Laser Comb Published Clinical Trial Explained

Laser Comb Info


HairMax LaserComb(R) Laser Phototherapy Device in the Treatment of Male Androgenetic Alopecia: A Randomized, Double-Blind, Sham Device-Controlled, Multicentre Trial

The company that makes the laser comb is using the results of their study as proof that the laser comb does work and that you should buy it.   Just the name of the study is confusing.  The intent of this article is to parse out the language and tell you what this study really means.

Phototherapy, or light therapy, uses artificial wavelengths of light to treat conditions.  Laser is a loosely defined part of the light spectrum.  So laser phototherapy means that a certain range of light wavelengths (near the infrared wavelength) are used.  The field of photobiology is extensive so I am not going to go into the details of the science.  However, typically laser phototherapy is used to stimulate the growth of cells.  Essentially it takes in the energy from the light and that energy stimulates cell growth.

Androgenetic Alopecia is the scientific name for male pattern baldness.  This is the most common type of baldness in men.  Typically it involves a receding hairline into the classic “m” shape as well as a bald spot on the crown of the head.

Controlling for external factors is a huge part of whether a clinical trial can be trusted or not.  For instance, if you put people on a strict calorie diet, exercise a lot, and take a diet pill.  If the participants lost weight, there is no way you could no exactly what was responsible for the weight loss.  There for, you would have a group that only dieted, only exercised, or took diet pills and also all possible combinations of the three.  Then you compare the weight loss for all control groups to see which factor seems to be responsible for the weight loss.  Other factors that may be controlled in a clinical trial are age, medical history etc.  It is important to control any factor that may be at all relevant to the study.  A randomized trial is when the study participants do not know if they are in the control group or receiving the actual treatment that is being studied.  This is important because for instance if you knew you were not actually being given the treatment you may behave or report finding differently than if you think you are being given the treatment.

A double-blind study is when neither the participants nor the scientists performing the study know if the participants are in the control group or not.  This way, they will treat everyone as if they are being given treatment and are more prone to collect data objectively.

Sham0device control means that the control group did not actually use a working laser comb, even though they thought they were.  Lastly, a multicentre trial is when a study is carried out at more than one medical center.  This means that a scientist’s opinions and findings cannot be affected by others.  When different scientists come to the same conclusion independently, the findings carry more weight.

Types of Baldness Laser Comb Can Treat

Laser Comb Info


The HairMax Laser Comb is designed to work for androgenetic alopecia – or male pattern baldness. This is the most common type of baldness in men, even though there could be other medical reasons why you are losing your hair.

Specifically, the laser comb should be used to treat those with male pattern baldness with Norwood Hamilton Classifications of IIa-V and Fitzpatrick Skin Types I to IV. So – what does this actually mean and how do you know if your hair loss and skin fall into those classifications?

First of all, there were two doctors, a Norwood and a Hamilton who are credited with contributing to the classification system. In the 1950’s, Hamilton defined certain patterns of baldness as frontal and frontotemporal (i.e. receding hairline) recession and vortex thinning (i.e. bald spot on your crown). Then in the 1970’s Norwood added on to this by creating a classification system of Hamilton’s patterns of hair loss based on severity.

laser-comb-nh-scale

Type I is basically a normal hairline, even though there may be a slighting receding hairline in the frontotemporal region. Type II is slight recession on the frontal temporal areas. This is where you can start to see the classic “m” shaped that defines male pattern baldness.

Type III is when there is the minimum amount of hair loss needed to be considered baldness. Type III classification consists of hair loss only in the vortex, or crown, region.

Types IV-VII consists of a receding hairline and a bald spot. The severity increases as the classification progresses until there is complete baldness and no hair in between the hairline and the crown (Type VII)

Basically, you can just look at your hair and decide how your hair loss is classified. As you can see, the laser comb is intended for people with moderate hair loss. The laser comb probably will not help you if you have minimal hair loss or severe hair loss.


Fitzpatrick skin type is a similar classification system to determine what type of skin you have. There are six categories ranging from pale skinned people to dark skinned people. It is not just how your skin looks that determines your classification but also how your skin reacts to sunlight. Answer the questions on this simple questionnaire to see what skin type you are.

People with higher Fitzpatrick classification tend to be darker skinned. They are darker skinned because they produce more melanin than lighter skinned people. It may seem counter-intuitive but it is recommended that people with Fitzpatrick skin types of V or VI do not use laser therapy because of this. They could produce enough melanin to have permanent scarring or discoloration.

Is the Laser Comb Approved by FDA?

Laser Comb Info


It can be very overwhelming to try and find your way through product claims, marketing campaigns, and advertisements.  Sometimes it feels like if everything they say in the commercial is true – then it would seem like I would have heard great reviews from someone I know.  I could be way off base, because when there is new technology out there it takes time for it to infiltrate the market.  Hopefully this article will give you some information about the Laser Comb so you can decide for yourself.

 The company that makes the laser comb implies that the device has been apprived by the FDA for hair growth in males with a specific type of hair loss.  So how do we know if this is really true or not?  How do we decide what exactly the FDA has approved?

 One thing is for sure, there are not easy answers to those questions.  I will outline a little bit of what I do know for sure.  The HairMax LaserComb has received clearance from the FDA in accordance with the FDA 510(k) regulations. 

 Figuring out exactly what 510(k) clearance means is difficult.  According to some, it merely means that the device is safe to use.  According to others, it means that it is okay for the company to market the product according to their specific claims (ie hair regrowth). 

 According to the FDA, “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device..”  The devices that are listed on the 510(k) form for the Laser Comb do include devices that have nothing to do with hair growth.   So it does leave you to wonder if the FDA clearance that your device is “substantially equivilant” to A&M Hair Removal, is this really the kind of approval you want to promote? 

 Click here to view the actual HairMax Laser Comb 510(k) approval from the FDA.  As you can see, on the last page of the approval letter from the FDA, they have approved Lexington to market the device with the intended use “to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.”

 So the company is not lying or misrepresenting the truth, which is great news!  The FDA has given permission for Lexington to market the laser comb in this way.  However, I see no evidence that says this is because the FDA agrees that the device is effective.  This is something you will have to figure out on your own I suppose.