It’s been several years since the LaserComb debuted on the market as a unique hair loss treatment option. The response to this treatment has been mixed and HairlossHelp wanted to get an update on the latest info as far as the use of the device goes and its efficacy in treating hair loss.

For those unfamiliar with the LaserComb, it’s a handheld “hairbrush-looking” device that contains a low level laser on its underside. The LaserComb is used like a regular comb or brush and emits laser light while the user brushes their hair and scalp with it.

According to claims made in literature provided by the manufacturer Lexington International, “Within the first 12 weeks, you should notice early general improvements or activation of your hair occurring. These improvements should include a normalizing of scalp condition, shinier and thicker hair. Then, over the next few months, you may notice your hair gradually becoming fuller, stronger and denser. Also, as your scalp gets healthier, you may notice less dandruff and scalp irritation. “

While some people express skepticism that lasers can be beneficial for hair growth, others are confident that it can.

Dr Glenn Charles

Dr Glenn Charles, DO, a Florida-based hair transplant surgeon, became intrigued with the device and its possible uses. He wondered if in addition to helping patients with hair growth, the LaserComb could help speed up the healing process and minimize scarring in hair transplant patients. He also wanted to determine if there was less postoperative shock fall out (telogen effluvium) in hair transplant patient after using the device.

Dr Charles approached the company with his interest and conducted clinical trials on some of his patients where he monitored their hair counts, hair color, and overall health of the hair and scalp.

One clinical trial which was submitted to the FDA clinical trial involved five male subjects with ages ranging from 21 years to 59 years. All the participants were experiencing hair loss and were not taking any medications or using any products related to hair loss. (Propecia, Rogaine, or Avacor). Each patient had two areas tattooed, one in frontal region and the other in crown (back of head) region. Manual and computerized hair counts were taken at beginning of study and again at 4 months. Any changes in hair or scalp characteristics were also noted. In all subjects there was an increased hair count with the average increase being between 40 to 55%. Two patients also noticed a darkening of hair (decreased amount of gray hairs), One patient noted significant improvement of scalp dryness (flakiness) two participants noted no noticeable changes in the hair or scalp characteristics. There were no negative side effects or other complaints expressed by any of the subjects involved with the study.

Subjects from the clinical trial - (click to enlarge)

In a analysis that he conducted on his hair transplant patients, Dr Charles attempted to determine if patients who used the LaserComb immediately following surgery healed faster, had less shock fallout of original hair, and faster growth of transplanted follicles. Each patient in the study was instructed to only apply the laser light to the right side of the donor and recipient areas for 10 minutes each day. Follow up visits with comparisons of right and left sides were taken at 1 day, 1 week, 1 month, and 6 months. According to Dr Charles, in all patients postoperative redness of scalp faded faster on the laser treated side. There was also less shock fallout and faster regrowth of newly transplanted follicles in all but 3 patients. In these 3 patients there was no measurable difference between laser treated and untreated side.

After reviewing results of both studies Dr Charles feels very confident that the lasers cause no harm. (There were no adverse reactions or patient complaints from either study group), and that a significant percentage of people will benefit in one or more ways by using Laser Light Therapy. In hair transplant patients he feels that this may include decreased shock fallout of native hairs, quicker return to normal pigmentation of scalp, and faster growth cycles of the transplanted hair follicles. In non-transplanted patients there can be improvement of scalp dryness and flakiness (patients with seborrheic dermatitis). There may also be an increase in hair shaft diameter along with an increased number of total hair follicles. Some patients may even see more of their original hair color (pigment) after using the LaserComb. Overall, almost all patients felt that their hair and scalp felt healthier and fuller after using the Hairmax LaserComb â .

When was the LaserComb study submitted to the FDA?

We began the LaserComb study in April of 2002 by submitting protocols developed by the doctors and researchers under which the trials would be conducted. These protocols were a detailed description of how the data was to be gathered, who would be included in the study and all the criteria that would be presented in the findings.

After review of the protocols by the FDA, the actual study began in July 2002 and continued with male and female patients through the spring of 2003. Data was tabulated and a report issued with the results from the study. After all the preparation work and gathering data, the study was submitted to the FDA in May of 2003.

