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
We budgeted a significant amount of funds and proceeded as professionally as
possible. We strategically pursued the following tasks.
hired a world authority on hair loss Dr. Martin Unger
to coordinate the clinical trial.
wrote a comprehensive trial Protocol and presented it
to a research ethics committee known as an IRB (Institutional
contracted with a leading laser research center with
2 clinical investigators.
hired a Biostatistician to design the statistical model.
hired an experienced FDA Consultant to communicate with
the FDA and assist with our compliance.
presented a Pre-Ide directly to the FDA for their comments
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.
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.
believe the FDA is being extremely cautious in making its
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.
are three major steps to obtaining market clearance from
the FDA’s Center for Devices and Radiological
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
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.
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.
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
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?
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
hair loss in men and women of all ages in the frontal
and temporal zones.
regrowth of scalp hair
you don't get approval what will your next
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
Can you tell us what the results of the trials
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
The clinical data we submitted was statically significant.
These numbers are significantly better than any other product
approved to date for hair regrowth.
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.
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.