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 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.

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).

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.

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.

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.

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.