- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01391286
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis
April 17, 2019 updated by: Allergan
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chiba, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: bimatoprost solution 0.03%
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
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One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
Other Names:
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Placebo Comparator: bimatoprost vehicle solution
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
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One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline, Month 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
Time Frame: Baseline, Month 4
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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).
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Baseline, Month 4
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Change From Baseline in Eyelash Thickness as Measured by DIA
Time Frame: Baseline, Month 4
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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).
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Baseline, Month 4
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Change From Baseline in Eyelash Darkness as Measured by DIA
Time Frame: Baseline, Month 4
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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).
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Baseline, Month 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2011
Primary Completion (Actual)
May 25, 2012
Study Completion (Actual)
May 25, 2012
Study Registration Dates
First Submitted
July 8, 2011
First Submitted That Met QC Criteria
July 8, 2011
First Posted (Estimate)
July 12, 2011
Study Record Updates
Last Update Posted (Actual)
July 8, 2019
Last Update Submitted That Met QC Criteria
April 17, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 192024-067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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