Posts Tagged: U.S. Food and Drug Administration (FDA)

Dr. Schweiger Discusses LaserComb for Hair Loss in Women in Wall Street Journal

September 29th, 2009

Dr. Eric S. Schweiger, an Associate at Bernstein Medical – Center for Hair Restoration, was interviewed recently for an article in the Wall Street Journal.

The article — Can Lasers Stimulate a Hair-Growth Spurt? — discusses the efficacy of the HairMax LaserComb and low level laser therapy (LLLT) and also touches on Dr. Schweiger’s main area of expertise, the diagnosis and treatment of hair loss in women:

Eric S. Schweiger, a clinical instructor of dermatology at Mount Sinai Medical Center in New York, says the LaserComb helps grow hair, but adds that effects are often modest, typically take at least six months and aren’t seen in all patients.

The only home laser device cleared for hair growth by the Food and Drug Administration is the LaserComb, which claims to increase hair growth in men. While used by Dr. Schweiger and others for women, the device isn’t FDA cleared for them; a clinical trial is continuing, the company says.

Read more about low level laser therapy (LLLT) and the HairMax LaserComb on the Bernstein Medical – Center for Hair Restoration website. For further reading you can explore the Laser Therapy topic on the Hair Transplant Blog.

Topic: Laser Therapy

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Posted by Robert M. Bernstein M.D. at 8:40 am

After Hair Transplant Can One Replace Hair Loss Medication with Laser Therapy, Herbs?

September 15th, 2008

Q: I am interested in a hair transplant, but am turned off by the apparent side effects of follow up Propecia. Could herbs serve the purpose of Propecia? Regarding laser treatments, do they work on their own, or do you need drugs to supplement? Can laser damage in some cases, rather than benefit? It seems odd that laser therapy has been undertaken in Europe for 10 years, yet there are no published studies on the results. Might this be because it doesn’t work in the longer term?

A: Finasteride is the best medication. Herbs are not particularly effective for hair loss. You should consider trying finasteride.

If you are in the 2% group that has side effects with Propecia, just stop taking the medication. If you do not experience side effects, then there is no problem taking the medication long-term. Hair transplant surgery doesn’t prevent the progression of hair loss. That is why it is used in conjunction with medication.

Laser therapy can cause shedding initially (as can Propecia and Rogaine), but this means it is working. It does not cause actual hair loss. Your skepticism of the value of Laser therapy long term is one we have as well. Keep in mind, however, that while long-term studies are extremely important, they are very hard and costly to run and there is little incentive for companies to do this.

It is interesting that the FDA does not require longer term data on medications or devices that need to be used on a continued basis.

Topic: Post-op Care

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Posted by Robert M. Bernstein M.D. at 7:00 am

Which Laser Comb Works Best for Hair Restoration?

July 28th, 2008

Q: I have been trying to find some evaluation of which laser combs work best for “hair restoration”. I have seen some dermatologists speak about the Hair Max laser comb and its effectiveness (considering patient compliance, the amount of time the patient has been losing hair, the amount of total hair loss at time of treatment, etc.). I have also seen reference to the Sunetic laser comb which claims to have a superior technology to the Hair Max and offers a changeable head to allow treatment of the skin for healing, wrinkles, etc. A company in Michigan also offers a laser comb called the Hair Rejuvenator which it claims is superior to either of the other combs but I have not heard of any dermatologist who recommends this comb. A firm in Australia also offers a laser comb (Aculas) which it claims is the most effective; however, the makers of the Hair Rejuvenator comb say it is too powerful and dangerous and could cause blindness. Amidst all these claims, the consumer (patient) is left wondering which best option is and which is merely hype or fraud. What do you suggest?

A: There are no comparative studies thus far. For a hand-held device, I would stick with the Laser comb for now since it is the only one that has cleared the FDA.

Some others may work as well (and are less expensive) but we just don’t know at this time – and how useful any of them are long-term is also still not known.

Topic: Laser Therapy

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Posted by Robert M. Bernstein M.D. at 9:41 am

How Long Does Hair Loss Treatment with Low Level Laser Therapy (LLLT) Last?

May 14th, 2007

Q: How long will Low Level Laser Therapy (LLLT) treatments for hair loss last?

A: The studies submitted to the FDA looked at the effects of low level lasers over a 6-month period. There is no published data for use beyond this time period.

Therefore, the long-term effectiveness of these lasers in treating hair loss is not currently known.

Topic: Laser Therapy

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Posted by Robert M. Bernstein M.D. at 2:32 pm

Does Rogaine Hair Loss Medication Only Work on Crown?

April 24th, 2007

Q: I heard that Rogaine only works on the crown and not on the front or top of the scalp. Is this true?

A: Rogaine (Minoxidil) has the potential to work where ever there is miniaturized hair, either the front, top or crown (however, it will not work in areas that are completely devoid of hair).

The reason for the misconception that it will not work in the front is because the clinical trial performed by Merck in the 1980’s, that led to FDA approval, only studied the vertex (crown) and thus the company was limited to this labeling. Several years later, Merck realized that this was a misjudgment in the design protocol and ran a new study (approximately one fifth the size of their Phase III vertex trial) to document effectiveness of the drug in the front of the scalp. This allowed them to avoid the vertex restriction in their label.

Another reason for the confusion is that since the hair in the crown seems to have a longer miniaturization phase than hair in the temples, there is a greater window of time in which the medication can act on these hairs. This goes for both minoxidil and finasteride (Propecia).

Topic: Drugs & Medications

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Posted by Robert M. Bernstein M.D. at 7:13 am



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