Bernstein Medical - Center for Hair Restoration - Food & Drug Administration (FDA)
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Q: I have done a lot of research over the past year including seeing a dermatologist and receiving consultation from a surgeon. Both recommended Propecia and Rogaine. After my consults I researched these products online and read that they do not work on the front of the scalp to improve my receding hairline, only to regrow hair in the crown area. Can you settle the issue once and for all? Do Propecia and Rogaine work on the front of the scalp? Can they improve my receding hairline? — J.S., Great Falls, Virginia

A: Both Propecia and Minoxidil definitely can work in the front of the scalp as long as there is some hair in the area. Although their mechanisms of action are different, both Propecia (finasteride) and Rogaine (minoxidil) act to thicken miniaturized hair regardless of where it is on the scalp. In fact, there are published data ((Leyden, James et al. “Finasteride in the treatment of men with frontal male pattern hair loss.” J Am Acad Dermatol. 1999 Jun;40(6 Pt 1):930-7.)) demonstrating this improvement with finasteride in a controlled clinical trial of men with frontal hair loss.

The source of the confusion is that the FDA limited the application of the drugs to the crown on the package inserts for both Propecia and Rogaine. The FDA did this because Upjohn (the company that introduced Rogaine) and Merck (Propecia) only tested the medications on the crown in the clinical trials. Logically, the fact that DHT causes frontal hair loss and Propecia works by blocking DHT gives a reasonable explanation for the efficacy of the drug on the front of the scalp. Also, a side effect of the use of minoxidil is facial hair, so how could it not also work on the front of the scalp? It is regrettable that some doctors and many patients think that these medications won’t work on the front of the scalp. Unfortunately, many hair restoration surgeons have done little to educate the public and dispel this myth.

To reiterate, yes, both of these medications can work on the front of the scalp to prevent hair loss and thicken a thinning hairline. However, it is important to note that neither of these medications can grow hair on a totally bald scalp or lower an existing hairline. Hair follicles must exist for the medications to work. It is also important to stress that the best results come from using both finasteride and minoxidil together.

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Q: I’ve heard that FDA added a description of reports of male infertility to the side effect labels of both Propecia and Proscar (finasteride). Is this a likely side effect in your experience? — S.S., Rolling Hills, California

A: Propecia (finasteride 1mg) may lead to male infertility not only by changing the consistency of the male ejaculate but by decreasing the sperm count as well, but this is uncommon.

Ejaculate is a combination of sperm produced by the testes and a viscous fluid made by the prostate. Since finasteride shrinks the prostate, it can make the ejaculate less viscous (more watery).

Most patients trying to conceive will have no issues while taking Propecia.

If one is having difficulty trying to conceive for 4-6 months, then it is reasonable to stop taking Propecia.

It is important to know that taking Propecia while trying to conceive will not lead to congenital deformities or issues with the fetus as long as the woman does not come in direct contact with the medication.

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Q: I have heard that side effects from finasteride can persist even after stopping the medication. What is the most current information on this issue? — S.V., Short Hills, N.J.

A: For the past two years I have been on the International Society for Hair Restoration Surgery (ISHRS) Task Force on Finasteride Adverse Events and struggling to make sense of this issue. There seems to be a disconnect between the relatively low incidence of side effects that we, as physicians, see in our practices, what published controlled studies have shown, and what is now being reported on the internet and in some instances in the media. For example, a 2012 study by Sato of 3,177 Japanese men published the Journal of Dermatology, showed a 0.7% incidence of adverse reactions to finasteride 1mg and no persistent side effects after stopping the medication.

That said, there has been a recent increase in anecdotal reports of side effects from finasteride as well as reports of persistent side effects after the medication has been discontinued (referred to as “Post-finasteride Syndrome”).

