Where Are The HairMax Lasercomb Studies?

Dear Spencer,

Months ago when you interviewed David Michaels, one of the inventors of the HairMax Lasercomb, he said that he was going to give you a copy of the study that Lexington presented to the FDA in order for the Lasercomb to gain market clearance, did you ever see the study, and if so what were your thoughts or any experts thoughts on it? – Chris

————————
Dear Chris,

I never did receive that study. The truth is I still haven’t seen any substantial evidence that the HairMax Lasercomb can effectively treat hair loss to any appreciable degree. I’m still waiting.

Regards,

Spencer Kobren

Host of The Bald Truth Radio Show
Founder, American Hair Loss Association
Founder and Director of Consumer/Patient Affairs, International Alliance of Hair Restoration Surgeons (IAHRS.ORG)

 

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33 Comments

  • Dr. Alan Feller

    The lasercomb and all LLLT products are a sham. Thanks to the pressure placed on Hairmax boss David Michaels he has had to post on his own hairmax website that:
    OFTEN, RESULTS ARE NOT DEMONSTRATABLE (sic) IN PHOTOS.

    He knows by now that “demonstratable” is not a true word. I believe he continues to use it in an effort to confuse readers of his website.

    I have already asked every LLLT doctor and industry hack the following question and am still waiting for the answer:
    How can LLLT of any kind work if the laser can’t penetrate the skins natural optical barrier. I have shown surgically that laser light simply CAN’T pass through the epidermis/dermis boundry to reach the follicles. So how in the world can LLLT work? The simple answer is that it can’t. But you wouldn’t know that from David Michaels nor ANY of the doctors on his so-called “medical advisory board” because they have REFUSED to stand by their product and explain the unexplainable.

  • Dr. Feller, riddle me this:

    Why can I pinch about a 2cm thick 4cm long wad of skin on my leg, shine a 650nm 150mw diffused laser against it and the entire wad of skin lights up like the 4th of July??? Even the backside of the skin opposite to where I placed the laser (a distance of 2cm through skin and flesh and YES, Hair Follicles ) is all aglow with beautiful monochromatic laser light!

    Why can I shine the same 150mw laser against the right side of my nose and my entire nose right through to the left side glows like Rudolph the Red Nosed Reindeer???

    Maybe a 5mw laser like those used in the HAIRMAX lasercomb can’t penetrate to the follicle but higher powered lasers have no problem whatsoever.

    Oh, I would sure like to see the science behind your statment that 650nm monochromatic coherent laser light reverts to normal everyday noncoherent light upon striking the skin.

    I’ll be waiting with bells on to see that mathematical proof!

    Good day!

    Mike
    LAZERFISH LLLT.

  • Joe S. (Justjoe)

    Dr. Feller, the laser does have some effect. I do agree it is priced WAY to high and gives minimal results. However, LLLT has SOME effect.

  • Dean M-retired RN

    @ “Dr. Feller:

    Interesting that you ding David Michaels for his spelling error while you are apparently incapable of correctly spelling “boundary”..

    .OBTW, would you kindly post your surgical demonstration of how laser light “CAN’T pass through the epidermis/dermis boundry to reach the follicles.”

    Certainly the FDA would be remiss if they did not immediately issue cease-and-desist orders to those medical laser suppliers who have been in business for the past couple of decades once they’ve seen your cutting-edge work-wait, I seem to recall that some surgeons even use lasers to cut tissue-how is that possible if your contention is true?

    Please go peddle your BS elsewhere…

  • Let’s keep this discussion civil. Even though we may disagree with Dr. Feller’s opinion on the effectiveness of laser therapy, let’s respect his credentials as a gifted hair transplant surgeon. I’m sure he has helped many men with their hair loss problems.

    Lasers certainly do penetrate the skin. We are talking cold lasers here, not lasers used for cutting etc…

    I’ve worked enough with lasers to know that cold Lasers in the 650nm range definitely do penetrate the skin.

    One thing you may be interested in knowing, is that some people who have gone in for laser hair removal have noted increased hair regrowth. Very interesting.

    Dr. Feller posed the question ‘ How in the world can LLLT work?’

    Well…how does minoxidil work to regrow hair???? The answer is nobody knows. Sure there are theories, but the exact mechanism of how minoxidil grows hair is still unkown even after 30years or so.

    I remember when I was about 19 back in 1983. I watched an episode of 60 minutes where they were talking about a drug cold Loniten(minoxidil) and that when it was applied topically, grew hair. Several doctors were interviewed all claiming that ‘Nothing Regrows Hair’ etc etc etc…..now some 25 years later, we know that minoxidil actual does work for many men.

