March 24 2008, 3:33 pm PT | Posted in: Hair Products
Greetings Dr. Rassman,
We’d like to thank you for taking the time to acknowledge the HairMax LaserComb on your Web site. We take this opportunity to respond to some of your comments and attempt to put to rest much of the ongoing debate over the HairMax LaserComb on your site.
In January of 2007, the HairMax LaserComb was Cleared by the FDA for the “Promotion of Hair Growth” in males with certain classes of Androgenetic Alopecia. This Clearance was based, not solely on a predicate device (as you’ve stated in your blog), but also on solid clinical data from our multi-centered double blind sham controlled study which followed all Good Clinical Practices.
For your readers reference, there are two processes for medical device approvals from the FDA, one being PMA (Pre-Market Approval) and the other is a 510K. Since our laser is considered a NSR (Non Significant Risk) device as defined by international laser safety standards, we appealed to the FDA to submit a 510K based on the safety of predicate devices.
Our clinical study, device labeling, GMP (Good Manufacturing Practices) and ISO (Quality) accreditation was the basis of receiving the FDA 510k Clearance.
The study took place at 5 sites throughout the United States. We are currently drafting a medical review of the study to be submitted to a peer-reviewed journal. We have every intention of publishing the study and making the full results available for public scrutiny.
Our statistical data, along with macro analyses of trial participants’ before and after images were proven to be medically significant. Our clinical protocol was IRB approved, followed GCP (Good Clinical Practices) and we utilized clinical trial monitors to verify all source data and case report forms. Please understand that we had to prove to the FDA, under the same statistical scrutiny as both Propecia and Minoxidil, that the HairMax was effective in increasing ‘Hair Counts’ in men with Androgenetic Alopecia.
In addition, we have just completed a clinical study for female Androgenetic Alopecia and have filed a new FDA 510K submission for females. We are cautiously optimistic that it will receive Clearance for females suffering from hair loss.
As for statements on your site concerning the difference between FDA approval and FDA clearance, here is the rule of thumb for submissions cleared by the FDA: In general, Drugs are ‘Approved’ for sale, and Medical Devices are ‘Cleared’ for an ‘Indication of Use’.
In your ongoing critique of the HairMax LaserComb, you also compare the technology to that of the laser hood. Here, again, you are not taking in to account the differences between the two devices. Yes, the HairMax LaserComb and the laser hood both use red lasers, but the HairMax uses a patented special array of hair parting teeth which allow for an unobstructed path of the laser to the scalp. We believe this direct laser path to the hair follicle is a critical design feature which makes the HairMax LaserComb standout from the laser hood and provides greater efficacy. Simple reasoning would indicate that an individual’s hair will block some of the laser energy from the laser hood and they would simply not see comparable results because the laser energy would not reach the scalp.
We have conducted an experiment aimed at assessing the delivery of our laser to the scalp with a specific emphasis on the efficacy of the HairMax LaserComb’s patented hair parting teeth. The results showed that 92% of the laser energy emitted from the HairMax is delivered precisely and accurately due simply to the movement of the hair away from the scalp by the hair parting teeth. The efficacy of laser therapy reaching the scalp of non-parted hair amounted to only 9-24%. Obviously this design feature is only valid for someone with hair.
Finally, your critique of the HairMax always seems to point to an alleged lack of clinical data and a clear mechanism of action.
Similar to Rogaine, how the HairMax LaserComb works is debatable and evolving. It is our hypothesis that the HairMax LaserComb, in some way, stimulates the dermal papilla leading to increased cell proliferation of the hair matrix. We believe this process causes increased production of the hair fiber. Supporting this hypothesis are user reports of faster growing hair.
We further hypothesize that the HairMax is an anagen inductor, and support this hypothesis by user reports of increased shedding at the onset of treatment. To us, this indicates an increase in telogen fallout leading to healthier anagen growth.
A few of your prominent colleagues suggest that the HairMax LaserComb may also have some effect on cell apoptosis, but we will not comment further as we know it will spark debate and we do not have any scientific premise to support this theory, yet.
We are about to conduct further research with histologic biopsies to document some of the changes which occur after HairMax LaserComb usage.
Please understand that when we went public with the fact that we were proceeding with clinical trials, naysayers complained that it was just a farce for us to attempt to increase business. Now that we have proven, through our FDA clearance, that clinical trials were conducted, some people still continue to be skeptics…The real issue seems to be that people are not willing to move away from the status quo. Rogaine and Propecia are approved; we are Cleared; all three of us have been proven as effective treatments for Androgenetic Alopecia.
We don’t guarantee that everyone will see results. From our extensive anecdotal experience spanning over 20 years, we have seen that 45% of users see benefits quickly, 45% of users see benefits over time, and 10% of people will see little results. Keep in mind, compliance is a major factor in the realization of benefits. In reality, treatments for any condition are never a sure bet, and we do not contend that our product is a miracle for hair loss sufferers. It does, however, offer well founded hope and quantifiable results, and that’s what we’re about.
To conclude, we have been collaborating with leading hair researchers and clinics across the world. What we’ve found is that the experts who actively use the HairMax LaserComb accept its efficacy; those who do not remain skeptical.
This seems to be the same issue we encounter with non-users of the HairMax LaserComb who are quick to complain that it is ineffective, but are unwilling to give it a chance to work. The HairMax LaserComb has been on the market since 2001, and one of the key factors in marketing a medical device is user experiences. We believe the HairMax LaserComb has one of the highest levels of customer satisfaction of any hair treatments. In addition to positive changes in hair growth, the quality, condition, tensile strength and manageability of the hair is enhanced. We offer a money back guarantee to our direct customers; if the HairMax LaserComb was not an efficacious treatment we would have been in the archives of a ‘hair loss snake oil’ schemes by now. Instead, we have achieved FDA accreditation and gained acceptance from hair experts and have satisfied users worldwide.