The FDA

Based on post-marketing reports of sexual dysfunction, in April 2012, the FDA announced changes to Propecia (finasteride 1 mg) labeling to expand the list of sexual adverse events and that some of these events had been reported to continue after the drug is no longer being used. It is important to note that no new clinical studies were reviewed to evaluate these adverse events and that the FDA is not aware of any additional controlled clinical studies conducted to evaluate these adverse events or to determine their cause or duration. (see FDA Label Changes for Finasteride 2012)

The FDA states that despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs. The FDA states that it believes that finasteride remains a safe and effective drug for its approved indications, but also advises that healthcare professionals and patients should consider this new label information when deciding the best treatment option.

The difficulty with interpreting anecdotal information is significant. The following need to be considered; first, sexual dysfunction, both temporary and persistent, is quite common in the general population and patients may have new-onset sexual dysfunction from some other, unrelated, cause and second, patients may have real (physiologic) side effects from the medication and then have psychological after effects. It is so difficult to sort these factors out.

The ISHRS

The Finasteride Symposium at the 2012 ISHRS, of which I was a panelist, explored safety issues with finasteride. Dr. Akio Sato presented his data (quoted above) suggesting that finasteride side effects are uncommon and that persistent side effects were not seen. Dr. Freedland, a urologist and featured guest speaker at the ISHRS symposium, questioned whether long-term effects of a slight elevation in estrogen levels could have adverse effects on the prostate. The panel discussed the paper of Dr. Michael Irwig at George Washington University that appeared in The Journal of Sexual Medicine this year. In his survey of 54 patients of men who had persistent sexual side effects three or more months after the discontinuation of finasteride, he reported that sexual dysfunction continued for many months or years in the majority of the patients.

Difficulties in interpreting this study are that it assumed that the patient’s sexual dysfunction were caused by finasteride when, in fact, there is no way of knowing that finasteride was the actual cause of the side effects (this would need a blinded, placebo-controlled study). A second reason that makes interpretation difficult is that, because there was selection bias in the Irwig survey, there is no way of knowing if these patients are representative of the population of men on finasteride. That said, the data presented by Dr. Irwig stresses the importance of having more clarity on the potential side effects of finasteride, since it is so widely prescribed.

It was clear from the presentations and questions asked, that many issues are still unresolved. All in attendance agreed that further research is urgently needed. In the short term, it is most important that all patients who are having problems can have easy access to doctors with expertise in this area, so that they can be diagnosed properly and treated.

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Q: Dr. Bernstein, I am an attending at Mass General Hospital in Boston and would like to ask you regarding your experiences using finasteride for male androgenetic alopecia. While I have not noticed any side effects in the patients that I have been treating, I increasingly get questions regarding side effects based on the recent media attention to reports of potentially permanent problems regarding libido or erectile dysfunction. I know that in the literature there is a slight increase of reversible sexual dysfunction (~4% vs. ~2% in placebo) with Propecia, and no convincing evidence to date in the medical literature that have used controlled studies regarding permanent problems even after discontinuing Propecia. — S.Z., Boston, Massachusetts

A: That is correct.

Q: I know that you have treated many patients over a long period of time, and I was thus wondering what your take is on potentially permanent sexual dysfunction after taking finasteride. Have you seen any convincing reports/patients or do you have any concerns regarding irreversible side effects?

A: I have seen 5 cases in over 10,000 patients on finasteride that complained of this but, of course, there is no way to know for sure if there is a cause and effect relationship. As you know, real side effects may be followed by psychological ones and if the sexual dysfunction has another cause, then stopping finasteride would have no effect on the symptoms. The incidence of intermittent or persistent sexual dysfunction in the general population of men is about 30%, so one would expect these numbers to be much higher just due to the normal incidence. It is really a difficult situation to understand. The experience that my colleagues and I have in our practices is much different than one would expect after reading the numerous anecdotal reports on the internet.

Q: Would you think it is safe to say that any potential sexual dysfunction is reversible after discontinuing the use of finasteride?

A: I don’t think that anyone knows at this point. The FDA is coming down on the side of caution and saying that it is possible, although it is not based on any new studies. If the phenomenon is real, the possible mechanism is not yet known.

