Hair Max Laser Comb FDA Approval (As a Device)

[|||Pelo|||]

New Comb Claims To Regrow Human Hair

Dr. Maria Simbra
Reporting

(KDKA) PITTSBURGH We are constantly bombarded by ads that claim to restore hair growth.

Now, a new comb claims it can grow back your hair and the FDA says it is legitimate.

About one in four men start to lose their hair at age 30.

About two out of every three are bald or are significantly balding by age 60.

Some men are okay with losing their locks, but many would try anything to keep their hair or to grow more.

The makers of the Hairmax Lasercomb say their product will make hair grow.

The low level lasers in this comb are supposed to work at the energy level of skin cells.

The $550 product is available on the internet.

It's been used in Europe and now the FDA just approved it for use in this country.

Unlike drugs, which are approved based on safety and effectiveness, the comb was approved as a device.

"All they had to prove was that their device did not cause any harm," said Dr. Suzan Obagi with UPMC Cosmetic Dermatology.

The only information backing up the claims comes from the company making the comb.

The results are based on what the people using the product perceived but this dermatologist says there needs to be more scientific rigor.

"We need now some unbiased studies to take place to measure this," said Dr. Obagi. "We need density counts to see how much hair is growing in a certain area, and not just what patients perceive."

http://kdka.com/health/local_story_047155723.html



FDA approves another treatment for thinning hair

The FDA has approved something new to help men losing their hair.

The device called a HairMax Laser Comb is already on the market. But the Food and Drug Administration is now allowing it to be sold as a treatment for the most common form of male baldness, based on studies conducted by the company

Dr. Marc Avram is a Cosmetic Dermatologist who has some familiarity with the product, "It is a new therapy that is not a magical cure unfortunately. But for some patients it will be helpful to help maintain or re-grow some hair."

According to the directions on the product, a person is supposed to comb his hair with the device three times a week. The laser light causes thinning hair follicles to expand in some people.

Experts say the device is not as effective as Rogaine or Propecia, the two medications approved to treat hair loss.

The cost of the comb is about $550."

http://www.kare11.com/news/news_article ... yid=243934

 

[Cassin]

Wow....great find. I think we all knew something was amiss since we haven't really seen anything on the news about this. This seems to be a puff of smoke whereas propecia and rogaine caused a firestorm of coverage.

My interest in using this is minimal at best.

 

[Guest]

this is what i said like two weeks ago, that it was probably just approved as something safe:

http://www.hairlosstalk.com/discussions ... afe#287696

score one for Jayman

"i don't think so. there's a difference between an fda approved medication for hair loss and the fda product approving a product to be sold intended for hair loss. propecia and minoxidil are the only two fda approved products for hair loss. $#iT like procede still has to go before the fda to make sure it's safe, etc. right?"

 

[Cassin]

this is what i said like two weeks ago

I said this about two years ago...

slam dunk over Jayman's head


/does the shoulder shimmy

 

[Guest]

prove it.

 

[Guest]

Why do you have that f.... picture JayMan???

 

[Fallout Boy]

I'm so confused! I thought that the LC already got it's safety evaluated when it was approved as a cosmetic device a long time ago?

 

[HLTguest]

I'm so confused! I thought that the LC already got it's safety evaluated when it was approved as a cosmetic device a long time ago?

Yes I am confused too. I have seen this all over the news and its all over the internet especially. All sources say the FDA approved/cleared it as a device to treat baldness. It has only been approved for men. They are planning on doing trials on women soon I think.

 

[HLTguest]

Also, Rogaine seems dangerous. Many people claim it gives them chest pain and palpitations. It also irritates the scalp which might make inflammation worse in the long run. Its nice to see another FDA approved alternative that doesn't seem to have these side effects. Its not a miracle cure or anything close to that, but it might work well as an additional treatment to propecia. Never know until you try I guess.