We hope that this clears up any misunderstandings you or your readers may have about our medical device.
Sincerely,
Lexington International LLC
I would love to believe that the technology works, but as yet, I can not become a supporter. I will look forward to your new publication and will read it with interest. I try to give controversial issues space on this blog to give a balanced view, so your response is appreciated.
Related Entries
- Continuing the LaserComb Debate…
- Where Are the Published LaserComb Trial Results That Lexington Promised?
- Any Difference Between the Various Laser Combs Offered?
- HairMax Say They Challenged You on Your LaserComb Findings
- The Study That Was Submitted to the FDA Before Approving the LaserComb
I am aphsyicain, clinical investigator, and baldness “patient.” It is comforting to know that the company is currently drafting a medical review of their pivotal study to be submitted to a peer-reviewed journal. This should have been done years ago. At present, the data presented on their site (including the aforementioned study) lacks significant information commonly associated with presentation of clinical data, and thus does not allow readers to evaluate risk/benefit. The cpmpany would be best served by altering their web site to include such information and including data that allows other claims to be put into context (e.g., information on length of time of lasercomb use associated with pictures). Until then, the company comes across as being run by marketing folks rather than the scientists who generate and are usually associated with presentation of clinical data.
I am impressed with the length that the company is going to to clear its name of being a scam. I myself purchased this device and am giving it a solid year to see if it will work. I started in mid-February 08,1 month after my 2500 graft hair transplant.
I hope this will in fact be proven to work to strengthen the hair/increase the diameter and make it healthier overall. If it promotes hair growth all the better.
Don
That’s intereting, according to the actual study, and the 510k letter, Lexington conducted tests at only 4 sites, makes me wonder how many sites and how many people actually participated in the study and if the FDA can confirm how many people Lexington initially enrolled for the study.
Dear Lexington
I am not able to comment on the reliability or scientific soundness of your clinical trials. Alas we’ve all been deprived of the opportunity by your rather strange and very atypical decision not to release full details for public scrutiny and for peer review. I’m aware of your promise to now do so, but there’s no reason why this shouldn’t have been done a long time ago.
What little we can see just adds further to the skeptisism. Dr Rassman, who your chief medical advisor holds in very high regard for his “professionalism” and “intellectual brilliance”, has disputed your hair counts, claiming to be an expert as he holds the patent for the technology used. Further to this, your before/after photos make a fair comparison difficult, and give the impression (rightly or wrongly) that standard methods have been employed to exaggerate the difference (if any), including hair wetting, combing of hair in different directions to alter the amount of scalp exposed and tilting the head so the hairline appears further forward.
In the absence of a peer-review, you use the FDA clearance as an effective equivalent, claiming it to be a process that is little different to the FDA’s PMA Approval. Indeed you claim that you “had to prove to the FDA, under the same statistical scrutiny as both Propecia and Minoxidil,” and proceed to give a very simplistic explanation of the difference in the two processes. But the FDA go to some lengths to make clear that there is a big difference between the two, for example under the DATA REQUIREMENTS FOR 510(k)s section within their K86-3 guidance notes:
“While the Center has concluded that it should sometimes require performance testing data in order to confirm that a new device is Substantially Equivalent, the 510(k) review process is not a substitute for premarket approval, and the Center does not attempt to address all of the issues would be answered in a PMA in its review of 510(k)s. Data in a 510(k) should show comparability of a new device to a predicate device, whereas demonstration, in an absolute sense, of a device’s safety and effectiveness, is reserved for PMAs.”
So this blows a massive hole in your claims.
Most 510(k) applications are not supported by clinical trials. Most are cleared by proving substantial equivalence (same technological characteristics and same intended use) to a preamendments device that itself has not been proven to be effective. So it just doesn’t make sense that because you submitted clinical information, your application suddenly inherited a massive burden of proof that most other applications don’t have. The FDA may largely have taken your trials at face value; because they showed that it is safe for the intended use, it delivers a laser beam to the scalp as claimed, and APPEARS to be a bit effective. This would be in line with their K86-3 guidance notes on clinical trials, and to do anything more involved would not have been in their remit.
If you disagree, what level of effectiveness did you have to prove to the FDA? Their definition is “at least as effective” as the predicate, which in your case is 0%.
The FDA has supposed safeguards to prevent against this kind of misrepresentation, in particular Sec. 807.97 instructs that a 510k clearance “does not in any way denote official approval of the device”, and that “any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.” Yet you’ve been doing exactly this, and using the word “cleared” instead of “approved” doesn’t mean that you’re complying with this directive. (Creating an “impression” of official approval is misbranding without actually stating “approval”.) You don’t always even use the word “cleared”, and have described it as “FDA accreditation” here.
If you have written confirmation from the FDA of the level of efficacy they required you to prove, of the analysis and scrutiny they applied to your trials and even whether you submitted the full version to enable them to do so, then prove it by publishing their correspondence. Otherwise you should not be making such claims as you really don’t know exactly how the FDA scrutinized them.
The documentation I’ve seen from the FDA makes reference only to your submission of summary details of the HairMax clinical trials (as is the norm for 510(k) applications), and that your clearance was granted due to the “finding of substantial equivalence to a legally marketed predicate device” (no mention of having been proven to be effective). Oh and it also makes clear that your clearance was granted subject to you complying with Sec. 807.97 “Misbranding by reference to premarket notification”, which forbids you from making “any representation that creates an impression of official approval” by the FDA of HairMax.