title: Efficacy, safety, and tolerability of dutasteride 0.5 mg once daily in male patients with male pattern hair loss: a randomized, double-blind, placebo-controlled, phase III study.
abstract: BACKGROUND
  Dutasteride (Avodart) is a dual inhibitor of both type I and type II 5 alpha reductases, and thus inhibits conversion of testosterone to dihydrotestosterone, a key mediator of male pattern hair loss.
  
  
  OBJECTIVE
  The aim of this randomized double-blind phase III study was to compare the efficacy, safety, and tolerability of dutasteride (0.5 mg) and placebo for 6 months of treatment in male patients with male pattern hair loss.
  
  
  METHODS
  A total of 153 men, 18 to 49 years old, were randomized to receive 0.5 mg of dutasteride or placebo daily for 6 months. Efficacy was evaluated by the change of hair counts, subject assessment, and photographic assessment by investigators and panels.
  
  
  RESULTS
  Mean change of hair counts from baseline to 6 months after treatment start was an increase of 12.2/cm(2) in dutasteride group and 4.7/cm(2) in placebo group and this difference was statistically significant (P = .0319). Dutasteride showed significantly higher efficacy than placebo group by subject self-assessment and by investigator and panel photographic assessment. There was no major difference in adverse events between two groups.
  
  
  CONCLUSIONS
  The study was limited to 6 months.
  
  
  CONCLUSIONS
  This study clearly showed that 0.5 mg of dutasteride improved hair growth and was relatively well tolerated for the treatment of male pattern hair loss.
authors.affiliation: Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea. hceun@snu.ac.kr
authors.forename: Hee Chul
authors.initials: HC
authors.lastname: Eun
authors.forename: Oh Sang
authors.initials: OS
authors.lastname: Kwon
authors.forename: Je Ho
authors.initials: JH
authors.lastname: Yeon
authors.forename: Hyo Seung
authors.initials: HS
authors.lastname: Shin
authors.forename: Byung Yoon
authors.initials: BY
authors.lastname: Kim
authors.forename: Byung In
authors.initials: BI
authors.lastname: Ro
authors.forename: Han Kyong
authors.initials: HK
authors.lastname: Cho
authors.forename: Woo Young
authors.initials: WY
authors.lastname: Sim
authors.forename: Bark Lynn
authors.initials: BL
authors.lastname: Lew
authors.forename: Won-Soo
authors.initials: WS
authors.lastname: Lee
authors.forename: Hwa Young
authors.initials: HY
authors.lastname: Park
authors.forename: Seung Phil
authors.initials: SP
authors.lastname: Hong
authors.forename: Jae Hong
authors.initials: JH
authors.lastname: Ji
mesh_terms: D000293:Adolescent; D000328:Adult; D000505:Alopecia / Q000188:drug therapy*; D001378:Azasteroids / Q000008:administration & dosage* / Q000009:adverse effects; D000068538:Dutasteride; D004791:Enzyme Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D006197:Hair / Q000187:drug effects* / Q000254:growth & development*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010781:Photography; D010919:Placebos; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001378:Azasteroids; D004791:Enzyme Inhibitors; D010919:Placebos; D000068538:Dutasteride