Ketoconazole as an adjunct to finasteride

[douggie]

This was not research toward any kind of FDA approval, and again, several 2% hair loss-related studies have been made by researchers who don't get their paycheck from Janssen, which cannot be said about the 1%.


avri

It doesn't matter, if they do ANY research for FDA approval, ALL of their research must meet that criteria, even those studies that are not seeking FDA Approval.

Yes, several 2% were not funded by the manufacturer, but the one being quoted here that refers to change in hair diameter was, so the others are irrelevant.

 

[Cassin]

Also......the studies were not done with men who had male pattern baldness. Only Sub derm and the like. They weren't targeting hair weight or hair count as a goal.

 

[Bryan]

Also......the studies were not done with men who had male pattern baldness. Only Sub derm and the like. They weren't targeting hair weight or hair count as a goal.

HUH? Which studies are you referring to?? The most famous one by the French doctor was DEFINITELY in men with male pattern baldness, and examined anagen/telogen ratios and hair thickness, IIRC.

Bryan

 

[vwsimple]

Also......the studies were not done with men who had male pattern baldness. Only Sub derm and the like. They weren't targeting hair weight or hair count as a goal.

HUH? Which studies are you referring to?? The most famous one by the French doctor was DEFINITELY in men with male pattern baldness, and examined anagen/telogen ratios and hair thickness, IIRC.

Bryan

thank god, because if the famous study was only done with non male pattern baldness patients then that wouldnt prove much for male pattern baldness sufferers, only that nizoral regrew hair for people with sebderm and alike.

 

[vwsimple]

Also......the studies were not done with men who had male pattern baldness. Only Sub derm and the like. They weren't targeting hair weight or hair count as a goal.

HUH? Which studies are you referring to?? The most famous one by the French doctor was DEFINITELY in men with male pattern baldness, and examined anagen/telogen ratios and hair thickness, IIRC.

Bryan

thank god, because if the famous study was only done with non male pattern baldness patients then that wouldnt prove much for male pattern baldness sufferers, only that nizoral regrew hair for people with sebderm and alike.

 

[vwsimple]

Also......the studies were not done with men who had male pattern baldness. Only Sub derm and the like. They weren't targeting hair weight or hair count as a goal.

HUH? Which studies are you referring to?? The most famous one by the French doctor was DEFINITELY in men with male pattern baldness, and examined anagen/telogen ratios and hair thickness, IIRC.

Bryan

thank god, because if the famous study was only done with non male pattern baldness patients then that wouldnt prove much for male pattern baldness sufferers, only that nizoral regrew hair for people with sebderm and alike.

 

[Cassin]

Damn I did make it sound like all of the studies.......not my intention.

I meant the big study most people refer to done by the makers of Nizoral.

Or is this wrong?

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Nizoral Shampoo for Hair Loss
Doctors have known for a long time that Nizoral shampoo, in prescription and non-prescription strength, works well for controlling dandruff. But at last year´s meeting of the American Academy of Dermatology, a group of scientists suggested that over-the-counter Nizoral might also be useful as a hair loss remedy.

The researchers compared Nizoral A-D Shampoo, containing 1% ketoconazole (the active ingredient), to another shampoo containing 1% zinc pyrithione. Zinc pyrithione is the active ingredient in dandruff shampoos such as Head & Shoulders. They found that Nizoral increased hair thickness and decreased hair shedding, whereas the zinc pyrithione shampoo had the opposite effect.

Their presentation didn´t make a big splash then, and it has faded into obscurity since. That´s probably because what they presented were the results of a preliminary study--the results have not yet been duplicated in other studies by other researchers--and perhaps because the scientists who did the research were under the employ of McNeil pharmaceuticals, the company that makes Nizoral.

Still, it´s not all flimflam. The study met the basic standards of good research: It was a randomized, double-blinded study. That means the researchers used a random process to decide who would use Nizoral and who would use the zinc pyrithione shampoo. Also, the study participants didn´t know which shampoo they were using, and neither did the researchers, until the results were in. Both of these measures are important in conducting a scientific study because they help eliminate any bias the researcher s or the study participants may have, which could skew the results.

Here is how the study was done:

Forty-four men with "mild to moderate dandruff and somewhat oily scalp" used Nizoral A-D Shampoo two or three times a week for six months, and 43 men with the same scalp problems used a dandruff shampoo containing zinc pyrithione just as frequently over the same period of time. Both shampoos had the same percentage (1%) of the active ingredient in them.

At the beginning of the study, the researchers looked at the health of the men´s hair and scalp. They counted the number of hairs growing on the scalp. They also measured the diameter of the hairs, and how many hairs fell out over a 24-hour period. They took these measurements again one month into the study, then again at three months, and one last time at six months.