Q: In the relatively few patients that I have treated with Propecia, they did not even report temporary problems regarding libido or erectile dysfunction. Do you think they are real or rather attributed to Propecia simply because the patient is made aware of these potential side effects?

A: I think that psychological effects may account for many cases. At this time, it is still not clear if a physiologic “post-finasteride syndrome” is real. A lot more work needs to be done before we have a definitive answer to this question.

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Q: I recently visited my dermatologist regarding my hair loss, and after checking my hair he said I am showing signs of Androgenetic Alopecia (common baldness), and said if I don’t treat it, it will progress. From my research on the net, I figured he will put me on Propecia. In fact he put me on Avodart. When I told him it is not FDA-approved for hair loss, and Propecia is, he said Avodart is better and brings DHT down more, and Propecia is nothing next to Avodart. He told me to take it every day for 2 weeks, then every other day from then on as it has a long half life. From researching on the net, many hair restoration doctors rarely prescribe Avodart for hair loss due to some dangers. What is your opinion on this? — T.G., Darien, Connecticut

A: Although dutasteride (Avodart) can be more effective for male pattern hair loss, I would start with finasteride (Propecia) as many patients do great with it and the safety profile is better. The following are things I would consider before starting dutasteride:

  1. As you point out, dutasteride is not FDA-approved for hair loss.
  2. There is no data on its safety when used for hair loss. This is important since dutasteride has been only tested on an older population of patients (with prostate disease) rather than a younger population of patients needing medical treatment for androgenetic alopecia.
  3. These is no natural model for dutasteride’s combined blockage of both type 1 and 2 5-alpha reductase (finasteride blocks only type 2 5-AR and there are families that have this deficiency and have no long-term problems. This, by the way, is how the drug was discovered).
  4. The type 1 enzyme which dutasteride blocks is present in many more tissues of the body (including the brain) compared to type 2 (which is more localized to the skin).
  5. Although so far unproven, there is a concern that finasteride may produce side effects than can be persistent after stopping the medication (post-finasteride syndrome). It this does turn out to be true, the effects from dutasteride would most likely be significantly more persistent.
  6. If you start with finasteride and do have side effects, you will most surely have side effects from dutasteride; therefore, by taking finasteride first you will have avoided the potentially more problematic side effects from dutasteride
  7. You may respond well to finasteride, and so do not need to consider dutasteride
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Journal of the American Academy of DermatologyLatisse, which is the brand name for the drug bimatoprost, has been found to effectively and safely grow eyelashes in a double-blinded scientific study published in the May 2012 issue of the Journal of the American Academy of Dermatology.

The study found that the drug starts showing improved eyelash growth at week 4 of using the medication. The growth is notable by week 8 and even more substantial by week 12. The majority of subjects using bimatoprost, 78.1% of the group, found improvements in eyelash prominence, length, fullness, and darkness by week 16. Only 18.4% of subjects using the placebo found such improvements at 16 weeks.

In the safety component of the study, adverse events were tallied and subjects were given ophthalmic examinations. Bimatoprost was found to have a “very good” safety profile. The only adverse event that occurred in a statistically significant greater proportion among those who used bimatoprost was conjunctival hyperemia, also known as “red eye”. This adverse event happened in only 3.6% of subjects — five out of 137 — and none of the subjects discontinued participation in the study. Ophthalmic examination of subjects during the study revealed that there is no statistically significant change in iris pigmentation due to bimatoprost. There was also no statistically significant change in visual acuity.

Bimatoprost, which mimics a type of “messenger molecule” called a prostaglandin, was initially designed to treat glaucoma. It was known for several years that the drug’s side effect was eyelash growth, and it was approved by the Food & Drug Administration in 2008 under the brand name of Latisse. The physiological mechanism by which bimatoprost affects eyelash growth is unknown and requires further scientific study.

Latisse — which is owned by the California-based pharmaceutical company Allergan, Inc. — is also being studied as a treatment for hair loss. That study is underway, and is on-going as of the most recent update in January 2012. The study should be complete by September 2012.

