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

• 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 ]

The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil formulation in males for the treatment of pattern hair loss. The secondary purpose is to evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for the treatment of pattern hair loss and to obtain the safety data on the investigational product when used twice daily for up to one year.

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.

Inclusion Criteria:

• presence of androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale
• Male sex, age 15 to 49, good health
• Willingness to have a dot tattoo placed in the target area of the scalp during the study
• Willingness to maintain normal shampooing habits and products during the study
• Willingness to maintain the same hair style, approximate length, and hair color throughout the study

Exclusion Criteria:

• Known sensitivity to the investigational product