Category: Hair Products

Dr Rassman

Thanks for your excellent blog. Much has been written in your blog about the LaserComb, with various degrees of advocates (and distracters). As a physician, I’d like to amplify on a previous blog, which emphasized that detailed data on the benefits of the LaserComb is not available and thus makes it difficult to evaluate its benefit beyond anecdotal experiences. In addition, the manufacturer makes claims likely to be criticized as unsupportable if similar claims were made for a drug and, to me, employs classic marketing techniques designed to give as little information as possible.

The data supplied to the FDA in support of the LaserComb, which is publicly available at FDA.gov (PDF File) is scant for 4 main reasons: (a) approval was based on use as a device rather than a drug, (b) the threshold of evidence was not the usual superiority of controls required of drugs but “equivalence” to “predicate” devices, (c) a single, controlled study involving a small number of patients was conducted (rather than the usual minimum of 3 studies required of drugs), and (d) unlike studies supporting drug approval, detailed data for the LaserComb is not shown on the aforementioned FDA site. Basic information, such as patient entry criteria, number of patients participating, participating centers and investigators, statistical analysis, etc is absent.

When the manufacturers of the LaserComb report their claims in peer-reviewed, scientific journals where the data can be evaluated by the public, it will allow me to better evaluate the risk/benefit is. In addition, claims made by the manufacturer (“greater than 90% user satisfaction reported!”) are the type of marketing statements that are impossible to evaluate without context. The site also speaks to the single study used to approve the device but fails to mention the number of patients used (likely very small), duration of baldness of patients, or what the placebo response is. Photos of successes are also shown on the manufacturer’s site, with no timeframe to let the reader appreciate how long the patient used the device.

Finally, a previous blog noted the 20-week return policy, which gave readers an impression that money will be refunded if the device does not work. This policy, as stated in the manufacturer’s site, is that a partial refund (60%) will be given if the device is returned within 20 weeks. As the site suggests using the device for more than 20 weeks if no growth is seen, (“many of our users report that even in this time frame, with continued use, they slowly start to notice a thickening of their hair, and even show signs of re-growth”), one wonders how many patients with no growth truly send the device in before the 20-week cut-off.

You make many great points and perhaps the manufacturer of the LaserComb (and other manufacturers of similar products) will see your post and address the points you brought up. I know they’ve read this site in the past, as I’ve received correspondence from them when I disputed claims made on their site over a year and a half ago. We’ll see.

Whatever the case may be, thank you for your comments!

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Hi, I used the search and see you have only replied to 1 question with regards to the hair “Hair Genesis” product. I am quite aware of the products “claims”, but I wish to get your opinion on the studys that they have posted on their website. Links marked Clinical Study 1 and 2, and your input on the published report in The Journal of Alternative and Complementary Medicine. I’m in my mid 20’s and my hair is thinning and the front of my hairline has been receeding. So I have been researching potential products to try. Not interested in the mess associated with rogaine, and the merck drug can have those sexual side effects.

While I agree with you that anyone should be wary of a product that touts the FDA, however their website is much more proffessional than other, similiar all herbal products.

Ultimately my question is: If you could review the study’s they claim to have done, do these studies apear to have been legit? Also, since your last question/post on this product was in 2005, has anything changed since?

HairGenesis, like some other botanicals, may have DHT blocking effects, but why play games? Any DHT blocker has the potential to depress the sex drive, but the frequency with finasteride is defined and it is relatively low. I certainly don’t believe that these HairGenesis products are “Proven DHT Blockers! With no side effects.” If you want a DHT blocker, I’d think you’d want one with known value like finasteride (talk to your doctor about Propecia, as it is a prescription medication).

I read the studies and I am afraid they do not meet the type of criteria I find statistically valid. For starters, I can’t find any information relating to who conducted these studies (who knows if they are even independently researched). Secondly, the photos presented in the studies are very poor quality with bad lighting. It is also worth noting that a professional website may give an appearance of a professional company, but it isn’t too difficult to find a good designer to make a great site nowadays. I don’t see their site as looking all that great, but beauty is in the eye of the beholder. You probably shouldn’t base your opinions simply on the look of their website, though.

I took a 3 month supply of Procerin for hair regrowth. I noticed a huge decrease in my sex drive about 2 1/2 months into taking the pills and it was obviously hard to perform in the bed room because of this. I stopped taking Procerin as soon as I figured out thats what was causing my problem(about 3 weeks ago). However, my sex drive is still not normal again. I have never ever had an issue with decreased libido or ability to get an erection so will this eventually wear off? Do you have an approximate time frame? Is there anything I can do to reverse it? I am really starting to worry here…..

