Clinical dose ranging studies
with finasteride, a type 2 5alpha-reductase inhibitor, in men with male pattern
hair loss.
Acad Dermatol. 1999 Oct
Roberts JL, Fiedler V, Imperato-McGinley J, Whiting D, Olsen E, Shupack J,
Stough D, DeVillez R, Rietschel R, Savin R, Bergfeld W, Swinehart J, Funicella
T, Hordinsky M, Lowe N, Katz I, Lucky A, Drake L, Price VH, Weiss D, Whitmore E,
Millikan L, Muller S, Gencheff C, et al.
Northwest Cutaneous Research Specialists, Portland, Oregan, USA.
BACKGROUND: Androgenetic alopecia is a common condition of adult men.
Finasteride, a type 2 5alpha-reductase inhibitor, decreases the formation of
dihydrotestosterone from testosterone.
OBJECTIVE: Two separate clinical studies
were conducted to establish the optimal dose of finasteride in men with this
condition.
METHODS: Men from 18 to 36 years of age with moderate vertex male
pattern hair loss received finasteride 5, 1, 0.2, or 0.01 mg/day or placebo
based on random assignment.
Efficacy was determined by scalp hair counts,
patient self-assessment, investigator assessment, and assessment of clinical
photographs.
Safety was assessed by clinical and laboratory measurements and by
analysis of adverse experiences.
RESULTS: Efficacy was demonstrated for all end
points for finasteride at doses of 0.2 mg/day or higher, with 1 and 5 mg
demonstrating similar efficacy that was superior to lower doses.
Efficacy of the
0.01 mg dose was similar to placebo. No significant safety issues were
identified in the trials.
CONCLUSION: Finasteride 1 mg/day is the optimal dose
for the treatment of men with male pattern hair loss and was subsequently
identified for further clinical development.
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