Hair Loss News

We just interviewed David Michaels (seen on the left), President of Lexington International, about their recent FDA clearance for making hair growth claims for the LaserComb. 

HLH - When did you receive your approval from the FDA?

DM - We received FDA Clearance for our device, the HairMax LaserComb, at the end of January. It is important to note that we received clearance as a medical device as opposed to an approval. In general drugs are approved and devices are cleared for an indication.
           

HLH - Can you tell us exactly what this approval means and what are you allowed to do by the FDA?

DM - We are allowed to claim that the HairMax LaserComb promotes hair growth in men with androgenetic alopecia with Norwood Hamilton scale IIa to V and Fitzpatrick skin types I to IV. The reason why we have to include both male pattern hair loss scales as well as a skin type is that is what our protocol inclusion criteria contained.

HLH - 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.

At first we enrolled both males and females into the study. The FDA guided us in suggesting that males and females are to be individual studies as the etiology of hair loss for each is different.

HLH - Does this clearance apply to your LaserComb only, or to other hand-held lasers as well?

DM - The clearance that we received is specific to the HairMax LaserComb. To date there are no other credible hand-held laser devices in the marketplace that even come close to the efficacy of that of the HairMax. We do get questioned quite a bit about comparisons. We need to emphasize that efficacy of laser treatments for hair is significantly more than just technical specifications of the diode. It is essential to have concentrated laser energy at the base of the hair follicle.

Please appreciate that in order to receive results and efficacy from laser hair treatments you need integrated mechanisms of action with an effective mechanics of delivery. These factors are far more important than a specification on paper. Specifically, you need a laser output that is ‘concentrated’ and coherency such that it produces the signature laser speckling that you see with the HairMax LaserComb. This ensures that the laser energy is ‘brilliant’ for the needed energy transfer for biostimulation even at the base of the hair follicle.

Additionally, the HairMax LaserComb contains patented hair parting teeth that allow the user to plow the hair so that the laser has an unobstructed path for the hair follicle. We believe this is a critical feature, as any device without it simply leaves hair in the way of the laser thus blocking and filtering most of the laser energy.

To date we have not seen any other device in the marketplace that comes close to the potential efficacy and results that a user would receive when using the HairMax LaserComb as directed. We have also not seen a product enter the market backed by a credible and quality-centric company. Please appreciate that when you use our product or an imitator’s product you are putting a laser beam on your scalp. While this is not an inherently dangerous type of device to use, we have seen products advertised on the internet we deem dangerous for general consumer use. With this in mind, we recommend not experimenting with anything that is not manufactured following strong quality controls governed by the ISO standard.

HLH - Have there been any other lasers cleared for hair growth by the FDA?

DM - Not at all.

HLH - What results can people expect from using the LaserComb?

DM - Our extensive clinical experience parallels user feedback and indicates that many people received some or all of the following benefits: a decrease in shedding (controlling hair loss), new hair growth throughout the scalp (including the temporal zone), increased speed of hair growth, an increase in tensile strength of a hair, increased manageability of the hair, normalization of problematic scalp conditions including dandruff and scalp itch, and an improvement in the overall condition and quality of the air. Please note, this is the typical user experience, results may vary from individual to individual. 

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Click here to read our previous coverage of the LaserComb’s FDA submission process