From the Procerin website:
“Procerin is a proprietary blend of herbal, mineral, and vitamin components. The 17-ingredient formula of Procerin tablets includes: Saw Palmetto Berries, Gotu Kola, Nettles, Magnesium, Zinc Sulfate,Eleuthero Root , Vitamin B-6, Pumpkin Seed Meal, and Muira Puma Root. Procerin XT Topical Serum ingredients include Gamma Linolenic Acid, Grape Seed Extract, Azelaic Acid, Saw Palmetto Extract, Avocado Oil, and Nettle”

Procerin is not a drug; it is an herbal supplement, and as such, it is not regulated by the FDA. Their claims of hair growth or side effects (or lack there of) are not substantiated by any non-biased or scientific authority.

Saw palmetto (serenoa repens) is a small plum plant native to the southeastern United States. It is believed that the medicinal properties of the plant come from its brown-black berries. Native Americans used it as they recognized that it had value in relieving urinary symptoms in older men who had difficulty urinating. Over the years, saw palmetto has become an accepted herbal treatment for symptoms associated with benign prostate gland enlargement (BPH), and is used quite frequently in many countries. It is also used by some to treat low libido, so if it is linked to your problem it seems to be providing an opposite effect.

There is a dosing issue in herbals, as you never know what is really in these pills or the way it is prepared (see VitaminStuff.com). I would suspect that your libido will eventually return, but in the meantime I’d recommend that you see a doctor about the decrease, as it affects many men.

(male) I was recently prescribed Nizoral 2% and clobex lotion for a condition of moderate seborrheic dermatitis. I was told to use each once per day for a month. At the time of my doctors visit, i made a point of telling the doctor that my hair has been chemically processed quite a bit over the past few years (coloring and bleaching) and that I was concerned that he give me something that would not damage it. Within a couple of days, my hair was dried out to the point of being like straw and was breaking off near the roots. Since then I have been experiencing an abnormal amount of hair fall on a daily basis. All of the literature I can find on the 2% Nizoral seems to say that is should be used only once and then on a very intermittent basis. I am wondering what you think of the dosage that was prescribed for my condition? I should add that I have since changed doctors and have been told to use Fluocinolone acetonide 0.01% which has cleared my scalp condition in only 2 weeks. So now my scalp condition is better but my hair is stlll breaking off and falling out. Any advice?

My response to such questions requires a face-to-face meeting and an examination. The practice of medicine is an art form that caring doctors in the ‘hair’ field base their views on such issues as yours after a direct examination of the hair and scalp. Nizoral should not be abused and should always be taken as directed. If a doctor recommended a more frequent use, your probe of the problem should be directed to that doctor. Chemicals that seep into the hair follicles can damage them. Questions that an examination of the hair and scalp would point to include the differential diagnosis between telogen effluvium and cyclical genetic hair loss. I am happy to hear that your seborrheic dermatitis has resolved.

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I’ve been suffering from some side effects with propecia, so I am looking for other solutions. Are you familiar with lignans and this pilot study?

Flax lignans: a cure for hair loss?

What are your thoughts? Could I conceivably get the same side effects?

I’ve not heard of flax lignans, which appears to be an herbal remedy… and as with any herbal supplement, safety should be somewhat of a concern. The pilot study that is referenced was sponsored by the same company that sells the flax lignans in a capsule, so their motives are highly suspect. Even in this very limited press release, the suppliers do not have a clue on the best dosage or what the dose related response might be for treating hair loss.

To top it off, this is from nearly 3 years ago — if there was anything to it, I’m sure there would be more about it in the press or within the hair industry.

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I have seen advertisements, and have listened to radio advertisement raving about the cool laser for the treatment of baldness. Are there any statistically valid studies that have shown that they work to either stop hairloss or grow new hair?

There are studies, but they were done by people connected with the business, so I will not believe them until they are done by a completely independent source. See my prior posts on lasers here.

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I have not had any growth due to long-term use of the LaserComb. As with many drugs and devices, some people benefit, others don’t. The real issue is: what is the probability of technical success? Unfortunately, the manufacturer has not published articles or studies in peer-reviewed journals, and thus has not enabled prospective users to evaluate the risk/benefit and answer this question. In addition, the regulatory designation of the LaserComb as a medical device also precludes finding the level of detailed information on the FDA web page that is usually reserved for drugs/biologics. In the absence of such information, one can only rely on anecdotal observations and your (Dr Rassman) experiences have been helpful in raising the prospect of questionable cosmetic improvement with this device. One also has to have a skeptical eye for any drug or device claiming benefit where detailed data usually available to evaluate is either missing or difficult to locate.

Thank you! I couldn’t have said it better myself.

Sometimes these products can be muddled in with the financial gain of selling a product and media hype and not have much to do with actual results (i.e. “buyer beware”).

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