Read about Latisse/Bimatoprost

Read more about Latisse/Bimatoprost on the Hair Transplant Blog

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Q: I am 27 years old and I have been on Propecia for 12 months now. Honestly, I have seen no response from it. In my dermatologist’s opinion I am a non-responder. I asked about Avodart and he said, since Propecia didn’t help then Avodart won’t help as well since both are DHT blockers, and if one didn’t work the other won’t either. In your opinion do you think Avodart is better? I have read that it blocks more DHT than Propecia. What is the dosing for Avodart? If someone does not respond to Propecia will they also not respond to Avodart? — A.C., West University Place, Texas

A: Avodart (dutasteride) is more effective than Propecia (finasteride) and some patients will respond to dutasteride who do not respond to finasteride. Dutasteride decreases serum DHT about 90% compared to 70% for finasteride. The usual starting dose of Avodart is 0.5mg a day.

That said, dutasteride is not FDA approved for use in hair loss and if a person has sexual side effects, the side effects are more likely to be persistent after stopping the medication compared to finasteride.

Read more about Avodart (dutasteride)

Read more about Propecia (finasteride)

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Journal of Drugs in DermatologyThe January 2012 issue of the Journal of Drugs in Dermatology contains an article, written by Drs. Schweiger and Bernstein, which is the first case study of eyebrow growth from the topical use of bimatoprost.

Latisse (bimatoprost) is a topical medication that is FDA-approved for eyelash growth. Some physicians have used the medication for “off-label” use, such as use with eyelashes and scalp hair. However, until recently, there had not been any published medical literature describing the off-label use.

In the case report, a 47-year-old Caucasian woman visited Bernstein Medical for an evaluation of hair loss in one of her eyebrows, also known as eyebrow hypotrichosis. The hair loss was gradual, but had become cosmetically significant, and so she became interested in treating her thinning left eyebrow.

At her evaluation, the doctor discussed treatment options with the patient, including Follicular Unit Transplantation (FUT) and medical treatment with bimatoprost. She decided on medical treatment, and so started a four month treatment regime.

At a follow-up visit four months later, the patient reported significant thickening of her left lateral eyebrow. […] Physical examination revealed increased left eyebrow density, hair length, darker color, slight skin pigmentation, and eyelash treatment.

The conclusion of the article states:

We report one of the first cases of topical bimatoprost for successful treatment of eyebrow hypotrichosis. Studies are needed to confirm the efficacy and safety of topical bimatoprost to treat eyebrow hypotrichosis.

Also noted is that if the efficacy and safety of the medication are confirmed through additional testing, it would be a viable non-surgical option for eyebrow restoration.

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Q: I am interested in trying home laser therapy for my androgenic alopecia? Which handheld laser device do you recommend? — N.M., Northfield, NJ

A: There are several handheld lasers currently marketed as a home use treatments for androgenic alopecia. To my knowledge there has never been a clinical study comparing different laser devices. Most of the devices use diodes to emit a narrow band red light. This wavelength of light is actually similar to those that are used in hair removal lasers, except they are at a much lower intensity. The theory is that high intensity laser damage hair follicles causing hair loss, but low level laser energy can have a bio-stimulation effect and actually induce hair growth.

If you would like to try laser therapy for hair loss, I suggest using a HairMax laser comb. This is the only device that is FDA approved. They sell a few different “strengths” of lasers for different costs. They have not shown any clinical evidence supporting one laser comb versus another. The more expensive ones have more diode lights so it would be reasonable to conclude that they are “stronger” and require less frequent use. I have patients who have used the “mid tier” laser comb, the Premium Lux 9 successfully, so that is the one I recommend to other patients.

Read more about Laser Therapy.

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Restoration Robotics, Inc. — based in Mountain View, CA — has developed a robotic system for follicular unit extraction (FUE), called the ARTAS robotic system for hair restoration. The computerized device has received 510(k) approval from the Food and Drug Administration. Restoration Robotics is due to begin marketing the system for use in hair restoration clinics in the United States.

