MEP-90 Laser and FDA Clearance
I know you guys know about the MEP-90 laser and its manufacturer MidwestRF, I was looking around on the internet and I found something rather interesting.I found a page that goes somewhat in depth about the methodology as to how the MEP-90 received its clearance.
Apparently the MEP-90 study wasn’t double blinded and the the only explanation that the report gave was this: “However, a sham/placebo study is not applicable to the long term required treatment of female androgenic alopecia because too many variations exist that would make it unfeasible to run a large number of experiments and it would constitute unethical treatment of the subjects.”
Interesting considering that the Hairmax lasercomb recently recently received clearance for the treatment of androgenetic alopecia in females by use of a double blinded study. This report also stated that Midwest RF has been manufacturing hair lasers since 1999 but all records I could find indicate that the only thing they manufactured were MRI components. It’s also interesting to note that for some reason this company received stimulus funds why I have no idea. Here is a link to the report: here.
tell me what you or someone familiar with clinical trials thinks about it.
I generally do not trust clinical studies that are not double blinded, or have researchers with something to gain from the results. Most studies in the low level light area have failed to prove that there is a scientific result that is clearly positive.
I’m not a laser expert by any means, so I’ll defer to our readers that have more experience with this.
Dr. Rassman, if it truly is AGA from DHT, it should have at least SOME response to Finasteride, correct? The pill lowers serum DHT 70 percent and scalp DHT nearly 40 percent, so it should help at least slow things down, right?
Obviously placebo-controlled studies in non-life threatening diseases where lack of therapy produces no significant adverse outcome – are not considered unethical by patients, regulators, and scientists – and are the only way to show proof of efficacy (which is why this design is required by the FDA and other agencies). True placebo controls by themselves are only considered unethical (and not allowed) if a condition is life-threatening and available therapy is on the market; however, even in these clinical trials, the standard of care with placebo vs standard of care with new experimental drug (i.e., combination therapy) is often the design employed. Without knowing anything else (and I’m not a laser expert), the statement about placebo would make me suspicious about the “robustness” of other statements in the white paper.
I can’t speak for the reason behind the trials, but I can tell you beyond any doubt that the machine works. I’m curretnly undergoing therapy at a clinic in Pittsburgh that has 2 machines. I’ve not only seen the results with my own eyes, but my own crown can show the exact difference in 3 months.
This isn’t like the cosmetic lasers at all. This is actually filling in my crown with NEW hair, not just thicker existing hairs.
And although the FDA trial was only done on women, I can assure you that I’m male and it works PERFECTLY.
Keep doubting… it’s easier to get my appointments when I need them with all of you balding doubters!
oh, and I’d be happy to show you the back of my head, before and after 3 months if someone wants to see it. I don’t know how to post a picture.
I’m not done yet, but in another 3 months it should look just like the rest of my head.
Call HRI and talk to the guy there. He has over 50 clients and all of us are having great success!
Steve: Are you taking finasteride?
I was thinking that perhaps Dr. Rassman has a much higher proportion of patients on finasteride (he tries to get all his transplant patients to take it for at least 1 year, etc), and that explains the difference in results.
Maybe the laser treatment is effective at neutralizing or degrading DHT in scalp tissues, but doesn’t offer much benefit in patients already lowering their scalp DHT with finasteride?
no. I take nothing orally besides the vitamins that they include in their “wet line” products.
I’m not sure that DHT blockers ultimately help with breaking the DHT up that’s already surrounding the hair shaft and follicle. I believe that’s why this laser is so effective. I’ve tried the Revage and another laser and saw nothing but supposedly thicker existing hair.
All of their products include DHT blockers, but my understanding of the laser is that because it gets the 650nM and actually maintains that wavelength (unlike the cosmetic lasers on the market that have plus or minus 5 to 10% tolerances) with a tolerance of less than .01%
Sorry, I tried to write down everything to understand it, but that’s the biggest part of it.
Steve how did you get a prescription to use the device considering that it is for women only? Is the “clinic” you go to run by doctors or hair stylists in white lab coats? If it’s the latter then there is an expression for that sort of thing, it’s called “Practicing medicine without a license.” This is another problem I have with the MEP90 it is a device that is supposed to be used by prescription only under the supervision of a doctor, but places like HRI are bascially hair salons in which no one there has any medical expertise whatsoever (with the exception of the hair surgeon who usually practices outside of the state that these offices are in). Oh if only someone would file a complaint to the local board of medical practice.
Bill – I think you describe a lot of places but you must not know much about HRI. It’s really wrong that people like you dominate these forums with little or no knowledge of what you’re talking about. There are indeed answers out there, but forums like this that get dominated by someone who THINKS they know everything do nothing more than scare off people who could be getting real results like I am.
Androgenic alopecia (which is what the MEP-90 is approved for) is the same whether in a female or male. If you haven’t tried the laser, you probably shouldn’t come across as an expert. It works.
The facility I’m talking about does in fact have a doctor who oversees the entire operation. I have met him and he’s a board certified transplant surgeon. I’ve talked to him about the possible need to do a transplant for the heavy recession in the corners. So far, the MEP-90 is doing everything as advertised if not more.
For Leonard: I’ve tried the comb. I don’t find it to be a real solution. Takes too long, can’t be for sure you have the brush positioned properly, etc.
I’m assuming you’re not here to compare a 9 diode “brush” to an 80+ diode helmet approved by the FDA.
mr. Gundern is the director of medical servicesand Dr. Jason lukesewicz is the nedical director. where does it say that operation of the laser musat be by a m.d. (you’reright, it doesnt!!)and doctors prescribe ‘OFF LABEL ” USE of medications all the time this is no different
it simply works thats all i know