title: Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study.
abstract: BACKGROUND
  A once-daily minoxidil topical foam (MTF) has been developed to treat female pattern hair loss.<br/>
  
  
  OBJECTIVE
  Determine noninferiority of once-daily 5% MTF versus twice-daily 2% minoxidil topical solution (MTS) based on the change from baseline in target area hair count (TAHC) at 24 weeks.
  
  
  METHODS
  In a randomized, phase III trial, women with female pattern hair loss received once-daily 5% MTF (n=161) or twice-daily 2% MTS (n=161) for 52 weeks. Primary endpoint was change from baseline in TAHC at 24 weeks. Secondary endpoint was change from baseline in TAHC at 12 weeks. Exploratory endpoints included change in total unit area density and change in overall scalp coverage.<br/>
  
  
  RESULTS
  Once-daily 5% MTF increased TAHC from baseline (adjusted mean ± standard error) by 23.9 ± 2.1 hairs/cm2at week 24. Twice-daily 2% MTS increased TAHC 24.2 ± 2.1 hairs/cm2at week 24. The treatment difference was -0.3 hairs/cm2(95% CI = -6.0, 5.4). Since the lower bound of the 95% CI was less than -5.0, the prespecified noninferiority goal was not met. Both treatments were well tolerated.<br/>
  
  
  CONCLUSIONS
  Once-daily 5% MTF and twice-daily 2% MTS induced hair regrowth in female pattern hair loss, but prespecified noninferiority criteria were not met.<br /> ClinicalTrials.gov identifier: NCT01145625 <br /><br /> <em>J Drugs Dermatol.</em> 2016;15(7):883-889.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Blume-Peytavi
authors.forename: Jerry
authors.initials: J
authors.lastname: Shapiro
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Messenger
authors.forename: Maria K
authors.initials: MK
authors.lastname: Hordinsky
authors.forename: Paul
authors.initials: P
authors.lastname: Zhang
authors.forename: Carlos
authors.initials: C
authors.lastname: Quiza
authors.forename: Uday
authors.initials: U
authors.lastname: Doshi
authors.forename: Elise A
authors.initials: EA
authors.lastname: Olsen
mesh_terms: D000328:Adult; D000368:Aged; D000505:Alopecia / Q000175:diagnosis* / Q000188:drug therapy*; D017453:Dermatitis, Irritant / Q000175:diagnosis / Q000209:etiology; D004334:Drug Administration Schedule; D004339:Drug Compounding; D005260:Female; D006801:Humans; D008875:Middle Aged; D008914:Minoxidil / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry*; D019999:Pharmaceutical Solutions / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D019999:Pharmaceutical Solutions; D008914:Minoxidil