The new pill for male baldness not only slows hair loss, it also increases hair regrowth, says a UCSF dermatologist who evaluated the effectiveness of the drug that was approved by the FDA yesterday.

The drug -- called Propecia and made by Merck & Co. -- is the first pill for baldness, and it gives men an alternative to Rogaine, an ointment applied to the scalp to keep or regrow hair.

FDA approval of the new pill was based on data from three one-year, double-blind, placebo-controlled, multicenter clinical trials involving 1,879 men aged 18 to 41 with mild to moderate hair loss of the vertex and anterior mid-scalp areas. In addition, 1,215 of the men who had hair loss at the vertex, or top of the head, were studied for another year.

Hair count increased during the first year and was maintained in those men taking Propecia for 24 months, while men in the placebo group showed progressive hair loss.

In another analysis, a panel of independent dermatologists evaluated photos in 508 patients after 24 months of treatment. An increase in hair growth was demonstrated in 66 percent of men treated with Propecia compared to 7 percent of men with placebo.

“This is real hair. This is not peach fuzz or light-colored hair, and it will continue to get longer and thicker the longer you use the medication,” said Price at a news conference yesterday.

“Patients will perceive a slowing down of hair thinning, and men who already have a balding scalp will see hair regrowth -- both effects of the drug are equally there,” said Price, UCSF professor of dermatology and a well-known hair loss researcher.

Propecia works by inhibiting the conversion of testosterone to DHT (dihydro-testosterone), which researchers believe make hair follicles smaller and smaller. Men with naturally low levels of DHT rarely lose their hair.

The pill-a-day treatment may be available for prescription -- for men only -- as early as mid-January, according to Merck, which estimates the retail cost will be $45 to $49 for a month’s supply.

Propecia is approved for men only. Women must not use the drug when they are or may potentially be pregnant because it may cause abnormalities of the male baby’s sex organs, a condition known as hypospadias. In addition, women should not handle crushed or broken tablets when they are pregnant or may potentially be pregnant.

In the clinical studies, side effects were uncommon. A small number of men, however, reported less desire for sex, difficulty in achieving an erection and/or a decrease in the amount of semen. Each of these effects occurred in less than 2 percent of men.

1st appeared 12/23/97

RETURN TO TOP