HairMax LaserComb(R) Laser Phototherapy Device in the Treatment of Male Androgenetic Alopecia

Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.
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.

Several years ago I tried this out. The shoulder pain and inconvenience got a little old after a few months. I don't remember seeing any improvement and I used nothing else during the experiment.

I thought this post was interesting if true ...

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"Having previously been requested to become involved in a clinical trial for laser therapy FDA approval, I know how manipulated these ˜clinical trials' can be. You pre-select your subjects in age, minimal hair thinning, total health check, supplement them with protein and nutrients until it comes out their ears – and you're ready to go.
˜98% success rate' can mean ONE additional hair has been counted within a one centimeter-square designated area of the subject's scalp ... In my opinion this is statistical crap that means nothing to the everyday consumer."

http://hair-restoration-info.com/eve/forums/a/tpc/f/3466060861/m/8651037373

This was also interesting .....

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"How long has it taken you to get FDA clearance?

DM - We started on the road to receiving FDA clearance back in November of 2001. This was our second submission. Unfortunately we had followed the guidance of our former medical director who had provided us with poor direction and failed miserably in professionally conducting a study. Our first clinical study was based on the protocol of laser hair removal and was only conducted at one site and without a control. We accepted this as our learning experience and paying tuition in clinical studies. After this submission was rejected by the FDA we hired true professionals in the field of clinical studies.

For the clinical study completed in 2005, Lexington closely followed GCP (Good Clinical Practices) with all protocol matters and consent forms approved by an IRB. We hired a professional trial monitor to visit all sites to review compliance and all case report forms. We hired a professional data manager to correlate all of the data for the Biostatistician. The hair counts were performed by a physician specializing in hair loss. The hair evaluation was a blinded undertaking which went through two reviews before they were signed off by the physician.

The Biostatistician analyzed the ideal subject enrollment ‘n’ (with a confidence level of 95%). It was considered that we would have drop outs and some clinical errors; therefore, we increased the ‘n’ by 30% for a successful trial."

http://news.hairlosshelp.com/fda-news/interview-with-hairmax-over-their-recent-fda-approval-for-the-lasercomb/

jdp710 - That's the best explanation I've heard about the Hairmax lasercomb.