Bernstein Medical Center for Hair Restoration - Merck

Merck

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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 know that Propecia works in only about half of patients. Are younger people more likely to be helped by this medication? — V.C. Greenpoint, Brooklyn

A: The main studies by Merck looked at men between the ages of 18 and 41. The five year data (which, in my view, is most important) showed that 48% of men had an increase in hair growth and 42% had no change over baseline. Thus a full 90% held on to their hair or had more over a 5-year period. This compares very favorably to the placebo group where 75% lost hair over the 5-year period.

I think the most interesting question relates to the 10% who continued to lose hair in the treated group. Did these men lose hair at a slower rate than the non-treated group? Based on the action of finasteride on blocking DHT and DHT’s central role in causing male pattern hair loss, it is reasonable to assume that even these “non-responders” did have some benefit from the drug, albeit small. If half of those on the medication who continued to lose hair did so at a rate slower than the placebo group, then 95% of patients actually benefited from the medication to some degree – an extraordinarily high success rate, in my opinion.

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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: 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: 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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Q: I am not yet ready for a hair transplant but am considering Propecia. What is your opinion on the “optimal dose”? I know Merck recommends 1 mg, but could I get away with taking less? Or would I get a better result by taking more (2-3 mgs)? — V.B, Darien, CT

A: You may get away with 0.5 mg a day. However, there are published data by Roberts et. Al. in the JAAD in 1999 showing a dose-response between 0.2 and 1 mg/day, with the lower dose showing reduced efficacy, from controlled clinical trials.

There is little evidence that a higher dose helps, but I often double the dose if a patient has been on 1mg a day for 3-5 years and then stops responding. The hope is that this can postpone the need for surgical hair restoration, but there is no scientific data to support that it will.

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Q: I was wondering why you chose two years as the amount of time one should wait to judge the effectiveness of Propecia. Have you had patients who only saw results after that long? Why does Merck say 3-6 months and Dr. Rassman at New Hair say 6-8 months? I know these numbers aren’t arbitrary, but I’m just wondering what the logic is behind this and how does this relate to planning a hair transplant? — I.P., Hempstead, Long Island, NY

A: The Merck data showed that over 90% of patients had peak response at 1 year and this has been my experience as well.

Most patients show the most dramatic response between 6 to 12 months with some getting additional benefit up to two years. Prior to 6 months, the results are quite variable and there may even be a net loss due to shedding during this period, as the Propecia (finasteride) stimulates a new anagen cycle.

If one is planning to go on Propecia before a hair transplant to minimize any shedding from the surgery and to prevent future hair loss, one should start the medication at least one month prior to the procedure.

If one wants to use Propecia for the purpose of possibly avoiding hair restoration surgery, then one needs to wait at least a year to see if there will be enough regrowth.

Finally, if one is younger (i.e. in the 23-25 age range) one should be on Propecia for at least two years to give it every possible chance of working and see its maximum benefit before considering a hair transplant.

Read more about taking Propecia before a hair transplant
Read more about Propecia (finasteride)

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