair loss, and only then will you be able to know if that product is really ‘clinically proven’, and not just ‘clinically shown’.[/QUOTE]"

    RE: My six month juncture assessment of using the Ultima 12 Laser Comb.
    I have stored photos from day one on into the present. (Now at 25 weeks) What I have empirically seen through Photo and video documentation, shared with my dermatologist is the following:

    HAIRS that afforded scalp coverage, were shed en masse, and replaced with vellus, thin hairs. My dermatologist validated a LOSS of scalp coverage on the crown after use with the laser comb over months. It is no surprise that if strong hairs are shed, replaced by weak ones, no matter how many weak ones crop up, then more scalp will appear with less coverage. I really wish I had used the laser on half my scalp, and not on the other, as a more definitive study of the efficacy of the laser comb. My diet is rich in natural phyto-estrogen sources, adequate protein, green and yellow vegetables, etc and my labs across the board are normal. The only variable is the laser comb. There's another forum based in the UK, but feeding around the world, that has not one testimony to the efficacy of the laser comb. On Amazon, there are a preponderance of negative reviews. I am only telling the truth as per my experience and all the photos and videos I have accrued through 6 months. Frankly, I wish I had never bought the laser comb. In conclusion, I had MORE hair BEFORE using the laser comb than I have now. Very sad, but true.
    Last edited by LAS; 12-24-2018, 08:25 AM.


    • #3
      Response to clinically proven

      It is important to understand how the HairMax works to stimulate hair growth. The laser energy works predominantly by stimulating energy production to the lining of the hair follicle, the mitochondria, and also helps stimulate blood flow to bring in ATP which stimulates energy delivery and removes waste products. In short, this activity is called "localized action". These mechanisms of action stimulate the hair follicle to shed the fine, velus hairs which are the hallmark of hereditary hair loss, and enter the anagen, or growth stage. Therefore, there is no physical change to the functioning of the hair follicle, so that if the laser device (or other hair loss medications for that matter, such as Rogaine) is stopped, hair will return to where it had been before treatment.

      In the over 17 years the HairMax has been on the market and in rigorously conducted clinical studies with over 460 male and female subjects, there have been NO REPORTS of any permanent damage occurring. In some cases, if the device (or other treatments) have been used and treatment is discontinued, there might have been further deterioration in the condition itself in the follicle during treatment which would not show up until treatment is discontinued. Finally, this statement is incorrect: "It is no surprise that if strong hairs are shed, replaced by weak ones, no matter how many weak ones crop up, then more scalp will appear with less coverage." This is because the HairMax energy only stimulates the hair follicle to shed the weakened hairs and deliver energy to regrow healthy hair. Therefore, there are no 'strong' hairs or 'healthy' hair shed.

      As to negative reviews, it is a known fact that people like to post complaints more than compliments. To date over 1.5 million men and women have chosen the HairMax to treat their condition, making the device a popular item to treat hair loss. It is important to know that NO treatment works on ALL people and that the results cannot be predicted. The HairMax web site, has numerous photographic and live testimonials as to the results attained with the HairMax device.
      Last edited by LAS; 12-24-2018, 08:50 AM.


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