What is the current status as far as approval goes? Please describe the process you went through.

For the last 2 years Lexington has been focused on conducting scientific clinical trials and preparing a FDA 510K Submission. We are extremely excited about the potential of the LaserComb as our experience since the1980s has clearly demonstrated a very effective treatment for hair with a high degree of user satisfaction. Our company agenda is to qualify the HairMax LaserComb as an attractive, affordable and user friendly treatment.

We budgeted a significant amount of funds and proceeded as professionally as possible. We strategically pursued the following tasks.

• We hired a world authority on hair loss Dr. Martin Unger to coordinate the clinical trial.
• We wrote a comprehensive trial Protocol and presented it to a research ethics committee known as an IRB (Institutional Review Board).
• We contracted with a leading laser research center with 2 clinical investigators.
• We hired a Biostatistician to design the statistical model.
• We hired an experienced FDA Consultant to communicate with the FDA and assist with our compliance.
• We presented a Pre-Ide directly to the FDA for their comments and guidance.
• We finalized the 510k submission and had formal panel review.

FDA Clearance of New devices and new ‘indications of use’ is an in-depth process with many factors considered. Once the submission is lodged they have 90 days for their comments and every time they ask a question another 90 day clock begins. A 510K submission assumes that there are ‘predicate device’ and ours was submitted on the basis of there being substantial equivalence of other light based devices (non hair related) in the market.

At this stage the FDA has stated that they have not found other predicated devices cleared for 510k acceptance, they suggested that we need a ‘De Novo’ filing. They also requested a second phase of studies. It is common for the FDA to make this request especially for devices with new indications of use. This does not take away any merit of the strength and statistical significance of the clinical data we presented.

Since our clinical results were statically significant and superior to any other product on the market we thought we would have clearance on our first attempt.

We are continuing in our communications with the FDA to qualify each and every one of their requirements, beyond any reasonable doubt, and will continue and proceed with additional studies.

As we hope everyone could appreciate FDA approvals and device clearance take years and require extensive scientific data, comprehensive FDA compliance documents and regulatory advisors to present a strong submission. Most rulings are through a panel decision with some variables based on objective and subjective information.

As one of the Directors at Lexington International LLC, the developers of the LaserComb, who managed the process of the FDA submission I can state that we have great confidence in the HairMax LaserComb and the clinical results. We are continuing our scientific studies and submissions until we receive market clearance for medical regrowth claims.

I only wish the process was less cumbersome and the tasks for clearance easier to define. In the meantime we will find out what the legalities are of publishing the clinical data on this site.

Why has it taken so long to get approval?

Approval for any product can be very time consuming. Some products have taken many years to get approval or clearance. This is the nature of this very large bureaucracy and that is an accepted fact for anyone who has dealt with the FDA.

The LaserComb is unlike any treatment for hair loss that has come before. However we underestimated the dropout rate of participants which skewed our final data. With Laser PhotoTherapy, a whole new category is being considered in the FDA for light therapies when applied to hair growth. Currently, several laser and LED light instruments have been cleared by the FDA for pain.

We believe the FDA is being extremely cautious in making its final decision. 

What does the FDA approval process entail?

The FDA approval process involves multiple layers of actions and a very complex set of requirements to meet.

There are three major steps to obtaining market clearance from the FDA’s Center for Devices and Radiological Health (CDRH):

STEP ONE in the process is to meet the definition of a medical device in section 201(h) of the FD&C Act.

STEP TWO is to determine how FDA may classify your device - which one of the three classes the device may fall into. Unless exempt, FDA will classify your device. Classification identifies the level of regulatory control that is necessary to assure the safety and effectiveness of a medical device. Most importantly, the classification of the device will identify, unless exempt, the marketing process (either premarket notification [510(k)] or premarket approval (PMA)) the manufacturer must complete in order to obtain FDA clearance/approval for marketing.

STEP THREE is the development of data and/or information necessary to submit a marketing application, and to obtain FDA clearance to market. For some [510(k)] submissions and most PMA applications, clinical performance data is required to obtain clearance to market. In these cases, conduct of the trial must be done in accord with FDA's Investigational Device Exemption (IDE) regulation, in addition to marketing clearance.

