I was just watching the news when this laser comb came on. It had just recently been appoved by the fda to actually work! Intrigued by this i went on there website to check it out....is this thing for real? anyone on her has actually tried it. The comb cost $500 plus bucks? I dont want to be a sucker to shell out the money for some dumb comb with a laser on it? Whats everyone else think?
Hair Max Laser Comb Fda Approved
- Thread starter Airforce1
- Start date
haunted-ballroom
Experienced Member
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Airforce1 said:
There are a few threads around here about it already. So how good is this comb supposed to be? Could it regrow slick bald areas at all?
Private Ryan
Established Member
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general feeling about the comb is from it does not work to it thicken hair, abit of regrow to making the hair look fuller.
i think like any treatment, it work for some people but not others just like minoxidil and propecia etc.
but laser is laser, if you want to try, just get other cheaper alternative.
i think like any treatment, it work for some people but not others just like minoxidil and propecia etc.
but laser is laser, if you want to try, just get other cheaper alternative.
scottie311
Established Member
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- 1
I'm pretty skeptical that shooting a beam of light on your scalp is gonna grow hair. They just use the novelty of the laser to sucker people in.
Fallout Boy
Experienced Member
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- 3
I'm pretty sure not all lasers are the same...to say " a laser is a laser" would be wrong. There might be other products out there that are the exact same but from what I've read on Hairmax's site...there isn't. If you want to buy another laser your choice. I wouldnt though.
And Scottie when you said they just use the novelty of the laser to sucker people in....that wouldnt be true if FDA approved it. FDA doesn't try to sucker people in...thats why there were only 2 FDA approved treatments for hairloss...now a third.
And Scottie when you said they just use the novelty of the laser to sucker people in....that wouldnt be true if FDA approved it. FDA doesn't try to sucker people in...thats why there were only 2 FDA approved treatments for hairloss...now a third.
Cassin said:
http://www.fda.gov/cdrh/pdf6/K060305.pdf
I got this from another post and it clearly states what its intended use is for and therefore what it is approved for. Heres a quote from the document:
"A multicenter, randomized, placebo-controlled trial was conducted at four sites in the United States. Subjects received either the LaserComb or a sham device. Subjects were instructed to use the device three times per week on nonconcurring days for a total of 26 weeks. Subjects in the LaserComb treatment group had significantly greater increases in mean terminal hair density than subjects in the placebo group. Subjects in the
LaserComb group also had significantly better subjective assessments of overall hair regrowth than subjects in the placebo group. No subject experienced a serious adverse event and the adverse event profiles were similar between the two treatment groups. In all instances, the LaserComb functioned as intended and the hair regrowth observed was as expected."
I dont understand why people aren't more excited by this. In my opinion this is officially the new big 4th treatment option; FDA approved and all.
G
Guest
Guest
Cassin said:
No. Let's just see how full of sh*t they are instead.
http://www.baldingblog.com/2006/08/03/a ... aser-comb/
Rassmowned.
JayMan said:
From Hairmax :
We have drafted a formal response to Dr. Rassman's comments that you can read on his blog here: http://www.baldingblog.com/2006/08/2...max-lasercomb/
We maintain that the count that Dr. Rassman and his associates made of our images, on our website (http://lasercomb.net/beforeafter.htm) is not accurate. Furthermore, we do not see a way that anyone could render an ethical and accurate re-count simply by examining the low resolution images posted on a website. The level of detail provided by these shots is not in any way close to the detail provided by our high resolution shots used for the actual hair counts. Dr. Rassman was formally challenged again on this issue at the annual ISHRS Convention in San Diego and was unable to justify the accuracy of the counts he presented and therefore had to retract his comments.
We encourage you to visit our before and after picture page (http://lasercomb.net/beforeafter.htm) and judge the images for yourself.
Kind Regards,
Alex
[/quote]
Because it is extremely vague. Don't you see that? Lets see some hair counts and hair weights. Lets see success rates...lets see the placebo group.
That PDF tells us NOTHING![/quote]
I agree the PDF is vague on their study because that isn't the actual scientific literature more like a summary. Has anyone actually seen the lit on this?