 

[CCS]

this is what i said like two weeks ago, that it was probably just approved as something safe:

http://www.hairlosstalk.com/discussions ... afe#287696

score one for Jayman

"i don't think so. there's a difference between an fda approved medication for hair loss and the fda product approving a product to be sold intended for hair loss. propecia and minoxidil are the only two fda approved products for hair loss. $#iT like procede still has to go before the fda to make sure it's safe, etc. right?"

phase I shows that it is safe. Phase II sees if it has a therapudic effect in humans, though phaseIII does something else?

 

[indie85]

Honestly, I dont know why you guys dont research these matters more, i mean you're all looking for something that works right? The whole point of this approval was so hairmax could advertise that it DOES infact grow hair. The issue of whether the device was safe or not was not a factor, as low-level laser has been proven to be safe a long time ago. 93% experienced growth of an average 19hairs/cm2, this is VERSUS a placebo control group who were given a dummy device. All hair counts etc were taken by independant specialists and met exacting standards, thus FDA has now given clearance to market the product as such. I mean what more do you want?
Yes, it is expensive, and you might be that 7% it doesnt work for, but for me its worth a go. As i said in another thread, I have recently ordered one. I will give updates on my progress.

 

[|||Pelo|||]

Man claims new laser comb restores hair
By KATHRYN CAGGIANELLI, For The Saratogian
02/24/2007

LATHAM - Men and women suffering from hair loss may now have a drug-free option for re-growing their hair that's as simple to use as a hairbrush.
The hand-held HairMax LaserComb, manufactured by Lexington International in Boca Raton, Fla., recently received approval from the Food and Drug Administration.
Federal recognition is something that Hair Loss Control Clinic (HLCC) President Bill Blatter has been waiting for since 2001.
"We are very excited about the major milestone in hair care and science. Laser hair therapy is the talk of the hair-restoration industry today. And not only were the results of this study extremely significant, but with the credibility of the FDA clearance, it will have a substantial impact in the emerging hair restoration industry," he said Wednesday from his office at 4 Avis Drive in Latham.
According to Blatter, as many as 50 million men and 30 million women suffer from hair loss. Women comprise 60 percent of the HLCC client base.
Blatter has been acting as a consultant with Lexington International. He founded HLCC 19 years ago and has been using lasers to stimulate hair growth on his clients for 14 years. HLCC's therapies are safe and medically-based, he said.
"Today's laser technology is 400 to 500 times better than what used to be available. We were the first in the area to use lasers and imported
our clinical lasers from Italy," Blatter said.
Even primitive laser hair therapy was marginally successful at re-growing hair for some people, he said.
The laser comb can work independent of drug and herbal therapies. A low-level laser beam stimulates the scalp and increases its number of thick hairs, claimed Blatter.
There were 3,500 studies conducted over 25 years with overwhelmingly positive results, he said
"The clinical study concluded that 93 percent of the participants (ages 30 to 60) using the HairMax LaserComb re-grew thick, dense hair over a six-month period," Blatter said.
Prices for the laser comb range from $349 to $545. A hand-held, rechargeable comb with one laser diode split into nine beams costs $545. Laser combs that pack more of a punch are also available, as are higher-powered clinic lasers.
In-clinic visits supplemented with laser combs, drug and herbal therapies used at home are what he recommends for maximum hair growth.
Not everyone regards the FDA approval as a product endorsement.
"FDA-approval refers to the product's safety not its efficacy," said Dr. Michael Beehner, a hair transplant surgeon at the Saratoga Hair Transplant Center in Saratoga Springs.
Long-term benefits of using the product haven't yet been proven, he said.
"There is some evidence that it's successful in a small percent of people but those I've talked to who have gotten the comb are still coming to me for hair," Beehner said.
Beehner admitted his own bias may unfairly influence his views about the laser comb.
"It seems as though the laser does stimulate the hair's growth cycle for about four to six years. It has a sort of burst effect on the blood vessels."
Criticism from hair-transplant surgeons is largely due to the fact that the product's efficacy is based on results derived from too few studies, Beehner said.

http://www.saratogian.com/site/news.cfm ... 2469&rfi=6

 

[Fallout Boy]

"The clinical study concluded that 93 percent of the participants (ages 30 to 60) using the HairMax LaserComb re-grew thick, dense hair over a six-month period," Blatter said.


hmm