Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia

• Change From Baseline in Target Area Hair Count (TAHC) [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs).
• Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

• Change from Baseline in Target Area Hair Count (TAHC) Measured in Terminal Hairs/cm2 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
• Subject Self Assessment (SSA) Score Measuring Scalp Hair Growth Using a 7-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

• Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
• Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
• Change From Baseline in Target Area Hair Width (TAHW) [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs).
• Change From Baseline in Target Area Hair Darkness (TAHD) [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).

• Investigator Global Assessment (IGA) Score Measuring Subject Scalp Hair Growth Using a 7-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
• Global Panel Review (GPR) Score Measuring Subject Scalp Hair Growth Using a 7-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
• Change from Baseline in Target Area Hair Width (TAHW) Measured in um/cm2 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]

• Alopecia
• Alopecia, Androgenetic
• Baldness

• Drug: bimatoprost Formulation A
  Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
• Drug: bimatoprost Formulation B
  Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
• Drug: bimatoprost Formulation C
  Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
• Drug: bimatoprost vehicle solution
  Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
• Drug: minoxidil 5% solution
  Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
  Other Names:

  • Rogaine®
  • Regaine®

• Experimental: bimatoprost Formulation A
  Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
  Intervention: Drug: bimatoprost Formulation A
• Experimental: bimatoprost Formulation B
  Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
  Intervention: Drug: bimatoprost Formulation B
• Experimental: bimatoprost Formulation C
  Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
  Intervention: Drug: bimatoprost Formulation C
• Placebo Comparator: bimatoprost vehicle solution
  Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
  Intervention: Drug: bimatoprost vehicle solution
• Active Comparator: minoxidil 5% solution
  Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
  Intervention: Drug: minoxidil 5% solution

Inclusion Criteria:

• Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
• Willingness to have micro-dot-tattoo applied to scalp
• Willingness to maintain same hair style, length and hair color during study

Exclusion Criteria:

• Drug or alcohol abuse within 12 months
• HIV positive
• Received hair transplants or had scalp reductions
• Use of hair weaves, hair extensions or wigs within 3 months
• Oral or topical minoxidil treatment within 6 months
• Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks