Clinical Trial: Bimatoprost for the Treatment of Eyebrow Hypotrichosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary: This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).

Detailed Summary:
Sponsor: Allergan

Current Primary Outcome: Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale [ Time Frame: Baseline, Month 7 ]

The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.


Original Primary Outcome: Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale [ Time Frame: Baseline, Month 7 ]

Current Secondary Outcome:

  • Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) [ Time Frame: Baseline, Month 7 ]
    Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement).
  • Change From Baseline in Eyebrow Darkness as Measured Using DMSIA [ Time Frame: Baseline, Month 7 ]
    Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement).
  • Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6 [ Time Frame: Month 7 ]
    ESS Item #6 measured the participant's satisfaction with eyebrow treatment: "Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now?" using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported.


Original Secondary Outcome:

  • Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) [ Time Frame: Baseline, Month 7 ]
  • Change From Baseline in Eyebrow Darkness as Measured Using DMSIA [ Time Frame: Baseline, Month 7 ]
  • Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6 [ Time Frame: Month 7 ]


Information By: Allergan

Dates:
Date Received: January 9, 2013
Date Started: March 2013
Date Completion:
Last Updated: January 16, 2015
Last Verified: January 2015