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You are here: Home » News & Research » Hair Loss News Center » Official Propecia 5 Year Trial Results
Complete analysis of Propecia 5 year results on side effects, hair count, maintenance, and regrowth
The longest controlled clinical trial of a hair loss treatment ever reported showed that men who took Propecia (finasteride 1 mg) compared to men who took a placebo had a considerable difference in their hair counts after five years, according to data presented at the 59th Annual Meeting of the American Academy of Dermatology.
The new study showed a difference of 277 hairs in a one-inch diameter circle of scalp in favor of men treated with Propecia for five years (n=219) vs. those who received a placebo (n=15). Baseline hair counts of all men at the start of the study averaged 876 hairs in the one-inch diameter circle.
"This study provides new, long-term scientific data that Propecia helped the majority of men with predominantly vertex male pattern hair loss keep the amount of hair they have," said Keith Kaufman, M.D., senior director, Clinical Research, Merck Research Laboratories. "The study also was the first controlled clinical trial to evaluate the course of untreated hair loss over a five-year period and to show the progressive nature of male pattern hair loss."
Made by Merck & Co., Inc., Propecia is indicated for the treatment of certain types of hair loss in men only, based upon two-year studies. Propecia is a once-a-day treatment and is the only pill for male pattern hair loss approved by the Food and Drug Administration. Hair loss affects approximately 30 million men in the United States. Propecia is not indicated for use in women or children.
The five-year data are from investigational extension studies of double- blind placebo-controlled clinical trials that first demonstrated the safety and efficacy of Propecia in 1,553 men age 18 to 41 with mild-to-moderate male pattern hair loss (androgenetic alopecia) in the vertex region (top of the head). Efficacy in bi-temporal recession (hair loss at the temples) has not been established.
Men who entered the initial 12-month studies of Propecia were randomized to receive either Propecia (n=779) or placebo (n=774). The initial 12-month studies were extended on an annual basis, with only a small number of men remaining on placebo in subsequent years, as specified in the study design. Men who completed each one-year extension were given the opportunity to enroll in the next one-year extension, for up to five years. The five-year data presented focused on the results of men who continued on the same therapy -- either Propecia or placebo -- for the entire five years.
Five-year efficacy results
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