title: A multicenter, randomized, placebo-controlled, double-blind clinical trial of a novel formulation of 5% minoxidil topical foam versus placebo in the treatment of androgenetic alopecia in men.
abstract: BACKGROUND
  An alternative to currently marketed topical minoxidil solutions is desirable.
  
  
  OBJECTIVE
  To assess the efficacy and safety of a new 5% minoxidil topical formulation in a propylene glycol-free foam vehicle in men with androgenetic alopecia (AGA).
  
  
  METHODS
  This was a 16-week, double-blind, placebo-controlled trial of 5% minoxidil topical foam (MTF) in 352 men, 18 to 49 years old. At week 16, 143 subjects continued on an open-label phase to collect 52 weeks of safety information on 5% MTF.
  
  
  RESULTS
  At week 16 compared with baseline, there was a statistically significant increase in (1) hair counts in the 5% MTF group versus placebo (P < .0001) and (2) subjective assessment of improved hair loss condition (P < .0001) in the 5% MTF group versus placebo. The 5% MTF was well tolerated over a 52-week period.
  
  
  CONCLUSIONS
  There was no collection of efficacy data beyond 16 weeks.
  
  
  CONCLUSIONS
  We believe that 5% MTF is a safe and effective treatment for men with AGA.
authors.affiliation: Duke University Medical Center, Durham, North Carolina 27516, USA. olsen001@mc.duke.edu
authors.forename: Elise A
authors.initials: EA
authors.lastname: Olsen
authors.forename: David
authors.initials: D
authors.lastname: Whiting
authors.forename: Wilma
authors.initials: W
authors.lastname: Bergfeld
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Miller
authors.forename: Maria
authors.initials: M
authors.lastname: Hordinsky
authors.forename: Rita
authors.initials: R
authors.lastname: Wanser
authors.forename: Paul
authors.initials: P
authors.lastname: Zhang
authors.forename: Bruce
authors.initials: B
authors.lastname: Kohut
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000505:Alopecia / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D006197:Hair / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D008914:Minoxidil / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008914:Minoxidil