title: Clinical dose ranging studies with finasteride, a type 2 5alpha-reductase inhibitor, in men with male pattern hair loss.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Northwest Cutaneous Research Specialists, Portland, Oregan, USA.
authors.forename: J L
authors.initials: JL
authors.lastname: Roberts
authors.forename: V
authors.initials: V
authors.lastname: Fiedler
authors.forename: J
authors.initials: J
authors.lastname: Imperato-McGinley
authors.forename: D
authors.initials: D
authors.lastname: Whiting
authors.forename: E
authors.initials: E
authors.lastname: Olsen
authors.forename: J
authors.initials: J
authors.lastname: Shupack
authors.forename: D
authors.initials: D
authors.lastname: Stough
authors.forename: R
authors.initials: R
authors.lastname: DeVillez
authors.forename: R
authors.initials: R
authors.lastname: Rietschel
authors.forename: R
authors.initials: R
authors.lastname: Savin
authors.forename: W
authors.initials: W
authors.lastname: Bergfeld
authors.forename: J
authors.initials: J
authors.lastname: Swinehart
authors.forename: T
authors.initials: T
authors.lastname: Funicella
authors.forename: M
authors.initials: M
authors.lastname: Hordinsky
authors.forename: N
authors.initials: N
authors.lastname: Lowe
authors.forename: I
authors.initials: I
authors.lastname: Katz
authors.forename: A
authors.initials: A
authors.lastname: Lucky
authors.forename: L
authors.initials: L
authors.lastname: Drake
authors.forename: V H
authors.initials: VH
authors.lastname: Price
authors.forename: D
authors.initials: D
authors.lastname: Weiss
authors.forename: E
authors.initials: E
authors.lastname: Whitmore
authors.forename: L
authors.initials: L
authors.lastname: Millikan
authors.forename: S
authors.initials: S
authors.lastname: Muller
authors.forename: C
authors.initials: C
authors.lastname: Gencheff
mesh_terms: D058891:5-alpha Reductase Inhibitors; D000293:Adolescent; D000328:Adult; D000505:Alopecia / Q000097:blood / Q000188:drug therapy*; D013196:Dihydrotestosterone / Q000097:blood; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000008:administration & dosage*; D018120:Finasteride / Q000008:administration & dosage*; D006197:Hair / Q000187:drug effects / Q000254:growth & development; D006801:Humans; D008297:Male; D017060:Patient Satisfaction
chemical_list: D058891:5-alpha Reductase Inhibitors; D004791:Enzyme Inhibitors; D013196:Dihydrotestosterone; D018120:Finasteride