Jim wants to know…I’ve tried products like Scalpmed and Rogaine but none of these have worked too 
good. Is there anything to the laser comb from Hairmax? It says it was approved by the FDA.
Right Brain reflects:
Wow, this question brings back memories. When we were first starting out with the Beauty Brains, we saw a press release or advertisement and wrote this post about the Laser Comb. We were a smidge skeptical (well, Left Brain was really skeptical!) but they did have a letter from the FDA. The letter didn’t say it worked. It just said it was safe to be sold.
Laser Comb Claims
Indeed things have changed. Modern technology can now be used to treat hair loss. An example of which is through hair restoration surgery. More work has also been done on the laser comb. More tests. More trials. They updated their website which now claims
“In January 2007, the HairMax LaserComb® became the first and only medical laser device to receive FDA Clearance to market for the “Promotion of Hair Growth” in males.”
Plus they say that 93% of men in their placebo controlled, randomized clinical study showed significant increase in hair growth.
They conclude that “HairMax Laser Comb
Guys, are you ready to get one?
Not So Fast
Being FDA approved was a big hurdle to clear, but it does not mean Laser Comb will work for you. In fact, the FDA recently sent Lexington International (the makers of HairMax Laser Comb
- The product is not approved for anyone except males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.
- The Premium and SE models have not been cleared for safety
This means that unless you are a male with a specific hair loss condition, you should not expect this product to work. How do you know if it might work for you? You’ll have to see a dermatologist to determine what type of hair loss you are experiencing.
Should you try a Laser Comb?
No doubt, some controlled studies show that the Laser Comb
Beauty Brains bottom line:
There are thousands of products that claim hair growth, but few have FDA accepted clinical studies. Even fewer have a noticeable impact on hair growth. It is easier to prove something in a clinical study than in real life. If you have a specific type of hair loss, the Laser Comb might just work for you. Or you might be out >$500. Is the money risk worth the reward? Only you can decide.
Have you tried the Laser Comb? Did it work for you or the man in your life? Leave a comment and let the rest of the Beauty Brains community know.
{ 6 comments… read them below or add one }
I participated in a clinical trial for the laser comb and no, it didn’t make my hair grow. BUT, like the progesterone cream I used before and after the trial, it kept more hair from falling out. I’m 45 and way post menopausal (surgical). When I started losing more than the standard amount of hair with other menopausal symptoms, my doctor recommended the cream which didn’t thicken nor regrow lost hair, but lengthened the anagen phase or shortened the telogen phase, I don’t know which but either made fewer hairs fall out and let my hair stay in my scalp longer. I took a few months break from the cream and when the hair started falling out in clumps again, I used the comb and it stopped. Once the trial was over I went back to the cream and haven’t noticed a difference between the 2 products. But overall, I prefer the cream.
PIVOTAL CLINICAL DATA PUBLISHED FOR THE ONLY LASER PHOTOTHERAPY DEVICE CLEARED BY THE FDA FOR HAIR GROWTH
Study proves clinical efficacy of the HairMax LaserComb in the treatment of Androgenetic Alopecia in males commonly known as ‘male pattern baldness’
April 27 , 2009 – Boca Raton, FL – Findings of the pivotal clinical trial of the HairMax Laser Comb that provided clear evidence of efficacy and safety to the U.S. Food and Drug Administration will be published in the prestigious peer review journal, Clinical Drug Investigation) in May 2009. Results of the clinical trial were a key factor in the clearance of the device for marketing in January 2007 for the promotion of hair growth in males with Androgenetic Alopecia.
The six-month study, titled, “Double-blind Efficacy Trial of HairMax LaserComb® Laser Phototherapy Device in the Treatment of Male Androgenetic Alopecia,” demonstrates that the device should be considered as first line therapy for all appropriate men with this condition.
According to Mr. Leonard Stillman, Director of Professional Services at Lexington International, “This is the first controlled clinical trial published that proved the clinical efficacy and safety of a laser phototherapy device for treating hereditary hair loss.”
Clinical assessment of treated scalp sites was carried out by objective evaluation of macro-images using dot mapping and computer aided hair counts, and with subjective evaluations by physicians and patients. The study showed that the HairMax LaserComb is an effective and well tolerated laser phototherapy device for the treatment of certain classes of Androgenetic Alopecia in males. The adverse event profile was similar in the two treatment groups and there were no reports of serious adverse events.
According to Mr. Stillman, “The HairMax LaserComb was introduced to the medical community in 2007. Since then, a large number of dermatologists have adopted the device for their patients and it has become a mainstay in their treatment protocols for this psychologically distressing condition.”
Mr. Stillman also noted that male pattern baldness affects more than 50 million men in the U.S and many more millions of men worldwide.
Study Design and Results
The four-center, double-blind, sham-device (placebo), controlled study was designed to compare the results of treatment of subjects randomized in a blinded fashion to either the HairMax LaserComb or the sham device per a protocol approved by an Investigational Review Board (IRB) and performed in accordance with Good Clinical Practices. Subjects were required to have a Norwood Hamilton classification of IIa to V based on the Male Classification System of Hair Loss, and have Fitzpatrick Skin Type Scale I through IV.
Of the patients who completed the six-month study, subjects in the HairMax LaserComb treatment group exhibited significantly greater increase in mean terminal hair density than that seen in subjects treated with the sham-device.
Mr. Stillman further commented, “The results of the study accomplished an important goal. By conducting a well designed and controlled efficacy trial, results showed that the HairMax LaserComb is truly an effective, convenient, well-tolerated treatment for hair loss caused by Androgenic Alopecia in males”.
Interesting press release. Do you have a link to the journal article? We would love to take a look at the way the study was done and the kind of results that were achieved!
Here is a copy of the abstract of the article as contained in PubMed and shows the source of the article.
“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]
It depends upon the amount of hair loss we have . It is normally used by those who have less amount of hair loss
laser therapy is normally being used at most of medical centers for quick relief. As it does not contain any side effects , it is making the things without creating any more complexity