search
Back to results

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

Primary Purpose

Eyelash Hypotrichosis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
bimatoprost solution 0.03%
bimatoprost vehicle solution
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eyelash Hypotrichosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have inadequate eyelashes due to chemotherapy treatment
  • Treated for solid tumors such as breast or colorectal cancer in early stages where the cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast cancer)
  • Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks and all side effects related to chemotherapy are recovered, improved or maintained, with the exception of hair loss

Exclusion Criteria:

  • Any disease/infection/abnormality of the eye or area around the eye
  • Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
  • Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
  • Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
  • Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
  • Use of treatments which may affect hair growth (eg, minoxidil) within 6 months except for prior chemotherapy

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

bimatoprost solution 0.03%

bimatoprost vehicle solution

Arm Description

One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.

One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.

Outcomes

Primary Outcome Measures

Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
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.

Secondary Outcome Measures

Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
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
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
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).

Full Information

First Posted
July 8, 2011
Last Updated
April 17, 2019
Sponsor
Allergan
search

1. Study Identification

Unique Protocol Identification Number
NCT01391286
Brief Title
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis
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-induced Hypotrichosis of the Eyelashes in Japanese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2011 (Actual)
Primary Completion Date
May 25, 2012 (Actual)
Study Completion Date
May 25, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelash Hypotrichosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bimatoprost solution 0.03%
Arm Type
Experimental
Arm Description
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
Arm Title
bimatoprost vehicle solution
Arm Type
Placebo Comparator
Arm Description
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Intervention Type
Drug
Intervention Name(s)
bimatoprost solution 0.03%
Other Intervention Name(s)
LATISSE®
Intervention Description
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
Intervention Type
Drug
Intervention Name(s)
bimatoprost vehicle solution
Intervention Description
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
Description
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.
Time Frame
Baseline, Month 4
Secondary Outcome Measure Information:
Title
Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
Description
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).
Time Frame
Baseline, Month 4
Title
Change From Baseline in Eyelash Thickness as Measured by DIA
Description
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).
Time Frame
Baseline, Month 4
Title
Change From Baseline in Eyelash Darkness as Measured by DIA
Description
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).
Time Frame
Baseline, Month 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have inadequate eyelashes due to chemotherapy treatment Treated for solid tumors such as breast or colorectal cancer in early stages where the cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast cancer) Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks and all side effects related to chemotherapy are recovered, improved or maintained, with the exception of hair loss Exclusion Criteria: Any disease/infection/abnormality of the eye or area around the eye Any ocular surgery within 3 months or anticipated need for ocular surgery during the study Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products Use of treatments which may affect hair growth (eg, minoxidil) within 6 months except for prior chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Chiba
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24643895
Citation
Harii K, Arase S, Tsuboi R, Weng E, Daniels S, VanDenburgh A. Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies. Aesthetic Plast Surg. 2014 Apr;38(2):451-60. doi: 10.1007/s00266-014-0293-7. Epub 2014 Mar 19. Erratum In: Aesthetic Plast Surg. 2014 Oct;38(5):1071-2.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs