Clinical dose ranging studies with finasteride, a type 2 5α-reductase inhibitor, in men with male pattern hair loss - 07/09/11

Doi : 10.1016/S0190-9622(99)80052-8

Janet L. Roberts, MD ^a,^⁎, Virginia Fiedler, MD ^b, Julianne Imperato-McGinley, MD ^c, David Whiting, MD ^d, Elise Olsen, MD ^e, Jerome Shupack, MD ^f, Dowling Stough, MD ^g, Richard DeVillez, MD ^h, Robert Rietschel, MD ⁱ, Ronald Savin, MD ^j, Wilma Bergfeld, MD ^k, James Swinehart, MD ^l, Toni Funicella, MD ^m, Maria Hordinsky, MD ⁿ, Nicholas Lowe, MD ^o, Irving Katz, MD ^p, Anne Lucky, MD ^q, Lynn Drake, MD ^r, Vera H. Price, MD ^s, Darryl Weiss, MD ^t, Elizabeth Whitmore, MD ^u, Larry Millikan, MD ^v, Sigfrid Muller, MD ^w, Christopher Gencheff, DO ^x, Patrick Carrington, MD ^y, Bruce Binkowitz ^z, Paul Kotey ^z, Weili He ^z, Karen Bruno ^aa, Carol Jacobsen ^aa, Lisa Terranella ^aa, Glenn J. Gormley, MD, PhD ^bb, Keith D. Kaufman, MD ^aa
^a Northwest Cutaneous Research Specialists, Portland
^b University of Illinois, Chicago
^c Cornell University Medical College, New York
^d Dallas Associated Dermatologists
^e Duke University Medical Center, Durham
^g New York University Medical Center
^f Stough Clinic, Hot Springs
^h University of Texas Health Science Center, San Antonio
ⁱ Ochsner Clinic, New Orleans
^j Savin Dermatology Center, New Haven
^k Cleveland Clinic Foundation
^l Colorado Medical Research Center, Denver
^m Derm Research, Inc, Austin
ⁿ University of Minnesota Twin Cities, Minneapolis
^o Clinical Research Specialists, Santa Monica
^p Minnesota Clinical Study Center, Fridley
^q Dermatology Research Associates, Cincinnati
^r Massachusetts General Hospital, Boston
^s University of California, San Francisco
^t Plastic Surgery and Dermatology Associates, Fairlawn
^u Johns Hopkins University School of Medicine, Baltimore
^v Tulane Medical School, New Orleans
^w Mayo Clinic Rochester
^x Lakeview Medical Center, Madison
^y University of Arkansas for Medical Sciences, Little Rock
^z Department of Biostatistics, Merck Research Laboratories, Rahway
^aa Department of Clinical Research, Merck Research Laboratories, Rahway
^bb Department of Clinical Development, US Medical and Scientific Affairs, Merck & Co, Inc, Horsham

¹Reprint requests: Keith D. Kaufman, MD, Senior Director, Clinical Research, Endocrinology and Metabolism, Merck Research Laboratories, PO Box 2000, Rahway, NJ 07065.

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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*	The reported clinical studies were entirely supported by Merck Research Laboratories, Merck & Co, Inc. Merck & Co, Inc is the company that manufactures and markets finasteride.
*	These data were originally presented at the First Tricontinental Meeting of Hair Research Societies, Brussels, Belgium, 1995.

Esportazione

Vol 41 - N° 4

P. 555-563 - ottobre 1999 Ritorno al numero

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The effects of finasteride on scalp skin and serum androgen levels in men with androgenetic alopecia
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Clinical dose ranging studies with finasteride, a type 2 5α-reductase inhibitor, in men with male pattern hair loss - 07/09/11

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