title: Effect of minoxidil topical foam on frontotemporal and vertex androgenetic alopecia in men: a 104-week open-label clinical trial.
abstract: BACKGROUND
  Topical minoxidil formulations have been shown to be effective in treating androgenetic alopecia (AGA) for 12 months. Efficacy and safety in both frontotemporal and vertex regions over longer application periods have not been studied so far.
  
  
  OBJECTIVE
  To evaluate the effect of 5% minoxidil topical foam (5% MTF) in the frontotemporal and vertex areas in patients with moderate AGA over 104 weeks.
  
  
  METHODS
  An 80-week, open-label extension phase was performed, following a 24-week randomized, double-blind, placebo-controlled study in men with AGA grade IIIvertex to VI. Group 1 (n = 22) received ongoing 5% MTF for 104 weeks, Group 2 (n = 23) received placebo topical foam (plaTF) until week 24, followed by 5% MTF until week 104 during the extension phase. Frontotemporal and vertex target area non-vellus hair counts (f-TAHC, v-TAHC) and cumulative hair width (f-TAHW, v-TAHW) were assessed at baseline and at weeks 24, 52, 76 and 104.
  
  
  RESULTS
  In Group 1, f-TAHW and f-TAHC showed a statistically significant increase from baseline to week 52 and week 76, respectively, returning to values comparable to baseline at week 104. No significant differences were found between baseline and week 104 in v-TAHC in Group 1 as well as f-TAHC, v-TAHC, f-TAHW and v-TAHW values in Group 2.
  
  
  CONCLUSIONS
  5% MTF is effective in stabilizing hair density, hair width and scalp coverage in both frontotemporal and vertex areas over an application period of 104 weeks, while showing a good safety and tolerability profile with a low rate of irritant contact dermatitis.
authors.affiliation: Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: V
authors.initials: V
authors.lastname: Kanti
authors.affiliation: Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Hillmann
authors.affiliation: Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Kottner
authors.affiliation: Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité - Universitätsmedizin Berlin, Berlin, Germany.|Department of Biometrics and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Stroux
authors.affiliation: Canfield Scientific, Inc., Fairfield, NJ, USA.
authors.forename: D
authors.initials: D
authors.lastname: Canfield
authors.affiliation: Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Blume-Peytavi
mesh_terms: D000287:Administration, Topical; D000505:Alopecia / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008914:Minoxidil / Q000008:administration & dosage*; D010919:Placebos
chemical_list: D010919:Placebos; D008914:Minoxidil