22 Jun Before/After Photos, Review: Hairmax Laser Comb – FDA Cleared, Approved Treatment For Hair Growth
The new HairMax Laser Comb introduced by Lexington International promotes hair growth. It also prevents further hair loss; thickens hair; improves quality, shine and manageability of hair. It employs Patented Low Level Laser Photo Therapy and is FDA Class-2 cleared. It is an effective, safe and convenient at home treatment with no known adverse side effects. It comes in 4 models: Advanced 7, Lux 9, Professional 12 and Premium 2011 model (each with varying levels of strength).
The device is placed flat on scalp making sure that both rows of teeth touch the scalp. With its Patented Teeth Mechanism and Patented Hair Parting Mechanism, the hair parting teeth push hair aside to create a direct path between the laser beams and the scalp. It is required to move the device very slowly at around half an inch every 4 seconds without lifting it from the scalp. If moved very fast, the treatment may not be as effective. It comes with an automated beep which lets you know when to move the device to the next portion of scalp. It is suggested to use for 10-15 mins a day, thrice a week on non consecutive days for at least 12 weeks.
The mechanism involved is Photo Biostimulation. The laser energy emitted increases cellular metabolism. The increase in blood flow brings the important nutrients into the follicle while taking away harmful waste products. The hair follicle then has the building blocks and energy to transform from a weakened follicle to one that is healthy and capable of producing thick hair.
Clinical Study:
Recent clinical study in 2007 at 26 weeks with 460 clinical study participants in 6 double blind clinical studies was conducted. They were advised to use the treatment 3 times a week on non consecutive days for 10-15 minutes per treatment. Subjects using HairMax Laser Comb showed 23.3 hairs/sq cm hair growth rate while compared to 0.9 hair/sq cm hair growth rate for a placebo device. Success rate was over 93% and an average of 24% hair regrowth.
Hairmax Laser Comb Advanced 7 comes in $295, Premium Luxe 9 comes in $495 and Professional 12 comes in $545 at Hairmax.com. These products are also available at Amazon, Overstock, Dermadoctor and Sears Marketplace.
So given what you’ve read, would you be willing to try this product? Leave us a comment below. By doing so, you’ll be joining our weekly newsletter where you’ll get tons of chances to win free beauty product samples.
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– by Upasana Sahu
Left Brain
Posted at 11:41h, 22 JuneI just have to wonder, why is the lighting different in the two photos? If this were a serious study, every effort would have been made to ensure that the photos had exactly the same lighting.
It should also be noted that the FDA has weak rules when it comes to approving medical devices (which this is considered). That they approved it for sale only means that it is safe for people to use.
I remain skeptical about hair growth.
Leonard Stillman
Posted at 15:41h, 23 JuneI am Leonard Stillman, Director of Marketing at Lexington International, LLC, manufacturer of the HairMax LaserComb. This post is not for commercial purposes, but to correct a statement as it pertains to the HairMax from the comment from ‘Left Brain’.
The FDA Clearance for medical devices uses the 510(k) filing method in most cases. This filing requires devices to prove that they are safe and equal in efficacy to devices that have been previously marketed. However, in some cases where a device is for a new indication such as hair growth, the manufacturer is required to submit evidence of efficacy and safety from well controlled, blinded, and control device studies. The HairMax was subject to this requirement and the results of a well controlled study conducted in 2006 was submitted to the FDA as part of the 510(k) submission and was a key factor in the Agency’s decision to grant Clearance for marketing in 2007 for treatment of males. Just recently in June 2011 the FDA Cleared for marketing the HairMax for the treatment of hereditary hair loss in females based on a rigorous clinical study. Further, the results of the 2006 study was published in a peer review journal, and the abstract from http://www.pubmed.gov is printed below:
“Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.
HairMax LaserComb 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.
SourcePrivate Dermatology Practice, Maitland, Florida, USA.
Abstract
BACKGROUND AND OBJECTIVE: 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 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 laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia (AGA).
METHODS: 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 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.
RESULTS: Of the 110 patients who completed the study, subjects in the HairMax LaserComb 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 was well tolerated with no serious adverse events reported and no statistical difference in adverse effects between the study groups.
CONCLUSIONS: The results of this study suggest that the HairMax LaserComb is an effective, well tolerated and safe laser phototherapy device for the treatment of AGA in males.
PMID:19366270[PubMed – indexed for MEDLINE]"
We hope that you will post this to set the record straight about the rigorous requirements that Lexington went through to become the only home use laser phototherapy medical device on the market with FDA Clearance for the treatment of hereditary hair loss in both males and females.
Tracy @ Ascending Butterfly
Posted at 07:46h, 26 JuneI think it’s great Leonard posted here about what had to be done for the FDA certification, what I’m not clear about here, is did Beauty Stat get to try this out? Is the person in the photo a Beauty Stat employee, or was the photo provided by Hair Max?
The article caught my interest because I have always had very fine, thin hair and during periods of very high stress will experience way more thinning. I’m always interested in products that will help with thicker/fuller hair, if you are reading this, send me one to test! 🙂
rb
Posted at 23:23h, 02 Julyi have really fine and now thinning hair. i hope this actually works because i need something! any personal reviews not from the company???
Upasana Sahu
Posted at 14:04h, 13 JulyThe picture is from HairMax