Clinical Trial: Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis

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

Official Title: A Multicenter, Double-masked, Randomized, Parallel-group Study Assessing the Safety and Efficacy of Once-daily Application of Bimatoprost Solution 0.03% Compared to Vehicle to Treat Chemotherapy-induc

Brief Summary: This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy treatment.

Detailed Summary:
Sponsor: Allergan

Current Primary Outcome: Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA) [ Time Frame: Baseline, Month 4 ]

The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.


Original Primary Outcome: Change from Baseline in Overall Eyelash Prominence [ Time Frame: Baseline, Month 4 ]

Current Secondary Outcome:

  • Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA) [ Time Frame: Baseline, Month 4 ]
    Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).
  • Change From Baseline in Eyelash Thickness as Measured by DIA [ Time Frame: Baseline, Month 4 ]
    Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).
  • Change From Baseline in Eyelash Darkness as Measured by DIA [ Time Frame: Baseline, Month 4 ]
    Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).


Original Secondary Outcome:

  • Change from Baseline in Eyelash Length [ Time Frame: Baseline, Month 4 ]
  • Change from Baseline in Eyelash Fullness [ Time Frame: Baseline, Month 4 ]
  • Change from Baseline in Eyelash Darkness [ Time Frame: Baseline, Month 4 ]


Information By: Allergan

Dates:
Date Received: July 8, 2011
Date Started: July 2011
Date Completion:
Last Updated: May 21, 2013
Last Verified: May 2013