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Early Proscar Hair Loss Study

Imperato-McGinley J et al (Science 1974; 186:1213-5) reported that adult males with congenital 5 alpha-reductase deficiency had decreased levels of dihydrotestosterone (DHT). These individuals had a small prostate gland throughout life and did not develop BPH. They also did not develop male pattern baldness or acne. Based on these findings, Merck Research laboratories theorized that DHT also plays a role in the development of male pattern baldness (androgenic alopecia). Because PROSCAR blocks the conversion of testosterone to DHT in the prostate, it is theorized that the drug could also work in the scalp and affect male pattern baldness.

At the 1995 American Association of Dermatology Meeting in New Orleans (February 5-8, 1995), results from a one year, double-blind, randomized, placebo-controlled study with finasteride in the treatment of male pattern baldness were presented. Approximately 200 men age 18 to 35 were randomized to receive finasteride 5 mg. or placebo. The objectives of the study were to determine whether finasteride retards hairloss and/or causes hair regrowth in men with early balding and to evaluate the drug’s safety and tolerability in this patient population. Men taking oral finasteride (5 mg/day) had significantly increased hair counts and significantly improved clinical change from baseline based on investigator rating of global photographs, investigator assessment of patients in the clinic, and patient self assessment from a self-administered hair growth questionnaire after six and twelve months of therapy compared to placebo. Based on blinded investigator assessment of patients after 12 months of therapy, the majority of balding men taking finasteride had greatly or moderately increased hair growth. In assessments of total change in hair counts, patients taking finasteride had a mean increase after 12 months of 95 hairs in a one-inch-diameter circle on the vertex of patient’s heads, compared to a mean decrease of 10 hairs for patients taking placebo. There were few drug-related side effects reported, with similar numbers reported in both finasteride and placebo groups.

Also presented at the 1995 American Association of Dermatology Meeting in New Orleans (February 5-8, 1995), were preliminary results from phase II dose-range-finding studies, designed to help determine the optimal dose of finasteride for use in male pattern baldness. A six-week trial measured concentrations of scalp-skin and serum DHT, using oral finasteride at doses of 0.01, 0.05, 0.2, 1 or 5 mg per day or placebo. Finasteride at doses of 0.01, 0.05, 0.2, 1 or 5 mg per day suppressed scalp-skin DHT. In men taking 0.05-5mg per day of oral finasteride, scalp-skin DHT was reduced between 56 and 69 percent from baseline. In men taking placebo, scalp-skin DHT decreased by 13 percent. Other than the group taking 0.01 mg, no significant differences between the doses were seen; however, significant differences were seen between the groups that received finasteride (not including 0.01), and the group that received placebo. Effects on hair growth, were determined in a 6-month trial using doses of 0.01, 0.2, or 1 mg per day or placebo.

According to the results of the clinical dose-range-finding study, which compared doses of 0.01, 0.2 and 1 mg finasteride and placebo, it was determined that a low dose of oral finasteride will be used for further studies in the treatment of male pattern baldness. Based on this and other studies, further clinical trials are ongoing with finasteride at doses below 5 mg per day for men with male pattern baldness. This research is in an early stage and no data are available.

PROSCAR is not indicated for treatment of male pattern baldness and further research is needed.

A review of the published literature pertaining to PROSCAR was conducted to identify references pertinent to your inquiry. No studies or case reports were retrieved in which PROSCAR was used to treat or prevent male pattern baldness in humans.


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