The FDA classifies the ARTAS robotic system for hair restoration as a “computer assisted hair harvesting system” and describes it as being used to identify and extract follicular units to aid the surgeon during hair transplant procedures.

The robot consists of a computer assisted station with needle mechanism, force sensor, robotic arm, and video imaging system. The software that runs the instrument helps the surgeon target follicular units for extraction and also uses stereoscopic video images to guide the needle mechanism and robotic arm.

At present, the device is used only for the graft harvesting aspect of the follicular unit transplant procedure.

Bernstein Medical – Center for Hair Restoration has been using the ARTAS robot for FUE since December 2011.

The following is an excerpt of a press release about the ARTAS™ System by the developer of the device, Restoration Robotics, Inc.

ARTAS System Receives FDA Clearance for Ground-Breaking Technology Treating Hair Loss

Restoration Robotics, Inc., a medical device company that pioneered the first robotic follicular unit harvesting system, today announced that it has received FDA 510K clearance for its revolutionary ARTAS System


ARTAS System for FUE Hair Transplantation

Mountain View, CA – April 14, 2011 – Restoration Robotics, Inc. a privately-held medical device company, today announced that its revolutionary technology, the ARTAS™ System, has received 510K clearance from the Food & Drug Administration (FDA) for harvesting hair follicles from the scalp in men diagnosed with androgenetic alopecia (male pattern hair loss) with black or brown straight hair. The ARTAS™ System was developed in close collaboration with several leading hair restoration physicians to enhance the quality of follicular unit harvesting for the benefit of physicians and their patients.

“We are thrilled to receive FDA clearance, and look forward to rolling out the ARTAS™ System to leading hair restoration physicians,” said Jim McCollum, Chief Executive Officer, Restoration Robotics. “Hair loss is a very real issue for millions of men in the United States. We’re pleased to offer a powerful new technology for patients who are interested in a safe new way to enhance their quality of life.”

ARTAS™ is a physician-controlled, state-of-the-art, interactive, computer-assisted system that enables harvesting of hair follicles during hair restoration procedures. It combines several features including an image-guided robotic arm, special imaging technologies, small dermal punches, and a computer interface. The ARTAS™ System is capable of identifying and harvesting individual follicular units to implement the follicular unit extraction (FUE) technique.

Read more about developments in Robotic FUE

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Q: When was the ARTAS robot for FUE approved for use in hair transplantation? — J.B., Jersey City, NJ

A: Restoration Robotics’ ARTAS System for robotic follicular unit harvesting, received 510K clearance by the Food and Drug Administration (FDA) on April 14, 2011. The indication is for “harvesting hair follicles from the scalp in men diagnosed with androgenetic alopecia (male pattern hair loss) with black or brown straight hair.”

Read about robotic FUE hair transplantation

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Robert M. Bernstein M.D.

Q: I saw your post on the clinical trials of Latisse (bimatoprost) for hair loss on the scalp. What is the status of the study? — B.V., New Providence, NJ

A: Allergan, the company that makes Latisse, conducted safety and efficacy testing of three formulations of the drug for men with androgenetic alopecia (male pattern baldness). Latisse is a drug that is approved by the FDA to help eyelash growth at a concentration of 0.03 %. The drug is applied daily to the upper eyelid.

Allergan studied the results of three formulations of Latisse (Bimatoprost .03% Opthalmic Solution) comparing them to results of a control option and also an over-the-counter minoxidil 5% solution. The drugs were applied directly to the scalp, and the progression of hair loss was measured.

This study began in June 2011 and the results were published in April 2014. The results of the study did not indicate that Latisse would be a viable alternative to use on the scalp to prevent hair loss.

It should also be noted that the cost of bimatoprost, the active ingredient in Latisse is significantly more expensive than minoxidil, the active ingredient in Rogaine. This means that even if the two treatments were equally effective, it would be cost-prohibitive to treat baldness with Latisse.