I'm not going to refute Dr. Rassman but is he looking at the actual controlled study or something else?
I just dont understand how the FDA can approve any product that makes a claim to do something it cannot do; even if it is "safe". But then again I dont know much about the FDA.
Because it is extremely vague. Don't you see that? Lets see some hair counts and hair weights. Lets see success rates...lets see the placebo group.
That PDF tells us NOTHING![/quote]
I agree the PDF is vague on their study because that isn't the actual scientific literature more like a summary. Has anyone actually seen the lit on this?
I'm not going to refute Dr. Rassman but is he looking at the actual controlled study or something else?
I just dont understand how the FDA can approve any product that makes a claim to do something it cannot do; even if it is "safe". But then again I dont know much about the FDA.
JayMan said:
http://www.baldingblog.com/2006/08/24/e ... lasercomb/
Greetings Dr. Rassman,
Firstly, I would like to thank you for taking interest in low-level laser therapy and fielding questions on your blog about our device, the “HairMax LaserComb.†Open discussions like this one can only help to further the advancement of LLLT. I spoke to our chief medical advisor, Dr. Matt Leavitt, about your remarks regarding the LaserComb on your blog and Dr. Leavitt spoke very highly of your professionalism, commenting especially about your intellectual brilliance.
We reviewed your blog page that contains comments about our clinical study’s macro photos and we encourage you to post this message as a follow up to your comments.
We would like to outline some of the background about the clinical study we concluded.
Our experience with using low-level laser therapy for hair dates back to the mid-80’s in Sydney, Australia. Our founder operated a laser clinic where he successfully treated thousands of people. I was one of these laser patients and had significant results. We then worked closely together to develop a hand held laser device for the international market that can assist individuals suffering from problem hair. The HairMax LaserComb has been on the market for five years and is in use in over 74 countries.
In 2005, we concluded a clinical study protocol entitled “A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THE HAIRMAX LASERCOMB FOR THE TREATMENT OF ANDROGENETIC ALOPECIA IN MALESâ€. The primary efficacy endpoint was: Change in terminal hair counts, which are non-vellus hairs, in the target region between baseline and endpoint, utilizing macro images.
This is our second clinical study; unfortunately, we had bad professional direction for our first study as it was only a single site without a control. Despite this, we used the results of this initial research as a pilot study to help develop our new protocol.
Our goal was to conduct this study scientifically and in accordance to Good Clinical Practices (GCP). We utilized four clinical research facilities, three of which participated in many of the Minoxidil studies. Each facility had a primary investigator with extensive experience in Androgenetic Alopecia. All study protocols were approved by an IRB. Professional independent site monitors were employed to verify all case report forms and data managers were used to ensure that all recorded data complied with the protocol and with all applicable section of 21 CFR as required by the FDA. A biostatistician was retained to independently analyze the resulting dataset.
The equipment in use was a Fuji S2 6 megapixel digital camera with a Canfield epilume attachment. The same location was photographed every time, marked by a tattoo and the hair counts, centered around this tattoo, are well documented using Canfield Mirror DPS 6.0 software which stores a image on each individual hair counted over the original macro image for verification.
While conducting our study, we sought to show that the HairMax LaserComb had an effect on the number of non-vellus hairs present on the scalp. In an effort to eliminate any potential bias, independent medical professionals were commissioned to perform the hair counts. These professionals were blinded to the treatment assignments thus removing any bias towards the subjects’ treatment. The data from these medical professionals was then monitored and sent directly to the data management team removing and potential for us to review the data or interact with it.
All terminal hairs were marked and registered in Canfield’s Mirror DPS software using a 19 inch computer monitor. They were evaluated and counted by two independent hair professional reviewers. We are sure you can appreciate that counting many hundred macro images is a laborious task and can be very tiring on the eye. For this reason, we ensured that all hair counts were not performed consecutively. The counts were split up over a reasonable period of time in an effort to eliminate any uncertainty introduced from reviewer fatigue. Although the reviewers may have missed one or two hairs, we are confident that our macro counts represent a fair and accurate assessment of our study.