The researchers found that the men using Nizoral had about an 8% increase in the thickness of their hair. The men using the zinc pyrithione shampoo had no such increase. In fact, their hair decreased in thickness by about 2%. The men who used Nizoral also shed fewer hairs over a 24-hour period than the zinc pyrithione shampoo users did. The Nizoral users shed about 16% fewer hairs, whereas the zinc pyrithione users shed about 6% fewer hairs.

The Nizoral users, however, had fewer hairs growing on the scalp at the end of six months than the zinc pyrithione users did. That means fewer of their hair follicles were in "anagen phase."

Not all the hair on your head grows at once. At any given time, some hair follicles are dormant, while others are actively pushing out hair: They´re in the anagen phase, which lasts about two to six years. After a short transitional phase, the dormant phase, or "telogen" phase begins, lasting about five to six weeks. When a follicle goes back into anagen phase, the hair that had been growing from it falls out, and a new hair begins to grow.

In the study, both the Nizoral users and the zinc pyrithione users had an increase in the number of hairs in anagen phase. The Nizoral group had about 6% more, whereas the zinc pyrithione had about 8% more.

These results may seem to prove that Nizoral A-D works against hair loss, but they really don´t: They merely suggest it. Scientists might be able to get a better idea of how well Nizoral works as a hair-loss remedy if they were to do a placebo-controlled study. That means one group of people would use Nizoral A-D, while another group would use a shampoo that contains no medicine at all.

One 1998 study showed that prescription-strength Nizoral, which contains 2% ketoconazole, worked just as well as minoxidil (brand name Rogaine) in men with androgenic alopecia (male hereditary balding). Both medicines increased hair thickness and increased the number of anagen-phase hair follicles on the scalp. But the researchers were guarded about the meaning of these results, saying that more rigorous studies on larger groups of men should be done.

The most certain results come from placebo-controlled studies done in more than one place, on groups of people that fit a wider profile (not just men with dandruff, in the case of the Nizoral A-D study). This is what´s known as the "gold standard" for medical research--in scientific terms, a randomized, double-blinded, placebo-controlled, multicenter study. This is the kind of study that the US Food and Drug Administration wants to see before it will approve a medicine for a particular use.

Nizoral A-D Shampoo has met the FDA´s standards as a dandruff treatment, but you will not see the shampoo advertised by its makers as a hair loss remedy. It would be illegal for them to do so, because that has not been proven.

The only medicines scientifically proven to regrow hair in some men with hereditary balding are minoxdil and finasteride (brand name Propecia). Even so, if you´re willing to accept the Nizoral A-D study at face value, you may want to try it for yourself.

While you´re thinking about it, however, do consider that it may cause some side effects, like pimples on the scalp, or itching and dryness. You should also ask your doctor about it if you´re taking any other medications, and you shouldn´t use it if you´re allergic to any of the ingredients.

There´s no guarantee that using Nizoral A-D will give you a thicker head of hair, but you´ll probably have less dandruff--assuming you have dandruff. If you´ve never had problems with dandruff, then you´re just buying an expensive shampoo for unproven benefits. Nizoral A-D costs about $10 for a 4-ounce bottle, compared to about $2 for a 16-ounce bottle bargain shampoo.

Martin Downs
Contributing writer to DERMAdoctor.com.


(Any topic discussed in this article is not intended as medical advice. If you have a medical concern, please check with your doctor.)

Article posted May 22, 2002.

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Copyright © 2000-2002 DERMAdoctor.com, Inc., All rights reserved.

 

[Bryan]

Actually, THIS is the one most people refer to:

Dermatology. 1998;196(4):474-7.

"Ketoconazole shampoo: effect of long-term use in androgenic alopecia"

Pierard-Franchimont C, De Doncker P, Cauwenbergh G, Pierard GE.

Department of Dermatopathology, University of Liege, Belgium.

BACKGROUND: The pathogenesis of androgenic alopecia is not fully understood. A microbial-driven inflammatory reaction abutting on the hair follicles might participate in the hair status anomaly. OBJECTIVE: The aim of our study was to determine if ketoconazole (KCZ) which is active against the scalp microflora and shows some intrinsic anti-inflammatory activity might improve alopecia. METHOD: The effect of 2% KCZ shampoo was compared to that of an unmedicated shampoo used in combination with or without 2% minoxidil therapy. RESULTS: Hair density and size and proportion of anagen follicles were improved almost similarly by both KCZ and minoxidil regimens. The sebum casual level appeared to be decreased by KCZ. CONCLUSION: Comparative data suggest that there may be a significant action of KCZ upon the course of androgenic alopecia and that Malassezia spp. may play a role in the inflammatory reaction. The clinical significance of the results awaits further controlled study in a larger group of subjects.

 

[Whammy]

Well I sure wish they'd do more studies on the active ingredient. It'd be nice to determine, like they with finasteride the best amount to use. Perhaps we'll see 5% along the line.