    The same can be applied to LLLT as well. Sure we say the ‘bio photo stimulation effect’, but really I think we don’t know the true mechanism by which Laser therapy works to stimulate hair regrowth in some people.

    I think any therapy that has some hope to help us men, should not be dismissed until it has been thoroughly researched and proven ineffective. I believe this is not the case with regards to LLLT ( I mean proven ineffective)!

    Mike
    LAZERFISH LLLT.

  • Chris

    My main problem with the whole LLLT hairloss industry is this: it is an industry that claims that it is revolutionary but avoids all scrutiny. They can’t have it both ways, if someone claims to have found a new way to treat hair loss then it is up to them to prove it. Doesn’t anyone find it odd that there is not one double blind placebo controlled study that has ever been published in a peer reviewed medical journal demonstrating that 620-650nm laser light can stop or reverse androgenetic alopecia (aka. male pattern baldness) yet, so many of these companies claim that they have performed such studies? For something that is so revolutionary, it’s amazing how this industry really doesn’t want to prove its’ skeptics wrong (I could only wonder how history would be different if Albert Einstein had these guys’ attitude) I know of studies demonstrating that hair removal lasers cause hair in about 10% of people to grow, but you have to also take into account that those lasers are far more powerful than the lasers in hair restoration devices. And as for comparing the skepticism of lasers to that of minoxidil, minoxidil was originally used as a heart medication and a side effect of it was hair growth in some people the laser industry basically came out with a device to treat hair and all claims of reported hair growth came from the manufacturers themselves. I’m not stating that lasers don’t work for hair loss, I’m just stating they got a long way to go to prove that they do.

  • Chris

    Apparently, the FDA lasercomb study exists online. I have reason to believe this because I requested the full lasercomb clearance documents through the Freedom of Information Act. The FDA sent me a cd that contained some 300 pages of documents. The study was deleted, but it did provide the names of the investigators as well as the test sites and the number of subjects. I googled one of the dermatologists who participated in the study and I found it. So Spencer, please google “Irwin Kantor + lasercomb” and you should find several web sites that provide the full study (I didn’t provide a link, because it is way too long). After you’ve found it please get as many experts who are familiar with conducting clinical research to see if you can find out why Lexington is so reluctant to let anyone, who’s skeptical about the efficacy of laser hair treatments, see this study. I don’t understand why Lexington refuses to publish it despite promising to do so on at least two hair loss websites (Baldingblog and Hair_Restoration_Info). Based on what I saw, it looks like they have nothing to hide, but then again I didn’t understand half of the information contained in the study.

  • I’ve just looked at the study and it’s quite clear why they have not posted it for all to see, because it did not work very well. Here is the fat of it,
    LaserComb (N=72) Placebo (N=40)

    Subjects’ Assessment of Overall Hair Regrowth
    Mean Change From Baseline in %

    No Growth 36.8% vs 53.9%
    Minimal Growth 39.5% vs 41.0%
    Moderate Growth 22.4% vs 5.1%
    Dense Growth 1.3% vs 0%

    Basically this shows that only 22% of people are likely to get a cosmetically noticeable benefit from using the comb, with only 1% getting dense growth.

    This means that 75% give or take did not receive any noticeable growth from using the lasercomb, and THAT’S why they did not send Spencer, or the Balding blog the study, because it shows 75% of people get no real effect from using it.

  • Destin

    I understand that it may not be a very effective regrowing tool, however, if it is good enough to just help maintain what you have now, then why not use it? I understand that it might not have the greatest benefit, but its better than doing nothing, right? I think that people who are in the early stages of hair loss and are just strictly worried about maintaining what they have, then I suggest taking both Finasteride and to also use the lasercomb.

    Like what Alan Bauman always says “It’s another tool in the toolshed”.

  • Chris

    I saw what you wrote Petchsky and you are right, but that is only the tip of the red flag iceberg. The above stats. are the opinion of the participants, if you read on, you see the invetigator assement at 26 weeks which is as follows:

    Table 15: Investigator’s Global Assessment of Hair Growth at 26 Weeks

    Assessment LaserComb Placebo P-Value
    (N=72) (N=38)
    n (%) n (%)

    No growth 46 (63.9%) 22 (57.9%)
    Minimal growth 18 (25.0%) 10 (26.3%)
    Moderate growth 7 (9.7%) 5 (13.2%)
    Dense growth 1 (1.4%) 1 (2.6%)

    According to the above chart the investigators believed that the placebo group had better results than the lasercomb group! But that is not all, at the end of the study, participants were asked to guess which device the were using, here are the results.