Our macro images were carefully reviewed by numerous professionals including many of your peers; all have complemented us on our fair evaluation of the data and our methods used in the study. We are unaware of what standard Dr. Rollins and you used in reviewing these images and where the difference exists in our hair counts. However, all the hairs that were counted are marked and we consider these counts to be an objective evaluation.
We will be bringing our clinical images with us to the ISHRS conference in San Diego; we invite you and Dr. Rollins to further review our images up close and hopefully once you see the standard of the images and documented counts you may have a different assessment of our macro images.
Kind regards,
David Michaels, Managing Director
Lexington Int LLC
Developers and Manufacturers of the HairMax LaserComb
19 hair per cm. This is the results from FDA.
Would be surprise if we all take an average of all the increase in hair count we all had using finasteride|minoxidil?
19 hairs per cm, all across the head. Not bad if you ask me.
If it can help me keep what i have now.... im a buyer. Specially my hairline. Adding 19 hairs per cm on my hairline now would be gravy for me.
Have a nice day all,
Would be surprise if we all take an average of all the increase in hair count we all had using finasteride|minoxidil?
19 hairs per cm, all across the head. Not bad if you ask me.
If it can help me keep what i have now.... im a buyer. Specially my hairline. Adding 19 hairs per cm on my hairline now would be gravy for me.
Have a nice day all,
Cassin said:
G
Guest
Guest
Wtf. Do you work for hairmax or something grabber?
Here it is for the hair count results :
For the FDA submission, Lexington conducted an extensive clinical study in four different locations across the United States. The study concluded that 93% of the participants (ages 30-60) using the HairMax LaserComb had an increase in the number of terminal (thick) hairs. The average number of terminal hairs per square centimeter increased by 19 hairs/cm² over a six-month period. During the study, there were no reports of serious adverse events. The number and types of adverse events were similar in both the active and placebo groups.
Lexington’s clinical study investigating the efficacy of the HairMax LaserComb in females is concluding and they will be submitting the data to the FDA shortly.
For the FDA submission, Lexington conducted an extensive clinical study in four different locations across the United States. The study concluded that 93% of the participants (ages 30-60) using the HairMax LaserComb had an increase in the number of terminal (thick) hairs. The average number of terminal hairs per square centimeter increased by 19 hairs/cm² over a six-month period. During the study, there were no reports of serious adverse events. The number and types of adverse events were similar in both the active and placebo groups.
Lexington’s clinical study investigating the efficacy of the HairMax LaserComb in females is concluding and they will be submitting the data to the FDA shortly.
JayMan said:
lol not at all man, i am just giving them the benefit of the doubt. Its easy to say Nah.... its not working because of X, Y, and Z.
I think this comb is something we should try, thats all.
And yes i have one since One WEEK !
One thing i can say is that it gives a warm feeling on the scalp at least 3-4 hours after using it. If you guys buy one... dont use it right before|after having used rogaine.... You will feel like if you smoked a whole bag of mariwana (spelling)
this thing increase the blood flow to the scalp like nothing else. Increasing the blood flow when there is DHT in blood IMO shouldnt be to good, but as i use to take approx 0.75mg of proscar for each breakfast, i assume that every time the blood flow is increasing on my scalp is like bringing more nutriment to my hair. Will see in 6 month from now.
G
Guest
Guest
Rassman has the patent on the technology they used to create the very photos they put on their website. He counted the hairs and found that people actually lost hair while using it.
JayMan said:
"We maintain that the count that Dr. Rassman and his associates made of our images, on our website (http://lasercomb.net/beforeafter.htm) is not accurate. Furthermore, we do not see a way that anyone could render an ethical and accurate re-count simply by examining the low resolution images posted on a website. The level of detail provided by these shots is not in any way close to the detail provided by our high resolution shots used for the actual hair counts. Dr. Rassman was formally challenged again on this issue at the annual ISHRS Convention in San Diego and was unable to justify the accuracy of the counts he presented and therefore had to retract his comments."
Did you not read?