Before marketing clearance is obtained the manufacturer must assure that the device is properly labeled in accordance with FDA's labeling regulations. Once clearance for marketing is obtained, the manufacturer must register their establishment and list the type of device they plan to market with the FDA. This registration and listing process is accomplished by the submission of FDA Form 2891 and 2892.

The LaserComb first made a submission as a cosmetic device for safety with claims for ‘thicker, fuller, healthier hair’. Lexington International has continued this certification process by seeking classification as an over-the-counter medical device with specific claims to ‘stop hair loss and stimulate the re-growth of hair’. This process required establishment and review of a study protocol.

PROTOCOLS

The LaserComb study was designed as a single group efficacy and safety study to evaluate the ability of the LaserComb device to promote hair growth in adult males and females of at least 18 years of age. Study subjects were required to have thinning hair in the scalp area, have Skin Types 1-IV, and have active hair loss at the time of entrance into the study.

Upon review of the protocols by the FDA, Lexington proceeded with studies with male and female patients at a leading USA research center performed by certified doctors, researchers and statisticians. Specifics on this study can be found under the last question.

How many people were in your study you submitted to the FDA?

A number deemed to be statically significant.

If you do get approval when is it likely to be and for what claims?

Date of clearance is out of our control. We will not stop the process and studies until we do receive clearance. We are targeting the follow indications of use

• Controls hair loss in men and women of all ages in the frontal and temporal zones.
• Stimulates regrowth of scalp hair

If you don't get approval what will your next step be?

Regardless of the status of the FDA clearance as a medical device, the LaserComb is already classified as an FDA cosmetic device capable of making hair “thicker, fuller and healthier”. People who have stress with their hair can be confident that the LaserComb can, indeed, deliver on these claims. As has been the case since the LaserComb was introduced to the market, each individual consumer has the ability to use the LaserComb under a very generous money-back guarantee. Each individual is different and has a greater or lesser response to the laser therapy. Since the LaserComb comes with a 12-week money-back guarantee and that guarantee can be extended an additional 8 weeks, each consumer has the confidence in knowing that he or she can get a refund if the product does not perform up to their expectations. The consumer is the final arbiter of the effectiveness of the HairMax LaserComb. To date, there is a 7 percent return rate on all purchases. This means that tens of thousands of LaserComb users have seen significant improvements to their hair and have decided to keep the LaserComb. Specifically, that’s 93 out of 100 men and women who have used the LaserComb from 3 to 5 months are satisfied with the results they have achieved. This is a remarkable statistic and FDA clearance will not change the reality that the LaserComb is effective in helping people .

Can you tell us what the results of the trials were?

Clinical studies were performed under an FDA reviewed protocol at one of America’s leading research centers to qualify and quantify the efficacies of the LaserComb as a medical device for use in treating Alopecia (hair loss). Both male and female patients, with ages ranging from 26 to 76, were included in a six month evaluation period. Study subjects were required to have thinning hair in the scalp area and have active hair loss at the time of entrance into the study. Analysis was conducted at two locations on the scalp, in the temporal and vertex areas.

Before the use of the LaserComb began, each area was clipped and a high-resolution photograph of the location was made. These photographs were loaded into an imaging system that identified each hair shaft. After magnification, a standard hair count was carried out and the number was recorded for comparison later in the study. Following the initial marking and hair count, each patient was provided a HairMax LaserComb. They were instructed to use it twice a week for the prescribed time of approximately 10 minutes, covering the entire scalp twice with each treatment.

Each month, the patient would return to the clinic to have the study areas clipped, new photographs taken, and new hair counts recorded.

The clinical data we submitted was statically significant. These numbers are significantly better than any other product approved to date for hair regrowth.

All p-values for the study were also statistically significant. The p-value (or the probability that a variate would assume a value greater than or equal to the observed value) for this study’s endpoint (<0.0001) indicates that the results of this study would have a very high probability of being valid across the general population.

Furthermore the LaserComb has been demonstrated in this clinical study to work effectively in both the frontal hairline region and in the vertex or crown area. This is very important as no other product on the market has shown significant effectiveness in both these areas.