title: A randomized, active- and placebo-controlled study of the efficacy and safety of different doses of dutasteride versus placebo and finasteride in the treatment of male subjects with androgenetic alopecia.
abstract: BACKGROUND
  Dihydrotestosterone is the main androgen causative of androgenetic alopecia, a psychologically and physically harmful condition warranting medical treatment.
  
  
  OBJECTIVE
  We sought to compare the efficacy and safety of dutasteride (type 1 and 2 5-alpha reductase inhibitor) with finasteride (type 2 5-alpha reductase inhibitor) and placebo in men with androgenetic alopecia.
  
  
  METHODS
  Men aged 20 to 50 years with androgenetic alopecia were randomized to receive dutasteride (0.02, 0.1, or 0.5 mg/d), finasteride (1 mg/d), or placebo for 24 weeks. The primary end point was hair count (2.54-cm diameter) at week 24. Other assessments included hair count (1.13-cm diameter) and width, photographic assessments (investigators and panel), change in stage, and health outcomes.
  
  
  RESULTS
  In total, 917 men were randomized. Hair count and width increased dose dependently with dutasteride. Dutasteride 0.5 mg significantly increased hair count and width in a 2.54-cm diameter and improved hair growth (frontal view; panel photographic assessment) at week 24 compared with finasteride (P = .003, P = .004, and P = .002, respectively) and placebo (all P < .001). The number and severity of adverse events were similar among treatment groups.
  
  
  CONCLUSIONS
  The study was limited to 24 weeks.
  
  
  CONCLUSIONS
  Dutasteride increased hair growth and restoration in men with androgenetic alopecia and was relatively well tolerated.
authors.affiliation: Centro Médico Skinmed and Universidad de los Andes, Santiago, Chile. Electronic address: wgubelin@skinmed.cl.
authors.forename: Walter
authors.initials: W
authors.lastname: Gubelin Harcha
authors.affiliation: Unidad de Investigación, Clínica Internacional, Lima, Peru.
authors.forename: Julia
authors.initials: J
authors.lastname: Barboza Martínez
authors.affiliation: Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Tsen-Fang
authors.initials: TF
authors.lastname: Tsai
authors.affiliation: Department of Dermatology, Kitasato University, Tokyo, Japan.
authors.forename: Kensei
authors.initials: K
authors.lastname: Katsuoka
authors.affiliation: Department of Dermatology, Tokyo Women's Medical University, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Kawashima
authors.affiliation: Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
authors.forename: Ryoji
authors.initials: R
authors.lastname: Tsuboi
authors.affiliation: GlaxoSmithKline Research & Development, Research Triangle Park, North Carolina.
authors.forename: Allison
authors.initials: A
authors.lastname: Barnes
authors.affiliation: GlaxoSmithKline Research & Development, King of Prussia, Pennsylvania.
authors.forename: Geraldine
authors.initials: G
authors.lastname: Ferron-Brady
authors.affiliation: GlaxoSmithKline Research & Development, Singapore.
authors.forename: Dushen
authors.initials: D
authors.lastname: Chetty
mesh_terms: D000328:Adult; D000505:Alopecia / Q000175:diagnosis / Q000188:drug therapy*; D001378:Azasteroids / Q000627:therapeutic use*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068538:Dutasteride; D018120:Finasteride / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006197:Hair / Q000187:drug effects* / Q000254:growth & development; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D012016:Reference Values; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001378:Azasteroids; D018120:Finasteride; D000068538:Dutasteride
keywords: 5-alpha reductase; 5-alpha reductase inhibitors; androgenetic alopecia; dutasteride; finasteride; male pattern baldness; male pattern hair loss; treatment