    Table 27: Subject’s Guess of Which Device They Had

    Study Week Actual Device Subject’s Guess Kappa

    8 LaserComb n (%) 37 (49.3%) 38 (50.7%)
    Placebo n (%) 8 (20.5%) 31 (79.5%) 0.24

    16 LaserComb n (%) 35 (48.6%) 37 (51.4%)
    Placebo n (%) 9 (23.7%) 29 (76.3%) 0.21

    26 LaserComb n (%) 30 (41.7%) 42 (58.3%)
    Placebo n (%) 5 (12.5%) 35 (87.5%) 0.24

    As you can see at week 8 roughly half of the lasercomb group thought that their device was a placebo, by week 16 it had increased slightly, but by week 26 almost 60% of the lasercomb participants believed that their device was a placebo! Which leads me to the ultimate red flag that I’ve found with this study, How can 63.2% of the lasercomb group give a positive assessment of their overall hair growth (referenced by above chart mentioned by Petchsky), yet only 41.7% guessed that their device was the real thing? Maybe Dr. Rassman was right about the hair counts being wrong.

  • I was considering the lasercomb device as a supplement to propecia but after digesting the study, I’m going to skip it. The cost and time required are not worth the benefit. I can keep what I have with the propecia.

    One question to the group – when ordering propecia, is the 1mg (low dose) pill effective, or do most people get the 5mg pill? I’ve been on the 1mg for a year and have not seen any results, though I take it about 4 days per week.

    Thanks for all the advise.

  • victor

    I’ve been taking propecia for more than 10 years and I can say for a fact that for me, though I may not have gained new hair, I definitely have kept what I had back then. Never see hair on my pillow or shower like I used to (was a class 2 and still am). Is it propecia or coincidence I don’t know???!?!?!
    Can’t wait till they come up with an undeniable cure though!

  • Robert

    Thanks everyone for convincing me not to shell out for the lasercomb.

    Side comment. Some of you apparently use Propecia. You might want to give Avodart a try as an alternative. I switched to Avodart around 2004 or 2005 and was soon very glad I did.

    Both drugs were originally developed for benign prostatic hyperplasia, both help with that condition by blocking the conversion of testosterone into DHT, and both have the side effect of helping with hair loss. Avodart, however, is more effective in blocking DHT as it apparently blocks two of the enzymes involved in the conversion of testosterone to DHT whereas Propecia only blocks one.

    Anyways, I found that while Propecia by and large (not 100%) halted my hair loss Avodart completely halted it and led to obvious regrowth. I’m confident that I have somewhat more hair today than I had in 2003.

    As far as I know, Avodart is still not approved for hair loss. (I wouldn’t be surprised if Merck’s lawyers and lobbyists are working hard to keep it that way.) So I’ve been using it off-label all these years.

  • I am the Director of Professional Services at Lexington International, LLC. Many of you have asked about the clinical study used for the FDA submission. The study was published in May 2009 in the journal Clinical Drug Investigation. This post is not for commercial purposes, simply to announce the publication of the article and to post the Abstract as contained below in PubMed.

    1: Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.Links
    HairMax LaserComb(R) Laser Phototherapy Device in the Treatment of Male Androgenetic Alopecia: A Randomized, Double-Blind, Sham Device-Controlled, Multicentre Trial.Leavitt M, Charles G, Heyman E, Michaels D.
    Private Dermatology Practice, Maitland, Florida, USA.

    The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years since the invention of lasers. The HairMax LaserComb(R) is a hand-held Class 3R lower level laser therapy device that contains a single laser module that emulates 9 beams at a wavelength of 655 nm (+/-5%). The device uses a technique of parting the user’s hair by combs that are attached to the device. This improves delivery of distributed laser light to the scalp. The combs are designed so that each of the teeth on the combs aligns with a laser beam. By aligning the teeth with the laser beams, the hair can be parted and the laser energy delivered to the scalp of the user without obstruction by the individual hairs on the scalp. The primary aim of the study was to assess the safety and effectiveness of the HairMax LaserComb(R) laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia (AGA). This double-blind, sham device-controlled, multicentre, 26-week trial randomized male patients with Norwood-Hamilton classes IIa-V AGA to treatment with the HairMax LaserComb(R) or the sham device (2 : 1). The sham device used in the study was identical to the active device except that the laser light was replaced by a non-active incandescent light source. Of the 110 patients who completed the study, subjects in the HairMax LaserComb(R) treatment group exhibited a significantly greater increase in mean terminal hair density than subjects in the sham device group (p < 0.0001). Consistent with this evidence for primary effectiveness, significant improvements in overall hair regrowth were demonstrated in terms of patients’ subjective assessment (p < 0.015) at 26 weeks over baseline. The HairMax LaserComb(R) was well tolerated with no serious adverse events reported and no statistical difference in adverse effects between the study groups. The results of this study suggest that the HairMax LaserComb(R) is an effective, well tolerated and safe laser phototherapy device for the treatment of AGA in males.

    PMID: 19366270 [PubMed - in process]

    This study will answer questions as to the efficacy of the device.

    Leonard Stillman
    Director of Professional Services
    Lexington International, LLC

  • mywillisgood

    Well i made an experiment on my dad with lasercomb. He is bald and i made him try the comb for months and he actually grew few very light hair on his head, like- between the crown and the front.

  • The laser comb sounded like a good idea to me but I was sceptical because finding results of any trials was hard. Many thanks for the posts from Chris and Petchsky above, you can’t argue with hard facts. The waffle from Leonard Stillman proves how this company is attempting to steer the public away from hard evidence. I would rather be bald than line the pockets of charlatans

  • Like everyone reading this blog, I am balding. It is very, very depressing. I am highly allergic to minoxidil. I would give anything to get back a full head of hair. Why don’t we organize and start a campaign to pressure the federal government to fund a “war on baldness”. I am not joking. Look at the funding that organized women got for breast cancer research (and NO, I am not suggesting that it is the same level of personal tragedy). Still, it affects us – our level of self esteem and even our productivity… Ultimately the solution lies in stem cell research.

  • Although there are a load of problems that have already been listed, I have a couple more:

    1) The level of light reaching the scalp from this device is much less on all wavelengths than the amount received from bright sunshine on thin to no hair so if you bald guys want to try it, go get a tan.

    2) The Hairmax ads say that noticeable results occur in 10-14 weeks (70-98 days) and yet the warranty is only 60 days. What this means is that you not only can’t deny results, but that they may actually be able to refuse a refund because it is not 100% satisfaction guaranteed.

  • Leonard Stillman

    Once again, I am Leonard Stillman, Director of Professional Services at Lexington and I am posting this to correct information contained in the post by JM on September 20, 2009. This post is important to correct misinformation and not for commercial purposes.

    First of all, JM’s flippant comment, indicates that there is a lack of understanding that the HairMax LaserComb emits laser light and NOT UVA light. The spectrum of visible light has many ranges. UVA from the sun has absolutely no effect on hair growth, and yet there is a plethora of data that shows that laser energy in the range of 655nm stimulates hair growth. Therefore, it is illogical that JR recommends a suntan for hair growth instead of the HairMax LaserComb.

    Second of all, we do not know where JR got his information as to the money back guarantee on the HairMax LaserComb. The correct information is that Lexington will refund the purchase price of the device less a 20% restocking fee for up to 20 weeks, NOT 60 days of purchase. Since results can be seen in as little as 8 – 12 weeks and NOT 10-14 weeks as JR stated, there is plenty of time to judge results before making a decision as to whether to continue therapy with the device.

    We hope that this corrected information proves helpful to your readers.

  • Lexington is now conducting three new trails for it’s Lasercomb lineup. One is for a new 12 beam model, and another is for a 5 or 7 beam model (I don’t remember the number exactly) but the third trial is yet another clinical trial for women (in all fairness though this is for the 9 beam model). Ever since the Lasercomb was cleared by the FDA for men within a certain Norwood class back in Feb 2007, Lexington has repeatedly stated on there website and others that the clinical trial for women results were similar to the men and that they expected a clearance shortly. Now it’s almost two years later and by the look of it, Lexington’s second bid for FDA clearance FAILED. Maybe I’m wrong, maybe Lexington withdrew their application in order to to focus solely on the 9 beam model, maybe the FDA granted Lexington clearance and they are waiting to announce it, but if I’m not, this would mean that Lexington can’t replicate their own results. To me their FDA clearance is like making hit movies, the first hit is relatively easy, the second hit is hard because the second time you have to prove that your first success wasn’t a fluke.

  • Chris

    It seems that the study was published officially in May of ’09 and the results appear conclusive. I don’t know why there is so much skepticism, some of it appears to be bordering on hostility. The director of the company even posts on here, siting the study, and on there website they post the findings of the study and give links to it. I am considering this product but with all the negativity, I’m not sure now.

