TY - JOUR
T1 - Clinical dose ranging studies with finasteride, a type 2 5α-reductase inhibitor, in men with male pattern hair loss
AU - Roberts, J. L.
AU - Fiedler, V.
AU - Imperato-McGinley, J.
AU - Whiting, D.
AU - Olsen, E.
AU - Shupack, J.
AU - Stough, D.
AU - DeVillez, R.
AU - Rietschel, R.
AU - Savin, R.
AU - Bergfeld, W.
AU - Swinehart, J.
AU - Funicella, T.
AU - Hordinsky, M.
AU - Lowe, N.
AU - Katz, I.
AU - Lucky, A.
AU - Drake, L.
AU - Price, V. H.
AU - Weiss, D.
AU - Whitmore, E.
AU - Millikan, L.
AU - Muller, S.
AU - Gencheff, C.
AU - Carrington, P.
AU - Binkowitz, B.
AU - Kotey, P.
AU - He, W.
AU - Bruno, K.
AU - Jacobsen, C.
AU - Terranella, L.
AU - Gormley, G. J.
AU - Kaufman, K. D.
PY - 1999
Y1 - 1999
N2 - Background: Androgenetic alopecia is a common condition of adult men. Finasteride, a type 2 5α-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.
AB - Background: Androgenetic alopecia is a common condition of adult men. Finasteride, a type 2 5α-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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U2 - 10.1016/S0190-9622(99)80052-8
DO - 10.1016/S0190-9622(99)80052-8
M3 - Article
C2 - 10495375
AN - SCOPUS:0032836486
VL - 41
SP - 555
EP - 563
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
SN - 0190-9622
IS - 4
ER -