A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss

• Mean change in non-vellus hair count in the target region as determined by validated computer-assisted dot-mapping technique and subject ratings [ Time Frame: Baseline to 16 Weeks ] [ Designated as safety issue: No ]
  

• Visual assessment of local dermatitis [ Time Frame: Each visit, Baseline through Week 16 ] [ Designated as safety issue: No ]
  
• Vital Signs [ Time Frame: Each visit, Baseline through Week 16 ] [ Designated as safety issue: No ]
  
• Secondary efficacy evaluated by expert panel review of hair regrowth when comparing global photographs [ Time Frame: Baseline vs Week 16 ] [ Designated as safety issue: No ]
  
• Percent change from baseline in non-vellus hair counts within a specified area of clipped hair [ Time Frame: Baseline vs Week 16 ] [ Designated as safety issue: No ]
  
• Adverse Events [ Time Frame: Each visit, Baseline through Week 16 ] [ Designated as safety issue: No ]
  
• Laboratory Tests (hematology, chemistries, and urinalysis) [ Time Frame: at Baseline, Week 8, and Week 16 and Final Visit ] [ Designated as safety issue: No ]
  
• Clinical safety assessments, including weight, blood pressure, pulse and adverse events [ Time Frame: Every eight weeks, up to one year ] [ Designated as safety issue: No ]
  

Male subjects with androgenetic alopecia were enrolled in this fourteen-center trial. Subjects were randomized to use either 5% minoxidil or placebo foam twice daily for 16 weeks. A total of 143 subjects continued use of the 5% minoxidil foam for 8 to 12 months in an open-label phase to obtain safety data on 5% minoxidil topical foam when used twice daily for up to one year.

The 5% minoxidil foam was shown to be effective in the treatment of male androgenetic alopecia in a 16 week trial. It was statistically significantly superior to placebo foam in the primary efficacy measure of mean change in the non-vellus hair count in the target region between Baseline and Week 16, and the subject rating assessed an overall improvement from Baseline.

The efficacy of 5% minoxidil compared to placebo was confirmed by the secondary efficacy endpoints of scores from the expert panel review of hair regrowth when comparing photographs obtained at Baseline with photographs obtained at Week 16, as well as the percent change from Baseline in non-vellus hair counts within a pre-specified area of clipped hair.

The 5% minoxidil foam formulation was well tolerated, the incidence of adverse events was similar between groups, and no safety concerns were raised based on clinical laboratory test results, vital signs or scalp irritation scores.