    Is there something I’m missing? I feel like I’m hearing two different stories; The skeptics who seem convinced that this is a scam but I’m not sure why. And the company who is providing actual data to support their claim (albeit somewhat late). I just don’t know. I will continue to search for more information before making my decision.

  • As in anything that involves science and money, opposing faction will always try to argue their points. It is presumed that as adults, we make our choices based on what we believe. There is no point in being disagreeable because we disgaree with anyone. I could walk aways from hirMax laser and live with thinning haair. Or invest a modest sum and try it out. Not unlike seeing a film: not all moveis I have seen were excellent or even good. But I do mak the choice to go to the movies. There are no guarantees in life. So, there.

  • Dina Melucci

    I am a woman who has used the laser comb.

  • Dina Melucci

    As I was saying, I purchased the laser comb in Macrh 2009, under the suggestion of my dermatologist. I am a woman, desperatly losing her hair. Trust me guys, bald woimen are far less accepted. Anyways, absolutely nothing happened,. I called the company on the one year anniversary of my owning and using the comb. They said to keep using it, I simply needed more time! I’ve decided I’d rather have my 15 minutes per day back. I’m mostly upset because this was very expensive for me to afford.

  • JOHN EDWARDS

    IS IT POSSIBLE TO BE A TEST PATIENT FOR THIS PROCEDURE? BOSLEY HAS BEEN MAKING ME GREAT OFFERS FOR YEARS. BUT I HAVE BEEN WAITING TO SEE IF CLONING WOULD BE A POSSIBILITY TO PREVENT HAVING SURGERY THAT WOULD MOVE MY HAIR ALL OVER MY HEAD IN A NON-NATURAL WAY. PLEASE HELP.

  • Just browsing

    If I am not mistaken, the only thing the FDA cleared the laser comb for was safety. They declared it was safe, an immediately it was sold as “FDA approved.” and now we have everyone bickering and arguing over efficacy and it was not FDA approved because it actually grows hair! It simply doesn’t cause any harm. Nobody on this blog has made this point, which shows how confused the general public at large is on the subject.

  • BubbaNFTL

    @Just Browsing – Thank you for pointing out the obvious. I was flabbergasted as I read the comments that no one seemed to have realized that. There is a HUGE difference between a device being FDA Cleared (the company just has to prove to the FDA that it doesn’t harm consumers) and FDA Approved (which means it has been proven to successfully treat, diagnose, or prevent a medical condition). This argument about the study is a moot point as their was no study done to FDA standards for efficacy, just safety. If this device truly worked then I would think that big pharma would’ve long ago bought the companies responsible, conducted a real gold standard study, and had the device Approved not just Cleared.

  • Hilda

    Thank you Bubba NFTL for clearing up FDA Approved and & Cleared. Dr. Oz today on his recommended the laser comb as a remedy for hair loss in women and was considering getting it for my mother. However, after reading all the posts, especially yours, am convinced it’s just a gimmick.

  • Robert G

    If it’s a scan then why does the NIH (National Library of Medice) have a published study on it saying it works? http://www.ncbi.nlm.nih.gov/pubmed/19366270

  • Pamela K

    A study means nothing without a report from the actual users about the success. Thank you, Dina, for telling us your story. You may have lost your money but you helped save mine and I’m grateful to you for that.

  • Amy S.

    glad I read these comments as I was ready to spend $ — more than I wanted to. Very helpful to know there is a difference between FDA cleared and FDA approved. Clearly, at these prices I will do more research before buying. Thanks to all.

  • Hello fellow pelones
    I’m a woman desperate to find a somewhat successful solution to at least
    keep the hair I have left after so many years of frustration and
    embarrassment. I notice these comments are a year old, so I’m wondering if by now 5/12 is still the believed that any of the HairMax Laser Hair Comb/
    brush work? I am considering buying the less expensive one $295 even if it takes longer to get the hair back to a normal state. Would you please let me know before I make such purchase. I am on a fixed income and it will be very costly for me to waste this much money on something that will only bring me more frustration. What about the NewHairGrow, or the
    others?
    Thank you so much for your help.

  • Rhonda

    I have been using the HairMax Laser Comb for almost 14 weeks and all I’ve noticed is my hair falling out even more! I look and feel worse then ever. I’ve called and spoke with CS at Lexington International and was told that I needed to give it more time and that hair shedding is one way you can tell the product is working. Does anyone know if this is true? My hair is really getting thin…and I can’t afford to lose more. And after reading all of this information I I will probably be sending it back.
    One question I have is will the hair I’ve lost grow back? If anyone knows this answer…please let me know. I am now more desperate then ever.

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