A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)

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A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)

Further study details as provided by Allergan:

Primary Outcome Measures

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) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).

Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score

Time Frame: 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.

Secondary Outcome Measures

Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score

Time Frame: 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: 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) and a negative change from Baseline indicated worsening (decrease 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) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs).

Read More on Clinicaltrials.gov

By |October 7th, 2016|Hair Loss Articles|Comments Off on A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)

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