Latisee (Bimatoprost .03% Opthalmic Solution) has not been FDA approved for the treatment of scalp hair loss.

For more information, view the results and details of the study on ClinicalTrials.gov .

Read more about Latisse/Bimatoprost.

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Q: I have read your page on robotics in hair restoration and am interested in learning more. Are there any updates in the development of the system you mentioned? — W.T., London, UK

A: Restoration Robotics, Inc. — based in Mountain View, CA — has spent the last few years developing and testing a robotic hair transplant device for follicular unit extraction (FUE). The ARTAS robot system has recently received 510(k) approval from the Food and Drug Administration, meaning that the company may now begin marketing the system for use in hair restoration clinics.

The FDA classifies the device as a “computer assisted hair harvesting system” and describes it as being used to identify and extract follicular units and to help the surgeon do the same during hair transplantation.

The ARTAS robot consists of a computer assisted station with needle mechanism, force sensor, robotic arm, and video imaging system. The software that runs the instrument helps the surgeon target follicular units for extraction and also uses stereoscopic video images to guide the needle mechanism and robotic arm.

We will update you as more information becomes available about the ARTAS system and Restoration Robotics.

See a photo of the ARTAS robot and stay on top of developments by visiting our Robotic Hair Transplantation page

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Wall Street JournalDr. 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. For further reading you can explore the Laser Therapy topic.

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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? — D.D., Richmond, U.K.

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.

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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.

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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.

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Q: I heard that Rogaine only works on the crown and not on the front or top of the scalp. Is this true? — D.D., New Haven, Connecticut

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).

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Q: I heard that you could get a laser treatment for hair loss in a doctor’s office with a new laser called the Revage. What is this and how does it compare to the laser comb that I can buy myself?

A: The Revage Laser is a Low Level Laser Therapy (LLLT) treatment for thinning hair manufactured by the company Laser Hair Therapy of North America, LLC. It is FDA classified or permitted to be sold as a cosmetic device, but not as a medical device at this time.

The Revage system contains 30 laser diodes that rotate 180 degrees around the scalp. This dynamic process increases the contact of the laser energy with the hair follicles. It is available only through a physician’s office.

In contrast, the laser comb is available without a doctor’s prescription. It is a static device that depends upon the user to properly move it across his/her head in the time recommended for treatment, and at the correct angle, and thus may deliver significantly lower energy to the follicles.

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Q: I am 26 years old and in the beginning of losing my hair and not ready for hair transplant surgery. It seems to have stopped now but 4 months ago I shed a lot of hair and can visually see that my hair on the scalp is thinning out. I have looked into and read up on taking Propecia or more exactly Finpecia (I’m a student so cost is a factor), but can I trust this generic drug? Have looked at the company (Cipla) website but I’m still a bit scared of taking something I don’t really know what it is. What is your opinion on choosing Finpecia over Propecia? — E.E., Midtown East, N.Y.

A: Finpecia is manufactured in India by a slightly different method than the way Propecia is produced in the U.S. Since finasteride 5mg is now available in a generic from in the U.S., I suggest that you use finasteride 5mg and quarter the 5mg tablet with a pill cutter and take 1/4 tablet a day. The parts do not need to be the same size. In the U.S., generic finasteride and Propecia (1mg) and Proscar (5mg) are all made the same way. Cipla is a large company, but is not under U.S. FDA supervision.

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Q: My friend just came back from Paris and said that his cousin was taking Avolve for hair loss. Can you tell me what that is and is it available in the U.S.? — N.W., Portland, Oregon

A: Avolve is the European trade name for dutasteride 0.5mg made by GlaxoSmithKline for prostate enlargement. In the U.S. dutasteride 0.5mg, under the brand name Avodart, is FDA approved to treat prostate enlargement (BPH). It has not been FDA approved for hair loss.

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Q: A friend of mine is taking Finpecia, is this the same as Propecia?

A: Both Propecia and Finpecia contain the active ingredient Finasteride 1mg. Finpecia is manufactured in India by the company Cipla. It comes in packets of 10. Finpecia contains the same chemical ingredient as Propecia, i.e. 1mg of Finasteride, but it is manufactured differently and it is less expensive. — A.B., St. Louis, Missouri

Indian patent law allows companies in India to make medications that are patented by drug companies in other countries, since Indian law protects only the processes by which drugs are made and not medication itself. Therefore, if an Indian company finds another way to make a drug, it can legally do so.

Cipla has not published any studies showing that their generic Finasteride is identical or as effective as Merck’s original product in treating hair loss. These alternative processes and drugs are not regulated by the FDA, so there is no assurance that the medication manufactured in India has the same biologic activity or potency as the FDA approved counterpart made in the United States.

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Q: My friend is taking Avodart, he bought it over the internet. Is it safe to take? — T.G., Denver, Colorado

A: Avodart (dutasteride 0.5mg) was approved by the FDA for the treatment of prostate enlargement in men in 2002. Avodart has not been approved for the treatment of androgenetic hair loss, although physicians can use an approved medication in ways other than for which it was specifically approved. That said, the use of dutasteride certainly requires a doctor’s supervision.

Like finasteride (the active ingredient in Proscar and Propecia), dutasteride blocks the enzyme 5-alpha reductase that converts testosterone to DHT (DHT is a key hormone that causes hair loss). However, unlike finasteride, which only inhibits the Type I form of the enzyme, dutasteride inhibits both the Type I and Type II forms. This combined effect lowers circulating DHT more with dutasteride than with finasteride, but also increases the incidence of its side effects.

The Type II form of the enzyme (blocked by finasteride) is found predominantly in the hair follicle. The Type I form of the enzyme has been found in the scalp and sebaceous glands, and many other parts of the body, but its exact role in hair growth has not been determined. It is felt that dutasteride’s ability to dramatically lower serum levels of DHT is what makes it a more potent medication in hair loss.

When considering the safety of dutasteride, one should consider the following:

  • It acts on other parts of the body besides the hair follicle.
  • Unlike finasteride, where families that had a deficiency of the Type II 5-alpha reductase enzyme were followed for years without any adverse effects, there is no natural biologic model to show the safety of dutasteride.
  • Dutasteride has been approved for prostate enlargement in an older male population. It is not approved for hair loss and, in fact, the clinical trials for hair loss were discontinued, so there is no safety data for its use in younger patients. There is a greater incidence of sexual side effects with dutasteride compared to finasteride.
  • The 1/2 life of dutasteride is 5 weeks compared to 6-8 hours for finasteride. Serum concentrations of dutasteride are detectable up to 4-6 months after discontinuation of treatment.
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Q: I heard that Propecia was being used originally for shrinking the prostate, is this true? — M.D., New Hyde Park, N.Y.

A: Propecia (finasteride 1mg) is not a prostate medication that was serendipitously noted to have a side effect of re-growing hair, it is a medication that was known all along that it might be able to slow hair loss and/or to grow hair.

Although finasteride was first approved for the treatment of prostate enlargement, the researchers at Merck knew, at the outset, that there were families whose members were deficient in the 5-alpha reductase Type II enzyme and that the men in these families neither developed prostate disease nor went bald. In addition they had no long-term problems from the lack of this enzyme.

Merck used this natural model to develop a medication that could block the 5-alpha reductase Type II enzyme – the result was finasteride. Because the only approved treatment for symptoms related to prostate enlargement at the time was surgery, Merck developed finasteride as a medical treatment for this condition prior to developing finasteride as a potential treatment for men with male pattern hair loss.

This also meant that Merck would understand the safety profile of finasteride, and have it approved for a medical disease (symptomatic prostate enlargement), before developing it for a cosmetic condition.

The drug was first submitted to the FDA for the treatment of prostate enlargement as Proscar (finasteride 5mg) in 1991 and it was approved for this use in 1992. The drug was submitted for the treatment of men with male pattern hair loss as Propecia (finasteride 1mg) in 1996 and was approved for this use in 1997.

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